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AstraZeneca

Loxicom
meloxicam


PACKAGE LEAFLET:

Loxicom 0.5 mg/ml oral suspension for dogs


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Marketing authorisation holder

    Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

    Monaghan Ireland


    Manufacturer responsible for batch release Norbrook Manufacturing Limited Rossmore Industrial Estate

    Monaghan Town Co. Monaghan H18 W620

    Ireland


    Norbrook Laboratories Limited 105 Armagh Road

    Newry

    Co. Down, BT35 6PU

    United Kingdom


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Loxicom 0.5 mg/ml oral suspension for dogs meloxicam


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    Each ml contains:


    Meloxicam 0.5 mg

    Sodium benzoate 1.5 mg


  4. INDICATION(S)


    Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.


  5. CONTRAINDICATIONS


    Do not use in pregnant or lactating animals.

    Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

    Do not use in case of hypersensitivity to the active substance or to any of the excipients.

    Do not use in dogs less than 6 weeks of age.


  6. ADVERSE REACTIONS


    Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports),

    haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

    These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.


    If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dogs.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dosage:

    Initial treatment is a single dose of 0.2 mg meloxicam/kg bodyweight (i.e. 4 ml/10 kg bodyweight) on the first day. Treatment is to be continued once daily by oral administration (at 24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg bodyweight (i.e. 2 ml/10 kg bodyweight).


    For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.


    Method and route of administration:


    Oral use.

    To be administered with food or directly into the mouth. Shake well before use.


    The suspension can be given using either of the two measuring syringes provided in the package. The syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg bodyweight). Thus for initiation of the therapy on the first day, twice the maintenance volume will be required. Alternatively therapy may be initiated with Loxicom

    5 mg/ml solution for injection.


    A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.


    Avoid introduction of contamination during use.


  9. ADVICE ON CORRECT ADMINISTRATION

    Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.


  10. WITHDRAWAL PERIOD(S)


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children.

    This veterinary medicinal product does not require any special storage conditions. Shelf-life after first opening the container: 6 months.

    Do not use after the expiry date which is stated on the carton and the bottle after EXP.


  12. SPECIAL WARNINGS


    Special precautions for use in animals


    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

    This product for dogs should not be used in cats due to the different dosing devices. In cats, Loxicom

    0.5 mg/ml oral suspension for cats should be used.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:


    People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

    In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label to the physician.


    Pregnancy and lactation:

    See section "Contraindications".


    Interaction with other medicinal products and other forms of interaction


    Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids.


    Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.


    Overdose (symptoms, emergency procedures, antidotes)


    In the case of overdose, symptomatic treatment should be initiated.

  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED



  15. OTHER INFORMATION


The veterinary medicinal product is available in polyethylene terephthalate bottle of 15 and 30 ml with two (1 ml and a 5 ml syringe, are supplied with each bottle to ensure accurate dosing of small and large dogs) polyethylene/polypropylene measuring syringes.


Not all pack sizes may be marketed.


For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:


België/Belgique/Belgien Luxembourg/Luxemburg Nederland

Fendigo sa/nv

Avenue Herrmann Debrouxlaan 17 BE 1160 BRUSSELS

Tel : +32 2 734 46 90

Fax : +32 2 734 48 99

Latvija

Magnum Veterinārija SIA

Ulbrokas 23, Rīga, LV-1021, Latvija Tel. +371 6716 0091

Fax. +371 6716 0095


Република България

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland

Lietuva

Magnum Veterinarija, UAB Martinavos g. 8, Martinavos k., LT-54463 Kauno r., Lietuva Tel. +370 688 96944

info@magnumvet.lt


Česká republika

Samohýl group a.s.

Smetanova 1058 512 51 Lomnice Nad Popelkou Česká republika

Tel: +420 481 653 111

Magyarország

Alpha-Vet Állatgyógyászati Kft.

H-8000 Székesfehérvár, Homoksor 7 Tel: 22/534-500


Danmark

ScanVet Animal Health A/S Kongevejen 66

3480 Fredensborg Danmark

Malta

Borg Cardona & Co. Ltd. ‘Eltex’ Dr. Zammit Street Balzan BZN 1434- MALTA Tel +356 21442698

Fax +356 21493082


Deutschland

Elanco Gmbh

Heinz- Lohmann- Straße 4 27472 Cuxhaven Deutschland

Email sales@borg-cardona.com

Norge Interfarm AS Dølasetta 5,

3408 Tranby


Norway

Tel +47 6758 1130

Mob +47 9057 0005


e-mail: post@interfarm.no


Eesti

AS Magnum Veterinaaria Vae 16

76 401 Laagri Harjumaa Eesti

Tel +372 650 1920

Fax +372 650 1996

Österreich

PRO ZOON Pharma GmbH A-4600 Wels


Ελλάδα

ΧΕΛΛΑΦΑΡΜ ΑΕ

1ο χλμ. Λ. Παιανίας – Μαρκοπούλου, ΤΘ 100, 19002, Παιανία

Τηλ.: +30 2106800900

E-mail: info@hellafarm.gr

Polska

ScanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9 62-200 Gniezno

Tel. 61 426 49 20


España

Laboratorios Karizoo

Pol. Ind. La Borda, Mas Pujades 11-12 08140 Caldes de Montbui

Barcelona (España)

Portugal

PRODIVET-ZN S.A

Av. Infante D. Henrique, 333-H-3º Piso, Esc.41 1800-282 LISBOA

PORTUGAL

Tel. (00351) 21 8511493


France

ALIVIRA FRANCE S.A.S.

14 Rue Scandicci Tour Essor

93500 PANTIN

France

Tél. 01 57 42 23 03

România

S.C. MARAVET S.R.L.

Str. Maravet nr.1, Baia Mare 430016, România

Tel/Fax: +40 262 211 964

e-mail: info@maravet.com www.maravet.com


Hrvatska

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan Ireland

Slovenija

GENERA SI d.o.o.

Parmova Ulica 53

1000 Ljubljana, Slovenija

Telefon: +386 1 4364466

Telefaks: +386 1 4364468 e-mail: info@generasi.si


Ireland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan,

Slovenská republika

PHARMACOPOLA s.r.o.

Svätokrížske nám. 11

SK – 965 01 Žiar nad Hronom

Ireland. Tel. +421 45 6781 400

www.pharmacopola.sk


Ísland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Italia

Vétoquinol Italia S.r.l. Via Piana, 265

47032 Bertinoro (FC)

Suomi/Finland

Vet Medic Animal Health Oy PL/PB 27,

FI-13721 Parola


Sverige

N-vet AB

Uppsala Science Park 751 83 Uppsala Sweden

+4618 57 24 30

info@n-vet.se


Κύπρος

Αποκλειστικός Διανομέας Κύπρου: Σπύρος Σταυρινίδης Κέμικαλς Λτδ

Λεωφ. Στασίνου 28, 1060 Λευκωσία, Κύπρος

Τηλ: 22 447464 / Φαξ: 22 756902

e-mail: chemicals@stavrinides.com.cy

United Kingdom

Norbrook Laboratories (GB) Ltd 1 Saxon Way East

Oakley Hay Industrial Estate Corby

Northamptonshire NN18 9EX

United Kingdom

PACKAGE LEAFLET:

Loxicom 1.5 mg/ml oral suspension for dogs


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT


    Marketing authorisation holder

    Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

    Monaghan Ireland


    Manufacturer responsible for batch release Norbrook Manufacturing Limited Rossmore Industrial Estate

    Monaghan Town Co. Monaghan H18 W620

    Ireland


    Norbrook Laboratories Limited 105 Armagh Road

    Newry

    Co. Down, BT35 6PU

    United Kingdom


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Loxicom 1.5 mg/ml oral suspension for dogs meloxicam


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    Each ml contains:


    Meloxicam 1.5 mg

    Sodium benzoate 1.5 mg Pale yellow suspension


  4. INDICATION(S)


    Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders.


  5. CONTRAINDICATIONS


    Do not use in pregnant or lactating animals.

    Do not use in dogs suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

    Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 6 weeks of age.


  6. ADVERSE REACTIONS


    Typical adverse reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports) haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported.

    These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.


    If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dogs.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dosage:

    Initial treatment is a single dose of 0.2 mg meloxicam/kg bodyweight (i.e. 1.33 ml/10 kg bodyweight) on the first day. Treatment is to be continued once daily by oral administration (at 24 hour interval) at a maintenance dose of 0.1 mg meloxicam/kg bodyweight (i.e. 0.667 ml/10 kg bodyweight).


    For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.


    Method and route of administration:


    Oral use. To be administered with food or directly into the mouth. Shake well before use.


    The suspension can be given using either of the two measuring syringes provided in the package. The syringes fit onto the bottle and have a kg-bodyweight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg bodyweight). Thus for initiation of the therapy on the first day, twice the maintenance volume will be required.


    Alternatively therapy may be initiated with Loxicom 5 mg/ml solution for injection.


    A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.


    Avoid introduction of contamination during use.


  9. ADVICE ON CORRECT ADMINISTRATION

    Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.


  10. WITHDRAWAL PERIOD(S)


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children.

    Shelf-life after first opening the container: 6 months.

    Do not use after the expiry date stated on the carton and the bottle.

    This veterinary medicinal product does not require any special storage conditions.


  12. SPECIAL WARNINGS


    Special precautions for use in animals:


    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought. Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.


    Interaction with other medicinal products and other forms of interaction:


    Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids.


    Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.


    Overdose (symptoms, emergency procedures, antidotes):


    In the case of overdose symptomatic treatment should be initiated.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:


    People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

    In case of accidental ingestion, seek medical advice immediately and show this package leaflet or the label to the physician.


    Pregnancy and lactation

    See section "Contraindications".


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, if any

    Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED



  15. OTHER INFORMATION


Polyethylene terephthalate bottle containing 10, 32, 100, 2 x 100 or 200 ml with two polyethylene/polypropylene measuring syringes. Not all pack sizes may be marketed.


For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder


België/Belgique/Belgien Luxembourg/Luxemburg Nederland

Fendigo sa/nv

Avenue Herrmann Debrouxlaan 17 BE 1160 BRUSSELS

Tel : +32 2 734 46 90

Fax : +32 2 734 48 99

Latvija

Magnum Veterinārija SIA

Ulbrokas 23, Rīga, LV-1021, Latvija Tel. +371 6716 0091

Fax. +371 6716 0095


Република България

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland

Lietuva

Magnum Veterinarija, UAB Martinavos g. 8, Martinavos k., LT-54463 Kauno r., Lietuva Tel. +370 688 96944

info@magnumvet.lt


Česká republika

Samohýl group a.s.

Smetanova 1058 512 51 Lomnice Nad Popelkou Česká republika

Tel: +420 481 653 111

Magyarország

Alpha-Vet Állatgyógyászati Kft.

H-8000 Székesfehérvár, Homoksor 7 Tel: 22/534-500


Danmark

ScanVet Animal Health A/S Kongevejen 66

3480 Fredensborg Danmark

Malta

Borg Cardona & Co. Ltd. ‘Eltex’ Dr. Zammit Street Balzan BZN 1434- MALTA Tel +356 21442698

Fax +356 21493082

Email sales@borg-cardona.com

DeutschlandElanco GbmH Heinz-Lohmann--Straße 4

27472 Cuxhaven Deutschland

Norge Interfarm AS Dølasetta 5,

3408 Tranby


Norway

Tel +47 6758 1130

Mob +47 9057 0005


e-mail: post@interfarm.no


Eesti

AS Magnum Veterinaaria Vae 16

76 401 Laagri Harjumaa Eesti

Tel +372 650 1920

Fax +372 650 1996

Österreich

PRO ZOON Pharma GmbH A-4600 Wels


Ελλάδα

ΧΕΛΛΑΦΑΡΜ ΑΕ

1ο χλμ. Λ. Παιανίας – Μαρκοπούλου, ΤΘ 100, 19002, Παιανία

Τηλ.: +30 2106800900

E-mail: info@hellafarm.gr

Polska

ScanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9 62-200 Gniezno

Tel. 61 426 49 20


España

Laboratorios Karizoo

Pol. Ind. La Borda, Mas Pujades 11-12 08140 Caldes de Montbui

Barcelona (España)

Portugal

PRODIVET-ZN S.A

Av. Infante D. Henrique, 333-H-3º Piso, Esc.41 1800-282 LISBOA

PORTUGAL

Tel. (00351) 21 8511493


France

ALIVIRA FRANCE S.A.S.

14 Rue Scandicci Tour Essor

93500 PANTIN

France

Tél. 01 57 42 23 03

România

S.C. MARAVET S.R.L.

Str. Maravet nr.1, Baia Mare 430016, România

Tel/Fax: +40 262 211 964

e-mail: info@maravet.com www.maravet.com


Hrvatska

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan Ireland

Slovenija

GENERA SI d.o.o.

Parmova Ulica 53

1000 Ljubljana, Slovenija

Telefon: +386 1 4364466

Telefaks: +386 1 4364468 e-mail: info@generasi.si


Ireland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan,

Slovenská republika

PHARMACOPOLA s.r.o.

Svätokrížske nám. 11

SK – 965 01 Žiar nad Hronom

Ireland Tel. +421 45 6781 400

www.pharmacopola.sk


Ísland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Italia

Vétoquinol Italia S.r.l. Via Piana, 265

47032 Bertinoro (FC)

Suomi/Finland

Vet Medic Animal Health Oy PL/PB 27,

FI-13721 Parola


Sverige

N-vet AB

Uppsala Science Park 751 83 Uppsala Sweden

+4618 57 24 30

info@n-vet.se


Κύπρος

Αποκλειστικός Διανομέας Κύπρου: Σπύρος Σταυρινίδης Κέμικαλς Λτδ

Λεωφ. Στασίνου 28, 1060 Λευκωσία, Κύπρος

Τηλ: 22 447464 / Φαξ: 22 756902

e-mail: chemicals@stavrinides.com.cy

United Kingdom

Norbrook Laboratories (GB) Ltd 1 Saxon Way East

Oakley Hay Industrial Estate Corby

Northamptonshire NN18 9EX

United Kingdom

PACKAGE LEAFLET:

Loxicom 5 mg/ml solution for injection for dogs and cats


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT


    Marketing authorisation holder

    Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

    Monaghan Ireland


    Manufacturer responsible for batch release Norbrook Manufacturing Limited Rossmore Industrial Estate

    Monaghan Town Co. Monaghan H18 W620

    Ireland


    Norbrook Laboratories Limited 105 Armagh Road

    Newry

    Co. Down, BT35 6PU

    United Kingdom


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Loxicom 5 mg/ml solution for injection for dogs and cats meloxicam


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    Each ml contains:


    Meloxicam 5 mg

    Ethanol, anhydrous 150 mg Pale yellow solution


  4. INDICATION(S)


    Dogs:

    Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.


    Cats:

    Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.

  5. CONTRAINDICATIONS


    Do not use in pregnant or lactating animals.

    Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

    Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.


  6. ADVERSE REACTIONS


    Typical adverse reactions of non-steroidal anti-inflammatory drugs NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have been reported.


    In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports), haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported.


    These adverse reactions occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.


    In very rare cases anaphylactoid reactions may occur and should be treated symptomatically.


    If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dogs and cats.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dosage for each species:

    Dogs:

    Single administration of 0.2 mg meloxicam/kg bodyweight (i.e. 0.4 ml/10 kg).


    Cats:

    Single administration of 0.3 mg meloxicam/kg bodyweight (i.e. 0.06 ml/kg) where no oral follow-up treatment is possible e.g. feral cats.

    Single administration of 0.2 mg meloxicam/kg bodyweight (i.e. 0.04 ml/kg) when administration of meloxicam is to be continued as an oral follow-up therapy


    Method and route of administration:


    Dogs:

    Musculo-skeletal disorders: single subcutaneous injection.

    Loxicom 1.5 mg/ml oral suspension or Loxicom 0.5 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg bodyweight, 24 hours after administration of the injection.

    Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.

    Cats:

    Reduction of post-operative pain in cats where no oral follow-up treatment is possible e.g. feral cats: Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg bodyweight (i.e. 0.06 ml/kg bodyweight) before surgery, for example at the time of induction of anaesthesia. In this case do not use oral follow up treatment.


    Reduction of post-operative pain in cats when administration of meloxicam is to be continued as an oral follow-up therapy:

    Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.04 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.

    To continue treatment for up to five days, this initial dose may be followed 24 hours later by administration of Loxicom 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.


    Avoid introduction of contamination during use.


  9. ADVICE ON CORRECT ADMINISTRATION


    Particular care should be taken with regard to the accuracy of dosing.


    A suitably graduated 1 ml syringe should be used for administration of the product to cats.


  10. WITHDRAWAL PERIOD(S)


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children.

    This veterinary medicinal product does not require any special storage conditions. Shelf-life after first opening the container: 28 days.

    Do not use after the expiry date stated on the carton and the bottle.


  12. SPECIAL WARNING(S)


    For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.


    Special precautions for use in animals:

    If adverse effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.

    Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

    During anaesthesia, monitoring and fluid therapy should be considered as standard practice.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:

    Accidental self-injection may give rise to pain. People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

    In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.


    Pregnancy and lactation:

    See section "Contraindications".


    Interaction with other medicinal products and other forms of interaction:

    Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.

    Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the products used previously.


    Overdose (symptoms, emergency procedures, antidotes):

    In the case of overdose symptomatic treatment should be initiated.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, if any


    Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED



  15. OTHER INFORMATION


10 ml, 20 ml or 100 ml injection vial. Not all pack sizes may be marketed.


For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder


België/Belgique/Belgien Luxembourg/Luxemburg Nederland

Fendigo sa/nv

Avenue Herrmann Debrouxlaan 17 BE 1160 BRUSSELS

Tel : +32 2 734 46 90

Fax : +32 2 734 48 99

Latvija

Magnum Veterinārija SIA

Ulbrokas 23, Rīga, LV-1021, Latvija Tel. +371 6716 0091

Fax. +371 6716 0095

Република България

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan Ireland

Lietuva

Magnum Veterinarija, UAB Martinavos g. 8, Martinavos k., LT-54463 Kauno r., Lietuva Tel. +370 688 96944

info@magnumvet.lt


Česká republika

Samohýl group a.s.

Smetanova 1058 512 51 Lomnice Nad Popelkou CZECH REP.

Tel: +420 481 65 31

Magyarország

Alpha-Vet Állatgyógyászati Kft.

H-8000 Székesfehérvár, Homoksor 7 Tel: 22/534-500


Danmark

ScanVet Animal Health A/S Kongevejen 66

3480 Fredensborg Danmark

Malta

Borg Cardona & Co. Ltd. ‘Eltex’ Dr. Zammit Street Balzan BZN 1434- MALTA Tel +356 21442698

Fax +356 21493082

Email sales@borg-cardona.com


Deutschland

Elanco GmbH

Heinz-Lohmann Straße 4

27472 Cuxhaven Deutschland

Norge Interfarm AS Dølasetta 5,

3408 Tranby


Norway

Tel +47 6758 1130

Mob +47 9057 0005


e-mail: post@interfarm.no


Eesti

AS Magnum Veterinaaria Vae 16

76 401 Laagri Harjumaa Eesti

Tel +372 650 1920

Fax +372 650 1996

Österreich

PRO ZOON Pharma GmbH A-4600 Wels


Ελλάδα

ΧΕΛΛΑΦΑΡΜ ΑΕ

1ο χλμ. Λ. Παιανίας – Μαρκοπούλου, ΤΘ 100, 19002, Παιανία

Τηλ.: +30 2106800900

E-mail: info@hellafarm.gr

Polska

ScanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9 62-200 Gniezno

Tel. 61 426 49 20


España

Laboratorios Karizoo

Pol. Ind. La Borda, Mas Pujades 11-12 08140 Caldes de Montbui

Barcelona (España)

Portugal

PRODIVET-ZN S.A

Av. Infante D. Henrique, 333-H-3º Piso, Esc.41 1800-282 LISBOA

PORTUGAL

Tel. (00351) 21 8511493

France

ALIVIRA FRANCE S.A.S.

14 Rue Scandicci Tour Essor

93500 PANTIN

France

él. 01 57 42 23 03F

România

S.C. MARAVET S.R.L.

Str. Maravet nr.1, Baia Mare 430016, România

Tel/Fax: +40 262 211 964

e-mail: info@maravet.com www.maravet.com


Hrvatska

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan Ireland

Slovenija

GENERA SI d.o.o.

Parmova Ulica 53

1000 Ljubljana, Slovenija

Telefon: +386 1 4364466

Telefaks: +386 1 4364468 e-mail: info@generasi.si


Ireland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland

Slovenská republika

PHARMACOPOLA s.r.o.

Svätokrížske nám. 11

SK – 965 01 Žiar nad Hronom Tel. +421 45 6781 400

www.pharmacopola.sk


Ísland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Italia

Vétoquinol Italia S.r.l. Via Piana, 265

47032 Bertinoro (FC)

Suomi/Finland

Vet Medic Animal Health Oy PL/PB 27,

FI-13721 Parola


Sverige

N-vet AB

Uppsala Science Park 751 83 Uppsala Sweden

+4618 57 24 30

info@n-vet.se


Κύπρος

Αποκλειστικός Διανομέας Κύπρου: Σπύρος Σταυρινίδης Κέμικαλς Λτδ

Λεωφ. Στασίνου 28, 1060 Λευκωσία, Κύπρος

Τηλ: 22 447464 / Φαξ: 22 756902

e-mail: chemicals@stavrinides.com.cy

United Kingdom

Norbrook Laboratories (GB) Ltd 1 Saxon Way East

Oakley Hay Industrial Estate Corby

Northamptonshire NN18 9EX

United Kingdom

Loxicom 0.5 mg/ml oral suspension for cats


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Marketing authorisation holder

    Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

    Monaghan Ireland


    Manufacturer responsible for batch release Norbrook Manufacturing Limited Rossmore Industrial Estate

    Monaghan Town Co. Monaghan H18 W620

    Ireland


    Norbrook Laboratories Limited 105 Armagh Road

    Newry

    Co. Down, BT35 6PU

    United Kingdom


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Loxicom 0.5 mg/ml oral suspension for cats. meloxicam


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    Each ml contains

    Active Substance:

    Meloxicam 0.5 mg


    Excipient:

    Sodium benzoate 1.5 mg


    Pale yellow suspension.


  4. INDICATION(S)


    Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

    Alleviates inflammation and pain in acute and chronic musculo-skeletal disorders in cats.


  5. CONTRAINDICATIONS

    Do not use in pregnant or lactating animals.

    Do not use in cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

    Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in cats less than 6 weeks old.


  6. ADVERSE REACTIONS


    Typical adverse drug reactions of NSAIDS such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports) gastrointestinal ulceration and elevated liver enzymes have been reported.

    These side effects are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.


    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.


    If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Cats.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION


    Dosage

    Post-operative pain and inflammation following surgical procedures:

    After initial treatment with Loxicom 5 mg/ml Solution for Injection for Dogs and Cats continue treatment 24 hours later with Loxicom 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.


    Acute musculo-skeletal disorders:

    Initial treatment is a single oral dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a dose of 0.05 mg meloxicam/kg body weight for as long as acute pain and inflammation persist.


    Chronic musculo-skeletal disorders:

    Initial treatment is a single oral dose of 0.1 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24 hour intervals) at a maintenance dose of

    0.05 mg meloxicam/kg body weight.

    A clinical response is normally seen within 7 days. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.


    Route and method of administration

    The recommended dose should not be exceeded. Loxicom 0.5 mg/ml Oral Suspension for Cats is to be administered orally either mixed with food or directly into the mouth. The suspension is given

    using the Loxicom measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose. Thus for initiation of the treatment of chronic musculo-skeletal disorders on the first day, twice the maintenance volume will be

    required. For initiation of the treatment of acute musculo-skeletal disorders on the first day, 4 times the maintenance volume will be required.


  9. ADVICE ON CORRECT ADMINISTRATION


    Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels. To ensure administration of a correct dose, body weight should be determined as accurately as possible.

    Please carefully follow the instructions of the veterinarian. Shake well before use.

    Avoid introduction of contamination during use.


  10. WITHDRAWAL PERIOD(S)


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children.

    This veterinary medicinal product does not require any special storage conditions. Shelf life after first opening the container: 6 months

    Do not use after the expiry date stated on the carton and the bottle after EXP.


  12. SPECIAL WARNINGS


    Special precautions for use in animals:


    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

    Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.


    Post-operative pain and inflammation following surgical procedures:

    In case additional pain relief is required, multimodal pain therapy should be considered.


    Chronic musculoskeletal disorders:

    Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon. Treatment should be discontinued after 14 days at the latest if no clinical improvement is apparent.

    Special precautions to be taken by the person administering the veterinary medicinal product to animals:


    People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

    In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.


    Pregnancy and lactation

    See section "Contraindications".

    Interaction with other medicinal products and other forms of interaction:


    Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided.

    Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment with Loxicom. The treatment free period, however, should take into account the pharmacological properties of the products used previously.


    Overdose (symptoms, emergency procedures, antidotes):

    Meloxicam has a narrow therapeutic safety margin in cats and clinical signs of overdose may be seen at relatively small overdose levels.

    In case of overdose, adverse reactions, as listed in section "Adverse reactions", are expected to be more severe and more frequent. In case of overdose symptomatic treatment should be initiated.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED



  15. OTHER INFORMATION Mode of Action

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).


Pack size


Loxicom 0.5 mg/ml Oral Suspension for Cats is available in bottle of 5 ml, 15 ml and 30 ml volumes. Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.


België/Belgique/Belgien Luxembourg/Luxemburg

Latvija

Nederland

Fendigo sa/nv

Avenue Herrmann Debrouxlaan 17 BE 1160 BRUSSELS

Tel : +32 2 734 46 90

Fax : +32 2 734 48 99

Magnum Veterinārija SIA

Ulbrokas 23, Rīga, LV-1021, Latvija Tel. +371 6716 0091

Fax. +371 6716 0095


Република България

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland

Lietuva

Magnum Veterinarija, UAB Martinavos g. 8, Martinavos k., LT-54463 Kauno r., Lietuva Tel. +370 688 96944

info@magnumvet.lt


Česká republika

Samohýl group a.s.

Smetanova 1058 512 51 Lomnice Nad Popelkou Česká republika

Tel: +420 481 653 111

Magyarország

Alpha-Vet Állatgyógyászati Kft.

H-8000 Székesfehérvár, Homoksor 7 Tel: 22/534-500


Danmark

ScanVet Animal Health A/S Kongevejen 66

3480 Fredensborg Danmark

Malta

Borg Cardona & Co. Ltd. ‘Eltex’ Dr. Zammit Street Balzan BZN 1434- MALTA Tel +356 21442698

Fax +356 21493082

Email sales@borg-cardona.com


Deutschland


Elanco GmbH

Heinz-Lohmann- Straße 4

27472 Cuxhaven Deutschland

Norge Interfarm AS Dølasetta 5,

3408 Tranby


Norway

Tel +47 6758 1130

Mob +47 9057 0005


e-mail: post@interfarm.no


Eesti

AS Magnum Veterinaaria Vae 16

76 401 Laagri Harjumaa Eesti

Tel +372 650 1920

Fax +372 650 1996

Österreich

PRO ZOON Pharma GmbH A-4600 Wels


Ελλάδα

ΧΕΛΛΑΦΑΡΜ ΑΕ

1ο χλμ. Λ. Παιανίας – Μαρκοπούλου, ΤΘ 100, 19002, Παιανία

Τηλ.: +30 2106800900

E-mail: info@hellafarm.gr

Polska

ScanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9 62-200 Gniezno

Tel. 61 426 49 20


España

Laboratorios Karizoo

Pol. Ind. La Borda, Mas Pujades 11-12 08140 Caldes de Montbui

Barcelona (España)

Portugal

PRODIVET-ZN S.A

Av. Infante D. Henrique, 333-H-3º Piso, Esc.41 1800-282 LISBOA

PORTUGAL

Tel. (00351) 21 8511493


France

ALIVIRA FRANCE S.A.S.

14 Rue Scandicci Tour Essor

93500 PANTIN

France

Tél. 01 57 42 23 03

România

S.C. MARAVET S.R.L.

Str. Maravet nr.1, Baia Mare 430016, România

Tel/Fax: +40 262 211 964

e-mail: info@maravet.com www.maravet.com


Hrvatska

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan Ireland

Slovenija

GENERA SI d.o.o.

Parmova Ulica 53

1000 Ljubljana, Slovenija

Telefon: +386 1 4364466

Telefaks: +386 1 4364468 e-mail: info@generasi.si


Ireland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland

Slovenská republika

PHARMACOPOLA s.r.o.

Svätokrížske nám. 11

SK – 965 01 Žiar nad Hronom Tel. +421 45 6781 400

www.pharmacopola.sk


Ísland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Italia

Vétoquinol Italia S.r.l. Via Piana, 265

47032 Bertinoro (FC)


Κύπρος

Αποκλειστικός Διανομέας Κύπρου: Σπύρος Σταυρινίδης Κέμικαλς Λτδ

Λεωφ. Στασίνου 28, 1060 Λευκωσία, Κύπρος

Τηλ: 22 447464 / Φαξ: 22 756902

e-mail: chemicals@stavrinides.com.cy

Suomi/Finland

Vet Medic Animal Health Oy PL/PB 27,

FI-13721 Parola


Sverige

N-vet AB

Uppsala Science Park 751 83 Uppsala Sweden

+4618 57 24 30

info@n-vet.se

United Kingdom

Norbrook Laboratories (GB) Ltd 1 Saxon Way East

Oakley Hay Industrial Estate Corby

Northamptonshire NN18 9EX

United Kingdom

PACKAGE LEAFLET:

Loxicom 20 mg/ml solution for injection for cattle, pigs and horses


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IN THE EEA, IF DIFFERENT


    Marketing authorisation holder: Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

    Monaghan Ireland


    Manufacturer responsible for batch release: Norbrook Manufacturing Limited Rossmore Industrial Estate

    Monaghan Town Co. Monaghan H18 W620

    Ireland


    Norbrook Laboratories Limited 105 Armagh Road

    Newry

    Co. Down, BT35 6PU

    United Kingdom


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Loxicom 20 mg/ml solution for injection for cattle, pigs and horses meloxicam


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    One ml contains: Meloxicam 20 mg

    Ethanol 150mg A yellow solution.


  4. INDICATIONS


    Cattle:

    For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.

    For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.

    For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy. For the relief of post-operative pain following dehorning in calves.

    Pigs:

    For use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis- agalactia syndrome) with appropriate antibiotic therapy.


    Horses:

    For use in the alleviation of inflammation and relief of pain in both acute and chronic musculo- skeletal disorders.

    For the relief of pain associated with equine colic.


  5. CONTRAINDICATIONS


    Do not use in horses less than 6 weeks of age. Do not use in pregnant or lactating mares.

    Do not use in animals suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions.

    Do not use in case of hypersensitivity to the active substance or to any of the excipients. For the treatment of diarrhoea in cattle, do not use in animals of less than one week of age.


  6. ADVERSE REACTIONS


    Administration of the product by the subcutaneous route in cattle and the intramuscular route in pigs is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in cattle treated in clinical studies.

    In horses, transient swellings at the injection site can occur but resolves without intervention. In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports),

    anaphylactoid reactions which may be serious (including fatal), may occur and should be treated symptomatically.


    If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Cattle, pigs and horses.


  8. DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION


    Cattle:

    Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e.,

    2.5 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate. The recommended maximum volume to be administered at a single injection site is 10 ml.


    Pigs:

    Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e., 2.0 ml/100 kg body weight) in combination with antibiotic therapy, as appropriate. If required, a second administration of meloxicam can be given after 24 hours. The recommended maximum volume to be administered at a single injection site is 2 ml.

    Horses:

    Single intravenous injection as a dosage of 0.6 mg meloxicam/kg body weight (i.e., 3.0 ml/100 kg body weight).


    For use in the alleviation of inflammation and the relief of pain in both acute and chronic musculoskeletal disorders, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment.


    Do not exceed 50 broachings per vial. If more than 50 broachings are required, the use of a draw-off needle is recommended.


  9. ADVICE ON CORRECT ADMINISTRATION


    Avoid introduction of contamination during use.


  10. WITHDRAWAL PERIOD(S)


    Cattle:

    Meat and offal:

    15 days

    Milk: 5 days

    Pigs:

    Meat and offal:

    5 days

    Horses:

    Meat and offal:

    5 days.

    Not authorised for use in horses producing milk for human consumption.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children.

    This veterinary medicinal product does not require any special storage conditions. Shelf life after first broaching the glass vial: 28 days.

    Do not use after the expiry date (EXP) stated on the carton and vial after EXP.


  12. SPECIAL WARNINGS


    Treatment of calves with Loxicom 20 minutes before dehorning reduces post-operative pain. Loxicom alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.


    Special precautions for use in animals:

    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

    Avoid use in very severely dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.

    In case of inadequate relief of pain when used in the treatment of equine colic, careful re-evaluation of the diagnosis should be made as this could indicate the need for surgical intervention.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:

    Accidental self-injection may give rise to pain. People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

    In case of accidental self-injection, seek medical advice immediately and show this package leaflet or the label to the physician.

    Use during pregnancy and lactation:

    Cattle and pigs: Can be used during pregnancy and lactation. Horses: See section "Contraindications".


    Interaction with other medicinal products and other forms of interaction:

    Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.


    Overdose (symptoms, emergency procedures, antidotes):

    In the case of overdose, symptomatic treatment should be initiated.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Any unused medicines or waste materials should not be disposed of via wastewater or household waste but in accordance with local requirements. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED



  15. OTHER INFORMATION


Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 30, 50 or 100 ml. Cardboard box with 1, 6 or 12 colourless glass injection vial(s) each containing 250 ml.

Not all pack sizes may be marketed


Each vial is closed with a bromobutyl bung and sealed with an aluminium cap.


For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder


België/Belgique/Belgien Luxembourg/Luxemburg Nederland

Fendigo sa/nv

Avenue Herrmann Debrouxlaan 17 BE 1160 BRUSSELS

Tel : +32 2 734 46 90

Fax : +32 2 734 48 99

Latvija

Magnum Veterinārija SIA

Ulbrokas 23, Rīga, LV-1021, Latvija Tel. +371 6716 0091

Fax. +371 6716 0095


Република България

АСКЛЕП - ФАРМА ООД

гр. София, ж.к. Люлин - 7, бл. 711А, магазин 3

Република България

Lietuva

Magnum Veterinarija, UAB Martinavos g. 8, Martinavos k., LT-54463 Kauno r., Lietuva Tel. +370 688 96944

info@magnumvet.lt

Česká republika

Samohýl group a.s.

Smetanova 1058 512 51 Lomnice Nad Popelkou CZECH REP.

Tel: +420 481 65 31

Magyarország

Alpha-Vet Állatgyógyászati Kft.

H-8000 Székesfehérvár, Homoksor 7 Tel: 22/534-500


Danmark

ScanVet Animal Health A/S Kongevejen 66

3480 Fredensborg

Malta

Borg Cardona & Co. Ltd. ‘Eltex’ Dr. Zammit Street Balzan BZN 1434- MALTA Tel +356 21442698

Fax +356 21493082

Email sales@borg-cardona.com


Deutschland

Elanco GmbH

Heinz-Lohmann--Straße 4

27472 Cuxhaven Deutschland

Norge

Dansk Repræsentant ScanVet Animal Health A/S Kongevejen 66

DK-3480 Fredensborg Phone: +45 4848 4317

E-mail: QA@scanvet.dk


Eesti

AS Magnum Veterinaaria Vae 16

76 401 Laagri Harjumaa Eesti

Tel +372 650 1920

Fax +372 650 1996

Österreich

PRO ZOON Pharma GmbH A-4600 Wels


Ελλάδα

ΧΕΛΛΑΦΑΡΜ ΑΕ

1ο χλμ. Λ. Παιανίας – Μαρκοπούλου, ΤΘ 100, 19002, Παιανία

Τηλ.: +30 2106800900

E-mail: info@hellafarm.gr

Polska

ScanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9 62-200 Gniezno

Tel. 61 426 49 20


España

Laboratorios Karizoo

Pol. Ind. La Borda, Mas Pujades 11-12 08140 Caldes de Montbui

Barcelona (España)

Portugal

PRODIVET-ZN S.A

Av. Infante D. Henrique, 333-H-3º Piso, Esc.41 1800-282 LISBOA

PORTUGAL

Tel. (00351) 21 8511493


France

Biotopis

Le Conquérant

100 avenue Guillaume Le Conquérant 14100 LISIEUX

France


Hrvatska

Norbrook Laboratories (Ireland) Limited

România

S.C. MARAVET S.R.L.

Str. Maravet nr.1, Baia Mare 430016, România

Tel/Fax: +40 262 211 964

e-mail: info@maravet.com www.maravet.com Slovenija

GENERA SI d.o.o.

Rossmore Industrial Estate Monaghan

Ireland

Parmova Ulica 53

1000 Ljubljana, Slovenija

Telefon: +386 1 4364466

Telefaks: +386 1 4364468 e-mail: info@generasi.si


Ireland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland

Slovenská republika

PHARMACOPOLA s.r.o.

Svätokrížske nám. 11

SK – 965 01 Žiar nad Hronom Tel. +421 45 6781 400

www.pharmacopola.sk


Ísland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland Italia

Elanco Italia S.p.A. Via Colatori 12

50019 Sesto Fiorentino (FI)

Suomi/Finland

Vet Medic Animal Health Oy PL/PB 27,

FI-13721 Parola


Sverige

N-vet AB

Uppsala Science Park 751 83 Uppsala Sweden

+4618 57 24 30

info@n-vet.se


Κύπρος

Αποκλειστικός Διανομέας Κύπρου: Σπύρος Σταυρινίδης Κέμικαλς Λτδ

Λεωφ. Στασίνου 28, 1060 Λευκωσία, Κύπρος

Τηλ: 22 447464 / Φαξ: 22 756902

e-mail: chemicals@stavrinides.com.cy

United Kingdom

Norbrook Laboratories (GB) Ltd 1 Saxon Way East

Oakley Hay Industrial Estate Corby

Northamptonshire NN18 9EX

United Kingdom

PACKAGE LEAFLET

Loxicom 1 mg chewable tablets for dogs Loxicom 2.5 mg chewable tablets for dogs


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Marketing authorisation holder: Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

    Monaghan Ireland


    Manufacturer responsible for batch release: Norbrook Manufacturing Limited Rossmore Industrial Estate

    Monaghan Town Co. Monaghan H18 W620

    Ireland


    Norbrook Laboratories Limited 105 Armagh Road,

    Newry, Co. Down, BT35 6PU

    United Kingdom


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Loxicom 1 mg chewable tablets for dogs. Loxicom 2.5 mg chewable tablets for dogs. meloxicam


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    One chewable tablet contains: Meloxicam 1 mg

    Meloxicam 2.5 mg


    Light brown oval biconvex tablet with a score line on one face and plain on the other. The tablet can be divided into equal halves.


  4. INDICATION(S)


    Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.


  5. CONTRAINDICATIONS

    Do not use in pregnant or lactating animals.

    Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

    Do not use in dogs less than 6 weeks of age or less than 4 kg body weight.

    Do not use in case of hypersensitivity to the active substance or to any of the excipients.


  6. ADVERSE REACTIONS


    Typical adverse drug reactions of non-steroidal anti-inflammatory drugs (NSAIDs) such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports), haemorrhagic diarrhoea, haematemesis, gastrointestinal ulceration and elevated liver enzymes have been reported. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.


    If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dogs.


  8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION


    Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day, which can be given orally or alternatively using meloxicam 5 mg/ml solution for injection for dogs and cats.

    Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight. Alternatively, therapy may be initiated with a solution for injection containing 5 mg meloxicam/ml.

    Each chewable tablet contains either 1 mg or 2.5 mg meloxicam, which corresponds to the daily maintenance dose for a 10 kg body weight dog or a 25 kg body weight dog, respectively.

    Each chewable tablet can be halved for accurate dosing according to the individual body weight of the animal. The veterinary medicinal product can be administered with or without food, are flavoured and are taken by most dogs voluntarily.


    Dose scheme for the maintenance dose:


    Body weight (kg)

    Number of chewable tablets

    1 mg

    Number of chewable tablets

    2.5 mg

    mg/kg

    4.0-7.0

    ½

    0.13-0.1

    7.1-10.0

    1

    0.14-0.1

    10.1-15.0

    0.15-0.1

    15.1-20.0

    2

    0.13-0.1

    20.1-25.0

    1

    0.12-0.1

    25.1-35.0

    0.15-0.1

    35.1-50.0

    2

    0.14-0.1

    The use of a meloxicam containing oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of meloxicam containing oral suspension for dogs is recommended.

    A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days if no clinical improvement is apparent.


  9. ADVICE ON CORRECT ADMINISTRATION


    To ensure correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing or overdosing.


  10. WITHDRAWAL PERIOD(S)


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS

    Keep out of the sight and reach of children. Do not store above 25°C.

    Store in the original package in order to protect from light.

    Shelf-life of the halved tablet: 24-hours


    Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the blister after EXP.


  12. SPECIAL WARNINGS


    Special precautions for use in animals:

    If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

    Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of renal toxicity.

    This veterinary medicinal product for dogs should not be used in cats as it is not suitable for use in this species. In cats, a meloxicam containing oral suspension authorised for that species should be used.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:

    People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

    In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.


    Pregnancy and lactation:

    See section "Contraindications".


    Interaction with other medicinal products and other forms of interaction:

    Other non-steroidal anti-inflammatory drugs (NSAIDs), diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Loxicom must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

    Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.


    Overdose (symptoms, emergency procedures, antidotes):

    In case of overdose symptomatic treatment should be initiated.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Any unused medicines or waste materials should not be disposed of via wastewater or household waste but in accordance with local requirements. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED



  15. OTHER INFORMATION


Blister packs of 10 tablets per strip in cartons containing 10, 20, 100 or 500 tablets. Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder


België/Belgique/Belgien Luxembourg/Luxemburg Nederland

Fendigo sa/nv

Avenue Herrmann Debrouxlaan 17 BE 1160 BRUSSELS

Tel : +32 2 734 46 90

Fax : +32 2 734 48 99

Latvija

Magnum Veterinārija SIA

Ulbrokas 23, Rīga, LV-1021, Latvija Tel. +371 6716 0091

Fax. +371 6716 0095


Република България

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland

Lietuva

Magnum Veterinarija, UAB Martinavos g. 8, Martinavos k., LT-54463 Kauno r., Lietuva Tel. +370 688 96944

info@magnumvet.lt


Česká republika

Samohýl group a.s.

Smetanova 1058 512 51 Lomnice Nad Popelkou CZECH REP.

Tel: +420 481 65 31

Magyarország

Alpha-Vet Állatgyógyászati Kft.

H-8000 Székesfehérvár, Homoksor 7 Tel: 22/534-500

Danmark

ScanVet Animal Health A/S Kongevejen 66

3480 Fredensborg Danmark

Malta

Borg Cardona & Co. Ltd. ‘Eltex’ Dr. Zammit Street Balzan BZN 1434- MALTA Tel +356 21442698

Fax +356 21493082

Email sales@borg-cardona.com


Deutschland

Elaco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven Deutschland

Norge Interfarm AS Dølasetta 5,

3408 Tranby


Norway

Tel +47 6758 1130

Mob +47 9057 0005


e-mail: post@interfarm.no


Eesti

AS Magnum Veterinaaria Vae 16

76 401 Laagri Harjumaa Eesti

Tel +372 650 1920

Fax +372 650 1996

Österreich

PRO ZOON Pharma GmbH A-4600 Wels


Ελλάδα

ΧΕΛΛΑΦΑΡΜ ΑΕ

1ο χλμ. Λ. Παιανίας – Μαρκοπούλου, ΤΘ 100, 19002, Παιανία

Τηλ.: +30 2106800900

E-mail: info@hellafarm.gr

Polska

ScanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9 62-200 Gniezno

Tel. 61 426 49 20


España

Laboratorios Karizoo

Pol. Ind. La Borda, Mas Pujades 11-12 08140 Caldes de Montbui

Barcelona (España)

Portugal

PRODIVET-ZN S.A

Av. Infante D. Henrique, 333-H-3º Piso, Esc.41 1800-282 LISBOA

PORTUGAL

Tel. (00351) 21 8511493


France

ALIVIRA FRANCE S.A.S.

14 Rue Scandicci Tour Essor

93500 PANTIN

France

Tél. 01 57 42 23 03

România

S.C. MARAVET S.R.L.

Str. Maravet nr.1, Baia Mare 430016, România

Tel/Fax: +40 262 211 964

e-mail: info@maravet.com www.maravet.com


Hrvatska

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Slovenija

GENERA SI d.o.o.

Parmova Ulica 53

1000 Ljubljana, Slovenija

Telefon: +386 1 4364466

Telefaks: +386 1 4364468 e-mail: info@generasi.si


Ireland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Slovenská republika

PHARMACOPOLA s.r.o.

Svätokrížske nám. 11

SK – 965 01 Žiar nad Hronom Tel. +421 45 6781 400

www.pharmacopola.sk


Ísland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Italia

Vétoquinol Italia S.r.l. Via Piana, 265

47032 Bertinoro (FC)

Suomi/Finland

Vet Medic Animal Health Oy PL/PB 27,

FI-13721 Parola


Sverige

N-vet AB

Uppsala Science Park 751 83 Uppsala Sweden

+4618 57 24 30

info@n-vet.se


Κύπρος

Αποκλειστικός Διανομέας Κύπρου: Σπύρος Σταυρινίδης Κέμικαλς Λτδ

Λεωφ. Στασίνου 28, 1060 Λευκωσία, Κύπρος

Τηλ: 22 447464 / Φαξ: 22 756902

e-mail: chemicals@stavrinides.com.cy

United Kingdom

Norbrook Laboratories (GB) Ltd 1 Saxon Way East

Oakley Hay Industrial Estate Corby

Northamptonshire NN18 9EX

United Kingdom

PACKAGE LEAFLET:

Loxicom 50 mg/g oral paste for horses


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Marketing authorisation holder: Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

    Monaghan Ireland


    Manufacturer responsible for batch release: Norbrook Manufacturing Limited Rossmore Industrial Estate

    Monaghan Town Co. Monaghan H18 W620

    Ireland


    Norbrook Laboratories Limited 105 Armagh Road

    Newry

    Co. Down, BT35 6PU

    United Kingdom


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Loxicom 50 mg/g oral paste for horses meloxicam


  3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS


    One gram contains:


    Active substance:


    Meloxicam 50 mg


    Excipient:


    Benzyl Alcohol 10 mg


    A pale yellow homogenous paste.


  4. INDICATION(S)


    Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.

  5. CONTRAINDICATIONS


    Do not use in pregnant or lactating mares.

    Do not use in horses suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

    Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in horses less than 6 weeks of age.


  6. ADVERSE REACTIONS


    Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. Commonly, a reduction in blood albumin concentration will occur during the period of treatment (up to 14 days). In very rare cases (less than 1 animal in 10,000 animals treated, including isolated reports) loss of appetite, lethargy, abdominal pain and colitis have been reported. In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically. If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.


    If you notice any side effects, even those not already listed in this package leaflet, or you think that the medicine has not worked please inform your veterinary surgeon.


  7. TARGET SPECIES


    Horses.


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION


    Administer 0.6 mg/kg body weight, once daily for up to 14 days.

    To be administered directly into the mouth over the back of the tongue keeping the animal’s head raised until swallowed.


    One syringe division of paste should be administered per 50 kg bodyweight. The syringe has an integrated adapter and has a kg/body weight graduation.

    Each syringe delivers 420 mg meloxicam, sufficient to treat 700 kg of bodyweight.


  9. ADVICE ON CORRECT ADMINISTRATION


    Avoid introduction of contamination during use.


  10. WITHDRAWAL PERIOD(S)


    Meat and offal: 3 days.

    Not authorised for use in animals producing milk for human consumption.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the sight and reach of children. Store below 30ºC

    Do not use after the expiry date (EXP) stated on the carton and syringe. Shelf life after first opening the immediate packaging: 28 days


  12. SPECIAL WARNING(S)


    Special precautions for use in animals:

    Avoid use in any dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of renal toxicity.

    Do not exceed the recommended dose or duration of treatment due to the possibility of severe adverse reactions.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals:

    People with known hypersensitivity to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

    Avoid skin and eye contact with the product. If skin and/or eye contact occurs, wash the affected parts immediately with water. Should irritation occur and persist, seek medical advice.

    In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.


    Use during pregnancy and lactation:

    Do not use in pregnant or lactating mares


    Interaction with other medicinal products and other forms of interaction:

    Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents.


    Overdose (symptoms, emergency procedures, antidotes):

    The following clinical signs (some of which may be serious) have been reported in clinical studies following administration of the product at 5x overdose: dull behaviour, diarrhoea, oedema, buccal mucosal ulceration and/or dark coloured urine.

    In case of overdose, symptomatic treatment should be initiated.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.


  14. DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED


    Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.


  15. OTHER INFORMATION

For animal treatment only. To be supplied only on veterinary prescription. The oral paste is available in the following pack sizes:

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder


België/Belgique/Belgien Luxembourg/Luxemburg Nederland

Fendigo sa/nv

Avenue Herrmann Debrouxlaan 17 BE 1160 BRUSSELS

Tel : +32 2 734 46 90

Fax : +32 2 734 48 99

Latvija

Magnum Veterinārija SIA

Ulbrokas 23, Rīga, LV-1021, Latvija Tel. +371 6716 0091

Fax. +371 6716 0095


Република България

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland


Česká republika

Samohýl group a.s.

Smetanova 1058 512 51 Lomnice Nad Popelkou CZECH REP.

Tel: +420 481 65 31

Danmark

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan Ireland

Lietuva

Magnum Veterinarija, UAB Martinavos g. 8, Martinavos k., LT-54463 Kauno r., Lietuva Tel. +370 688 96944

info@magnumvet.lt

Magyarország

Alpha-Vet Állatgyógyászati Kft.

H-8000 Székesfehérvár, Homoksor 7 Tel: 22/534-500


Malta

Borg Cardona & Co. Ltd. ‘Eltex’ Dr. Zammit Street Balzan BZN 1434- MALTA Tel +356 21442698

Fax +356 21493082

Email sales@borg-cardona.com


Deutschland

Elanco GmbH

Heinz-Lohmann-Straße 4

27472 Cuxhaven Deutschland

Norge

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan Ireland


Eesti

AS Magnum Veterinaaria Vae 16

76 401 Laagri Harjumaa Eesti

Tel +372 650 1920

Fax +372 650 1996

Österreich

PRO ZOON Pharma GmbH A-4600 Wels


Ελλάδα

ΧΕΛΛΑΦΑΡΜ ΑΕ

1ο χλμ. Λ. Παιανίας – Μαρκοπούλου,

Polska

ScanVet Poland Sp. z o.o. Skiereszewo, ul. Kiszkowska 9

ΤΘ 100, 19002, Παιανία

Τηλ.: +30 2106800900

E-mail: info@hellafarm.gr

España

Laboratorios Karizoo

Pol. Ind. La Borda, Mas Pujades 11-12 08140 Caldes de Montbui

Barcelona (España)

62-200 Gniezno

Tel. 61 426 49 20


Portugal

PRODIVET-ZN S.A

Av. Infante D. Henrique, 333-H-3º Piso, Esc.41 1800-282 LISBOA

PORTUGAL

Tel. (00351) 21 8511493


France

ALIVIRA FRANCE S.A.S.

14 Rue Scandicci Tour Essor

93500 PANTIN

France

Tél. 01 57 42 23 03

România

S.C. MARAVET S.R.L.

Str. Maravet nr.1, Baia Mare 430016, România

Tel/Fax: +40 262 211 964

e-mail: info@maravet.com www.maravet.com


Hrvatska

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Slovenija

GENERA SI d.o.o.

Parmova Ulica 53

1000 Ljubljana, Slovenija

Telefon: +386 1 4364466

Telefaks: +386 1 4364468 e-mail: info@generasi.si


Ireland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Slovenská republika

PHARMACOPOLA s.r.o.

Svätokrížske nám. 11

SK – 965 01 Žiar nad Hronom Tel. +421 45 6781 400

www.pharmacopola.sk


Ísland

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan, Ireland.

Italia

F.M. ITALIA Group s.r.l. Zona Industriale Isola, 31 05031 Arrone (TR) – Italia


Κύπρος

Αποκλειστικός Διανομέας Κύπρου: Σπύρος Σταυρινίδης Κέμικαλς Λτδ

Λεωφ. Στασίνου 28, 1060 Λευκωσία, Κύπρος

Τηλ: 22 447464 / Φαξ: 22 756902

e-mail: chemicals@stavrinides.com.cy

Suomi/Finland

Orion Oyj ORION PHARMA ELÄINLÄÄKKEET,

PL 425,

FI-20101 Turku

Sverige

Norbrook Laboratories (Ireland) Limited Rossmore Industrial Estate

Monaghan Ireland

United Kingdom

Norbrook Laboratories (GB) Limited 1 Saxon Way East,

Oakely Hay Industrial Estate, Corby,

NN18 9EX

United Kingdom