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Meloxivet
meloxicam

24

Medicinal product no longer authorised


PACKAGE LEAFLET FOR:


Meloxivet 0.5 mg/ml oral suspension for dogs


authorised

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


    Marketing authorisation holder: Eli Lilly and Company Limited Elanco Animal Health

    Lilly House, Priestley Road Basingstoke

    Hampshire RG24 9NL United Kingdom


    Manufacturer for the batch release: Lusomedicamenta S.A.

    Estrada Consiglieri Pedroso, 69 B Queluz de Baixo 2730-055 Barcarena

    Portugal


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    no

    Meloxivet 0.5 mg/ml oral suspension for dogs


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)


    One ml contains:


    Meloxicam 0.5 mg

    Sodium benzoate 1 mg


  4. INDICATION(S)


    Medicinal

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


  5. CONTRAINDICATIONS


    Do not administer Meloxivet:

    • if your dog is pregnant or during lactation

    • if your dog is suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders

    • if your dog is hypersensitive (allergic) to the active substance or to any of the other ingredients.

    • if your dogs is 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, lethargy and renal failure have occasionally 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.

    In very rare cases haemorrhagic diarrhoea, haematemisis, gastrointestinal ulceration and elevated liver

    enzymes have been reported.

    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dogs.


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


    Oral use. To be administered with food .

    longer

    The suspension has to be given with the 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 (i.e. 0.1 mg meloxicam/kg body weight). Thus for the first day, twice the maintenance volume will be required.


    Dosage

    Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (24 hour intervals) at a maintenance dose of 0.1 mg

    meloxicam/kg body weight.



    o

    image

    image

    Route and method of administration

    image


    n


    produ

    Medicinal

    Shake bottle well.

    Push down and unscrew bottle top. Attach the dosing syringe to the bottle by gently pushing the end onto the top the bottle

    ct

    Turn the bottle

    syringe upside down. Pull the plunger out until the black on the plunger corresponds to your dog’s bodyweight in kilograms.

    Turn the bottle right

    way up and with a twisting movement separate the dosing syringe from the bottle.

    By pushing the

    plunger in empty the contents of the syringe onto the food.


    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.

    For longer term treatment once clinical response has been observed (after 4 or more days), the dose of Meloxivet 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.

    Avoid introduction of contamination during use.

  9. ADVICE ON CORRECT ADMINISTRATION


    authorised

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


  10. WITHDRAWAL PERIOD


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the reach and sight of children.

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

    After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The syringe should be stored in the carton box in between uses.

    Do not use after the expiry date stated on the label and carton after EXP. Shelf life after first opening the container: 6 months.


  12. SPECIAL WARNING(S)


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

    no

    Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxivet 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 pharmacokinetic properties of the products used previously.

    In the case of overdose symptomatic treatment should be initiated.

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

    Medicinal

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


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


    Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    Detailed information on this product is available on the website of the European Medicines Agency

    .

  15. OTHER INFORMATION


10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and an amber polypropylenedosing syringe.

authorised

30 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and an amber polypropylene dosing syringe.


Medicinal

no

Not all pack sizes may be marketed.

PACKAGE LEAFLET FOR:


Meloxivet 1.5 mg/ml oral suspension for dogs


authorised

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


    Marketing authorisation holder: Eli Lilly and Company Limited Elanco Animal Health

    Lilly House, Priestley Road Basingstoke

    Hampshire RG24 9NL United Kingdom


    Manufacturer for the batch release: Lusomedicamenta S.A.

    Estrada Consiglieri Pedroso, 69 B Queluz de Baixo 2730-055 Barcarena

    Portugal


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    no

    Meloxivet 1.5 mg/ml oral suspension for dogs


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)


    One ml contains:


    Meloxicam 1.5 mg

    Sodium benzoate 1 mg


  4. INDICATION(S)


    Medicinal

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


  5. CONTRAINDICATIONS


    Do not administer Meloxivet:

    • if your dog is pregnant or during lactation

    • if your dog is suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders

    • if your dog is hypersensitive (allergic) to the active substance or to any of the other ingredients.

    • if your dogs is 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, lethargy and renal failure have occasionally 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.

    In very rare cases haemorrhagic diarrhoea, haematemisis, gastrointestinal ulceration and elevated liver

    enzymes have been reported.

    If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dogs.


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


    Oral use. To be administered with food.

    longer

    The suspension has to be given with the measuring syringe provided in the package of the 30 and 150 ml pack size or with one of the two measuring syringes provided in the package of the 10 ml pack size. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight). Thus for the first day, twice the maintenance volume will be required.


    Dosage

    Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.


    o

    image

    image

    ct

    Route and method of administration

    image


    n


    produ

    Medicinal

    Shake bottle well.

    Push down and unscrew bottle top. Attach the dosing syringe to the bottle by gently pushing the end onto the top the bottle

    Turn the bottle

    syringe upside down. Pull the plunger out until the black on the plunger corresponds to your dog’s bodyweight in kilograms.

    Turn the bottle right

    way up and with a twisting movement separate the dosing syringe from the bottle.

    By pushing the

    plunger in empty the contents of the syringe onto the food.


    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.

    For longer term treatment once clinical response has been observed (after 4 or more days), the dose of Meloxivet 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.

    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.

    authorised

    The suspension of the 10 ml pack size could be administered using the smallest syringe for dogs less than 8 kg body weight (one graduation corresponding to 0.5 kg of body weight) or the largest syringe for dogs over than 8 kg body weight (one graduation corresponding to 2.0 kg of body weight).


  10. WITHDRAWAL PERIOD


    Not applicable.


  11. SPECIAL STORAGE PRECAUTIONS


    Keep out of the reach and sight of children.

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

    After each dose, the tip of the syringe should be wiped and the bottle cap screwed back on tightly. The syringe should be stored in the carton box in between uses.

    Do not use after the expiry date stated on the label and carton after EXP. Shelf life after first opening the container: 6 months.


  12. SPECIAL WARNING(S)


    no

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

    Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxivet 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 pharmacokinetic properties of the products used previously.

    In the case of overdose symptomatic treatment should be initiated.

    Medicinal

    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.


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


    Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED


    Detailed information on this product is available on the website of the European Medicines Agency

    .

  15. OTHER INFORMATION


10 ml presentation: amber glass bottle (type III) with polyethylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe. Two measuring syringes are provided.

authorised

30 ml and 150 ml presentation: amber glass bottle (type III) with polypropylene child resistant closure, polyethylene insert and clear polypropylene dosing syringe.


Medicinal

no

Not all pack sizes may be marketed.