Rheumocam
meloxicam
Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway, Ireland.
Rheumocam 1.5 mg/ml oral suspension for dogs
Each ml contains: 1.5 mg of meloxicam, 5 mg of sodium benzoate.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
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.
Do not use in dogs less than 6 weeks of age.
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. In very rare cases 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 adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Dogs.
Shake well before use. To be administered mixed with food. Avoid introduction of contamination during use.
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 (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
The suspension can be given using the measuring syringe provided in the package. The syringe has a scale which corresponds to the volume required.
The following dosing table indicates what volume to administer depending on the weight of the dog:
Bodyweight (kg) | Maintenance dosage (ml) |
7.5 | 0.5 |
15 | 1 |
22.5 | 1.5 |
30 | 2 |
37.5 | 2.5 |
45 | 3 |
52.5 | 3.5 |
60 | 4 |
For the first day, twice the maintenance dosage will be required.
A clinical response is normally seen within 3 to 4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.
Please follow these steps: | |
Step 1. Before using Rheumocam | Step 2. Place the circular |
for the very first time ensure that | plastic insert into the neck of |
you have the bottle, circular | the bottle and push down until |
plastic insert and syringe. | securely in place. Once in place |
the insert will not need to be | |
removed. | |
Step 3. | Step 4. |
Replace the cap on the bottle and | Turn the bottle with the syringe |
shake it well. Take off the bottle | in place upside down and |
cap and attach the dosing syringe | slowly withdraw the plunger |
to the bottle by gently pushing | until the required dose is |
the end into the hole. | evident. |
Step 5. Turn the bottle/syringe | Step 6. Push the plunger until |
the right way up and with a | all contents of the syringe have |
twisting movement separate the | been dispensed onto the food. |
syringe from the bottle. |
Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.
Not applicable.
This veterinary medicinal product does not require any special storage conditions. Keep out of the sight and reach of children.
Do not use after the expiry date (EXP) stated on the carton and the bottle.
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 animal, as there is a potential risk of increased renal toxicity. This product for dogs should not be used in cats as it is not suitable for use in this species. In cats, Rheumocam 0.5 mg/ml oral suspension for cats should be used.
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Rheumocam must not be administered in conjunction with other NSAIDs or glucocorticosteriods.
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary 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 veterinary products used previously.
In the case of overdosage symptomatic treatment should be initiated.
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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (https://www.ema.europa.eu).
To be supplied only on veterinary prescription.
15, 42, 100 or 200 ml bottle with two 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.
Baltic Agro, Ukmerges g. 322
Vilnius
Lithuania 12106
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Kela Veterinaria nv/sa T: +32 3 780 63 90
Antala Staška 2027/77, Praha 4 – Krč, 140 00, ČR
Tolnagro Állatgyógyászati Kft.
7100 Szekszárd, Rákóczi u. 142-146.
DK-3480 Fredensborg
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Alfavet Tierarzneimittel GmbH Leinestr. 32
24539 Neumünster Deutschland
Kela Veterinaria nv/sa T: +32 3 780 63 90
Baltic Agro, Ukmerges g. 322
Vilnius
Lithuania 12106
Biovet ApS Kongevejen 66
DK-3480 Fredensborg
Agroseed Candilidis SA. Exit 1 of Attica Road,
Thesi Xero Pigadi, Attikis 19600
Richter Pharma AG Feldgasse 19
4600 Wels
Fatro Ibérica S.L. Constitución 1. PB 3 08960. Sant Just Desvern. Barcelona. ESPAÑA
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
MEDINFAR- SOROLÓGICO- PRODUTOS E EQUIPAMENTOS, S.A.
Rua Henrique Paiva Couceiro, 27 Venda Nova , 2704-006 Amadora
Portugal
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
SC Montero Vet SRL Str, Celofibrei nr. 25-27,
Bragadiru, llfov,
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
110 Reykjavík Iceland
Antala Staška 2027/77, Praha 4 – Krč, 140 00, ČR
Teknofarma S.r.l.
Strada Comunale da Bertolla all’Abbadia di Stura, 14
10156 Torino
ITALIA
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
VTN Veterinary and Pharmacy Ltd. PO Box 23886
CY1687
Nicosia Cyprus
SE-114 57 Stockholm
Baltic Agro, Ukmerges g. 322 Vilnius Lithuania 12106
Co. Galway
Tel: + 353 91 841788
Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd.
Loughrea,
Co. Galway, Ireland.
Rheumocam 1 mg chewable tablets for dogs Rheumocam 2.5 mg chewable tablets for dogs Meloxicam
Each chewable tablet contains:
Meloxicam 1 mg
Meloxicam 2.5 mg
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.
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.
Typical adverse drug reactions of non-steroidal anti-inflammatory drugs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. In very rare cases 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 adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Dogs
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 (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight.
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. Rheumocam chewable tablets 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 | mg/kg | |
1 mg | 2.5 mg | ||
4.0–7.0 | ½ | 0.13–0.1 | |
7.1–10.0 | 1 | 0.14–0.1 | |
10.1–15.0 | 1½ | 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 | 1½ | 0.15–0.1 | |
35.1–50.0 | 2 | 0.14–0.1 | |
The use of Rheumocam oral suspension for dogs may be considered for an even more precise dosing. For dogs weighing less than 4 kg the use of Rheumocam 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.
To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing or overdosing.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
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.
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.
Use during pregnancy and lactation: See section “5. 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. Rheumocam 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.
Overdose (symptoms, emergency procedures, antidotes):
In the case of overdosage symptomatic treatment should be initiated.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (https://www.ema.europa.eu).
20 tablets
100 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.
Orion Pharma Kubiliaus str.6
LT-08234 Vilnius
ASKLEP-PHARMA LIMITED,
Shop No 3 & 4
bl.711A, Lulin-7 complex, Sofia 1324,
Kela Veterinaria nv/sa T: +32 3 780 63 90
Antala Staška 2027/77, Praha 4 – Krč, 140 00, ČR
DK-3480 Fredensborg
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Alfavet Tierarzneimittel GmbH Leinestr. 32
24539 Neumünster Deutschland
Kela Veterinaria nv/sa T: +32 3 780 63 90
Orion Pharma Kubiliaus str.6
LT-08234 Vilnius, Lithuania
Biovet ApS Kongevejen 66
DK-3480 Fredensborg
ΚΑΝΔΗΛΙΔΗ ΑΕ
Λεωφ. Κύμης & Ηλέκτρας 4β 15122 Μαρούσι, Αττική, Ελλάδα
Τηλ.: +30 210 6910311
Richter Pharma AG Feldgasse 19
4600 Wels
Fatro Ibérica Constitución 1. P.B. 3 Sant Just Desvern. 08960 Barcelona (ESPAÑA)
Orion Pharma Poland Sp. z o.o. ul. Fabryczna 5A
00-446 Warszawa
Laboratoires AUVEX 3, rue André Citroën
ZAC de Champ Lamet 63430 Pont-du-Château
France
MEDINFAR- SOROLÓGICO- PRODUTOS E EQUIPAMENTOS, S.A.
Rua Henrique Paiva Couceiro, 27 Venda Nova , 2704-006 Amadora
Portugal
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
SC Montero Vet SRL Str, Celofibrei nr. 25-27,
Bragadiru, llfov,
Romania
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
ORION CORPORATION P.O.Box 65
FI-02101, Espoo, Finland Predstavnik:
IRIS d.o.o.
1000 Ljubljana
Cesta vGorice 8
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Antala Staška 2027/77, Praha 4 – Krč, 140 00, ČR
Teknofarma S.r.l.
Strada Comunale da Bertolla all’Abbadia di Stura, 14
10156 Torino
ITALIA
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
VTN Veterinary and Pharmacy Ltd. PO Box 23886
CY1687
Nicosia
SE-114 57 Stockholm
Orion Pharma Kubiliaus str.6
LT-08234 Vilnius, Lithuania
Co. Galway
Tel: + 353 91 841788
Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway,
Ireland.
Rheumocam 15 mg/ml oral suspension for horses Meloxicam
Each ml contains: 15 mg of meloxicam, 5 mg of sodium benzoate.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in horses.
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.
Isolated cases of adverse reactions typically associated with non-steroidal anti-inflammatory drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. In very rare cases 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.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Horses.
Oral suspension to be administered at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days. This is equivalent to 1 ml of Rheumocam per 25 kg body weight of horse. For example, a horse weighing 400 kg will receive 16 ml of Rheumocam, a horse weighing 500 kg will receive 20 ml of Rheumocam, and a horse weighing 600 kg will receive 24 ml of Rheumocam.
Shake well before use. To be administered either mixed with a small quantity of food, prior to feeding, or directly into the mouth.
The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a 2 ml scale.
Avoid introduction of contamination during use.
Step 1. Before using Rheumocam for the very first time ensure that
you have the bottle, circular plastic insert and syringe.
Step 2. Place the circular plastic insert into the neck of the bottle and push down until securely in place. Once in place the insert will not need to be removed
Step 3.
Replace the cap on the bottle and shake it well. Take off the bottle
cap and attach the dosing syringe
to the bottle by gently pushing the end into the hole.
Step 4.
Turn the bottle with the syringe in place upside down and
slowly withdraw the plunger
until the required dose is evident.
None.
Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.
Do not use after the expiry date (EXP) stated on the carton and the bottle.
Shelf life after first opening of the container: 3 months.
Special precautions for use in animals:
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 animal, as there is a potential risk of increased renal toxicity.
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.
Use during pregnancy and lactation:
See the section under “Contraindications”.
Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticoids, 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.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (https://www.ema.europa.eu).
To be supplied only on veterinary prescription. 100 or 250 ml bottle with a measuring syringe. 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.
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Kela Veterinaria nv/sa T: +32 3 780 63 90
Antala Staška 2027/77, Praha 4 – Krč, 140 00, ČR
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Kela Veterinaria nv/sa T: +32 3 780 63 90
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
ScanVet informasjonskontor
Postboks 3050 Alexander Kiellands Plass 0132 Oslo
Tlf: +47 2269 0737
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Richter Pharma AG Feldgasse 19
4600 Wels
Fatro Ibérica S.L. Constitución 1. PB 3 08960. Sant Just Desvern. Barcelona. ESPAÑA
Orion Pharma Poland Sp. z o.o. ul. Fabryczna 5A
00-446 Warszawa
Audevard Laboratoires 42-46 Rue Médéric,
92110 Clichy
France
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Distribuit de
ORION CORPORATION P.O.Box 65
FI-02101, Espoo, Finland Reprezentat:
Vanelli S.R.L.
Sos.Iasi
Tg.Frumos, km. 10, Iasi 707410
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
SE-114 57 Stockholm
110 Reykjavík Iceland
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
VET MEDIC ANIMAL HEALTH OY
PB 27, FI-13721 PAROLA
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Co. Galway
Tel: + 353 91 841788
Marketing authorisation holder:
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland
Manufacturers responsible for the batch release:
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland
and
Eurovet Animal Health B.V., Handelsweg 25, 5531 AE Bladel, The Netherlands
and
Labiana Life Sciences, S.A., C/ Venus, 26, Pol. Ind. Can Parellada, Tarrasa, 08228 Barcelona
Rheumocam 20 mg/ml solution for injection for cattle, pigs and horses Meloxicam
One ml contains: Meloxicam 20 mg
Ethanol (96 percent) 159.8 mg Clear, yellow solution.
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 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.
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.
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.
In cattle and pigs, subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
In horses, a transient swelling at the injection site can occur but resolves without intervention.
In very rare cases anaphylactoid reactions, which may be serious (including fatal), may occur and should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Cattle, pigs and horses.
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.
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.
Single intravenous injection at 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, Rheumocam 15 mg/ml oral suspension may be used for continuation of
treatment at a dosage of 0.6 mg meloxicam/kg body weight, 24 hours after administration of the injection.
Avoid introduction of contamination during use.
Maximum number of piercings is 14 for the 20 ml, 50 ml and 100 ml stoppers and 20 for the 250 ml stopper.
Not authorised for use in horses producing milk for human consumption.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions. Do not use after the expiry date (EXP) stated on the carton and vial.
Shelf life after first opening the container: 28 days.
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.
Waste materials should be disposed of in accordance with local requirements.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (https://www.ema.europa.eu/).
Cardboard box containing one colourless glass injection vial of 20 ml, 50 ml, 100 ml or 250 ml. 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.
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Antala Staška 2027/77, Praha 4 – Krč, 140 00, ČR
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
ΚΑΝΔΗΛΙΔΗ Α.Ε.
Λεωφ. Κύμης & Ηλέκτρας 4β
15122 Μαρούσι, Αττική, Ελλάδα
Τηλ.: +30 210 6910311
Richter Pharma AG Feldgasse 19
4600 Wels
Laboratorios e Industrias Iven, S.A.
C/ Luis I, 56-58 Polígono Industrial de Vallecas
28031 – Madrid
Orion Pharma Poland Sp. z o.o. ul. Fabryczna 5A
00-446 Warszawa
Audevard Laboratoires 42-46 Rue Médéric,
92110 Clichy
France
NePhar - Farma, Lda
R. Francisco Lyon de Castro, 28
2725-397 Mem Martins
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Distribuit de
ORION CORPORATION P.O.Box 65
FI-02101, Espoo, Finland Reprezentat:
Vanelli S.R.L.
Sos.Iasi
Tg.Frumos, km. 10, Iasi 707410
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
110 Reykjavík Iceland
Antala Staška 2027/77, Praha 4 – Krč, 140 00,
ČR
MSD Animal Health S.r.l. Via Fratelli Cervi s.n.c.
Palazzo Canova, Centro Direzionale Milano Due
20090 Segrate (Milano)
ITALY
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
VTN Veterinary and Pharmacy Ltd. PO Box 23886
CY1687
Nicosia
SE-114 57 Stockholm
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Co. Galway
Tel: + 353 91 841788
Marketing authorisation holder:
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway,
Ireland
Manufacturers responsible for the batch release: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway,
Ireland
and
Eurovet Animal Health B.V. Handelsweg 25, 5531 AE Bladel, The Netherlands
and
Labiana Life Sciences, S.A.,
C/ Venus, 26, Pol. Ind. Can Parellada, Tarrasa, 08228 Barcelona
Rheumocam 5 mg/ml solution for injection for dogs and cats Meloxicam
One ml contains: Meloxicam 5 mg,
Ethanol (96%) 159.8 mg. Clear, yellow solution.
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.
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.
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, haemorrhagic diarrhoea, haematemesis, and gastrointestinal ulceration 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.
In very rare cases, anaphylactoid reactions may occur and should be treated symptomatically.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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.
Dogs and cats.
Dogs: single administration of 0.2 mg meloxicam /kg body weight (i.e. 0.4 ml/10 kg). Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).
Dogs:
Musculo-skeletal disorders: single subcutaneous injection.
Rheumocam 1.5 mg/ml oral suspension for dogs or Rheumocam 1 mg and 2.5 mg chewable tablets for dogs may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg body weight,
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 after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example, at the time of induction of anaesthesia.
Particular care should be taken with regard to the accuracy of dosing. Avoid introduction of contamination during use.
Maximum number of piercings is 42 for all presentations.
Not applicable.
Keep out of the reach and sight of children. Keep the vial in the outer carton.
Do not use after the expiry date (EXP) stated on the carton and vial. Shelf life after first opening the container: 28 days.
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.
During anaesthesia, monitoring and fluid therapy should be considered as standard practice.
Any oral follow-up therapy using meloxicam or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should not be administered in cats, as appropriate dosage regimens for such follow-up
treatments have not been established.
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:
Do not use in pregnant or lactating animals.
Interaction with other medicinal products and other forms of interaction:
Other NSAIDs, diuretics, anti-coagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Rheumocam 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 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 pharmacological properties of the products used previously.
Overdose (symptoms, emergency procedures, antidotes):
In the case of overdose, symptomatic treatment should be initiated.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (https://www.ema.europa.eu/).
Carton box containing one colourless glass injection vial of 10 ml, 20 ml or 100ml, closed with a bromobutyl rubber stopper and sealed with an aluminium cap.
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.
Baltic Agro, Ukmerges g. 322
Vilnius
Lithuania 12106
ASKLEP-PHARMA LIMITED,
Shop No 3 & 4
bl.711A, Lulin-7 complex, Sofia 1324,
Kela Veterinaria nv/sa T: +32 3 780 63 90
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
DK-3480 Fredensborg
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Alfavet Tierarzneimittel GmbH Leinestr. 32
24539 Neumünster
Deutschland
Kela Veterinaria nv/sa T: +32 3 780 63 90
Baltic Agro, Ukmerges g. 322
Vilnius Lithuania 12106
Biovet ApS Kongevejen 66
DK-3480 Fredensborg
ΚΑΝΔΗΛΙΔΗ ΑΕ
Λεωφ. Κύμης & Ηλέκτρας 4β 15122 Μαρούσι, Αττική, Ελλάδα
Τηλ.: +30 210 6910311
e-mail: info@candilagro.gr
Richter Pharma AG Feldgasse 19
4600 Wels
Ecuphar Veterinaria S.L.U.
Av. Río de Janeiro, 60-66 Planta 13, 08016 Barcelona (España)
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
MEDINFAR- SOROLÓGICO- PRODUTOS E EQUIPAMENTOS, S.A.
Rua Henrique Paiva Couceiro, 27 Venda Nova , 2704-006 Amadora Portugal
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Montero Vet Bulevardul Iuliu Maniu,
nr. 602 B, sector 6,
Bucuresti
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
110 Reykjavík Iceland
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Teknofarma S.r.l.
Strada Comunale da Bertolla all’Abbadia di Stura, 14
10156 Torino
ITALIA
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
VTN Veterinary and Pharmacy Ltd. PO Box 23886
CY1687
Nicosia
SE-114 57 Stockholm
Baltic Agro, Ukmerges g. 322
Vilnius Lithuania 12106
Co. Galway
Tel: + 353 91 841788
Marketing authorisation holder:
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland
Manufacturers responsible for the batch release:
Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, Ireland
and
Eurovet Animal Health B.V., Handelsweg 25, 5531 AE Bladel, The Netherlands
and
Labiana Life Sciences, S.A., C/ Venus, 26, Pol. Ind. Can Parellada, Tarrasa, 08228 Barcelona
Rheumocam 5 mg/ml solution for injection for cattle and pigs Meloxicam
One ml contains: Meloxicam 5 mg
Ethanol (96%) 159.8 mg Clear, yellow solution.
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 use in non-infectious locomotor disorders to reduce the symptoms of lameness and inflammation. For the relief of post operative pain associated with minor soft tissue such as castration.
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. Do not use in pigs less than 2 days old.
Subcutaneous, intramuscular as well as intravenous administration is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10 % of the cattle treated in clinical studies.
In very rare cases anaphylactoid reactions which may be serious (including fatal) may occur and should be treated symptomatically.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reaction(s))
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Cattle (calves and young cattle) and pigs.
Single subcutaneous or intravenous injection at a dosage of 0.5 mg meloxicam/kg body weight (i.e. 10 ml/100 kg body weight) in combination with antibiotic therapy or with oral re-hydration therapy, as appropriate.
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2.0 ml/25 kg body weight). If required, a second administration of meloxicam can be given after 24 hours.
Reduction of post-operative pain:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 0.4 ml/5 kg body weight) before surgery.
Particular care should be taken with regard to the accuracy of dosing including the use of an appropriate dosing device and careful estimation of bodyweight.
Avoid introduction of contamination during use.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions. Do not use after the expiry date (EXP) stated on the carton and vial.
Shelf life after first opening the container: 28 days.
Treatment of piglets with Rheumocam before castration reduces post-operative pain. To obtain pain relief during surgery co-medication with an appropriate anaesthetic/sedative is needed.
To obtain the best possible relieving effect post surgery Rheumocam should be administered 30minutes before surgical intervention.
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.
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: Can be used during pregnancy.
Pigs: Can be used during pregnancy and lactation.
Interaction with other medicinal products and other forms of interaction:
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Overdose (symptoms, emergency procedures, antidotes):
In the case of overdose symptomatic treatment should be initiated.
Waste materials should be disposed of in accordance with local requirements.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (https://www.ema.europa.eu).
Cardboard box containing 1 colourless glass injection vial of 20 ml, 50 ml or 100 ml. 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.
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Richter Pharma AG Feldgasse 19
4600 Wels
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
MEDINFAR- SOROLÓGICO- PRODUTOS E EQUIPAMENTOS, S.A.
Rua Henrique Paiva Couceiro, 27
Venda Nova , 2704-006 Amadora Portugal
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
110 Reykjavík Iceland
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
MSD Animal Health S.r.l. Via Fratelli Cervi s.n.c.
Palazzo Canova, Centro Direzionale Milano Due
20090 Segrate (Milano)
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
SE-114 57 Stockholm
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
Tel: + 353 91 841788
Co. Galway
Tel: + 353 91 841788
Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway, IRELAND.
Rheumocam 330 mg granules for horses. Meloxicam
One sachet contains: 330 mg of meloxicam. Pale yellow granules.
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in horses weighing between 500 and 600 kg.
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.
Isolated cases of adverse reactions typically associated with non-steroidal anti-inflammatory drugs (NSAIDs) were observed in clinical trials (slight urticaria, diarrhoea). Symptoms were reversible. In very rare cases 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.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Horses.
In-feed use.
To be administered mixed with food at a dose of 0.6 mg/kg body weight, once daily, up to 14 days. The product should be added to 250 g of muesli feed, prior to feeding.
Each sachet contains one dose for a horse weighing between 500 kg and 600 kg and the dose must not be divided into smaller doses.
Avoid introduction of contamination during use.
Meat and offal: 3 days.
Not authorised for use in lactating animals producing milk for human consumption.
Keep out of the sight and reach of children.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the sachet after EXP.
Shelf life after incorporation into muesli feed: use immediately.
Special precautions for use in animals:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
In order to minimise risk of intolerance, the product should be mixed into muesli feed. This product is only for use in horses weighing between 500 and 600 kg.
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 this package leaflet or the label to the physician.
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 glucocorticoids, other NSAIDs or with anti-coagulant agents.
Overdose (symptoms, emergency procedures, antidotes):
In the case of overdose symptomatic treatment should be initiated.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (https://www.ema.europa.eu).
Pack size: 100, 10 sachets.
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.
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tél/Tel: +353 91 841788
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Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tél/Tel: +353 91 841788
Biovet Aps Kongevejen 66
DK-3480 Fredensborg
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tél/Tel: +353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Vet Medic Animal Health Oy PL 27
FI-13721 Parola
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
VM Pharma AB Box 45010
SE-104 30 Stockholm
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Co. Galway IE - Ireland
Tel: + 353 91 841788
Marketing authorisation holder and manufacturer responsible for batch release: Chanelle Pharmaceuticals Manufacturing Ltd.,
Loughrea, Co. Galway,
IRELAND.
Rheumocam 0.5 mg/ml oral suspension for cats. meloxicam
One ml contains: Active substance
Meloxicam 0.5 mg.
Excipient
Sodium benzoate 1.5 mg. Smooth light yellow suspension.
Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.
Alleviation of pain and inflammation in acute and chronic musculo-skeletal disorders in cats.
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 of age.
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. Gastrointestinal ulceration and elevated liver enzymes were reported in very rare cases.
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.
The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals treated displaying adverse reactions)
common (more than 1 but less than 10 animals in 100 animals treated)
uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
rare (more than 1 but less than 10 animals in 10,000 animals treated)
very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
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.
Cats.
Oral use.
Post-operative pain and inflammation following surgical procedures:
After initial treatment with Rheumocam 5 mg/ml solution for injection for cats, continue treatment 24 hours later with Rheumocam 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 4 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
To be administered orally either mixed with food or directly into the mouth.
The syringe fits onto the drop dispenser of the bottle and has a kg-body weight scale which corresponds to the dose of 0.05 mg meloxicam/kg bodyweight. 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.
Particular care should be taken with regard to the accuracy of dosing. The recommended dose should not be exceeded.
Please carefully follow the instructions of the veterinarian.
Avoid introduction of contamination during use.
Not applicable.
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Shelf life after first opening of the container:
3 ml and 5 ml bottles: 14 days
10 ml and 15 ml bottles: 6 months.
Special precautions for use in animals:
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased 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.
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 this package leaflet or the label to the physician.
Pregnancy and lactation:
The safety of the veterinary medicinal product has not been established during 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. Rheumocam must not be administered
in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential
nephrotoxic veterinary medicinal products 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 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 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.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (https://www.ema.europa.eu).
Pack size: 1 x 3 ml, 1 x 5 ml 1 x 10 ml or 1 x 15 ml bottle with a measuring syringe. 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.
Baltic Agro, Ukmerges g. 322
Vilnius
Lithuania 12106
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Teл: +353 91 841788
Kela Veterinaria nv/sa T: +32 3 780 63 90
Antala Staška 2027/77, Praha 4 – Krč, 140 00, ČR
Tolnagro Állatgyógyászati Kft.
7100 Szekszárd, Rákóczi u. 142-146.
DK-3480 Fredensborg
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
Alfavet Tierarzneimittel GmbH Leinestr. 32
24539 Neumünster Deutschland
Kela Veterinaria nv/sa T: +32 3 780 63 90
Baltic Agro, Ukmerges g. 322
Vilnius
Lithuania 12106
Biovet ApS Kongevejen 66
DK-3480 Fredensborg
ΚΑΝΔΗΛΙΔΗ ΑΕ
Λεωφ. Κύμης & Ηλέκτρας 4β 15122 Μαρούσι, Αττική, Ελλάδα
Τηλ.: +30 210 6910311
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Fatro Ibérica S.L. Constitución 1. PB 3
08960. Sant Just Desvern.
Barcelona. ESPAÑA
Orion Pharma Poland Sp. z o.o. ul. Fabryczna 5A
00-446 Warszawa
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tél: + 353 91 841788
KimiPharma, Lda
Parque Industrial de Vendas Novas, Rua 3, Lote 710/711
7080-341 Vendas Novas Portugal
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
ORION CORPORATION P.O.Box 65
FI-02101, Espoo, Finland Reprezentat:
Vanelli S.R.L.
Sos.Iasi
Tg.Frumos, km. 10, Iasi 707410
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway
IE - Ireland
Tel: + 353 91 841788
Chanelle Pharmaceuticals Manufacturing Ltd. Loughrea
Co. Galway IE - Ireland
Tel: + 353 91 841788
SE-114 57 Stockholm
Baltic Agro, Ukmerges g. 322
Vilnius Lithuania 12106
Co. Galway IE - Ireland
Tel: + 353 91 841788