Rheumocam 20mg/ml Solution for Injection for Cattle, Pigs and Horses Species: Cattle, Horses and other equidae, Pigs Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Injections: NSAIDs Active ingredient: Meloxicam Product:Rheumocam 20mg/ml Injection for Cattle, Pigs and Horses Product index: Rheumocam 20mg/ml Injection for Cattle, Pigs and Horses Cattle - milk: 120 hours Cattle - meat: 15 days Pig - meat: 5 days Withdrawal notes: Horse: Meat - 5 days. Not authorised for use in horses producing milk for human consumption Presentation One ml contains 20mg meloxicam and 159.8 mg of ethanol (96 percent). Uses 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. 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. Dosage and 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. 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. Horses 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. Advice on correct administration 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. Contra-indications, warnings, etc 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. Adverse reactions 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 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). 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. User warnings 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". Interactions Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anti-coagulant agents. Overdose In the case of overdose, symptomatic treatment should be initiated. Withdrawal periods Cattle: Meat and offal: 15 days Milk: (120 hours) 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 Pharmaceutical precautions Keep out of the reach and sight 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. Legal category Legal category: POM-V