NOAH Compendium

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Date: Wednesday, August 5, 2020 7:08

Release 2.74
Rheumocam 20mg/ml Solution for Injection for Cattle, Pigs and Horses
 
Species: Horses and other equidae, Pigs, Cattle
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: 5 days
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 may occur and should be treated symptomatically.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
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: 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
Packaging quantities
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.
Marketing Authorisation Number
EU/2/07/078/011 20 ml
EU/2/07/078/012 50 ml
EU/2/07/078/013 100 ml
EU/2/07/078/014 250 ml
Significant changes