NOAH Compendium

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Date: Thursday, May 19, 2022 2:05

Release 2.165
Rheumocam 5mg/ml Solution for Injection for Cats and Dogs
Species: Cats, Dogs
Therapeutic indication: Pharmaceuticals: Anti-inflammatory preparations: Injections: NSAIDs
Active ingredient: Meloxicam
Product:Rheumocam 5mg/ml Injection for Cats and Dogs
Product index: Rheumocam 5mg/ml Injection for Cats and Dogs
Each ml contains 5 mg meloxicam and 159.8 mg of ethanol (96%) as a preservative.
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.
Dosage and administration
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).
Method and routes of administration
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.
Contra-indications, warnings, etc
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.
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.
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
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
Do not use in pregnant or lactating animals.
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.
In the case of overdose, symptomatic treatment should be initiated.
Adverse reactions (frequency and seriousness)
Typical adverse 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 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 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).
Pharmaceutical precautions
Keep the vial in the outer carton.
Legal category
Legal category: POM-V
Packaging quantities
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.
Marketing Authorisation Number
EU/2/07/078/015 - 10 ml
EU/2/07/078/016 - 20 ml
EU/2/07/078/017 - 100 ml
Significant changes