Target species
Dogs, cats, cattle (calves) and pigs.
Indications for use
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.
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.
For the relief of post-operative pain following dehorning in calves.
Pigs:
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 surgery such as castration.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in dogs and cats suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.
Do not use in dogs and cats less than 6 weeks of age nor in cats of less than 2 kg.
Do not use in cattle and pigs suffering from impaired hepatic, cardiac or renal function and haemorrhagic disorders, or where there is evidence of ulcerogenic gastrointestinal lesions. 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.
See also Use during pregnancy and lactation.
Special warnings for each target species
Treatment of piglets with Meloxidolor before castration reduces post-operative pain.
To obtain pain relief for cattle and pigs during surgery co-medication with an appropriate anaesthetic/sedative/analgesic is needed.
To obtain the best possible pain relieving effect for pigs post-surgery Meloxidolor should be administered 30 minutes before surgical intervention.
Treatment of calves with Meloxidolor 20 minutes before dehorning reduces post-operative pain. Meloxidolor alone will not provide adequate pain relief during the dehorning procedure.
Special precautions for use in animals
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 NSAIDs should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
The veterinary medicinal product should not be administered by pregnant women or women of child- bearing potential as Meloxicam may be harmful to the foetus and unborn child.
Adverse reactions
For dogs and cats:
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have rarely 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 adverse reactions 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.
For cattle and pigs:
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 anaphylactic 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).
Use during pregnancy and lactation
Dogs and cats: Do not use in pregnant or lactating dogs or cats.
Cattle: Can be used during pregnancy.
Pigs: Can be used during pregnancy and lactation.
Interactions
For dogs and cats:
Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxidolor must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic veterinary medicinal products 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.
For cattle and pigs:
Do not administer concurrently with glucocorticosteroids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.
Amounts to be administered and administration route
Dogs:
Musculo-skeletal disorders:
Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg body weight).
Oral suspensions of meloxicam 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 at a dosage of 0.2 mg meloxicam/kg body weight (i.e.
0.4 ml/10 kg body weight) before surgery, for example at the time of induction of anaesthesia.
Cats:
Reduction of post-operative pain:
Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.
Cattle:
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.
Pigs:
Locomotor disorders:
Single intramuscular injection at a dosage of 0.4 mg meloxicam/kg body weight (i.e. 2 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 body weight.
Avoid introduction of contamination during use. The stopper should not be punctured more than 20 times.
Overdose
In case of overdose symptomatic treatment should be initiated.
Withdrawal periods
Cattle: Meat and offal: 15 days
Pigs: Meat and offal: 5 days