Target species
Dogs, cats, cattle (calves) and pigs.
Indications for use for each target species
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, lactation or lay.
Special warnings
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
Special precautions for safe use in the target species:
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 precaution to be taken by 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.
Special precautions for the protection of the environment
Not applicable
Adverse events
Dogs, cats:
Rare (1 to 10 animals/ 10, 000 animals treated): | Appetite lossa, Lethargya Vomitinga, Diarrhoeaa, Blood in faecesa,b Renal failurea |
Very rare (<1 animals/ 10, 000 animals treated, including isolated reports): | Elevated liver enzymes Haemorrhagic diarrhoeac, Haematemesisc, Gastrointestinal ulcerationc Anaphylactic reactiond |
aTypical adverse reactions of NSAIDs
bOccult
cThese 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.
dshould be treated symptomatically.
Cattle:
Very rare (<1 animals/ 10, 000 animals treated, including isolated reports): | Injection site swellinga Anaphylactic reactionb |
a Following subcutaneous injection. Slight and transient.
b May be serious (including fatal) and should be treated symptomatically.
Pigs:
Very rare (<1 animals/ 10, 000 animals treated, including isolated reports): | Anaphylactic reactiona |
aMay be serious (including fatal) and should be treated symptomatically.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Use during pregnancy, lactation or lay
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.
Interaction with other medicinal products and other forms of interaction
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.
Administration route and dosage
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In case of overdose symptomatic treatment should be initiated.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable
Withdrawal period(s)
Cattle: Meat and offal: 15 days
Pigs: Meat and offal: 5 days