Target species
Cattle, pigs and horses.
Indications for use, specifying the target species
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. 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 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.
Contraindications
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 cases 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.
Special warnings for each target species
Treatment of calves with the veterinary medicinal product 20 minutes before dehorning reduces post-operative pain. The veterinary medicinal product alone will not provide adequate pain relief during the dehorning procedure. To obtain adequate pain relief during surgery co-medication with an appropriate analgesic is needed.
Special precautions for use
Special precautions for use in animals
If adverse events 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product may cause hypersensitivity (allergic reactions). People with known hypersensitivity to non-steroidal antiinflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.
This veterinary medicinal product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Avoid dermal and oral exposure, including hand-to-mouth contact. Wash hands after use.
Accidental self-injection may give rise to pain. Take precautions to avoid self injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Meloxicam may have adverse effects on pregnancy and/or embryofoetal development. This veterinary medicinal product should not be administered by pregnant women or women attempting to conceive.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
Cattle:
Common (1 to 10 animals / 100 animals treated): | Injection site swelling (1) |
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactic-type reaction (2) |
(1) following subcutaneous administration, slight, transient (2) may be serious (including fatal), should be treated symptomatically
Pigs:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Anaphylactic-type reaction (3) |
(3) may be serious (including fatal), should be treated symptomatically
Horses:
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Injection site swelling (4), anaphylactic type reaction (5) |
(4) transient, resolved without intervention (5) may be serious (including fatal), should be treated symptomatically
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Cattle and pigs: can be used during pregnancy and lactation.
Horses: do not use in pregnant or lactating mares.
Interaction with other medicinal products and other forms of interaction
Do not administer concurrently with glucocorticosteroids, other NSAIDs or with anticoagulant agents.
Amount(s) to be administered and administration route
For subcutaneous or intravenous use in cattle.
For intramuscular use in pigs.
For intravenous use in horses.
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, an oral meloxicam product may be used for continuation of treatment, 24 hours after administration of the injection.
Avoid introduction of contamination during use.
The closure may be safely punctured 15 times.
In order to prevent excessive broaching of the stopper, a suitable multiple dosing device should be used.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In case of overdose, symptomatic treatment should be initiated.
Withdrawal period(s)
Cattle:
Meat and offal: 15 days
Milk: 5 days (120 hours)
Pigs:
Meat and offal: 5 days
Horses:
Meat and offal: 5 days
Not authorised for use in horses producing milk for human consumption.