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-metritisagalactia 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
See also section, "Use during pregnancy, lactation or lay"
Do not use in horses less than 6 weeks of age.
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.
Special warnings for each target species
Treatment of calves with Loxicom 20 minutes before dehorning reduces post-operative pain. Loxicom 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 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 cases 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
Accidental self injection may cause 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 the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Administration of the veterinary medicinal product by the subcutaneous route in cattle and the intramuscular route in pigs is well tolerated; only a slight transient swelling at the injection site following subcutaneous administration was observed in less than 10% of cattle treated in clinical studies.
In horses, a transient swelling at the injection site can occur but resolved without intervention.
In very rare cases anaphylactoid 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 reactions)
•common (more than 1 but less than 10 animals treated in 100 animals)
•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, lactation or lay
Cattle and Pigs: Can be used during pregnancy and lactation. See also section, Contraindications
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 non-steroidal anti-inflammatory drugs or with anti-coagulant agents.
Amounts to be administered and administration route
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. The recommended maximum volume to be administered at a single injection site is 10ml.
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. The recommended maximum volume to be administered at a single injection site is 2 ml.
Horses:
Single intravenous injection as 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, a suitable oral therapy containing meloxicam, administered in accordance with label recommendations, may be used for continuation of treatment.
Avoid introduction of contamination during use.
Do not exceed 50 broachings per vial. If more than 50 broachings are required, the use of a draw-off needle is recommended.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In the case of overdose, symptomatic treatment should be initiated.
Withdrawal period(s)
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.