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Loxicom
Active substance
ATC code
Species
Cattle, pigs and horses.
Indications
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.
Dose to be administered and administration route
Cattle: subcutaneous or intravenous use
Pigs: intramuscular use Horses: intravenous use
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 10 ml.
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.
Adverse reactions
Cattle:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Injection site swelling1, Anaphylactoid reaction2 |
1 Slight and transient following subcutaneous administration.
2 May be serious (including fatal). Treat symptomatically.
Pigs:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Anaphylactoid reaction1 |
1 May be serious (including fatal). Treat symptomatically.
Horses:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Injection site swelling1, Anaphylactoid reaction2 |
1 Transient and resolves without intervention.
2 May be serious (including fatal). Treat symptomatically.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
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.
Dispensing
POM-V - Prescription Only Medicine – Veterinarian
TRUSTED SOURCE
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Loxicom 20 mg/ml solution for injection for cattle, pigs and horses
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substances:
Meloxicam 20 mg Excipients:
|
Qualitative composition of excipients and other constituents |
Quantitative composition if that information is essential for proper administration of the veterinary medicinal product |
|
Ethanol |
150 mg |
|
Meglumine |
|
|
Glycine |
|
|
Poloxamer 188 |
|
|
Sodium chloride |
|
|
Macrogol 300 |
|
|
Hydrochloric acid |
|
|
Sodium hydroxide |
|
|
Water for injections |
|
A yellow solution.
3. CLINICAL INFORMATION
3.1 Target species
Cattle, pigs and horses.
3.2 Indications for use for each 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.
3.3 Contraindications
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 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.
3.4 Special warnings
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.
3.5 Special precautions for use
Special precautions for safe use in the target species:
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.
This veterinary medicinal product can cause eye irritation. In case of contact with the eyes, immediately rinse thoroughly with water.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Cattle:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Injection site swelling1, Anaphylactoid reaction2 |
1 Slight and transient following subcutaneous administration. 2 May be serious (including fatal). Treat symptomatically.
Pigs:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Anaphylactoid reaction1 |
1 May be serious (including fatal). Treat symptomatically.
Horses:
|
Very rare (<1 animal / 10,000 animals treated, including isolated reports): |
Injection site swelling1, Anaphylactoid reaction2 |
1 Transient and resolves without intervention.
2 May be serious (including fatal). Treat symptomatically.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.
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.
3.7 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.
3.8 Interaction with other medicinal products and other forms of interaction
Do not administer concurrently with glucocorticosteroids, other non-steroidal antiinflammatory drugs or with anti-coagulant agents.
3.9 Administration routes and dosage
Cattle: subcutaneous or intravenous use
Pigs: intramuscular use Horses: intravenous use
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 10 ml.
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.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
In the case of overdose, symptomatic treatment should be initiated.
3.11 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.
3.12 Withdrawal periods
|
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.
4. PHARMACOLOGICAL INFORMATION
4.1 ATCvet code: QM01AC06
4.2 Pharmacodynamics
Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, anti-exudative, analgesic and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by E. coli endotoxin administration in calves, lactating cows and pigs.
4.3 Pharmacokinetics
Absorption
After a single subcutaneous dose of 0.5 mg meloxicam/kg, Cmax values of 2.1 μg/ml and 2.7 μg/ml were reached after 7.7 hours and 4 hours in young cattle and lactating cows, respectively.
After two intramuscular doses of 0.4 mg meloxicam/kg, a Cmax value of 1.9 μg/ml was reached after 1 hour in pigs.
Distribution
More than 98% of meloxicam is bound to plasma proteins. The highest meloxicam concentrations are to be found in liver and kidney. Comparatively low concentrations are detectable in skeletal muscle and fat.
Metabolism
Meloxicam is predominantly found in plasma. In cattle, meloxicam is also a major excretion product in milk and bile whereas urine contains only traces of the parent compound. In pigs, bile and urine contain only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive. The metabolism in horses has not been investigated.
Elimination
Meloxicam is eliminated with a half-life of 26 hours and 17.5 hours after subcutaneous injection in young cattle and lactating cows, respectively.
In pigs, after intramuscular administration the mean plasma elimination half-life is approximately 2.5 hours.
In horses, after intravenous injection meloxicam is eliminated with a terminal half-life of 8.5 hours.
Approximately 50% of the administered dose is eliminated via urine and the remainder via faeces.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
5.2 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: 28 days.
5.3 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
5.4 Nature and composition of immediate packaging
Cardboard box with either 1 or 12 colourless glass injection vial(s) each containing 30 ml, 50 ml or 100 ml solution for injection.
Cardboard box with 1, 6 or 12 colourless glass injection vial(s) each containing 250 ml solution for injection.
Each vial is closed with a bromobutyl bung and sealed with an aluminium cap.
Not all pack sizes may be marketed.
5.5 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
6. NAME OF THE MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
7. MARKETING AUTHORISATION NUMBER
Vm 02000/5005
8. DATE OF FIRST AUTHORISATION
10 February 2009
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
September 2026
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT
Veterinary medicinal product subject to prescription.
Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.
Gavin Hall Approved: 13 October 2026
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| GTIN | • • • • • • • • • 2337 |
