SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Loxicom 5 mg/ml solution for injection for dogs and cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substances:

Meloxicam 5 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, anhydrous	150 mg
Meglumine
Glycine
Poloxamer 188
Sodium chloride
Glycofurol
Sodium hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injection

Pale yellow solution.

3. CLINICAL INFORMATION

3.1 Target species

Dogs and cats.

3.2 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.

3.3 Contraindications

Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders. Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.

3.4 Special warnings

For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.

3.5 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.

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 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 Dogs and cats:

Very rare (<1 animal / 10,000 animals treated, including isolated reports):

Appetite loss1, lethargy1 Vomiting1, diarrhoea1, blood in faeces1,2, haemorrhagic diarrhoea1, haematemesis1, gastric ulcer1, small intestine ulcer1 Elevated liver enzymes1 Renal failure1 Anaphylactoid reaction3

¹ Transient in most cases, occur within the first week of treatment and disappear following termination of treatment. In very rare cases, may be serious or fatal.

² Occult.

³ 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

Do not use in pregnant or lactating animals.

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

3.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. The veterinary medicinal product must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs 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 other anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs 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.

3.9 Administration routes and dosage

Dogs: subcutaneous or intravenous use. Cats: subcutaneous use.

Dogs:

Musculo-skeletal disorders: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg bodyweight (i.e. 0.4 ml/10 kg bodyweight). Loxicom 1.5 mg/ml oral suspension and Loxicom 0.5 mg/ml oral suspension may be used for continuation of treatment at a dosage of 0.1 mg meloxicam/kg bodyweight, 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 bodyweight (i.e. 0.4 ml/10 kg bodyweight) before surgery, for example at the time of induction of anaesthesia.

Cats:

Reduction of post-operative pain in cats where no oral follow-up treatment is possible e.g. feral cats:

Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg bodyweight (i.e. 0.06 ml/kg bodyweight) before surgery, for example at the time of induction of anaesthesia. In this case do not use oral follow up treatment.

Reduction of post-operative pain in cats when administration of meloxicam is to be continued as an oral follow-up therapy:

Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.04 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.

To continue treatment for up to five days, this initial dose may be followed 24 hours later by administration of Loxicom 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered for up to a total of four doses at 24-hour intervals.

Particular care should be taken with regard to the accuracy of dosing.

A suitably graduated 1 ml syringe should be used for administration of the veterinary medicinal product to cats.

Avoid introduction of contamination during use.

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 Not applicable.

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, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

4.3 Pharmacokinetics

Absorption

Following subcutaneous administration, meloxicam is completely bioavailable and maximal mean plasma concentrations of 0.73 µg/ml in dogs and 1.1 µg/ml in cats were reached approximately 2.5 hours and 1.5 hours post-administration, respectively.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range in dogs and cats. More than 97 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg in dogs and 0.09 l/kg in cats.

Metabolism

In dogs, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains 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.

In cats, meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Five major metabolites were detected all having been shown to be pharmacologically inactive. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. As for other species investigated, the main pathway of meloxicam biotransformation in cats is oxidation.

Elimination

In dogs, meloxicam is eliminated with a half-life of 24 hours. Approximately 75 % of the administered dose is eliminated via faeces and the remainder via urine.

In cats, meloxicam is eliminated with a half-life of 24 hours. The detection of metabolites from the parent compound in urine and faeces, but not in plasma is indicative for their rapid excretion. 21 % of the recovered dose is eliminated in urine (2 % as unchanged meloxicam, 19 % as metabolites) and 79 % in the faeces (49 % as unchanged meloxicam, 30 % as metabolites).

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 containing colourless glass injection vial of 10, 20 or 100 ml solution for injection, closed with a bromobutyl stopper 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 02000/5006

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