Arthrocam 1.5 mg/ml Oral Suspension for Dogs

Composition

One ml contains:

Active substance:

Meloxicam 1.5 mg.

Excipient:

Sodium benzoate 5 mg.

For the full list of excipients, see section 6.1.

6.1 List of excipients

Sodium Benzoate

Saccharin Sodium

Sodium Carboxyl Methyl Cellulose

Colloidal Silicon Dioxide

Citric Acid Monohydrate

Sorbitol Solution

Disodium Hydrogen-Phosphate Dodecahydrate

Honey Flavour.

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Pharmaceutical form

Oral suspension.

An off white to yellowish coloured suspension.

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Pharmacological properties

Pharmacotherapeutic group: Anti-inflammatory and Anti-rheumatic products, Non-steroids (oxicams).

ATCvet code: QM01AC06.

5.1 Pharmacodynamic properties

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).

5.2 Pharmacokinetic particulars

Absorption

Meloxicam is completely absorbed following oral administration and maximal plasma concentrations are obtained after approximately 4.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

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

Metabolism

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.

Elimination

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.

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Target species

Dogs.

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Indications

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

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Dosage

Shake well before use.

To be administered mixed with a small amount of food, or directly into the mouth.

Initial treatment is a single dose of 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oral administration (at 24-hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight. For longer term treatment, once a clinical response has been observed (after ≥ 4 days), the dose can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

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

The suspension can be given using the measuring syringes provided in the package. The appropriate syringe should be used depending on the body weight of the animal. The syringes fit onto the bottle and have a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight). Thus for the first day, twice the maintenance volume will be required.

A clinical response is normally seen within 3–4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.

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Contraindications

Do not use in pregnant or lactating animals.

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 known cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in dogs less than 6 weeks of age.

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Adverse reactions

Dogs:

* Typical adverse reactions of NSAIDs

These side effects 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.

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 the national competent authority via the national reporting system. See also section 16 of the package leaflet for contact details.

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Warnings

Special precautions for use in animals

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

This product for dogs should not be used in cats as it is not suitable for use in this species.

Special precautions to be taken by the person administering the veterinary medicinal product to animals.

People with known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

Accidental ingestion of the product by a child may cause gastro-intestinal effects, such as nausea and gastric pain.

Any uneaten medicated food must be disposed of immediately and the bowl washed thoroughly.

Do not leave an unattended filled syringe in the sight or reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

This 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.

Other precautions:

Not applicable.

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see section 4.3).

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Interactions

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. Meloxicam must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

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 veterinary products used previously.

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Overdose

In the case of overdosage symptomatic treatment should be initiated.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

42, 100 or 200 ml polyethylene terephthalate (PET) bottle with a tamper resistant child proof closure, and a 15 ml HDPE bottle with a tamper resistant child proof closure, and two polypropylene measuring syringes: one for small dogs (up to 20 kg) and one for bigger dogs (up to 60 kg).

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 6 months.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

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Additional information

Vm 08749/5162

9 DATE OF FIRST AUTHORISATION

02 February 2024

10 DATE OF REVISION OF THE TEXT

November 2025

PROHIBITION OF SALE, SUPPLY AND/OR USE

To be supplied only on veterinary prescription.

Gavin Hall Approved: 04 November 2025

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Registration holder

Chanelle Pharmaceuticals Manufacturing Ltd

Loughrea

Co Galway

H62 FH90

Ireland

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