Animeloxan 1.5 mg/ml Oral Suspension for Dogs

Composition

Each ml of suspension contains:

Active substance:

Meloxicam 1.5 mg

Excipient:

Sodium benzoate 1.5 mg

For a full list of excipients, see section 6.1.

6.1 List of excipients

Sodium benzoate

Microcrystalline cellulose

Carmellose sodium

Glycerol

Sorbitol, Liquid (non-crystallising)

Xylitol

Sodium dihydrogen phosphate dihydrate

Saccharin Sodium

Honey Flavour IFF RS 80008

Citric acid monohydrate

Purified Water

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Pharmaceutical form

Oral suspension

The veterinary medicinal product is a pale yellow viscous suspension.

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Pharmacological properties

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)

ATC Vet Code: QM 01 AC 06

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 7.5 hours. When the veterinary medicinal 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.

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Dosage

Shake well before use.

To be administered mixed with 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 (equivalent to 0,07 ml/kg).

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

The suspension can be given using the measuring syringe provided in the package. The syringe provided allows dosing for dogs with a body weight of 2.5 – 45 kg. For dosing dogs with a body weight of less than 2.5 kg, a syringe with a smaller volume (0.5 ml, 1 ml) must be used. The syringe fits onto the bottle and has a kg-body weight scale which corresponds to the maintenance dose (i.e. 0.1 mg meloxicam/kg body weight corresponds to 0,07 ml/kg bodyweight). Thus for the first day, twice the maintenance volume will be required.

Illustration captions:

Shake bottle well. Push down and unscrew bottle top. Attach the dosing syringe to the bottle by gently pushing the end onto the top of the bottle.

Turn the bottle/syringe upside down. Pull the plunger out until the line on the plunger corresponds to your dog’s bodyweight in kilograms

Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle

Empty the contents of the syringe onto the food by pushing the plunger in or directly into the mouth.

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.

For longer term treatment, once clinical response has been observed (after ≥ 4 days), the dose of the veterinary medicinal product 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.

Avoid introduction of contamination during use.

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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 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

Dog:

Undetermined frequency (cannot be estimated from the available data):

Appetite loss¹, vomiting¹, diarrhoea¹, blood in faeces¹˒², apathy¹

¹These typical adverse drug reactions of NSAIDs occur occasionally and 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.

²occult

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 the last section of the package leaflet for respective contact details.

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Warnings

i). 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 any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

In case of prolonged use, monitoring during treatment should be carried out.

ii). Special precautions to be take by the person administering the veterinary medicinal product to animals

People with known hypersensitivity to NSAIDs should avoid contact with the veterinary medicinal product.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment:

Not applicable.

iii). 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 or lactation.

Pregnancy:

Do not use during pregnancy

Lactation:

Do not use for nursing bitches

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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 drugs should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacokinetic properties of the veterinary medicinal products used previously.

Meloxicam may antagonise the antihypertensive effects of ACE inhibitors.

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Overdose

In the case of overdosage symptomatic treatment should be initiated. Please refer to Section 4.6 (Adverse reactions) for details of symptoms.

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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

High density polyethylene bottle with polyethylene inner and outer cap.

Measuring device: Polypropylene syringe

Pack size(s): Bottles of 10 ml, 25 ml, 50ml, 100 and 125 ml

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: 3 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 24745/5000

9 DATE OF FIRST AUTHORISATION

15 August 2008

10 DATE OF REVISION OF THE TEXT

August 2023

11 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Veterinary medicinal product subject to prescription.

Approved 23 January 2024

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Registration holder

aniMedica GmbH

Im Südfeld 9

48308 Senden-Bösensell

Germany

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