1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Novaquin 15 mg/ml oral suspension for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml contains:

Active substance:

Meloxicam Excipients:	15 mg
Sodium benzoate	1.75 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral suspension.

Yellowish-green viscous oral suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Horses.

4.2 Indications for use, specifying the target species

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

4.3 Contraindications

Do not use in pregnant or lactating mares.

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

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

Avoid use in any dehydrated, hypovolemic or hypotensive animals as there is a potential risk of renal toxicity.

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.

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

4.6 Adverse reactions (frequency and seriousness)

Isolated cases of adverse reactions typically associated with NSAIDs were observed in clinical trials (slight urticaria, diarrhoea). The clinical signs were reversible.

Loss of appetite, lethargy, abdominal pain and colitis have been reported in very rare cases.

Anaphylactoid reactions, which may be serious (including fatal), may occur in very rare cases and should be treated symptomatically.

If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals treated displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals treated)

- 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).

4.7 Use during pregnancy, lactation or lay

Laboratory studies in cattle have not provided any evidence for teratogenic, foetotoxic, or maternotoxic effects. However, no data have been generated in horses. Therefore do not use the product during pregnancy and lactation (see section 4.3).

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer concurrently with glucocorticoids, other non-steroidal anti-inflammatory drugs or with anticoagulant agents.

4.9 Amounts to be administered and administration route

For oral use.

To be administered either mixed with food or directly into the mouth at a dosage of 0.6 mg/kg body weight, once daily, up to 14 days. In case the product is mixed with food, it should be added to a small quantity of food, prior to feeding.

The suspension should be given using the measuring syringe provided in the package. The syringe fits onto the bottle and has a kg-body weight scale.

Shake vigorously at least 20 times before use.

After administration of the veterinary medicinal product, close the bottle by replacing the cap, wash the measuring syringe with warm water and let it dry.

Avoid introduction of contamination during use.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose symptomatic treatment should be initiated.

4.11 Withdrawal period(s)

Meat and offal: 3 days.

Not authorised for use in mares producing milk for human consumption.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinflammatory and antirheumatic 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. Meloxicam also has anti-endotoxic properties because it has been shown to inhibit production of thromboxane B2 induced by intravenous E. coli endotoxin administration in calves and pigs.

5.2 Pharmacokinetic particulars

Absorption

When the product is used according to the recommended dosage regime the oral bioavailability is approximately 98 %. Maximal plasma concentrations are obtained after approximately 2–3 hours. The accumulation factor of 1.08 suggests that meloxicam does not accumulate when administered daily.

Distribution

Approximately 98 % of meloxicam is bound to plasma proteins. The volume of distribution is 0.12 l/kg.

Metabolism

The metabolism is qualitatively similar in rats, mini-pigs, humans, cattle and pigs although quantitatively there are differences. The major metabolites found in all species were the 5-hydroxy- and 5-carboxy-metabolites and the oxalyl-metabolite. The metabolism in horses was not investigated. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a terminal half-life of 7.7 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium benzoate

Glycerol

Polysorbate 80

Hydroxyethylcellulose

Silica, colloidal anhydrous

Disodium phosphate dodecahydrate

Citric acid monohydrate

Sodium cyclamate

Sorbitol, liquid

Sucralose

Anise aroma

Water, purified

6.2 Major incompatibilities

None known.

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. Shelf-life after first opening of the immediate packaging: 5 months.

6.4. Special precautions for storage

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

6.5 Nature and composition of immediate packaging

Cardboard box containing one high density polyethylene (HDPE) bottle of 125 ml or 336 ml with a HDPE screw cap and a polypropylene measuring syringe.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Le Vet Beheer B.V. Wilgenweg 7

3421 TV Oudewater

The Netherlands

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/15/186/001-002

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 08/09/2015 Date of last renewal: 24/06/2020

10. DATE OF REVISION OF THE TEXT

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.