Quadrisol - summary of medicine characteristics

SUMMARY OF PRODUCT CHARACTERISTICS

• 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Quadrisol 100 mg/ml oral gel for horses

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of Quadrisol oral gel contains:

Active substance:

Vedaprofen:            100 mg

Excipients:

Propylene glycol:         130 mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Oral gel

4. CLINICAL PARTICULARS4.1 Target species

Horse.

• 4.2 Indications for use, specifying the target species

Reduction of inflammation and relief of pain associated with musculo-skeletal disorders and soft tissue lesions (traumatic injuries and surgical trauma). In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least 3 hours prior to elective surgery.

4.3 Contraindications

Do not use in animals suffering from alimentary tract disorders, impaired heart, liver and kidney function. Do not use in foals under the age of 6 months. Do not use in lactating mares.

Do not use in the case of hypersensitivity to the active substance or to any of the excipients.

• 4.4 Special warnings for each target species

Horses intended for racing and competition should be treated according to local requirements. Appropriate precautions must be taken for such horses to ensure compliance with competition regulations. In case of doubt, it is advisable to test the urine.

• 4.5 Special precautions for use

Special precautions for use in animals

If side effects occur, treatment should be discontinued. Horses with oral lesions should be assessed clinically and the attending veterinarian should take a decision as to whether treatment should be continued. If oral lesions persist, treatment should be discontinued. Horses should be monitored for oral lesions during treatment. Avoid use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.

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

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)

Typical undesirable effects associated with NSAID use, such as lesions in the alimentary tract, soft faeces, urticaria and lethargy.

Side effects are reversible.

• 4.7 Use during pregnancy, lactation or lay

Can be used during pregnancy.

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

4.8 Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics and substances with high protein binding may compete for binding and lead to toxic effects. Quadrisol must not be given with other NSAIDs or glucocorticos­teroids.

• 4.9 Amounts to be administered and administration route

For oral use.

Twice daily administration. An initial dose of 2 mg/kg (2.0 ml/100 kg) is followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours. Treatment can be continued for a maximum of 14 consecutive days. In case of prophylactic treatment, a maximum duration of treatment of 7 consecutive days is sufficient.

Bodyweight and dosage must be accurately determined to avoid overdosing.

The gel is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of gel on the back of the tongue. Before administration, the syringe should be adjusted to the calculated dosage by setting the ring on the plunger.

It is advisable to administer the product before feeding.

In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least 3 hours prior to elective surgery.

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

Lesions and bleedings in the alimentary tract, diarrhoea, urticaria, lethargy, inappetence. If symptoms occur, treatment should be discontinued. Symptoms are reversible. Overdosing may lead to death of treated animals.

• 4.11 Withdrawal period(s)

Meat and offal: 12 days

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

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: non-steroidal anti-inflammatory drug

ATCvet code: QM01AE90

5.1 Pharmacodynamic properties

Vedaprofen is a non-steroidal anti-inflammatory drug (NSAID) belonging to the propionic acid derivate group. Vedaprofen inhibits the prostaglandin synthesis enzyme system (cyclo-oxygenase enzyme) and thus possesses anti-inflammatory, antipyretic and analgesic properties. Studies in the horse have demonstrated potent inhibition of prostaglandin E2 (PG E2) synthesis in exudate and thromboxane B2 synthesis in serum and exudate. Vedaprofen contains an asymmetric carbon atom and, therefore, is a racemic mixture of a (+) enantiomer and a (-) enantiomer. Both enantiomers contribute to therapeutic actions of the compound. The (+) enantiomer is more potent in inhibiting prostaglandin synthesis. Both enantiomers are equipotent PGF2aantagonists.

• 5.2 Pharmacoki­netic particulars

Vedaprofen is rapidly absorbed following oral administration. Bioavailability after oral administration is 80–90%, but is reduced significantly if medication is administered with food. The terminal half-life following oral administration is 350–500 minutes and no accumulation occurs following repeated oral dosing. Steady state is reached quickly following onset of treatment. Vedaprofen is highly bound to plasma proteins and extensively metabolised. The most abundant metabolite is a monohydroxylated derivative. All metabolites of vedaprofen were shown to be less active than the parent compound as determined by a thromboxane B2 formation inhibition assay. Approximately 70% of an orally administered dose is excreted in the urine.

6. PHARMACEUTICAL PARTICULARS6.1 List of excipients

Water (minimum purified grade),

Propylene glycol,

Hydroxyethylce­llulose,

Potassium hydroxide (E525),

Hydrochloric acid, Chocolate flavour.

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 the immediate packaging: 2 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

A 30 ml adjustable multidose syringe consisting of high density polyethylene (white) and low density polyethylene (white and natural). The syringe is fitted with variable dose capability, adjustable in steps of 0.5 ml and graduated to 1 ml. The product is presented as a single syringe in a carton box or as a multipack of 3 syringes in a carton box.

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

7. MARKETING AUTHORISATION HOLDER

VETCOOL B.V.

Otto Hahnweg 24

3542 AX Utrecht

NETHERLANDS

8. MARKETING AUTHORISATION NUMBER(S)

EU/2/97/005/001

EU/2/97/005/005

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 4 December 1997

Date of last renewal: 13 November 2007