Quadrisol (vedaprofen) – Summary of product characteristics - QM01AE90
Updated on site: 09-Feb-2018
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 3. PHARMACEUTICAL FORM
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.3 Contraindications
- 4.4 Special warnings for each target species
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period(s)
- 5. PHARMACOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBER(S)
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF REVISION OF THE TEXT
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:
Propylene glycol: 130 mg
For the full list of excipients, see section 6.1.
4.2Indications for use, specifying the target species
Reduction of inflammation and relief of pain associated with
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.
4.4Special 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.
4.5Special 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.
4.6Adverse 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.
4.7Use during pregnancy, lactation or lay
Can be used during pregnancy.
The safety of the veterinary medicinal product has not been established during lactation
4.8Interaction 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.
4.9Amounts 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.
ATCvet code: QM01AE90
Vedaprofen is a
Vedaprofen is rapidly absorbed following oral administration. Bioavailability after oral administration is
6.1List of excipients
Water (minimum purified grade),
Potassium hydroxide (E525),
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
6.4Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5Nature 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
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
Otto Hahnweg 24
3542 AX Utrecht
8.MARKETING AUTHORISATION NUMBER(S)
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 4 December 1997
Date of last renewal: 13 November 2007
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