PACKAGE LEAFLET:

Quadrisol 100 mg/ml oral gel for horses

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Marketing authorisation holder:

   
   

   VETCOOL B.V.

   Otto Hahnweg 24

   3542 AX Utrecht NETHERLANDS

   
   

   Manufacturers responsible for batch release:

   
   

   Purna Pharmaceuticals N.V. Rijksweg 17

   B-2870 Puurs BELGIUM

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   Quadrisol 100 mg/ml oral gel for horses.

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

   
   

   Vedaprofen: 100 mg/ml Propylene glycol: 130 mg/ml

   
   

4. INDICATION(S)

   
   

   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

   
   

5. 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. Quadrisol must not be given with other NSAIDs or glucocorticosteroids.

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

   
   

6. ADVERSE REACTIONS

   
   

   Typical non-steroidal anti-inflammatory drugs (NSAIDs) side effects such as 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.

   
   

   If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

7. TARGET SPECIES

   
   

   Horse.

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

   
   

   Quadrisol is intended for twice daily administration. The advised dosage is an initial dose of 2 mg/kg

   (2.0 ml/100 kg) followed by a maintenance dose of 1 mg/kg (1.0 ml/100 kg) given every 12 hours.

   
   

   For oral use.

   
   

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   Treatment can be continued for a maximum of 14 consecutive days. Bodyweight and dosage rate must be accurately determined to avoid overdosing. In case of prophylactic treatment, a maximum duration of treatment of 7 consecutive days is sufficient.

   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.

   
   

10. WITHDRAWAL PERIOD(S)

    
    

    Meat and offal: 12 days.

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

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the sight and reach of children. No special precautions for storage.

    Shelf-life after first opening of the product: 2 months.

    Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

    
    

12. SPECIAL WARNING(S)

    
    

    The safety of the veterinary medicinal product has not been established during lactation. Quadrisol 100 mg/ml can be used during pregnancy.

    
    

    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 the use in any dehydrated, hypovolaemic or hypotensive animals, as there may be potential risk of increased renal toxicity.

    
    

    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.

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

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

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

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    Detailed information on this product is available on the website of the European Medicines Agency ()

    
    

15. OTHER INFORMATION

For animal treatment only.