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Quadrisol

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Summary for the public


What is Quadrisol?

Quadrisol is an oral gel presented in graduated multidose oral syringes that contain the active substance vedaprofen as 100 mg/ml (for horses).


What is Quadrisol used for?

Quadrisol is a pain killer (an anti-inflammatory and analgesic) used in horses.

In horses, Quadrisol 100 mg/ml oral gel is used to relieve pain and reduce inflammation due to problems with and injury to the muscles, bones and joints and also injuries to other non-bony areas of the body(so called soft tissue lesions) including the trauma caused by surgery. The oral gel can be given 3 hours or earlier before a surgical operation. The dose, frequency, route, and length of treatment depends on the weight and type of animal and the condition to be treated. For details, please see the Package Leaflet.


How does Quadrisol work?

Quadrisol contains vedaprofen, which belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Vedaprofen blocks an enzyme (cyclo-oxygenase) that is involved in the production of prostaglandins. Prostaglandins are substances that trigger pain, swelling and inflammation, and the action of Quadrisol reduces these responses.


How has Quadrisol been studied?

Quadrisol has been studied in laboratory animals, as well as specifically in horses treated in a number of veterinary practices/clinics (“clinical studies”) across Europe.

Horse:
Quadrisol has been studied in a large number of horses with bone, muscle and other soft tissue and joint problems. The response of the horses to treatment was measured using the improvement in specific clinical scores for each condition studied. The efficacy of Quadrisol was compared with another similar product.


What benefit has Quadrisol shown during the studies?

Quadrisol oral gel improved the clinical scores for lameness and soft tissue injuries in horses. The response to treatment with Quadrisol was similar to the response to the other similar product.


What are the side effects of Quadrisol?

The side effects of Quadrisol are typical for those seen with other medicines from this product class (NSAIDs) such as damage to (lesions) the mouth, stomach, intestines (including soft stools or diarrhea) and the kidneys or lethargy. In horses, skin rashes (urticaria) have been reported. All of these effects are reversible.

Quadrisol must not be administered in conjunction with other drugs that work in the same way (NSAIDs) or with other anti-inflammatory drugs such as the glucocorticosteroids.

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


What are the precautions for the person who gives the medicine or comes into contact with the animal?

Quadrisol has been developed especially for horses and is not intended for use in humans.


What is the time to allow before a horse can be slaughtered and the meat used for human consumption (withdrawal period)?

After the last day of treatment with Quadrisol, horses should not be slaughtered for 12 days.


What is the time to allow before milk can be taken from the animal for human consumption?

The use of Quadrisol is not permitted in horses producing milk that is intended for human consumption.


Why has Quadrisol been approved?

The Committee for Medicinal Products for Veterinary Use (CVMP) agreed that the benefits of Quadrisol to reduce of inflammation and relieve pain caused by musculoskeletal disorders and trauma are greater than any risks associated with this treatment. CVMP recommended that Quadrisol should be given a marketing authorisation. The benefit-risk balance may be found in module 6 of this EPAR.


Other information about Quadrisol

The European Commission granted a marketing authorisation valid throughout the European Union, for Quadrisol to Intervet International B.V. on 16 July 1997. Later approval was given for the oral use in dogs (February 1999) and a solution for injection for horses (November 1999); however, in August 2008 the Marketing Authorisation Holder withdrew these presentations for commercial reasons. Information on the prescription status of this product may be found on the label of the carton box that contains the product.

Authorisation details
Name: Quadrisol
EMEA Product number: EMEA/V/C/000032
Active substance: vedaprofen
INN or common name: Vedaprofen
Species: Horses
ATCvet Code: QM01AE90
Marketing Authorisation Holder: Pfizer Ltd.
Revision: 16
Date of issue of Market Authorisation valid throughout the European Union: 04/12/1997
Contact address:
Pfizer Ltd.
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom



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    • Product Characteristics

    ANNEX I

    SUMMARY OF PRODUCT CHARACTERISTICS


    1.
    NAME OF VETERINARY THE 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 a full list of excipients, see section 6.1.
    3.
    PHARMACEUTICAL FORM
    Oral gel
    4.
    CLINICAL PARTICULARS
    4.1 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.
    2
    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 Withdrawalperiod(s)
    Meat and offal: 12 days
    Not authorised for use in lactating animals producing milk for human consumption.
    5.
    PHARMACOLOGICAL PROPERTIES
    Pharmacotherapeutic group:
    non-steroidal anti-inflammatory drug
    ATCvet code: QM01AE90
    3
    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 E 2 (PG E 2 ) synthesis in exudate and
    thromboxane B 2 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 PGF 2α antagonists.
    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 B 2 formation inhibition assay. Approximately 70% of an orally
    administered dose is excreted in the urine.
    6.
    PHARMACEUTICAL PARTICULARS
    6.1 List of excipients
    Water (minimum purified grade),
    Propylene glycol,
    Hydroxyethylcellulose,
    Potassium hydroxide (E525),
    Hydrochloric acid
    Chocolate flavour.
    6.2 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. Specialprecautionsforstorage
    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.
    4
    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
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    United Kingdom
    8.
    MARKETING AUTHORISATION NUMBERS
    EU/2/97/005/001
    EU/2/97/005/005
    9.
    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
    4 December 1997 / 13 November 2007
    10. DATE OF REVISION OF THE TEXT
    29.01.2010
    PROHIBITION OF SALE, SUPPLY AND/OR USE
    Not applicable.
    5
    ANNEX II
    A.
    MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR
    BATCH RELEASE
    B.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION REGARDING SUPPLY OR USE
    C.
    CONDITIONS OR RESTRICTIONS OF THE MARKETING
    AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
    D.
    STATEMENT OF THE MRLs
    6
    A. MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH
    RELEASE
    Name and address of the manufacturer responsible for batch release
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Intervet Productions S.A.
    Rue de Lyons
    F – 27460 Igoville
    France
    The printed package leaflet of the medicinal product must state the name and address of the
    manufacturer responsible for the release of the concerned batch.
    B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION
    REGARDING SUPPLY OR USE
    To be supplied only on veterinary prescription.
    C. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH
    REGARD TO THE SAFE AND EFFECTIVE USE OF THE PRODUCT
    Not applicable.
    D.
    STATEMENT OF THE MRLs
    Vedaprofen is included in Annex I of Council Regulation (EEC) No 2377/90 in accordance with the
    following table:
    Pharmacologically
    active substance
    Marker
    residue
    Animal
    species
    MRLs
    Target tissues Other provisions
    vedaprofen
    vedaprofen
    Equidae
    1000 µg/kg
    100 µg/kg
    50 µg/kg
    20 µg/kg
    Kidney
    Liver
    Muscle
    Fat
    Excipients are included in Annex II of Council Regulation (EEC) No. 2377/90 in accordance with the
    following table:
    Pharmacologically active substance Animal Species
    Other provisions
    Potassium hydroxide (E525) 1
    All food producing species
    Hydrochloric acid
    Propylene glycol 2
    Hydroxyethylcellulose and chocolate flavour are not within the scope of
    Council Regulation 2377/90.
    1 OJ No. L 272 of 25.10.96
    2 OJ No. L 045 of 15.02.97
    7
     
    ANNEX III
    LABELLING AND PACKAGE LEAFLET
    8
    A. LABELLING
    9
    PARTICULARS TO APPEAR ON THE OUTER PACKAGE
    100 mg/ml oral gel for horses
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Quadrisol 100 mg/ml oral gel for horses
    2.
    STATEMENT OF ACTIVE AND OTHER SUBSTANCES
    Vedaprofen:
    100 mg/ml
    3.
    PHARMACEUTICAL FORM
    Oral gel.
    4.
    PACKAGE SIZE
    Adjustable dose syringe, containing 30 ml gel (EU/2/97/005/001)
    3 adjustable dose syringes, each containing 30 ml gel (EU/2/97/005/005)
    5.
    TARGET SPECIES
    Horse.
    6.
    INDICATION
    Reduction of inflammation and relief of pain.
    7.
    METHOD AND ROUTE OF ADMINISTRATION
    For oral use.
    8.
    WITHDRAWAL PERIOD
    Meat and offal: 12 days
    Not authorised for use in lactating animals producing milk for human consumption.
    9.
    SPECIAL WARNINGS, IF NECESSARY
    If side effects occur, treatment should be discontinued.
    Do not use in lactating mares.
    For full contra-indications, see package leaflet.
    10
     
    10. EXPIRY DATE
    EXP: {Month/year}
    11. SPECIAL STORAGE CONDITIONS
    No special precautions for storage.
    Shelf-life after first opening the immediate packaging: 2 months
    12. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS 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.
    13. THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR
    RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
    For animal treatment only. To be supplied only on veterinary prescription.
    14. THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
    Keep out of the reach and sight of children.
    15. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    United Kingdom
    16. MARKETING AUTHORISATION NUMBERS
    EU/2/97/005/001 (1 x 30 ml)
    EU/2/97/005/005 (3 x 30 ml)
    17. MANUFACTURER’S BATCH NUMBER
    Batch: {number}
    11
     
    MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
    {label on the syringe}
    1.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Quadrisol 100 mg/ml oral gel for horses
    2.
    QUANTITY OF THE ACTIVE SUBSTANCE(S)
    Vedaprofen:
    100 mg/ml
    Propylene glycol:
    130 mg/ml
    3.
    CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
    30 ml
    4.
    ROUTE OF ADMINISTRATION
    For oral use.
    5.
    WITHDRAWAL PERIOD
    Meat and offal: 12 days
    6.
    BATCH NUMBER
    Batch: {number}
    7.
    EXPIRY DATE
    EXP: {Month/year}
    8.
    THE WORDS “FOR ANIMAL TREATMENT ONLY”
    For animal treatment only.
    12
     
    B. PACKAGE LEAFLET
    13
    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 :
    Pfizer Limited
    Ramsgate Road
    Sandwich
    Kent CT13 9NJ
    United Kingdom
    Manufacturers for the batch release :
    Intervet International B.V.
    Wim de Körverstraat 35
    5831 AN Boxmeer
    The Netherlands
    Intervet Productions S.A.
    Rue de lyons
    F- 27460 Igoville
    France
    The printed package leaflet of the medicinal product must state the name and address of the
    manufacturer responsible for the release of the concerned batch.
    2.
    NAME OF VETERINARY THE MEDICINAL PRODUCT
    Quadrisol 100 mg/ml oral gel for horses.
    3.
    STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S)
    Propylene glycol:
    100 mg/ml
    4.
    INDICATION
    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.
    14
    Vedaprofen:
    130 mg/ml
    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 other side effects, please inform your veterinary surgeon.
    7.
    TARGET SPECIES
    Horse.
    8.
    DOSAGE FOR EACH SPECIES, ROUTE 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
    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 reach and sight of children.
    No special precautions for storage.
    Shelf-life after first opening of the product: 2 months.
    Do not use after the expiry date stated on the label.
    12. SPECIAL WARNINGS
    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.
    15
    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
    29.01.2010
    15. OTHER INFORMATION
    For animal treatment only.
    16


    Source: European Medicines Agency


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