Quadrisol
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
24-08-2017
Fachinformation
(SPC)
24-08-2017
Öffentlichen Beurteilungsberichts
(PAR)
24-08-2017
Wirkstoff:
vedaprofen
Verfügbar ab:
VETCOOL B.V.
ATC-Code:
QM01AE90
INN (Internationale Bezeichnung):
vedaprofen
Therapiegruppe:
Horses
Therapiebereich:
Anti inflammatory and antirheumatic products
Anwendungsgebiete:
Reduction of inflammation and relief of pain associated with musculoskeletal disorders and soft-tissue lesions (traumatic injuries and surgical trauma). In cases of anticipated surgical trauma, Quadrisol can be given prophylactically at least three hours prior to elective surgery.,
Produktbesonderheiten:
Revision: 18
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
1997-12-04
Gebrauchsinformation
13
B.
PACKAGE LEAFLET
14
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.
15
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
k
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 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.
3
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals
In case of accidental ingestion, seek medical advice imme
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