EQUITAPE 90 MG/G ORAL GEL FOR HORSES
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
02-05-2024
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Ingredient activ:
PRAZIQUANTEL
Disponibil de la:
Bayer Limited
Codul ATC:
QP52AA01
INN (nume internaţional):
PRAZIQUANTEL
Dozare:
90 mg/g
Forma farmaceutică:
Oral Gel
Tip de prescriptie medicala:
LM-Licensed Merchant
Grupul Terapeutică:
Equine - Food
Zonă Terapeutică:
Praziquantel
Indicații terapeutice:
Endoparasiticide
Statutul autorizaţiei:
Authorised
Data de autorizare:
2002-02-08
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Equitape 90 mg/g Oral Gel for Horses.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Praziquantel …………………...........................90.0 mg
EXCIPIENTS
Propyl Parahydroxybenzoate (E 216) …………0.2 mg
Methyl Parahydroxybenzoate (E 218) …………1.4 mg
Excipients ad……………………………………1.0 g
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Gel.
White soft gel.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections with cestodes of the species _Anoplocephala perfoliata_, sensitive to praziquantel.
4.3 CONTRAINDICATIONS
None known.
Milk: see section 4.11.
(Do not use in mares from which milk is taken for human consumption).
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/01/2012_
_CRN 7011335_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As tapeworm infestation is unlikely to occur in horses before two months of age, treatment of foals below this age is
not considered necessary.
In order to limit excretion of the product and its metabolites on the pasture horses should remain stabled for 2 days after
treatment.
Parasite resistance to a particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic
of that class.
MRLs for milk have not been established.
See section 4.11 Withdrawal periods.
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCTS TO ANIMALS
Wash hands thoroughly after treating animals.
Any spillage of the product
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