Equitape 90 mg/g Oral Gel for Horses

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Praziquantel

Disponibil de la:

Bayer plc

Codul ATC:

QP52AA01

INN (nume internaţional):

Praziquantel

Forma farmaceutică:

Oral gel

Tip de prescriptie medicala:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Grupul Terapeutică:

Horses

Zonă Terapeutică:

Anthelmintic

Statutul autorizaţiei:

Expired

Data de autorizare:

2002-01-31

Caracteristicilor produsului

Revised: May 2014
AN: 01882/2013
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Droncit 9% Oral Gel for Horses
[AT, DE, PT]
Droncit vet oral gel (for horses)
[DK, FI, IS, NO, SE]
Equitape 90 mg/g Oral Gel for Horses
[IE, UK]
Droncit 9% Gel Oral Cheval
[FR]
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)
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
Revised: May 2014
AN: 01882/2013
Page 2 of 4
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 onto human skin should be removed by
washing with soap and water.
Do not eat, drink or smoke during application
4.6.
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In case of very high infestation levels, destruction of the tapeworms
may cause
a mild transient colic and loose faeces