Zerofen 22% Equine Granules

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Fenbendazole

MAH:

Chanelle Animal Health Ltd

ATC_code:

QP52AC13

INN:

Fenbendazole

pharmaceutical_form:

Granules for oral suspension

prescription_type:

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

therapeutic_group:

Horses

therapeutic_area:

Anthelmintic

authorization_status:

Authorized

authorization_date:

1998-07-31

SPC

ID: S49 UK
VERSION: 06
EFFECTIVE DATE: 02/12/03
PREPARED BY:
APPROVED BY:
PAGE 1 OF 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zerofen 22% Equine Granules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Fenbendazole 22% w/w
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules
White to greyish white granules
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses and other equines
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
Zerofen 22% Equine Granules is a broad spectrum anthelmintic for the
treatment of
horses and other equines infected with benzimidazole susceptible
immature and
mature stages of nematodes of the gastro-intestinal including large
redworms
(_Strongylus _
_vulgaris, _
_Strongylus _
_edentatus_)
and
migrating
large
redworms,
benzimidazole susceptible small redworms and encysted mucosal larvae,
_Ascarids_,
_Oxyuris_ and Strongyloides species. Also kills nematode eggs.
4.3
CONTRAINDICATIONS
Not to be used in animals hypersensitive to the ingredients.
4.4
SPECIAL WARNINGS
Care should be taken to avoid the following practices because they
increase
the risk of development of resistance and could ultimately result in
ineffective
therapy:
•
Too frequent and repeated use of anthelmintics from the same class,
over an extended period of time.
•
Underdosing, which may be due to underestimation of body weight,
misadministration of the product, or lack of calibration of the dosing
device (if any).
ID: S49 UK
VERSION: 06
EFFECTIVE DATE: 02/12/03
PREPARED BY:
APPROVED BY:
PAGE 2 OF 5
Suspected clinical cases of resistance to anthelmintics should be
further investigated
using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where
the results of
the test(s) strongly suggest resistance to a particular anthelmintic,
an anthelmintic
belonging to another pharmacological class and having a different mode
of action
should be used.
Resistance to Fenbendazole (a benzimidazole) has been reported in
cyathostomes in ho