Wormazole 880 mg Granules for Dogs

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Fenbendazole

MAH:

Norbrook Laboratories Limited

ATC_code:

QP52AC13

INN:

Fenbendazole

pharmaceutical_form:

Granules

prescription_type:

NFA-VPS - Non-Food Animal – Veterinarian, Pharmacist, Suitably Qualified Person

therapeutic_group:

Dogs

therapeutic_area:

Anthelmintic

authorization_status:

Expired

authorization_date:

2001-08-14

SPC

SPC_265252.DOC
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Wormazole 880 mg Granules for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 4 g sachet contains
ACTIVE SUBSTANCE:
MG
Fenbendazole
880
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Granules.
White to off-white Granules.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Wormazole is a broad spectrum anthelmintic for the treatment and
control of mature
and immature stages of nematodes and cestodes of the gastrointestinal
and respiratory
tracts of dogs. Wormazole has also an ovicidal effect on nematode
eggs. It is also
effective against the protozoa, _Giardia_ spp.
Adult Dogs:
For the treatment of adult dogs infected with clinical and subclinical
gastrointestinal
nematodes and cestode burden detailed below and the protozoa,
_Giardia_ spp:
_Ascarid_ spp (_Toxocara canis _and _Toxascaris leonina_)
_Ancylostoma_ spp
_Trichuris_ spp
_Uncinaria_ spp
_Taenia_ spp
Puppies:
For the treatment of weaned puppies infected with gastrointestinal
nematodes and the
protozoa _Giardia_ spp.
Pregnant Dogs:
SPC_265252.DOC
For the treatment of pregnant dogs to reduce prenatal infections of _
Toxocara canis_
and the transfer of _T. canis_ and _Ancylostoma caninum_ to their pups
via the milk.
Also Wormazole is indicated for the treatment of dogs infected with
lungworm
_Oslerus (Filaroides) osleri_ and protozoa _Giardia _spp.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Assess bodyweight as accurately as possible before calculating the
dosage.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Direct contact with the skin should be kept to a minimum. Wash hands
after use.
Avoid inhalation of dust.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Wormazole is saf