Fenbendazole Wormer Granules 888 mg for Adult Dogs

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Fenbendazole

Fáanlegur frá:

C&H Generics Ltd

ATC númer:

QP52AC13

INN (Alþjóðlegt nafn):

Fenbendazole

Lyfjaform:

Granules

Gerð lyfseðils:

AVM-GSL - Authorised Veterinary Medicine – General Sales List

Meðferðarhópur:

Dogs

Lækningarsvæði:

Anthelmintic

Leyfisstaða:

Expired

Leyfisdagur:

2016-08-17

Vara einkenni

Issued: August 2016
AN: 01702/2013
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenbendazole Wormer Granules 888 mg for Adult Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
ACTIVE SUBSTANCE:
Fenbendazole 888.8 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Granules
A free flowing white to greyish white granular powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs
For the treatment of immature and mature stages of Toxacara canis and
Taenia
hydatigena.
4.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None
Issued: August 2016
AN: 01702/2013
Page 2 of 4
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
The product can cause irritation to the skin, eyes and lungs. Direct
contact with the
skin should be kept to a minimum. Avoid inhalation of granule dust.
Wash hands
after use. Avoid contact with the eyes. In case of accidental eye
contact, irrigate the
eyes with plenty of clean water. If irritation persists, seek medical
advice. Only use
for the bodyweight of animal recommended. The entire contents of the
sachet must
be directly sprinkled onto food as a single dose. Discard any uneaten
medicated
feed.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known
4.7
USE DURING PREGNANCY, LACTATION OR LAY
Not recommended.
Seek the advice of a veterinary surgeon before using the product
during pregnancy
or lactation
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral administration only; sprinkled onto food.
For the routine treatment of adult dogs a dosage of 100 mg/kg is
recommended.
This equates to approximately 1