Zerofen 22 % Granules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fenbendazole

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP52AC13

INN (International Name):

Fenbendazole

Dosage:

22 percent weight/weight

Pharmaceutical form:

Granules

Prescription type:

CAM: Companion Animal Medicine as defined in relevant national legislation

Therapeutic area:

fenbendazole

Authorization status:

Authorised

Authorization date:

1996-03-15

Summary of Product characteristics

Health Products Regulatory Authority
15 November 2018
CRN008PVY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zerofen 22 % Granules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Fenbendazole 222.2 mg/g
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
Dogs and cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Zerofen 22% Granules is indicated for the treatment of immature and
mature stages
of nematodes of the gastro-intestinal and respiratory tracts of
domestic dogs and
cats. It also has an ovicidal effect and is indicated for the
following:
For the treatment of gastrointestinal nematodes and cestodes of
domestic dogs and
cats affected with _Ascarid_ spp., _Ancylostoma_ spp., _Uncinaria_
spp., _Trichuris_ spp. and
_Taenia_ spp.. Also for the treatment of lungworm nematodes of
domestic dogs
affected with _Oslerus (Filaroides) osleri,_ and domestic cats
affected with
_Aelurostrongylus abstrusus_.
For the treatment of pregnant bitches to reduce pre-natal infections
with _Toxocara _
_canis_ and the transfer of _Toxocara canis_ and _Ancylostoma caninum_
to their pups _via_
the milk.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active
ingredient.
Health Products Regulatory Authority
15 November 2018
CRN008PVY
Page 2 of 4
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO
ANIMALS
Direct contact with the skin should be kept to a minimum. Avoid the
inhalation of
dust. Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Zerofen 22% Granules may be safely used in pregnant and young animals
when
administered according to the recommended dosing schedules.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND