Zanil Fluke Drench 34 mg/ml Oral Suspension

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxyclozanide

Available from:

MSD Animal Health UK Limited

ATC code:

QP52AG06

INN (International Name):

Oxyclozanide

Pharmaceutical form:

Oral suspension

Prescription type:

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

Therapeutic group:

Cattle, Sheep

Therapeutic area:

Anthelmintic flukicide

Authorization status:

Authorized

Authorization date:

1972-09-01

Summary of Product characteristics

Revised: December 2020
AN: 01225/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Zanil Fluke Drench 34 mg/ml Oral Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
mg/ml
Oxyclozanide
34
EXCIPIENTS:
Methyl hydroxybenzoate (E218)
1.5
Propyl hydroxybenzoate
0.15
Sodium metabisulphite (E223)
1.0
For full list of excipients, see section
6.1
3.
PHARMACEUTICAL FORM
Oral suspension
A smooth off white pourable suspension
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and Sheep
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Indications: _ For the treatment and control of chronic fascioliasis
in cattle and
sheep.
It removes practically all flukes (_Fasciola_ spp.) present in the
bile ducts of the liver.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
At normal dose levels, oxyclozanide is not active against immature
flukes present
in liver tissue.
Milking cattle, particularly high yielders, may occasionally show a
reduction in yield
of 5% or more for about 48 hours after handling. The effect of this
small loss may
be minimised by spreading herd dosing over a period of about a week.
Revised: December 2020
AN: 01225/2020
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
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).
Suspected clinical cases of resistance to anthelmintics should be
further
investigates 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 anthe