Zerofen 10% Oral Suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Fenbendazole
Available from:
Chanelle Pharmaceuticals Manufacturing Limited
ATC code:
QP52AC13
INN (International Name):
Fenbendazole
Dosage:
10 percent weight/volume
Pharmaceutical form:
Oral suspension
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cattle
Therapeutic area:
fenbendazole
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization number:
VPA10987/017/001
Authorization date:
1991-01-04

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Zerofen 10% Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substances:

Fenbendazole

% w/v

Excipients:

Methyl Parahydroxybenzoate

% w/v

Propyl Parahydroxybenzoate

0.02

% w/v

Amaranth (E123)

0.0015

% w/v

For a full list of excipients, see Section 6.1

3 PHARMACEUTICAL FORM

Oral suspension.

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle.

4.2 Indications for use, specifying the target species

Zerofen 10% is a broad spectrum anthelmintic for the control of mature and developing immature forms of the following

major species of roundworm in cattle. In cattle it is effective against the following parasites:

Gastro-intestinal roundworms:

Ostertagia

Cooperia

Trichostrongylus

Nematodirus

Haemonchus

Oesophagostomum

Bunostomum

Strongyloides and

Trichuris species

Lungworms:

Dictyocaulus viviparus

It is usually effective against inhibited larvae of Ostertagia species in cattle.

Zerofen 10% has an ovicidal effect on

nematode eggs.

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4.3 Contraindications

None.

4.4 Special warnings for each target species

As with other anthelmintics, veterinary advice should be sought on appropriate dosing programmes and stock management

to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing. If the product does not

achieve the desired clinical effect, other diseases, nutritional disturbances or anthelmintic resistance may be involved.

4.5 Special precautions for use

Special precautions for use in animals

Shake container before use.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Direct contact with skin should be kept to a minimum.

Wear suitable protective clothing including impermeable rubber

gloves.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

None known.

4.7 Use during pregnancy, lactation or lay

Zerofen 10% can be safely used at the recommended dose rate during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

4.9 Amounts to be administered and administration route

Assess bodyweight as accurately as possible before calculating the dosage.

Cattle:

Given as an oral drench at the rate of 7.5 mg fenbendazole per kg bodyweight (approximately 1 ml per 13 kg bodyweight).

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Not applicable.

4.11 Withdrawal Period(s)

Animals must not be slaughtered for human consumption during treatment.

Cattle may be slaughtered for human

consumption only after 14 days from the last treatment.

Milk for human consumption must not be taken during treatment.

Milk for human consumption may be taken from cows only after 96 hours from the last treatment.

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5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Zerofen 10% is a broad spectrum anthelmintic containing fenbendazole 100mg/ml.

Benzimidazoles bind to nematode

tubulin, a protein necessary for the formation and viability of microtubules.

This occurs primarily in absorptive intestinal

cells resulting in a complete absence of microtubules in the intestinal cells of the nematode, which means that these cells

cannot absorb nutrients, a consequent reduction in glycogen and effective starvation of the parasites.

Structural differences

have been shown to exist between tubulin from mammalian and helminth sources, thus resulting in the preferential toxicity

of fenbendazole to the helminth and not to the host.

Benzimidazoles have also been shown to inhibit the fumarate

reductase system of helminths and impair energy production

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Methyl Parahydroxybenzoate

Propyl Parahydroxybenzoate

Amaranth

Citric Acid Monohydrate

Sodium citrate

Xanthan Gum

Povidone

Polysorbate

Propylene Glycol

Simethicone emulsion

Purified Water.

6.2 Incompatibilities

None.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale:

3 years.

6.4 Special precautions for storage

Do not freeze.

6.5 Nature and composition of immediate packaging

The product is presented in 0.5 L, 1 L, 2.5 L, 5 L and 10 L containers composed of high density polyethylene with high

density polyethylene closures.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials

Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste

under national waste disposal regulations. Do not contaminate ponds, waterways or ditches with product or used

containers.

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7 MARKETING AUTHORISATION HOLDER

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea,

Co. Galway.

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10987/17/1

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

January 2006

10 DATE OF REVISION OF THE TEXT

November 2009

May 2013

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