Oxfencare Oral Suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Oxfendazole
Available from:
Ancare Ireland Ltd.
ATC code:
QP52AC02
INN (International Name):
Oxfendazole
Dosage:
22.65 milligram(s)/millilitre
Pharmaceutical form:
Oral suspension
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cattle, Sheep
Therapeutic area:
oxfendazole
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization number:
VPA10915/001/001
Authorization date:
1992-06-09

Read the complete document

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Oxfencare Oral Suspension

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Oral suspension.

Aqueous off white free flowing suspension

4 CLINICAL PARTICULARS

4.1 Target Species

Cattle and sheep.

4.2 Indications for use, specifying the target species

For the control of sensitive mature and immature gastrointestinal roundworms, lungworms and tapeworms in cattle and

sheep, including:

Gastro

intestinal roundworms:

Ostertagia spp.

Haemonchus spp.

Trichostrongylus spp.

Nematodirus spp., including N. battus

Cooperia spp.

Capillaria spp.

Oesophagostomum spp.

Chabertia spp.

Trichuris spp.

Lungworms:

Dictyocaulus spp.

Tapeworms:

Monezia spp.

Each ml contains:

Active substance

Oxfendazole

22.65 mg

Excipients

Formaldehyde Solution 2.0

Potassium sorbate

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4.3 Contraindications

Do not use in cases of known hypersensitivity to the active ingredient.

Do not use in sheep producing milk for human consumption.

4.4 Special warnings for each target species

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,

lack of

calibration of the dosing device.

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g.

Faecal

Egg Count

Reduction Test).

Where the results of the test(s) strongly suggest

resistance to a particular anthelmintic,

anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

4.5 Special precautions for use

Special precautions for use in animals

Do not exceed stated dose.

When treating sheep great care must be taken to avoid trauma to the pharyngeal area with the nozzle of drenching guns.

Special Precautions to be taken by the Person Administering the Medicinal Product to Animals

Direct contact with the 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

Oxfendazole is not embryotoxic.

This product can be used during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

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4.9 Amounts to be administered and administration route

Shake well before use.

Using standard drenching equipment administer orally.

To ensure administration of a correct dose, body weight should be determined as accurately as possible; accuracy of the

dosing device should be checked.

The recommended dose rates are:

Cattle, 4.5 mg Oxfendazole/kg

Sheep, 5.0 mg Oxfendazole/kg

Example:

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

This product is very well tolerated, at the recommended dose rates.

In the case of accidental overdosage, depression and

anorexia may occur.

4.11 Withdrawal Period(s)

Animals intended for human consumption must not be slaughtered during treatment.

Cattle and sheep intended for human

consumption may only be slaughtered from 28 days after the last treatment.

Milk intended for human consumption may

only be taken from cows after 4 days from the last treatment.

Do not use in sheep producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anthelmintics, benzimidazoles and related substances

ATCvet code: QP52AC02

5.1 Pharmacodynamic properties

Oxfendazole is an anthelmintic belonging to the benzimidazole (I – BZ) class of compounds.

CATTLE

SHEEP

Liveweight

Dose

Liveweight

Dose

100 kg (2 cwt) 20 ml

Up to 15 kg 3 ml

150 kg (3 cwt) 30 ml

16 - 20 kg

4 ml

200 kg (4 cwt) 40 ml

21 - 25 kg

5 ml

250 kg (5 cwt) 50 ml

26 - 30 kg

6 ml

300 kg (6 cwt) 60 ml

31 - 35 kg

7 ml

350 kg (7 cwt) 70 ml

36 - 40 kg

8 ml

400 kg (8 cwt) 80 ml

41 - 45 kg

9 ml

Over 400 kg

Give 10 ml/50 kg Over 45 kg Give 1 ml/5 kg

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Anhydrous Citric Acid

Formaldehyde Solution

Propylene Glycol

Polyethylene Glycol 6000

Polyoxyl 40 Stearate

Potassium Sorbate

Colloidal Anhydrous Silica

Xanthan Gum

Water Purified

6.2 Incompatibilities

None known.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

6.4 Special precautions for storage

Do not store above 25

Store in a dry place in the original container and keep the container tightly closed.

6.5 Nature and composition of immediate packaging

White HDPE packs with polypropylene screw caps. Packs contain 1 litre (flat bottom backpack), 2.5 litre (jerrican), 5 litre

(jerrican) and 10 litre (jerrican).

Not all pack sizes may be marketed.

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

Any unused product or waste materials should be disposed of in accordance with national requirements.

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7 MARKETING AUTHORISATION HOLDER

Ancare (Ireland) Limited,

30 Coolmine Business Park,

Clonsilla Road,

Dublin 15.

8 MARKETING AUTHORISATION NUMBER(S)

VPA 10915/001/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

June 2007

10 DATE OF REVISION OF THE TEXT

December 2013

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