Introduction

Company name: Pfizer Limited

Address: Ramsgate Road

Sandwich

Kent CT13 9NJ

Telephone: 0845 300 8034 (Out of hours: 01304 616161)

Fax: 01737 332521

Email: UKVetLine@pfizer.com

Website: www.only4vets.co.uk

Presentation

A pale green aqueous suspension for administration as a drench. Contains 2.5% albendazole w/v (25 mg/ml). Each ml of Valbazen SC 2.5% contains 0.27 mg elemental selenium and 0.63 mg elemental cobalt.

Uses

A broad-spectrum multi-purpose anthelmintic for the control of the following types of benzimidazole susceptible mature and immature internal parasites in sheep:

Gastro-intestinal roundworms: Mature and developing immature forms of Ostertagia, Haemonchus, Trichostrongylus, Nematodirus (including N. battus), Chabertia and Oesophagostomum spp. It is usually effective against inhibited larvae of benzimidazole susceptible Ostertagia.

Lungworms: Dictyocaulus filaria.

Tapeworms: Moniezia spp.

Adult liver fluke: Fasciola hepatica.

Valbazen is ovicidal and will kill worm and fluke eggs, thus reducing pasture contamination.

Dosage and administration

Valbazen SC 2.5% is given as an oral drench and is suitable for use with most types of automatic drenching equipment. Assess bodyweight as accurately as possible before calculating the dosage.

Worm dose

For the control of roundworm, lungworm, tapeworm, worm and fluke eggs.

Dosage

Approximately 5 mg albendazole per kg bodyweight.

Fluke and worm dose

For the additional treatment of adult liver fluke (chronic fascioliasis).

Dosage

Approximately 7.5 mg albendazole per kg bodyweight.

Bodyweight	Worm Dose	Fluke and Worm Dose
Up to 10 kg	2 ml	3 ml
11 to 20 kg	4 ml	6 ml
21 to 30 kg	6 ml	9 ml
31 to 40 kg	8 ml	12 ml
41 to 50 kg	10 ml	15 ml
51 to 60 kg	12 ml	18 ml
61 to 70 kg	14 ml	21 ml
Over 70 kg	Give a further 2 ml for each additional 10 kg bodyweight	Give a further 3 ml for each additional 10 kg bodyweight

Contra-indications, warnings, etc

Valbazen SC 2.5% is highly effective, when used as recommended. Side effects are not to be expected following treatment. Overdosage of five times the highest recommended dose is unlikely to cause adverse reactions in healthy animals.

Valbazen SC 2.5% is not recommended for the treatment of acute fascioliasis in sheep. Do not dose ewes at the 'fluke and worm' dose rate (7.5 mg/kg) during tupping and for 1 month after removing the rams. Do not use in cattle.

Do not administer at the same time as other products containing cobalt and selenium unless specifically advised by your vet. Do not dilute.

Intensive use or misuse of anthelmintics can give rise to resistance. To reduce the risk, dosing programmes should be discussed with your vet.

For animal treatment only. Keep out of the reach of children.

The product should only be used in areas where deficiencies of selenium and cobalt are likely to occur. In cases of doubt, consult your veterinary surgeon.

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

Resistance to benzimidazoles (which includes albendazole) has been reported in Teladorsagia, Haemonchus, Cooperia and Trichostrongylus species in small ruminants in a number of countries, including the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

Withholding times

Animals must not be slaughtered for human consumption during treatment. Eight days should elapse between treatment and the slaughter of sheep for human consumption. Valbazen SC 2.5% should not be used in sheep producing milk for human consumption.

Operator warnings

Direct contact with the skin should be kept to a minimum. Wear suitable protective clothing including impermeable rubber gloves. Wash hands after use.

Protecting livestock, wildlife and others

Dangerous to fish and aquatic life. Do not contaminate ponds, waterways or ditches with product or used containers. Dispose of any unused product and empty containers in accordance with guidance from your local waste regulation authority.

Pharmaceutical precautions

Shake container before use. Do not store above 25°C.

Legal category

POM-VPS

Packaging Quantities

Packs containing 1 litre, 2.5 litres, 5 litres and 10 litres are available. Not all pack sizes may be marketed.

Further information

No special control of diet is necessary before or after treatment.

The use of Valbazen SC 2.5% in breeding rams is not expected to interfere with their reproductive performance.

Selenium and cobalt are included in Valbazen SC 2.5% as nutritional supplements and are not intended to be used therapeutically.

Albendazole belongs to the benzimidazole (1-BZ) class of anthelmintics.

Marketing authorisation number

Vm 00057/4155.