Introduction

Company name: Janssen Animal Health

A division of Janssen-Cilag Ltd

50-100 Holmers Farm Way

High Wycombe

Buckinghamshire

HP12 4EG

Telephone: 01494 567555

Fax: 01494 567556

Email: ahealth@jacgb.jnj.com

Presentation

A pale green-coloured aqueous suspension for oral administration only. Each ml of Ovispec S & C 2.5 % contains 25 mg albendazole, 0.27 mg selenium (as sodium selenite) and 0.624 mg cobalt (as cobalt sulphate).

Uses

Sheep and cattle:

For the control of mature and developing immature forms of gastro-intestinal roundworms, lungworms, tapeworms and adult liver fluke. The product is also ovicidal against fluke and roundworm eggs.

In sheep, it is active against benzimidazole-susceptible strains of the following species:

Roundworms: Ostertagia, Haemonchus, Tricho- strongylus, Nematodirus (including N. battus), Chabertia and Oesophagostomum. It is usually effective against inhibited larvae of Ostertagia.

Lungworms: Dictyocaulus filaria.

Tapeworms: Moniezia spp.

Adult liver fluke: Fasciola hepatica.

In cattle, it is active against the following species:

Roundworms: Ostertagia, Haemonchus, Tricho- strongylus, Nematodirus, Oesophagostomum, Buno- stomum, Cooperia and Strongyloides spp. It is usually effective against inhibited larvae of Cooperia and Ostertagia.

Lungworms: Dictyocaulus viviparus.

Tapeworms: Moniezia spp.

Adult liver fluke: Fasciola hepatica.

The product is ovicidal and will kill fluke and roundworm eggs, thus reducing pasture contamination. The selenium and cobalt in this product are trace elements of use as nutritional supplements.

Dosage and administration

For oral administration only using properly calibrated dosing equipment. Estimate bodyweight accurately before calculating the dose. Shake the container before use.

Sheep

Worm Dose: For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs. Dosage: 5 mg albendazole per kg bodyweight (2 ml/10 kg bodyweight).

Fluke and Worm Dose: For the additional treatment of adult liver fluke (chronic fascioliasis) in sheep. Dosage: Approximately 7.5 mg albendazole per kg bodyweight (3 ml/10 kg bodyweight).

Cattle

Worm dose: For the control of roundworms, lungworms, tapeworms and fluke and roundworm eggs. Dosage: 7.5 mg albendazole per kg bodyweight (3 ml/10 kg bodyweight).

Fluke and worm dose: For the additional treatment of adult liver fluke (chronic fascioliasis) in cattle. Dosage: 10 mg albendazole per kg bodyweight (4 ml/10 kg bodyweight).

Administration with a suitable drenching gun is recommended.

Sheep
Bodyweight	Worm Dose (5.0 mg/kg)	Fluke and Worm Dose (7.5 mg/kg)
Up to 10 kg	2 ml	3 ml
11-20 kg	4 ml	6 ml
21-30 kg	6 ml	9 ml
31-40 kg	8 ml	12 ml
41-50 kg	10 ml	15 ml
51-60 kg	12 ml	18 ml
61-70 kg	14 ml	21 ml
71-80 kg	16 ml	24 ml
Sheep over 80 kg, give a further 2 ml (worm dose) or 3 ml (fluke and worm dose) for each additional 10 kg bodyweight.

Cattle
Bodyweight	Worm Dose (7.5 mg/kg)	Fluke and Worm Dose (10 mg/kg)
50 kg	15 ml	20 ml
100 kg	30 ml	40 ml
150 kg	45 ml	60 ml
200 kg	60 ml	80 ml
250 kg	75 ml	100 ml
300 kg	90 ml	120 ml
350 kg	105 ml	140 ml
400 kg	120 ml	160 ml
Cattle over 400 kg, give a further 3 ml (worm dose) or 4 ml (fluke and worm dose) for each additional 10 kg bodyweight.

Contra-indications, warnings, etc

Do not administer other cobalt and selenium supplements concurrently unless specifically advised by a veterinary surgeon. Care must be taken not to damage the pharyngeal region when dosing, particularly in sheep. Not to be used in animals known to be hypersensitive to the active ingredient. Not to be diluted or mixed with other products. Avoid the introduction of contamination during use. Intensive use or misuse of anthelmintics can give rise to resistance. To reduce this risk, dosing programmes should be discussed with a veterinary surgeon. The use of the product in breeding bulls or pregnant cattle is not expected to interfere with their reproductive performance. Do not dose ewes at the and worm’dose rate (7.5 mg/kg), during tupping or for 1 month after removing the rams. Ovispec S & C 2.5 % can be safely used during lactation. This product should only be used in areas where deficiencies of cobalt and selenium are likely to occur. If in doubt, please seek the advice of your veterinary surgeon. Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after dosing.

Withdrawal periods

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

Cattle must not be slaughtered for human consumption until 14 days after the last treatment. Sheep must not be slaughtered for human consumption until 4 days after the last treatment.

Milk intended for human consumption may be taken from cows only after 60 hours from the last treatment. Not for use 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.

Disposal

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

Pharmaceutical precautions

Do not store above 25 °C. For animal treatment only. Keep out of reach of children.

Further information

Albendazole belongs to the benzimidazole (1-BZ) class of anthelmintics. Selenium and cobalt are included in this product as nutritional supplements and are not intended to be used therapeutically. Administration of ionophores to lambs have been shown to enhance selenium bioavailability. Concurrent administration of ionophores and Ovispec S & C 2.5 % may therefore lead to an increased risk of selenium toxicity.

Legal category

POM-VPS

Packaging Quantities

2.5 L, 5 L and 10 L polyethylene containers.

Marketing authorisation number

Vm 00242/4050.