Mebadown Super Oral Suspension

Introduction

Company name: Elanco Animal Health

Address: Eli Lilly and Company Limited

Lilly House

Priestley Road, Basingstoke

Hampshire, RG24 9NL

Telephone: 01256 353131

Veterinary Education & Technical Services (24 hr response 01256 353131 option 1)

Fax: 01256 779510

Email: elancouk@elanco.com

Website: www.elanco.com

 

Company name: Elanco Companion Animal Health

Address: Eli Lilly and Company Limited

Lilly House

Priestley Road, Basingstoke

Hampshire, RG24 9NL

Telephone: 01256 353131

Veterinary Education & Technical Services (24 hr response 01256 353131 option 1)

Fax: 01256 779508

Email: elancoCAH.UK@elanco.com

Website: www.elanco.com

Presentation

White to faintly cream oral suspension containing equivalent of 50 mg closantel (as closantel sodium dihydrate) and 75 mg mebendazole per ml.

Uses

For the control of fascioliasis (due to Fasciola hepatica - mature and immature) and gastrointestinal nematodes and cestodes in sheep and lambs.

Mebadown Super is active against benzimidazole susceptible strains of lungworm, roundworms, tapeworms (heads and segments):

Gastro-intestinal roundworms: Ostertagia spp., Trichostrongylus spp., Nematodirus spp., Cooperia spp., Oesophagostomum spp., Chabertia ovina, Bunostomum spp., Trichuris ovis, Stronglyloides papillosus.

Lungworm: Dictyocaulus filaria

Tapeworm: Moniezia spp.

For the control of the larval stages of Oestrus ovis (Sheep nasal bot fly).

For the control of inhibited, immature and adult stages of Haemonchus contortus (Barber Pole worm) including benzimidazole-resistant strains.

Fluke activity

Stage

% Kill

Adults

97–100%

6–8 weeks immature

91–95%

5 weeks immature

91%

3–4 weeks immature

23–73%

Ticks: Ixodes ricinus feeding on sheep at the time of treatment are likely to produce fewer viable eggs.

Dosage and administration

1 ml of Mebadown Super per 5 kg bodyweight (ie 10 mg/kg bodyweight closantel and 15 mg/kg bodyweight mebendazole).

For example:

Bodyweight

Dose

up to 5 kg

1 ml

6–10 kg

2 ml

11–20 kg

4 ml

21–30 kg

6 ml

31–40 kg

8 ml

41–50 kg

10 ml

51–60 kg

12 ml

61–70 kg

14 ml

71–80 kg

16 ml

Give orally as a drench. Suitable for use with most types of standard drenching equipment. Shake container well before each use. Do not mix with other products.

To ensure the administration of the correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Suggested dosing schedule

Gastrointestinal worms

The frequency of treatment will depend on the level of pasture contamination. Treat ewes prior to lambing, 6 weeks after lambing and prior to tupping to reduce pasture contamination. Dose lambs at regular intervals during high risk periods. Rams may be treated at any time as necessary.

H. contortus: For the treatment and prevention of inhibited, immature and adult stages of benzimidazole resistant and susceptible H. contortus, dose at lambing to help prevent pasture contamination by infected ewes. Treat all animals at 6 weekly intervals during high risk periods in summer and autumn.

Fluke

All sheep on infested pasture should be dosed at regular intervals during the fluke season (Sept - Mar).

Since closantel has been shown to delay egg-laying for up to 13 weeks after artificial infection, treatment intervals of 10 - 12 weeks throughout the fluke season are recommended. In severe fluke seasons, more frequent dosing may be necessary.

The treatment of ewes with a single dose in the spring will contribute to reducing pasture contamination during the following summer and autumn.

Any sheep brought in from fluke areas should be dosed before they join the flock.

Contra-indications, warnings, etc

Mebadown Super may be administered to pregnant animals. The product may be used during the lactation period but should not be administered to animals producing milk for human consumption.

Do not exceed the stated dose. Assess bodyweight as accurately as possible before calculating dosage. Mebadown Super should be administered carefully with a drenching gun. Care should be taken to avoid injury to the mouth and pharynx during drenching.

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 mebendazole) has been reported in Teladorsagia, Haemonchus, Cooperia and Trichostrongylus species in small ruminants in a number of countries including the EU. Resistance to closantel has been reported in Haemonchus in sheep outside 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.

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

At therapeutic doses, Mebadown Super is not toxic and causes no side effects.

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

Withdrawal periods

Meat and offal: 65 days Milk: not to be used in animals producing milk for human consumption.

Overdose

Symptoms of serious closantel overdosage are decreased vision or blindness, anorexia, inco-ordination and general weakness.

Operator warnings

Wash hands after administration. Wash splashes from skin and eyes immediately. Take off immediately any contaminated clothing. Wash hands and exposed skin before meals and after work.

Disposal

DANGEROUS to aquatic life. Do not contaminate ponds, waterways or ditches with product or empty containers. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Pharmaceutical precautions

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

Protect from light.

Legal category

POM-VPS

Packaging Quantities

1, 2.5 L and 5 L plastic flexipacks. Not all pack sizes may be marketed.

Further information

Mebadown Super can be used in all age groups of sheep. It can be used in rams at any time including during the breeding season. It can be used at any time during pregnancy. The product may be used during the lactation period.

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

Marketing authorisation number

Vm 00006/4144.

GTIN (Global Trade Item No)

Mebadown 75mg/ml 2.5 litre

05420036902256

Mebadown 75mg/ml 5.0 litre

05420036902263