Introduction

Company name: Bimeda

Address: A division of Cross Vetpharm Group UK Limited

Bryn Cefni Industrial Park,

Llangefni,

Anglesey LL77 7XA.

Telephone: 0800 526769

Fax: 01248 725416

Email: sales@bimeda.co.uk

Presentation

A clear, colourless, slightly viscous, sterile solution for injection containing 1 % w/v Ivermectin.

Uses

Cattle: For the treatment and control of gastro-intestinal nematodes, lungworms, eyeworms, warbles, mange mites and lice of cattle, as shown below.

Bimectin Injection at the recommended dosage level of 200 mcg ivermectin per kg bodyweight:

1. Provides effective control against the following parasites of cattle.

Gastro-intestinal roundworms (adult and fourth stage larvae): Ostertagia spp (including inhibited O. ostertagi), Haemonochus placei, Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp, Bunostomum phlebotomum, Oesophagostamum radiatum, Strongyloides papillosus (adult), Nematodirus helvetianus (adult), N. spathiger (adult), Trichuris spp. (adult).

Lungworms (adult and fourth stage larvae): Dictyocaulus viviparus.

Eyeworms (adult): Thelazia spp.

Warbles (parasitic stages): Hypoderma bovis and H. lineatum.

Mange mites: Psoroptes bovis, Sarcoptes scabiei var. bovis.

Sucking lice: Linognathus vituli, Haematopinus eurysternus and Solenopotes capillatus.

2. May also be used as an aid in the control of the mange mite Chorioptes bovis and biting lice Damalinia bovis, but complete elimination may not occur.

Treatment at the recommended dose rate controls re-infection with Haemonchus placei, and Cooperia spp. acquired up to 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and Dictyocaulus viviparus acquired up to 28 days after treatment.

To obtain optimal benefit from the persistent activity of Bimectin Injection for grazing animals it is recommended that calves which are set-stocked in their first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out. This can protect the animals from parasitic gastro-enteritis and lungworm disease throughout the grazing season, provided they are set-stocked, all the calves are included in the programme and that no untreated cattle are added to the pasture.

Treated calves should always be monitored according to good husbandry practices.

Sheep: For the treatment and control of gastro-intestinal nematodes, lungworms and nasal bots.

Bimectin Injection at the recommended dose rate of 200 mcg ivermectin per kg bodyweight provides effective control of the following:

Gastrointestinal roundworms (adult and fourth-stage larvae): Ostertagia circumcincta including inhibited larvae, O.trifurcata, Haemonchus contortus including inhibited larvae, Trichostrongylus axei (adults), T.colubriformis and T.vitrinus (adults), Cooperia curticei, Oesophagostomum columbianum, O.venulosum (adults), Nematodirus filicollis, Chabertia ovina, Trichuris ovis (adults).

Lungworms: Dictyocaulus filaria (adult and fourth-stage larvae), Protostrongylus rufescens (adults).

Nasal bots (all larval stages): Oestrus ovis

Pigs: For the treatment and control of gastro-intestinal nematodes, lungworms, lice and mange mites of pigs.

Bimectin Injection at the recommended dose rate of 300 mcg ivermectin per kg bodyweight provides effective control against the following parasites of pigs:

Gastro-intestinal roundworms (adults and fourth stage larvae): Ascaris suum, Hyostrongylus rubidus, Oesophagostomum spp. and adult and somatic larval stages of Strongyloides ransomi (adults and somatic larval stages).

Lungworms: Metastrongylus spp. (adults)

Lice: Haematopinus suis.

Mites: Sarcoptes scabiei var. suis.

Dosage and administration

Each ml contains 10 mg ivermectin sufficient to treat 50 kg of bodyweight of cattle and 33 kg of bodyweight of pigs. The injection may be given with any standard automatic or single-dose or hypodermic syringe. Use of 17 gauge x ½ inch needle is suggested. Replace with a fresh sterile needle after every 10 to 12 animals. Injection of wet or dirty animals is not recommended. If using a single-dose hypodermic syringe, use a separate sterile needle to withdraw Bimectin Injection from the container. Massage the injection site after administration of the product.

Cattle

Bimectin Injection should be given only by subcutaneous injection at the recommended dosage level of 200 mcg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle. This is equivalent to 1 ml per 50 kg bodyweight. The volume administered per injection site should not exceed 10ml.

Sheep

In sheep the recommended dosage level is 200mcg ivermectin per kg bodyweight. The recommended route of administration is over the neck. In young lambs weighing less than 20.0kg give 0.1 ml per 5 kg. In these lambs the use of a syringe that can deliver as little as 0.1ml is recommended.

Pigs

In pigs, the recommended dosage level is 300 mcg ivermectin per kg bodyweight. This is equivalent to 1 ml per 33 kg bodyweight. The recommended route of administration is by subcutaneous injection into the neck.

Young Pigs

In young pigs, especially those below 16 kg for which less than 0.5ml Bimectin Injection is indicated, dosing accuracy is important. The use of a syringe that can accurately deliver as little as 0.1 ml is recommended.

Contra-indications, warnings, etc

Known hypersensitivity to the active ingredient.

This product is not for intravenous or intramuscular use.

Bimectin Injection for Cattle, Sheep and Pigs has been formulated specifically for use in those species. It should not be used in other species as severe adverse reactions, including fatalities in dogs, may occur.

For animal treatment only.

Bimectin Injection can be used concurrently without adverse effects with foot and mouth disease vaccine and clostridial vaccine, given at separate injection sites.

Overdose:

Cattle: Single doses of 4.0 mg ivermectin per kg (20 x the recommended dose) given subcutaneously resulted in ataxia and depression.

Sheep: At dose levels up to 4mg ivermectin per kg (20x the normal use level) given subcutaneously resulted in ataxia and depression. No signs of systemic toxicity were observed in sheep treated with the product at up to 3 times the recommended dose rate, soft tissue swellings at the injection site were observed.

Pigs: A dose of 30 mg ivermectin per kg (100 x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.

Use during pregnancy and lactation

Bimectin Injection can be administered to beef cows, sheep and pigs at any stage of pregnancy. Do not use in dairy cows or sheep producing milk for human consumption. Do not use in non-lactating dairy cows or sheep within 60 days of calving/lambing. The product can be used in sows during lactation. Fertility is not affected by administration of the product.

Operator warning

Take care to avoid self administration: the product may cause local irritation and/or pain at the site of injection.

Do not smoke or eat while handling the product.

Wash hands after use.

Withdrawal periods

Cattle: Must not be treated within 35 days of slaughter for human consumption.

Do not use in cattle producing milk for human consumption or in dairy cows within 60 days prior to calving.

Sheep: Must not be treated within 42 days of slaughter for human consumption. Do not use in lactating sheep producing milk for human consumption. Do not use in sheep within 60 days of lambing where milk is to be used for human consumption.

Pigs:

Must not be treated within 28 days of slaughter for human consumption.

Environmental Safety

Any unused veterinary product or waste material derived from the product should be disposed of in accordance with local requirements. The product should not enter water courses as this may be dangerous to fish and other aquatic organisms.

Pharmaceutical precautions

This product does not contain an antimicrobial preservative.

Avoid the introduction of contamination during use.

Swab septum before removing each dose.

Use a dry sterile needle and syringe.

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

Should any apparent growth or discolouration occur the product should be discarded.

Do not mix with other medicinal products.

Keep out of reach and sight of children.

Legal category

POM-VPS

Packaging Quantities

50 ml, 250 ml, 500 ml multiple dose polyethylene bottles.

Further information

Cattle: Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed.

Sheep: Discomfort, sometimes intense but usually transient, has been observed in some sheep immediately following subcutaneous administration.

Pigs: Mild and transitory pain reactions have been observed in some pigs following subcutaneous administration.

All these reactions have disappeared without treatment.

Ivermectin belongs to the avermectin (3-AV) class of anthelmintic endectocides.

Marketing authorisation number

VM 12597/4029.