Introduction

Company name: Virbac Limited

Address: Woolpit Business Park

Windmill Avenue

Woolpit

Bury St Edmunds

Suffolk

IP30 9UP

Telephone: 01359 243243

Fax: 01359 243200

Website: www.virbac.co.uk

Presentation

A sterile, non-aqueous solution of 1 % w/v ivermectin PhEur.

Uses

Cattle

For the treatment and control of the following species of gastro-intestinal roundworms, lungworms, eyeworms, warbles, mites and lice of cattle:

Gastro-intestinal roundworms (adult and fourth-stage larvae)

Ostertagia ostertagi (including inhibited O. ostertagi)

Ostertagia lyrata

Haemonchus placei

Trichostrongylus axei

Trichostrongylus colubriformis

Cooperia onchophora

Cooperia punctata

Cooperia pectinata

Bunostomum phlebotomum

Oesophagostomum radiatum

Strongyloides papillosus (adult)

Nematodirus helvetianus (adult)

Nematodirus spathiger (adult)

Trichuris spp. (adult)

Lungworms (adult and fourth stage larvae)

Dictyocaulus viviparus

Eyeworms (adult)

Thelazia spp.

Warbles

Hypoderma bovis

Hypoderma lineatum

Mange mites

Psoroptes bovis

Sarcoptes scabei var. bovis

Sucking lice

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus.

Virbamec Injectable Solution may also be used as an aid in the control of the biting louse Damalinia bovis and the mange mite Chorioptes bovis, but complete elimination may not occur.

Persistent activity

When cattle have to graze on pasture contaminated with infective larvae of cattle nematodes, treatment with Virbamec Injectable Solution at the recommended dose rate controls re-infection with Cooperia spp. for at least 7 days after treatment, Haemonchus placei acquired up to 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days and Dictyocaulus viviparus acquired up to 28 days after treatment.

To obtain optimal benefit from the persistent activity of Virbamec Injectable Solution for cattle, 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 animals should always be monitored according to good husbandry practices.

Swine

For the treatment and control of the following species of gastro-intestinal roundworms, lungworms, mites and lice:

Gastro-intestinal roundworms (adult and fourth stage larvae)

Ascaris suum

Oesophagostomum spp.

Hyostrongylus rubidus

Strongyloides ransomi (adults and somatic larval stages)

Lungworms

Metastrongylus spp. (adults)

Mites

Sarcoptes scabei var.suis

Lice

Haematopinus suis

Virbamec injectable solution may also be used as an aid in the control of adult whipworm (Trichuris suis).

Recommended treatment programme

Breeding animals

At the time of initiating any parasite control it is important to treat all breeding animals in the herd. After the initial treatment use VIRBAMEC INJECTABLE SOLUTION regularly as follows:

Sows

Treat 7-14 days prior to farrowing

Gilts

Treat 7-14 days prior to farrowing

Treat 7-14 days prior to service

Boars

Frequency of and need for treatments are dependent upon exposure

Treat at least twice per year.

Fatteners

All pigs received for fattening should be treated before placement in clean quarters. Pigs exposed to soil may need re-treatment if re-infection occurs. All brought-in pigs should be isolated and treated with VIRBAMEC INJECTABLE SOLUTION before being introduced into the herd.

The above programme is a guide for effective parasite control using VIRBAMEC INJECTABLE SOLUTION. Alternatively, a wide measure of control may be achieved by ``total herd treatments'' at six monthly intervals.

Note: for effective mange control, care must be taken to prevent re-infestation from exposure to untreated animals or contaminated facilities.

Sheep

For the treatment and control of the following species of gastro-intestinal roundworms, lungworms, nasal bots and mites:

Gastro-intestinal roundworms (adult and fourth stage larvae)

Ostertagia circumcincta (including inhibited O.circumcincta)

Ostertagia trifurcata

Haemonchus contortus (including inhibited H. contortus)

Trichostrongylus axei (adult)

Trichostrongylus colubriformis

Trichostrongylus vitrinus (adult)

Cooperia curticei

Oesophagostomum columbianum

Oesophagostomum venulosum (adult)

Nematodirus filicollis

Chabertia ovina

Trichuris ovis (adult)

Lungworms

Dictyocaulus filaria (adult and fourth-stage larvae)

Protostrongylus rufescens (adult)

Nasal bots

Oestrus ovis (immature stage)

Mange mites

Psoroptes ovis (adult and immature stage)

For the treatment and control of sheep scab Psoroptes ovis, two injections with a seven-day interval are required to treat clinical signs of scab and to eliminate mites. Benzimidazole-resistant strains of Haemonchus contortus and Ostertagia circumcincta are also controlled.

Dosage and administration

Cattle

Virbamec Injectable Solution should be given only by subcutaneous injection at the recommended dosage level of 2 mg ivermectin per 10 kilogram bodyweight (equivalent to 1 ml per 50 kg bodyweight). Each ml contains 10 mg of ivermectin.

Dosage schedule
Bodyweight (kg)	Dose Volume (ml)
Up to 50	1.0
51 – 100	2.0
101 – 150	3.0
151 – 200	4.0
201 – 250	5.0
251 – 300	6.0
301 – 350	7.0
351 – 400	8.0
401 – 450	9.0
451 – 500	10.0
501 – 550	11.0
551 – 600	12.0

Use a dry sterile needle. Inject under the loose skin in front of or behind the shoulder. The injection may be given with any standard automatic, multidose or single dose hypodermic syringe. For 200, 500 and 1000 ml pack sizes, use of a multiple dose syringe is recommended. To refill the syringe, use of a draw-off needle is recommended to avoid excessive broaching of the stopper.

Swine

VIRBAMEC INJECTABLE SOLUTION should be given only by subcutaneous injection at the recommended dosage level of 3mg ivermectin per 10kg bodyweight (equivalent to 1ml per 33kg bodyweight).

Dosage schedule
Bodyweight (kg)	Dose Volume (ml)
Up to 16	0.5
17-33	1.0
34-50	1.5
51-66	2.0
67-99	3.0
100-133	4.0
134-166	5.0
167-200	6.0
Over 200 kg bodyweight, give 1.0 ml per 33 kg bodyweight.

To be given subcutaneously only.

This product does not contain an antimicrobial preservative. Swab stopper before removing each dose.

The injection may be given with any standard automatic or single-dose or hypodermic syringe. use of 17 gauge 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 or hypodermic syringe, use a separate sterile needle to withdraw the product from the pack. In young pigs, especially those below 16 kg for which less than 0.5 of the product is indicated, dosing accurately is important. The use of a syringe that can accurately deliver as little as 0.1 ml is recommended.

Sheep

VIRBAMEC INJECTABLE SOLUTION should be given only by subcutaneous injection observing aseptic precautions at the recommended dose level of 200 mcg ivermectin per kilogram body weight (equivalent to 0.5ml per 25kg bodyweight) in the neck.

For the treatment and control of Psoroptes ovis (sheep scab) two injections with a seven day interval are required to treat clinical signs of scab and to eliminate living mites.

Dosage schedule
Bodyweight (kg)	Dose volume (ml)
Up to 5	0.1
5.1-10	0.2
10.1-15	0.3
15.1-25	0.5
25.1-50	1.0
50.1-75	1.5
75.1-100	2.0

For sheep weighing over 100kg, calculate the dose at the rate of 0.5ml per 25kg. When treating sheep of less than 16kg seek veterinary advice regarding the use of 1ml disposable syringes graduated in increments of 0.1ml. For the treatment of individual sheep, a syringe not exceeding 2.0ml and calibrated in increments of 0.1ml should be used.

Contra-indications, warnings, etc

For animal treatment only. This product should not be used intravenously or intramuscularly.

Do not use in cattle or sheep producing milk for human consumption.

Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

Do not use in species other than cattle, pigs and sheep as severe adverse reactions, including fatalities in dogs, may occur.

In sheep, treatment of psoroptic mange (sheep scab) with one injection is not recommended because, although a clinical improvement may be seen, elimination of all mites may not occur. Sheep scab (Psoroptes ovis) is an extremely contagious external parasite of sheep. Following treatment of infected sheep, great care must be taken to avoid re-infestation, as mites may be viable for up of to 15 days off the sheep. It is important to ensure all sheep which have been in contact with infected sheep are treated. Contact between treated, infected and non-treated, non-infected flocks must be avoided until at least 7 days after the last treatment.

Adequate vaccination of sheep against clostridial infections is strongly recommended.

Operator warnings

Do not smoke or eat whilst handling the product. Wash hands after use. Take care to avoid self-administration: the product may cause irritation and/or pain at the site of injection.

Withdrawal period

Cattle

Cattle must not be treated within 35 days of slaughter for human consumption. Do not use in cattle producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

Swine

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

Sheep

Sheep must not be treated within 42 days of slaughter for human consumption. Do not use in sheep producing milk for human consumption.

Disposal of containers

Unused product and containers should be disposed of in accordance with any guidance from an appropriate waste regulation authority.

EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with product or used product container.

Pharmaceutical precautions

This product does not contain an antimicrobial preservative, therefore the stopper should be swabbed before removing each dose. Use a dry, sterile needle and syringe. Store below 30°C. Following withdrawal of the first dose, use the product within 6 months. Discard unused material. Avoid introduction of contamination. Protect from light.

Legal category

POM-VPS

Packaging Quantities

50 ml, 200 ml, 500 ml and 1000ml multidose colourless, plastic vials.

Further information

Studies have shown a wide safety margin and at the recommended dosage, no adverse effects on breeding performance were observed. Virbamec Injectable Solution can be used in breeding ewes and rams and will not affect fertility. At therapeutic doses, ivermectin has no adverse effect on cattle, pigs or sheep since it does not readily penetrate their central nervous systems.

Transitory discomfort has occasionally been observed in some cattle, pigs and sheep following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed in those species. These reactions have disappeared without treatment.

Ivermectin is a highly active, broad spectrum, internal and external parasiticide of the avermectin family.

Ivermectins are isolated after fermentation of the soil organism Streptomyces avermitilis. Ivermectin stimulates the release of gamma amino butyric acid (GABA) at presynaptic nerve terminals (in nematodes) or the neuromuscular junctions (in arthropods, acarids, flies and fleas), leading to the paralysis and death of the parasite concerned.

Virbamec Injectable Solution provides a large safety margin to mammals when used at the recommended dosage. Acetylcholine, the main peripheral neurotransmitter, is not affected by ivermectin. Furthermore, ivermectin does not enter the central nervous system in the mammals, where GABA acts as neurotransmitter.

Market authorisation number

Vm 16971/4000