Qualimec 10 mg/ml Solution for Injection

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

Each ml of the solution for injection contains 10 mg ivermectin as active substance and 10 mg benzyl alcohol as an excipient.

Uses

For the effective treatment and control of the following parasites of cattle, sheep and pigs:

Cattle

Gastro-intestinal roundworms

(adults and fourth stage larvae):

Ostertagia ostertagi

Ostertagia lyrata

Haemonchus placei

Trichostrongylus colubriformis

Cooperia oncophora (adults)

Cooperia punctata (adults)

Bunostomum phlebotomum

Oesophagostomum radiatum

Lungworm

(adult and fourth stage larvae)

Dictyocaulus viviparus

Eye worm

(adult)

Thelazia spp.

Warble flies

(parasitic stages)

Hypoderma bovis

H. lineatum

Mange mites

Psoroptes ovis

Sarcoptes scabiei var. bovis

Sucking lice

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

May also be used as an aid in the control of the mange mite Chorioptes bovis but complete elimination may not occur

Persistant activity

Treatment with Qualimec 10 mg/ml Solution for Injection at the recommended dose rate prevents re-infection with Haemonchus placei, Cooperia oncophora, Cooperia pectinata and Trichostrongylus axei for 7 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum for 14 days after treatment and Dictyocaulus viviparus for 21 days after treatment.

Sheep

Gastro-intestinal roundworms

(adults and fourth stage larvae):

Ostertagia circumcincta

Haemonchus contortus

Trichostrongylus axei

Trichostrongylus colubriformis

Trichostrongylus vitrinus

Cooperia curticei

Nematodirus filicollis

Variable activity may be observed against:

Cooperia curticei

Nematodirus filicollis

Lungworm

Dictyocaulus filaria (adult)

Mange mites

Psoroptes ovis

Nasal bots

Oestrus ovis all larval stages

Pigs

Gastrointestinal roundworms

(adults and fourth stage larvae):

Ascaris suum

Hyostrongylus rubidus

Oesophagostomum spp.

Strongyloides ransomi (adults)

Lungworm

Metastrongylus spp. (adults)

Lice

Haematopinus suis

Mange mites

Sarcoptes scabiei var. suis

Dosage and administration

For single administration only (except for the treatment of Psoroptes ovis infections in sheep).

Cattle

1 ml per 50 kg bodyweight (based on a recommended dosage level of 200 micrograms ivermectin per kg bodyweight). Inject subcutaneously in front of, or behind, the shoulder using aseptic technique. A sterile 1.4 x 15 mm (17G x ½ inch) needle is recommended.

Sheep

0.5 ml per 25 kg of bodyweight (based on a recommended level of 200 micrograms ivermectin per kg bodyweight). For the treatment of gastrointestinal roundworms, lungworms and nasal bots inject once subcutaneously in the neck, using aseptic precautions; a sterile 1.4 x 15 mm (17G x ½ inch) needle is recommended. For the treatment 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. For young lambs weighing less than 20 kg give 0.1 ml per 5 kg. In these lambs the use of a syringe which can deliver as little as 0.1 ml is recommended.

Pigs

1.5 ml per 50 kg bodyweight (based on a recommended dosage level of 300 micrograms ivermectin per kg bodyweight). The recommended route of administration is by subcutaneous injection into the neck using aseptic technique and a sterile 1.4 x 15 mm (17 G x ½ inch) needle. For piglets weighing less than 16 kg give 0.1 ml per 3 kg. In these piglets the use of a syringe which can deliver as little as 0.1 ml is recommended.

Advice on correct administration

Use a dry sterile needle and syringe. Swab septum before removing each dose. When using the 200 or 500 ml pack sizes, use only automatic syringe equipment. For the 50 ml pack size, 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.

Contra-indications, warnings, etc

Do not use in lactating dairy cows or ewes producing milk for human consumption. Do not use in non-lactating dairy cows, including pregnant dairy heifers within 60 days of calving. Do not use in sheep which are intended to produce milk for human consumption within 60 days of lambing. Do not use in cases of known hypersensitivity to ivermectin. Do not administer by the intravenous or intramuscular route.

Special precautions for use in animals

Treatment of psoroptic mange (sheep scab) with one injection is not recommended because although 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 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.

Do not combine treatment with vaccination against lungworms. If vaccinated animals are to be treated, treatment should not be carried out within a period of 28 days before or after vaccination.

The shedding of nematode eggs can continue for some time after treatment.

In cattle, to avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine, it is recommended to administer the product at the end of warble fly activity and before the larvae reach their resting sites.

The product can be administered during pregnancy in cows, ewes and sows. The fertility of males is not affected by administration of the product.

Avermectins may not be well tolerated in all non-target species. Cases of intolerance with fatal results are reported in dogs – especially Collies, Old English Sheepdogs and related breeds and crosses, and also in turtles/tortoises.

Special precautions to be taken by the person administering the product

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

Withdrawal Period

Meat and offal: 42 days in sheep and cattle. 28 days in pigs. Do not use in lactating dairy cows and sheep producing milk for human consumption. Do not use in non-lactating dairy cows, including pregnant dairy heifers or non-lactating dairy sheep within 60 days of calving/lambing.

Disposal

Extremely dangerous to fish and aquatic life. Do not contaminate surface waters or ditches with product or used container. Any unused product or waste material should be disposed of in accordance with national requirements.

Pharmaceutical precautions

Store below 25 °C. Protect from direct sunlight. Keep container tightly closed. Store in original carton. Keep out of reach and sight of children. For animal treatment only.

Following withdrawal of the first dose, use the product within 28 days. Should any apparent growth or discolouration occur, the product should be discarded.

Legal category

POM-VPS

Packaging Quantities

200 ml and 500 ml.

Further information

Frequent and repeated use may lead to the development of resistance. It is important that the correct dose is given in order to minimise the risk of resistance. To avoid under-dosing, animals should be grouped according to their bodyweight and dosed according to the dose of the heaviest animal in the group.

Overdose

Clinical symptoms of ivermectin toxicity include ataxia and depression. No antidote has been identified. In case of overdose, symptomatic treatment should be given. No signs of toxicity were observed in animals treated at up to 3 times the recommended dose rate.

Adverse reactions

Transitory discomfort has been observed in some animals immediately following subcutaneous administration. In cattle this may include jumping and rolling, but behaviour returns to normal after 15 minutes. Soft tissue swelling and thickening of the skin at the injection site has been observed in treated animals. Typically these reactions are transient and disappear within one to four weeks. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

Marketing authorisation number

Vm 13277/4017.

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