A clear, colourless to slight yellow-coloured solution with no visible particulates containing 1% w/v Ivermectin (10 mg/ml).

Animec Injection is indicated for the treatment of infections with the following parasites in beef and non-lactating dairy cattle, pigs and sheep:

For the effective treatment and control of gastro-intestinal roundworms, lungworms, warbles, mange mites and lice as shown below:

Gastro-intestinal roundworms (adult and fourth stage larvae): Ostertagia spp (including inhibited O. ostertagi), Haemonchus placei, Trichostrongylus axei, Trichostrongylus colubriformis, Cooperia spp, Oesophagostomum radiatum, Nematodirus helvetianus (adult), N. spathiger (adult)

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

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

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

Sucking lice: Linognathus vituli, Haematopinus eurysternus.

The use of the product in cattle should take into account geographical differences in the occurrence patterns of parasites.

For the effective treatment and control of gastro-intestinal roundworms, lungworms, mange mites and lice as shown below:

Gastro-intestinal worms (adult and fourth stage larvae): Ascaris suum, Hyostrongylus rubidus, Oesophagostomum spp, Strongyloides ransomi (adult only)

Lungworms: Metastrongylus spp. (adult)

Lice: Haematopinus suis

Mange mites: Sarcoptes scabiei var. suis

Dictyocaulus filaria (adult and fourth-stage larvae)

Protostrongylus rufescens (adults)

For single administration only by subcutaneous injection. Each ml contains 10 mg of ivermectin sufficient to treat 50 kg of bodyweight of cattle and sheep, and 33 kg of bodyweight of pigs. Replace with a fresh sterile needle after every 10 to 12 animals. Massage the injection site after administration of the product. Injection of wet or dirty animals is not recommended.

Underdosing could result in ineffective use and may favour resistance development.

To ensure administration of a correct dose, body weight should be determined as accurately as possible. Accuracy of the dosing device should be checked.

If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one.

The product should be given only by subcutaneous injection at the recommended dosage level of 200 microgram 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 10 ml.

In pigs, the recommended dosage level is 300 microgram 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.The volume administered per injection site should not exceed 5ml.

In young pigs, especially those below 16 kg for which less than 0.5 ml 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.

The recommended dose is 200 µg ivermectin per kg bodyweight (corresponding to 1 ml of the product per 50 kg bw) by subcutaneous injection over the neck.

The volume administered per injection site should not exceed 1ml.

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.

In young lambs weighing less than 25 kg give 0.1 ml of the product per 5 kg. The use of a syringe that can deliver as little as 0.1 ml is recommended.

This product does not contain any antimicrobial preservative. Swab septum before removing each dose.

When using the 250 or 500ml pack sizes, use only automatic syringe equipment. For the 50ml 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

In the case of overdose a symptomatic treatment should be given.

Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

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.

At dose levels up to 4 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

No antidote has been identified; however, symptomatic therapy may be beneficial.

Do not administer by the intravenous or intramuscular route.

Do not use in cases of hypersensitivity to the active ingredient or to any of excipients.

Do not use in dogs or cats as severe adverse reactions 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. To ensure complete control 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 that all sheep which have been in contact with infected sheep are treated. Contact between treated, infected and untreated flocks must be avoided until at least seven days after treatment.

Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each herd or flock.

Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd or flock, maintenance of susceptible refugia is essential to reduce that risk. Systematically applied interval-based treatment and treatment of a whole herd or flock should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific herd/flock should be sought from the responsible veterinarian.

Resistance to ivermectin has been reported in Cooperia spp. and in Ostertagia ostertagi in cattle. Resistance has also been reported in Haemonchus contortus in cattle outside the EU.

In sheep, resistance to ivermectin is widespread in Teladorsagia circumcincta, Trichostrongylus spp., Haemonchus contortus and in other gastro-intestinal parasite species.

Multiple resistance was reported in Teladorsagia circumcincta to benzimidazoles, macrocyclic lactones and levamisole and in Haemonchus contortus to ivermectin and benzimidazoles.

Multiple resistance to macrocyclic lactones has also been reported in Psoroptes ovis scab mites in sheep and in cattle.

The use of this product should take into account local information about susceptibility of the target parasites, where available. It is recommended to further investigate cases of suspected resistance, using an appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test). Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.

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. Consult your veterinarian on the correct timing of treatment.

Avermectins may not be well tolerated in 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. In addition, care should be taken to avoid ingestion of spilled product or access to used containers by these other species.

Since ivermectin is highly bound to plasma proteins, special care should be taken in cases of sick animals or in nutritional conditions associated with low plasma protein levels.

'This product may cause eye and skin irritation. Avoid contact with skin or eyes. In case of skin or eye contact, wash exposed area with plenty of clean water. If symptoms persist, seek medical advice.

Take care to avoid accidental self-injection: the product may cause local irritation and/or pain at the site of injection. In case of accidental self-injection, seek immediate medical advice and show the information leaflet or the label to the physician.

Do not eat or smoke while handling the product.

Wash hands after use.

The product is very toxic to aquatic organisms and dung insects.

Long term effects on dung insects caused by continuous or repeated use cannot be excluded therefore repeated treatment of animals on a pasture with an ivermectin-containing product within a season should only be given in the absence of alternative treatments or approaches to maintain animal/flock health, as advised by a veterinarian.

Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.

Transitory discomfort has been observed in some cattle. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment.

Mild and transient pain reactions may be seen in some pigs.

All these reactions disappeared without treatment.

Immediately following subcutaneous injection, activity suggesting pain, sometimes intense but usually transient, has been observed in some sheep.

The product can be administered during pregnancy and lactation in cows, ewes and sows. The product does not affect fertility. It can be used in breeding cows and bulls, breeding ewes and rams, in sows and boars.

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

In the absence of incompatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.

In the case of overdose a symptomatic treatment should be given.

Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

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.

At dose levels up to 4 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

No antidote has been identified; however, symptomatic therapy may be beneficial.

Meat and offal: 49 days.

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

Meat and offal: 28 days.

Meat and offal: 25 days

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

This veterinary medicinal product does not require any special storage conditions.

Shelf life after first opening the immediate packaging: 28 days.

Do not use after the expiry date stated on the label and carton.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal 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.

50 ml, 250 ml and 500 ml containers.

Nil.

UK (NI):11990/3001

UK (GB):11990/5001