Instructions for medications
Instructions for medications

Instruction for use of Ivermek

I. General information

1. Tradename of the veterinary medicinal product: Ivermek

International nonproprietary name: ivermectin.

2. Ivermek is transparent opalescent colorless or light yellow liquid. Shelf-life of the medicinal product under specified conditions is 2 years from the date of manufacture, after first opening – 42 days. The use of the Ivermek after the expiration date is prohibited.

3. Ivermek is available as sterile solution prepackaged in glass vials of 1, 20, 50, 100, 250 ml and 500 ml glass bottles sealed with rubber stoppers and flip-off caps with first opening control clips. Ivermek is available as solution for oral administration prepackaged in polymer bottles of 500 ml, sealed with plastic screw caps with first opening control clips.

1 ml vials are available in carton packs containing 50 of these vials.

4. The veterinary medicinal product is stored in sealed original package, separately from food and feed, in a dry place, protected from direct sunlight, storage temperature range: 0 °C to 25 °C.

5. Ivermek should be kept out of reach of children.

6. Unused drug shall be disposed of in accordance with the applicable legislation

7. The veterinary medicinal product Ivermek is available without veterinary prescription.

II. Сomposition

2. Pharmaceutical form: solution for injections and solution for oral administration.

1 ml of Ivermek contains 10 mg of ivermectin and 40 mg of tocopherol acetate (vitamin E) as an active substance, and excipients.

III. Pharmacological properties

9. Ivermek refers to antiparasitic drugs of systemic action of the class of macrocyclic lactones.

10. Ivermectin, an active substance of this drug, is very effective against larva and mature forms of gastrointestinal and pulmonary nematodes as well as larvae of bomb flies, bot flies, stomach bot flies, lice, louse flies and sarcoptoid mites. Ivermectin also increases inhibitory neurotransmitter (γ-aminobutiric acid) production which leads to disruption of nerve impulses, paralysis and subsequent death of parasitic agent.

After parenteral application of drug, ivermectin is quickly absorbed from the place of injection and distributed along the organs and tissues of animal which helps to prolong drug’s antiparasitic activity for 10-14 days. The drug leaves the body with urine and bile; for lactating animals it can also partially leave the body with milk.

By the degree of its effect on the body, Ivermek belongs to 3rd hazard category substances (moderately hazardous substances) while it’s active substance (ivermectin) belongs to 1st hazard category substances (extremely hazardous substances) (according to GOST No. 12.1.007-76). If the recommended doze is observed, the drug does not have any embryotoxic, teratogenic or mutagenic effect. The drug quickly decomposes in ambient environment.

IV. Administration procedure

11. Ivermek is used as a curative and preventative measure against the following animal diseases caused by arachnids, insects and nematodes:

-cattle: strongylatosis, trichocephalosis, strongyloidosis, thelaziosis, sifunculatosis, hypodermosis, psoroptic mange, sarcoptic mange and chorioptic mange;

-sheep and goats: dictyocaulosis, protostrongyloidosis, mulleriosis, haemonchosis, ostertagiosis, nematodirosis, marshallagiosis, cooperiosis, chabertiosis, oesophagostomiasis, bunostomosis, trichocephalosis, strongyloidosis, mallophagosis, oestrosis, psoroptic mange and chorioptic mange;

-deers: dictyocaulosis, ostertagiosis, nematodirosis, strongyloidosis, trichocephalosis, oedemagenosis, cephenomyosis and sarcoptic mange;

-camels: dictyocaulosis, ostertagiosis, nematodirosis, strongyloidosis, trichocephalosis and sarcoptic mange;

-swine: trichocephalosis, ascariasis, metastrongylus, esophagostomosis, strongyloidiasis, stephanurus, haematopinus and sarcoptosis;

- poultry (broilers, breeding poultry, replacement chicks and poultry in molting season) in case of ascariasis, heterakidosis, capillariasis, entomoses caused by Dermatoryktes mutans, Aphaniptera spp. Menacanthus stramineus, Ceratophyllus gallinae, acariasis caused by Dermanyssus gallinae, Knemidocoptes mutans, Menopon gallinae.

12. Contraindications include individual sensitivity of animals to the components of the drug (including in the anamnesis). It is not allowed to use the drug for exhausted and ill (infectious diseases) animals.

13. The drug is administered to animals in accordance with all aseptic regulations once intramuscularly: the drug is injected to cattle into regions of croup and neck, to swine - in the neck or inner thigh. The injected dose shall be as follows:

- 1.0 ml of Ivermek per 50 kg of animal weight (200 μg of ivermectin per 1 kg) for bovine and small cattle, deer and camels;

- 1.0 ml of Ivermek per 33 kg of animal weight (300 μg of ivermectin per 1 kg) for swine.

In severe cases of sarcoptic mange, the drug shall be applied once again after 8-10 days since the first application.

If the required volume of drug exceeds 10.0 ml, several injections in various places shall be made.

The animals shall be treated against nematode-caused diseases in autumn before transferring to stables and in spring before transferring to pastures; against gadfly invasions – straight after the end of gadfly swarming season; against arachnid- and insect-caused diseases – according to results of veterinary observation.

Before mass application of Ivermek, each drug series is first tested on a small group of animals (7-10 subjects). If no complications are observed after 3 days, all herd shall be treated with this drug series.

- 400 mcg of ivermectin per 1 kg of poultry weight, which corresponds to 0.4 ml per 1 L of drinking water for poultry (broilers, breeding poultry, replacement chicks and moulting poultry). The drug is administered orally, group method.

A single dose of Ivermek, calculated according to poultry population size, is diluted in ¼ of the daily amount of drinking water

In nematodes infections, the working solution is administered once; in arthropod or insect infestations, it is administered three times: twice at an interval of 24 hours, and then once in 14 days.

To ensure intake of the product therapeutic dose by the poultry, supply of drinking water is turned off for 2 hours before the product is administered.

14. Overdose of the medicinal product results in increased agitation and salivation; more frequent defecation and urination; ataxia. These symptoms usually disappear by themselves without application of any therapeutic agents.

15. No specific actions were reported at the first use and discontinuance of the drug.

16. Do not use the drug to dairy, sick infectious diseases and exhausted animals, pregnant females whose milk will be used for food purposes, less than 28 days before lactation. It is prohibited to apply the preparation to chickens, laying hens, less than 14 days before laying, due to the accumulation of ivermectin in eggs.

17. Avoid missing prescribed dose administration as this may reduce the treatment effectiveness. When a dose is missed, continue to administer the product in the same dose and according to the same schedule.

18. No adverse reactions were observed at the administration of Ivermek if administered subject to the instructions for use. In rare cases, some animals may develop increased salivation, frequent bowel movements and urination, and ataxia. These symptoms pass off, spontaneously without the use of therapeutic agents. In the case of allergic hypersensitivity to ivermectin, the drug use shall be terminated; antihistamines and symptomatic treatment should be prescribed.

19. Ivermek should not be used concomitantly with drugs containing macrocyclic lactones, due to the possible mutual enhancement of toxic effects.

20. Slaughter for meat of cattle, small ruminants, camels and swine is allowed no earlier than 28 days, poultry - no earlier than 9 days after the last application of the drug Ivermek. In the case of forced slaughter of animals and poultry before the established deadlines, the meat can be used for feeding fur-bearing animals.

Milk of milking animals is allowed to be used for food purposes no earlier than 28 days after the last injection of Ivermek. Milk, obtained earlier than this period, can be used after boiling in animal feed.

V. Special precautions for use

21. General rules of personal hygiene and safety measures required during work with medical agents should be followed when handling Ivermek. It is prohibited to drink, smoke or eat while handling the product. Wash your hands with soap and water after handling the product.

22. People with hypersensitivity to the drug components should avoid direct contact with Ivermek. If product accidentally comes in contact with mucous membranes, flush them with water. In the case of allergic reactions or accidental ingestion of the product, you should contact your medical facility (you should take the instructions for use of the product or the product label with you).

23. Use of the empty vials of Ivermek for domestic purposes is prohibited; they must be disposed of along with household waste.