Инструкции к препаратам

Instruction for use of Meradok

I. General information

1. Tradename of the veterinary medicinal product: Meradok

International nonproprietary name: doramectin

2. Meradok is a sterile, light yellow or colorless solution.

Shelf-life of the medicinal product under specified conditions is 3 years from the date of manufacture, after first opening – 90 days. The use of the Meradok after the expiration date is prohibited.

3. Meradok is prepackaged in 100 ml glass vials, sealed with rubber stoppers and rolled with aluminum caps with first opening control clips.

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: 5 °C to 30 °C.

5. Meradok 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 Meradok is available without veterinary prescription.

II. Сomposition

8.  Pharmaceutical form: solution for injections

1 ml of Meradok contains 10 mg of doramectin (25-cyclohexyl-25 -5-0 dimethyl-di (1-methylpropyl) avermectin Ala) as an active substance and excipients.

III. Pharmacological properties

9. Meradok is a systemic antiparasitic medicinal product of the avermectin class.

10. Doramectin, an active substance of Meradok, binds to cell receptors of parasites’ muscle and nerve tissues and increases membrane permeability to chloride ions, thus blocking electrical activity of nerve and muscle cells of nematodes and arthropods, which results in their paralysis and death. In mammals these receptors are localized only in the central nervous system and doramectin cannot penetrate the blood-brain barrier; thus, recommended doses of the medication are safe for mammals. Oral Meradok LD50 in mice is over 2000 mg/kg. At recommended doses, the medication has no mutagenic, teratogenic and embryotoxic effects.

Meradok is easily resorbed from the injection site. The medication is excreted unchanged in the feces.

Doramectin’s pharmacokinetic properties allow for sustained therapeutic concentrations of the drug in animals’ blood, which protects them against from re-infestation and parasitic diseases for a long time (up to 28 days).

By the degree of its effect on the body, Meradok is classified as a moderately hazardous substance (hazard class 3 as per GOST 12.1.007).

IV. Administration procedure

11. Meradok is used for the treatment and prevention of cattle, sheep and swine with diseases caused by nematodes of the gastrointestinal tract, lungs, subcutaneous tissue, tear ducts, gadflies, subcutaneous or nasopharyngeal larvae, fly larvae, fleas, lice, itch mite and ixodic ticks.

In cattle, Meradok is indicated to treat diseases caused by the following:

- nematodes, gastrointestinal tract (mature larvae); Ostertagia ostertagi (including inhibited larvae), Ostertagia lyrata, Haemonchus placei, Haemonchus similis, Trichostrongylus axei, Trichostrongylus colubriformis, Trichostrongylus longispicularis, Mecistocirrus digitatus, Cooperia oncophora (including inhibited larvae), Cooperia pectinata, Cooperia punctata, Cooperia spatulata, Cooperia sumabada (synonym Mcmasteri), Nematodirus helvetianus, Nematodirus spathiger, Bunostomum phlebotomum, Strongyloides papillosus, Oesophagostomum radiatum, Trichocephalus discolor, and Trichocephalus ovis.

- pulmonary nematodes (mature form and larvae): Dictyocaulus viviparus.

- nematodes of tear ducts: Thelazia spp.

- subcutaneous nematodes: Parafilaria bovicola.

- larvae of nasopharyngeal and subcutaneous gadfly: Hypoderma bovis, Hypoderma lineatum.

- lice: Haematopinus eurystemus, Linognathus vituli, Solenopotes capillatus

- itch mites: Psoroptes bovis, Chorioptes bovis

- ixodic ticks: Boophilus microplus, Omithodoros spp.

In sheep, Meradok is indicated to treat diseases caused by the following:

- nematodes of gastrointestinal tract – Ostertagia (Teladorsagia) circumcincta (mature forms and larvae, including nematodes resistant to benzimidazole derivatives), Haemonchus contortus (mature forms and larvae), Trichostrongilus axei (mature forms and larvae), T. colubriformis (mature forms and larvae), T . vitrinus (mature forms and larvae), Cooperia curticei (larvae), S. oncophora (mature forms and larvae), Oesophagostomum venulosum (mature forms), Nematodirus spp. (mature forms and larvae), and Strongyloides papillosus.

- pulmonary helminths - Dictyocaulus filaria.

- itch mites - Psoroptes ovis.

- nasopharyngeal gadfly larvae: Oestrus ovis.

In swine, Meradok is indicated to treat diseases caused by the following:

– nematodes of gastrointestinal tract (adults and larvae): Hyostrongylus rubidus, Ascaris suum, Strongyloides ransomi (adult), Oesophagostomum dentatum, Oesophagostomum quadrispinulatum, Trichocephalus suis;

– pulmonary nematodes (adult) – Metastrongylus spp.;

renal nematodes (Mature) – Stephanurus dentatus;

– lice – Haematopinus suis;

– mange mites – Sarcoptes Scabiei.

12. It is forbidden to use the medication in animals with individual hypersensitivity to the medication’s ingredients.

13. Single doses of Meradok are administered subcutaneously or intramuscularly to cattle and sheep. The product should be administered aseptically using dry sterile syringes and needles.

In cattle, the medication is injected into the neck in a dose of 0.2 mg of doramectin per 1 kg of body weight, which corresponds to 1 ml of Meradok solution per 50 kg of animal body weight.

In sheep, the medication is administered in a dose of 0.2 mg of doramectin per 1 kg of body weight, which corresponds to 1 ml of Meradok solution per 50 kg of animal body weight. In the treatment of severe cases of scabies, especially chronic forms, the drug dose may be increased by a factor of 1.5 to 0.3 mg of doramectin per 1 kg of body weight, which corresponds to 1.5 ml per 50 kg of animal body weight.

In swine, the drug is administered intramuscularly at the base of the ear in a dose of 1 ml per 33 kg of animal weight (equivalent to 0.3 mg doramectin per 1 kg of body weight).

The product’s viscosity slightly increases at temperatures below 5°C, hence it may become difficult to administer. In this case, it is recommended to heat the solution and syringes to room temperature to facilitate drawing the product into a syringe and injecting it into an animal.

14. Overdose of the medicinal product results in depression, feed refusal, tremor, increased salivation of animals. The general measures aimed at removing the drug from the body should be undertaken.

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

16. Due to the allocation of doramectin with milk the administration of the drug to milking and pregnant cows less than 60 days prior to calving, lactating, and ewes with lamb in less than 70 days prior to lambing is prohibited. The drug is allowed for use to young animals.

17. The product is intended for single use only.

18. No adverse reactions were observed at the administration of Meradok if administered subject to the instructions for use.

In the case of allergic hypersensitivity to doramectin, the drug use shall be terminated; antihistamines and symptomatic treatment should be prescribed.

19. Meradok should not be used concurrently with medications containing macrocyclic lactones due to the risk of interaction and toxicity.

20. The slaughter of cattle and sheep for meat is allowed no earlier than 70 days, swine – no earlier than 77 days after the last dose of the product.

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 Meradok. 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 Meradok. 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 Meradok for domestic purposes is prohibited; they must be disposed of along with household waste.