Gamavit

Gamavit

I. GENERAL INFORMATION

1. Trade name: Gamavit.

International nonproprietary name: sodium nucleinate and acid hydrolysate of emulsified denatured placenta.

2. Pharmaceutical form: sterile solution for injection.

Each 1 ml of Gamavit contains the following active ingredients: sodium nucleinate 0.02 mg, acid hydrolysate of emulsified denatured placenta (EDP) 0.50 mg, Medium 199 (10x concentrate) 0.1 ml, and up to 1 ml of water for injection as an excipient. The product is a clear red liquid.

3. Gamavit is packaged in 6 ml, 10 ml and 100 ml glass vials of suitable capacity, closed with a rubber stopper and covered with an aluminum cap. Glass vials with drug product are placed in cardboard boxes. Each packing unit is provided with the package insert.

4. Store in sealed original container, away from food and feed, in a dry place away from direct sunlight and out of reach of unauthorized persons at 2°C to 25°C. Shelf-life when stored according to storage conditions is 2 year from date of manufacture.

Do not use the product if its color has changed, if it contains impurities, or after the expiration date.

5. Keep out of the reach and sight of children.

6. Dispose unused product in accordance with applicable legal requirements.

II. PHARMACOLOGICAL PROPERTIES

7. Gamavit belongs to the combined immunomodulatory drugs.

It stimulates innate immunity, increases bactericidal activity of blood serum, enhances resistance of animals to stress and excessive load; also, it has an immunomodulatory effect and increases safety and weight gain of young animals.

Gamavit belongs to low-hazardous materials by its degree of impact on the body (hazard class 4, according to GOST 12.1.007-76). When used in recommended doses and concentrations, Gamavit has no local irritating, allergenic, embryotoxic, teratogenic, or carcinogenic effects.

III. APPLICATION

8. Gamavit is used to enhance innate immunity, adjust immune system and reduce the effects of intoxication in animals and birds.

9. Contraindication to the use of this product is increased individual sensitivity of animals and birds to its components.

10. It can be administered in different ways: subcutaneously, intravenously, intramuscularly, and by water feeding with potable water. For prevention purposes, Gamavit is given:

  • intramuscularly in anemia, intoxication, acidosis, in the post-vaccination period, to old and debilitated animals, in the recovery period after diseases or surgeries at 0.1 ml per kg of body weight 1-3 times a week for 2-4 weeks;
  • to increase the weight gain of young stall-fed animals subcutaneously once daily at 0.1 ml per kg of body weight at the beginning of stall-feeding period on Days 1, 4, and 9;
  • to improve safety of newborn calves and piglets intramuscularly once daily at 0.1 ml per kg of body weight on Days 1, 3, 5, 7, and 21 of life;
  • at excessive loads to increase resistance of animals to technological stress (training for exhibitions, competitions, transportation, internal movement) and vaccination intramuscularly once before stress exposure or in a course on Days -8, -6, -4 prior to and immediately before the exposure.
  • to laying hens to increase egg production and egg weight, to day-old chicks to increase their safety, as well to increase weight gain in broilers, Gamavit used by bottle-feeding. For this, dilute 5 ml of the product in 1 L of water (working solution) and fill water feed based on 2-hour needs of birds. Conduct water feeding for 2 hours 1 times a day for 4-5 days. Before watering, keep birds without water for 1 hour.

For medical purposes, Gamavit is used:

  • for treatment of infectious and parasitic diseases (including piroplasmosis) at 0.5 ml per kg of animal body weight. The product is administered intramuscularly 2-3 times a day for 3-5 days together with therapeutic agents in accordance with their instructions for use;
  • for anthelminthic treatment together with anthelmintic products, according to their instructions for use, Gamavit is administered once intramuscularly at 0.3 ml per kg of animal body weight at the day of antheminthization and, repeatedly, at the same dose every other day;
  • to increase female fertility of agricultural animals, the product is given subcutaneously at 0.04 ml per kg of body weight a few hours before insemination;
  • for facilitation of labor and prevention of obstetric complications (retention of placenta and endometritis), the product is given subcutaneously at 0.05 ml per kg of body weight 1 week before birth and during the preparatory stage of labor;
  • In case of poisoning, product is administered intravenously or subcutaneously twice daily at 0.5-1.5 ml per kg of body weight. Intravenous administration is the most effective route.

11. No cases of Gamavit overdose, side effects or complications were established.

12. No specifics of the action at the first use or its discontinuation were found.

13. It is recommended that gaps when administering another product dose be avoided, as it may reduce its therapeutic effectiveness. When a dose is missed, it should be administered as soon as possible. Further, the interval before the next injection is not changed.

14. No side effects or complications are generally observed, when applying Gamavit in accordance with this insert.

In the case of allergic reactions, stop the drug product and prescribe antihistamines or other symptomatic treatment.

15. Gamavit is compatible with other drug products and foods.

16. Products from animals and birds, which were given Gamavit, is used for food purposes without any restrictions.

IV. INDIVIDUAL PREVENTIVE MEASURES

17. When handling Gamavit, general rules of personal hygiene and safety should be followed required for handling veterinary drug products. It is prohibited to drink, smoke or eat when handling the product. Wash face and hands with soap and water after handling the product.

18. People with known hypersensitivity to the product components should avoid direct contact with Gamavit. In case of accidental contact with the skin or mucous membranes, immediately rinse with running water and soap. In case of allergic reactions and/or ingestion, immediately contact a medical facility (bring product insert or label).

19. Empty containers from the drug product should not be used for domestic purposes; they should be disposed with household waste.

20. Product developer: ZAO Micro-Plus, 18 Gamalei St, Moscow 123098. Package insert for Gamavit was developed by ZAO Micro-Plus:18 Gamalei St, Moscow 123098. With the approval of this insert, package insert for Gamavit approved by Rosselkhoznadzor on March 21, 2011, is voided.

The drug is recommended for authorization in the Russian Federation by Federal State Budget

Institution "All-Russia State Centre for Quality and Standardization of Veterinary Drugs and Feed" (VGNKI)

Marketing authorization No. 77-3-5.14-2020 №ПВР-3-3.3/01313

ZAO Micro-Plus