GENTAMICIN SULFATE 4%

INSTRUCTIONS

of using Gentamicin Sulfate 4% solution for injection 

for the treatment of animals with bacterial infections 

(Organization-developer:  “BioKhimPharm”, Vladimir region, Raduzhny town) 

I. General information 

1. Gentamycin sulfate 4% solution for injection (Gentamycini sulfas 4% injectionibus solutio pro) – a drug intended for the treatment of farm animals, dogs and cats in diseases of bacterial etiology.

2. Gentamicin sulfate 4% solution for injection as an active substance in 1 cm3 contains gentamycin sulfate – 40 mg, as well as auxiliary components: sodium pyrosulfite, disodium ethylenediamine tetraacetic acid (Trilon B) and water for injection.

3. In appearance, the drug is a sterile, transparent yellowish solution.

4. Gentamycin sulfate is given 4% solution for injection packaged by 5; 10; 20; 50 and 100 cm3 in glass, sterile bottles of appropriate capacity, sealed with rubber stoppers, reinforced aluminum caps.

Each vial is labeled with the indication of: the manufacturer’s organization, its address and trademark, the name, purpose and method of application of the medicinal product, the name and content of the active substance, the volume in the vial, the inscriptions “For veterinary use” and “Sterile,” serial numbers, dates manufacturing, expiry date, storage conditions, state registration number, information on compliance confirmation, TU designation and provide instructions for use.

Store the medicinal product in the manufacturer’s closed container in a dry, protected from light place, separate from food and feed at a temperature of 5 ° C to 25 ° C.

Shelf life of the medicinal product under the conditions of storage in closed packaging – 2 years from the date of manufacture, after opening the bottle – no more than 25 days. Do not use the drug after the expiration date.

II. Pharmacological properties 

5. Gentamycin sulfate, which is part of the drug, belongs to the group of aminoglycoside antibiotics and is a mixture of several antibiotics produced by Micromonospora purpurea. It has a broad spectrum of antimicrobial activity, is active against most gram-positive and some gram-negative microorganisms, including Staphylococcus spp., Streptococcus spp., Salmonella spp., Proteus mirabilis, Escherichia coli. Antibiotic does not affect anaerobic bacteria, viruses, protozoa and fungi.

The mechanism of bactericidal action of an antibiotic is the ability to inhibit the biosynthesis of the cell wall of microorganisms, which leads to its death.

After parenteral administration, the drug is well and rapidly absorbed from the injection site and penetrates most of the organs and tissues of the animal. The maximum concentration of gentamycin sulfate in the blood serum is reached after 1 hour and is maintained at the therapeutic level for 8-12 hours. The antibiotic is excreted from the body mainly with urine, mostly in unmodified form.

When used internally, the drug is practically not absorbed from the gastrointestinal tract and exerts its effect only in the intestine for 12 hours and is excreted mainly with feces.

6. Gentamicin sulfate 4% solution for injection by the degree of exposure to the body refers to moderately hazardous substances (hazard class 3) according to GOST 12.1.007.

III. The order of application 

7. Gentamicin sulfate 4% solution for injection is used for cattle, horses, sheep, pigs, dogs and cats for the treatment of respiratory and gastrointestinal, urogenital infections, sepsis, pneumonia, pleural empyema, peritonitis, meningitis, pyelonephritis, purulent skin infections and soft tissues and other diseases of bacterial etiology whose pathogens are sensitive to gentamicin.

8. Gentamicin sulfate 4% solution for injection is used intramuscularly or orally twice a day at intervals of 10-12 hours in the following doses:

The maximum volume of solution for the introduction of cattle and horses in one place should not exceed 15 ml, pigs – 10 ml, sheep – 5 ml, dogs and cats – 2.5 ml.

9. When applying Gentamycin sulfate 4% solution for injection in accordance with this instruction, side effects and complications are usually not observed. In rare cases, the animal at the injection site may develop edema, which dissolves spontaneously within 1-2 days.

10. Gentamicin sulfate 4% solution for injection should not be applied simultaneously and sequentially with antibiotics of the penicillin group, streptomycin, kanamycin, neomycin, and mixed in the same syringe with other drugs.

Do not use Gentamicin Sulfate 4% solution for injection to animals with severe impaired renal function.

11. With increased individual sensitivity of the animal to gentamicin and the appearance of side effects (refusal of feed, vomiting, impaired coordination of movements), the use of Gentamycin sulfate 4% solution for injection is discontinued and desensitizing therapy is administered.

12. Slaughter of animals for meat is allowed no earlier than 21 days after the last use of the medicinal product. Meat of animals, who were forced to die before the expiration of this period, can be used in fodder for fur animals.

Milk milking animals are allowed to use for food purposes no earlier than 72 hours after the last injection of the drug. Milk, obtained earlier than the prescribed period, can be used after boiling in animal feed.

IV. Personal prevention measures 

13. When working with Gentamycin Sulfate 4% solution for injection, you should observe the general rules of personal hygiene and safety, provided when working with medicines.

14. It is prohibited to use vials from a medicinal product for domestic purposes.

15. Gentamicin Sulfate 4% solution for injection should be stored out of the reach of children.