1. GENERAL INFORMATION
1.1 Gentamitsin 4% Solution for injection
1.2 Gentamicin sulphate is as active ingredient.
1.3 This drug is a clear liquid from light brown to dark brown color without visible mechanical particles. 1 ml of the drug contains 40 mg of gentamycin.
1.4 The product is prepackaged in glass vials by 10, 20, 50, 50, 100, 200 and 250ml.
1.5 The drug should be stored with caution (see List B ) in a dry, dark place within the temperature range from +5ºC to +25ºC. Shelf life is 2 years under specified storage conditions.
2. PHARMACOLOGICAL PROPERTIES
2.1 Gentamicin has a broad spectrum of antimicrobic effects and high efficiency against Staphylococcus strains resistant to penicillin and other types of antibiotics; some Streptococcus strains of the most gram-positive and gram-negative bacteria (blue pus bacillus, Klebsiella, Enterobacter, Salmonella, Shigella, Proteus). Antibiotic does not affect anaerobic bacteria, viruses and fungus.
2.2 The drug has a high bioavailability effect. During intramuscular injection it is rapidly penetrates through many organs and tissues. Maximum concentration in blood is reached approximately 30-60 minutes after injection. Therapeutic effect of this antibiotic in the body lasts for 8-12 hours after single injection. It is excreted mainly by kidneys generating high concentration in urine.
3. DRUG USAGE PROCEDURE
3.1 Gentamitsin 4% solution for injection is used in cattle and small ruminants, pigs, dogs and cats as a remedy for respiratory and gastro-intestinal diseases, sepsis, peritonitis, pyelonephritis, arthritis, polyarthritis, dermatitis (in dogs) and other deceases in animals induced by microorganism sensitive to gentamycin
3.2 The drug is administered intramuscularly in the following dosage:
- In cattle, small cattle (sheet and goats), horses and pigs: 0.5-0.75 ml per 10 kg of animal weight (2-3 mg of gentamycin per 1 kg of animal weight) twice a day.
- In cats and dogs: first day – 1.0 ml of solution per 10 kg of animal weight twice a day; second and further days – 1.0 ml of solution per10 kg of animal weight twice a day Only half dose of the drug is administered in newly born animals during the first days of life. The course of treatment is 3-5 days.
3.3 It is not recommended to mix in one syringe Gentamitsin 4% solution for injection with other medical drugs.
3.4 Adverse effects. After drug injection local allergic reaction may be developed (skin rash, itching, fever). The drug has ototoxic and nefrotoxic effects. Continued use of this drug can bring to impairment of hearing organs and the eighth brain nerve (in cats and dogs) and can adversely affect fetus as well.
3.5 Contraindications: impaired renal function, hypersensitivity to gentamycin, simultaneous use with other nephrotoxic drugs, muscle relaxants and some general anesthetics, hypersensitivity to gentamycin. Gentamycin shall not be simultaneously used with penicillin, some types of cephalosporin, other aminoglycoside antibiotics (kanamycin, neomycin, streptomycin), chloramphenicol, colistin, polymyxin B and sulfonamides. Gentamicin 4% Solution for injection should be used with caution if you are sensitive to antibiotic aminoglycosides and during pregnancy.
3.6 Slaughtering of animals for meat shall be allowed 21 days after cessation of the drug administration. Injection sites and kidneys shall not be used for food within 45 days. Meat of animals during urgent slaughter before expiry of specified period shall be used to feed fur animals or for production of meat and bone meal tankage. Milk obtained from animals treated by this drug is restricted for consumption to humans within 3 days after cessation of the drug administration. Such milk can be used for feeding animals.
4. CLAIMS PROCEDURE
4.1 In case of inconsistency of the drug with requirements of this Instruction, its use should be discontinued and reported to the Uzbek State Scientific and Veterinary Drugs Control Laboratory at: 700178, Tashkent, No.1a, A.Yunusov Street. Tel. / Fax: 228-76-14, 229-30 - 47. E-mail: email@example.com. Simultaneously unpacked drug package should be sent to the laboratory address with the drug in quantity previously agreed with laboratory including detailed description of the nature of complaints regarding its inconsistency with this Instruction.