1. GENERAL INFORMATION
1.1 Oksitetratsiklin-100 is an injectable medical drug containing oxytetracycline antibiotic as active ingredient.
1.2 This drug is a clear, slightly viscous liquid from light brown to dark brown color without visible mechanical particles. 1 ml of the drug contains 100 mg of oxytetracycline.
1.3 The product is prepackaged in glass vials by 10, 20, 50, 50, 100, 200 and 250ml. The drug should be stored with caution (see List B ) in a dry, dark place within the temperature range from +4ºC to +20ºC Shelf life is 2 years under specified storage conditions.
2. PHARMACOLOGICAL PROPERTIES
2.1 Oxytetracycline is a bacteriostatic antibiotic. Oxytetracycline is represented in the drug as a complex with magnesium which stipulates its long lasting (prolonged) effect. Oxytetracycline as a drug component inhibits synthesis of bacterial protein by blocking bind of amino acid-tRNA with 30S ribosome subunit. Antibiotic spectrum covers most gram-positive and gram-negative bacteria, namely Streptococcus, Staphylococcus, Corynebacterium, Clostridium, Erysipelothrix, Pasteurella, Fusobakterium, Salmonella, Pseudomonade, Haemophilus, Actinobacterium, Shigella, Escherichia, chlamydia, rickettsia, spirochetes and mycoplasma.
2.2 During intramuscular injection antibiotic is rapidly reabsorbed from the injection point and reaches maximum concentration in the tissue approximately 30-50 minutes after injection. Therapeutic effect of this antibiotic in tissues retains for at least 20 hours. It is eliminated primarily with urine and with milk in lactating animals. It penetrates into all animal organs and tissues overcoming placental barrier. It is eliminated primarily with urine and bile and with milk as well in lactating animals.
3. DRUG USAGE PROCEDURE
3.1 Oksitetratsiklin-100 is used for the following diseases
- In cattle (mature animals and calves): pneumonia, mastitis, pasteurellosis, pleurisy, diphtheria in calves, foot rot, keratoconjunctivitis, wound infections, anaplasmosis, and secondary bacterial infections at viral diseases.
- In pigs: pneumonia, atrophic rhinitis, pasteurellosis, pleurisy, mastitis, rose, Mastitis-Metritis-Agalactia Syndrome, purulent synovitis, umbilical sepsis, abscess, wound and obstetric infections and secondary bacterial infections at viral diseases
- In sheep and goats: enzootic abortion, foot rot, Metritis, Mastitis, peritonitis, wound infections and pneumonia in goats
3.2. Depending on the selected treatment scheme therapeutic concentration of antibiotic retains for 24 or 48 hours (prolonged effect).Treatment can be carried out by one of the following schemes:
- 24 hour scheme: the drug is administered intramuscularly (slowly!) once a day based on 0.3-0.8 ml per10 kg of animal weight. Treatment duration is 3-7 days;
- 48 hour scheme: the drug is administered intramuscularly based on 1.0-2.0 ml per10 kg of animal weight. Injection shall be repeated after 48 hours.
The course of treatment is 3-4 injections.
|Species||Single dosage in ml per 10 kg of animal weight|
|24 hour scheme||48 hour scheme|
|Sheep and goats||0,8||2,0|
Desired drug dose should be injected in several body sites based on assumption that maximum amount of administered drug per injection site should not exceed 20 ml in cattle, 5-10 ml in pigs and 5 ml in sheep and goats.
3.3 Adverse effects. After drug injection local allergic reaction may be developed in the form of erythema and itching, which usually disappear without medical intervention. With development of severe allergic reaction intravenous calcium injection (calcium chloride, calcii borglukonas) or use of antihistamines (diphenylhidramine) shall be recommended
3.4 Contraindications: Individual sensitivity to the drug components. It is not recommended to use this drug in conjunction with corticosteroid and estrogens. Due to apparent reduction of antibacterial effect of oxytetracycline it is not used in conjunction with such antibiotics as penicillin and cephalosporin. This drug is not administered in horses, dogs, cats and other animals with renal insufficiency, pregnant females and newborn animals.
3.5 Slaughtering of animals for meat shall be allowed 12 days after the last drug administration. Meat of animals during urgent slaughter before expiry of specified period shall be used to feed flesh eaters or for production of meat and bone meal tankage. Milk shall not be used for food purposes within 7 days after the last drug administration, but after boiling such milk may be used for feeding animals.
4. INDIVIDUAL PREVENTION MEASURES
4.1 A person working with this drug shall follow general personal hygiene regulations and safety precautions.
5. CLAIMS PROCEDURE
5.1 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.