1. GENERAL INFORMATION
1.1 Enrofloxacin-100 (Solution for Injection).
1.2 Enrofloxacin is an active ingredient of the drug. 1 ml of the drug contains 100 mg enrofloxacin.
1.3 The drug by its appearance is a sterile clear liquid with light-yellow to yellow color, without visible mechanical particles.
1.4 The drug is available in glass or plastic vials by 10, 20, 50, 100, 200 and 250g. The drug should be stored with caution (see List B) within the temperature range from +5ºC to +25ºC, in a dry place protected from direct sunlight. Shelf life is 2 years under specified storage conditions.
2. PHARMACOLOGICAL PROPERTIES
2.1 Enrofloxacin as a drug component belongs to the fluoroquinolones group. Mechanism of the enrofloxacin action on bacterial cells based on inhibiting apple acid biosynthesis. It causes morphological changes and destruction of pathogenic microorganisms. The drug is characterized by quick absorption and achieving high concentrations in blood serum.
2.2 The drug has a broad spectrum of antibacterial action against Gram-positive bacteria (staphylococci, streptococci, Corynebacterium, Clostridium and Listeria), Gram-negative bacteria (E. coli, Salmonella, Klebsiella, Proteus, Yersinia, Haemophilus influenzae bacteria, Pasteurella, actinobacillus, Pseudomonas, Bordetella, Brucella, Campylobacter) and mycoplasmas as well.
2.3 Enrofloxacin is quickly absorbed from the injection site and penetrates into all tissues and organs of the body. Maximum concentration of the drug in blood is achieved through 0.5-1 hour after administration and retains for 4-6 hours, and therapeutic concentration - for 24 hours.
2.4 The drug doesn’t undergo biotransformation in the body and is eliminated mainly unchanged with urine and bile.
3. DRUG USAGE PROCEDURE
3.1 The drug is prescribed for prevention and treatment of the following diseases in farm animals and poultry:
- in ruminants: enteritis, respiratory infections, colibacillosis, pasteurellosis, salmonellosis, mycoplasmosis, clostridioz, dysentery, leptospirosis;
- in pigs: bacterial diseases of gastrointestinal tract (kolidiareya, koliseptitsemiya) and bacterial respiratory diseases;
- in rabbits: pasteurellosis, enterotoxemia, enteritis, dysentery, respiratory infections, listeriosis, endometritis, runny nose, rodentioz etc.;
- in fur-bearing animals (mink, fox, Arctic fox), dogs: bacterial disease of gastrointestinal tract and respiratory tract, leptospirosis.
3.2 The drug is administered intramuscularly once a day.
In ruminants, pigs: a daily dose is based on 0,5-1ml of the drug per 20 kg of animal weight (2,5 – 5 mg enrofloxacin per 1 kg). Treatment is 3-5 days, depending on the disease severity.
In fur-bearing animals (mink, fox, Arctic fox), dogs: a daily dose is based on 0,5 ml of the drug (5mg enrofloxacin) per 10 kg of animal weight. The course of treatment is 3-5 days depending on the disease severity. Half dose is administered within 3-5 days for prevention treatment.
3.3 To avoid possible pain reaction the drug should be administered in amount not more than 2-3 ml in one place to large animal and not more than 1 ml – to small animals.
3.4 Adverse effects. Enrofloxacin injection in pigs sometimes causes local irritation. During treatment occasionally indigestion can be observed in calves and pigs. Application of enrofloxacin drug may cause changes in articular cartilages in dogs of small and medium species aged 2 to 8 months and in large, slow-growing species - up to 18 months.
3.5 Contraindications. The drug should not be applied to horses, pregnant female dogs and breeding pigs as well as to female dogs in lactation. It is restricted to apply this drug to dogs less than 12 months and large dog species - up to 18 months. It is not allowed to use Enrofloxacin-100 in milking animals.
3.6 Incompatibilities. This drug should not be used simultaneously with tetracyclines, macrolides and chloramphenicol.
3.7 Slaughter for meat of cattle, sheep, pigs and rabbits shall be allowed not earlier than 14 and 4 days after the last drug administration. 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 and milk for - for feeding farm 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.