Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Oxytetracycline
Norbrook Laboratories Limited
QJ01AA06
Oxytetracycline
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs, Sheep
Antimicrobial
Authorized
1993-12-13
Amended Pages: August 2022 AN: 00434/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Alamycin LA 300 Solution for Injection 300 mg/ml. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: %W/V Oxytetracycline 30.00 (as Oxytetracycline dihydrate 32.40) EXCIPIENTS: Sodium Formaldehyde Sulphoxylate Anhydrous 0.40 For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection Clear dark amber liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle Sheep Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of conditions caused by or associated with organisms sensitive to oxytetracycline including: _Bordetella bronchiseptica _ _Actinomyces pyogenes _ _Erysipelothrix rhusiopathiae _ _Pasteurella spp _ _Staphylococcus spp _ _Streptococcus spp_ Certain mycoplasma, rickettsiae, protozoa and chlamydia are also sensitive to oxytetracycline. Amended Pages: August 2022 AN: 00434/2022 Page 2 of 6 The product is indicated for the treatment and control of pasteurellosis, pneumonia, atrophic rhinitis, erysipelas, joint-ill, navel-ill, summer mastitis in cows, ovine keratoconjunctivitis (pink-eye) and enzootic abortion in sheep. 4.3 CONTRAINDICATIONS Do not dilute the product. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Oxytetracycline therapy does not completely eliminate chlamydial infection in the flock. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS If concurrent treatment is administered, use a separate injection site. Resistance against oxytetracycline may vary. Use of the product should be based on susceptibility testing of bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Inappropriate use of the product may increase the prevalence of bacteria resistant to oxytetracycline and may decrease the effectiveness of treatment with tetracyclines due to the po Citiți documentul complet