Land: Storbritannien
Språk: engelska
Källa: VMD (Veterinary Medicines Directorate)
Oxytetracycline Hydrochloride
MSD Animal Health UK Limited
QD06AA03
Oxytetracycline Hydrochloride
Cutaneous spray, suspension
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Pigs, Sheep
Antimicrobial
Authorized
2009-10-13
Revised: August 2020 AN. 00299/2020 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Engemycin Spray, 25mg/mL, cutaneous spray, suspension for cattle, sheep and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL contains Active substance: Oxytetracycline hydrochloride 25.00 mg (equivalent to oxytetracycline 23.15 mg Excipients: Patent blue V (E131) 1.25 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cutaneous spray, suspension Green to green-blue suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of the following infections caused by, or associated with, organisms sensitive to oxytetracycline in cattle, sheep and pigs: Treatment of foot infections caused in particular by: _Dichelobacter nodosus_, _Fusobacterium _ _necrophorum_ and other _Fusobacterium_ spp., and _Bacteroides_ spp. Supporting treatment of superficial wound infections following surgery or physical injuries, e.g., tail biting in pigs, scratches and abrasions. 4.3 CONTRAINDICATIONS Do not use for treatment of teats in order to prevent the product from getting into milk. Revised: August 2020 AN. 00299/2020 Page 2 of 5 Do not use in animals in cases of hypersensitivity to oxytetracycline or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS The animals should be treated in a well ventilated area. Do not spray in or near the eyes. Use of the product should be based on susceptibility testing of the 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. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Because of the risk of sensitisation and contact dermatitis, the user should avoid skin Läs hela dokumentet