Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE HYDROCHLORIDE
Zoetis Ireland Limited
QD06AA03
OXYTETRACYCLINE HYDROCHLORIDE
4 Per Cent
Cutaneous Spray, suspension
POM
Ovine
Oxytetracycline
Antibacterial
Authorised
2013-12-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Terramycin Aerosol Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PER AEROSOL CAN: ACTIVE SUBSTANCE Oxytetracycline hydrochloride 4.0g EXCIPIENTS Patent Blue V (E131) 0.2g n-Butane 62.8g For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Spray, suspension. A blue, fine mist spray. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES General: for the treatment and control of topical infections caused by, or associated with, organisms sensitive to oxytetracycline. Specific: treatment of foot rot and scald 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not spray in or near the eyes. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/12/2013_ _CRN 7016377_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS Do not spray in or near eyes. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Use only in a well-ventilated area. Wash any splashes immediately. Operator should wear impervious gloves. Wash hands after use. Do not spray on naked flame or any incandescent material. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None. 4.7 USE DURING PREGNANCY, LACTATION OR LAY Suitable for use in pregnant and lactating animals. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE For topical administration only. Shake well before use and apply topically. For ovine foot conditions a spray-ti Přečtěte si celý dokument