Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
OXYTETRACYCLINE HYDROCHLORIDE
Pfizer Healthcare Ireland
QD06AA03
3.2 %w/v
Cutaneous Spray Solution
Antibacterial
Ovine
2012-04-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Duphacycline Aerosol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous spray, solution. A blue opaque solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Duphacycline Aerosol is indicated for the treatment of foot rot and topical infections caused by organisms sensitive to oxytetracycline in sheep. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None Each 140g aerosol can contains: ACTIVE SUBSTANCE Oxytetracycline 3.2 % w/v (as oxytetracycline hydrochloride) EXCIPIENT Patent Blue V (E131) 0.3 % w/v IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/04/2012_ _CRN 7012617_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS None SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Keep away from eyes. Avoid contact with skin. Avoid inhaling vapours. Wash hands after use. Do not spray on a naked flame or any incandescent material. Highly flammable. Must be used in a well-ventilated area. Do not smoke when using this product. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None 4.7 USE DURING PREGNANCY, LACTATION OR LAY The product can be safely administered to pregnant and lactating animals. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None 4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Before spraying the infected area, the hooves should be cleaned and pared. Shake the can before u Lestu allt skjalið