Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CHLORTETRACYCLINE HYDROCHLORIDE, SULFANILAMIDE
Vetoquinol Ireland Limited
QD06AA52
CHLORTETRACYCLINE HYDROCHLORIDE, SULFANILAMIDE
Unknown
Cutaneous Spray Powder
POM
Bovine, Canine, Caprine, Equine - Food, Ovine
Chlortetracycline, combinations
Antibacterial
Authorised
1988-10-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Orospray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous spray, powder. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses, Cattle, Goat, Sheep and Dog. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the topical treatment of wounds infected by organisms sensitive to the active ingredients. For the prevention and treatment of post operative infections following surgical procedures by topical application. 4.3 CONTRAINDICATIONS Do not use in animals with known hypersensitivity to one of the ingredients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each 100g powder contains : Active substances: Chlortetracycline (as hydrochloride) 2.850 g Sulfanilamide 50.000 g Excipients: Methyl parahydroxybenzoate 0.115 g HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 14/08/2015_ _CRN 7021600_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTION(S) FOR USE IN ANIMALS 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. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS Pressurised container. Do not spray on or near a naked flame or any incandescent material. Do not smoke. Do not use or store near an open flame, heat, ignition and sparkle source, electric device in use. The product should be used unaltered from the original container. Treat animals outdoors or in a well ventilated area. Read the complete document