OROSPRAY
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
29-08-2015
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Ingredient activ:
CHLORTETRACYCLINE HYDROCHLORIDE, SULFANILAMIDE
Disponibil de la:
Vetoquinol Ireland Limited
Codul ATC:
QD06AA52
INN (nume internaţional):
CHLORTETRACYCLINE HYDROCHLORIDE, SULFANILAMIDE
Dozare:
Unknown
Forma farmaceutică:
Cutaneous Spray Powder
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Bovine, Canine, Caprine, Equine - Food, Ovine
Zonă Terapeutică:
Chlortetracycline, combinations
Indicații terapeutice:
Antibacterial
Statutul autorizaţiei:
Authorised
Data de autorizare:
1988-10-11
Caracteristicilor produsului
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.
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