Orospray

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Chlortetracycline; Sulphanilamide

Available from:

Vetoquinol Ireland Limited

ATC code:

QD06AA52

INN (International Name):

Chlortetracycline; Sulphanilamide

Dosage:

2.85, 50 gram/100gram

Pharmaceutical form:

Cutaneous spray, powder

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Dogs, Goats, Horses, Sheep

Therapeutic area:

chlortetracycline, combinations

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-11

Summary of Product characteristics

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
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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 co