TERRAMYCIN AEROSOL SPRAY
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
15-05-2024
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Active ingredient:
OXYTETRACYCLINE HYDROCHLORIDE
Available from:
Pfizer Healthcare Ireland
ATC code:
QD06AA03
Dosage:
4 Per Cent
Pharmaceutical form:
Cutaneous Spray, suspension
Therapeutic group:
Antibacterial
Therapeutic area:
Ovine
Authorization date:
1988-10-01
Summary of Product characteristics
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 02/08/2011_
_CRN 7011154_
_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
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