Terramycin Aerosol Spray 3.92% w/w Cutaneous Spray

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxytetracycline Hydrochloride

Available from:

Zoetis UK Limited

ATC code:

QD06AA03

INN (International Name):

Oxytetracycline Hydrochloride

Pharmaceutical form:

Cutaneous spray, solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1989-02-08

Summary of Product characteristics

Revised: November 2019
AN: 00956/2019
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
TERRAMYCIN™ AEROSOL SPRAY
3.92% w/w cutaneous spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Oxytetracycline hydrochloride
3.92% w/w
Excipient
Patent Blue V (E131)
0.192% w/w
For the full list of all other excipients see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous spray, solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and 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 digital dermatitis in cattle and treatment of
foot rot and
scald in sheep.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
For external use only.
Do not spray in or near the eyes.
Revised: November 2019
AN: 00956/2019
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not spray in or near eyes.
Use only in a well ventilated area.
For external use only.
(ii)
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.
Extremely flammable.
Do not pierce or burn, even after use.
Do not spray on a naked flame or any incandescent material.
Keep away from sources of ignition – No smoking.
People with known hypersensitivity to oxytetracycline should avoid
contact with the product.
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
Any solution containing metal salts.
4.9
AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
Shake can before use and apply topically. For ovine foot conditions a
spray-
time of 3-5 seconds sho