Alamycin Aerosol 3.58% w/w Cutaneous Spray, Solution

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxytetracycline Hydrochloride

Available from:

Norbrook Laboratories 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, Pigs, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1984-06-05

Summary of Product characteristics

Revised: December 2019
AN: 01302/2019
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Alamycin Aerosol 3.58% w/w Cutaneous Spray, Solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Each 140g aerosol can contains 5g Oxytetracycline Hydrochloride
(equivalent to 3.58%
w/w).
EXCIPIENTS
Patent Blue V (E 131) 0.33% w/w as a marker dye
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Cutaneous spray solution A blue opaque solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES:
Cattle, sheep and pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:
Alamycin Aerosol is indicated for the treatment of foot rot in sheep
and topical infections
caused by organisms sensitive to oxytetracycline in cattle, sheep and
pigs.
4.3
CONTRAINDICATIONS:
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES:
None.
4.5
SPECIAL PRECAUTIONS FOR USE:
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Keep away from the animal’s eyes.
Revised: December 2019
AN: 01302/2019
Page 2 of 4
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO THE
ANIMALS:
Keep away from eyes.
Avoid contact with skin. Avoid inhaling vapours. Wash hands after use.
Do not spray on a naked flame or any incandescent material.
Highly flammable.
Must be used in a well ventilated area. Do not smoke when using this
product.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS):
None.
4.7
USE DURING PREGNANCY, LACTATION OR LAY:
The product can be safely administered to pregnant and lactating
animals.
4.8
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION:
None.
4.9
AMOUNT TO BE ADMINISTERED AND ADMINISTRATION ROUTE:
For the treatment of foot rot, clean the affected area prior to
administration. Wounds
should be cleaned prior to administration. Shake the can before use.
Spray for a few
seconds or until the lesion is adequately covered.
Treated sheep should be allowed to stand on dry ground for one hour
before returning to
pasture.
4.10
OVERDOSE (SYMPTOMS, EMERGENC