Aurofac Granular 250 mg/g Premix for Medicated Feeding Stuff

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Chlortetracycline Hydrochloride

Available from:

Zoetis UK Limited

ATC code:

QJ01AA03

INN (International Name):

Chlortetracycline Hydrochloride

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens, Duck, Pigs, Turkeys

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2007-09-28

Summary of Product characteristics

Revised: August 2020
AN: 00656/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Aurofac Granular 250 mg/g Premix for Medicated Feeding Stuff
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance:
Chlortetracycline hydrochloride 250mg/g
Carrier:
Calcium sulphate dihydrate
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Premix for medicated feeding stuff
The product is a premix consisting of yellow free flowing granules
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs, chickens, turkeys, ducks
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For treatment and control of respiratory and systemic infections
associated with
organisms sensitive to chlortetracycline.
4.3
CONTRAINDICATIONS
Do not use in ruminants
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
None ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Revised: August 2020
AN: 00656/2020
Page 2 of 5
If you know you are hypersensitive (allergic) to chlortetracycline, do
not
handle the product.
When handling the product, inhalation of the dust must be avoided by
wearing a disposable half-mask respirator conforming to European
Standard EN 149 or a non-disposable respirator to European Standard EN
140 with a filter to EN 143.
Avoid contact with skin and eyes.
Gloves should be worn whilst handling the product. If contact with the
skin
or eyes occurs, wash area immediately with clean fresh water.
If irritation persists seek medical attention.
Do not eat, drink or smoke whilst handling the product.
Hands and exposed skin should be washed thoroughly after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
The product is of low toxicity and side effects are rarely
encountered. If
suspected
adverse
reactions
occur,
treatment
should
be
discontinued
immediately.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
No problems known
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER F