CTC 10 %w/w Premix for Medicated Feed

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Chlortetracycline hydrochloride

Disponibbli minn:

Univet Limited

Kodiċi ATC:

QJ01AA03

INN (Isem Internazzjonali):

Chlortetracycline hydrochloride

Dożaġġ:

10 percent weight/weight

Għamla farmaċewtika:

Premix for medicated feeding stuff

Tip ta 'preskrizzjoni:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupp terapewtiku:

Cattle

Żona terapewtika:

chlortetracycline

Indikazzjonijiet terapewtiċi:

Antibacterial

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2006-06-23

Karatteristiċi tal-prodott

Health Products Regulatory Authority
11 February 2020
CRN009KKY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CTC 10 %w/w Premix for Medicated Feed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains
ACTIVE SUBSTANCE
Chlortetracycline hydrochloride 100 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Premix for Medicated Feed
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves (less than 6 months of age) and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves: The product is indicated as an aid in the treatment of
respiratory disease in calves caused by Pasteurella spp., sensitive
to chlortetracycline.
Pigs: The product is indicated as an aid in the treatment of
respiratory disease in pigs caused by micro-organisms sensitive to
chlortetracycline.
4.3 CONTRAINDICATIONS
Do not use in adult ruminants, dairy cows and veal calves.
Do not use in animals with known hypersensitivity to the active
substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS 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.
Inappropriate use of the product may increase the prevalence of
bacteria resistant to chlortetracycline and may decrease the
effectiveness of treatment with related substances, due to the
potential for cross-resistance.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
When incorporating into feed, care must be taken not to inhale any
dust. It is recommended that a face mask be worn during
the dispensing and mixing of the product.
Avoid skin contact when handling this product. Wash hands and all
exposed skin at the end of the operation.
Health Products Regulatory Authority
11 February 2020
CRN009KKY
Page 2 o