Soluchlor 150 mg/g Oral Powder for Calves

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Chlortetracycline hydrochloride

Disponível em:

Interchem Ireland Ltd

Código ATC:

QJ01AA03

DCI (Denominação Comum Internacional):

Chlortetracycline hydrochloride

Dosagem:

150 milligram(s)/gram

Forma farmacêutica:

Oral powder

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Cattle

Área terapêutica:

chlortetracycline

Indicações terapêuticas:

Antibacterial

Status de autorização:

Authorised

Data de autorização:

2012-12-07

Características técnicas

Health Products Regulatory Authority
20 March 2018
CRN000VLN
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Soluchlor 150 mg/g Oral Powder for Calves
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each g contains 150 mg chlortetracycline hydrochloride.
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Powder.
Yellow uniform powder / a yellow powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves (less than 6 months of age).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves:
The product is indicated in the treatment of respiratory disease in
calves caused by
_Pasteurella spp_., sensitive to chlortetracycline.
4.3 CONTRAINDICATIONS
Do not use in calves over 6 months of age and dairy cows.
Do not use in animals with known hypersensitivity to tetracycline.
Do not use in animals with severe liver and renal disorders.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The uptake of oral medication by animals can be altered as a
consequence of illness.
In case of insufficient uptake of feed, animals should be treated
parenterally.
Health Products Regulatory Authority
20 March 2018
CRN000VLN
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing and take
into account
official and local antimicrobial policies.
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.
Long term use of this product is not recommended as it may lead to the
development of bacterial resistance.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Handle this product with care to avoid exposure when incorporating
into feed and
administering medicated feed to the animals.
Take adequate measures to avoid dust formation when incorporating the
veterinary
medicinal product into feed.