Lincocin Soluble Powder, 400 mg/g powder for use in drinking water

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Lincomycin hydrochloride

Disponible desde:

Zoetis Belgium S.A.

Código ATC:

QJ01FF02

Designación común internacional (DCI):

Lincomycin hydrochloride

Dosis:

400 milligram(s)/gram

formulario farmacéutico:

Powder for use in drinking water

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Pigs

Área terapéutica:

lincomycin

indicaciones terapéuticas:

Antibacterial

Estado de Autorización:

Authorised

Fecha de autorización:

2014-09-26

Ficha técnica

Health Products Regulatory Authority
15 July 2020
CRN009S2J
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Lincocin Soluble Powder, 400 mg/g powder for use in drinking water
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Lincomycin (as lincomycin hydrochloride) 400 mg/g
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water.
White to off-white powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs
Treatment and metaphylaxis of enzootic pneumonia caused by _Mycoplasma
hyopneumoniae_.
The presence of the disease in the group must be established before
the product is used.
Chickens
Treatment and metaphylaxis of necrotic enteritis caused by
_Clostridium perfringens_.
The presence of the disease in the group must be established before
the product is used.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
Do not administer, and do not allow access to water containing
lincomycin, to rabbits, hamsters, guinea pigs, chinchillas, horses
or ruminants as this could result in severe gastro-intestinal
disturbance.
Do not use in cases of known resistance to lincosamides.
Do not use in cases of hepatic dysfunction.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Medicated drinking water uptake can be affected by the severity of the
disease. In case of insufficient uptake of water, pigs
should be treated parenterally.
The susceptibility of _Mycoplasma hyopneumoniae_ to antimicrobial
agents is difficult to test _in vitro_ owing to technical
constraints. In addition, there is a lack of clinical breakpoints for
both _M. hyopneumoniae _and _C. perfringens_. Where possible,
therapy should be based on local (regional, farm level)
epidemiological information concerning the response of enzootic
pneumonia/necrotic enteritis to treatment with lincomycin.
Health Products Regulatory Au