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

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Lincomycin hydrochloride

Доступна з:

Zoetis Belgium S.A.

Код атс:

QJ01FF02

ІПН (Міжнародна Ім'я):

Lincomycin hydrochloride

Дозування:

400 milligram(s)/gram

Фармацевтична форма:

Powder for use in drinking water

Тип рецепту:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична група:

Pigs

Терапевтична области:

lincomycin

Терапевтичні свідчення:

Antibacterial

Статус Авторизація:

Authorised

Дата Авторизація:

2014-09-26

Характеристики продукта

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