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

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Lincomycin hydrochloride

Tilgængelig fra:

Zoetis Belgium S.A.

ATC-kode:

QJ01FF02

INN (International Name):

Lincomycin hydrochloride

Dosering:

400 milligram(s)/gram

Lægemiddelform:

Powder for use in drinking water

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Pigs

Terapeutisk område:

lincomycin

Terapeutiske indikationer:

Antibacterial

Autorisation status:

Authorised

Autorisation dato:

2014-09-26

Produktets egenskaber

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