Lincocin Soluble Powder, 400 mg/g Powder for Use in Drinking Water

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: VMD (Veterinary Medicines Directorate)

Aktif bileşen:

Lincomycin

Mevcut itibaren:

Zoetis UK Limited

ATC kodu:

QJ01FF02

INN (International Adı):

Lincomycin

Farmasötik formu:

Powder for use in drinking water

Reçete türü:

POM-V - Prescription Only Medicine – Veterinarian

Terapötik grubu:

Chickens, Pigs

Terapötik alanı:

Antimicrobial

Yetkilendirme durumu:

Authorized

Yetkilendirme tarihi:

1993-01-21

Ürün özellikleri

Revised: July 2020
AN: 00263/2020
Page 1 of 7
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.
Revised: July 2020
AN: 00263/2020
Page 2 of 7
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.
4.