Ocnil 400 mg/g Powder for Use in Drinking Water

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Lincomycin

Commercializzato da:

Vetpharma Animal Health, S.L

Codice ATC:

QJ01FF02

INN (Nome Internazionale):

Lincomycin

Forma farmaceutica:

Powder for use in drinking water

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Chickens, Pigs

Area terapeutica:

Antimicrobial

Stato dell'autorizzazione:

Authorized

Data dell'autorizzazione:

2017-07-19

Scheda tecnica

Revised: August 2022
AN: 02021/2021 & 02022/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
OCNIL 400 mg/g powder for use in drinking water
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Lincomycin
...................................................................................400
mg
_(equivalent to 450 mg of lincomycin hydrochloride)_
EXCIPIENTS:
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for use in drinking water.
White powder, inodorous and without lumps.
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 hypersensitivity to the active substance or to
any of the
excipients.
Revised: August 2022
AN: 02021/2021 & 02022/2021
Page 2 of 7
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 gastrointestinal disturbances.
Do not use in cases of resistance to lincosamides.
Do not use in cases of hepatic dysfunction.
4.4
SPECIAL WARNINGS FOR 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