LIFE COLI 10%W/W PREMIX POWDER

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

COLISTIN SULPHATE

Available from:

Life Biopharma Sdn. Bhd.

INN (International Name):

COLISTIN SULPHATE

Units in package:

25 kg

Manufactured by:

Life Biopharma Sdn. Bhd.

Patient Information leaflet

LIFE COLI 10%W/W PREMIX POWDER
FOR ANIMAL USE ONLY
BRAND OR PRODUCT NAME :
Life Coli 10%w/w Premix Powder
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each kg contains 100g Colistin Sulphate (equivalent to Colistin
2,300,000 IU/g )
PRODUCT DESCRIPTION
Life Coli 10%w/w Premix Powder is a white or off white powder to be
mixed with animal feed.
PHARMACODYNAMICS
Colistin is a polypeptide antibiotic belonging to the class of
polymyxins. Colistin exerts a bactericidal action on sensitive
bacterial strains, by disorganization of their cytoplasmic membrane,
leading to an
alteration of the cell permeability and thereby to loss of
intracellular material. Colistin possesses a bactericidal activity
against a broad spectrum of Gram-negative bacteria, including
Enterobacteriaceae, in
particular Escherichia coli. Colistin has very little activity against
gram-positive bacteria and fungi. Gram positive bacteria as well as
certain species of Gram-negative bacteria such as Proteus and Serratia
are
naturally resistant to colistin. However, the development of
resistance of gram-negative enteric bacteria to colistin is rare and
explained by mutation only. Colistin has a concentration dependent
activity
against Gram-negative bacteria. Following oral administration, high
concentrations are observed in the gastrointestinal tract, i.e. the
target site, because of the low absorption of the substance.
PHARMACOKINETICS
Colistin (as sulphate) is very poorly absorbed from the
gastrointestinal tract. In serum and tissue concentrations of colistin
are very low. In contrast, colistin is present in large quantity and
persistently in the
different sections of the digestive tract. No metabolism was observed.
Colistin is almost exclusively eliminated in the faeces.
INDICATION
Lambs, goats, pigs, rabbits, poultry (chickens and turkeys):
Treatment and metaphylaxis digestive infections due to Escherichia
coli noninvasive susceptible to colistin.
The presence of the disease in the herd should be established before
proceeding with a metaphylactic treatment.