Coldostin, 4800000 IU/g, Powder for Use in Drinking Water/Milk

País: Reino Unido

Idioma: inglés

Fuente: VMD (Veterinary Medicines Directorate)

Ingredientes activos:

Colistin Sulphate

Disponible desde:

Dopharma Research B.V.

Código ATC:

QA07AA10

Designación común internacional (DCI):

Colistin Sulphate

formulario farmacéutico:

Powder for use in drinking water/milk

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Cattle, Chickens, Pigs, Sheep, Turkeys

Área terapéutica:

Antimicrobial

Estado de Autorización:

Authorized

Fecha de autorización:

2016-10-25

Ficha técnica

Revised: September 2021
AN: 01722/2020 & 01723/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coldostin, 4800000 IU/g, powder for use in drinking water/milk
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE_:_
Colistin sulfate
4 800 000 IU
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for use in drinking water/milk.
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (calves), sheep (lambs), pigs, chickens and turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and metaphylaxis of enteric infections caused by
non-invasive _Escherichia coli_
susceptible to colistin sulfate.
In the case of metaphylaxis, 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 colistin sulfate or to any
of the excipients.
Do not use in cases of resistance to polymyxins.
Do not use in horses, particularly in foals, since colistin sulfate,
due to a shift in the
gastrointestinal microflora balance could lead to the development of
antimicrobial
associated colitis (Colitis X), typically associated with Clostridium
difficile, which may be
fatal.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As an adjunct to treatment, good management and hygiene practices
should be introduced
in order to reduce the risk of infection and to control the potential
build-up of resistance.
There is cross-resistance between colistin sulfate and polymyxin B.
Colistin sulfate exerts concentration-dependent activity against
Gram-negative bacteria.
Following oral administration high concentrations are achieved in the
gastrointestinal tract,
i.e. the target site, due to the poor absorption of the substance.
These factors indicate that
a longer duration of treatment than the one indicated in section 4.9,
leading to
unnecessary exposure, is not recommended.
Revised: September 2021
AN: 01722/2020 & 01723/