Coliscour Oral Solution of Colistin Sulphate 2 MIU/ml

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)

Aktīvā sastāvdaļa:

Colistin Sulphate

Pieejams no:

Ceva Animal Health Ltd

SNN (starptautisko nepatentēto nosaukumu):

Colistin Sulphate

Zāļu forma:

Oral solution

Receptes veids:

POM-V - Prescription Only Medicine – Veterinarian

Ārstniecības grupa:

Pigs

Ārstniecības joma:

Antimicrobial

Autorizācija statuss:

Authorized

Autorizācija datums:

2004-12-03

Produkta apraksts

Revised: May 2015
AN: 00117/2015
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliscour oral solution of colistin sulphate 2MIU/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml:
Active substance:
Colistin (as Colistin sulphate)……………………………..
2 MIU
Excipients:
Benzyl alcohol…………………………………………….. 10
mg
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Oral solution.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs: in particular suckling and post weaning.
4.2
INDICATIONS FOR USE
Treatment and metaphylaxis of gastrointestinal infections caused by
non-invasive
_E.coli _susceptible to colistin.
The presence of the disease in the herd should be established before
metaphylactic
treatment.
4.3
CONTRA-INDICATIONS
Do not use in horses, particularly in foals, since colistin, 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
Colistin 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: May 2015
AN: 00117/2015
Page 2 of 7
4.5
SPECIAL PRECAUTIONS FOR USE, INCLUDING SPECIAL PRECAUTIONS TO BE TAKEN
BY THE
PERSON ADMINISTERING THE MEDICINAL PRODUCT TO THE ANIMALS
i.
Special precautions for use in animals
Do not use colistin as a substitute for good management practices.
Colistin is a last resort drug in human medicine for treatment of
infections
caused
by
certain
multi-drug
resistant
bacteria.
In
order
to
minimise
any
potential risk associat