Coliscour 2 000 000 IU/ml, concentrate for oral solution, pigs, poultry

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Colistin

Mevcut itibaren:

Ceva Santé Animale

ATC kodu:

QA07AA10

INN (International Adı):

Colistin

Doz:

2,000,000 international unit(s)/millilitre

Farmasötik formu:

Oral solution

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Chickens, Ducks, Pigs, Turkeys

Terapötik alanı:

colistin

Terapötik endikasyonlar:

Antibacterial

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2007-09-14

Ürün özellikleri

Health Products Regulatory Authority
13 April 2018
CRN000X31
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliscour 2 000 000 IU/ml, concentrate for oral solution, pigs,
poultry.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Colistin (as sulphate)
2,000,000 IU
EXCIPIENTS:
Benzyl alcohol (E1519)
10 mg
Excipients qs
1 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and poultry.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 CONTRAINDICATIONS
Do not use in case of hypersensitivity to polypeptide antibiotics or
to any of the
excipients.
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.
Health Products Regulatory Authority
13 April 2018
CRN000X31
Page 2 of 5
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.
4.5 SPECIAL PRECAUTIONS FOR USE
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
associated with widespread use of colistin, its u