Sogecoli 2 000 000 IU/ml concentrate for oral solution for calves, lambs, pigs, chickens and turkeys

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Colistin

Tilgjengelig fra:

Ceva Santé Animale

ATC-kode:

QA07AA10

INN (International Name):

Colistin

Dosering :

2000000 international unit(s)/millilitre

Legemiddelform:

Oral solution

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle, Chickens, Pigs, Sheep, Turkeys

Terapeutisk område:

colistin

Indikasjoner:

Antibiotics

Autorisasjon status:

Authorised

Autorisasjon dato:

2016-04-22

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Sogecoli 2 000 000 IU/ml concentrate for oral solution for calves,
lambs, pigs, chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ONE ML CONTAINS :
ACTIVE SUBSTANCE:
Colistin (as sulphate)........................................ 2000
000 IU
EXCIPIENTS:
Benzyl alcohol (E1519)…………………………0.01 ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution.
Clear, yellowish to orange solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves), sheep (lambs), pigs, chickens and turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves - lambs – pigs - chickens – turkeys .:
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 known hypersensitivity to polypeptide
antibiotics or to any of the excipients.
Do not use in case of resistance to polymyxins.
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.
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