Colfive 5,000,000 IU/ml concentrate for oral solution for calves, pigs, lambs, chickens and turkeys

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Colistin sulfate

Disponible des:

LIVISTO Int'l, S.L.

Codi ATC:

QA07AA10

Designació comuna internacional (DCI):

Colistin sulfate

Dosis:

5,000,000 international unit(s)/millilitre

formulario farmacéutico:

Oral solution

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle, Chickens, Pigs, Sheep, Turkeys

Área terapéutica:

colistin

indicaciones terapéuticas:

Antibiotics

Estat d'Autorització:

Authorised

Data d'autorització:

2015-05-01

Fitxa tècnica

Health Products Regulatory Authority
17 September 2020
CRN009T7S
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Colfive 5,000,000 IU/ml concentrate for oral solution for calves,
pigs, lambs, chickens and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
ACTIVE SUBSTANCE:
​
Colistin sulfate
​​5,000,000 IU
​
​
​
EXCIPIENTS:
​
​
Benzyl alcohol (E1519)
​10 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for oral solution
Clear orange-brown solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (calves), pigs, sheep (lambs), chickens and turkeys
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Calves, lambs, pigs, chickens, turkeys:
Treatment and metaphylaxis of enteric infections caused by
non-invasive _E. coli _
susceptible to colistin sulfate. The presence of
the disease in the herd should be established before metaphylactic
treatment.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to colistin sulfate or
to any of the excipients.
Do not use in known 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.
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 recom