COLISTIN APSA 1,200,000 IU/g Premix for medicated feeding stuff for pigs

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Colistin

Disponible des:

Andres Pintaluba S.A.

Codi ATC:

QA07AA10

Designació comuna internacional (DCI):

Colistin

Dosis:

1,200,000 international unit(s)/gram

formulario farmacéutico:

Premix for medicated feeding stuff

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Pigs

Área terapéutica:

colistin

indicaciones terapéuticas:

Antibiotics

Estat d'Autorització:

Authorised

Data d'autorització:

2016-07-01

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
COLISTIN APSA 1,200,000 IU/g
Premix for medicated feeding stuff for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Colistin (as sulfate)
1,200,000 IU
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Premix for medicated feeding stuff
Granulated brown powder
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pig (piglet and pig for fattening).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and metaphylaxis of enteric infections caused by
non-invasive_ E.coli_ susceptible to colistin.
The presence of disease in the herd should be established before
metaphylactic treatment.
4.3 CONTRAINDICATIONS
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.
Do not use in case of hypersensitivity to colistin or to any of the
excipients.
Do not use in case resistance to polymyxins.
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 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.
The intake of medicated feed by animals can be altered as a
consequence of illness. In case of insufficient intake of feed,
animals should be treated parenterally.
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