COLISTIN APSA 1,200,000 IU/G PREMIX FOR MEDICATED FEEDING STUFF FOR PIGS
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
16-07-2016
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Aktiva substanser:
COLISTIN (AS SULFATE)
Tillgänglig från:
Andres Pintaluba S.A.
ATC-kod:
QA07AA10
INN (International namn):
COLISTIN (AS SULFATE)
Dos:
1,200,000 International Unit
Läkemedelsform:
Premix for Med.Feedstuffs
Receptbelagda typ:
POM
Terapeutisk grupp:
Porcine
Terapiområde:
Colistin
Terapeutiska indikationer:
Antibiotics
Bemyndigande status:
Authorised
Tillstånd datum:
2016-07-01
Produktens egenskaper
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 alter
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