Colistin APSA 1,200,000 IU/g Premix for Medicated Feeding Stuff for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Colistin Sulphate

Available from:

ANDRES PINTALUBA, S.A.

ATC code:

QA07AA10

INN (International Name):

Colistin Sulphate

Pharmaceutical form:

Premix for medicated feeding stuff

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2016-07-06

Summary of Product characteristics

Issued: July 2016
AN: 00554/2015
Page 1 of 6
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.
Issued: July 2016
AN: 00554/2015
Page 2 of 6
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.
4.5.
SPECIAL PRECAUTION