Coliplus 2,000,000 IU/ml Concentrate for Oral Solution for Use in Drinking Water for Cattle, Sheep, Pigs and Chickens

Țară: Regatul Unit

Limbă: engleză

Sursă: VMD (Veterinary Medicines Directorate)

Ingredient activ:

Colistin Sulphate

Disponibil de la:

Divasa - Farmavic S.A

Codul ATC:

QA07AA10

INN (nume internaţional):

Colistin Sulphate

Forma farmaceutică:

Concentrate for oral solution

Tip de prescriptie medicala:

POM-V - Prescription Only Medicine – Veterinarian

Grupul Terapeutică:

Cattle, Chickens, Pigs, Sheep

Zonă Terapeutică:

Antimicrobial

Statutul autorizaţiei:

Authorized

Data de autorizare:

2010-12-08

Caracteristicilor produsului

Revised: June 2015
AN: 00102/2015
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Coliplus 2,000,000 IU/ml Concentrate for Oral Solution for use in
drinking water for
Cattle, Sheep, Pigs and Chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition for 1 ml:
ACTIVE SUBSTANCE:
Colistin (as Colistin sulfate)
2 MIU (equivalent to 83.33 mg)
EXCIPIENT(S):
Benzyl Alcohol (E1519)
10 mg
Disodium edetate
0.1 mg
Excipients qs
1 ml
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Concentrate for oral solution for use in drinking water.
Clear yellow-brown solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (calves), sheep (lambs), pigs and chickens
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and metaphylaxis of gastrointestinal infections caused by
non-invasive
_Escherichia 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 hypersensitivity to polypeptide antibiotics or
to any of the
excipients.
Do not use in case of resistance to the polymyxin.
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
Revised: June 2015
AN: 00102/2015
Page 2 of 7
Use of the product should be based on susceptibility testing and take
into account
official and local antimicrobials policies.
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.
4