Colfive 5,000,000 IU/ml Concentrate for Oral Solution for Calves, Pigs, Lambs, Chickens and Turkeys

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Colistin Sulphate

Available from:

Livisto Int'l S.L.

ATC code:

QA07AA10

INN (International Name):

Colistin Sulphate

Pharmaceutical form:

Concentrate for oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Chickens, Pigs, Sheep, Turkeys

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2015-05-06

Summary of Product characteristics

Revised: October 2020
AN: 00428/2020
Page 1 of 6
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
Revised: October 2020
AN: 00428/2020
Page 2 of 6
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 recommended.
4.5
SPE