Hidrocol, 4000000 IU/ml Solution for Use in Drinking Water/Milk

Ország: Egyesült Királyság

Nyelv: angol

Forrás: VMD (Veterinary Medicines Directorate)

Aktív összetevők:

Colistin Sulphate

Beszerezhető a:

SP Veterinaria, S.A.

ATC-kód:

QA07AA10

INN (nemzetközi neve):

Colistin Sulphate

Gyógyszerészeti forma:

Solution for use in drinking water

Recept típusa:

POM-V - Prescription Only Medicine – Veterinarian

Terápiás csoport:

Cattle, Chickens, Pigs, Sheep, Turkeys

Terápiás terület:

Antimicrobial

Engedélyezési státusz:

Authorized

Engedély dátuma:

2016-07-29

Termékjellemzők

Revised: September 2021
AN: 01841/2020 & 01864/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIDROCOL, 4000000 IU/ml solution for use in drinking water/milk
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Colistin (as sulfate)
4000000 IU
Excipients:
Benzyl alcohol
(E1519)
0.010 ml
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for use in drinking water/milk
A brown –orange solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (calves), sheep (lambs), pigs, chickens and turkeys.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment and metaphylaxis of enteric infections caused by
non-invasive E. _ Coli_,
susceptible to colistin.
In the case of metaphylaxis, the presence of the disease in the group
/ flock must be
established before the product is used.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to colistin sulfate or to any
of the excipients.
Do not use in 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.
Revised: September 2021
AN: 01841/2020 & 01864/2020
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
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.
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.
There is cross-resistanc