HIDROCOL, 4000000 IU/ml solution for use in drinking water/milk

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Colistin

Available from:

SP Veterinaria, S.A.

ATC code:

QA07AA10

INN (International Name):

Colistin

Dosage:

4000000 international unit(s)/millilitre

Pharmaceutical form:

Solution for use in drinking water/milk

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Chickens, Pigs, Sheep, Turkeys

Therapeutic area:

colistin

Therapeutic indications:

Antibiotics

Authorization status:

Authorised

Authorization date:

2016-07-15

Summary of Product characteristics

Health Products Regulatory Authority
29 July 2021
CRN00CHHX
Page 1 of 5
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.
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-resistance between colistin sulf