VIDENE ANTISEPTIC SOLUTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IODINATED POVIDONE PH.EUR.

Available from:

Ecolab Limited

ATC code:

D08AG02

INN (International Name):

IODINATED POVIDONE PH.EUR.

Dosage:

10 %w/w

Pharmaceutical form:

Cutaneous Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

povidone-iodine

Authorization status:

Marketed

Authorization date:

2000-06-23

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Videne Antiseptic Solution 10% w/w Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of cutaneous solution contains 10%w/w iodinated povidone,
equivalent to 11mg iodine.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution.
A dark reddish brown mobile liquid with a characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
FOR ONCE-ONLY USE:
Disinfection of intact external skin or as a mucosal antiseptic, for
example prior to surgery, biopsies, injections,
punctures, blood-taking and bladder catheterisations.
FOR REPEATED, TIME-LIMITED USE:
Antiseptic wound treatment (eg, decubitus and varicose ulcers), burns,
infected and superinfected dermatoses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Videne Antiseptic Solution is intended for topical application either
undiluted or diluted.
Used as a disinfectant or an antiseptic for the skin or mucosa, eg,
prior to surgery, biopsies, injections, punctures,
blood-taking and bladder catheterisations Videne Antiseptic Solution
should be applied undiluted.
For the disinfection of skin areas with a sparse distribution of
sebaceous glands the exposure time is at least one
minute, in skin areas with a dense distribution of sebaceous glands at
least 10 minutes.
The skin should be kept moist
for the entire duration of the exposure time with the undiluted
preparation.
For the antiseptic treatment of superficial wounds Videne Antiseptic
Solution is applied undiluted to the areas to be
treated.
In antiseptic topical therapy of burn wounds, Videne Antiseptic
Solution is generally applied undiluted to the areas to
be treated.
For antiseptic irrigation, washes and baths Videne Antiseptic Solution
can be diluted.
The following dilutions are
recommended as standard ratios:
– Irrigation within the scope of wound treatment (eg, decubitus,
varicose ulcer and gangrene) and perioperative
infection prophylaxis 1:2 to 1:20
– Antiseptic washes 1:2 to 1:25
–