Videne Antiseptic Solution 10% w/w Cutaneous Solution

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Iodinated povidone ph.eur.

Fáanlegur frá:

Ecolab Deutschland GmbH

ATC númer:

D08AG; D08AG02

INN (Alþjóðlegt nafn):

Iodinated povidone ph.eur.

Skammtar:

10 percent weight/weight

Lyfjaform:

Cutaneous solution

Lækningarsvæði:

Iodine products; povidone-iodine

Leyfisstaða:

Marketed

Leyfisdagur:

2000-06-23

Upplýsingar fylgiseðill

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
6
VIDENE ANTISEPTIC SOLUTION 10% W/W CUTANEOUS SOLUTION
Iodinated Povidone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use this medicine exactly as described in this leaflet or as
your doctor or nurse has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask if you need more information or advice.
-
If you get any side effects, talk to your doctor , nurse or pharmacist
This includes any possible
side effects not listed in this leaflet.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
WHAT IS IN THIS LEAFLET
1.
What it is and what it is used for
2.
What you need to know before use
3.
How to use
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IT IS AND WHAT IT IS USED FOR
This product, referred to as Videne Antiseptic Solution in this
label-leaflet, contains povidone-iodine as
the active substance. It is used by a doctor or nurse to disinfect
skin (e.g. prior to surgery, biopsies,
injections, punctures, blood taking, bladder catheterisations) or
mucous membranes such as the mouth,
eye, bowel and female genitals. It can also be used by a patient for
self-treatment as an antiseptic
treatment for wounds, superficial and limited burns and infected skin.
Videne Antiseptic Solution
gradually releases iodine to help destroy bacteria,fungi and some
viruses
2.
WHAT YOU NEED TO KNOW BEFORE USE
DO NOT USE:
-
If you have hyperthyroidism (an over-active thyroid gland) or other
thyroid disorders.
-
If you have Duhrings’s disease (a skin disease with severe itching
and blistering).
-
Before or immediately after radioiodine therapy.
-
If you know that you are sensitive to iodinated povidone or any of the
ingredients.
-
For regular or prolonged periods if you are taking lithium (an
anti-depressant).
WARNINGS AND PRECAUTIONS
Talk to your doctor, nurse or pharmacist before using Videne
Antiseptic Solutio

Vara einkenni

Health Products Regulatory Authority
03 November 2023
CRN00DH7Y
Page 1 of 7
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.
Excipients with known effect:
Glycerol 2.0% w/w
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. 200ml pack size is for single use only.
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