Videne 7.5% w/w Surgical Scrub

Šalis: Airija

kalba: anglų

Šaltinis: HPRA (Health Products Regulatory Authority)

Veiklioji medžiaga:

Iodinated povidone

Prieinama:

Ecolab Deutschland GmbH

ATC kodas:

D08AG; D08AG02

INN (Tarptautinis Pavadinimas):

Iodinated povidone

Dozė:

7.5 percent weight/weight

Vaisto forma:

Cutaneous solution

Gydymo sritis:

Iodine products; povidone-iodine

Autorizacija statusas:

Marketed

Leidimo data:

2000-06-23

Pakuotės lapelis

Page 1 of 3
Videne
7.5% w/w Surgical Scrub
(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 your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
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 Surgical Scrub in this
label-leaflet, contains iodinated povidone
as the active substance. It is an antiseptic skin cleanser for use as
a pre-operative skin disinfection
for the surgical team and for disinfecting the site of incision prior
to surgery.
Solutions of iodinated povidone gradually release iodine to kill or
stop the growth of bacteria, fungi,
viruses, protozoa, cysts and spores.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
DO NOT USE:

On newborn children.

During pregnancy and breastfeeding.

If you are sensitive to iodine or any of the other ingredients of this
medicine (listed in section 6).

For regular or prolonged periods if you have thyroid problems or if
you are taking lithium (an anti-
depressant).

For external use only. Do not swallow.
WARNINGS AND PRECAUTIONS:
Talk to your doctor or nurse before using Videne Surgical Scrub if:

You are using on large wounds or severe burns as it could produce
adverse effects such as changes
in blood chemistry and problems with the kidneys.

You are prone to, or have ever been treated in the past for
hyperthyroidism.
OTHER MEDICINES AND VIDENE SURGICAL SCRUB

Talk to your doctor or nurse before using Videne Surgical Scrub if you
are t

Prekės savybės

Health Products Regulatory Authority
14 June 2023
CRN00DMC8
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Videne 7.5% w/w Surgical Scrub
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated Povidone 7.5% 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
Videne 7.5% w/w Surgical Scrub is a broad-spectrum antiseptic for
topical use. It is indicated for pre-operative hand
disinfection by the surgical team, or for disinfecting the site of
incision prior to elective surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
PRE-OPERATIVE SURGICAL SCRUB - after first wetting the hands and arms
with water, approximately 3.5ml of Videne 7.5% w/w
Surgical Scrub is applied and rubbed thoroughly on to these areas. A
brush may be used to scrub the nails. A little water is
added to develop a lather and finally this MUST BE RINSED OFF with
running water.
PRE-OPERATIVE SKIN PREPARATION - the site of incision should be washed
with Videne 7.5% w/w Surgical Scrub two or three
times a day prior to the operation. Immediately before surgery the
skin should be moistened with water, Videne 7.5% w/w
Surgical Scrub applied and rubbed thoroughly into the area for several
minutes. A sterile gauze swab is used to develop a
lather which MUST BE FINALLY RINSED OFF with water.
Only water should be used to dilute Videne 7.5% w/w Surgical Scrub.
_Neonates:_
Do not use on neonates, refer to Section 4.3 Contraindications.
_Children and Elderly:_
There are no special dosage recommendations for children or elderly
patients.
_Renal Impairment:_
Patients with renal impairment should refer to Section 4.4, special
warnings and precautions for use.
4.3 CONTRAINDICATIONS
Videne 7.5% w/w Surgical Scrub must never be administered orally, and
is contra-indicated in neonates, and during pregnancy
and lactation.
Regular or prolonged use should be avoided in patients with thyroid
di