VIDENE SURGICAL SCRUB

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

IODINATED POVIDONE PH.EUR.

Inapatikana kutoka:

Ecolab Limited

ATC kanuni:

D08AG02

INN (Jina la Kimataifa):

IODINATED POVIDONE PH.EUR.

Kipimo:

7.5 %w/w

Dawa fomu:

Cutaneous Solution

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

povidone-iodine

Idhini hali ya:

Marketed

Idhini ya tarehe:

2000-06-23

Taarifa za kipeperushi

7.5 W/W SURGICAL SCRUB
(IODINATED POVIDONE)
PRODUCT TITLE:
PRODUCT SIZE:
LABEL NO:
FILE NO. / DATE:
Videne Surgical Scrub Irish
500ml
3030450F
09/12/13
ADAMS HEALTHCARE APPROVAL
APPROVED BY
PRODUCTION
MARKETING
TECHNICAL
DGTG
SIGNATURE
DATE
REASON FOR CHANGE:
User Testing
PACK DIMENSIONS:
DESIGN INFORMATION
COLOURS:
FONTS:
POINT SIZES:
115 x 48mm
Helvetica Neue 55 Roman
Helvetica Neue 75 Bold
Helvetica Neue 56 Italic
Helvetica Compressed
Pantone Process Cyan
Black
Die Cut
Minimum 5pt
Videne
®
500ML
Videne Surgical Scrub 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.
Contains 7.5% w/w povidone-iodine.
Also contains alkyl phenol ether sulphate
(ammonium salt), macrogol 400,
cocoamide diethanolamide, glycerol,
povidone, citric acid, anhydrous disodium
hydrogen phosphate, purified water.
READ LEAFLET BEFORE USE.
CUTANEOUS SOLUTION.
FOR EXTERNAL USE ONLY.
Keep out of the reach and sight
of children. Do not store above 25°C.
MA Holder:
ECOLAB LTD.
Lotherton Way, Garforth
Leeds LS25 2JY England
Tel: [phone]
P
PA1110/10/1
3030450F/16NOV13/IE
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
VIDENE SURGICAL SCRUB
7.5% W/W 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 thi

Tabia za bidhaa

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
disorders or those receiving lithium therapy.
Hypersensitivity to any of t