Betadine 10.00% w/v Antiseptic Solution

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

POVIDONE, IODINE

Tilgængelig fra:

Mundipharma Pharmaceuticals Limited 13 Othellos Street, Dhali Industrial Zone, Nicosia, Cyprus

ATC-kode:

D08AG02

INN (International Name):

POVIDONE-IODINE 10 % (W/V)

Lægemiddelform:

CUTANEOUS SOLUTION

Sammensætning:

POVIDONE-IODINE 10 % (W/V)

Recept type:

OTC

Terapeutisk område:

ANTISEPTICS AND DISINFECTANTS

Autorisation status:

Authorised

Autorisation dato:

2006-05-26

Indlægsseddel

PILBASLMT01v2.01
PACKAGE LEAFLET:
INFORMATION FOR THE USER
BETADINE
_®_ 10% W/V ANTISEPTIC SOLUTION
POVIDONE IODINE
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR 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 pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What
BETADINE
_®_ ANTISEPTIC SOLUTION
is and what it is used for
2.
What you need to know before you use
BETADINE
_®_ ANTISEPTIC SOLUTION
3.
How to use
BETADINE
_®_ ANTISEPTIC SOLUTION
4.
Possible side effects
5.
How to store
BETADINE
_®_ ANTISEPTIC SOLUTION
6.
Contents of the pack and other information
1
WHAT BETADINE
_®_ ANTISEPTIC SOLUTION IS AND WHAT IT IS USED FOR
BETADINE
_®_ ANTISEPTIC SOLUTION
is an antiseptic solution. It is indicated for use as pre-operative
antiseptic skin cleanser for major and minor surgical procedures.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE BETADINE
_®_ ANTISEPTIC SOLUTION
DO NOT USE BETADINE
_®_ ANTISEPTIC SOLUTION:
-
if you are allergic to povidone iodine or any of the other ingredients
of this medicine (listed in
section 6).
-
in patients hypersensitive to the povidone iodine or to any of the
excipients listed in section 6.
-
if you have thyroid disorders (in particular nodular colloid goiter,
endemic goiter and Hashimoto’s
thyroiditis).
-
if you are taking lithium.
-
for body cavity irrigation.
-
before, during and after radio-iodine administration.
-
in patients using products containing mercury
-
in children under 1 year of age.
WARNINGS AND PRECAUTIONS
Talk to your doctor or, pharmacist or nurse before using BETADINE
_®_ ANTISEPTIC SOLUTION
.
-
Special caution is needed when regular applications to broken skin are
made to patients with pre-
existing renal insufficiency.
-
Povidone-Iodine should not cover for a long period large area o

Produktets egenskaber

SPCBSSLMT01v2.01
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BETADINE
®
10.00% w/v ANTISEPTIC SOLUTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-Iodine Ph. Eur. 10.00% w/v
3.
PHARMACEUTICAL FORM
Aqueous solution
For topical administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use as pre-operative antiseptic skin cleanser for major and minor
surgical procedures.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, the elderly and children: Apply full strength as a
preoperative antiseptic skin cleanser.
Avoid pooling both under the patient and in the skin folds. Wash off
excess solution before
using occlusive dressings.
Spread the solution, undiluted, onto the parts to be treated. After
drying, an air- permeable film
is formed, which can be easily washed off with water. The solution can
be applied several
times a day.
_For disinfection of the hands the procedure is as follows:_
Hygienic disinfection of the hands:
3ml undiluted – allow to work in for one minute.
Surgical disinfection
2x5ml undiluted – allow to work in for 5 minutes.
_For disinfection of the skin the procedure is as follows:_
Application on skin with few sebaceous glands
Before injections, punctures and surgical operations, allow the
solution to act for at least 1
minute.
Application on skin with many sebaceous glands
Before all operations allow the solution to act for at least 10
minutes,
keeping
the
skin
constantly moist.
SPCBSSLMT01v2.01
BETADINE
_®_ ANTISEPTIC SOLUTION
can be used diluted for rinsing and washing.
For different use different dilutions are recommended.
_Paediatric population _
BETADINE
_®_ ANTISEPTIC SOLUTION
is contraindicated in children below the age of 1 year (see
section 4.3).
Method of administration
Topical
4.3
CONTRAINDICATIONS
Contraindicated in:
•
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
•
Hyperfunction of the thyroid (hyperthyroidism), other manifest thyroid
diseases esp.
nodular colloidal goitre, end