Betadine Surgical Scrub 7.5% w/v

Страна: Малта

Език: английски

Източник: Malta Medicines Authority

Активна съставка:

POVIDONE, IODINE

Предлага се от:

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

АТС код:

D08AG02

INN (Международно Name):

POVIDONE-IODINE 7.5 % (W/V)

Лекарствена форма:

CUTANEOUS SOLUTION

Композиция:

POVIDONE-IODINE 7.5 % (W/V)

Вид предписание :

OTC

Терапевтична област:

ANTISEPTICS AND DISINFECTANTS

Статус Оторизация:

Authorised

Дата Оторизация:

2006-05-26

Листовка

PILBSCMT01v2.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETADINE
® SURGICAL SCRUB 7.5% W/V
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.
-
If you have any further questions, ask your doctor, pharmacist, or
nurse.
-
If you get any side effects, talk to your doctor, 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
® SURGICAL SCRUB is and what it is used for
2.
What you need to know before you use BETADINE
® SURGICAL SCRUB
3.
How to use BETADINE
® SURGICAL SCRUB
4.
Possible side effects
5.
How to store BETADINE
® SURGICAL SCRUB
6.
Contents of the pack and other information
1.
WHAT BETADINE
® SURGICAL SCRUB IS AND WHAT IT IS USED FOR
BETADINE
® SURGICAL SCRUB is an antiseptic surgical scrub, used as an
antiseptic cleanser, for pre-operative scrubbing and washing by
surgeons and
the other stuff and pre-operative preparation of patients’ skin.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BETADINE
® SURGICAL
SCRUB
DO NOT USE BETADINE
® SURGICAL SCRUB
-
If you are allergic to Povidone-Iodine or any of the other excipients
of
this medicine (listed in section 6)
-
In patients hypersensitive to iodine or any other of the excipients
listed
in section 6.
-
In patients with thyroid disorders (in particular nodular colloid
goiter,
endemic goiter and Hashimoto’s thyroiditis).
-
In patients taking lithium.
-
Do not use in children under 1 year of age.
-
before, during and after radio-iodine administration.
-
in patients using products containing mercury
WARNINGS AND PRECAUTIONS
PILBSCMT01v2.01
Talk to your doctor, pharmacist or nurse before using BETADINE
® SURGICAL
SCRUB
-
Special caution is needed when regular applications to broken skin are
made to patients with pre-existing renal insufficiency.
-
Avoid solutions containing a detergent if treating open wounds with
Povidone-Iodine.

Данни за продукта

Page 1 of 6
SPCBSCMT01v2.01
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BETADINE
® SURGICAL SCRUB
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-Iodine Ph. Eur. 7.5% w/v
For the full list of esxipients, see section 6.1
3.
PHARMACEUTICAL FORM
Surgical scrub.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BETADINE
® SURGICAL SCRUB is indicated for use as antiseptic cleanser, for
pre-operative
scrubbing and washing by surgeons and theatre staff, and pre-operative
preparation of
patients’ skin.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
BETADINE
® SURGICAL SCRUB is contraindicated in children below the age of 1 year
(see
section 4.3).
Method of administration
For topical administration.
Adults, the elderly and children: Apply full strength as a
preoperative antiseptic skin cleanser.
Moisten the hands and/or the areas of skin to be treated. Apply
BETADINE
_®_ SURGICAL SCRUB,
for the hands about 5ml (otherwise about 2ml/100 cm
2
of body surface) and rub well for 1
minute – to obtain a better lather a few drops of water can be
added. Then rinse off or wash off
with clean water.
4.3
CONTRAINDICATIONS
Contraindicated in:
•
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
•
Hyperfunction of the thyroid (hyperthyroidism), other manifest thyroid
diseases esp.
nodular colloidal goitre, endemic goitre, Hashimoto’s thyroiditis,
as well as before and
after radioiodine therapy for hyperthyroidism, until a lasting cure
has been obtained.
•
Before, during and after radio-iodine administration (see section
4.5).
•
Patients with goitre, thyroid nodules, or other thyroid diseases
(especially elderly
patients) are at risk of developing thyroid hyperfunction
(hyperthyroidism) from the
administration of large amounts of iodine.
•
Do not use in children under 1 year of age.
•
Not to be used on patients on concurrent lithium therapy.
•
Products containing mercury, should not be used concomitantly due to