Betadine Alcoholic Solution 10.0% w/v

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

POVIDONE, IODINE

Mevcut itibaren:

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

ATC kodu:

D08AG02

INN (International Adı):

POVIDONE-IODINE 10 % (W/V)

Farmasötik formu:

CUTANEOUS SOLUTION

Kompozisyon:

POVIDONE-IODINE 10 % (W/V)

Reçete türü:

OTC

Terapötik alanı:

ANTISEPTICS AND DISINFECTANTS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2006-05-26

Bilgilendirme broşürü

PILBALCMT01v2.01
PACKAGE LEAFLET: INFORMATION FOR THE USER
BETADINE
® ALCOHOLIC SOLUTION 10% 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
® ALCOHOLIC SOLUTION is and what it is used for
2.
What you need to know before you use BETADINE
® ALCOHOLIC SOLUTION
3.
How to use BETADINE
® ALCOHOLIC SOLUTION
4.
Possible side effects
5.
How to store BETADINE
® ALCOHOLIC SOLUTION
6.
Contents of the pack and other information
1.
WHAT BETADINE
® ALCOHOLIC SOLUTION IS AND WHAT IT IS USED FOR
_ _
BETADINE
® ALCOHOLIC SOLUTION is an antiseptic indicated for degerming skin, and
wounds in:
-
Pre-operative preparation of skin.
-
Post-operative surgical wound infection.
-
Casualty procedures, including prevention of infection in lacerations
and abrasions.
BETADINE
® ALCOHOLIC SOLUTION is an antiseptic skin cleanser for wounds where a
quick drying effect
is desired.
It is used also for the treatment of various bacterial, viral,
protozoal and mycotic skin infections.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BETADINE
® ALCOHOLIC SOLUTION
_ _
DO NOT USE BETADINE
® ALCOHOLIC SOLUTION_ _
-
If you are allergic to Povidone-Iodine or any of the other excipients
of this medicine (listed in
section 6).
-
in patients hypersensitive to the active substance(s) or to any 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.
-
in children under 1 year of age.
-
before during and after radio-iodine administration.
-
in patients using products containing mercury
WARNINGS AND PRECAUTIONS_ _
Talk

Ürün özellikleri

Page 1 of 7
SPCBALCMT01v2.01
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BETADINE
® ALCOHOLIC SOLUTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-Iodine Ph. Eur. 10.00% w/v
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hydro alcoholic solution
For topical administration.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BETADINE
® ALCOHOLIC SOLUTION is indicated for degerming skin, and wounds in
hospital and
office procedures.
•
Pre-operative preparation of skin.
•
Post-operative surgical wound infection.
•
Casualty procedures, including prevention of infection in lacerations
and abrasions.
BETADINE
® ALCOHOLIC SOLUTION is an antiseptic cleanser for skin and wounds
where a quick
drying effect is desired.
It is used also for the treatment of various bacterial, viral,
protozoal and mycotic skin infections.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Paediatric population _
BETADINE
® ALCOHOLIC SOLUTION is contraindicated in children below the age of 1
year (see
section 4.3).
Method of administration
For topical use only.
Spread the solution, undiluted, onto the areas to be treated. The
solution can be applied
twice daily. Cover with dressing if desired.
A.
For disinfection of the hands the procedure is as follows:
a)
Hygienic disinfection of the hands:
3ml undiluted – allow drying.
b)
Surgical disinfection
2x5ml undiluted – allow drying.
B.
For disinfection of the skin the procedure is as follows:
Before injections, punctures and surgical operations, allow the
solution to dry.
Page 2 of 7
SPCBALCMT01v2.01
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 afte