BETADINE TOPICAL SPRAY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

POVIDONE-IODINE

متاح من:

RAFA LABORATORIES LTD

ATC رمز:

D08AG02

الشكل الصيدلاني:

DRY POWDER SPRAY

تركيب:

POVIDONE-IODINE 2.5 %

طريقة التعاطي:

DERMAL

نوع الوصفة الطبية :

Not required

المصنعة من قبل:

MUNDIPHARMA PHARMACEUTICALS LTD., CYPRUS

المجال العلاجي:

POVIDONE-IODINE

الخصائص العلاجية:

As antiseptic for prevention and treatment of infections associated with burns, cuts and scrapes, and for preventive treatment of wounds at risk of infection, e.g. after placement of a suture for wound treatment or after surgery.

تاريخ الترخيص:

2023-10-31

نشرة المعلومات

PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) – 1986
This medicine is sold without a doctor’s prescription
BETADINE
® TOPICAL SPRAY
ACTIVE INGREDIENT:
Povidone Iodine 2.5% (equivalent to 0.25% available iodine).
For the list of the other ingredients, please see section 6.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
Use the medicine according to the instructions in the dosage section
of this leaflet. Consult
your pharmacist if you require additional information.
Refer to your doctor if the symptoms get worse or do not improve.
1. WHAT IS THE MEDICINE INTENDED FOR?
This medicine is intended for skin disinfection:

For treatment and prevention of skin infections as a result of burns,
cuts and scrapes.

For preventive treatment of wounds that might become infected, e.g.:
after surgery or
stitches.
THERAPEUTIC GROUP:
Antiseptics
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:

You are sensitive (allergic) to the active ingredient, to iodine, or
to any of the other
ingredients this medicine contains (for the list of the other
ingredients, please see section
6).

You suffer from overactive thyroid gland (hyperthyroidism manifested
by increase in heart
rate and restlessness), or from any other thyroid gland disorder.

You suffer from dermatitis herpetiformis (Duhring’s Disease), which
is an autoimmune
disease with blisters.

Do not use together with mercury-containing products or antiseptics
based on octenidine.

Do not use before and after treatment with radioactive iodine (until
completion of the
treatment).

Do not use before tests with radioactive iodine (thyroid gland
scintigraphy).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE:

Do not inhale the spray mist.

Do not spray into eyes or on areas around the eyes.

The spray mist is flammable! Avoid proximity to fire (when spraying
a

خصائص المنتج

1
Betadine Topical Spray-DL-Nov 2018-01
This leaflet format has been determined by the Ministry of Health and
the content thereof has been
checked and approved
in November 2018
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Betadine Topical Spray
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone-iodine 2.5 %
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dry Powder Spray
Spray for application on skin.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
As antiseptic for prevention and treatment of infections associated
with burns, cuts
and scrapes, and for preventive treatment of wounds at risk of
infection, e.g. after
placement of a suture for wound treatment or after surgery.
4.2.
POSOLOGY AND ROUTE OF ADMINISTRATION
POSOLOGY
The dose is proportionate to the size of the area to be treated.
Spray once or multiple times daily on the area to be treated until
this is visibly
covered with the golden-brown coloured povidone-iodine powder.
In the event the Betadine Topical Spray becomes discoloured, it may be
reapplied.
NEW-BORNS AND INFANTS UNDER 6 MONTHS
Betadine Topical Spray may only be used in new-borns and infants up to
the age
of 6 months after a thorough risk-benefit analysis has been carried
out by the
doctor, and applied only to a very limited extent (see Section 4.4
Special Warnings
and Precautions for Use).
ROUTE OF ADMINISTRATION
Betadine Topical Spray is intended for external use.
2
Betadine Topical Spray forms a dry film on the treated area and can be
washed
off easily.
Shake the spray can well before use, hold upright and spray from a
distance of
15 cm on the area to be treated. The propellant evaporates immediately
and the
cold sensation experienced when the product is sprayed on quickly
disappears.
If necessary, a dressing can then be applied on top.
DURATION OF ADMINISTRATION
Betadine Topical Spray should continue to be administered for as long
as there is
evidence of an infection or a clear risk of infection. Should an
infection recur after
treatme