Betaiodine cream

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

povidone-iodine

Available from:

Arpimed LLC

ATC code:

D08AG02

INN (International Name):

povidone-iodine

Dosage:

100mg/g

Pharmaceutical form:

cream

Units in package:

aluminium tube 15g, aluminium tube 20g

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2019-12-17

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS (SPC) BETAIODINE 10% CREAM FOR TOPICAL USE
1. BRAND NAME - Betaiodine INTERNATIONAL NON-PROPERTY NAME – Povidone iodine
2. QUANTITATIVE AND QUALITATIVE COMPOSITION
Each gram of Betaiodine, 10% cream contains:
_ACTIVE INGREDIENT: _povidone iodine – 100 mg;
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
A brown colored cream having a characteristic iodine odor.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Betaiodine cream is a broad spectrum antiseptic for the topical
treatment or prevention of
infection in minor cuts and abrasions, minor surgical procedures and
small areas of burns.
Treatment of mycotic and bacterial skin infections pyodermas.
Treatment of infections in
decubitus and stasis ulcers.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Topical
For the treatment of infection: Apply once or twice daily for a
maximum of 14 days.
For the prevention of infection: Apply once or twice a week, for as
long as necessary.
The affected skin should be cleaned and dried. Apply Betaiodine cream
to the affected area. May
be covered with a dressing or bandage.
Not for use in children under two years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient.
History of abnormal thyroid
function
or
goitre
(in
particular
nodular
colloid
goitre,
endemic
goitre
and
Hashimoto’s
thyroiditis). Use in children under two years of age. Regular use
should be avoided in patients on
concurrent lithium therapy.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of this preparation may interfere with tests of thyroid function.
Iodine is absorbed through
burns and broken skin and to a lesser extent through intact skin and
may lead to toxic levels of
iodine
in
the
blood,
particularly
in
patients
with
renal
insufficiency.
If
symptoms
occur
suggesting changes in thyroid function, these should be investigated.
In patients with impaired
renal function, blood levels of iodine should be monitored.
If local irritation