Betaiodine solution for external use

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

povidone-iodine

Dostępny od:

Arpimed LLC

Kod ATC:

D08AG02

INN (International Nazwa):

povidone-iodine

Dawkowanie:

100mg/ml

Forma farmaceutyczna:

solution for external use

Sztuk w opakowaniu:

30ml, 60ml, 100ml, 1l, 3.6l and 4l plastic container

Typ recepty:

OTC

Status autoryzacji:

Registered

Data autoryzacji:

2018-04-17

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
BETAIODINE
10% SOLUTION FOR EXTERNAL USE
1.1 NAME OF THE MEDICAL PRODUCT – Betaiodine
1.2 INTERNATIONAL NON-PROPERTY NAME – Povidone - iodine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the solution contains povidone-iodine 100 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for external use.
A brown colored liquid having a characteristic iodine odor.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use as a pre-operative and post-operative antiseptic skin cleanser
for major and
minor surgical procedures.
As a general antiseptic solution in the prevention and treatment of
infections.
For the treatment of cold sores.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Topical administration.
Adults, the elderly and children over 2 years of age: Apply full
strength as a pre-operative and
post-operative antiseptic skin cleanser.
For use as a pre-operative and post-operative antiseptic skin cleanser
for major and minor
surgical procedures: Avoid pooling both under the patients and in the
skin folds. Wash off excess
solution before using occlusive dressings.
As a general antiseptic solution in the prevention and treatment of
infections: apply Povidone-
iodine solution undiluted as necessary to the affected area and allow
to dry. Rinse the brush
thoroughly after use.
For the treatment of cold sores: apply twice daily to the affected
area and allow to dry.
Not to be used on children under 2 years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidine 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