Zineryt powder for solution for external use

Страна: Армения

Язык: английский

Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Активный ингредиент:

erythromycin, zinc acetate dihydrate

Доступна с:

Astellas Pharma Europe B.V.

код АТС:

D10AF52

ИНН (Международная Имя):

erythromycin, zinc acetate dihydrate

дозировка:

40mg/ml+ 12mg/ml

Фармацевтическая форма:

powder for solution for external use

Штук в упаковке:

plastic container, 30ml solvent in plastic container and applicator

Тип рецепта:

Prescription

Статус Авторизация:

Registered

Дата Авторизация:

2017-12-08

Характеристики продукта

Zineryt
®
erythromycin-zinc complex
LEO Pharma A/S
CTD Module 1
application fludi (powder for reconstitution)
Section 1.3: Product Information
SmPC PIL LABEL NL Zineryt
–
MAH LEO Pharma - 02-May-2016
APPENDIX I
SUMMARY OF PRODUCT CHARACTERISTICS
Zineryt
®
erythromycin-zinc complex
LEO Pharma A/S
CTD Module 1
application fludi (powder for reconstitution)
Section 1.3: Product Information
SmPC PIL LABEL Armenia Zineryt
–
MAH LEO
Pharma
–
02-May-2016
Page 1 of 3
1. NAME OF THE MEDICINAL PRODUCT
Zineryt
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Zineryt contains 40 mg/ml of erythromycin
and zinc acetate dehydrate micronized 12 mg/ml
3. PHARMACEUTICAL FORM
Powder for solution for external use
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moderate to severe forms of acne, in cases where local treatment
without antibiotics has yielded little or
no results or is not tolerated
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Zineryt must be applied 2x daily on the affected skin, usually for a
period of 10 to 12 weeks. Significant
therapeutic effect is generally reached within the first 12 weeks.
If no or insufficient improvement or even a deterioration occurred
after this period, the patient must
consult his/her doctor and the possibility of bacterial resistance
must be taken into account. If bacterial
resistance occurred, the use of the product must be stopped for a
period of two months.
METHOD OF ADMINISTRATION
Zineryt must be applied generously to the skin of the entire face or
to other affected areas (not just the
laesion), until the entire treatable area is covered (each time, ±0.5
ml is required for this).
Zineryt is administered by holding the bottle slanting and upside down
with the swab against the skin and
moving it back and forth while pressing it softly. The outflow of
Zineryt may be regulated by increasing
or decreasing the pressure of the swab against the skin.
4.3 CONTRAINDICATIONS
Zineryt is contraindicated in patients who are hypersenstive to
erythromycin or other macrolide
antibiotics, o