Orungal capsules

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

itraconazole

متاح من:

Janssen Cilag S.p.A.

ATC رمز:

J02AC02

INN (الاسم الدولي):

itraconazole

جرعة:

100mg

الشكل الصيدلاني:

capsules

الوحدات في الحزمة:

(14/1x14/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2019-10-18

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Orungal 100 mg Capsules.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains itraconazole 100 mg. For excipients,
see 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard
Capsule (Size 0): opaque blue cap and pink transparent body containing
coated beads.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
1.
Vulvovaginal candidosis.
2.
Pityriasis versicolor.
3.
Dermatophytoses caused by organisms susceptible to itraconazole
_(Trichophyton spp._
,
_Microsporum spp._
,
_Epidermophyton floccosum_
) e.g. tinea
pedis, tinea cruris, tinea corporis,
tinea manuum.
4.
Oropharyngeal candidosis.
5.
Onychomycosis caused by dermatophytes and/or yeasts.
6.
The treatment of histoplasmosis.
7.
Orungal is indicated in the following systemic fungal conditions when
first-line systemic anti-
fungal therapy is inappropriate or has proved ineffective. This
may be due to underlying
pathology, insensitivity of the pathogen or drug
toxicity.
-
Treatment of aspergillosis and candidosis
-
Treatment of cryptococcosis (including cryptococcal meningitis): in
immunocompromised patients with cryptococcosis and in all patients
with
cryptococcosis of the central nervous system.
-
Maintenance therapy in AIDS patients to prevent relapse of underlying
fungal
infection.
Orungal is also indicated in the prevention of fungal infection during
prolonged
neutropenia
when standard therapy is considered inappropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Orungal is for oral administration and must be taken immediately after
a meal for maximal absorption.
The capsules must be swallowed whole.
Treatment schedules in adults for each indication are as follows:
_ _
_INDICATION_
_DOSE_
_REMARKS_
Vulvovaginal candidosis
200 mg twice daily for 1 day
1
Pityriasis versicolor
200 mg once daily for 7 days
Tinea corporis, tinea cruris
100 mg once daily for 15 days
or 200 mg once daily for 7
days
Tinea pedis, tinea manuum
100 mg once daily for 30 days
Oropharyngeal candidosis
100 mg once daily for