DARUNAVIR TEVA 800 MG

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

DARUNAVIR

제공처:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

ATC 코드:

J05AE10

약제 형태:

FILM COATED TABLETS

구성:

DARUNAVIR 800 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

치료 영역:

DARUNAVIR

치료 징후:

Darunavir Teva co-administered with 100 mg ritonavir and with other antiretroviral agents,is indicated for the treatment of human immunodeficiency virus (HIV-1) infection for patients over 18 years of age.

승인 날짜:

2018-11-27

환자 정보 전단

•
نم غلم 100 عم امئاد نمازتلابو ،تقولا سفن
يف ،موي لك ءاودلا لوانت بجي
تسيل .ماعطلاو ريڤانوتير نود نم هل
يغبني امك ءاودلا لمعي نل .ماعطلاو
ريڤانوتير
ةقيقد 30 للاخ ريڤانوتيرو عاڤيت
ريڤانوراد لوانت بجي .ماعطلا عونل ةيمهأ
كانه
.(ماعطلا عونل ةيمهأ كانه تسيل) ماعط يأ
لوانت ةظحل نم
•
.هقحس وأ صرقلا غضم لوح تامولعم كانه
تسيل
•
.صرقلا ىلع رطشلل ط
ّ
خ رهظي .رطشلا طخ يف رطشلا نكمي
•
.بيلحلا ،ءاملاك بورشم عم هلمكأب ءاودلا
علاتبا بجي
•
اهتيق
ّ
لت يتلا تاميلعتلل ا
ً
قفو HIV جلاعل اهلمعتست يتلا ىرخلأا
ةيودلأا لامعتسا بجي
.بيبطلا نم
•
:ةنينقلا حتف تاميلعت
عنمت نامأ دادس ىلع ةنينقلا يوتحت
.دلاولأا لب
ِ
ق نم يئاوشعلا حتفلا
ةدادسلا ىلع طغضلاب ةنينقلا حتف بجي
(1) لفسلأا وحن
هاجتا سكعب كيرحتلا ربع كلذو
(2) ةعاسلا براقع
.ج
ِ
لاعملا بيبطلا هددح ام قفو ةتباث تاقوأ
يف ءاودلا اذه لامعتسا بجي
•
.لااح يلديصلا وأ بيبطلاب لصتا ىلعأ
ةعرج أطخلا قيرط نع تلوانت اذإ
اروف
ْ
ه
ّ
جوت ،أطخلا قيرط نع ءاودلا نم لفط علتبا
اذإ وأ ةطرفم ةعرج تلوانت اذإ
.ءاودلا ة
ّ
وبع كعم ا
ً
ب
ِ
حطصم ىفشتسملل ةعباتلا ئراوطلا ةفرغ
ىلإ وأ بيبطلا ىلإ
•
ءاودلا لوانت تيسن اذإ
-
يف ءاودلا اذه لوانت تيسنو مويلا يف
ةدحاو ةرم عاڤيت ريڤانوراد لوانتت تنك
اذإ
كيلع ناك يذلا دعوملا نم ةعاس 12 للاخ كلذ
ت�

제품 특성 요약

1
Darunavir-800mg-Tablets_SPC-update_
Notif
_10-2021_NS
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
DARUNAVIR TEVA 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 800 mg of darunavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Red, film coated, oval shaped tablet, scored on one side, and debossed
with "800" on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Darunavir Teva, co-administered with ritonavir and with other
antiretroviral agents, is indicated for the
treatment of human immunodeficiency virus (HIV -1) infection for
patients over 18 years of age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Darunavir Teva must be co-administered with ritonavir to exert its
therapeutic effect. Failure to correctly co-
administer Darunavir Teva with ritonavir will result in plasma levels
of darunavir that will be insufficient to
achieve the desired antiviral effect and will alter some drug
interactions.
_Treatment-Naïve Adult Patients _
The recommended oral dose of Darunavir Teva tablets is 800 mg taken
with ritonavir 100 mg once daily and
with food.
_ _
_ _
_Treatment-Experienced Adult Patients_
Treatment-Experienced Adult Patients
With no darunavir resistance associated
substitutions*
800 mg Darunavir Teva once daily with
ritonavir 100 mg once daily and with food
* V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V
For antiretroviral treatment-experienced patients genotypic testing is
recommended.
_Advice on missed doses_
If once daily dose of Darunavir Teva and/or ritonavir is missed within
12 hours of the time it is usually
taken, patients should be instructed to take the prescribed dose of
Darunavir Teva and ritonavir with food as
soon as possible. If this is noticed later than 12 hours after the
time it is usually taken, the missed dose should
not be taken and the patient should resume the usual dosing schedule.
2
Darunavir-800mg-Tablets_SPC-upda