INTELENCE 100 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

ETRAVIRINE

可用日期:

J-C HEALTH CARE LTD

ATC代码:

J05AG04

药物剂型:

TABLETS

组成:

ETRAVIRINE 100 MG

给药途径:

PER OS

处方类型:

Required

厂商:

JANSSEN CILAG S.P.A., ITALY

治疗组:

ETRAVIRINE

治疗领域:

ETRAVIRINE

疗效迹象:

Intelence is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients including those with non-nucleoside reverse transcriptase inhibitor (NNRTI) resistance. Treatment history and when available resistance testing should guide the use of Intelence. In patients who have experienced virological failure on an NNRTI- and nucleoside or nucleotide reverse transcriptase inhibitor (N[t]RTI) - containing regimen Intelence is not recommended for use in combination with N(t)RTIs only.

授权日期:

2014-07-31

资料单张

:غلم 100 تاذ صارقأ لوانتت تنك اذإ
ماعطلا ةبجو دعب حابصلا يف غلم 100
سنليتنيإ نم نيصرق لوانت بجي
.ماعطلا ةبجو دعب ءاسملا يف غلم 100
سنليتنيإ نم نيصرق لوانت بجيو
:غلم 200 تاذ صارقأ لوانتت تنك اذإ
ماعطلا ةبجو دعب حابصلا يف غلم 200
سنليتنيإ نم دحاو صرق لوانت بجي
.ماعطلا ةبجو دعب ءاسملا يف غلم 200
سنليتنيإ نم دحاو صرق لوانت بجيو
ةدعم ىلع سنليتنيإ لوانتب تمق اذإ
.ماعطلا ةبجو دعب ءاودلا لوانت
ً
ادج مهملا نم
ةبسنلاب بيبطلا ةراشتسإ بجي .صتم
ُ
ت فوس سنليتنيإ ةيمك نم فصن نإف ،ةيواخ
.بسانملا ماعطلا عونل
غضم زوجي لا .ءاملا
نم ةئيلم سأك عم هلمكأب صرقلا
علب بجي
.رطشلا/قحسلا صوصخب تامولعم دجوت لا
.صرقلا
:ةيلاتلا تاميلعتلا بجومب فرصت ءاجرلا
،هلمكأب صرقلا علب ىلع رداق ريغ تنك اذإ
ةيطغتل يفكت لئاس ةيمكب وأ ،ءاملا نم
)ةريغص ةقعلم( للم 5 ـب صرقلا عض
-
.لقلأا ىلع ءاودلا
.بيلحلاك ءاملا ودبي ىتح ،ةقيقد ةدمل
ديجلا طلخلاب مق -
كلذ نع
ً
لادب وأ ءاملا نم يفاضإ )نيتريبك
نيتقعلم( للم 30 ىتح ةفاضإ ناكملإاب
-
وأ لاقتربلا ريصع يف ةرشابم صرقلا عضو
زوجي لا( بيلحلا وأ لاقتربلا ريصع
.)بيلحلا
.
ً
لااح اهبرشب مق -
يف لماكلاب اهبرشب مقو بيلحلا وأ
لاقتربلا ريصع ،ءاملاب تارم ةدع سأكلا
لسغإ
-
.ةيئاودلا ةعرجلا لماك لوانت نم دكأتلل
ةرم لك
لبق
ً
لاوأ اهلوانت/هلوانت بجي ،لئاس عم
سنليتنيإ

产品特点

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Intelence SPC 01_2019_sub
1
NAME OF THE MEDICINAL PRODUCT
INTELENCE
100 mg, tablets.
INTELENCE
200 mg, tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
INTELENCE
100 mg:
Each tablet contains 100 mg of etravirine.
Excipient
with known effect
: Each tablet contains 160 mg lactose (as monohydrate).
For a full list of excipients, see section 6.1.
INTELENCE
200 mg:
Each tablet contains 200 mg of etravirine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
INTELENCE
100 mg:
White to off-white, oval tablet, debossed with “T125” on one side
and “100” on the other side
INTELENCE
200 mg:
White to off-white, biconvex, oblong tablet debossed with “T200”
on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INTELENCE, in combination with other antiretroviral medicinal
products, is indicated for the treatment
of human immunodeficiency virus type 1 (HIV-1) infection in
antiretroviral treatment-experienced adult
patients, including those with non-nucleoside reverse transcriptase
inhibitor (NNRTI) resistance.
Treatment history and, when available, resistance testing, should
guide the use of INTELENCE. In
patients who have experienced virological failure on an NNRTI- and
nucleoside or nucleotide reverse
transcriptase inhibitor (N[t]RTI)-containing regimen, INTELENCE is not
recommended for use in
combination with N(t)RTIs only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
INTELENCE must always be given in combination with other
antiretroviral medicinal products.
_ _
Adults
_ _
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Intelence SPC 01_2019_sub
The recommended dose of
etravirine for adults
is 200 mg (one 200mg tablet or two 100 mg tablets)
taken orally twice daily, following a meal (see section 5.2).
Children (less than 12 years of age) and adolescents (12 to 17 years
of age)
Treatment with
etravirine
is not approved in Israel in children and adolescents.
Missed dose
If the patient misses a dose of INTELENC