INTELENCE 100 MG

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

ETRAVIRINE

Inapatikana kutoka:

J-C HEALTH CARE LTD

ATC kanuni:

J05AG04

Dawa fomu:

TABLETS

Tungo:

ETRAVIRINE 100 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

JANSSEN CILAG S.P.A., ITALY

Kundi la matibabu:

ETRAVIRINE

Eneo la matibabu:

ETRAVIRINE

Matibabu dalili:

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.

Idhini ya tarehe:

2014-07-31

Taarifa za kipeperushi

: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

Tabia za bidhaa

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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