Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
ETRAVIRINE
J-C HEALTH CARE LTD
J05AG04
TABLETS
ETRAVIRINE 100 MG
PER OS
Required
JANSSEN CILAG S.P.A., ITALY
ETRAVIRINE
ETRAVIRINE
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.
2014-07-31
: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 Izlasiet visu dokumentu
Page 1 of 26 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 _ _ Page 2 of 26 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 Izlasiet visu dokumentu