País: Israel
Idioma: anglès
Font: Ministry of Health
DOLUTEGRAVIR AS SODIUM; RILPIVIRINE AS HYDROCHLORIDE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AR21
FILM COATED TABLETS
RILPIVIRINE AS HYDROCHLORIDE 25 MG; DOLUTEGRAVIR AS SODIUM 50 MG
PER OS
Required
GLAXO WELLCOME SA, SPAIN
DOLUTEGRAVIR AND RILPIVIRINE
Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor
2023-12-31
ربكأ ً ايئاود ً ارادقم أطخلاب تلوانﺗ اذإ ً لااح هجوﺗ ،اكولوج صارقأ نم مزلالا نم رثكأ أطخلاب تلوانت اذإ .نكمأ اذإ اكولوج ةبلع مهيرأ .كب صاخلا يلديصلا وأ بيبطلا ىلإ ةفرغل وأ بيبطلا ىلإ ً لااح هجوت ،ءاودلا نم أطخلاب لفط علب اذإ .ءاودلا ةبلع كعم رضحأو ىفشتسملا يف ئراوطلا ءاودلا اذه لوانﺗ تيسن اذإ لوانت دعوم نم ةعاس 12 للاخ رملأا اذهل كتظحلام لاح يف كركذت ةظحل صرقلا لوانت ،كب صاخلا يدايتعلإا يئاودلا رادقملا دعب لصاو .ماعطلا ةبجو عم اكولوج صرق لوانت بجي .كلذب .داتعملاك كب صاخلا جلاعلا كلذ يئاودلا رادقملا ت ّ وف ،ةعاس 12 دعب رملأا اذهل كتظحلام لاح يف .يدايتعلإا تقولا يف مداقلا يئاودلا رادقملا لوانتو يسنملا رادقملا نع ضيوعتلل ً افعاضم ً ايئاود ً ارادقم لوانتﺗ لا ← .يسنملا يئاودلا ،اكولوج لوانت دعوم نم تاعاس 4 نم لقأ دعب ؤيقتلا لاح يف نم رثكأ دعب ؤيقتلا لاح يف .ماعطلا ةبجو عم ً ايفاضإ ً اصرق لوانت ً ايفاضإ ً اصرق لوانتل يعاد لا ،اكولوج لوانت دعوم نم تاعاس 4 .ةمداقلا كتعرج لوانت دعوم ىتح كبيبط ةراشتسإ نودب اكولوج لوانﺗ نع فقوتلا زوجي لا كاصوأ اذإ لاإ فقوتت لا .كلذب كبيبط كاصوأ املاطل اكولوج لوانت .كلذ لعفب كبيبط ءاودلا عباط صيخشﺗ بجي !ةمتعلا يف ةيودأ لوانﺗ زوجي لا .ءاود اهيف لوانتﺗ ةرم لك يف يئاودلا رادقملا نم دكأتلاو .كلذ رملأا Llegiu el document complet
1 1. NAME OF THE MEDICINAL PRODUCT Juluca 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir and rilpivirine hydrochloride equivalent to 25 mg rilpivirine. Excipient with known effect Each film-coated tablet contains 52 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Pink, oval, biconvex tablets, approximately 14 x 7 mm, debossed with ‘SV J3T’ on one side. _ _ 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dolutegravir/rilpivirine should be prescribed by physicians experienced in the management of HIV infection. _ _ Posology The recommended dose of Juluca is one tablet once daily. The tablet must be taken with a meal (see section 5.2). Separate preparations of dolutegravir or rilpivirine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated (see section 4.5). In these cases the physician should refer to the Physician leaflets for these medicinal products. _Missed doses _ If the patient misses a dose of Juluca, the patient should take the missed dose with a meal as soon as possible, providing the next dose is not due within 12 hours. If the next dose is due within 12 hours, the patient should not take the missed dose and simply resume the usual dosing schedule. If a patient vomits within 4 hours of taking dolutegravir/rilpivirine, another dolutegravir/rilpivirine tablet should be taken with a meal. If a patient vomits more than 4 hours after taking dolutegravir/ri Llegiu el document complet