Country: ইস্রায়েল
ভাষা: ইংরেজি
সূত্র: Ministry of Health
BALOXAVIR MARBOXIL
ROCHE PHARMACEUTICALS (ISRAEL) LTD
J05AX25
FILM COATED TABLETS
BALOXAVIR MARBOXIL 20 MG
PER OS
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
BALOXAVIR MARBOXIL
Xofluza is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Limitations of Use: Influenza viruses change over time and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use Xofluza.
2020-01-16
.بيبطلا ةيصوتل ا ً قفو جلاعلا ىلع ةبظاوملا كيلع عض .ءاود اهيف لوانتت ة ّ رم ّ لك يف ة ّ يئاودلا ةعرجلا نمو ءاودلا ة ّ وبع ىلع قصلملا نم ق ّ قحت !ملاظلا يف ةيودلأا لوانت عنم ُ ي .اهيلإ ةجاحب تنك اذإ ةي ّ بطلا تارا ّ ظنلا . ّ يلديصلا وأ بيبطلا ر ِ شتساف ءاودلا لامعتسا ىلإ ةبسنلاب ة ّ يفاضإ ةلئسأ كيدل تناك اذإ .4 ةيبناجلا ضارعلأا ضارعلأا ةمئاق ةءارق دنع عزفت لا .نيلمعتسملا نم مسق ىدل ة ّ يبناج ا ً ضارعأ ازولفوسكإ لامعتسا ب ّ بس ُ ي دق ،ةيودلأا عيمجك .اهنم ٍ ّ يأ نم يناعت لا دقف .ة ّ يبناجلا :ىلع لمتشي يذلا ،ءاودلا هاجت سسحتلا طرف لعف درل تضرعت اذإ ج ِ لاعملا بيبطلا ىلإ هجوت س ُّ فنتلا يف تابوعص ةيدلج تارثب وأ ىرش ،يدلج حفط مفلا وأ ةرجنحلا ،هجولا مروت راودلاب روعشلا وأ ةخود ىرخأ ةيبناج ضارعأ لاهسإ تابصقلا باهتلا نايثغ ةيفنلأا بويجلا باهتلا عادص .هقيوست دعب كلذو ازولفوسكإ ءاود لامعتسا للاخ ةيلاتلا ةيبناجلا ضارعلأا ةظحلام تمت لعف دودر ؛)Angioedema( ةمذو ؛)ملاكلا يف ةبوعص( توصلا تابارطضا ؛ناسللا وأ نينفجلا ،هجولا مروت :هلك مسجلا .ةيقأت ةمدصو ؛)سسحتلا طرف( ةيجرأو ةيقأت .(Erythema multiforme( لاكشلأا ةددعتم ىمامح ،ىرش ،حفط :ةيدلج تحتو ةيدلج ضارعأ ةظيلغلا ءاعملأا باهتلا ،دوسأ زار ُ ب ،يمد لاهسإ ،ؤيقت :(Gastrointestinal) يمضهلا زاهجلاب ةقلعتم ضارعأ .(colitis) .ةسولهو সম্পূর্ণ নথি পড়ুন
1 Xofluza PI version 1.0 XOFLUZA ® BALOXAVIR MARBOXIL Film coated tablets NAME OF THE MEDICINAL PRODUCT Xofluza 20 mg Xofluza 40 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Xofluza 20 mg film-coated tablets Each tablet contains 20 mg baloxavir marboxil. Xofluza 40 mg film-coated tablets Each tablet contains 40 mg baloxavir marboxil. Excipients with known effect Lactose Intolerance Each Xofluza 20mg tablet contains 77.9 mg lactose monohydrate. Each Xofluza 40mg tablet contains 155.8 mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium Each Xofluza 20mg tablet contains 1.13 mg sodium Each Xofluza 40mg tablet contains 2.26 mg sodium. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium- free’. For the full list of excipients, see section 11. PHARMACEUTICAL FORM Film-coated tablets 2 CLINICAL PARTICULARS 1 THERAPEUTIC INDICATIONS Xofluza is indicated for the treatment of acute uncomplicated influenza in patients 12 years of age and older who have been symptomatic for no more than 48 hours. Limitations of Use: Influenza viruses change over time and factors such as the virus type or subtype, emergence of resistance, or changes in viral virulence could diminish the clinical benefit of antiviral drugs. Consider available information on drug susceptibility patterns for circulating influenza virus strains when deciding whether to use Xofluza. _[see Microbiology (12.4) and Clinical Studies (14)]_. 2 DOSAGE AND ADMINISTRATION Initiate treatment with XOFLUZA within 48 hours of influenza symptom onset. XOFLUZA is taken orally as a single dose and may be taken with or without food. However, co-administration of XOFLUZA with dairy products, calcium-fortified beverages, polyvalent cation-containing laxatives, antacids or oral supplements (e.g., calcium, iron, magnesium, selenium, or zinc) should be avoided _[see Drug Interactions সম্পূর্ণ নথি পড়ুন