XOFLUZA 20 MG

Страна: Израел

Език: английски

Източник: Ministry of Health

Активна съставка:

BALOXAVIR MARBOXIL

Предлага се от:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

АТС код:

J05AX25

Лекарствена форма:

FILM COATED TABLETS

Композиция:

BALOXAVIR MARBOXIL 20 MG

Начин на приложение:

PER OS

Вид предписание :

Required

Произведено от:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Терапевтична област:

BALOXAVIR MARBOXIL

Терапевтични показания:

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.

Дата Оторизация:

2020-01-16

Листовка

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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
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ب ،يمد لاهسإ ،ؤيقت :(Gastrointestinal) يمضهلا
زاهجلاب ةقلعتم ضارعأ
.(colitis)
.ةسولهو

Данни за продукта

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