XOFLUZA 20 MG

Quốc gia: Israel

Ngôn ngữ: Tiếng Anh

Nguồn: Ministry of Health

Thành phần hoạt chất:

BALOXAVIR MARBOXIL

Sẵn có từ:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Mã ATC:

J05AX25

Dạng dược phẩm:

FILM COATED TABLETS

Thành phần:

BALOXAVIR MARBOXIL 20 MG

Tuyến hành chính:

PER OS

Loại thuốc theo toa:

Required

Sản xuất bởi:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Khu trị liệu:

BALOXAVIR MARBOXIL

Chỉ dẫn điều trị:

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.

Ngày ủy quyền:

2020-01-16

Tờ rơi thông tin

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لعف دودر ؛)Angioedema( ةمذو ؛)ملاكلا يف
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.ةسولهو

Đặc tính sản phẩm

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