XOFLUZA FILM-COATED TABLET 20MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Baloxavir marboxil

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Baloxavir marboxil

Unit dalam pakej:

4 Tablets

Dikeluarkan oleh:

Shionogi Pharma Co., Ltd.

Risalah maklumat

_ _
_Consumer Medication Information Leaflet (RiMUP) _
XOFLUZA
®
FILM-COATED TABLET
Baloxavir marboxil (20mg, 40mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Xofluza is used for
2.
How Xofluza works
3.
Before you use Xofluza
4.
How to use Xofluza
5.
While you are using Xofluza
6.
Side effects
7.
Storage and disposal of Xofluza
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
WHAT XOFLUZA IS USED FOR
Xofluza is a prescription medicine
used to:

treat the flu (influenza) in people
12 years of age and older who
have had flu symptoms for no
more than 48 hours.

prevent the flu in people 12
years of age and older following
contact with a person who has
the flu.
It is not known if XOFLUZA is safe
and effective in children less than 12
years of age.
XOFLUZA does not treat or prevent
illness that is caused by infections
other than the influenza virus.
XOFLUZA does not prevent
bacterial infections that may happen
with the flu.
HOW XOFLUZA WORKS
Xofluza blocks part of the influenza
virus that is instrumental in making
proteins that are required to produce
extra copies of the virus within a
host cell. Xofluza interferes with the
ability of the flu virus to multiply.
Xofluza is taken as a one-time dose.
BEFORE YOU USE XOFLUZA
-
_WHEN YOU MUST NOT USE IT _
Do not take Xofluza if:
1.
YOU ARE ALLERGIC TO BALOXAVIR
MARBOXIL OR ANY OF THE
INGREDIENTS IN XOFLUZA. SEE THE
END OF THIS LEAFLET FOR A
COMPLETE LIST OF INGREDIENTS IN
XOFLUZA.
2.
the package is torn or shows
signs of tampering
3.
the expiry date (EXP) printed on
the pack has passed. If you take
this medicine after the expiry
date has passed, it may not work
as well.
4.
if you are not sure if you should
be taking Xofluza, talk to your
doctor.
-
_BEFORE YOU START TO USE IT_
Tell your doctor if:
1.
you are pregnant or plan to
become pregnant. It is not
known whether Xofluza can
harm your unborn baby.
2.
you are breast-feeding or plan to
breast-feed. It is not known if
Xofluza passes into your breast
milk.
-
_TA

Ciri produk

XOFLUZA
®
Baloxavir Marboxil
FULL PRESCRIBING INFORMATION
1. INDICATIONS AND USAGE
1.1 TREATMENT OF INFLUENZA
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 and who are:

otherwise healthy, or

at high risk of developing influenza-related complications _[see
Clinical Studies (13.2)]._
1.2 POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
XOFLUZA is indicated for post-exposure prophylaxis of influenza in
persons 12 years of age and older following
contact with an individual who has influenza [see Clinical Studies
(13.3)].
1.3 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 (11.4) and Clinical Studies (13)]_.
2. DOSAGE AND ADMINISTRATION
2.1 DOSAGE AND ADMINISTRATION OVERVIEW
Initiate treatment with XOFLUZA
XOFLUZA should be taken as soon as possible after influenza symptom
onset
or exposure to influenza and may
be taken with or without food. However, coadministration 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 (7.1) and
Clinical Pharmacology (11.3)]_.
2.2 RECOMMENDED DOSAGE
Treatment of Acute Uncomplicated Influenza or Post-Exposure
Prophylaxis in Adults and Adolescents (12 Years
of Age and Older)
XOFLUZA should be taken as a single dose as soon as possible and
within 48 hours of influenza symptom onset
for treatment of acute uncomplicated influenza or following contact
with an individual who has influenza.
The recommended dosage of XOFLUZA in patients 12 years of age or older
is a single weight-based dos