XOFLUZA baloxavir marboxil 40 mg film-coated tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

baloxavir marboxil, Quantity: 40 mg

Tilgjengelig fra:

Roche Products Pty Ltd

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: lactose monohydrate; croscarmellose sodium; microcrystalline cellulose; povidone; sodium stearylfumarate; purified talc; hypromellose; titanium dioxide

Administreringsrute:

Oral

Enheter i pakken:

2 tablets, 1 tablet

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Treatment of influenza,Xofluza is indicated for the treatment of 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 complications.,Prophylaxis of influenza,Xofluza is indicated for the post-exposure prophylaxis of influenza in patients aged 12 years of age and older following contact with an individual who has confirmed influenza.,Vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

Produkt oppsummering:

Visual Identification: White to light yellow, oblong-shaped film-coated tablets debossed on one side with BXM40.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 60 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorisasjon status:

Registered

Autorisasjon dato:

2020-02-21

Informasjon til brukeren

XOFLUZA 20210527
1

This medicine is subject to additional monitoring in Australia. This
will allow quick identification of new safety
information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or
directly at www.tga.gov.au/reporting-problems.
XOFLUZA
®
_Baloxavir marboxil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Xofluza. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Xofluza
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT XOFLUZA IS USED
FOR
Xofluza is used for treating and
preventing the flu (influenza) in
people 12 years of age and older. It
stops the flu virus from spreading in
the body and can help you recover
more quickly from flu symptoms.
•
Xofluza is used to treat flu in
patients aged 12 and above who
have had flu symptoms for less
than 48 hours. This includes
otherwise healthy people and
people at high risk of
complications from the flu.
•
Xofluza is used to prevent flu in
patients aged 12 and above who
have been in contact with
someone who has a confirmed
case of flu.
People at high risk of flu
complications include those who:
•
are elderly or obese
•
have other diseases, e.g. asthma,
diabetes, heart failure, epilepsy
•
have reduced immunity due to
disease or medication
There is not enough information to
recommend the use of Xofluza for
children under the age of 12 years or
weighing less than 40 kg.
Xofluza reduces the symptoms of the
flu so that you feel better faster. It
also reduces the amount of flu virus
shed when you cough or sneeze.
You may also be less likely to
develop complications of flu, such as
bronchitis or sinusitis.
Xofluza is an antiviral

Preparatomtale

This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
Xofluza 20210527
1
▼

AUSTRALIAN PRODUCT INFORMATION
XOFLUZA
® (BALOXAVIR MARBOXIL) TABLETS
1.
NAME OF THE MEDICINE
Baloxavir marboxil.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mg film-coated tablet contains 20 mg baloxavir marboxil.
Each 40 mg film-coated tablet contains 40 mg baloxavir marboxil.
Excipients with known effect
Each 20 mg tablet contains 77.9 mg of lactose monohydrate and each 40
mg tablet contains
155.8 mg of lactose monohydrate. For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Xofluza 20 mg tablets are white to light yellow, oblong-shaped
film-coated tablets debossed
with “
772” on one side and “20” on the other side.
Xofluza 40 mg tablets are white to light yellow, oblong-shaped
film-coated tablets debossed
on one side with “BXM40”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF INFLUENZA
Xofluza is indicated for the treatment of 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 complications.
PROPHYLAXIS OF INFLUENZA
Xofluza is indicated for the post-exposure prophylaxis of influenza in
patients aged 12 years
of age and older following contact with an individual who has
confirmed influenza.
Vaccination is the preferred method of routine prophylaxis against
infection with influenza
virus.
Xofluza 20210527
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4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
Xofluza may be taken with or without food (see section 5.2
Pharmacokinetic Properties).
Avoid co-administration of Xofluza with calcium-fortified beverages,
polyvalent cation-
containing laxatives, antacids or oral supplements, e.g., calcium,
iron, magnesium, selenium,
or