XOFLUZA baloxavir marboxil 80 mg film-coated tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

baloxavir marboxil, Quantity: 80 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:

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: Xofluza 80 mg tablets are white to light yellow, oblong-shaped film-coated tablets debossed on one side with "BXM80".; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorisasjon status:

Registered

Autorisasjon dato:

2023-05-02

Informasjon til brukeren

XOFLUZA
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING XOFLUZA?
Xofluza contains the active ingredient baloxavir marboxil. Xofluza is
used to treat flu (influenza) and prevent flu after exposure, in
people 12 years of age and older.
For more information, see Section 1. Why am I using Xofluza? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE XOFLUZA?
Do not use if you have ever had an allergic reaction to Xofluza or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Xofluza? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Xofluza and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE XOFLUZA?
•
For treatment of flu and prevention of flu, take as a single dose,
within 48 hours after flu symptoms or exposure to an infection.
•
The recommended dose is 40mg if you weigh between 40kg or more, and
less than 80kg. This is one 40mg tablet or two 20mg
tablets. The recommended dose is 80mg if you weigh 80kg or more. This
is one 80mg tablet or two 40 mg tablets. Swallow the
tablets whole with a full glass of water. If possible, do not take
Xofluza with dairy products, such as milk, cheese or yoghurt.
•
More instructions can be found in Section 4. How do I use Xofluza? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING XOFLUZA?
THINGS YOU
SHOULD DO
•
Tell your doctor if your symptoms do not start to get better or if you
feel worst or develop new symptoms
while taking Xofluza.
THINGS THAT
WOULD

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 20230426
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.
Each 80 mg film-coated tablet contains 80 mg baloxavir marboxil.
Excipients with known effect
Each 20 mg tablet contains 77.9 mg of sugars as lactose monohydrate.
Each 40 mg tablet contains 155.8 mg of sugars as lactose monohydrate.
Each 80 mg tablet contains 311.6 mg of sugars as 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”.
Xofluza 80 mg tablets are white to light yellow, oblong-shaped
film-coated tablets debossed
on one side with “BXM80”.
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.
Xofluza 20230426
2
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.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL