XOFLUZA 40 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

BALOXAVIR MARBOXIL

متاح من:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

ATC رمز:

J05AX25

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

BALOXAVIR MARBOXIL 40 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

HOFFMANN LA ROCHE LTD, SWITZERLAND

المجال العلاجي:

BALOXAVIR MARBOXIL

الخصائص العلاجية:

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. 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.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

تاريخ الترخيص:

2020-01-16

نشرة المعلومات

1
Xofluza_PL_Ver 4
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
This medicine is dispensed with a doctor’s prescription only
Xofluza
40 mg
Film-coated tablets
Each film-coated tablet contains:
baloxavir marboxil 40 mg
Inactive ingredients and allergens: See section 2 “Important
information about some of the
medicine ingredients” and section 6 “Further information”.

Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have further questions,
contact the doctor or
pharmacist.

This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others.
It may harm them, even if it seems to you that their medical condition
is similar.

The medicine is intended for patients above the age of 12.
1.
WHAT IS THE MEDICINE INTENDED FOR?
This medicine is used for:

Treatment of acute uncomplicated flu (influenza) in patients above the
age of 12 years who
have experienced flu symptoms for no more than 48 hours and who are:
o Otherwise healthy
o At high risk of developing influenza-related complications

Prevention of influenza in persons above the age of 12 following
contact with a person who has
influenza
Note: the medical approach is that prevention by vaccine is preferable
to prevention by
antimicrobial products.
Limitations: Influenza viruses change over time and therefore factors
such as virus type and sub-
type, development of resistance or changes in aggressiveness of the
virus may reduce the clinical
value of antiviral medicines. Information on the medicine
susceptibility pattern of the seasonal
influenza strains should be considered while making a decision
regarding the use of Xofluza.
Therapeutic group: antiviral medicines.
Xofluza is an antiviral medicine acting against the influenza virus.
It is not intended to prevent or treat illness that is caused by
infections other than the influenza
virus and does not prevent bacterial infe

خصائص المنتج

XOFLUZA_PI_Ver 4.0
XOFLUZA
®


BALOXAVIR MARBOXIL
Film coated tablets
NAME OF THE MEDICINAL PRODUCT
XOFLUZA 40 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
XOFLUZA 40 mg film-coated tablets
Each tablet contains 40 mg baloxavir marboxil.
Excipients with known effect
Lactose Intolerance:
Each XOFLUZA 40 mg 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 40 mg 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 CLINICAL PARTICULARS
1 THERAPEUTIC INDICATIONS
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_ ._
1.2
POST-EXPOSURE PROPHYLAXIS OF INFLUENZA
Important note: the medical approach is that prevention by vaccination
is better than prevention by
antimicrobial agents.
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.
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 Warnings and Precautions (5.2), Microbiology (12.4) and Clinical
Studies (14)]_.
2 DOSAGE AND ADMINISTRATION
2.1 DOSAGE AND ADMINISTRATION OVERVIEW
XOFLUZA
should be taken as soon as possible after
influenza symptom onset or exposure to influen