Sovaldi

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Sofosbuvir 400mg;  ;  ;  

متاح من:

Gilead Sciences (NZ)

INN (الاسم الدولي):

Sofosbuvir 400 mg

جرعة:

400 mg

الشكل الصيدلاني:

Film coated tablet

تركيب:

Active: Sofosbuvir 400mg       Excipient: Colloidal silicon dioxide Croscarmellose sodium Magnesium stearate Mannitol Microcrystalline cellulose Opadry yellow 85F92259 Purified water

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

F.I.S. Fabbrica Italiana Sintetici SpA

الخصائص العلاجية:

SOVALDI is indicated in combination with other agents for the treatment of chronic hepatitis C (CHC) in adults and in pediatric patients 12 years of age and older or weighing at least 35 kg with genotype 2 or 3, without cirrhosis or with compensated cirrhosis.

ملخص المنتج:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP child resistant cap and desiccant - 28 tablets - 60 months from date of manufacture stored at or below 30°C

تاريخ الترخيص:

2013-07-30

نشرة المعلومات

SOVALDI Consumer Medicine Information v6.0 (26 March 2018)
1
SOVALDI

TABLETS
_400 mg Sofosbuvir _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
This leaflet answers some common
questions about SOVALDI tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist about your medical
condition or treatment.
This leaflet was last updated on the
date at the end of this leaflet. More
recent information may be available.
The latest Consumer Medicine
Information is available from your
pharmacist or doctor and may
contain important information about
the medicine and its use of which
you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SOVALDI
against the benefits it is expected to
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.
This medicine has been prescribed
for you personally and you should
not pass it on to others. It may harm
them, even if their symptoms are the
same as yours.
WHAT IS SOVALDI
USED FOR
SOVALDI is given with other
medicines to treat hepatitis C virus
infection (also called HCV infection)
in adults and pediatric patients 12
years of age and older.
Hepatitis C is a virus that infects the
liver.
_HOW SOVALDI WORKS _
SOVALDI contains the active
ingredient sofosbuvir.
SOVALDI works together with other
medicines by lowering the amount of
hepatitis C virus in your body and
may lead to a cure of your HCV
infection over at least 12 weeks.
Cure means the HCV virus is cleared
from your blood (remains at an
undetectable level) when measured 3
months after finishing all treatment.
SOVALDI does not protect against
re-infection with the HCV virus if
cure has been achieved.
SOVALDI must always be taken
together with other medicines as it
will not work on its own.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUES

خصائص المنتج

SOVALDI Data Sheet v8.0 – (13 August 2019) Page 1
NEW ZEALAND DATA SHEET
1 SOVALDI
® (SOFOSBUVIR 400 MG) TABLETS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sofosbuvir 400 mg.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
SOVALDI tablets are yellow, capsule shaped debossed with “GSI” on
one side and the
number “7977” on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SOVALDI is indicated in combination with other agents for the
treatment of chronic hepatitis
C (CHC) in adults and in pediatric patients 12 years of age and older
or weighing at least 35
kg with genotype 2 or 3, without cirrhosis or with compensated
cirrhosis.
4.2 DOSE AND METHOD OF ADMINISTRATON
4.2.1 ADULTS
The recommended dose of SOVALDI tablets in adults is 400 mg once daily
taken orally with
or without food.
SOVALDI should be used in combination with other agents. The
recommended dose and
treatment duration for SOVALDI combination therapy is provided in
Table 1 and Figure 1.
SOVALDI Data Sheet v8.0 – (13 August 2019) Page 2
TABLE 1
RECOMMENDED DOSE AND TREATMENT DURATION FOR SOVALDI COMBINATION
THERAPY IN ADULT PATIENTS
PATIENT POPULATION*
TREATMENT
DURATION
Patients with genotype 1, 4, 5
or 6 CHC
SOVALDI + ribavirin +
peginterferon alfa
12 weeks
a,b
SOVALDI + ribavirin
Only for use in patients
ineligible or intolerant to
peginterferon alfa
24 weeks
Patients with genotype 2 CHC
SOVALDI
+ ribavirin
12 weeks
b
Patients with genotype 3 CHC
SOVALDI + ribavirin +
peginterferon alfa
12 weeks
b
SOVALDI + ribavirin
24 weeks
Patients with CHC awaiting
liver transplantation
SOVALDI
+ ribavirin
Until liver
transplantation
c
* Includes patients co infected with human immunodeficiency virus
(HIV).
a.
For previously treated patients with HCV genotype 1 infection, no data
exists with the combination of SOVALDI,
ribavirin and peginterferon alfa
b.
Consideration should be given to potentially extending the duration of
therapy beyond 12 weeks and up to 24 weeks;
especially for those subgrou