HARVONI

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

LEDIPASVIR; SOFOSBUVIR

Boleh didapati daripada:

GILEAD SCIENCES ISRAEL LTD

Kod ATC:

J05AP51

Borang farmaseutikal:

FILM COATED TABLETS

Komposisi:

LEDIPASVIR 90 MG; SOFOSBUVIR 400 MG

Laluan pentadbiran:

PER OS

Jenis preskripsi:

Required

Dikeluarkan oleh:

GILEAD SCIENCES IRELAND UC, IRELAND

Kawasan terapeutik:

SOFOSBUVIR AND LEDIPASVIR

Tanda-tanda terapeutik:

Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in adults.

Tarikh kebenaran:

2021-04-30

Risalah maklumat

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS)
REGULATIONS - 1986
This medicine is to be supplied by doctor’s prescription only
HARVONI
®
Film-coated tablets
ACTIVE INGREDIENTS
: Each tablet contains –
ledipasvir
90 mg
sofosbuvir
400 mg
Inactive and allergenic substances: see section 6 “
_Additional information”_
.
_ _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
This leaflet contains essential information about this medicine. Keep
this leaflet. You may need to read it again. If you have any further
questions, ask your doctor or
pharmacist. This medicine has been prescribed for you only. Do not
pass it on to others. It may harm
them, even if their signs of illness are the same as yours. If you get
any side effects talk to your doctor
or pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
This medicine is intended for adults aged 18 years and over.
1.
WHAT IS THE MEDICINE INTENDED FOR
Harvoni is indicated to treat chronic (long-term) hepatitis C virus
infection in adults.
THERAPEUTIC GROUP:
•
LEDIPASVIR AND SOFOSBUVIR
are antivirals which suppress the hepatitis C virus.
Harvoni is a medicine that contains the active substances ledipasvir
and sofosbuvir in a single tablet.
Hepatitis C is a virus that infects the liver. The active substances
ledipasvir and sofosbuvir work
together by blocking two different proteins that the virus needs to
grow and reproduce itself, allowing
the infection to be permanently eliminated from the body.
Harvoni is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other
medicines that you will be taking with
Harvoni. If you have any questions about your medicines, please ask
your doctor or pharmacist.
HEPATITIS B VIRUS REACTIVATION:
BEFORE STARTING TREATMENT WITH HARVONI, YOUR HEALTHCARE PROVIDER WILL
DO BLOOD
TESTS TO CHECK FOR HEPATITIS B VIRUS INFECTION. IF YOU HAVE OR HAD IN

Ciri produk

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HARVONI
®
(LEDIPASVIR/SOFOSBUVIR)
FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Harvoni
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 mg ledipasvir and 400 mg
sofosbuvir.
Excipients with known effect
Each film-coated tablet contains 157 mg of lactose (as monohydrate)
and 47 micrograms of sunset
yellow FCF.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange, diamond-shaped, film-coated tablet of dimensions of
approximately 19 mm x 10 mm,
debossed with “GSI” on one side and “7985” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Harvoni is indicated for the treatment of chronic hepatitis C (CHC) in
adults (see sections 4.2, 4.4 and
5.1).
For hepatitis C virus (HCV) genotype-specific activity see sections
4.4 and 5.1.
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS
COINFECTED WITH HCV AND HBV
TEST ALL PATIENTS FOR EVIDENCE OF CURRENT OR PRIOR HEPATITIS B VIRUS
(HBV) INFECTION
BEFORE INITIATING TREATMENT WITH HARVONI. HBV REACTIVATION HAS BEEN
REPORTED IN
HCV/HBV COINFECTED PATIENTS WHO WERE UNDERGOING OR HAD COMPLETED
TREATMENT WITH
HCV DIRECT ACTING ANTIVIRALS AND WERE NOT RECEIVING HBV ANTIVIRAL
THERAPY. SOME
CASES HAVE RESULTED IN FULMINANT HEPATITIS, HEPATIC FAILURE, AND
DEATH. MONITOR
HCV/HBV COINFECTED PATIENTS FOR HEPATITIS FLARE OR HBV REACTIVATION
DURING HCV
TREATMENT AND POST-TREATMENT FOLLOW-UP. INITIATE APPROPRIATE PATIENT
MANAGEMENT FOR
HBV INFECTION AS CLINICALLY INDICATED _[SEE SPECIAL WARNINGS AND
PRECAUTIONS FOR USE _
_(SECTION 4.4)]._
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Harvoni treatment should be initiated and monitored by a physician
experienced in the management of
patients with CHC.
Posology
The recommended dose of Harvoni is one tablet once daily with or
without food (see section 5.2).
TABLE 1: RECOMMENDED TREATMENT DURATION FOR HARVONI AND THE
RECOMMENDED USE OF
CO-ADMINISTERED RIBAVIRIN FOR CERTAIN SUBGROUPS
PATIENT POPULATION
*
TREATMENT