HARVONI TABLET 90MG400MG

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

LEDIPASVIR; SOFOSBUVIR

Verfügbar ab:

GILEAD SCIENCES SINGAPORE PTE. LTD.

ATC-Code:

Pending

Darreichungsform:

TABLET, FILM COATED

Zusammensetzung:

LEDIPASVIR 90 mg; SOFOSBUVIR 400 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

Prescription Only

Hergestellt von:

Patheon Inc.

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2016-01-13

Fachinformation

1
HARVONI
®
(LEDIPASVIR, SOFOSBUVIR) TABLETS
RX ONLY
1.
NAME OF THE MEDICINAL PRODUCT
Harvoni
®
90 mg/400 mg film-coated tablets
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 165.0 mg of lactose monohydrate and
261 micrograms of sunset
yellow FCF aluminium lake.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Orange, diamond-shaped, film-coated tablet of dimensions 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 and in adolescents aged
12 to <18 years (see sections 4.2, 4.4 and 5.1).
For hepatitis C virus (HCV) genotype-specific activity see sections
4.4 and 5.1.
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
_Adults and adolescents aged 12 to < 18 years_
The recommended dose of Harvoni is one tablet once daily with or
without food (see section 5.2).
2
TABLE 1: RECOMMENDED TREATMENT DURATION FOR HARVONI AND THE
RECOMMENDED USE OF CO-ADMINISTERED
RIBAVIRIN FOR CERTAIN SUBGROUPS
PATIENT POPULATION
(INCLUDING HIV CO-INFECTED PATIENTS)
TREATMENT AND DURATION
_Adult patients with genotype 1, 4, 5 or 6 CHC_
Patients without cirrhosis
Harvoni for 12 weeks.
-
Harvoni for 8 weeks may be considered in previously
untreated genotype 1-infected patients with pre-treatment
HCV RNA less than 6 million IU/mL. (see section 5.1, ION-3
study).
Patients with compensated cirrhosis
Harvoni + ribavirin
A
for 12 weeks
or
Harvoni (without ribavirin) for 24 weeks.
-
Harvoni (without ribavirin) for 12 weeks may be considered
for patients deemed at low risk for clinical disease
progression and who have subsequent retreatment options
(see section 4.4).
_Adult patients with genoty