ODEFSEY

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

EMTRICITABINE; RILPIVIRINE AS HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE AS FUMARATE

Tilgjengelig fra:

J-C HEALTH CARE LTD

ATC-kode:

J05AG05

Legemiddelform:

FILM COATED TABLETS

Sammensetning:

TENOFOVIR ALAFENAMIDE AS FUMARATE 25 MG; EMTRICITABINE 200 MG; RILPIVIRINE AS HYDROCHLORIDE 25 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

JANSSEN CILAG S.P.A., ITALY

Terapeutisk område:

RILPIVIRINE

Indikasjoner:

ODEFSEY is indicated for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus 1 (HIV 1) without known mutations associated with resistance to the non nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine and with a viral load ≤ 100,000 HIV 1 RNA copies/mL

Autorisasjon dato:

2019-06-17

Informasjon til brukeren

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
ODEFSEY
®
FILM-COATED TABLETS
ACTIVE INGREDIENTS AND QUANTITIES PER DOSAGE UNIT:
emtricitabine 200 mg,
rilpivirine hydrochloride equivalent to 25 mg of rilpivirine,
tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir
alafenamide.
Inactive and allergenic ingredients in the preparation – see section
2 under “Important
information about some of the ingredients of the medicine” and
section 6 “Further
Information”.
READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the doctor or pharmacist. This medicine has been prescribed for the
treatment of
your ailment. Do not pass it on to others. It may harm them, even if
it seems to you
that their ailment is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Odefsey is intended for adults and adolescents (aged 12 years and
over, who weigh
at
least
35
kg),
for
the
treatment
of
infection
with
the
HIV-1
virus
(Human
Immunodeficiency Virus-1), without known mutations associated with
resistance of the
virus to non-nucleoside analog reverse transcriptase inhibitor –
NNRTI, tenofovir or
emtricitabine, and with a viral load that is less than or equal to
100,000 HIV-1 RNA
copies per mL (viral load ≤ 100,000 HIV
‑
1 RNA copies/mL).
Odefsey contains three active ingredients – emtricitabine,
rilpivirine and tenofovir
alafenamide – in one tablet.
Each of these active ingredients impairs the function of an enzyme (a
protein called
“reverse transcriptase”) that is essential for the HIV virus to
multiply.
Odefsey reduces the amount of HIV virus in the body, thus improving
the immune
system and reducing the risk of developing illnesses linked to HIV
infection.
THERAPEUTIC GROUP
•
Emtricitabine, nucleoside reverse transcriptase inhibitors (NRTI)
•
Rilpivirine, non-nucleoside reverse

Preparatomtale

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Odefsey_film_coated_tablets_PI_May2023
1
ODEFSEY FILM COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Odefsey 200 mg/25 mg/25 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of emtricitabine, rilpivirine
hydrochloride equivalent to 25 mg
of rilpivirine and tenofovir alafenamide fumarate equivalent to 25 mg
of tenofovir alafenamide.
Excipients with known effect
Each tablet contains 189.8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Grey, capsule-shaped, film-coated tablet, debossed with “GSI” on
one side of the tablet and “255” on
the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Odefsey is indicated for the treatment of adults and adolescents (aged
12 years and older with body
weight at least 35 kg) infected with human immunodeficiency virus-1
(HIV-1) without known
mutations associated with resistance to the non-nucleoside reverse
transcriptase inhibitor (NNRTI)
class, tenofovir or emtricitabine and with a viral load ≤ 100,000
HIV-1 RNA copies/mL (see
sections 4.2, 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
One tablet to be taken once daily with food (see section 5.2).
If the patient misses a dose of Odefsey within 12 hours of the time it
is usually taken, the patient should
take Odefsey with food as soon as possible and resume the normal
dosing schedule. If a patient misses a
dose of Odefsey by more than 12 hours, the patient should not take the
missed dose and simply resume
the usual dosing schedule.
If the patient vomits within 4 hours of taking Odefsey another tablet
should be taken with food. If a
patient vomits more than 4 hours after taking Odefsey they do not need
to take another dose of Odefsey
until the next regularly scheduled dose.
_ _
Odefsey_film_coated_tablets_PI_May2023
2
_Elderly_
No dose adjustment of