GENDEVRA

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

COBICISTATE; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE

Fáanlegur frá:

GILEAD SCIENCES ISRAEL LTD

ATC númer:

J05AR18

Lyfjaform:

FILM COATED TABLETS

Samsetning:

TENOFOVIR ALAFENAMIDE 10 MG; EMTRICITABINE 200 MG; COBICISTATE 150 MG; ELVITEGRAVIR 150 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

GILEAD SCIENCES IRELAND UC, IRELAND

Lækningarsvæði:

EMTRICITABINE, TENOFOVIR ALAFENAMIDE, ELVITEGRAVIR AND COBICISTAT

Ábendingar:

Gendevra is indicated for the treatment of human immunodeficiency virus 1 (HIV 1) infection without any known mutations associated with resistance to the integrase inhibitor class, emtricitabine or tenofovir as follows:• In adults and adolescents aged from 12 years and with body weight at least 35 kg• In children aged from 6 years and with body weight at least 25 kg for whom alternative regimens are unsuitable due to toxicities.תוספת התוויה: 2/7/2019Addition of new info to posology section: precaution in pregnant women

Leyfisdagur:

2021-11-30

Upplýsingar fylgiseðill

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ (PRODUCTS)
REGULATIONS
- 1986
This medicine is to be supplied by doctor’s prescription only
GENDEVRA
®
150 MG/150 MG/200 MG/10 MG FILM-COATED TABLETS
ACTIVE INGREDIENTS:
Each tablet contains –
elvitegravir
150 mg
cobicistat
150 mg
emtricitabine
200 mg
tenofovir alafenamide
10 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. If
you have any further questions, ask your doctor or pharmacist. Keep
this leaflet. You may need to
read it again. This medicine has been prescribed for you only. Do not
pass it on to others. It may
harm them, even if it seems to you that their illness is the same as
yours. If you get any side effects,
talk to your doctor or pharmacist. Even if you experience any side
effects that are not listed in this
leaflet (see section 4).
This medicine is intended for adults, adolescents and children aged 6
years of age and older, who
weigh at least 25 kg.
1.
WHAT IS GENDEVRA INTENDED FOR
Gendevra is a single tablet for the
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION
in adults, adolescents and in children aged 6 years and older who
weigh at least 25 kg.
IF GENDEVRA HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
THE INFORMATION IN THIS
LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR
CHILD” INSTEAD OF “YOU”).
THERAPEUTIC GROUP:
Gendevra contains four active substances:
•
ELVITEGRAVIR,
an antiretroviral medicine known as an integrase inhibitor
•
COBICISTAT,
a booster (enhancer) of the effects of elvitegravir
•
EMTRICITABINE,
an antiretroviral medicine known as a nucleoside reverse transcriptase
inhibitor
(NRTI)
•
TENOFOVIR ALAFENAMIDE,
an antiretroviral medicine known as a nucleotide reverse transcriptase
inhibitor (NtRTI)
Gendevra reduces the amount of HIV in yo

Vara einkenni

1
GENDEVRA
®
(ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, TENOFOVIR ALAFENAMIDE (AS
FUMARATE))
FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Gendevra
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of
cobicistat, 200 mg of emtricitabine
and tenofovir alafenamide fumarate equivalent to 10 mg of tenofovir
alafenamide.
Excipient(s) with known effect
Each tablet contains 58 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Green, capsule-shaped, film-coated tablet of dimensions 19 mm x 8.5
mm, debossed with “GSI” on
one side of the tablet and “510” on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gendevra is indicated for the treatment of human immunodeficiency
virus-1 (HIV-1) infection without
any known mutations associated with resistance to the integrase
inhibitor class, emtricitabine or
tenofovir as follows:
•
In adults and adolescents aged from 12 years and with body weight at
least 35 kg
•
In children aged from 6 years and with body weight at least 25 kg for
whom alternative
regimens are unsuitable due to toxicities.
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
_ _
_Adults and paediatric patients aged 6 years and older, weighing at
least 25 kg_
One tablet to be taken once daily with food.
If the patient misses a dose of Gendevra within 18 hours of the time
it is usually taken, the patient
should take Gendevra with food as soon as possible and resume the
normal dosing schedule. If a
patient misses a dose of Gendevra by more than 18 hours, the patient
should not take the missed dose
and simply resume the usual dosing schedule.
2
If the patient vomits within 1 hour of taking Gendevra another tablet
should be taken.
Special populations
_ _
_Elderly_
No dose adjustment of Gendevra is required in e