Genvoya

Country: New Zealand

Bahasa: Inggeris

Sumber: Medsafe (Medicines Safety Authority)

Bahan aktif:

Cobicistat 150mg (As a blend with silicon dioxide);  ;  ;  ; Elvitegravir 150mg;  ;  ; Emtricitabine 200mg;  ;  ;  ;  ; Tenofovir alafenamide 10mg (As tenofovir alafenamide fumarate 11.2mg);  

Boleh didapati daripada:

Gilead Sciences (NZ)

INN (Nama Antarabangsa):

Cobicistat 150 mg (As a blend with silicon dioxide)

Borang farmaseutikal:

Tablet

Komposisi:

Active: Cobicistat 150mg (As a blend with silicon dioxide)       Elvitegravir 150mg     Emtricitabine 200mg         Tenofovir alafenamide 10mg (As tenofovir alafenamide fumarate 11.2mg)   Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry green 85F110095 Sodium laurilsulfate

Jenis preskripsi:

Prescription

Dikeluarkan oleh:

Esteve Quimica SA

Tanda-tanda terapeutik:

GENVOYA is indicated as a single tablet regimen for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 25 kg who are either treatment-na?ve; or virologically suppressed (HIV-1 RNA GENVOYA is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide HIV-1 reverse transcriptase inhibitors.

Ringkasan produk:

Package - Contents - Shelf Life: Bottle, 100mL HDPE bottle with a PP child resistant cap & al foil liner - 30 tablets - 36 months from date of manufacture stored at or below 25°C

Tarikh kebenaran:

2016-01-27

Risalah maklumat

GENVOYA Consumer Medicine Information v4.0 (05 March 2020) Page 1 of 5
GENVOYA
® TABLETS
(150 MG ELVITEGRAVIR / 150 MG COBICISTAT / 200 MG EMTRICITABINE / 10
MG
TENOFOVIR ALAFENAMIDE)
_elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE.
This leaflet answers some of the
common questions about GENVOYA
tablets. It does not contain all of the
available information.
It does not take the place of talking to
your doctor or pharmacist about your
medical condition or treatment. If you
have further questions, please ask your
doctor or your pharmacist.
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.
MEDICINES ARE SOMETIMES PRESCRIBED
FOR CONDITIONS THAT ARE NOT MENTIONED
IN THIS LEAFLET.
KEEP THIS LEAFLET WITH YOUR
GENVOYA MEDICINE.
You may need to read it again.
WHAT IS GENVOYA
_HOW _
_GENVOYA WORKS_
_ _
GENVOYA tablets consist of the
following four medicines:
•
elvitegravir
•
cobicistat
•
emtricitabine
•
tenofovir alafenamide
These are combined in one tablet to help
control Human Immunodeficiency Virus
(HIV) infection.
GENVOYA helps block HIV-1 reverse
transcriptase, a viral chemical in your
body (enzyme) that is needed for HIV-1
to multiply.
GENVOYA lowers the amount of HIV
in the blood (viral load). GENVOYA
may also help to increase the number of
T cells (CD4
+
cells), allowing your
immune system to improve. Lowering
the amount of HIV in the blood lowers
the chance of death or infections that
happen when your immune system is
weak (opportunistic infections).
HIV infection destroys CD4 T cells,
which are important to the immune
system. The immune system helps fight
infection. After a large number of T
cells are destroyed, acquired immune
deficiency syndrome (AIDS) may
develop.
GENVOYA is for people who do not
have a resistant HIV virus to
GENVOYA.
Elvitegravir

Ciri produk

NEW ZEALAND DATA SHEET
GENVOYA Data Sheet v8.0 (15 March 2022)
Page 1
GENVOYA
® (ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENAMIDE)
TABLETS
1 PRODUCT NAME
GENVOYA (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
GENVOYA is available as tablets. Each tablet contains 150 mg of
elvitegravir, 150 mg of
cobicistat, 200 mg emtricitabine and tenofovir alafenamide fumarate
equivalent to 10 mg of
tenofovir alafenamide. The tablets are film-coated, capsule shaped and
green in colour. Each
tablet is debossed with ‘GSI’ on one side and the number “510”
on the other side.
For the full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Each GENVOYA tablet is capsule shaped, film-coated and green in
colour. Each tablet is
debossed with ‘GSI’ on one side and the number ’510’ on the
other side. The tablets are
supplied in bottles with child resistant closures.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GENVOYA is indicated as a single tablet regimen for the treatment of
HIV-1 infection in
adults and paediatric patients weighing at least 25 kg who are either
treatment–naïve; or
virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable
antiretroviral regimen at
start of therapy in order to replace their current antiretroviral
treatment regimen (see section
5.1 Pharmacodynamic properties, Clinical trials). Patients must not
have a history of
treatment failure or known mutations associated with resistance to the
antiretroviral
components of GENVOYA.
GENVOYA is a fixed dose combination of one integrase inhibitor, one
pharmacokinetic
enhancer and two nucleos(t)ide HIV
‐
1 reverse transcriptase inhibitors.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of GENVOYA is one tablet once daily taken with
food.
_ _
CHILDREN AND ADOLESCENTS UP TO 18 YEARS OF AGE
In paediatric patients weighing ≥ 25 kg, the recommended dose of
GENVOYA is one tablet
once daily taken with food.
NEW ZEALAND DATA SHEET