Genvoya 150mg150mg200mg10mg tablets

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Tenofovir alafenamide; Emtricitabine; Cobicistat; Elvitegravir

Dostupno od:

Gilead Sciences International Ltd

INN (International ime):

Tenofovir alafenamide; Emtricitabine; Cobicistat; Elvitegravir

Doziranje:

10mg ; 200mg ; 150mg ; 150mg

Farmaceutski oblik:

Tablet

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Never Valid To Prescribe As A VMP

Proizvod sažetak:

BNF: 05030100

Uputa o lijeku

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
GENVOYA 150 MG/150 MG/200 MG/10 MG FILM-COATED TABLETS
Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
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.
WHAT IS IN THIS LEAFLET
1.
What Genvoya is and what it is used for
2.
What you need to know before you take Genvoya
3.
How to take Genvoya
4.
Possible side effects
5.
How to store Genvoya
6.
Contents of the pack and other information
IF GENVOYA 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”).
1.
WHAT GENVOYA IS AND WHAT IT IS USED FOR
Genvoya contains four active substances:
•
ELVITEGRAVIR,
an antiretroviral medicine known as an integrase inhibitor
•
COBICISTAT,
a booster (pharmacokinetic 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)
Genvoya is a single tablet for the
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS 1 (HIV-1) INFECTION
in adults, adolescents and children 6 years of age and older, who
weigh at least 25 kg.
Genvoya reduces

Svojstava lijeka

OBJECT 1
GENVOYA 150MG/150MG/200MG/10MG FILM COATED
TABLETS
Summary of Product Characteristics Updated 25-Jun-2018 | Gilead
Sciences Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Genvoya 150 mg/150 mg/200 mg/10 mg film-coated tablets.
2. Qualitative and quantitative composition
Each 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.
Excipients with known effect
Each tablet contains 61 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
Genvoya 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 Genvoya within 18 hours of the time it
is usually taken, the patient should
take Genvoya with food as soon as possible and resume the normal
dosing schedule. If a patient misse