Stribild
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
02-02-2023
Produktets egenskaber
(SPC)
02-02-2023
Offentlige vurderingsrapport
(PAR)
15-11-2017
Aktiv bestanddel:
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate
Tilgængelig fra:
Gilead Sciences Ireland UC
ATC-kode:
J05AR09
INN (International Name):
elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil
Terapeutisk gruppe:
Antivirals for treatment of HIV infections, combinations, Antivirals for systemic use
Terapeutisk område:
HIV Infections
Terapeutiske indikationer:
Treatment of human immunodeficiency virus 1 (HIV 1) infection in adults aged 18 years and over who are antiretroviral treatment-naïve or are infected with HIV 1 without known mutations associated with resistance to any of the three antiretroviral agents in Stribild.
Produkt oversigt:
Revision: 25
Autorisation status:
Authorised
Autorisation dato:
2013-05-24
Indlægsseddel
44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
STRIBILD 150 MG/150 MG/200 MG/245 MG FILM-COATED TABLETS
elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
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 Stribild is and what it is used for
2.
What you need to know before you take Stribild
3.
How to take Stribild
4.
Possible side effects
5.
How to store Stribild
6.
Contents of the pack and other information
1.
WHAT STRIBILD IS AND WHAT IT IS USED FOR
STRIBILD 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 DISOPROXIL,
an antiretroviral medicine known as a nucleotide reverse transcriptase
inhibitor (NtRTI)
Stribild is a single tablet regimen for the treatment of human
immunodeficiency virus (HIV) infection
in adults.
Stribild is also used to treat HIV-1 infected adolescents aged 12 to
less than 18 years who weigh at
least 35 kg, and who have already been treated with other HIV
medicines that have caused side effects.
STRIBILD REDUCES THE AMOUNT OF HIV IN YOUR BODY. THIS WILL IMPROVE
YOUR IMMUNE SYSTEM AND
REDUCE
the risk of developing illnesses linked to HIV infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE STRIBILD
DO NOT TAKE STRIBILD
•
IF YOU ARE ALLERGIC TO ELVITEGRAVIR, COBICISTAT, EMTRICITABINE,
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Stribild 150 mg/150 mg/200 mg/245 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of
cobicistat, 200 mg of emtricitabine
and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir
disoproxil fumarate or 136 mg
of tenofovir).
Excipients with known effect
Each tablet contains 10.4 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 20 mm x 10 mm,
debossed on one side with
“GSI” and the number “1” surrounded by a square box on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Stribild is indicated for the treatment of human immunodeficiency
virus-1 (HIV-1) infection in adults
aged 18 years and over who are antiretroviral treatment-naïve or are
infected with HIV-1 without
known mutations associated with resistance to any of the three
antiretroviral agents in Stribild (see
sections 4.2, 4.4 and 5.1).
Stribild is also indicated for the treatment of HIV-1 infection in
adolescents aged 12 to < 18 years
weighing ≥ 35 kg who are infected with HIV-1 without known mutations
associated with resistance to
any of the three antiretroviral agents in Stribild and who have
experienced toxicities which preclude
the use of other regimens that do not contain tenofovir disoproxil
(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 adolescents aged 12 years and older weighing at least 35
kg_
: One tablet, once daily with
food.
If the patient misses a dose of Stribild within 18 hours of the time
it is usually taken, the patient should
take Stribild with food as soon as possible and resume the normal
dosing schedule. If a patient misses
a dose of Stribild by more than 18 hou
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