STRIBILD

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

COBICISTATE; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL AS FUMARATE

متاح من:

GILEAD SCIENCES ISRAEL LTD

ATC رمز:

J05AR09

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

TENOFOVIR DISOPROXIL AS FUMARATE 245 MG; EMTRICITABINE 200 MG; COBICISTATE 150 MG; ELVITEGRAVIR 150 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

GILEAD SCIENCES IRELAND UC, IRELAND

المجال العلاجي:

EMTRICITABINE, TENOFOVIR DISOPROXIL, ELVITEGRAVIR AND COBICISTAT

الخصائص العلاجية:

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.תוספת התוויה: 2/7/2019Addition of new info to posology section: precaution in pregnant women

تاريخ الترخيص:

2019-04-30

نشرة المعلومات

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' (PRODUCTS)
REGULATIONS - 1986
The medicine is to be supplied by doctor’s prescription only
STRIBILD
®
Film
-
coated tablets
ACTIVE INGREDIENTS:
Each capsule contains -
Elvitegravir
150 mg
Cobicistat
150 mg
Emtricitabine
200 mg
Tenofovir
disoproxil
245 mg
Equivalent to tenofovir disoproxil fumarate 300 mg or 136 mg of
tenofovir
Inactive agents and allergens: 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 issimilar to yours. If you
experience 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).
The medicine is intended for adults above the age of 18.
1.
WHAT IS STRIBILD INTENDED FOR
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.
THERAPEUTIC GROUP:
•
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 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
2.
BE

خصائص المنتج

1
STRIBILD
®
(ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, TENOFOVIR DISOPROXIL (AS
FUMARATE))
FILM-COATED TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Stribild
®
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) (equiv. to 10.9
mg lactose 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).
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 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 hours and it is almost time for the
next dose, the patient should not
take the missed dose and simply resume the usual dosing schedule.
If the patient vomits within 1 hour of taking Stribild another tablet
should be taken.
2
Special populations
_Elderly_
No data are available on which to make a dose recommendation for
patients over the age of 65 years
(see sections 4.4 and 5.1). Stribild sh