Stribild

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Cobicistat 150mg;  ;  ;  ; Elvitegravir 150mg;  ;  ; Emtricitabine 200mg;  ;  ;  ;  ; Tenofovir disoproxil fumarate 300mg;  ;  ;  

Prieinama:

Gilead Sciences (NZ)

INN (Tarptautinis Pavadinimas):

Cobicistat 150 mg

Vaisto forma:

Film coated tablet

Sudėtis:

Active: Cobicistat 150mg       Elvitegravir 150mg     Emtricitabine 200mg         Tenofovir disoproxil fumarate 300mg       Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry Green Sodium laurilsulfate

Recepto tipas:

Prescription

Pagaminta:

Yuhan Chemical Industries Co Ltd

Terapinės indikacijos:

STRIBILD is indicated as a single tablet regimen for the treatment of HIV infection in treatment-naive adults. STRIBILD is also indicated in certain virologically suppressed (HIV1 RNA STRIBILD is a fixed dose combination of one integrase inhibitor, one pharmacokinetic enhancer and two nucleos(t)ide HIV-1 reverse transcriptase inhibitors.

Produkto santrauka:

Package - Contents - Shelf Life: Bottle, plastic, HDPE 100 ml capacity with child-resistant closure - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Leidimo data:

2013-03-11

Pakuotės lapelis

STRIBILD Consumer Medicine Information v13 – (13 November 2020)
Page
1
of
5
STRIBILD
® TABLETS
_300_
_ _
_mg tenofovir disoproxil fumarate / 200 mg emtricitabine/ 150 mg of
elvitegravir / 150 mg of cobicistat _
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 STRIBILD
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.
Keep this leaflet with your STRIBILD
medicine.
You may need to read it again.
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.
WHAT IS STRIBILD
STRIBILD is used to treat HIV
infection. STRIBILD is for people who
have
NEVER
taken HIV medicines before,
or who do not have a resistant HIV virus
to STRIBILD.
STRIBILD consists of four medicines:
•
tenofovir disoproxil fumarate, also
called tenofovir DF (VIREAD
®
)
•
emtricitabine or FTC (EMTRIVA
®
)
•
elvitegravir
•
cobicistat (TYBOST
®
)
These are
combined in one tablet to help
control Human Immunodeficiency Virus
(HIV) infection.
VIREAD and EMTRIVA belong to a
group of antiviral medicines known as
nucleoside and nucleotide reverse
transcriptase inhibitors (NRTI).
Elvitegravir belongs to a class of
antiviral medicines known as integrase
inhibitors.
Cobicistat is a “booster”, to help
increase the levels of elvitegravir.
_HOW STRIBILD WORKS _
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.
STRIBILD helps block HIV-1 reverse
transcriptase, a viral chemical in your
body (enzyme) that is needed for HIV-1
to multiply. STRIBILD lowers the
am

Prekės savybės

STRIBILD Data Sheet v11.0 – (03 March 2021) Page 1
NEW ZEALAND DATA SHEET
1
STRIBILD
® (TENOFOVIR DISOPROXIL FUMARATE/
EMTRICITABINE/ELVITEGRAVIR/COBICISTAT) TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tenofovir disoproxil fumarate (tenofovir DF) 300 mg /Emtricitabine
(FTC) 200 mg/Elvitegravir
(EVG) 150 mg/Cobicistat (COBI) 150 mg
tablets.
For full list of excipients, see section 6.1
List of Excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Each STRIBILD tablet is capsule shaped, film-coated and green in
colour. Each tablet is
debossed with ‘GSI’ on one side and the number “1” surrounded
by a square box ( 1 ) on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
STRIBILD is indicated as a single tablet regimen for the treatment of
HIV infection in treatment-
naive adults. STRIBILD is also indicated in certain virologically
suppressed (HIV1 RNA <50
copies/mL) adult patients on a stable antiretroviral regimen at start
of therapy in order to replace
their
current
antiretroviral
treatment
regimen
(see
section
5.1
Pharmacodynamics
under
subsection “Clinical Data”). Patients must not have a history of
treatment failure or known
mutations associated with resistance to the antiretroviral components
of STRIBILD (tenofovir
DF, emtricitabine or elvitegravir).
STRIBILD 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 STRIBILD is one tablet once daily taken orally
with a meal.
_Renal impairment:_
STRIBILD
should not be initiated in patients with estimated creatinine
clearance below 70 mL/min. STRIBILD should be discontinued if
estimated creatinine clearance
declines below 50 mL/min during treatment with STRIBILD as dose
interval adjustment required
for emtricitabine and tenofovir DF cannot be achieved with the
fixed-dose combination tablet
(see section 4.4 Special Warnings and Precautions for Use).
_Not Recommende