STRIBILD tenofovir disoproxil fumarate 300mg, emtricitabine 200 mg, elvitegravir 150 mg, cobicistat 150 mg tablet bottle

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

tenofovir disoproxil fumarate, Quantity: 300 mg; emtricitabine, Quantity: 200 mg; elvitegravir, Quantity: 150 mg; cobicistat, Quantity: 150 mg

Dostupno od:

Gilead Sciences Pty Ltd

INN (International ime):

Cobicistat,Elvitegravir,Emtricitabine,Tenofovir disoproxil fumarate

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: hyprolose; lactose monohydrate; microcrystalline cellulose; silicon dioxide; croscarmellose sodium; magnesium stearate; sodium lauryl sulfate; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; indigo carmine aluminium lake

Administracija rute:

Oral

Jedinice u paketu:

30

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

STRIBILD is indicated as a single tablet regimen for the treatment of HIV infection in treatment-na?ve 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 Clinical Trials). 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.

Proizvod sažetak:

Visual Identification: Film coated, green, capsule-shaped tablets, debossed with 'GSI' on one side and '1' in a square box on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status autorizacije:

Licence status A

Datum autorizacije:

2013-02-22

Uputa o lijeku

STRIBILD Consumer Medicine Information v12.0 – (15 July 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
amo

Svojstava lijeka

STRIBILD Product Information v17.0 – (24 August 2021) Page 1
AUSTRALIAN PRODUCT INFORMATION
STRIBILD
®
(TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE/ELVITEGRAVIR/COBICISTAT)
TABLETS
1
NAME OF THE MEDICINE
STRIBILD (tenofovir disoproxil
fumarate/emtricitabine/elvitegravir/cobicistat).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substances in STRIBILD tablets are tenofovir disoproxil
fumarate (tenofovir DF),
emtricitabine, elvitegravir and cobicistat. Each tablet contains 300
mg tenofovir DF (which is
equivalent to 245 mg of tenofovir disoproxil), 200 mg emtricitabine,
150 mg of elvitegravir and
150 mg of cobicistat.
Tenofovir DF is a white to off-white crystalline powder with a
solubility of 13.4 mg/mL in water at
25
°
C. The partition coefficient (
_log p_
) for tenofovir disoproxil is 1.25 and the pKa is 3.75.
Emtricitabine is a white to off-white crystalline powder with a
solubility of approximately 112
mg/mL in water at 25
°
C. The partition coefficient (
_log_
_ _
_p_
) for emtricitabine is -0.43 and the pKa is
2.65.
Elvitegravir is a white to pale yellow powder with a solubility of
less than 0.5 µg/mL in water at
20 °C. The partition coefficient (
_log p_
) for elvitegravir is 4.5 and the pKa is 6.6.
Cobicistat is a white to pale yellow solid with a solubility of 0.1
mg/mL in water with pH 6.8
phosphate buffer at 20 °C. The partition coefficient (
_log p_
) for cobicistat is 4.3 and the pKa is 6.4.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
STRIBILD is available as tablets. The tablets are film-coated, capsule
shaped 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 antiretrov