SYMTUZA 800/150/200/10 darunavir/cobicistat/emtricitabine/tenofovir alafenamide 800/150/200/10 mg film-coated tablets

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

tenofovir alafenamide, Quantity: 10 mg; darunavir, Quantity: 800 mg; cobicistat, Quantity: 150 mg; emtricitabine, Quantity: 200 mg

Dostupno od:

Janssen-Cilag Pty Ltd

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: magnesium stearate; croscarmellose sodium; silicon dioxide; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350

Administracija rute:

Oral

Jedinice u paketu:

30 tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents (aged 12 years and older with body weight at least 40 kg). Genotypic testing should guide the use of SYMTUZA (see section 4.2 Dose and method of administration, section 4.4 Special warnings and precautions for use and section 5.1 Pharmacodynamic properties).

Proizvod sažetak:

Visual Identification: A 2.2 x 1.1 cm, yellow to yellowish brown, capsule-shaped, film-coated tablet, debossed with 8121 on one side and JG on the opposite side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Status autorizacije:

Registered

Datum autorizacije:

2019-11-22

Uputa o lijeku

SYMTUZA (220110) ACMI
1
SYMTUZA
®
800/150/200/10 TABLETS
_Darunavir/cobicistat/emtricitabine/tenofovir alafenamide _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START TAKING THIS
MEDICINE.
This leaflet answers some common
questions about SYMTUZA tablets.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given
SYMTUZA against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN SYMTUZA ASK YOUR
DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE
TAKING SYMTUZA.
You may need to read it again.
WHAT SYMTUZA IS
USED FOR
SYMTUZA is a single tablet
regiment used to treat adults and
adolescents 12 years of age and older
who weigh at least 40 kg, who are
infected by HIV (Human
Immunodeficiency Virus).
SYMTUZA contains four active
ingredients which work in
combination for the treatment of
HIV. These active ingredients are
darunavir, cobicistat, emtricitabine
and tenofovir alafenamide.
Darunavir, emtricitabine and
tenofovir alafenamide are called
antiretroviral medicines. Darunavir is
medicine known as a protease
inhibitor. Emtricitabine is a medicine
known as a nucleoside reverse
transcriptase inhibitor. Tenofovir
alafenamide is a medicine known as
a nucleotide reverse transcriptase
inhibitor. Each of these three active
ingredients work to reduce the
amount of HIV in your body.
Cobicistat is a type of medicine
called a pharmacokinetic enhancer
(or "booster"). Cobicistat helps to
increase the levels of darunavir in
your body.
Reducing the amount of HIV in your
blood improves your immune system
and reduces the risk of developing
illnesses as a result of HIV infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SYMTUZA
HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU TAKE
SYMTUZA
_WHEN YOU MUST NOT USE IT: _
DO NOT TAKE SYM

Svojstava lijeka

CCDS210601
1
SYMTUZA (220105) API
AUSTRALIAN PRODUCT INFORMATION
SYMTUZA
®
DARUNAVIR
/
COBICISTAT
/
EMTRICITABINE
/
TENOFOVIR
ALAFENAMIDE
FILM-COATED TABLETS
1. NAME OF THE MEDICINE
Darunavir/cobicistat/emtricitabine/tenofovir alafenamide
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
SYMTUZA 800/150/200/10 mg tablets contain 800 mg of darunavir (as 867
mg darunavir
ethanolate), 150 mg of cobicistat (as 288.5 mg of cobicistat on
silicon dioxide), 200 mg of
emtricitabine and 10 mg of tenofovir alafenamide (as 11.2 mg tenofovir
alafenamide fumarate).
For a full list of excipients, see SECTION 6.1 List of excipients.
3. PHARMACEUTICAL FORM
SYMTUZA is supplied as a 2.2 x 1.1 cm, yellow to yellowish brown,
capsule-shaped, film-coated
tablet, debossed with “8121” on one side and “JG” on the
opposite side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
SYMTUZA is indicated as a complete regimen for the treatment of human
immunodeficiency virus
type 1 (HIV-1) infection in adults and adolescents (aged 12 years and
older with body weight at
least 40 kg). Genotypic testing should guide the use of SYMTUZA (see
SECTION 4.2 Dose and
method of administration, SECTION 4.4 Special warnings and precautions
for use and SECTION 5.1
Pharmacodynamic properties).
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE IN ADULTS
The recommended dose of SYMTUZA is one tablet taken once daily with
food.
DOSE IN ADOLESCENTS (12-17 YEARS OF AGE)
In adolescent patients aged 12 years and older weighing at least 40
kg, the recommended dosage
is one tablet taken once daily with food. No dose has been established
for SYMTUZA for paediatric
patients 3-11 years of age or weighing less than 40 kg (see SECTION
5.2 Pharmacokinetic
properties, Special populations). SYMTUZA should not be used in
paediatric patients below
3 years of age in view of toxicity observed in juvenile rats dosed
with darunavir (from 20 mg/kg to
1000 mg/kg) up to days 23 to 26 of age (see SECTION 5.3 Preclinical
safety data).
Product Information - Australia
CCDS210601
2
SYMTUZA (2