VIREAD tenofovir disoproxil fumarate 300mg tablet bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

tenofovir disoproxil fumarate, Quantity: 300 mg

Disponible des:

Gilead Sciences Pty Ltd

formulario farmacéutico:

Tablet, film coated

Composición:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinised maize starch; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; triacetin

Vía de administración:

Oral

Unidades en paquete:

30 tablets

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

VIREAD in combination with other antiretroviral agents is indicated for the treatment of HIV-infected adults and paediatric patients 12 years of age and older.,VIREAD is indicated for the treatment of chronic hepatitis B in adults (see CLINICAL TRIALS).,VIREAD is indicated for the treatment of chronic hepatitis B in paediatric patients 12 years of age and older with compensated liver disease and with evidence of immune active disease, i.e. active viral replication, persistently elevated serum ALT levels or evidence of active inflammation. VIREAD in combination with other antiretroviral agents is indicated for the treatment of HIV-infected adults. VIREAD is indicated for the treatment of chronic hepatitis B in adults with evidence of active viral replication and active liver inflammation.

Resumen del producto:

Visual Identification: Light blue, almond-shaped, film-coated tablets, debossed on one side with the markings "GILEAD" and "4331" and on the other side with the marking "300".; Container Type: Bottle; Container Material: HDPE; Container Life Time: 60 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Estat d'Autorització:

Licence status A

Data d'autorització:

2002-08-13

Informació per a l'usuari

VIREAD Consumer Medicine Information v9.0 – (27 May 2021)
Page
1
of
4
VIREAD
® TABLETS
_300_
_ _
_mg tenofovir disoproxil fumarate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before you
start taking VIREAD. Also, read it each
time you get your VIREAD prescription
refilled, in case something has changed.
This information does not take the place
of talking with your doctor or
pharmacist when you start this medicine
and at check-ups. You should stay
under a doctor’s care when taking
VIREAD.
It is extremely important that you do not
change or stop your medicine without
first
talking
with
your
doctor
or
pharmacist
(see
HOW
SHOULD
I
TAKE VIREAD and WHAT ARE THE
POSSIBLE
SIDE
EFFECTS
OF
VIREAD).
Talk to your doctor or pharmacist if you
have any questions about VIREAD.
WHAT IS VIREAD
VIREAD is an antiviral medication used
to treat two different viruses; Chronic
Hepatitis B (CHB) and Human
Immunodeficiency Virus (HIV)
infection.
VIREAD is a type of medicine called a
HBV polymerase inhibitor and a
nucleotide analog reverse transcriptase
inhibitor (NRTI).
_HOW VIREAD WORKS IN THE _
_TREATMENT OF CHB _
VIREAD IS USED TO TREAT CHB (AN
INFECTION WITH HEPATITIS B VIRUS
[HBV]) IN ADULTS AND PAEDIATRIC
PATIENTS AGED 12 YEARS AND OLDER AND
WEIGHING AT LEAST 35 KG.
VIREAD works by interfering with the
normal working of enzymes (HBV DNA
polymerase) that are essential for HBV
to reproduce itself. VIREAD may help
lower the amount of hepatitis B virus in
your body by lowering the ability of the
virus to multiply and infect new liver
cells and can improve the inflammation
and scar tissue caused by the hepatitis B
virus in your liver. Lowering the amount
of virus in your body may reduce the
chance of developing cirrhosis, liver
failure and liver cancer.
We do not know how long VIREAD
may help treat your hepatitis.
Sometimes viruses change in your body
and medicines no longer work. This is
called drug resistance.
_HOW VIREAD WORKS IN THE _
_TREATMENT OF HIV-INFECTION _
VIREAD IS ALSO USED TO TR

Fitxa tècnica

VIREAD Product Information (27 May 2021)
1
AUSTRALIAN PI – VIREAD
®
(TENOFOVIR DISOPROXIL
FUMARATE) TABLETS
1
NAME OF THE MEDICINE
VIREAD (tenofovir disoproxil fumarate).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active substance in VIREAD is tenofovir disoproxil fumarate.
VIREAD film-coated
tablets contain 300 mg tenofovir disoproxil fumarate (tenofovir DF).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each VIREAD tablet is light blue and almond-shaped. Each tablet is
debossed on one side
with the markings “GILEAD” and “4331” and on the other side
with the marking “300”. The
tablets are supplied in bottles with screw cap closures.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
VIREAD in combination with other antiretroviral agents is indicated
for the treatment of
HIV-infected adults and paediatric patients 12 years of age and older.
VIREAD is indicated for the treatment of chronic hepatitis B in adults
(see Section 5.1
Pharmacodynamic properties, Clinical trials).
VIREAD is indicated for the treatment of chronic hepatitis B in
paediatric patients 12 years
of age and older with compensated liver disease and with evidence of
immune active disease,
i.e. active viral replication, persistently elevated serum ALT levels
or evidence of active
inflammation.
4.2
D
OSE AND METHOD OF ADMINISTRATION
_ADULTS: _
The recommended dose is 300 mg (one tablet) once daily taken orally.
In order to
optimise the absorption of tenofovir, it is recommended that VIREAD be
taken with food.
_PAEDIATRIC PATIENTS (≥ 12 YEARS OF AGE AND ≥ 35 KG): _
The recommended dose for paediatric
patients (12 years of age and older), who weigh ≥ 35 kg, is 300 mg
(one tablet) once daily
taken orally. In order to optimise the absorption of tenofovir, it is
recommended that
VIREAD be taken with food.
_ _
The safety and efficacy of VIREAD in patients under the age
of 12 years have not been established. VIREAD must not be administered
to children under
12, until further data become