TENOFOVIR DISOPROXIL VIATRIS tenofovir disoproxil maleate 300 mg film coated tablet bottle

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

tenofovir disoproxil maleate, Quantity: 300 mg

Fáanlegur frá:

Alphapharm Pty Ltd

INN (Alþjóðlegt nafn):

tenofovir disoproxil maleate

Lyfjaform:

Tablet, film coated

Samsetning:

Excipient Ingredients: lactose monohydrate; hyprolose; magnesium stearate; microcrystalline cellulose; colloidal anhydrous silica; titanium dioxide; hypromellose; triacetin; indigo carmine aluminium lake

Stjórnsýsluleið:

Oral

Einingar í pakka:

30

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

TENOFOVIR DISOPROXIL VIATRIS in combination with other antiretroviral agents is indicated for the treatment of HIV infected adults and paediatric patients 12 years of age and older.,TENOFOVIR DISOPROXIL VIATRIS is indicated for the treatment of chronic hepatitis B in adults (see CLINICAL TRIALS).,TENOFOVIR DISOPROXIL VIATRIS 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

Vörulýsing:

Visual Identification: Light blue colored, 12 mm round, biconvex, film coated tablets debossed with 'TM300' on one side of the tablet and 'M' on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Leyfisstaða:

Licence status A

Leyfisdagur:

2016-12-15

Upplýsingar fylgiseðill

TENOFOVIR
DISOPROXIL VIATRIS
_tenofovir disoproxil maleate 300 mg_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before you
start taking TENOFOVIR
DISOPROXIL VIATRIS. Also, read
it each time you get your
TENOFOVIR DISOPROXIL
VIATRIS 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 TENOFOVIR
DISOPROXIL VIATRIS.
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 TENOFOVIR DISOPROXIL
VIATRIS and WHAT ARE THE
POSSIBLE SIDE EFFECTS OF
TENOFOVIR DISOPROXIL
VIATRIS).
Talk to your doctor or pharmacist if
you have any questions about
TENOFOVIR DISOPROXIL
VIATRIS.
WHAT TENOFOVIR
DISOPROXIL VIATRIS
IS USED FOR
Tenofovir disoproxil maleate is an
antiviral medication used to treat two
different viruses;
•
Chronic Hepatitis B (CHB) and
•
Human Immunodeficiency Virus
(HIV) infection.
TENOFOVIR DISOPROXIL
VIATRIS is a type of medicine
called HBV polymerase inhibitor and
a nucleotide analogue reverse
transcriptase inhibitor (NRTI).
_HOW TENOFOVIR_
_DISOPROXIL VIATRIS WORKS_
_IN THE TREATMENT OF CHB:_
TENOFOVIR DISOPROXIL
VIATRIS 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.
TENOFOVIR DISOPROXIL
VIATRIS works by interfering with
the normal working of enzymes
(HBV DNA polymerase) that are
essential for HBV to reproduce itself.
TENOFOVIR DISOPROXIL
VIATRIS 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 k

Vara einkenni

AUSTRALIAN PRODUCT INFORMATION
TENOFOVIR DISOPROXIL VIATRIS
_Tenofovir disoproxil maleate film coated tablets _
1
NAME OF THE MEDICINE
Tenofovir disoproxil maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each TENOFOVIR DISOPROXIL VIATRIS tablet contains 300 mg of tenofovir
disoproxil as maleate
(equivalent to 245 mg of tenofovir disoproxil) as the active
ingredient.
Excipients with known effect: Sugars as lactose.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TENOFOVIR DISOPROXIL VIATRIS (tenofovir disoproxil maleate) 300 mg:
Light blue colored, 12 mm
round, biconvex, film coated tablets debossed with ‘TM300’ on one
side of the tablet and ‘M’ on other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TENOFOVIR DISOPROXIL VIATRIS in combination with other antiretroviral
agents is indicated for the
treatment of HIV infected adults and paediatric patients 12 years of
age and older.
TENOFOVIR DISOPROXIL VIATRIS is indicated for the treatment of chronic
hepatitis B in adults (see
Section 5.1 PHARMACODYNAMIC PROPERTIES: Clinical trials).
TENOFOVIR DISOPROXIL VIATRIS 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
DOSE 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 TENOFOVIR DISOPROXIL VIATRIS 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
TENOFOVIR DISOPROXIL VIATRIS be taken with food.
The safety and efficacy of tenofovir disoproxil in patients under