TENOFOVIR GH tenofovir disoproxil phosphate 291 mg film-coated tablet

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

tenofovir disoproxil phosphate, Quantity: 291 mg

Dostupno od:

Lupin Australia Pty Limited

INN (International ime):

tenofovir disoproxil phosphate

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: microcrystalline cellulose; croscarmellose sodium; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake

Administracija rute:

Oral

Jedinice u paketu:

HDPE bottle pack of 100, HDPE bottle pack of 30

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Tenofovir GH 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 GH is indicated for the treatment of chronic hepatitis B in adults (see CLINICAL TRIALS). Tenofovir GH 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.

Proizvod sažetak:

Visual Identification: Blue coloured, oval shaped, biconvex film-coated tablets debossed with T1 on one side and plain on the 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

Status autorizacije:

Licence status A

Datum autorizacije:

2017-01-30

Uputa o lijeku

CONSUMER MEDICINE INFORMATION
TENOFOVIR GH
(TENOFOVIR DISOPROXIL PHOSPHATE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before
you start taking Tenofovir GH.
Also, read it each time you get
your Tenofovir GH 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 GH.
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 GH and ‘Side effects’).
Talk to your doctor or
pharmacist if you have any
questions about Tenofovir GH.
WHAT TENOFOVIR GH IS
USED FOR
Tenofovir GH is an antiviral
medication used to treat two
different viruses: Chronic
Hepatitis B (CHB) and Human
Immunodeficiency Virus (HIV)
infection.
Tenofovir GH is a type of
medicine called an HBV
polymerase inhibitor and a
nucleotide analogue reverse
transcriptase inhibitor (NRTI).
_HOW TENOFOVIR GH WORKS IN _
_THE TREATMENT OF CHB _
TENOFOVIR GH 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 GH works by
interfering with the normal
working of enzymes (HBV DNA
polymerase) that are essential
for HBV to reproduce itself.
Tenofovir GH 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
Tenofovir GH may help treat
your hepatitis.
Sometimes viruses change in
your body and medicines no
longer work. This is called drug
resistance.
_HOW TENOFOVIR GH WORKS IN _
_THE TREATMENT OF HIV-_
_INFECTION _
TENOFOVIR GH IS ALS

Svojstava lijeka

AUSTRALIAN PRODUCT INFORMATION – TENOFOVIR GH
(TENOFOVIR DISOPROXIL PHOSPHATE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Tenofovir disoproxil phosphate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tenofovir GH film-coated tablets contain 291 mg of tenofovir
disoproxil phosphate. The innovator
product contains 300 mg of tenofovir disoproxil fumarate - 291 mg of
tenofovir disoproxil phosphate is
equivalent to 300 mg of tenofovir disoproxil fumarate.
List of excipients with known effects: lactose monohydrate
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Each Tenofovir GH film-coated tablet is blue, oval shaped, biconvex
and debossed with 'T1' on one side
and plain on other side. The tablets are supplied in bottles with a
screw cap closure.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Tenofovir GH 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
GH
is
indicated
for
the
treatment
of
chronic
hepatitis
B
in
adults
(see
SECTION
5.1
PHARMACODYNAMIC PROPERTIES – CLINICAL TRIALS).
Tenofovir GH 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, ie. active viral
replication, persistently elevated serum ALT levels or evidence of
active inflammation.
4.2 DOSE AND METHOD OF ADMINISTRATION
_EACH TENOFOVIR GH TABLET CONTAINS 291 MG OF TENOFOVIR DISOPROXIL
PHOSPHATE. THE INNOVATOR PRODUCT _
_CONTAINS 300 MG OF TENOFOVIR DISOPROXIL FUMARATE – 291 MG OF
TENOFOVIR DISOPROXIL PHOSPHATE IS _
_EQUIVALENT TO 300 MG OF TENOFOVIR DISOPROXIL FUMARATE. BIOEQUIVALENCE
HAS BEEN ESTABLISHED BETWEEN _
_THE TWO SALT FORMS OF TENOFOVIR DISOPROXIL. _
Tenofovir GH v4
Page 2 of 44
(tenofovir disoproxil phosphate) film-coated tablet
ADULTS
_ _
The recommended dose of Tenofovir GH (tenofovir disoproxil phosphate)
is 291 mg (one tablet) once
daily taken orally.