TENOFOVIR SANDOZ tenofovir disoproxil fumarate 300mg tablets bottle

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

tenofovir disoproxil fumarate, Quantity: 300 mg

Доступна з:

Sandoz Pty Ltd

Фармацевтична форма:

Tablet

Склад:

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

Адміністрація маршрут:

Oral

Одиниць в упаковці:

30's

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

TENOFOVIR SANDOZ 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 SANDOZ is indicated for the treatment of chronic hepatitis B in adults (see CLINICAL TRIALS).,TENOFOVIR SANDOZ 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.

Огляд продуктів:

Visual Identification: White coloured, almond shaped, film-coated tablets debossed with 'H' on one side and '123' 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

Статус Авторизація:

Registered

Дата Авторизація:

2018-12-06

інформаційний буклет

Tenofovir sandoz/CMI/29Jun2021
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TENOFOVIR SANDOZ
® TABLETS
_300_
_ _
_mg tenofovir disoproxil fumarate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read this leaflet carefully before you start
taking TENOFOVIR SANDOZ. Also,
read it each time you get your
TENOFOVIR SANDOZ 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 SANDOZ.
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
SANDOZ
and
WHAT
ARE
THE
POSSIBLE
SIDE
EFFECTS
OF
TENOFOVIR
SANDOZ).
Talk to your doctor or pharmacist if you
have any questions about TENOFOVIR
SANDOZ.
WHAT IS TENOFOVIR
SANDOZ
TENOFOVIR SANDOZ is an antiviral
medication used to treat two different
viruses; Chronic Hepatitis B (CHB) and
Human Immunodeficiency Virus (HIV)
infection.
TENOFOVIR SANDOZ is a type of
medicine called a HBV polymerase
inhibitor and a nucleotide analog reverse
transcriptase inhibitor (NRTI).
_ _
_ _
_ _
_HOW TENOFOVIR SANDOZ _
_WORKS IN THE TREATMENT OF CHB _
TENOFOVIR SANDOZ 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 SANDOZ works by
interfering with the normal working of
enzymes (HBV DNA polymerase) that
are essential for HBV to reproduce itself.
TENOFOVIR SANDOZ 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
SANDOZ may help treat your hepatitis.
Sometimes viruses change in your body
and medicin

Характеристики продукта

210813-tenofovir-sandoz-pi
Page 1 of 45
AUSTRALIAN PRODUCT INFORMATION
TENOFOVIR SANDOZ
® (TENOFOVIR DISOPROXIL FUMARATE) TABLETS
1.
NAME OF THE MEDICINE
Tenofovir disoproxil fumarate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tenofovir Sandoz contains 300 mg of tenofovir disoproxil fumarate.
_Excipient with known effect:_
Sugars as lactose.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tenofovir Sandoz tablets are white coloured, almond shaped,
film-coated tablets debossed with
‘H’ on one side and ‘123’on the other side.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Tenofovir Sandoz 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 Sandoz is indicated for the treatment of chronic hepatitis B
in adults (see Section 5.1
Pharmacodynamic properties - Clinical trials).
Tenofovir Sandoz 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
DOSAGE
_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 fumarate 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 fumarate be taken with food.
_ _
The safety and efficacy of tenofovir disoproxil fumarate in patients
under the age of 12 years
have not been established. Tenofovir disoproxil fumarate must not be
administered to children
under 12, until further da