TENOFOVIR EMT GH tenofovir disoproxil phosphate and emtricitabine 291mg/200mg film coated tablets

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

emtricitabine, Quantity: 200 mg; tenofovir disoproxil phosphate, Quantity: 291 mg

Prieinama:

Lupin Australia Pty Limited

INN (Tarptautinis Pavadinimas):

Emtricitabine,tenofovir disoproxil phosphate

Vaisto forma:

Tablet, film coated

Sudėtis:

Excipient Ingredients: mannitol; purified water; colloidal anhydrous silica; croscarmellose sodium; microcrystalline cellulose; stearic acid; titanium dioxide; lactose monohydrate; hypromellose; triacetin; indigo carmine aluminium lake

Vartojimo būdas:

Oral

Vienetai pakuotėje:

HDPE bottle pack of 30 shelf life 18 months, HDPE bottle pack of 100 shelf life only 15 months

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

Treatment of HIV-1 infection TENOFOVIR EMT GH is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.,Pre-Exposure Prophylaxis TENOFOVIR EMT GH is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see CLINICAL STUDIES).

Produkto santrauka:

Visual Identification: Blue, oval-shaped, biconvex, film-coated tablets plain on both sides.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Autorizacija statusas:

Licence status A

Leidimo data:

2017-01-31

Pakuotės lapelis

CONSUMER MEDICINE INFORMATION
TENOFOVIR EMT GH
(TENOFOVIR DISOPROXIL PHOSPHATE AND EMTRICITABINE) FILM-COATED TABLET
WHAT IS IN THIS LEAFLET
Read all of this leaflet carefully
before you start taking this
medicine.
This leaflet answers some of the
common questions about
Tenofovir EMT GH. It does not
contain all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist about your medical
condition or treatment. If you
have further questions, please
ask your doctor or your
pharmacist.
KEEP THIS LEAFLET WITH YOUR
TENOFOVIR EMT GH MEDICINE.
You may need to read it again.
WHAT TENOFOVIR EMT GH
IS USED FOR
Tenofovir EMT GH is used to
treat Human Immunodeficiency
Virus (HIV) infection in adults.
This medicine must be taken in
combination with other anti-HIV
medicines.
Tenofovir EMT GH contains two
active ingredients that belong to
a group of antiviral medicines
known as nucleoside and
nucleotide reverse transcriptase
inhibitors (NRTI).
Tenofovir EMT GH is used:
•
to treat Human
Immunodeficiency Virus-1
(HIV-1) infection in adults
when taken in combination
with other anti-HIV
medicines.
•
to help reduce the risk of
getting HIV infection when
used with safer sex practices
in:
-
HIV-negative men who
have sex with men, who
are at high risk of getting
infected with HIV-1
through sex; and
-
Male-female sex partners
when one partner has HIV-
1 infection and the other
does not.
_WHEN TENOFOVIR EMT GH IS _
_USED TO TREAT HIV INFECTION _
When used with other HIV-1
medicines to treat HIV-1
infection, Tenofovir EMT GH
may help:
•
Reduce the amount of HIV-1
in your blood. This is called
“viral load”.
•
Increase the number of
CD4+ (T) cells in your blood
that help fight off other
infections.
Reducing the amount of HIV-1
and increasing the CD4+ (T)
cells in your blood may help
improve your immune system.
This may reduce your risk of
death or infections that can
happen when your immune
system is weak.
_USE IN CHILDREN AND ELDERLY _
Tenofovir EMT GH is for adults.
Do not take Tenofovir

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION – TENOFOVIR EMT GH
(TENOFOVIR DISOPROXIL PHOSPHATE/EMTRICITABINE) FILM-COATED TABLET
1
NAME OF THE MEDICINE
Tenofovir disoproxil phosphate and emtricitabine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
Tenofovir
EMT
GH
tablet
contains
291
mg
tenofovir
disoproxil
phosphate
and
200
mg
emtricitabine.
List of excipients with known effects: mannitol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
The tablets are blue, oval-shaped, biconvex, film-coated, plain on
both sides.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HIV-1 INFECTION
Tenofovir EMT GH is indicated for the treatment of HIV-infected adults
over the age of 18 years, in
combination with other antiretroviral agents.
PRE-EXPOSURE PROPHYLAXIS
Tenofovir EMT GH is indicated in combination with safer sex practices
for pre-exposure prophylaxis
(PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high
risk. This indication is based on
clinical trials in men who have sex with men (MSM) at high risk for
HIV-1 infection and in heterosexual
serodiscordant couples (see SECTION 5.1 PHARMACODYNAMIC PROPERTIES –
CLINICAL TRIALS).
4.2 DOSE AND METHOD OF ADMINISTRATION
_EACH TENOFOVIR EMT GH TABLET CONTAINS 291 MG OF TENOFOVIR DISOPROXIL
PHOSPHATE AND 200 MG OF _
_EMTRICITABINE. THE INNOVATOR PRODUCT CONTAINS 300 MG OF TENOFOVIR
DISOPROXIL FUMARATE AND 200 MG OF _
_EMTRICITABINE - 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 EMT GH v4.0
Page 2 of 39
(tenofovir disoproxil phosphate/ emtricitabine) film-coated tablet
RECOMMENDED DOSE FOR TREATMENT OF HIV-1 INFECTION
Adults
The recommended dose of Tenofovir EMT GH is one tablet (containing 291
mg tenofovir disoproxil
phosphate and 200 mg emtricitabine), taken orally, once daily. In
order to optimise the absorption of
tenofovir, it is recommended that Tenofovir