TENOFOVIR DISOPROXIL/EMTRICITABINE/EFAVIRENZ Viatris 300/200/600 tenofovir disoproxil maleate 300mg/emtricitabine 200mg/efavirenz 600mg tablet bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

emtricitabine, Quantity: 200 mg; efavirenz, Quantity: 600 mg; tenofovir disoproxil maleate, Quantity: 300 mg

Tillgänglig från:

Alphapharm Pty Ltd

Läkemedelsform:

Tablet, film coated

Sammansättning:

Excipient Ingredients: lactose monohydrate; microcrystalline cellulose; sodium metabisulfite; hyprolose; colloidal anhydrous silica; croscarmellose sodium; magnesium stearate; ferric oxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

Administreringssätt:

Oral

Enheter i paketet:

30

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

Tenofovir Disoproxil/ Emtricitabine/ Efavirenz Mylan 300/200/600 is indicated for the treatment of HIV infected adults over the age of 18 years.,This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of VIREAD, EMTRIVA and STOCRIN in treatment-na?ve and treatment experienced adults.

Produktsammanfattning:

Visual Identification: A pink film-coated, capsule shaped, biconvex, beveled edge tablet debossed with M on one side of the tablet and TEE 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

Bemyndigande status:

Registered

Tillstånd datum:

2018-05-17

Bipacksedel

TENOFOVIR DISOPROXIL/
EMTRICITABINE/ EFAVIRENZ
MYLAN 300/200/600
_contains the active ingredient tenofovir disoproxil maleate 300 mg,
emtricitabine 200 mg and efavirenz_
_600 mg_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about Tenofovir
Disoproxil/Emtricitabine/Efavirenz
Mylan 300/200/600 tablets. 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
Disoproxil/Emtricitabine/Efavirenz
Mylan 300/200/600 medicine. You
may need to read it again.
This medicine has been prescribed
for you personally and you should
not pass it on to others. It may harm
them, even if their symptoms are the
same as yours.
WHAT IS TENOFOVIR
Tenofovir Disoproxil/Emtricitabine/
Efavirenz Mylan 300/200/600 is used
to treat Human Immunodeficiency
Virus (HIV-1) infection in adults.
This medicine can be taken alone or
in combination with other anti-HIV
medicines.
Tenofovir Disoproxil/Emtricitabine/
Efavirenz Mylan 300/200/600
consists of three medicines:
•
tenofovir disoproxil maleate
•
emtricitabine
•
efavirenz
These are combined in one tablet to
help control Human
Immunodeficiency Virus (HIV-1)
infection.
Tenofovir Disoproxil/Emtricitabine/
Efavirenz Mylan 300/200/600
contains three active ingredients.
Tenofovir disoproxil and
emtricitabine belong to a group of
antiviral medicines known as
nucleoside and nucleotide reverse
transcriptase inhibitors (NRTI).
Efavirenz belongs to a group of
antiviral medicines known as non-
nucleoside reverse transcriptase
inhibitors (NNRTI).
_HOW TENOFOVIR DISOPROXIL/_
_EMTRICITABINE/EFAVIRENZ_
_MYLAN 300/200/600 WORKS_
HIV-1 infection destroys CD4 T
cells, which are important to the
immune system. The immune system
helps fight infection. After a large
number of T cells are destroyed,
acquired immune deficiency
syndrome (AIDS)

Produktens egenskaper

AUSTRALIAN PRODUCT INFORMATION
_TENOFOVIR _
_DISOPROXIL/EMTRICITABINE/EFAVIRENZ _
_MYLAN 300/200/600 _
_ tenofovir disoproxil maleate 300 mg, emtricitabine 200 mg and
efavirenz 600 mg _
_ _
_ _
1
NAME OF THE MEDICINE
Tenofovir disoproxil maleate, emtricitabine and efavirenz
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600
tablet contains 300 mg of tenofovir
disoproxil maleate (equivalent to 245 mg of tenofovir disoproxil), 200
mg of emtricitabine and 600 mg of
efavirenz.
Excipients with known effect:
Tablet core: lactose monohydrate and sodium metabisulfite.
For the full list of excipients, see Section
6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600 is
available as tablets.
Each Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600
tablet is capsule shaped and pink in
colour. Each tablet is debossed with “M” on one side of the tablet
and “TEE” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600 is
indicated for the treatment of HIV infected
adults over the age of 18 years. This indication is based on analyses
of plasma HIV-1 RNA levels and CD4 cell
counts in controlled studies of VIREAD, EMTRIVA and STOCRIN in
treatment-naïve and treatment experienced
adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS:
The recommended dose of Tenofovir/Emtricitabine/Efavirenz is one
tablet once daily taken orally on
an empty stomach. Dosing at bedtime may improve the tolerability of
nervous system symptoms.
CHILDREN AND ADOLESCENTS
: Tenofovir/Emtricitabine/Efavirenz is not recommended for use in
children below
18 years of age due to insufficient data on safety and efficacy.
ELDERLY:
Tenofovir/Emtricitabine/Efavirenz should be administered with caution
to elderly patients (see Section
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
).
Tenofovir Disoproxil/Emtricitabine/Efavirenz Mylan 300/200/600
– PRODUCT INF