ATRIPLA 300 mg tenofovir disoproxil fumarate/200 mg emtricitabine/600 mg efavirenz tablets bottle

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

efavirenz,emtricitabine,tenofovir disoproxil fumarate

Beszerezhető a:

Gilead Sciences Pty Ltd

INN (nemzetközi neve):

Efavirenz,Emtricitabine,Tenofovir disoproxil fumarate

Engedélyezési státusz:

Registered

Betegtájékoztató

ATRIPLA Consumer Medicine Information v12.0 – (07 May 2019) Page 1
of 6
ATRIPLA
® TABLETS
_300_
_ _
_mg tenofovir disoproxil fumarate / 200 mg emtricitabine/ 600 mg
efavirenz _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about ATRIPLA
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 ATRIPLA
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 ATRIPLA
ATRIPLA 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.
ATRIPLA consists of three medicines:

VIREAD
®
(tenofovir disoproxil
fumarate, also called tenofovir DF)

EMTRIVA
®
(emtricitabine or FTC)

STOCRIN® (efavirenz)
These are combined in one tablet to help
control Human Immunodeficiency Virus
(HIV-1) infection.
VIREAD and EMTRIVA belong to a
group of antiviral medicines known as
nucleoside and nucleotide reverse
transcriptase inhibitors (NRTI).
STOCRIN belongs to a group of
antiviral medicines known as non-
nucleoside reverse transcriptase
inhibitors (NNRTI).
Tenofovir DF and emtricitabine are
components of TRUVADA
®
and
ATRIPLA
®
tablets.
_HOW ATRIPLA 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) may
develop.
ATRIPLA helps block HIV-1 reverse
transcriptase, a viral chemical in your
body (enzyme) that is needed for HIV-1
to multiply. ATRIPLA lowers the
amount of HIV-1 in the blood (viral
load). ATRIPLA may also help to
increase the number of

Termékjellemzők

ATRIPLA Product Information v19.0 – (18 March 2020) Page 1
AUSTRALIAN PRODUCT INFORMATION - ATRIPLA
®
(TENOFOVIR DISOPROXIL FUMARATE,
EMTRICITABINE AND EFAVIRENZ) TABLETS
1
NAME OF THE MEDICINE
ATRIPLA (tenofovir disoproxil fumarate/ emtricitabine/ efavirenz).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg tenofovir disoproxil fumarate
(tenofovir DF) which is
equivalent to 245 mg of tenofovir disoproxil, 200 mg emtricitabine and
600 mg efavirenz.
Tenofovir DF is a white to off-white crystalline powder.
Emtricitabine is a white to off-white crystalline powder.
Efavirenz is a white to slightly pink crystalline powder.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ATRIPLA is available as film-coated tablets. The tablets are capsule
shaped and pink in colour.
Each tablet is debossed with ‘123’ on one side and plain on the
other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ATRIPLA 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
DOSAGE
_Adults:_
The recommended dose of ATRIPLA 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:_
ATRIPLA is not recommended for use in children below 18 years of
age due to insufficient data on safety and efficacy.
_Elderly:_
ATRIPLA should be administered with caution to elderly patients (see
Section 4.4
Special warnings and precautions for use).
ATRIPLA Product Information v19.0 – (18 March 2020) Page 2
DOSAGE ADJUSTMENT
_Renal impairment:_
ATRIPLA is not recommended for patients with moderate or severe renal
impairment (Creatinine Clearance (Cl
Cr
) < 50 mL/min). Patients with moderate or severe renal
impairment require do