Atripla

Land: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Efavirenz 600mg;  ;  ;  ; Emtricitabine 200mg;  ;  ;  ; Tenofovir disoproxil fumarate 300mg;  ;  ;  

Fáanlegur frá:

Gilead Sciences (NZ)

INN (Alþjóðlegt nafn):

Efavirenz 600 mg

Lyfjaform:

Film coated tablet

Samsetning:

Active: Efavirenz 600mg       Emtricitabine 200mg       Tenofovir disoproxil fumarate 300mg       Excipient: Croscarmellose sodium Hyprolose Magnesium stearate Microcrystalline cellulose Opadry pink 85F94172 Purified water Sodium laurilsulfate

Einingar í pakka:

Bottle, HDPE white, 30 tablets

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

BASF Orgamol Pharma Solutions France SAS

Ábendingar:

ATRIPLA is indicated for the treatment of HIV infected adults over the age of 18 years, alone or in combination with other antiretroviral agents.

Vörulýsing:

Package - Contents - Shelf Life: Bottle, HDPE white - 30 tablets - 48 months from date of manufacture stored at or below 30°C

Leyfisdagur:

2008-09-17

Upplýsingar fylgiseðill

ATRIPLA CMI v14.0 – (05 June 2019)
Page 1
ATRIPLA
® TABLETS
_300_
_ _
_mg tenofovir disoproxil fumarate / 200 mg emtricitabine/ 600 mg
efavirenz _
CONSUMER MEDICINE INFORMATION
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 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). AT

Vara einkenni

ATRIPLA Data Sheet 15.0 (19 May 2020) Page 1
DATA SHEET
1. ATRIPLA
®
(TENOFOVIR DISOPROXIL FUMARATE, EMTRICITABINE AND
EFAVIRENZ) TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
300 mg tenofovir disoproxil fumarate/200 mg emtricitabine/600 mg
efavirenz tablets.
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
ATRIPLA 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, alone or
in combination with other antiretroviral agents
4.2 DOSE AND METHOD OF ADMINISTRATION
_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.
_PAEDIATRIC PATIENTS:_
ATRIPLA is not recommended for use in children below 18 years of age
due to insufficient data on safety and efficacy.
SPECIAL POPULATIONS
_ELDERLY:_
ATRIPLA should be administered with caution to elderly patients (see
section 4.4
Special warnings and precautions for use).
_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 dose interval adjustments of tenofovir disoproxil
fumarate (tenofovir DF) and
emtricitabine that cannot be achieved with the combination tablet (see
section 4.4 Special
warnings and precautions for use).
The safety and efficacy of once daily dosing of tenofovir DF with
emtricitabine in patients with
mild renal impairment (Cl
Cr
50 to 80 mL/min), have been demonstrated in clinical studies. No
dosage adjustment is recommended for patients with renal impairment
who receive efavirenz.
Therefore no dosage adjustment is required for ATRIPLA in patients
with mild renal impairment.
_ _
ATRIPLA Data Sheet 15.0 (19 May 2020) Page 2
_HEPATIC IMPAIRM