ATRIPLA

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL AS

Disponibil de la:

GILEAD SCIENCES ISRAEL LTD

Codul ATC:

J05AF07

Forma farmaceutică:

FILM COATED TABLETS

Compoziție:

TENOFOVIR DISOPROXIL AS 245 MG; EMTRICITABINE 200 MG; EFAVIRENZ 600 MG

Calea de administrare:

PER OS

Tip de prescriptie medicala:

Required

Produs de:

GILEAD SCIENCES INTERNATIONAL LTD, UK

Zonă Terapeutică:

TENOFOVIR DISOPROXIL

Indicații terapeutice:

Atripla is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

Data de autorizare:

2015-09-30

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is to be supplied upon physician’s prescription only
ATRIPLA
®
FILM-COATED TABLETS
COMPOSITION:
Active ingredients:
Each tablet contains 600 mg of efavirenz, 200 mg of emtricitabine and
245 mg of tenofovir disoproxil (as
fumarate).
NON ACTIVE INGREDIENTS AND ALLERGENS:
see section 6:
"FURTHER INFORMATION"
.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE
. This leaflet contains summary information
about the medicine. If you have any other questions, refer to the
physician or the pharmacist. This medicine
has been prescribed for the treatment of your illness. Do not pass it
on to others. It may harm them even if it
seems to you that their medical condition is similar.
1.
WHAT ATRIPLA IS USED FOR?
Atripla can be used alone as a complete regimen, or in combination
with other antiretroviral medicines to
treat HIV-1 infection in adults.
THERAPEUTIC GROUP:
Antiviral for systemic use, antivirals for treatment of HIV
infections, combinations.
HIV 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)
develops.
Atripla helps block HIV-1 reverse transcriptase enzyme, a viral
chemical in your body 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 T cells (CD4+ cells), allowing your immune
system to improve. Lowering the
amount of HIV-1 in the blood lowers the chance of death or infections
that happen when your immune
system is weak (opportunistic infections).
Atripla does not cure HIV-1 infection or AIDS and you may continue to
experience illnesses associated with
HIV-1 infection, including opportunistic infections. You should remain
under the care of a physician when
using Atripla.
Atripla has not been shown to lower your chance of passing HIV-1 to
other pe

Caracteristicilor produsului

1
1.
NAME OF THE MEDICINAL PRODUCT
Atripla
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of
emtricitabine and 245 mg of
tenofovir disoproxil (as fumarate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, capsule-shaped, film-coated tablet, of dimensions 20 mm x 10.4
mm, debossed with “123” on
one side, plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ATRIPLA
®
is indicated for use alone as a complete regimen or in combination
with other
antiretroviral agents for the treatment of HIV-1 infection in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posology
_ _
_Adults_
The recommended dose of Atripla is one tablet taken orally once daily.
If a patient misses a dose of Atripla within 12 hours of the time it
is usually taken, the patient should
take Atripla as soon as possible and resume the normal dosing
schedule. If a patient misses a dose of
Atripla by more than 12 hours and it is almost time for the next dose,
the patient should not take the
missed dose and simply resume the usual dosing schedule.
If the patient vomits within 1 hour of taking Atripla, another tablet
should be taken. If the patient
vomits more than 1 hour after taking Atripla he/she does not need to
take another dose.
It is recommended that Atripla be taken on an empty stomach since food
may increase efavirenz
exposure and may lead to an increase in the frequency of adverse
reactions (see sections 4.4 and 4.8).
In order to improve the tolerability to efavirenz with respect to
undesirable effects on the nervous
system, bedtime dosing is recommended (see section 4.8).
It is anticipated that tenofovir exposure (AUC) will be approximately
30% lower following
administration of Atripla on an empty stomach as compared to the
individual component tenofovir
disoproxil when taken with food (see section 5.2). Data on the
cli