Atripla 600mg200mg245mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Efavirenz; Tenofovir disoproxil fumarate; Emtricitabine

Tilgjengelig fra:

Gilead Sciences International Ltd

ATC-kode:

J05AR06

INN (International Name):

Efavirenz; Tenofovir disoproxil fumarate; Emtricitabine

Dosering :

600mg ; 245mg ; 200mg

Legemiddelform:

Tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05030100; GTIN: 5391507140029

Informasjon til brukeren

1
B. PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATRIPLA 600 MG/200 MG/245 MG FILM-COATED TABLETS
Efavirenz/emtricitabine/tenofovir disoproxil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Atripla is and what it is used for
2.
What you need to know before you take Atripla
3.
How to take Atripla
4.
Possible side effects
5.
How to store Atripla
6.
Contents of the pack and other information
1.
WHAT ATRIPLA IS AND WHAT IT IS USED FOR
ATRIPLA CONTAINS THREE ACTIVE SUBSTANCES that are used to treat human
immunodeficiency virus
(HIV) infection:
-
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI)
-
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI)
-
Tenofovir is a nucleotide reverse transcriptase inhibitor (NtRTI)
Each of these active substances, also known as antiretroviral
medicines, work by interfering with an
enzyme (reverse transcriptase) that is essential for the virus to
multiply.
ATRIPLA IS A TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV)
infection in adults aged 18 years
and over who have previously been treated with other antiretroviral
medicines and have their HIV-1
infection under control for at least three months. Patients must not
have experienced failure of a
previous HIV therapy.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATRIPLA
DO NOT TAKE ATRIPLA
-
IF YOU ARE ALLERGIC to efavirenz, emtricitabine, tenofovir, tenofovir
disoproxil fumarate or any of
the other ingredients of this medicine (listed in section 6).
-
IF YOU HAVE SEV

Preparatomtale

OBJECT 1
ATRIPLA 600 MG/200 MG/245 MG FILM COATED TABLETS
Summary of Product Characteristics Updated 25-Apr-2018 | Gilead
Sciences Ltd
1. Name of the medicinal product
Atripla 600 mg/200 mg/245 mg film-coated tablets
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).
Excipient with known effect
Each film-coated tablet contains 1 mmol (23.6 mg) of sodium.
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 a fixed-dose combination of efavirenz, emtricitabine and
tenofovir disoproxil fumarate. It is
indicated for the treatment of human immunodeficiency virus-1 (HIV-1)
infection in adults aged 18 years
and over with virologic suppression to HIV-1 RNA levels of < 50
copies/ml on their current combination
antiretroviral therapy for more than three months. Patients must not
have experienced virological failure
on any prior antiretroviral therapy and must be known not to have
harboured virus strains with mutations
conferring significant resistance to any of the three components
contained in Atripla prior to initiation of
their first antiretroviral treatment regimen (see sections 4.4 and
5.1).
The demonstration of the benefit of Atripla is primarily based on
48-week data from a clinical study in
which patients with stable virologic suppression on a combination
antiretroviral therapy changed to
Atripla (see section 5.1). No data are currently available from
clinical studies with Atripla in treatment-
naïve or in heavily pretreated patients.
No data are available to support the combination of Atripla and other
antiretroviral agents.
4.2 Posology and method of administration
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Posol