Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

efavirenz, emtricitabine, tenofovir disoproxil, phosphate

Tilgængelig fra:

Zentiva k.s.

ATC-kode:

J05AR06

INN (International Name):

efavirenz / emtricitabine / tenofovir disoproxil

Terapeutisk gruppe:

Antivirals for systemic use,

Terapeutisk område:

HIV Infections

Terapeutiske indikationer:

Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva prior to initiation of their first antiretroviral treatment regimen., The demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil 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 efavir

Produkt oversigt:

Revision: 2

Autorisation status:

Authorised

Autorisation dato:

2017-07-17

Indlægsseddel

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA 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 Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is and what
it is used for
2.
What you need to know before you take
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
3.
How to take Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
4.
Possible side effects
5.
How to store Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA IS AND WHAT
IT IS USED FOR
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA 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.
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL ZENTIVA 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 H

Produktets egenskaber

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF
THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva 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 tenofovir disoproxil
phosphate equivalent to 245 mg of tenofovir disoproxil.
Excipient with known effect: each tablet contains a maximum of 10.96
mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, oval biconvex film coated tablet of dimensions approx. 20.0 x
10.7 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a f
ixed-dose combination of efavirenz,
emtricitabine and tenofovir disoproxil. 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 resist
ance to any of the
t
hree components contained in Efavirenz/Emtricitabine/Tenofovir
disoproxil Zentiva prior to initiation
of their first antiretroviral treatment regimen (see sections 4.4 and
5.1).
The demonstration o
f the benefit of the combination efavirenz/emtricitabine/tenofovir
disoproxil 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
efavirenz/emtricitabine/tenofovir
disoproxil (see section 5.1). No data are currently available from
clinical studies with combination
efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in
heavily pretreated patients.
No data are available to support the combination of
efavirenz/emtricitabin