Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 600 mg/200 mg/245 mg Film-coated Tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

TENOFOVIR DISOPROXIL, EFAVIRENZ, EMTRICITABINE

Inapatikana kutoka:

Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands

ATC kanuni:

J05AR06

INN (Jina la Kimataifa):

TENOFOVIR DISOPROXIL 245 mg EFAVIRENZ 600 mg EMTRICITABINE 200 mg

Dawa fomu:

FILM-COATED TABLET

Tungo:

TENOFOVIR DISOPROXIL 245 mg EFAVIRENZ 600 mg EMTRICITABINE 200 mg

Dawa ya aina:

POM

Eneo la matibabu:

ANTIVIRALS FOR SYSTEMIC USE

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2017-02-02

Taarifa za kipeperushi

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

Tabia za bidhaa

Page 1 of 45
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 600 mg/200 mg/245 mg
Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600mg of efavirenz, 200 mg of
emtricitabine and 245 mg of tenofovir
disoproxil (equivalent to 291.22 mg of tenofovir disoproxil phosphate
or 136 mg of tenofovir).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval shaped film coated tablet, approximately 23mm x 11mm x 8mm,
debossed with “TEE” on
one side of the tablet and plainon the other side of the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Efavirenz/Emtricitabine/Tenofovir disoproxil Teva is a fixed-dose
combination of efavirenz,
emtricitabine and tenofovir disoproxil phosphate. 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 Teva prior to initiation
of their first antiretroviral
treatment regimen (see sections 4.4 and 5.1).
The demonstration of the benefit of the fixed-dose combination of
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 the fixed-dose combination
of efavirenz/emtricitabine/tenofovir disoproxil (see section 5.1). No
data are currently available from
clinical studies with the fixed-dose combination of
efavirenz/emtricitabine/tenofovir disoproxil in
treatment-naïve or in heavily pretreate