Efatriten 600 mg/200 mg/245 mg, filmomhulde tabletten

Country: Holland

Tungumál: hollenska

Heimild: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Virkt innihaldsefni:

EFAVIRENZ 600 mg/stuk ; EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILSUCCINAAT 300,6 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

Fáanlegur frá:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC númer:

J05AR06

INN (Alþjóðlegt nafn):

EFAVIRENZ 600 mg/stuk ; EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILSUCCINAAT 300,6 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

Lyfjaform:

Filmomhulde tablet

Samsetning:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; POLOXAMEER 407 ; POLYVINYLALCOHOL (E 1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROLOSE (E 463) ; IJZEROXIDE ROOD (E 172) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; POLOXAMEER 407 ; POLYVINYLALCOHOL (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Stjórnsýsluleið:

Oraal gebruik

Lækningarsvæði:

Emtricitabine, Tenofovir Disoproxil And Efavirenz

Vörulýsing:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROLOSE (E 463); IJZEROXIDE ROOD (E 172); IJZEROXIDE ZWART (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); NATRIUMLAURILSULFAAT (E 487); POLOXAMEER 407; POLYVINYLALCOHOL (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);

Leyfisdagur:

2017-09-25

Upplýsingar fylgiseðill

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFATRITEN 600 MG/200 MG/245 MG, FILMOMHULDE TABLETTEN
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 is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IS AND WHAT IT IS USED FOR

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.
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
DO NOT TAKE
•
IF YOU ARE ALLERGIC to efavirenz, emtricitabine, tenofovir, tenofovir
disoproxil or any of the
other ingredients of t

Vara einkenni

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Efatriten 600 mg/200 mg/245 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of efavirenz, 200 mg of
emtricitabine and 245 mg of
tenofovir disoproxil (equivalent to 300.6 mg tenofovir disoproxil
succinate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Pink, capsule-shaped film-coated tablets, plain on both sides, with
dimensions 11 mm x
22 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS

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
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
pretreated patients.
No data are available to support the combination of efavirenz,
emtricitabine and tenofovir
disoproxil and other antiretroviral agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be ini