Efavirenz/Emtricitabine/Tenofovirdisoproxil Sandoz 600 mg/200 mg/245 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EFAVIRENZ ; EMTRICITABINE ; TENOFOVIRDISOPROXILSUCCINAAT SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

J05AR06

INN (Algemene Internationale Benaming):

EFAVIRENZ ; EMTRICITABINE ; TENOFOVIRDISOPROXILSUCCINAAT COMPOSITION corresponding to ; TENOFOVIRDISOPROXIL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Emtricitabine, Tenofovir Disoproxil And Efavirenz

Product samenvatting:

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);

Autorisatie datum:

2017-09-07

Bijsluiter

Sandoz B.V.
Page 1/12
Efavirenz/Emtricitabine/Tenofovirdisoproxil Sandoz 600
mg/200 mg/245 mg, filmomhulde tabletten
RVG 120143
1313-v5
1.3.1.3 Bijsluiter
Maart 2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL SANDOZ 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[NATIONALLY COMPLETED NAME] 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.
[NATIONALLY COMPLETED NAME] 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

Productkenmerken

Sandoz B.V.
Efavirenz/Emtricitabine/Tenofovirdisoproxil Sandoz 600
mg/200 mg/245 mg, filmomhulde tabletten
Page 1/57
RVG 120143
1311-v9
1.3.1.1 Samenvatting van de Productkenmerken
December 2022
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovirdisoproxil Sandoz 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
disoproxilsuccinate).
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