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

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EFAVIRENZ 600 mg/stuk ; EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILFOSFAAT 291,2 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

Beschikbaar vanaf:

Teva Nederland B.V. Swensweg 5 2031 GA HAARLEM

ATC-code:

J05AR06

INN (Algemene Internationale Benaming):

EFAVIRENZ 600 mg/stuk ; EMTRICITABINE 200 mg/stuk ; TENOFOVIRDISOPROXILFOSFAAT 291,2 mg/stuk SAMENSTELLING overeenkomend met ; TENOFOVIRDISOPROXIL 245 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; CROSPOVIDON (E 1202) ; HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463) ; HYPROLOSE (E 463) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; KARMIJN (E120) ; MACROGOL 3350 ; MANNITOL (D-) (E 421) ; NATRIUMSTEARYLFUMARAAT ; PLANTAARDIGE OLIE, GEHYDREERD ; POLOXAMEER 407 ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (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); CROSPOVIDON (E 1202); HYDROXYPROPYLCELLULOSE, LAAG GESUBSTITUEERD (E 463); HYPROLOSE (E 463); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); KARMIJN (E120); MACROGOL 3350; MANNITOL (D-) (E 421); NATRIUMSTEARYLFUMARAAT; PLANTAARDIGE OLIE, GEHYDREERD; POLOXAMEER 407; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-02-08

Bijsluiter

Efavirenz/Emtricitabine/Tenofovir disoproxil, NL/H/3688/001, 09.03.23
rvg 118677 EU PIL IB-029 met NL info tracked
PACKAGE LEAFLET
2
rvg 118677 EU PIL IB-029 met NL info tracked
PACKAGE LEAFLET: INFORMATION FOR THE USER
EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL TEVA 600/200/245 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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take use [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[PRODUCT 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.
[PRODUCT 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 months. Patients must
not have experienced failure of a
previous HIV therapy.
2.
WHAT

Productkenmerken

Efavirenz/Emtricitabine/Tenofovir disoproxil, NL/H/3688/001, 09.03.23
rvg 118677 EU SPC IB-029 met NL info tracked
SUMMARY OF PRODUCT CHARACTERISTICS
2
rvg 118677 EU SPC IB-029 met NL info tracked
1.
NAME OF THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovirdisoproxil Teva 600/200/245 mg,
filmomhulde tabletten
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 plain on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product name] 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 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
efaviren