Efavirenz/ Emtricitabine/Tenofovirdisoproxil Dr. Reddy's 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:

Dr. Reddy's Laboratories (UK) Ltd.

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:

2017-09-25

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL DR. REDDY’S 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 Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s is and
what it is used
for
2.
What you need to know before you take
Efavirenz/Emtricitabine/Tenofovirdisoproxil
Dr. Reddy’s
3.
How to take Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s
4.
Possible side effects
5.
How to store Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL DR. REDDY’S IS AND
WHAT IT IS
USED FOR
EFAVIRENZ/EMTRICITABINE/TENOFOVIRDISOPROXIL DR. REDDY’S 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/TENOFOVIRDISOPROXIL DR. REDDY’S 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
t

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s 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
Efavirenz/Emtricitabine/Tenofovirdisoproxil Dr. Reddy’s 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/Tenofovirdisoproxil Dr. Reddy’s 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,
e