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

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Efavirenz; Emtricitabine; Tenofovir disoproxil

थमां उपलब्ध:

Teva B.V.

ए.टी.सी कोड:

J05AR; J05AR06

INN (इंटरनेशनल नाम):

Efavirenz; Emtricitabine; Tenofovir disoproxil

डोज़:

600 mg/200 mg/245 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may not be renewed (A)

चिकित्सीय क्षेत्र:

Antivirals for treatment of HIV infections, combinations; emtricitabine, tenofovir disoproxil and efavirenz

प्राधिकरण का दर्जा:

Marketed

प्राधिकरण की तारीख:

2017-03-24

सूचना पत्रक

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovir disoproxil Teva 600mg/ 200mg/ 245mg
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 plain on 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 pretreated patient

उत्पाद विशेषताएं

Health Products Regulatory Authority
09 August 2022
CRN00CV48
Page 1 of 39
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 600 mg 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
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/