Efavirenz/Emtricitabine/Tenofovir Disoproxil Clonmel 600 mg/200 mg/245 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Efavirenz; Emtricitabine; Tenofovir disoproxil

제공처:

Clonmel Healthcare Ltd

ATC 코드:

J05AR; J05AR06

INN (International Name):

Efavirenz; Emtricitabine; Tenofovir disoproxil

복용량:

600 mg/200 mg/245 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

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

치료 영역:

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

승인 상태:

Marketed

승인 날짜:

2017-12-22

환자 정보 전단

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL CLONMEL 600 MG/200 MG/245
MG FILM-COATED
TABLETS
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/Tenofovir Disoproxil Clonmel is and what
it is used for
2.
What you need to know before you take
Efavirenz/Emtricitabine/Tenofovir Disoproxil Clonmel
3.
How to take Efavirenz/Emtricitabine/Tenofovir Disoproxil Clonmel
4.
Possible side effects
5.
How to store Efavirenz/Emtricitabine/Tenofovir Disoproxil Clonmel
6.
Contents of the pack and other information
1.
WHAT EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL CLONMEL IS AND WHAT
IT IS USED FOR
EFAVIRENZ/EMTRICITABINE/TENOFOVIR DISOPROXIL CLONMEL 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/TENOFOVIR DISOPROXIL CLONMEL 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
infectio

제품 특성 요약

Health Products Regulatory Authority
28 October 2022
CRN00CZTH
Page 1 of 46
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Efavirenz/Emtricitabine/Tenofovir Disoproxil Clonmel 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 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/Tenofovir Disoproxil Clonmel 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/Tenofovir Disoproxil Clonmel
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