Sustiva
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
14-03-2024
Fachinformation
(SPC)
14-03-2024
Öffentlichen Beurteilungsberichts
(PAR)
26-01-2018
Wirkstoff:
efavirenz
Verfügbar ab:
Bristol-Myers Squibb Pharma EEIG
ATC-Code:
J05AG03
INN (Internationale Bezeichnung):
efavirenz
Therapiegruppe:
Antivirals for systemic use
Therapiebereich:
HIV Infections
Anwendungsgebiete:
Sustiva is indicated in antiviral combination treatment of human-immunodeficiency-virus-1 (HIV-1)-infected adults, adolescents and children three years of age and older.Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease-inhibitor (PI)-containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI-based combination therapy after failure of regimens containing Sustiva.
Produktbesonderheiten:
Revision: 48
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
1999-05-28
Gebrauchsinformation
85
B. PACKAGE LEAFLET
Medicinal product no longer authorised
86
PACKAGE LEAFLET: INFORMATION FOR THE USER
SUSTIVA 50 MG HARD CAPSULES
efavirenz
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, pharmacist or
nurse.
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What SUSTIVA is and what it is used for
2.
What you need to know before you take SUSTIVA
3.
How to take SUSTIVA
4.
Possible side effects
5.
How to store SUSTIVA
6.
Contents of the pack and other information
1.
WHAT SUSTIVA IS AND WHAT IT IS USED FOR
SUSTIVA, which contains the active substance efavirenz, belongs to a
class of antiretroviral
medicines called non-nucleoside reverse transcriptase inhibitors
(NNRTIs). It is an
ANTIRETROVIRAL
MEDICINE THAT FIGHTS HUMAN IMMUNODEFICIENCY VIRUS
(HIV-1) infection by reducing the amount of
the virus in blood. It is used by adults, adolescents and children 3
months of age and older and
weighing at least 3.5 kg.
Your doctor has prescribed SUSTIVA for you because you have HIV
infection.
SUSTIVA taken in combination with other antiretroviral medicines
reduces the amount of the virus in
the blood. This will strengthen your immune system and reduce the risk
of developing illnesses linked
to HIV infection.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SUSTIVA
DO NOT TAKE SUSTIVA
IF YOU ARE ALLERGIC
to efavirenz or any of the other ingredients of this medicine (listed
in section
6). Contact your doctor or pharmacist for advice.
IF YOU HAVE SEVERE LIVER DISEASE.
IF YOU HAVE A HEART CONDITION, SUCH AS CHANGES IN THE RHYTHM OR RATE
OF THE HEARTBEAT
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
SUSTIVA 50 mg hard capsules
SUSTIVA 100 mg hard capsules
SUSTIVA 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SUSTIVA 50 mg hard capsules
Each hard capsule contains 50 mg of efavirenz.
Excipient with known effect
Each hard capsule contains 28.5 mg of lactose (as monohydrate).
SUSTIVA 100 mg hard capsules
Each hard capsule contains 100 mg of efavirenz.
Excipient with known effect
Each hard capsule contains 57.0 mg of lactose (as monohydrate).
SUSTIVA 200 mg hard capsules
Each hard capsule contains 200 mg of efavirenz.
Excipient with known effect
Each hard capsule contains 114.0 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
SUSTIVA 50 mg hard capsules
Dark yellow and white, printed with "SUSTIVA" on the dark yellow cap
and "50 mg" on the white
body.
SUSTIVA 100 mg hard capsules
White, printed with "SUSTIVA" on the body and "100 mg" on the cap.
SUSTIVA 200 mg hard capsules
Dark yellow, printed with "SUSTIVA" on the body and "200 mg" on the
cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SUSTIVA is indicated in antiviral combination treatment of human
immunodeficiency virus-1 (HIV-
1) infected adults, adolescents and children 3 months of age and older
and weighing at least 3.5 kg.
SUSTIVA has not been adequately studied in patients with advanced HIV
disease, namely in patients
with CD4 counts < 50 cells/mm
3
, or after failure of protease inhibitor (PI) containing regimens.
Although cross-resistance of efavirenz with PIs has not been
documented, there are at present
insufficient data on the efficacy of subsequent use of PI based
combination therapy after failure of
regimens containing SUSTIVA.
Medicinal product no longer authorised
3
For a summary of clinical and pharmacodynamic information, see section
5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienc
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