Lamivudine/Zidovudine Teva
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
21-03-2023
Fachinformation
(SPC)
21-03-2023
Öffentlichen Beurteilungsberichts
(PAR)
21-03-2023
Wirkstoff:
lamivudine, zidovudine
Verfügbar ab:
Teva Pharma B.V.
ATC-Code:
J05AR01
INN (Internationale Bezeichnung):
lamivudine, zidovudine
Therapiegruppe:
Antivirals for systemic use
Therapiebereich:
HIV Infections
Anwendungsgebiete:
Lamivudine/Zidovudine Teva is indicated in antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV) infection.
Produktbesonderheiten:
Revision: 16
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2011-02-28
Gebrauchsinformation
32
B. PACKAGE LEAFLET
Medicinal product no longer authorised
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMIVUDINE/ZIDOVUDINE TEVA 150 MG/300 MG FILM-COATED TABLETS
lamivudine/zidovudine
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 Lamivudine/Zidovudine Teva is and what it is used for
2.
What you need to know before you take Lamivudine/Zidovudine Teva
3.
How to take Lamivudine/Zidovudine Teva
4.
Possible side effects
5.
How to store Lamivudine/Zidovudine Teva
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE/ZIDOVUDINE TEVA IS AND WHAT IT IS USED FOR
LAMIVUDINE/ZIDOVUDINE TEVA IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS) INFECTION IN
ADULTS AND CHILDREN.
Lamivudine/Zidovudine Teva contains two active ingredients that are
used to treat HIV infection:
lamivudine and zidovudine. Both of these belong to a group of
anti-retroviral medicines called
_nucleoside analogue reverse transcriptase inhibitors_
(
_NRTIs_
)
_. _
_ _
Lamivudine/Zidovudine Teva does not completely cure HIV infection; it
reduces the amount of virus
in your body, and keeps it at a low level. It also increases the CD4
cell count in your blood. CD4 cells
are a type of white blood cells that are important in helping your
body to fight infection.
Not everyone responds to treatment with Lamivudine/Zidovudine Teva in
the same way. Your doctor
will monitor the effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE/ZIDOVUDINE TEVA
DO NOT TAKE LAMIVUDINE/ZIDOVUDINE TEVA
•
if you ar
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine/Zidovudine Teva
150 mg/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg lamivudine and 300 mg
zidovudine.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White, capsule shaped, biconvex, film-coated scored tablet –
engraved with “L/Z” on one side and
“150/300” on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine/Zidovudine Teva is indicated in antiretroviral combination
therapy for the treatment of
Human Immunodeficiency Virus (HIV) infection (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Lamivudine/Zidovudine Teva may be administered with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing. For patients who are unable to swallow tablets, tablets may
be crushed and added to a small
amount of semi-solid food or liquid, all of which should be consumed
immediately (see section 5.2).
Adults and adolescents weighing at least 30 kg
The recommended oral dose of Lamivudine/Zidovudine Teva is one tablet
twice daily.
Children weighing between 21 kg and 30 kg
The recommended oral dose of Lamivudine/Zidovudine Teva is one-half
tablet taken in the morning
and one whole tablet taken in the evening.
Children weighing from 14 kg to 21 kg
The recommended oral dose of Lamivudine/Zidovudine Teva is one-half
tablet taken twice daily.
The dosing regimen for paediatric patients weighing 14-30 kg is based
primarily on pharmacokinetic
modelling and supported by data from clinical studies using the
individual components lamivudine
and zidovudine. A pharmacokinetic overexposure of zidovudine can
occur, therefore close safety
monitoring is warranted in thes
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