Lamivudine Teva Pharma B.V.
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
21-04-2023
Fachinformation
(SPC)
21-04-2023
Öffentlichen Beurteilungsberichts
(PAR)
06-10-2016
Wirkstoff:
lamivudine
Verfügbar ab:
Teva B.V.
ATC-Code:
J05AF05
INN (Internationale Bezeichnung):
lamivudine
Therapiegruppe:
Antivirals for systemic use
Therapiebereich:
HIV Infections
Anwendungsgebiete:
Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.
Produktbesonderheiten:
Revision: 19
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2009-12-10
Gebrauchsinformation
33
B. PACKAGE LEAFLET
34
PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMIVUDINE TEVA PHARMA B.V. 150 MG FILM-COATED TABLETS
lamivudine
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 Teva Pharma B.V. is and what it is used for
2.
What you need to know before you take Lamivudine Teva Pharma B.V.
3.
How to take Lamivudine Teva Pharma B.V.
4.
Possible side effects
5.
How to store Lamivudine Teva Pharma B.V.
6.
Contents of the pack and other information
1.
WHAT LAMIVUDINE TEVA PHARMA B.V. IS AND WHAT IT IS USED FOR
LAMIVUDINE TEVA PHARMA B.V. IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS AND CHILDREN.
The active ingredient in Lamivudine Teva Pharma B.V. is lamivudine.
Lamivudine Teva Pharma B.V.
is a type of medicine known as an antiretroviral. It belongs to a
group of medicines called
_nucleoside _
_analogue reverse transcriptase inhibitors (NRTIs)_
.
Lamivudine Teva Pharma B.V. 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 Teva Pharma B.V. in
the same way. Your doctor
will monitor the effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LAMIVUDINE TEVA PHARMA B.V.
DO NOT TAKE LAMIVUDINE TEVA PHARMA B.V.
•
if you are
ALLERGIC
to lamivudine or any of the other ingredients of
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets
Lamivudine Teva Pharma B.V. 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets
Each film-coated tablet contains 150 mg lamivudine.
Lamivudine Teva Pharma B.V. 300 mg film-coated tablets
Each film-coated tablet contains 300 mg lamivudine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Lamivudine Teva Pharma B.V. 150 mg film-coated tablets
Light grey, diamond shaped, biconvex film-coated tablet with approx.
14.5 mm length and 7.0 mm
width – engraved with “L 150” and breakline on one side and
breakline on the other.
The tablet can be divided into equal doses.
Lamivudine Teva Pharma B.V. 300 mg film-coated tablets
Grey, diamond shaped, biconvex film-coated tablet with approx. 18.0 mm
length and 8.0 mm width –
engraved with “L 300” on one side and plain on the other
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral
combination therapy for the
treatment of Human Immunodeficiency Virus (HIV) infected adults and
children.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The therapy should be initiated by a physician experienced in the
management of HIV infection.
Lamivudine is also available as an oral solution for children over
three months of age and who weigh
less than 14 kg or for patients who are unable to swallow tablets (see
section 4.4).
Patients changing between lamivudine oral solution and lamivudine
tablets should follow the dosing
recommendations that are specific for the formulation (see section
5.2)
Posology
_Adults, adolescents and children (weighing at least 25 kg) _
The recommended dose of lamivudine is 300 mg daily. This may be
administered as either 150 mg
twice daily or 300 mg once daily (see section 4.4).
The 300 mg tablet is only suitable for the once a day regimen.
_Children
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