Lamivudine Sandoz 150 mg, filmomhulde tabletten

Kraj: Holandia

Język: niderlandzki

Źródło: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Składnik aktywny:

LAMIVUDINE 0,2-WATER 150 mg/stuk

Dostępny od:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kod ATC:

J05AF05

INN (International Nazwa):

LAMIVUDINE 0,2-WATER 150 mg/stuk

Forma farmaceutyczna:

Filmomhulde tablet

Skład:

CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; ISOMALT (E 953) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; POLYSORBAAT 80 (E 433) ; TITAANDIOXIDE (E 171),

Droga podania:

Oraal gebruik

Dziedzina terapeutyczna:

Lamivudine

Podsumowanie produktu:

Hulpstoffen: CROSPOVIDON (E 1202); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); ISOMALT (E 953); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); POLYSORBAAT 80 (E 433); TITAANDIOXIDE (E 171);

Data autoryzacji:

1900-01-01

Ulotka dla pacjenta

Sandoz B.V.
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Lamivudine Sandoz 150 mg, filmomhulde tabletten
RVG 111999
V07
1.3.1.3 Bijsluiter
November 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LAMIVUDINE SANDOZ
® 150 MG, FILMOMHULDE TABLETTEN
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 of the 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[NATIONALLY COMPLETED NAME] IS USED TO TREAT HIV (HUMAN
IMMUNODEFICIENCY VIRUS) INFECTION IN
ADULTS AND CHILDREN.
The active ingredient in [Nationally completed name] is lamivudine.
[Nationally completed name] is a
type of medicine known as an anti-retroviral. It belongs to a group of
medicines called nucleoside
analogue reverse transcriptase inhibitors (NRTIs).
[Nationally completed name] 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 [Nationally completed name] in
the same way. Your doctor
will monitor the effectiveness of your treatment.
2
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [

Charakterystyka produktu

Sandoz B.V.
Page 1/15
Lamivudine Sandoz 150 mg, filmomhulde tabletten
RVG 111999
1311-V10
1.3.1.1 Samenvatting van de Productkenmerken
November 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lamivudine Sandoz 150 mg, filmomhulde tabletten
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg of lamivudine.
Excipient with known effect
Each film-coated tablet contains 261.00 mg of
isomalt (E 953).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White capsule shaped, biconvex scored film coated tablets with a
dimension of 15 x 6.5 mm, debossed
with J on one side and 16 on the other side, 1 and 6 separated by a
score line
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed Name] 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.
[Nationally completed Name] may be administered with or without food.
To ensure administration of
the entire dose, the tablet(s) should ideally be swallowed without
crushing.
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).
Alternatively, for patients who are unable to swallow tablets, the
tablet(s) 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, adolescents and children (weighing at least 25 kg): _
Sandoz B.V.
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Lamivudine Sandoz 150 mg, filmomhulde tabletten
RVG 111999
1311-V10
1.3.1.1 Samenvatting