Combivir

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

lamivudine, zidovudine

Saatavilla:

ViiV Healthcare BV

ATC-koodi:

J05AR01

INN (Kansainvälinen yleisnimi):

lamivudine, zidovudine

Terapeuttinen ryhmä:

Antivirals for systemic use

Terapeuttinen alue:

HIV Infections

Käyttöaiheet:

Combivir is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection.,

Tuoteyhteenveto:

Revision: 37

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

1998-03-18

Pakkausseloste

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
COMBIVIR 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 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 Combivir is and what it is used for
2.
What you need to know before you take Combivir
3.
How to take Combivir
4.
Possible side effects
5.
How to store Combivir
6.
Contents of the pack and other information
1.
WHAT COMBIVIR IS AND WHAT IT IS USED FOR
COMBIVIR IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS AND CHILDREN.
Combivir contains two active ingredients that are used to treat HIV
infection: lamivudine and
zidovudine. Both of these belong to a group of antiretroviral
medicines called
_nucleoside analogue _
_reverse transcriptase inhibitors_
(
_NRTIs_
)
_. _
_ _
Combivir 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 Combivir in the same way. Your
doctor will monitor the
effectiveness of your treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE COMBIVIR
DO NOT TAKE COMBIVIR:
•
if you are ALLERGIC
to lamivudine or zidovudine, or any of the other ingredients of this
medicine
_ _
(listed in section 6)
•
if you have A VERY LOW RED BLOOD CELL COUNT
(
_anaemia_
)
_ _
or
A
VERY LOW WHITE BLOOD CELL
COUNT
(
_neutrop

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Combivir 150 mg/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 150 mg lamivudine and 300 mg
zidovudine.
Excipient(s) with known effect:
Each 150/300 mg tablet contains 0.945 mg sodium.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, capsule-shaped film-coated scored tablets engraved
with “GXFC3” on both sides.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Combivir 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.
Combivir 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 dose of Combivir is one tablet twice daily.
Children weighing between 21 kg and 30 kg
The recommended oral dose of Combivir 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 Combivir 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 these patients. If gastrointestinal
intolerance occurs in patients weighing
3
21-30 kg, an alternative dosing schedule with one-half tablet taken
th