Kivexa
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
27-11-2023
Valmisteyhteenveto
(SPC)
27-11-2023
Julkisesta arviointikertomuksesta
(PAR)
23-07-2020
Aktiivinen ainesosa:
abacavir, lamivudine
Saatavilla:
ViiV Healthcare BV
ATC-koodi:
J05AR02
INN (Kansainvälinen yleisnimi):
abacavir, lamivudine
Terapeuttinen ryhmä:
Antivirals for treatment of HIV infections, combinations, Antivirals for systemic use
Terapeuttinen alue:
HIV Infections
Käyttöaiheet:
Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Tuoteyhteenveto:
Revision: 37
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2004-12-16
Pakkausseloste
40
B. PACKAGE LEAFLET
41
PACKAGE LEAFLET: INFORMATION FOR THE USER
KIVEXA 600 MG/300 MG FILM-COATED TABLETS
abacavir/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.
IMPORTANT — HYPERSENSITIVITY REACTIONS
KIVEXA CONTAINS ABACAVIR
(which is also an active substance in medicines such as
TRIZIVIR, TRIUMEQ
and
ZIAGEN
). Some people who take abacavir may develop a
HYPERSENSITIVITY REACTION
(a serious
allergic reaction), which can be life-threatening if they continue to
take abacavir containing products.
YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY
REACTIONS’ IN THE PANEL IN
SECTION 4
.
The Kivexa pack includes an
ALERT CARD
, to remind you and medical staff about abacavir
hypersensitivity.
DETACH THIS CARD AND KEEP IT WITH YOU AT ALL TIMES
.
WHAT IS IN THIS LEAFLET
1.
What Kivexa is and what it is used for
2.
What you need to know before you take Kivexa
3.
How to take Kivexa
4.
Possible side effects
5.
How to store Kivexa
6.
Contents of the pack and other information
1.
WHAT KIVEXA IS AND WHAT IT IS USED FOR
KIVEXA IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
IN ADULTS, ADOLESCENTS AND
IN CHILDREN WEIGHING AT LEAST 25 KG.
Kivexa contains two active ingredients that are used to treat HIV
infection: abacavir and lamivudine.
These belong to a group of anti-retroviral medicines called
_nucleoside analogue reverse transcriptase _
_inhibitors (NRTIs)_
.
Kivexa does not completely cure HIV infection; it reduces the amount
of virus in your body, and keeps
it at a low level. It also incr
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kivexa 600 mg/300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and
300 mg lamivudine.
Excipient(s) with known effect:
Each 600 mg/300 mg tablet contains 1.7 mg sunset yellow FCF (E110) and
2.31 mg sodium.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Orange, film-coated, modified capsule shaped tablets, debossed with GS
FC2 on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Kivexa is indicated in antiretroviral combination therapy for the
treatment of Human
Immunodeficiency Virus (HIV) infection in adults, adolescents and
children weighing at least 25 kg
(see sections 4.4 and 5.1).
Before initiating treatment with abacavir, screening for carriage of
the HLA-B*5701 allele should be
performed in any HIV-infected patient, irrespective of racial origin
(see section 4.4). Abacavir should
not be used in patients known to carry the HLA-B*5701 allele.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be prescribed by a physician experienced in the
management of HIV infection.
Posology
_Adults, adolescents and children weighing at least 25 kg_
The recommended dose of Kivexa is one tablet once daily.
_Children Under 25 kg _
Kivexa should not be administered to children who weigh less than 25
kg because it is a fixed-dose
tablet that cannot be dose reduced.
Kivexa is a fixed-dose tablet and should not be prescribed for
patients requiring dose adjustments.
Separate preparations of abacavir or lamivudine are available in cases
where discontinuation or dose
adjustment of one of the active substances is indicated. In these
cases the physician should refer to the
individual product information for these medicinal products.
3
Special Populations
_ _
_Elderly_
No pharmacokinetic data are currently available in patients over 65
years of age. Special care is
advised in this age group due to
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