KIVEXA

Երկիր: Իսրայել

Լեզու: անգլերեն

Աղբյուրը: Ministry of Health

Ակտիվ բաղադրիչ:

ABACAVIR AS SULFATE; LAMIVUDINE

Հասանելի է:

GLAXO SMITH KLINE (ISRAEL) LTD

Դեղագործական ձեւ:

FILM COATED TABLETS

Կազմը:

ABACAVIR AS SULFATE 600 MG; LAMIVUDINE 300 MG

Կառավարման երթուղին:

PER OS

Ռեկվիզորի տեսակը:

Required

Պատրաստված է:

GLAXO WELLCOME SA, SPAIN

Թերապեւտիկ ցուցումներ:

Kivexa is a fixed-dose combination of two nucleoside analogues (abacavir and lamivudine). It is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age.28/10/2018 עדכון התוויה: Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and, adolescents s of and children weighing at least 25 kg.שינוי משטר מינון: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 children who weigh less than 25 kg because it is a fixed dose tablet that cannot be dose reduced.Paediatric population: The safety and efficacy of Kivexa in children weighing less than 25 kg has not been established. Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on posology can be made.

Հաստատման ամսաթիվը:

2017-07-23

Տեղեկատվական թերթիկ

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
KIVEXA
EACH FILM-COATED TABLET CONTAINS 600 MG ABACAVIR (AS SULFATE) AND
300 MG LAMIVUDINE.
A list of the additional ingredients is detailed in section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise information about the medicine. If you have
any
other questions, refer to the physician or the pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It
may harm them even if it seems to you that their medical condition is
similar.
IMPORTANT - HYPERSENSITIVITY REACTIONS
KIVEXA
CONTAINS
ABACAVIR
(which
is
also
an
active
ingredient
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 the medical
staff about abacavir hypersensitivity. DETACH THIS CARD AND KEEP IT
WITH
YOU AT ALL TIMES.
This card contains important safety information that you must know and
abide by before starting treatment and during the course of treatment
with Kivexa. Read the alert card and patient leaflet before starting
to use
the preparation.
1.
WHAT IS THE MEDICINE INTENDED FOR?
KIVEXA IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY SYNDROME)
INFECTION IN ADULTS, ADOLESCENTS AND IN CHILDREN WEIGHING AT LEAST
25 KG.
THERAPEUTIC GROUP: 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.

Ապրանքի հատկությունները

1
_The format of this leaflet was determined by the Ministry of Health
and its content was checked _
_and approved in January 2019 _
_ _
KIVEXA
1.
NAME OF THE MEDICINAL PRODUCT
Kivexa
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: sunset yellow (E110) 1.7 mg per tablet
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.
2
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.
_Special Populations _
_ _
_Elderly:_
No pharmacokinetic data are currently available in patients over 65
years of age. Special care
is advised in