Kivexa
País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Folheto informativo - Bula
(PIL)
07-03-2023
Características técnicas
(SPC)
14-07-2023
Ingredientes ativos:
Abacavir sulfate 702mg equivalent to abacavir 600 mg; ; ; Lamivudine 300mg;
Disponível em:
GlaxoSmithKline NZ Limited
DCI (Denominação Comum Internacional):
Abacavir sulfate 702 mg (equivalent to abacavir 600 mg)
Dosagem:
600mg/300mg
Forma farmacêutica:
Film coated tablet
Composição:
Active: Abacavir sulfate 702mg equivalent to abacavir 600 mg Lamivudine 300mg Excipient: Magnesium stearate Microcrystalline cellulose Opadry orange YS-1-13065A Sodium starch glycolate
Unidades em pacote:
Blister pack, PVdC x 30 tablets, 30 tablets
Classe:
Prescription
Tipo de prescrição:
Prescription
Fabricado por:
Piramal Enterprises Limited
Indicações terapêuticas:
KIVEXA is a 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.
Resumo do produto:
Package - Contents - Shelf Life: Blister pack, PVC/child resistant/senior friendly foil - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVdC - 30 tablets - 36 months from date of manufacture stored at or below 30°C
Data de autorização:
2004-02-27
Folheto informativo - Bula
KIVEXA TABLETS
1
KIVEXA TABLETS
_Film-coated tablets _
_600 mg abacavir (as sulfate) and 300 mg lamivudine _
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING KIVEXA, WHICH CONTAINS ABACAVIR, MAY DEVELOP A
HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF
TREATMENT
WITH KIVEXA IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE
ON WHETHER
YOU SHOULD STOP TAKING KIVEXA IF:
1)
YOU GET A SKIN RASH OR
2)
YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING
GROUPS:
FEVER
SHORTNESS OF BREATH, SORE THROAT OR COUGH
NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN
SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO KIVEXA
TABLETS, NEVER TAKE
KIVEXA, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (ZIAGEN,
TRIZIVIR AND
TRIUMEQ) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH
CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE KIVEXA PACK, TO REMIND YOU AND
MEDICAL STAFF
ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE
PACK AND
KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE
KIVEXA.
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you start KIVEXA tablets.
This leaflet answers some common
questions about KIVEXA tablets. It
does not contain all of the available
information.
It does not take the place of talking to
your doctor or pharmacist (also
known as a chemist).
All medicines have benefits and
risks. Your doctor has weighed the
expected benefits of you taking
KIVEXA tablets against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE TABLETS.
You may need to read it again.
WHAT KIVEXA TABLETS
ARE USED FOR
KIVEXA tablets contain abacavir
and lamivudine which belong to a
group of medicines called
antiretrovirals. These are also
available as separate medicinal
products: ZIAGEN (abacavir) and
3TC (lamivudine).
KIVEXA tablets are
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Características técnicas
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
KIVEXA abacavir and lamivudine 600 mg/300 mg film coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of abacavir as abacavir
sulfate and 300 mg
lamivudine.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Orange, film-coated, modified capsule shaped tablets, debossed with GS
FC2 on
one side. Do not halve tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
KIVEXA is a 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV
infection.
KIVEXA should not be administered to adults or adolescents who weigh
less than
40 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
dosage adjustments, such as those with creatinine clearance less than
50 mL/min.
Separate preparations of abacavir (ZIAGEN) or lamivudine (3TC) should
be
administered in cases where discontinuation or dose adjustment is
indicated. In
these cases the physician should refer to the individual product
information for these
medicinal products.
Dose
KIVEXA can be taken with or without food. Do not halve tablet.
_Adults and adolescents _
The recommended dose of KIVEXA in adults and adolescents weighing 40
kg or
more is one tablet once daily.
2
Special populations
_Elderly _
The pharmacokinetics of abacavir and lamivudine have not been studied
in patients
over 65 years of age. When treating elderly patients, consideration
needs to be
given to the greater frequency of decreased hepatic, renal and cardiac
function,
concomitant medicinal products or disease.
_Renal impairment _
Whilst no dosage adjustment of abacavir is
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