Ziagen
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
09-01-2024
Charakterystyka produktu
(SPC)
09-01-2024
Sprawozdanie z oceny publicznego
(PAR)
28-07-2020
Składnik aktywny:
abacavir
Dostępny od:
ViiV Healthcare B.V.
Kod ATC:
J05AF06
INN (International Nazwa):
abacavir
Grupa terapeutyczna:
Antivirals for systemic use
Dziedzina terapeutyczna:
HIV Infections
Wskazania:
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children.The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy.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.
Podsumowanie produktu:
Revision: 47
Status autoryzacji:
Authorised
Data autoryzacji:
1999-07-08
Ulotka dla pacjenta
51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIAGEN 300 MG FILM-COATED TABLETS
abacavir
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
ZIAGEN CONTAINS ABACAVIR
(which is also an active substance in medicines such as
KIVEXA, TRIUMEQ
and
TRIZIVIR
). 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 Ziagen 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 Ziagen is and what it is used for
2.
What you need to know before you take Ziagen
3.
How to take Ziagen
4.
Possible side effects
5.
How to store Ziagen
6.
Contents of the pack and other information
1.
WHAT ZIAGEN IS AND WHAT IT IS USED FOR
ZIAGEN IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION.
Ziagen contains the active ingredient abacavir. Abacavir belongs to a
group of anti-retroviral
medicines called
_nucleoside analogue reverse transcriptase inhibitors (NRTIs)_
.
Ziagen 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
cell that are important in helping your body to fight infect
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Ziagen 300 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of abacavir (as sulfate).
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablets)
The scored tablets are yellow, biconvex, capsule shaped and are
engraved with ‘GX 623’ on both
sides.
The tablet can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ziagen is indicated in antiretroviral combination therapy for the
treatment of Human
Immunodeficiency Virus (HIV) infection in adults, adolescents and
children (see sections 4.4 and
5.1).
The demonstration of the benefit of Ziagen is mainly based on results
of studies performed with a
twice daily regimen, in treatment-naïve adult patients on combination
therapy (see section 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
Ziagen should be prescribed by physicians experienced in the
management of HIV infection.
Ziagen can be taken with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed without
crushing.
Ziagen is also available as an oral solution for use in children over
three months of age and weighing
less than 14 kg and for those patients for whom the tablets are
inappropriate.
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): _
3
The recommended dose of Ziagen is 600 mg daily. This may be
administered as either 300 mg (one
tablet) twice daily or 600 mg (tw
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