ZIAGEN ORAL SOLUTION

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

ABACAVIR AS SULFATE

זמין מ:

GLAXO SMITH KLINE (ISRAEL) LTD

קוד ATC:

J05AF06

טופס פרצבטיות:

SOLUTION (ORAL)

הרכב:

ABACAVIR AS SULFATE 20 MG/ML

מסלול נתינה (של תרופות):

PER OS

סוג מרשם:

Required

תוצרת:

GLAXO SMITH KLINE INC., CANADA

קבוצה תרפויטית:

ABACAVIR

איזור תרפויטי:

ABACAVIR

סממני תרפויטית:

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected .28/10/2018 בקשה לשינוי משטר מינון

תאריך אישור:

2014-03-31

עלון מידע

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician's prescription only
ZIAGEN ORAL SOLUTION
EACH ML OF ZIAGEN ORAL SOLUTION CONTAINS:
ABACAVIR (AS SULFATE) 20 MG.
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 the treatment of your illness.
Do not
pass it on to others. It may harm them even if it seems to you that
their illness
is similar.
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 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
Ziagen. Read the Alert Card and patient leaflet before starting to use
the
preparation.
1.
WHAT IS THE MEDICINE INTENDED FOR?
ZIAGEN IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION.
THERAPEUTIC GROUP: 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 cells that are
im

מאפייני מוצר

Page 1 of 20
ZIAGEN TABLETS
1.
NAME OF THE MEDICINAL PRODUCT
Ziagen 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.
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.
Page 2 of 20
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): _
The recommended dose of Ziagen is 600 mg daily. This may be
administered as either
300 mg (one tablet) twice daily or 600 mg (two tablets) once daily
(see sections 4.4 and 5.1).
_Children (weighing less than 25 kg): _
Dosi