ZIAGEN TABLETS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ABACAVIR AS SULFATE

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J05AF06

Pharmaceutical form:

FILM COATED TABLETS

Composition:

ABACAVIR AS SULFATE 300 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

VIIV HEALTHCARE UK LIMITED, UK

Therapeutic area:

ABACAVIR

Therapeutic indications:

Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected .

Authorization date:

2023-11-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician s prescription only
ZIAGEN TABLETS, 300 mg
Film-coated tablets
Each tablet contains abacavir (as sulfate) 300 mg
For the list of the inactive and allergenic ingredients in the
medicine, see section 2 –
Important information about some of the ingredients in the medicine
and section 6
– Additional information .
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions, refer
to the physician or 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
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 preparations.
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 syndrome)
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,

Summary of Product characteristics

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 engr
aved with ‘GX 623’ on
both sides.
The tablet can be divided into equal halves.
PATIENT ALERT CARD
The marketing of Ziagen Tablets is subject to risk management plan
(RMP) including a
"Patient Alert card". The "Patient Alert card", emphasizes important
safety information that
the patient should be aware of before and during treatment.
Please explain to the patient the need to review the card before
starting treatment.
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.
Page 2 of 20
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 o