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:

GLAXO SMITH KLINE PHARMACEUTICALS S.A., POLAND

Therapeutic group:

ABACAVIR

Therapeutic area:

ABACAVIR

Therapeutic indications:

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

Authorization date:

2013-11-30

Patient Information leaflet

לפוטמל הרהזא סיטרכ – בושח
תוילבט )abacavir sulfate( ןגאיז
)lamivudine/ dolutegravir/ abacavir( קמוירט
תוילבט
ןמזה לכ ךתיא הז סיטרכ אש
םילפוטמהמ קלח ,ריוקבא םיליכמ קמוירט
/ןגאיזו תויה
תושיגר תבוגת חתפל םייושע קמוירט /ןגאיז
םיחקולה תויהל הלוכי וז הבוגת .)הרומח תיגרלא
הבוגת( רתי
.ךישממ קמוירט /ןגאיזב לופיטה םא םייח
תנכסמ ךילע םאה תוצעייתהל
דימ ךלש אפורל הנפ
:םא קמוירט /ןגאיז תחקל קיספהל
וא רועב החירפ חתפמ התא )1 תוחפל ךותמ רתוי וא דחא ןימסת חתפמ התא )2
תואבה תוצובקה ןיבמ 2
םוח -
לועיש וא ןורג באכ ,המישנ רצוק -
ןטב באכ וא לושלש וא האקה וא הליחב -
תיללכ ילוח תשגרה וא םיבאכ וא השק
תופייע -
IMPORTANT – PATIENT ALERT CARD
Ziagen (abacavir sulfate) Tablets
Triumeq (lamivudine/ dolutegravir/ abacavir)
Tablets
Carry this card with you at all times
Since Ziagen/ Triumeq contain abacavir,
some patients taking Ziagen/ Triumeq may
develop a hypersensitivity reaction (serious
allergic reaction). This reaction CAN BE
LIFE-THREATENING if treatment with Ziagen/
Triumeq is continued.
CONTACT YOUR DOCTOR IMMEDIATELY FOR
ADVICE ON WHETHER YOU SHOULD STOP TAKING
ZIAGEN/ TRIUMEQ IF:
1)
YOU GET A SKIN RASH OR
2)
YOU GET ONE OR MORE SYMPTOMS FROM AT
LEAST 2 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
feeling ill
A. Card v4B 20376
جلاعتملل ريذحت ةقاطب ـ ماه
صارقأ )abacavir sulfate( نچايز
(lamivudine/ dolutegravir/ abacavir( ك
ِ
مويرت
صارقأ
تقولا لاوط كعم ةقاطبلا هذه لمحإ
نيجلاعتملا ضعب نإف ،ريڤاكابأ ىلع ك
ِ

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
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