JULUCA

Country: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

DOLUTEGRAVIR AS SODIUM; RILPIVIRINE AS HYDROCHLORIDE

Fáanlegur frá:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC númer:

J05AR21

Lyfjaform:

FILM COATED TABLETS

Samsetning:

RILPIVIRINE AS HYDROCHLORIDE 25 MG; DOLUTEGRAVIR AS SODIUM 50 MG

Stjórnsýsluleið:

PER OS

Gerð lyfseðils:

Required

Framleitt af:

GLAXO WELLCOME SA, SPAIN

Lækningarsvæði:

DOLUTEGRAVIR AND RILPIVIRINE

Ábendingar:

Juluca is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least six months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor

Leyfisdagur:

2023-12-31

Upplýsingar fylgiseðill

ربكأ
ً
ايئاود
ً
ارادقم أطخلاب تلوانﺗ اذإ
ً
لااح هجوﺗ ،اكولوج صارقأ نم مزلالا نم
رثكأ أطخلاب تلوانت اذإ
.نكمأ اذإ اكولوج ةبلع مهيرأ .كب صاخلا
يلديصلا وأ بيبطلا ىلإ
ةفرغل وأ بيبطلا ىلإ
ً
لااح هجوت ،ءاودلا نم أطخلاب لفط علب
اذإ
.ءاودلا ةبلع كعم رضحأو ىفشتسملا يف
ئراوطلا
ءاودلا اذه لوانﺗ تيسن اذإ
لوانت دعوم نم ةعاس 12 للاخ رملأا اذهل
كتظحلام لاح يف
كركذت ةظحل صرقلا لوانت ،كب صاخلا
يدايتعلإا يئاودلا رادقملا
دعب لصاو .ماعطلا ةبجو عم اكولوج صرق
لوانت بجي .كلذب
.داتعملاك كب صاخلا جلاعلا كلذ
يئاودلا رادقملا ت
ّ
وف ،ةعاس 12 دعب رملأا اذهل كتظحلام لاح
يف
.يدايتعلإا تقولا يف مداقلا يئاودلا
رادقملا لوانتو يسنملا
رادقملا نع ضيوعتلل
ً
افعاضم
ً
ايئاود
ً
ارادقم لوانتﺗ لا ←
.يسنملا يئاودلا
،اكولوج لوانت دعوم نم تاعاس 4 نم لقأ
دعب ؤيقتلا لاح يف
نم رثكأ دعب ؤيقتلا لاح يف .ماعطلا ةبجو
عم
ً
ايفاضإ
ً
اصرق لوانت
ً
ايفاضإ
ً
اصرق لوانتل يعاد لا ،اكولوج لوانت دعوم
نم تاعاس 4
.ةمداقلا كتعرج لوانت دعوم ىتح
كبيبط ةراشتسإ نودب اكولوج لوانﺗ نع
فقوتلا زوجي لا
كاصوأ اذإ لاإ فقوتت لا .كلذب كبيبط
كاصوأ املاطل اكولوج لوانت
.كلذ لعفب كبيبط ءاودلا عباط صيخشﺗ بجي !ةمتعلا يف
ةيودأ لوانﺗ زوجي لا .ءاود اهيف لوانتﺗ ةرم لك يف يئاودلا
رادقملا نم دكأتلاو
.كلذ رملأا �

Vara einkenni

1
1.
NAME OF THE MEDICINAL PRODUCT
Juluca
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains dolutegravir sodium equivalent to 50
mg dolutegravir and rilpivirine
hydrochloride equivalent to 25 mg rilpivirine.
Excipient with known effect
Each film-coated tablet contains 52 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet (tablet).
Pink, oval, biconvex tablets, approximately 14 x 7 mm, debossed with
‘SV J3T’ on one side.
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Juluca is indicated for the treatment of human immunodeficiency virus
type 1 (HIV-1) infection in adults
who are virologically-suppressed (HIV-1 RNA <50 copies/mL) on a stable
antiretroviral regimen for at least
six months with no history of virological failure and no known or
suspected resistance to any non-nucleoside
reverse transcriptase inhibitor or integrase inhibitor (see section
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dolutegravir/rilpivirine should be prescribed by physicians
experienced in the management of HIV infection.
_ _
Posology
The recommended dose of Juluca is one tablet once daily. The tablet
must be taken with a meal (see section
5.2).
Separate preparations of dolutegravir or rilpivirine are available in
cases where discontinuation or dose
adjustment of one of the active substances is indicated (see section
4.5). In these cases the physician should
refer to the Physician leaflets for these medicinal products.
_Missed doses _
If the patient misses a dose of Juluca, the patient should take the
missed dose with a meal as soon as possible,
providing the next dose is not due within 12 hours. If the next dose
is due within 12 hours, the patient should
not take the missed dose and simply resume the usual dosing schedule.
If a patient vomits within 4 hours of taking dolutegravir/rilpivirine,
another dolutegravir/rilpivirine tablet
should be taken with a meal. If a patient vomits more than 4 hours
after taking dolutegravir/ri