LEQVIO 284 MG

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

INCLISIRAN AS SODIUM

Disponible desde:

NOVARTIS ISRAEL LTD

Código ATC:

C10AX16

formulario farmacéutico:

SOLUTION FOR INJECTION

Composición:

INCLISIRAN AS SODIUM 189 MG/ML

Vía de administración:

S.C

tipo de receta:

Required

Fabricado por:

CORDEN PHARMA S.P.A, ITALY

Área terapéutica:

INCLISIRAN

indicaciones terapéuticas:

Leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin or statin with other lipid lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin, or• alone or in combination with other lipid lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

Fecha de autorización:

2021-07-29

Información para el usuario

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Leaflet-Leqvio 284mg
1
X
DOR
1986 - )تار
َ
ضحتسم( ةلدايصلا ةمظنأ بجومب كلهتسملل
ةرشن
طقف بيبط ةفصو بجومب ءاودلا ق
ّ
وس
ُ
ي
غلم 284 ويڨكيل
دلجلا تحت نقحلل ،ةربإ يقاو عم
لامعتسلال ةزهاج ةنقحم يف نقحلل لولحم
:ةلا
ّ
عفلا ةداملا
inclisiran ( مويدوصلا ناريسيلكنإ ىلع ةربإ
يقاو عم لامعتسلال ةزهاج ةنقحم يف
لولحملا نم للم 1.5 لك يوتحي
.ناريسيلكنإ غلم 284 لداعي امب )
sodium
.ناريسيلكنإ نم غلم 189 لداعي مويدوصلا
ناريسيلكنإ ىلع يوتحي للم 1 لك
تاب
ّ
كرم نم مسق نع ةمهم تامولعم" 2 دنبلاو
"ةيفاضإ تامولعم" 6 دنبلا رظنا :ةيساسحلا
تاببس
ُ
مو ةلا
ّ
عفلا ريغ داوملا
."ءاودلا
نـ
ـع ةزـ
ـجوم تاــمولعم ىــلع ةرـ
ـشنلا هذــه يوــتحت .ءاودـ
ـلا لامعتــساب ءدـ
ـبلا لــبق كـ
ـلذو اــهتياهن ىــتح نــ
ّ
عمتب ةرـ
ـشنلا أرـ
ـقا
.
ّ
يــلديصلا وأ بــيبطلا ىــلإ هـ
ـ
ّ
جوت ،ةـ
ـيفاضإ ةلئــسأ كـ
ـيدل تــناك اذإ .ءاودـ
ـلا
ةـ
ـيحصلا كـ
ـتلاح نــيب هباــشت كـ
ـل ادــب وــل ىــتح ،مـ
ـهرضي دــق هـ
ـ
ّ
نلأ ؛نـ
ـيرخلآل

Ficha técnica

1
LEQ SPI OCT22 V2 EU SmPC 08.2022
1.
NAME OF THE MEDICINAL PRODUCT
Leqvio 284 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains inclisiran sodium equivalent to 284
mg inclisiran in 1.5 ml solution.
Each ml contains inclisiran sodium equivalent to 189 mg inclisiran.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection, (S.C.).
The solution is clear, colourless to pale yellow, and essentially free
of particulates.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Leqvio is indicated in adults with primary hypercholesterolaemia
(heterozygous familial and
non-familial) or mixed dyslipidaemia, as an adjunct to diet:
•
in combination with a statin or statin with other lipid-lowering
therapies in patients unable to
reach LDL-C goals with the maximum tolerated dose of a statin, or
•
alone or in combination with other lipid-lowering therapies in
patients who are statin-intolerant,
or for whom a statin is contraindicated.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 284 mg inclisiran administered as a single
subcutaneous injection: initially,
again at 3 months, followed by every 6 months.
_Missed doses _
If a planned dose is missed by less than 3 months, inclisiran should
be administered and dosing
continued according to the patient’s original schedule.
If a planned dose is missed by more than 3 months, a new dosing
schedule should be started –
inclisiran should be administered initially, again at 3 months,
followed by every 6 months.
_Treatment transition from monoclonal antibody PCSK9 inhibitors_
Inclisiran can be administered immediately after the last dose of a
monoclonal antibody PCSK9
inhibitor. To maintain LDL-C lowering it is recommended that
inclisiran is administered within
2 weeks after the last dose of a monoclonal antibody PCSK9 inhibitor.
_Special populations_
_Elderly (age ≥65 years)_
No dose adjustment is necessary in elderly patients.
2
LEQ API OCT22 V2 EU SmPC 08.2022
_Hepatic impairment_
No