RAPAMUNE SOLUTION

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SIROLIMUS

Available from:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC code:

L04AA10

Pharmaceutical form:

SOLUTION (ORAL)

Composition:

SIROLIMUS 1 MG/ML

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

WYETH PHARMACEUTICALS LIMITED, U.K.

Therapeutic group:

SIROLIMUS

Therapeutic area:

SIROLIMUS

Therapeutic indications:

Rapamune is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunological risk receiving a renal transplant. It is recommended that Rapamune be used initially in combination with cyclosporine microemulsion and corticosteroids for 2 to 3 months. Rapamune may be continued as maintenance therapy with corticosteroids only if cyclosporine can be progressively discontinued.

Authorization date:

2011-03-31

Patient Information leaflet

نم للقت لا ةيبابضلا .ةنينقلا لخادب
ةيبابض لكشي دق داربلا يف ءاودلا نيزخت
نإ
ةرتفل داربلا نم
®
نويماﭘر لولحم جارخإ بجي ،ةرهاظلا هذه
تثدح اذإ .ءاودلا ةعاجن
.ةيبابضلا لاوز ىتح فطلب هضخو ةفرغلا
ةرارح ةجرد غولب نم هنيكمتل ،ةريصق
ةعباتمو صوحف
ءاودلا ةبسن ةبقارم لجأ نم مد صوحف
ءارجلإ كهيجوت متيس جلاعلا ةرتف للاخ
مدلا يف موحشلاو ىلكلا فئاظو ةبقارمل
ةيرود صوحفل كلذكو ،كمد يف
ءارجإب بيبطلا موقي نأ
ً
اضيأ زئاجلا نم .)تاديريسيلچيرتلا وأ/و
لورتسلوكلا(
.دبكلا فئاظول صحف
هجوت ،ءاودلا نم أطخلاب لفط علب اذإ وأ
ربكأ
ً
ايئاود
ً
ارادقم أطخلاب تلوانت اذإ
.كعم ءاودلا ةبلع رضحأو ىفشتسملا يف
ئراوطلا ةفرغ ىلإ وأ بيبطلا ىلإ
ً
لااح
لاح
ً
ايئاود
ً
ارادقم لوانت بجيف ،بولطملا تقولا يف
ءاودلا اذه لوانت تيسن اذإ
لوانت نيب لقلأا ىلع تاعاس 4 هردق لصاف
ىلع ةظفاحملا ركذت نكلو ،كلذ كركذت
دعب !نيروﭙسولكيس نم مداقلا يئاودلا
رادقملا لوانت نيبو لولحم
®
نويماﭘر
تقولا يف مداقلا يئاودلا رادقملا لوانت
،داتعملاك جلاعلا ةلصاوم ناكملإاب كلذ
نع ضيوعتلل
ً
افعاضم
ً
ايئاود
ً
ارادقم لوانت زوجي لا .بيبطلا ةراشتسإو
داتعملا
.يسنملا يئاودلا رادقملا
لولحم
®
نويماﭘر لوانت نيب تاعاس 4 هردق لصاف
ىلع ةظفاحملا
ً
امئاد ركذت
.نيروﭙسولكيسو
.كلذب كبيبط غلابإ كيلعف ،ءاودلا نم
ً
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Summary of Product characteristics

Rapamune 1 mg/ml oral solution LPD 09 July 2019
0052666
-
2019
1
1.
NAME OF THE MEDICINAL PRODUCT
RAPAMUNE
1 MG/ML ORAL SOLUTION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL contains 1 mg sirolimus.
Each 60 mL bottle contains 60 mg sirolimus.
Excipients with known effect:
Each mL contains
up to 25
mg of ethanol
, approximately 350 mg of propylene glycol
(E1520),
and 20 mg of soya oil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Pale yellow to yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rapamune is indicated for the prophylaxis of organ rejection in adult
patients at low to
moderate immunological risk receiving a renal transplant. It is
recommended that Rapamune
be used initially in combination with ciclosporin microemulsion and
corticosteroids for 2 to 3
months. Rapamune may be continued as maintenance therapy with
corticosteroids only if
ciclosporin microemulsion can be progressively discontinued (see
sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by and remain under the guidance of an
appropriately qualified
specialist in transplantation.
Posology
_Initial therapy (2 to 3 months post_
-
_transplantation) _
The usual dose regimen for Rapamune is a 6 mg single oral loading
dose, administered as
soon as possible after transplantation, followed by 2 mg once daily
until results of therapeutic
monitoring of the medicinal product are available (see
_Therapeutic monitoring of the _
_medicinal product and dose adjustment_
). The Rapamune dose should then be individualised
to obtain whole blood trough levels of 4 to 12 ng/mL (chromatographic
assay). Rapamune
therapy should be optimised with a tapering regimen of steroids and
ciclosporin
microemulsion. Suggested ciclosporin trough concentration ranges for
the first 2-3 months
after transplantation are 150-400 ng/mL (monoclonal assay or
equivalent technique) (see
section 4.5
_)_
.
To minimise variability, Rapamune should be taken at the same time in
r