RAPAMUNE SOLUTION

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

SIROLIMUS

から入手可能:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATCコード:

L04AA10

医薬品形態:

SOLUTION (ORAL)

構図:

SIROLIMUS 1 MG/ML

投与経路:

PER OS

処方タイプ:

Required

製:

PATHEON INC. WHITBY OPERATIONS, CANADA

治療領域:

SIROLIMUS

適応症:

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.

承認日:

2021-03-31

情報リーフレット

Rapamune Solution PIL CC technical change 22 March 2022 English
1
2022-0076905
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor’s prescription only
RAPAMUNE
®
SOLUTION
ORAL SOLUTION
Each 1 mL contains: sirolimus 1 mg
Inactive ingredients and allergens: See section 2 under ‘Important
information about
some of this medicine’s ingredients’ and section 6 ‘Further
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains
concise information about this medicine. If you have any further
questions, consult
your doctor 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
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Rapamune
®
is intended to suppress the immune system. This medicine is intended
for prevention of transplant rejection in patients receiving a kidney
transplant.
THERAPEUTIC GROUP:
selective immunosuppressant.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
• You are sensitive (allergic) to the active ingredient or to any of
the other
ingredients in this medicine (see section 6).
• you are allergic to peanuts or soya.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH RAPAMUNE
®
, TELL YOUR DOCTOR IF:
• you are pregnant, see the section ‘Pregnancy, breastfeeding, and
fertility’.
• you have impaired liver function or have had a disease which may
have affected
your liver. Your dose may need to change and you may need additional
blood tests.
• you have problems with your immune system. Rapamune
®
, like other
immunosuppressive medicines, may decrease your body’s immune
resistance, and
may increase your risk of developing cancer of the lymphoid tissues
and skin.
• you have a body mass index (BMI) greater than 30
(weight[kg]/height
2
[m
2
]). You
may be at increased risk of abnormal wound knitting and scabbing.
• you a

製品の特徴

Rapamune 1 mg/ml oral solution LPD CC 14 October
2021-00684031
RAPAMUNE® SOLUTION
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 t