Rapamune

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

Sirolimus

Saatavilla:

Pfizer Europe MA EEIG

ATC-koodi:

L04AA10

INN (Kansainvälinen yleisnimi):

sirolimus

Terapeuttinen ryhmä:

Immunosuppressants

Terapeuttinen alue:

Graft Rejection; Kidney Transplantation

Käyttöaiheet:

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. Rapamune is indicated for the treatment of patients with sporadic lymphangioleiomyomatosis with moderate lung disease or declining lung function.,

Tuoteyhteenveto:

Revision: 46

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2001-03-13

Pakkausseloste

64
B. PACKAGE LEAFLET
65
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAPAMUNE 1 MG/ML ORAL SOLUTION
sirolimus
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rapamune is and what it is used for
2.
What you need to know before you take Rapamune
3.
How to take Rapamune
4.
Possible side effects
5.
How to store Rapamune
6.
Contents of the pack and other information
1.
WHAT RAPAMUNE IS AND WHAT IT IS USED FOR
Rapamune contains the active substance sirolimus, which belongs to a
group of medicines called
immunosuppressants. It helps to control your body’s immune system
after you have received a kidney
transplant.
Rapamune is used in adults to prevent your body from rejecting
transplanted kidneys and is normally
used with other immunosuppressant medicines called corticosteroids and
initially (the first 2 to
3 months) with ciclosporin.
Rapamune is also used for the treatment of patients with sporadic
lymphangioleiomyomatosis
(S-LAM) with moderate lung disease or declining lung function. S-LAM
is a rare progressive lung
disease that affects predominantly women of childbearing age. The most
common symptom of S-LAM
is shortness of breath.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAPAMUNE
DO NOT TAKE RAPAMUNE

if you are allergic to sirolimus or any of the other ingredients of
this medicine (listed in
section 6).

if you are allergic to peanut or soya.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Rapamune

If you have any liver problems or have had a disease which

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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).
Rapamune is indicated for the treatment of patients with sporadic
lymphangioleiomyomatosis with
moderate lung disease or declining lung function (see sections 4.2 and
5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Prophylaxis of organ rejection_
Treatment should be initiated by and remain under the guidance of an
appropriately qualified specialist
in transplantation.
_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 mo