Rapamune 1mgml oral solution

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Sirolimus

Saatavilla:

Pfizer Ltd

ATC-koodi:

S01XA23

INN (Kansainvälinen yleisnimi):

Sirolimus

Annos:

1mg/1ml

Lääkemuoto:

Oral solution

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 08020200; GTIN: 5010981001724

Pakkausseloste

Page 1 of 9
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.
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 may have
affected your liver, please
tell your doctor as this may affect the dose of Rapamune that you
receive and may result in your
having additional blood tests._ _

Rapamune, like other immunosuppressive medicines, may decrease your
body’s ability to fight
infection, and may increase the risk of developi

Valmisteyhteenveto

OBJECT 1
RAPAMUNE 0.5MG, 1MG AND 2MG COATED TABLETS
Summary of Product Characteristics Updated 29-Mar-2017 | Pfizer
Limited
1. Name of the medicinal product
Rapamune 0.5 mg coated tablets
Rapamune 1 mg coated tablets
Rapamune 2 mg coated tablets
Rapamune 1 mg/mL oral solution
2. Qualitative and quantitative composition
Rapamune 0.5mg coated tablets
Each coated tablet contains 0.5 mg sirolimus.
Rapamune 1 mg coated tablets
Each coated tablet contains 1 mg sirolimus.
Rapamune 2 mg coated tablets
Each coated tablet contains 2 mg sirolimus.
Rapamune 1 mg/mL oral solution
Each mL contains 1 mg sirolimus.
Each 60 mL bottle contains 60 mg sirolimus.
Excipients with known effect
Rapamune 0.5 mg coated tablets
Each tablet contains 86.4 mg of lactose monohydrate and 215.7 mg of
sucrose.
Rapamune 1 mg coated tablets
Each tablet contains 86.4 mg of lactose monohydrate and 215.8 mg of
sucrose.
Rapamune 2 mg coated tablets
Each tablet contains 86.4 mg of lactose monohydrate and 214.4 mg of
sucrose.
Oral Solution
Each mL contains 20 mg of ethanol and 20 mg of soya oil.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Coated tablet (tablet).
Rapamune 0.5 mg coated tablets
Tan-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 0.5
mg” on one side.
Rapamune 1 mg coated tablets
White-coloured, triangular-shaped, coated tablet marked “RAPAMUNE 1
mg” on one side.
Rapamune 2 mg coated tablets
Yellow to beige-coloured, triangular-shaped, coated tablet marked
“RAPAMUNE 2 mg” on one side.
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 disconti