Everolimus Ascend 0.75 mg tablets

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Inapatikana kutoka:

Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany

ATC kanuni:

L04AA18

INN (Jina la Kimataifa):

EVEROLIMUS 0.75 mg

Dawa fomu:

TABLET

Tungo:

EVEROLIMUS 0.75 mg

Dawa ya aina:

POM

Eneo la matibabu:

IMMUNOSUPPRESSANTS

Bidhaa muhtasari:

Licence number in the source country: NOT APPLICAPABLE

Idhini hali ya:

Authorised

Idhini ya tarehe:

2023-02-21

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
EVEROLIMUS ASCEND 0.25 MG TABLETS
EVEROLIMUS ASCEND 0.5 MG TABLETS
EVEROLIMUS ASCEND 0.75 MG TABLETS
EVEROLIMUS ASCEND 1 MG TABLETS
everolimus
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 Everolimus Ascend is and what it is used for
2.
What you need to know before you take Everolimus Ascend
3.
How to take Everolimus Ascend
4.
Possible side effects
5.
How to store Everolimus Ascend
6.
Contents of the pack and other information
1.
WHAT EVEROLIMUS ASCEND IS AND WHAT IT IS USED FOR
The active substance is Everolimus.
Everolimus Ascend belongs to a group of medicines called
immunosuppressants. It is used in adults to
prevent the body’s immune system from rejecting a transplanted
kidney, heart or liver.
Everolimus Ascend is used together with other medicines, such as
ciclosporin for kidney and heart
transplantation, tacrolimus for liver transplantation, and
corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE EVEROLIMUS ASCEND
DO NOT TAKE EVEROLIMUS ASCEND
•
if you are allergic (hypersensitive) to everolimus or any of the other
ingredients of this medicine
(listed in section 6).
•
if you are allergic (hypersensitive) to sirolimus.
IF ANY OF THE ABOVE APPLIES TO YOU, TELL YOUR DOCTOR AND DO NOT TAKE
EVEROLIMUS ASCEND.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING EVEROLIMUS ASCEND:
•
Medicines that suppress the immune system like Everolimus Ascend
reduce your body´s ability to
fight against infections. It is advisable to c

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Everolimus Ascend 0.25 mg tablets
Everolimus Ascend 0.5 mg tablets
Everolimus Ascend 0.75 mg tablets
Everolimus Ascend 1 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.25/0.5/0.75/1 mg everolimus.
Excipient(s) with known effect:
Each tablet contains 2.225/4.450/6.675/8.900 mg lactose monohydrate
and 37.167/74.334/111.501/148.668
mg lactose anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Tablets are white to off white, round shaped tablets.
0.25 mg: debossed with "EVR" on one side and "25" on other side.
0.5 mg: debossed with "EVR" on one side and "50" on other side.
0.75 mg: debossed with "EVR" on one side and "75" on other side.
1 mg: debossed with "EVR" on one side and "100" on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kidney and heart transplantation
Everolimus Ascend is indicated for the prophylaxis of organ rejection
in adult patients at low to moderate
immunological risk receiving an allogeneic renal or cardiac
transplant. In kidney and heart transplantation,
Everolimus Ascend should be used in combination with ciclosporin for
microemulsion and corticosteroids.
Liver transplantation
Everolimus Ascend is indicated for the prophylaxis of organ rejection
in adult patients receiving a hepatic
transplant. In liver transplantation, Everolimus Ascend should be used
in combination with tacrolimus and
corticosteroids.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Everolimus Ascend should only be initiated and
maintained by physicians who are
experienced in immunosuppressive therapy following organ
transplantation and who have access to
everolimus whole blood concentration monitoring.
Posology
_Adults _
An initial dose regimen of 0.75 mg twice daily in co-administration
with ciclosporin is recommended for
the general kidney and heart transplant population, administered as
soon as possible after transplantation.
The dose of 1.0 mg twice daily in