CERTICAN 0.25 Milligram Dispersable Tablet

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

EVEROLIMUS (STABILISED WITH BHT)

Sẵn có từ:

Novartis Pharmaceuticals UK Ltd

Mã ATC:

L04AA18

INN (Tên quốc tế):

EVEROLIMUS (STABILISED WITH BHT)

Liều dùng:

0.25 Milligram

Dạng dược phẩm:

Dispersable Tablet

Loại thuốc theo toa:

Product subject to prescription which may not be renewed (A)

Khu trị liệu:

Selective immunosuppressants

Tình trạng ủy quyền:

Authorised

Ngày ủy quyền:

2014-12-12

Tờ rơi thông tin

1 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

CERTICAN 0.25 MG TABLETS 
CERTICAN 0.5 MG TABLETS 
CERTICAN 0.75 MG TABLETS 
CERTICAN 1.0 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 Certican is and what it is used for 
2.  What you need to know before you take Certican 
3.  How to take Certican 
4.  Possible side effects 
5.  How to store Certican 
6.  Contents of the pack and other information 

1. 
WHAT CERTICAN IS AND WHAT IT IS USED FOR 

The active substance of Certican is everolimus. 

Everolimus 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. 
Certican 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 CERTICAN 

DO NOT TAKE CERTICAN 


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 CERTICAN. 

WARNINGS AND PRECAUTIONS 
TALK TO YOUR DOCT

Đặc tính sản phẩm

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Certican 0.25mg Dispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dispersible tablet contains 0.25 mg everolimus.
Each dispersible tablet contains 2 mg lactose monohydrate and 179 mg
anhydrous lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Dispersible tablet
Dispersible tablets are white to yellowish, marbled, round, flat with
a bevelled edge.
0.25 mg (diameter of 9 mm): engraved with “JO” on one side and
“NVR” on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Kidney and heart transplantation
Certican 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, Certican should be used in
combination with ciclosporin for microemulsion and corticosteroids.
Liver transplantation
Certican is indicated for the prophylaxis of organ rejection in adult
patients receiving a hepatic transplant. In liver
transplantation, Certican should be used in combination with
tacrolimus and corticosteroids.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Certican 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 co-administration with tacrolimus is
recommended for the hepatic transplant
population with the initial dose approximately 4 weeks after
transplantation.
Patients receiving Certican may require dose adjustments based on
blood concentrations achieved, tolerability,
individual response, change in co-medications and the clinical
situat