Certican 0,75 mg Tablett

Land: Sverige

Språk: svenska

Källa: Läkemedelsverket (Medical Products Agency)

Aktiva substanser:

everolimus

Tillgänglig från:

Northern Medical Group ApS

ATC-kod:

L04AH02

INN (International namn):

everolimus

Dos:

0,75 mg

Läkemedelsform:

Tablett

Sammansättning:

everolimus 0,75 mg Aktiv substans; laktos (vattenfri) Hjälpämne; laktosmonohydrat Hjälpämne; butylhydroxitoluen Hjälpämne

Klass:

Apotek

Receptbelagda typ:

Receptbelagt

Terapiområde:

Everolimus

Bemyndigande status:

Avregistrerad

Tillstånd datum:

2014-07-04

Bipacksedel

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 DOCTOR BEFORE TAKING CERTICAN:
•
Medicines that suppress the immune system like Certican reduce your
body´s ability to fight
against infections. It is advisable to consult your doctor or
transplant centre if you have a fever
or generally feel unwell, or have local symptoms such as coughing

Produktens egenskaper

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Certican 0.25 mg tablets
Certican 0.5 mg tablets
Certican 0.75 mg tablets
Certican
1.0 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.25/0.5/0.75/1.0 mg everolimus.
Excipient(s) with known effect:
Each tablet contains 2/4/7/9 mg lactose monohydrate and 51/74/112/149
mg Anhydrous lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Tablets are white to yellowish, marbled, round, flat with a bevelled
edge.
0.25 mg (diameter of 6 mm): engraved with “C” on one side and
“NVR” on the other.
0.5 mg (diameter of 7 mm): engraved with “CH” on one side and
“NVR” on the other.
0.75 mg (diameter of 8.5 mm): engraved with “CL” on one side and
“NVR” on the other.
1.0 mg (diameter of 9 mm): engraved with “CU” 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