CERTICAN 1.0 MG TABLETS

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

EVEROLIMUS

Disponible des:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

Designació comuna internacional (DCI):

EVEROLIMUS

Unidades en paquete:

50 Tablet Tablets; 250 Tablet Tablets; 60 Tablet Tablets; 100 Tablet Tablets

Fabricat per:

NOVARTIS PHARMA STEIN AG

Informació per a l'usuari

_Consumer Medication Information Leaflet (RiMUP) _
_ _
CERTICAN
®
Everolimus (
0.25 mg, 0.75 mg, 1.0 mg Tablet)
1
WHAT IS IN THIS LEAFLET
1.
What Certican is used for
2.
How Certican works
3.
Before you use Certican
4.
How to use Certican
5.
While you are using Certican
6.
Side effects
7.
Storage and Disposal of Certican
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT CERTICAN IS USED FOR
Certican is used to help prevent your
body from rejecting a transplanted
kidney, heart or liver. Certican must be
used together with other
immunosuppressant medicines, notably
ciclosporin for microemulsion for kidney
and heart transplantation or tacrolimus
for liver transplantation and
corticosteroids.
HOW CERTICAN WORKS
Certican belongs to a group of medicines
known as immunosuppressants.
BEFORE YOU USE CERTICAN
Certican will only be prescribed for you
by a doctor with experience in
transplantation medicine. Follow your
doctor’s instructions carefully. They may
differ from the general information
contained in this leaflet.
_When you must not use it _
•
If you are allergic (hypersensitive) to
everolimus, sirolimus
_ _
or to any of
the other components of Certican.
•
The ingredients contained in each
tablet are listed at the end of this
leaflet.
Tell your doctor if you suspect you may
have had an allergic reaction to any of
these ingredients in the past.
_PREGNANCY AND BREAST-FEEDING _
Ask your doctor or pharmacist for advice
before taking any medicine.
•
Certican must not be used during
pregnancy unless indicated by your
doctor to be clearly necessary. If you
are pregnant or think that you may
be, tell your doctor who will discuss
with you the potential risk of taking
Certican during pregnancy.
•
Breast-feeding should be
discontinued by patients taking
Certican
_Females of child-bearing potential and _
_male patients _
You should use an effective
contraceptive method during treatment
with Certican and for 8 weeks after
treatment has stopped. If you are unsure
or think y

Fitxa tècnica

Novartis
Page 2
Malaysian Package Leaflet
05 Nov 2018
Certican

CERTICAN

Selective immunosuppressive agent
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
The tablets are white to yellowish, marbled, round, flat with a
bevelled edge.
ACTIVE SUBSTANCE
Certican
®
tablets contain 0.25 mg, 0.75 mg or 1.0 mg everolimus.
Certain dosage strengths and dosage forms may not be available in all
countries.
ACTIVE MOIETY
Everolimus.
EXCIPIENTS
TABLETS
Butylated hydroxytoluene (E321), magnesium stearate, lactose
monohydrate, hypromellose,
crospovidone, lactose anhydrous.
Pharmaceutical formulations may vary between countries.
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.
DOSAGE REGIMEN AND 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 levels monitoring.
Novartis
Page 3
Malaysian Package Leaflet
05 Nov 2018
Certican

DOSAGE REGIMEN
GENERAL TARGET POPULATION_ _
ADULTS
KIDNEY AND HEART TRANSPLANTATION
An initial dose regimen of 0.75 mg b.i.d. which is recommended for the
general kidney and
heart transplant population, should be administered as soon as
possible after transplantation.
LIVER TRANSPLANTATION
The dose of 1.0 mg b.i.d is recommended for the hepatic transplant
population with the initial
dose approximately 4 weeks after transplantation.
SPECIAL POPULATIONS
BLACK PATIENTS
The incidence of biopsy-proven acute reje