Everolimus Sandoz 1 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

EVEROLIMUS

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

L04AA18

INN (Algemene Internationale Benaming):

EVEROLIMUS

farmaceutische vorm:

Tablet

Samenstelling:

BUTYLHYDROXYTOLUEEN (E 321) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 0-WATER ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Everolimus

Autorisatie datum:

2019-02-19

Bijsluiter

Sandoz B.V.
Page 1/8
Everolimus Sandoz 0.25, 0.5, 0.75, 1 mg, tabletten
RVG 121998-2001
1313-v7
1.3.1.1 Bijsluiter
November 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
EVEROLIMUS SANDOZ
® 0,25 MG, TABLETTEN
EVEROLIMUS SANDOZ
® 0,5 MG, TABLETTEN
EVEROLIMUS SANDOZ
® 0,75 MG, TABLETTEN
EVEROLIMUS SANDOZ
® 1 MG, TABLETTEN
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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
The active substance of [Nationally completed name] 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.
[Nationally completed name] 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
•
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 D

Productkenmerken

Sandoz B.V.
Page 1/29
Everolimus Sandoz 0.25, 0.5, 0.75, 1 mg, tabletten
RVG 121998-2001
1311-v7
1.3.1.1 Samenvatting van de Productkenmerken
April 2023
1.
NAAM VAN HET GENEESMIDDEL
Everolimus Sandoz 0,25 mg, tabletten
Everolimus Sandoz 0,5 mg, tabletten
Everolimus Sandoz 0,75 mg, tabletten
Everolimus Sandoz 1 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Nationally completed name] 0.25 mg tablets
Each tablet contains 0.25 mg of everolimus.
[Nationally completed name] 0.5 mg tablets
Each tablet contains 0.5 mg of everolimus.
[Nationally completed name] 0.75 mg tablets
Each tablet contains 0.75 mg of everolimus.
[Nationally completed name] 1.0 mg tablets
Each tablet contains 1.0 mg of everolimus.
Excipient(s) with known effect
[Nationally completed name] 0.25 mg tablets
Each tablet contains 53 mg of lactose.
[Nationally completed name] 0.5 mg tablets
Each tablet contains 79 mg of lactose.
[Nationally completed name] 0.75 mg tablets
Each tablet contains 118 mg of lactose.
[Nationally completed name] 1.0 mg tablets
Each tablet contains 157 mg of lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
The 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.
Sandoz B.V.
Page 2/29
Everolimus Sandoz 0.25, 0.5, 0.75, 1 mg, tabletten
RVG 121998-2001
1311-v7
1.3.1.1 Samenvatting van de Productkenmerken
April 2023
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kidney and heart transplantation
[Nationally completed name] 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