Everolimus Sandoz 10 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

EVEROLIMUS 10 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

L01XE10

INN (Algemene Internationale Benaming):

EVEROLIMUS 10 mg/stuk

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:

2019-03-15

Bijsluiter

Sandoz B.V.
Page 1/10
Everolimus Sandoz
®
2,5, 5, 10 mg, tabletten
RVG 122426, 122427, 122428
1311-v7
1.3.1.1 Bijsluiter
Mei 2022
BIJSLUITER: INFORMATIE VOOR DE PATIËNT
EVEROLIMUS SANDOZ
® 2,5 MG, TABLETTEN
EVEROLIMUS SANDOZ
® 5 MG, TABLETTEN
EVEROLIMUS SANDOZ
® 10 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
_ _
[Nationally completed name] is an anticancer medicine containing the
active substance everolimus.
Everolimus reduces the blood supply to the tumour and slows down the
growth and spread of cancer
cells.
[Nationally completed name] is used to treat adult patients with:
•
hormone receptor-positive advanced breast cancer in postmenopausal
women, in whom other
treatments (so called “non-steroidal aromatase inhibitors”) no
longer keep the disease under
control. It is given together with a medicine called exemestane, a
steroidal aromatase inhibitor,
which is used for hormonal anticancer therapy.
•
advanced tumours called neuroendocrine tumours that originate from the
stomach, bowels,
lung or pancreas. It is given if the tumours are inoperable and do not
overproduce specific
hormones or other related natural sub

Productkenmerken

Sandoz B.V.
Page 1/32
Everolimus Sandoz 2,5, 5, 10 mg, tabletten
RVG 122426, 122427, 122428
1311-v9
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
1.
NAAM VAN HET GENEESMIDDEL
Everolimus Sandoz 2,5 mg, tabletten
Everolimus Sandoz 5 mg, tabletten
Everolimus Sandoz 10 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[NATIONALLY COMPLETED NAME] 2.5 MG TABLETS
Each tablet contains 2.5 mg of everolimus.
Excipient with known effect
Each tablet contains 74.2 mg of lactose.
[NATIONALLY COMPLETED NAME] 5 MG TABLETS
Each tablet contains 5 mg of everolimus
_. _
_ _
Excipient with known effect
Each tablet contains 148.4 mg of lactose.
[NATIONALLY COMPLETED NAME] 10 MG TABLETS
Each tablet contains 10 mg of everolimus.
Excipient with known effect
Each tablet contains 296.8 mg of lactose.
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Tablet.
[NATIONALLY COMPLETED NAME] 2.5 MG TABLETS
White to slightly yellow, elongated tablets approximately 10.1 x 4.1
mm with a bevelled edge and no
score, engraved with “LCL” on one side and “NVR” on the other.
[NATIONALLY COMPLETED NAME] 5 MG TABLETS
White to slightly yellow, elongated tablets approximately 12.1 x 4.9
mm with a bevelled edge and no
score, engraved with “5” on one side and “NVR” on the other.
[NATIONALLY COMPLETED NAME] 10 MG TABLETS
Sandoz B.V.
Page 2/32
Everolimus Sandoz 2,5, 5, 10 mg, tabletten
RVG 122426, 122427, 122428
1311-v9
1.3.1.1 Samenvatting van de Productkenmerken
Mei 2023
White to slightly yellow, elongated tablets approximately 15.1 x 6.0
mm with a bevelled edge and no
score, engraved with “UHE” on one side and “NVR” on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hormone receptor-positive advanced breast cancer
[Nationally completed name] is indicated for the treatment of hormone
receptor-positive, HER2/neu
negative advanced breast cancer, in combination with exemestane, in
postmenopausal women without
symptomatic visceral disease after recurrence or progression following
a no