Menelri 10 mg, zachte capsules

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

CICLOSPORINE

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

L04AD01

INN (Algemene Internationale Benaming):

CYCLOSPORIN

farmaceutische vorm:

Capsule, zacht

Samenstelling:

ALUMINIUM CHLORIDE 6-WATER ; CARMINEZUUR (E 120) ; ETHANOL ; GELATINE (E 441) ; GLYCEROL 85 PER CENT (E 422) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOLGLYCEROLHYDROXYSTEARAAT ; MAÏSOLIE, MONO-DI-TRIGLYCERIDE ESTERS ; NATRIUMHYDROXIDE (E 524) ; PROPYLEENGLYCOL (E 1520) ; RODE INKT ; TITAANDIOXIDE (E 171) ; TOCOFEROL, DL-ALFA (E 307) ; WATER, GEZUIVERD

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ciclosporin

Autorisatie datum:

2019-08-19

Bijsluiter

Sandoz B.V.
Page 1/13
MENELRI 10, 25, 50, 100 mg, zachte capsules (ciclosporine)
RVG 122304-7
1311-v4
1.3.1.3 Package leaflet
December 2022
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MENELRI 10 MG, ZACHTE CAPSULES
MENELRI 25 MG, ZACHTE CAPSULES
MENELRI 50 MG, ZACHTE CAPSULES
MENELRI 100 MG, ZACHTE CAPSULES
ciclosporin
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
name
of
your
medicine
is
[Nationally
completed
name].
It
contains
the
active
substance
ciclosporin. This belongs to a group of medicines known as
immunosuppressive agents. These
medicines are used to lower the body’s immune reactions.
What [nationally completed name] is used for and how [nationally
completed name] works
•
IF YOU HAVE HAD AN ORGAN TRANSPLANT, BONE MARROW AND STEM CELL
TRANSPLANTATION
, the
function of [nationally completed name] is to control your body’s
immune system. [nationally
completed name] prevents rejection of transplanted organs by blocking
the development of
certain cells which would normally attack the transplanted tissue.
•
IF YOU HAVE AN AUTOIMMUNE DISEASE
, in which your body’s immune response attacks your
body’s own cells, [nationally completed nam

Productkenmerken

Sandoz B.V.
Page
1/30
MENELRI 10, 25, 50, 100 mg, zachte capsules
(ciclosporine)
RVG 122304-7
1311-v4
1.3.1.1 Summary of Product Characteristics
December 2022
1.
NAAM VAN HET GENEESMIDDEL
MENELRI 10 mg, zachte capsules
MENELRI 25 mg, zachte capsules
MENELRI 50 mg, zachte capsules
MENELRI 100 mg, zachte capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 10 mg of ciclosporin.
Excipients with known effect
Each soft capsule contains 10 mg of ethanol, 20.84 mg of propylene
glycol and 40.5 mg of
macrogolglycerol hydroxystearate.
Each soft capsule contains 25 mg of ciclosporin.
Excipients with known effect
Each soft capsule contains 25 mg of ethanol, 46.42 mg of propylene
glycol and 101.25 mg of
macrogolglycerol hydroxystearate.
Each soft capsule contains 50 mg of ciclosporin.
Excipients with known effect
Each soft capsule contains 50 mg of ethanol, 90.36 mg of propylene
glycol and 202.5 mg of
macrogolglycerol hydroxystearate.
Each soft capsule contains 100 mg of ciclosporin.
Excipients with known effect
Each soft capsule contains 100 mg of ethanol, 148.31 mg of propylene
glycol and 405.0 mg of
macrogolglycerol hydroxystearate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sandoz B.V.
Page
2/30
MENELRI 10, 25, 50, 100 mg, zachte capsules
(ciclosporine)
RVG 122304-7
1311-v4
1.3.1.1 Summary of Product Characteristics
December 2022
Capsule, soft.
_10 mg capsules, soft: _
Yellow-white oval shaped soft gelatin capsule, imprinted with “NVR
10” in red.
Length: 7.4 – 8.9 mm
Diameter: 5.9 – 6.7 mm
_25 mg capsules, soft: _
Blue-grey oval shaped soft gelatin capsule, imprinted with “NVR
25mg” in red.
Length: max. 14.0 mm
Diameter: max. 8.2 mm
_50 mg capsules, soft: _
Yellow-white oblong shaped soft gelatin capsule, imprinted with “NVR
50mg” in red.
Length: max. 21.9 mm
Diameter: max. 8.5 mm
_100 mg capsules, soft: _
Blue-grey oblong shaped soft gelatin capsule, imprinted with “NVR
100mg” in red.
Length: max. 27.7 mm
Diameter: max. 9.5 mm
4.
CLINICAL PARTIC