Imnovid (previously Pomalidomide Celgene)

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

Pomalidomide

Διαθέσιμο από:

Bristol-Myers Squibb Pharma EEIG

Φαρμακολογική κατηγορία (ATC):

L04AX06

INN (Διεθνής Όνομα):

pomalidomide

Θεραπευτική ομάδα:

Immunosuppressants

Θεραπευτική περιοχή:

Multiple Myeloma

Θεραπευτικές ενδείξεις:

Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Περίληψη προϊόντος:

Revision: 24

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-08-05

Φύλλο οδηγιών χρήσης

56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMNOVID 1 MG HARD CAPSULES
IMNOVID 2 MG HARD CAPSULES
IMNOVID 3 MG HARD CAPSULES
IMNOVID 4 MG HARD CAPSULES
pomalidomide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
IMNOVID IS EXPECTED TO CAUSE SEVERE BIRTH DEFECTS AND MAY LEAD TO THE
DEATH OF AN UNBORN BABY.
•
Do not take this medicine if you are pregnant or could become
pregnant.
•
You must follow the contraception advice described in this leaflet.
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, pharmacist or
nurse.
•
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, pharmacist or nurse.
•
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imnovid is and what it is used for
2.
What you need to know before you take Imnovid
3.
How to take Imnovid
4.
Possible side effects
5.
How to store Imnovid
6.
Contents of the pack and other information
1.
WHAT IMNOVID IS AND WHAT IT IS USED FOR
WHAT IMNOVID IS
Imnovid contains the active substance ‘pomalidomide’. This
medicine is related to thalidomide and
belongs to a group of medicines which affect the immune system (the
body’s natural defences).
WHAT IMNOVID IS USED FOR
Imnovid is used to treat adults with a type of cancer called
‘multiple myeloma’.
Imnovid is either used with:
•
TWO OTHER MEDICINES - called ‘bortezomib’ (a type of chemotherapy
medicine) and
‘dexamethasone’ (an anti-inflammatory medicine) in people who have
had at least one other
trea

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Imnovid 1 mg hard capsules
Imnovid 2 mg hard capsules
Imnovid 3 mg hard capsules
Imnovid 4 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Imnovid 1 mg hard capsules
Each hard capsule contains 1 mg of pomalidomide.
Imnovid 2 mg hard capsules
Each hard capsule contains 2 mg of pomalidomide.
Imnovid 3 mg hard capsules
Each hard capsule contains 3 mg of pomalidomide.
Imnovid 4 mg hard capsules
Each hard capsule contains 4 mg of pomalidomide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
Imnovid 1 mg hard capsules
Dark blue opaque cap and yellow opaque body, imprinted “POML” in
white ink and “1 mg” in black
ink, size 3 gelatin hard capsule.
Imnovid 2 mg hard capsules
Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg”
in white ink, size 1 gelatin
hard capsule.
Imnovid 3 mg hard capsules
Dark blue opaque cap and green opaque body, imprinted “POML 3 mg”
in white ink, size 1 gelatin
hard capsule.
Imnovid 4 mg hard capsules
Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg”
in white ink, size 1 gelatin hard
capsule.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Imnovid in combination with bortezomib and dexamethasone is indicated
in the treatment of adult
patients with multiple myeloma who have received at least one prior
treatment regimen including
lenalidomide.
Imnovid in combination with dexamethasone is indicated in the
treatment of adult patients with
relapsed and refractory multiple myeloma who have received at least
two prior treatment regimens,
including both lenalidomide and bortezomib, and have demonstrated
disease progression on the last
therapy.
4.2
POSOLOGY AND METHOD OF