IMNOVID 1 MG

Land: Israel

Sprache: Englisch

Quelle: Ministry of Health

Wirkstoff:

POMALIDOMIDE

Verfügbar ab:

NEOPHARM SCIENTIFIC LTD

ATC-Code:

L04AX06

Darreichungsform:

HARD CAPSULE

Zusammensetzung:

POMALIDOMIDE 1 MG

Verabreichungsweg:

PER OS

Verschreibungstyp:

Required

Hergestellt von:

CELGENE INTERNATIONAL SARL, SWITZERLAND

Therapiebereich:

POMALIDOMIDE

Anwendungsgebiete:

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.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

Berechtigungsdatum:

2019-05-31

Gebrauchsinformation

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor's prescription only
IMNOVID 1 MG
IMNOVID 2 MG
IMNOVID 3 MG
IMNOVID 4 MG
ACTIVE INGREDIENTS:
IMNOVID 1 MG: Each hard capsule contains pomalidomide 1 mg
IMNOVID 2 MG: Each hard capsule contains pomalidomide 2 mg
IMNOVID 3 MG: Each hard capsule contains pomalidomide 3 mg
IMNOVID 4 MG: Each hard capsule contains pomalidomide 4 mg
Inactive ingredients and allergens: See chapter 6 ‘_Additional
information_’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This
leaflet contains concise information about this medicine. If you have
any
further questions, consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to
others. It may harm them, even if it seems to you that their illness
is similar to
yours.
Imnovid is expected to cause severe harm to an unborn baby and may
lead to death. Do not take this medicine if you are pregnant or
anticipate
becoming pregnant. You must follow the contraception advice described
in
this leaflet.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Imnovid is used to treat adults with a type of cancer called
‘multiple myeloma’.
Imnovid is used with:
•
two other medicines - one called “bortezomib” (a type of
chemotherapy
medicine) and “dexamethasone” (an anti-inflammatory medicine) in
adults who
have had at least one other treatment - including lenalidomide.
Or
•
one other medicine called “dexamethasone” (in adults whose
multiple
myeloma has recurred or become worse, despite having received at least
two
other treatments, including lenalidomide and bortezomib) and presented
progression of the disease during the last treatment.
THERAPEUTIC GROUP: The medicine belongs to a group of medicines which
suppress the immune system.
WHAT IS MULTIPLE MYELOMA
Multiple myeloma is a type of cancer which affects a certain type of
white
blood cell (called ‘plasma cells’). These cells grow out of

Fachinformation

1
1.
NAME OF THE MEDICINAL PRODUCT
Imnovid 1 mg
Imnovid 2 mg
Imnovid 3 mg
Imnovid 4 mg
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
Hard gelatin capsule, size 3, with dark
blue opaque cap and yellow opaque body, imprinted “POML” in
white ink and “
1 mg
” in black ink.
Imnovid 2 mg hard capsules
Hard gelatin capsule, size 1, with d
ark blue opaque cap and orange opaque body, imprinted “POML 2
mg” in white ink.
Imnovid 3 mg hard capsules
Hard gelatin capsule, size 1, with d
ark blue opaque cap and green opaque body, imprinted, “POML 3
mg” in white ink
.
Imnovid 4 mg hard capsules
Hard gelatin capsule, size 1, with dark
blue opaque cap and blue opaque body, imprinted “POML 4 mg”
in white ink.
2
IMNOVID IS CONTRAINDICATED IN PREGNANCY. IMNOVID IS A THALIDOMIDE
ANALOGUE. THALIDOMIDE IS A
KNOWN HUMAN TERATOGEN THAT CAN CAUSE SEVERE BIRTH DEFECTS OR FETAL
DEATH. IN WOMEN OF CHILD
BEARING POTENTIAL, OBTAIN A NEGATIVE PREGNANCY TEXT BEFORE STARTING
IMNOVID TREATMENT. WARN
PATIENTS TO FOLLOW THE CONTRACEPTION ADVICE IN THIS LEAFLET.
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 A