Lemtrada

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

alemtuzumab

Διαθέσιμο από:

Sanofi Belgium

Φαρμακολογική κατηγορία (ATC):

L04AA34

INN (Διεθνής Όνομα):

alemtuzumab

Θεραπευτική ομάδα:

Selective immunosuppressants

Θεραπευτική περιοχή:

Multiple Sclerosis

Θεραπευτικές ενδείξεις:

Lemtrada is indicated for adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.

Περίληψη προϊόντος:

Revision: 22

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2013-09-12

Φύλλο οδηγιών χρήσης

35
B. PACKAGE LEAFLET
36
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LEMTRADA
12 MG CONCENTRATE FOR SOLUTION FOR INFUSION
alemtuzumab
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.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE ADMINISTERED 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.
-
If you get any side-effects talk to your doctor. This includes any
possible side-effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What LEMTRADA is and what it is used for
2.
What you need to know before you are administered LEMTRADA
3.
How LEMTRADA will be administered
4.
Possible side effects
5.
How to store LEMTRADA
6.
Contents of the pack and other information
1.
WHAT LEMTRADA
IS AND WHAT IT IS USED FOR
LEMTRADA contains the active substance alemtuzumab, which is used to
treat a form of multiple sclerosis
(MS) in adults, called relapsing remitting multiple sclerosis (RRMS).
LEMTRADA does not cure MS, but it
can reduce the number of MS relapses. It can also help to slow down or
reverse some of the signs and
symptoms of MS. In clinical studies, patients treated with LEMTRADA
had fewer relapses and were less
likely to experience worsening of their disability compared to
patients treated with a beta-interferon injected
multiple times per week.
LEMTRADA is used if your MS is highly active despite that you have
been treated with at least one other
medicine for MS or if your MS is rapidly evolving.
WHAT IS MULTIPLE SCLEROSIS?
MS is an autoimmune disease that affects the central nervous system
(brain and spinal cord). In MS your
immune system mistakenly attacks the protective layer (myelin) around
the nerve fibres, causing
inflammation. When the inflammation causes symptoms this is often
called an “a

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
LEMTRADA 12 mg
concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 12 mg alemtuzumab in 1.2 ml (10 mg/ml).
Alemtuzumab is a monoclonal antibody produced in mammalian cell
(Chinese Hamster Ovary) suspension
culture in a nutrient medium by recombinant DNA technology.
Excipients with known effect
This medicine contains less than 1 mmol potassium (39 mg) per
infusion, i.e. it is essentially ‘potassium-
free’.
This medicine contains less than 1 mmol sodium (23 mg) per infusion,
i.e. it is essentially ‘sodium- free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
A clear, colourless to slightly yellow concentrate with pH 7.0 –
7.4.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LEMTRADA is indicated as a single disease modifying therapy in adults
with highly active relapsing
remitting multiple sclerosis (RRMS) for the following patient groups:
•
Patients with highly active disease despite a full and adequate course
of treatment with at least one
disease modifying therapy (DMT) or
•
Patients with rapidly evolving severe relapsing remitting multiple
sclerosis defined by 2 or more
disabling relapses in one year, and with 1 or more Gadolinium
enhancing lesions on brain MRI or a
significant increase in T2 lesion load as compared to a previous
recent MRI.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
LEMTRADA treatment should only be initiated and supervised by a
neurologist experienced in the treatment
of patients with multiple sclerosis (MS) in a hospital with ready
access to intensive care. Specialists and
equipment required for the timely diagn