Lemtrada

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Alemtuzumab 10 mg/mL

Verfügbar ab:

sanofi-aventis new zealand limited

INN (Internationale Bezeichnung):

Alemtuzumab 10 mg/mL

Dosierung:

10 mg/mL

Darreichungsform:

Concentrate for infusion

Zusammensetzung:

Active: Alemtuzumab 10 mg/mL Excipient: Dibasic sodium phosphate Disodium edetate dihydrate Monobasic potassium phosphate Polysorbate 80 Potassium chloride Sodium chloride

Verschreibungstyp:

Prescription

Hergestellt von:

Boehringer Ingelheim Pharma GmbH & Co KG

Anwendungsgebiete:

Treatment of relapsing forms of multiple sclerosis (MS) for patients with active disease defined by clinical or imaging features to slow the accumulation of physical disability and reduce the frequency of clinical relapses.

Produktbesonderheiten:

Package - Contents - Shelf Life: Vial, glass, Glass Type 1, Closure: rubber stopper and flip off seal - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours diluted stored at or below 25°C

Berechtigungsdatum:

2015-10-02

Gebrauchsinformation

1
LEMTRADA
®
_Alemtuzumab _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lemtrada.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Lemtrada
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT LEMTRADA IS
USED FOR
Lemtrada contains the active
substance alemtuzumab and is used
to treat relapsing forms of multiple
sclerosis (MS) in adults with active
disease who are not stable on current
therapy.
Lemtrada slows down the
progression of physical disability in
people with relapsing forms of MS
and decreases the number of flare-
ups (relapses).
In MS your immune system
mistakenly attacks the protective
layer (myelin) around the nerve
fibres of your brain and spinal cord,
causing inflammation.
Lemtrada works on your immune
system so that it may reduce the
impact of the disease on your
nervous system.
Your doctor, however, may have
prescribed Lemtrada for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
Lemtrada is not intended to be used
in children below 18 years old as it
has not been studied in MS patients
below 18 years old.
BEFORE YOU TAKE
LEMTRADA
Before treatment your doctor should
have discussed the risks and benefits
of Lemtrada and the need for you to
commit to 48-months of follow-up
after the last infusion of Lemtrada
_WHEN YOU MUST NOT TAKE _
_LEMTRADA _
DO NOT TAKE LEMTRADA IF YOU:
•
have an allergy to alemtuzumab
(the active ingredient) or proteins
of mouse origin, or any of the
ingredients listed at the end of
this leaflet.
Symptoms that may indicate an
allergic reaction include
•
shortness of breath
•
wheezing or difficulty br

Fachinformation

New Zealand Data Sheet
Lemtrada - alemtuzumab 10mg/ml injection concentrated
Lemtrada-ccdsv15-dsv7-20oct20
1
NEW ZEALAND DATA SHEET
1. LEMTRADA, CONCENTRATE FOR INFUSION, 10 MG/ML
Lemtrada 10 mg/mL concentrate for solution for infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Alemtuzumab (rch) is a recombinant DNA-derived humanised monoclonal
antibody directed
against the 21-28 kD cell surface glycoprotein, CD52. Alemtuzumab
(rch) is an IgG1 kappa
antibody with human variable framework and constant regions, and
complementarity-determining
regions from a murine monoclonal antibody. The antibody has an
approximate molecular weight
of 150 kD. Alemtuzumab (rch) is produced in mammalian cell (Chinese
hamster ovary)
suspension culture in a nutrient medium.
Each 1.0 mL of concentrate solution contains 10 mg Alemtuzumab (rch)
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 for the treatment of relapsing forms of multiple
sclerosis (MS) for patients
with active disease defined by clinical or imaging features to slow
the accumulation of physical
disability and reduce the frequency of clinical relapses.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Lemtrada treatment should be initiated and supervised by a
neurologist. Specialists and equipment
required for the timely diagnosis and management of serious adverse
reactions, especially
autoimmune conditions and infections, should be available.
New Zealand Data Sheet
Lemtrada - alemtuzumab 10mg/ml injection concentrated
Lemtrada-ccdsv15-dsv7-20oct20
2
Facilities for the management of hypersensitivity and/or anaphylactic
reactions should be
available.
Patients treated with Lemtrada must be given the Patient Wallet Card
and Patient Guide and be
informed about the risks of Lemtrada.
POSOLOGY
Administer Lemtrada in a setting in which equipment and personnel