Aldurazyme

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

laronidase

Διαθέσιμο από:

Sanofi B.V.

Φαρμακολογική κατηγορία (ATC):

A16AB05

INN (Διεθνής Όνομα):

laronidase

Θεραπευτική ομάδα:

Other alimentary tract and metabolism products,

Θεραπευτική περιοχή:

Mucopolysaccharidosis I

Θεραπευτικές ενδείξεις:

Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis I (MPS I; alpha-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease.

Περίληψη προϊόντος:

Revision: 24

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2003-06-09

Φύλλο οδηγιών χρήσης

21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALDURAZYME 100 U/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Laronidase
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 your 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 Aldurazyme is and what it is used for
2.
What you need to know before you are given Aldurazyme
3.
How Aldurazyme is given
4.
Possible side effects
5.
How to store Aldurazyme
6.
Contents of the pack and other information
1.
WHAT ALDURAZYME IS AND WHAT IS IT USED FOR
Aldurazyme is used to treat patients with MPS I disease
(Mucopolysaccharidosis I). It is given to treat
the non-neurological manifestations of the disease.
People with MPS I disease have either a low level or no level of an
enzyme called
α
-L-iduronidase,
which breaks down specific substances (glycosaminoglycans) in the
body. As a result, these
substances do not get broken down and processed by the body as they
should. They accumulate in
many tissues in the body, which causes the symptoms of MPS I.
Aldurazyme is an artificial enzyme called laronidase. This can replace
the natural enzyme which is
lacking in MPS I disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALDURAZYME
YOU SHOULD NOT BE GIVEN ALDURAZYME
If you are allergic (hypersensitive) to laronidase or any of the other
ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Aldurazyme.
Contact your doctor immediately if treatment with Aldurazyme causes:
•
Allergic reactions, including anaphylaxis (a severe allergy reaction)
– see

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aldurazyme 100 U/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 100 U (approximately 0.58 mg) of laronidase.
Each vial of 5 ml contains 500 U of laronidase.
The activity unit (U) is defined as the hydrolysis of one micromole of
substrate (4-MUI) per minute.
Laronidase is a recombinant form of human
α
-L-iduronidase and is produced by recombinant DNA
technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Excipient(s) with known effect:
Each vial of 5 ml contains 1.29 mmol sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
A clear to slightly opalescent, and colourless to pale yellow
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aldurazyme is indicated for long-term enzyme replacement therapy in
patients with a confirmed
diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase
deficiency) to treat the non-
neurological manifestations of the disease (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Aldurazyme treatment should be supervised by a physician experienced
in the management of patients
with MPS I or other inherited metabolic diseases. Administration of
Aldurazyme should be carried out
in an appropriate clinical setting where resuscitation equipment to
manage medical emergencies would
be readily available.
Posology
The recommended dosage regimen of Aldurazyme is 100 U/kg body weight
administered once every
week.
_Paediatric population _
No dose adjustment is necessary for the paediatric population.
_Elderly _
The safety and efficacy of Aldurazyme in patients older than 65 years
have not been established and
no dosage regimen can be recommended in these patients.
3
_Renal and hepatic impairment _
The safety and efficacy of Aldurazyme in patients with renal or
hepatic insufficiency have not been
evaluated and no dosage regimen can be recommended in these patients.
M