ALDURAZYME laronidase (rch) 500U/5mL injection vial

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

Laronidase, Quantity: 0.58 mg/mL

Disponible depuis:

Sanofi-Aventis Australia Pty Ltd

DCI (Dénomination commune internationale):

Laronidase

forme pharmaceutique:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections; polysorbate 80; sodium chloride; monobasic sodium phosphate monohydrate; dibasic sodium phosphate heptahydrate

Mode d'administration:

Intravenous

Unités en paquet:

1 x 5 mL vial

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

Aldurazyme is indicated as long term enzyme replacement therapy in patients with Mucopolysaccharidosis (MPS I; alpha - L - iduronidase deficiency) to treat the non-neurological manifestations of the disease. Aldurazyme is indicated as long term enzyme replacement therapy in patients with Mucopolysaccharidosis (MPS I; alpha - L - iduronidase deficiency) to treat the non-neurological manifestations of the disease.

Descriptif du produit:

Visual Identification: Colourless to pale yellow, clear to slightly opalescent solution that must be diluted prior to administration.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Statut de autorisation:

Licence status A

Date de l'autorisation:

2004-05-07

Notice patient

ALDURAZYME
®
[AL-DUR-A-ZIME]
_laronidase-rch [lar-on-I-daze R.C.H.] 500 U, Concentrate for Solution
for Infusion_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ALDURAZYME.
It does not contain all the available
information.
It does not take the place of talking to
your treating physician or a trained
health care professional.
All medicines have risks and
benefits. Your treating physician has
weighed the risks of you or your
child having ALDURAZYME
against the benefits they expect it
will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR TREATING
PHYSICIAN OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ALDURAZYME
IS USED FOR
ALDURAZYME is used as enzyme
replacement therapy in
Mucopolysaccharidosis I (MPS I)
storage disorder, a disease in which
the level of
α
-L-iduronidase is absent
or lower than normal.
_HOW IT WORKS_
Patients with MPS I disease do not
produce enough of their own
enzyme,
α
-L-iduronidase. The
reduced or absent
α
-L-iduronidase
activity in patients results in the
accumulation of substances called
glycosaminoglycans (GAGs) in most
cell types and tissues.
ALDURAZYME is an enzyme
replacement therapy that is intended
to restore a level of enzyme activity
sufficient to remove the accumulated
GAGs and to prevent further
accumulation.
BEFORE YOU ARE GIVEN
ALDURAZYME
_WHEN YOU OR YOUR CHILD_
_MUST NOT BE GIVEN IT_
DO NOT TAKE ALDURAZYME IF
YOU OR YOUR CHILD HAVE A KNOWN,
SEVERE, LIFE-THREATENING ALLERGIC
REACTION TO ANY OF THE INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
skin rash, itching or hives
IF YOU ARE NOT SURE WHETHER YOU OR
YOUR CHILD SHOULD HAVE
ALDURAZYME, TALK TO YOUR
TREATING PHYSICIAN OR NURSE.
_BEFORE YOU OR YOUR CHILD ARE_
_GIVEN IT_
TELL YOUR TREATING PHYSICIAN IF YOU
OR YOUR CHILD HAVE REACTED TO
PREVIOUS TREATMENTS WITH ANY OF

Résumé des caractéristiques du produit

aldu-ccdsv2011-12-28-piv3-14dec18
Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION – ALDURAZYME®
(LARONIDASE-RCH CONCENTRATE FOR SOLUTION FOR
INFUSION)
1
NAME OF THE MEDICINE
Laronidase -rch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The extractable volume of 5.0 mL from each vial provides 2.9 mg (500
U) laronidase, 43.9 mg
sodium chloride, 63.5 mg monobasic sodium phosphate monohydrate, 10.7
mg dibasic sodium
phosphate heptahydrate, and 0.05 mg polysorbate 80. Aldurazyme does
not contain
preservatives; vials are for single use only. See section 6.1 List of
excipients.
3
PHARMACEUTICAL FORM
Aldurazyme is intended for intravenous infusion. It is supplied as a
sterile, nonpyrogenic,
colourless to pale yellow, clear to slightly opalescent solution that
must be diluted prior to
administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aldurazyme is indicated as long-term enzyme replacement therapy in
patients with
Mucopolysaccharidosis I (MPS I;

-L-iduronidase deficiency) to treat the non-neurological
manifestations of the disease.
4.2
DOSE 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
clinical emergencies would be readily available.
aldu-ccdsv2011-12-28-piv4-18sep19
Page 2 of 18
The recommended dosage regimen of Aldurazyme is 100 U/kg (0.58 mg/kg)
of actual body
weight administered once weekly as an intravenous infusion.
Pretreatment with antipyretics and/or antihistamines is recommended 60
minutes prior to the
start of the infusion. In the Phase 3 studies, all patients were
pretreated prior to each infusion
with age-appropriate dosages of antihistamines and antipyretics, such
as diphenhydramine or
hydroxyzine and paracetamol or ibuprofen, respectively (see section
4.4 SPECIAL WARNINGS
AND PRECAUTIONS FOR USE, General).
The total volume of the infusion