ELAPRASE idursulfase-rhu concentrate for solution for IV infusion vial

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

Idursulfase, Quantity: 6 mg

Beszerezhető a:

Sanofi-Aventis Australia Pty Ltd

INN (nemzetközi neve):

Idursulfase

Gyógyszerészeti forma:

Injection, intravenous infusion

Összetétel:

Excipient Ingredients: sodium chloride; water for injections; dibasic sodium phosphate heptahydrate; monobasic sodium phosphate monohydrate; polysorbate 20

Az alkalmazás módja:

Intravenous

db csomag:

6mg/3mL vial

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

For the long term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II) For the long term treatment of patients with Hunter syndrome (Mucoplysaccharidosis II, MPS II).

Termék összefoglaló:

Visual Identification: clear to slightly opalescent colourless solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Engedélyezési státusz:

Registered

Engedély dátuma:

2008-02-21

Betegtájékoztató

ELAPRASE
®
_Idursulfase 6 mg/3 mL, Concentrate for Solution for Infusion_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Elaprase.
It does not contain all the available
information about Elaprase.
It does not take the place of talking to
your doctor or a trained health care
professional.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child having
Elaprase against the benefits they
expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT ELAPRASE IS USED
FOR
Elaprase is used as enzyme
replacement therapy to treat Hunter
syndrome (Mucopolysaccharidosis
II), a rare genetic disease in which an
enzyme called iduronate-2-sulfatase
is missing or the level of the enzyme
is lower than normal.
Hunter syndrome generally occurs in
males and rarely in females.
Elaprase is available only with a
doctor's prescription. Only your or
your child’s treating doctor can start
the treatment and supervise the
ongoing treatment.
Elaprase is to be given only to the
person for whom it has been
prescribed.
_HOW IT WORKS_
Patients with Hunter syndrome do
not produce enough of their own
enzyme, iduronate-2-sulfatase. The
reduced iduronate-2-sulfatase levels
in patients result in the accumulation
of substances called
glycosaminoglycans (GAG) in a
number of cells and tissues. This
causes the affected cells and tissues
to function abnormally, thereby
causing problems for various organs
in the body.
Elaprase is an enzyme replacement
therapy that is intended to restore
sufficient levels of enzyme to assist
in the removal of the accumulated
substances and to reduce further
accumulation.
ASK YOUR TREATING DOCTOR IF YOU
HAVE ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU OR
YOUR CHILD.
BEFORE YOU ARE GIVEN
ELAPRASE
_WHEN YOU OR YOUR CHILD_
_MUST NOT BE GIVEN IT_
DO NOT TAKE ELAPRASE IF YOU OR YOUR
CHILD HAVE A KNOWN, SEVERE, LIFE-
THREATENING ALLERGIC REA

Termékjellemzők

Property of the Sanofi group - strictly confidential
elaprase-ccdsv14-piv5-11dec20
Page 1 of 19
AUSTRALIAN PRODUCT INFORMATION – ELAPRASE (IDURSULFASE)
1
NAME OF THE MEDICINE
Idursulfase
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
6 mg/3 mL concentrate for intravenous solution for infusion.
The solution in each vial contains an idursulfase
1
concentration of 2 mg/mL at a pH of
approximately 6. The extractable volume of 3 mL from each vial
provides 6 mg idursulfase.
ELAPRASE does not contain preservatives; vials are for single use
only.
For the full list of excipients, see Section 6.1
LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
ELAPRASE, for intravenous infusion, is supplied as a sterile, aqueous,
clear to slightly opalescent
colourless solution that must be diluted prior to administration in
0.9% Sodium Chloride for
Injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ELAPRASE is indicated for the long term treatment of patients with
Hunter syndrome
(Mucopolysaccharidosis II, MPS II).
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be supervised by a physician or healthcare
professional experienced in the
management of patients with MPS II or other inherited metabolic
disorders.
The recommended dosage regimen of ELAPRASE is 0.5 mg/kg of body weight
administered
every week as an intravenous infusion.
1
Idursulfase is produced by recombinant DNA technology in a continuous
human cell line.
Property of the Sanofi group - strictly confidential
elaprase-ccdsv14-piv5-11dec20
Page 2 of 19
Infusion of ELAPRASE at home may be considered after the most careful
consideration of the
risks and benefits in patients who:
a)
are tolerating their infusions well
b)
have received a minimum of 6 months of treatment in the clinic
c)
have been free of infusion related reactions for a period of 6 months
d)
have stable airway disease
Home infusions must be administered by a healthcare professional.
Health professionals administering the product must be:
a)
adequately trained in cardiopulmonary resuscitative measures
b)
hav