Elaprase

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Idursulfase 2 mg/mL;  

Disponible depuis:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

DCI (Dénomination commune internationale):

Idursulfase 2 mg/mL

Dosage:

2 mg/mL

forme pharmaceutique:

Concentrate for infusion

Composition:

Active: Idursulfase 2 mg/mL   Excipient: Dibasic sodium phosphate heptahydrate Monobasic sodium phosphate monohydrate Polysorbate 20 Sodium chloride Water for injection

Unités en paquet:

Vial, glass, 5mL Type 1, B2-coated butyl stopper, aluminium seal, plastic flip off cap, 1 dose unit

classe:

Prescription

Type d'ordonnance:

Prescription

Fabriqué par:

Shire Human Genetic Therapies Inc

indications thérapeutiques:

ELAPRASE is indicated for the long term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).

Descriptif du produit:

Package - Contents - Shelf Life: Vial, glass, 5mL Type 1, B2-coated butyl stopper, aluminium seal, plastic flip off cap - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. do not shake 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Date de l'autorisation:

2008-01-18

Notice patient

ELAPRASE
®
1
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-
THREAT

Résumé des caractéristiques du produit

elaprase-ccdsv14-dsv4-20jun22
Page 1 of 18
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
ELAPRASE (idursulfase) 6 mg/3 mL concentrate for intravenous solution
for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
The solution in each vial contains an idursulfase 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 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.
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
elaprase-ccdsv14-dsv4-20jun22
Page 2 of 18
Home infusions must be administered by a healthcare professional.
Health professionals administering the product must be:
a)
adequately trained in cardiopulmonary resuscitative measures
b)
have ready access to emergency medical services
c)
trained in recognising and managing serious infusion related
reactions,
hypersensitivity reactions and medical emergencies, including measures
appropriate for the age of the patient, und