Myozyme

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Alglucosidase alfa 52.5mg;  ;  ;  

Available from:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International Name):

Alglucosidase alfa 52.5 mg

Dosage:

50 mg/10mL

Pharmaceutical form:

Powder for infusion concentrate

Composition:

Active: Alglucosidase alfa 52.5mg       Excipient: Dibasic sodium phosphate heptahydrate Mannitol Monobasic sodium phosphate monohydrate Nitrogen Polysorbate 80

Units in package:

Vial, glass, Type I, 20 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Genzyme Flanders

Therapeutic indications:

Myozyme is indicated for the long - term treatment of patients with a confirmed diagnosis of Pompe disease (acid alfa - glucosidase deficiency).

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I - 20 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. Do not shake 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2007-09-03

Patient Information leaflet

Page 1 of 3
MYOZYME
®
_ _
_[my-oh-ZIME]_
_ _
Alglucosidase alfa-rch _[al-glue-co-SIDE-aze al-fa R.C.H]_ 50 mg/10
mL, Powder for Concentrate
for Solution for Infusion
CONSUMER MEDICINE INFORMATION (CMI)_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Myozyme.
It does not contain all the available
information about Myozyme.
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 Myozyme 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 IT IS USED FOR
_WHAT MYOZYME IS USED FOR_
Myozyme is used to treat Pompe
disease, a rare genetic disease in
which the level of an enzyme called
acid alfa-glucosidase is missing or
is lower than in healthy individuals.
Myozyme is used as a replacement
to the lack of or low levels of the
enzyme.
Myozyme contains the
active ingredient alglucosidase alfa-
rch. Alglucosidase alfa-rch is a
type of protein.
Myozyme is available only with a
doctor's prescription. Only the
treating physician can start the
treatment and supervise the
ongoing treatment.
Myozyme is to be given only to the
person for whom it has been
prescribed.
_HOW IT WORKS _
Patients with Pompe disease do
not produce enough of their own
enzyme, acid alfa-glucosidase. The
reduced acid alfa-glucosidase
activity in patients results in the
build up of glycogen
in many parts
of the body. Myozyme is an
enzyme replacement therapy that is
intended to restore a level of
enzyme activity sufficient to remove
the accumulated glycogen and to
prevent further accumulation.
Pompe disease has been
described under 2 forms: early-
onset and late-onset. Your
physician is in the best position to
determine the risks and benefits of
treatment with Myozyme and he will
discuss it with you or your child.
ASK YOUR TREATING PHYSICIAN IF
YOU HAVE

Summary of Product characteristics

myo-ccdsv11-dsv7-13dec23
Page 1
NEW ZEALAND DATA SHEET
1
MYOZYME 50 MG/10 ML POWDER FOR INFUSION
CONCENTRATE
MYOZYME 50 mg/10 mL powder for concentrate for solution for infusion.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg vial contains 52.5 mg alglucosidase alfa.
Following reconstitution as directed, each vial contains 10.5 mL
reconstituted solution and a total
extractable volume of 10 mL at 5.0 mg/mL alglucosidase alfa.
Alglucosidase alfa-rch is produced by recombinant DNA technology in a
Chinese hamster ovary
cell line.
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
MYOZYME does not contain preservatives.
Each vial is for single use only.
Each reconstituted vial must be diluted prior to administration in
0.9% sodium chloride for
injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MYOZYME is indicated for the long-term treatment of patients with a
confirmed diagnosis of
Pompe disease (acid alfa-glucosidase deficiency).
myo-ccdsv11-dsv7-13dec23
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended dosage regimen of MYOZYME is 20 mg/kg of body weight
administered
once every 2 weeks as an intravenous infusion.
_ELDERLY POPULATION _
Clinical studies did not include any subjects aged 65 years and older.
It is not known whether they
respond differently than younger subjects.
_PAEDIATRIC POPULATION _
There is no evidence for special considerations when MYOZYME is
administered to paediatric
patients of all ages.
METHOD OF ADMINISTRATION
Each reconstituted vial must be diluted prior to administration in
0.9% sodium chloride for
injection.
For instructions on reconstitution and dilution of the medicine before
administration, see section
6.6 Special precautions for disposal and other handling.
Infusions should be administered incrementally. MYOZYME should be
administered at an initial
infusion rate of no more than 1 mg/kg/hr. The infusion rate may be
increased by 2 mg/kg/hr every
30 minutes, after p