MYOZYME alglucosidase alfa-rch 50 mg / 10 mL powder for concentrate for solution for infusion

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

Alglucosidase alfa, Quantity: 52.5 mg

Commercializzato da:

Sanofi-Aventis Australia Pty Ltd

INN (Nome Internazionale):

Alglucosidase alfa

Forma farmaceutica:

Injection, powder for

Composizione:

Excipient Ingredients: monobasic sodium phosphate monohydrate; polysorbate 80; mannitol; nitrogen

Via di somministrazione:

Intravenous

Confezione:

50 mg / 10 mL

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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

Dettagli prodotto:

Visual Identification: White to off-white lyophilised cake of powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2008-03-14

Foglio illustrativo

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
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 ANY QUESTIONS ABOUT WHY IT
HAS

Scheda tecnica

Property of the Sanofi group - strictly confidential
myo-ccdsv9-piv4-06aug20
Page 1
AUSTRALIAN PRODUCT INFORMATION – MYOZYME
(ALGLUCOSIDASE ALFA) POWDER FOR SOLUTION FOR INFUSION
1
NAME OF THE MEDICINE
Alglucosidase alfa.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 50 mg vial contains 52.5 mg alglucosidase alfa.
For the full list of excipients, see section 6.1 -
List of excipients
3
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion. 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. 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).
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.
Property of the Sanofi group - strictly confidential
myo-ccdsv9-piv4-06aug20
Page 2
_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
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, a