NEXVIAZYME avalglucosidase alfa powder for injection100mg/10mL vial

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

Avalglucosidase alfa, Quantity: 100 mg

Beszerezhető a:

Sanofi-Aventis Australia Pty Ltd

Gyógyszerészeti forma:

Injection, powder for

Összetétel:

Excipient Ingredients: histidine; polysorbate 80; mannitol; histidine hydrochloride monohydrate; glycine

Az alkalmazás módja:

Intravenous Infusion

db csomag:

1

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

Nexviazyme is indicated for long-term enzyme replacement therapy for the treatment of patients one year of age and older with Pompe disease (acid ?-glucosidase deficiency).

Termék összefoglaló:

Visual Identification: White to pale yellow lyophilised powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Engedélyezési státusz:

Registered

Engedély dátuma:

2021-11-17

Betegtájékoztató

NEXVIAZYME
®
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new. Please report side effects. See the full CMI for
further details.
1.
WHY AM I BEING GIVEN NEXVIAZYME?
Nexviazyme contains the active ingredient avalglucosidase alfa.
Nexviazyme is used to treat Pompe disease in patients one year of
age and older.
For more information, see Section 1. Why am I being given Nexviazyme?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN NEXVIAZYME?
Do not use if you have had an allergic reaction to Nexviazyme or any
of the ingredients listed at the end of the CMI, and re-
administration of the medicine was not successful.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Nexviazyme? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Nexviazyme and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW WILL NEXVIAZYME BE GIVEN?
•
Your doctor or nurse will give you Nexviazyme into a vein
(intravenously) as a drip infusion.
More instructions can be found in Section 4. How will Nexviazyme be
given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN NEXVIAZYME?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Nexviazyme.
•
It is important to keep your appointments to make sure the medicine
works.
THINGS YOU
SHOULD NOT DO
•
Do not stop your treatment with Nexviazyme unless you have discussed
it with your doctor.
DRIVING
OR USING
MACHINES
•
Take care when driving shortly after infusion of Nexviazyme, since you
may experience dizziness
LOOKING AFTER
YOUR MEDICINE
•
Nexviazyme will be stored at the hospital or cl

Termékjellemzők

Property of the Sanofi group - strictly confidential
nexviazyme-ccdsv3.1-piv2-12oct22
Page 1 of 25
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – NEXVIAZYME
®
(AVALGLUCOSIDASE ALFA)
1
NAME OF THE MEDICINE
Avalglucosidase alfa
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial contains 100 mg of avalglucosidase alfa
*
as powder for injection. The
powder for injection is reconstituted with 10 mL sterile water for
injections (WFI).
Each vial contains an overfill to compensate for liquid loss during
preparation.
Following reconstitution, each vial contains 10.3 mL reconstituted
solution and a total
extractable volume of 10 mL. Each mL of the reconstituted solution
contains 10 mg of
Avalglucosidase alfa.
* Avalglucosidase alfa is a human acid α-glucosidase produced in
Chinese hamster ovary
cells (CHO) by recombinant DNA technology, which is subsequently
conjugated with
approximately 7 hexamannose structures (each containing two terminal
mannose-6-phosphate
(M6P) moieties) to oxidised sialic acid residues on the molecule,
thereby increasing bis-M6P
levels.
For the full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Powder for injection.
White to pale yellow lyophilised powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Nexviazyme is indicated for long-term enzyme replacement therapy for
the treatment of
patients one year of age and older with Pompe disease (acid
α-glucosidase deficiency).
▼

Property of the Sanofi group - strictly confidential
nexviazyme-ccdsv3.1-piv2-12oct22
Page 2 of 25
4.2
DOSE AND METHOD OF ADMINISTRATION
Nexviazyme treatment should be supervised by a physician experienced
in the management
of patients with Pompe disease or other inherited metabolic or
neuromuscular diseases.
DOSE
The recommended dose of Nexviazyme is 20 mg/k