Cerezyme

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Imiglucerase 212 U (biological product from recombinant CHO cells)

Saatavilla:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Kansainvälinen yleisnimi):

Imiglucerase 212 U (biological product from recombinant CHO cells)

Annos:

40 U/mL

Lääkemuoto:

Powder for infusion

Koostumus:

Active: Imiglucerase 212 U (biological product from recombinant CHO cells) Excipient: Citric acid monohydrate Mannitol Nitrogen Polysorbate 80 Sodium citrate dihydrate

Kpl paketissa:

Vial, glass, 1 x 400U, 10 mL

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Genzyme Corporation

Tuoteyhteenveto:

Package - Contents - Shelf Life: Vial, glass, 1 x 400U - 10 mL - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Valtuutus päivämäärä:

1998-08-12

Valmisteyhteenveto

New Zealand Data Sheet
Cerezyme - Imiglucerase
1
cere-ccdsv5-dsv4-12jun23
NEW ZEALAND DATA SHEET
1. CEREZYME POWDER FOR INFUSION
CEREZYME® Powder for infusion, 40U/mL, 400U/vial
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 400 units* of imiglucerase**.
After reconstitution, the solution contains 40 units (approximately
1.0 mg) of imiglucerase
per mL (400U/10 mL).
*An Enzyme Unit (U) is defined as the amount of enzyme that catalyses
the hydrolysis of one
micromole of the synthetic substrate para-nitrophenyl

-D-glucopyranoside (pNP-Glc) per
minute at 37

C.
**Imiglucerase is a modified form of human acid

-glucosidase and is produced by
recombinant DNA technology using a mammalian Chinese Hamster Ovary
(CHO) cell
culture, with mannose modification for targeting macrophages.
Excipients:
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
Cerezyme is a white to off-white powder.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cerezyme (imiglucerase) is indicated for long-term enzyme replacement
therapy for patients
with a confirmed diagnosis of non-neuronopathic (Type 1) or chronic
neuronopathic (Type 3)
Gaucher disease who exhibit clinically significant non-neurological
manifestations of the
disease.
The non-neurological manifestations of Gaucher disease include one or
more of the following
conditions:
a)
anaemia;
b)
thrombocytopenia;
c)
bone disease;
d)
hepatomegaly or splenomegaly.
New Zealand Data Sheet
Cerezyme - Imiglucerase
2
cere-ccdsv5-dsv4-12jun23
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Dosage should be individualised for each patient. Initial dosages
range from 2.5U/kg of body
weight 3 times a week to 60U/kg once every two weeks. 60U/kg every 2
weeks is the dosage
for which most data are available. Disease severity may dictate that
treatment be initiated at
a relatively high dose or relatively frequent administration. Dosage
adjustments should be
made on an individual basis, and may increase or decrea