CEREZYME 400 UNITS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IMIGLUCERASE

Available from:

SANOFI ISRAEL LTD

ATC code:

A16AB02

Pharmaceutical form:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

IMIGLUCERASE 400 U/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

GENZYME EUROPE B.V., THE NETHERLANDS

Therapeutic group:

IMIGLUCERASE

Therapeutic area:

IMIGLUCERASE

Therapeutic indications:

For the long term enzyme replacement therapy for patients with a confirmed diagnosis of Type 1 gaucher disease that results in one or more of the following conditions: - Anemia - Thrombocytopenia - Bone disease - Hepatomegaly or splenomegaly.

Authorization date:

2020-07-31

Summary of Product characteristics

1
_ _
_Cerezyme PI V11.0 _
_ _
FULL PRESCRIBING INFORMATION
CEREZYME 400 UNITS
Imiglucerase 400 units/vial
Powder for concentrate for solution for infusion
1
INDICATIONS AND USAGE
Cerezyme 400 units is indicated for the long term enzyme replacement
therapy for patients with
a confirmed diagnosis of Type 1 Gaucher disease that results in one or
more of the following
conditions:
•
anemia
•
thrombocytopenia
•
bone disease
•
hepatomegaly or splenomegaly
2
DOSAGE AND ADMINISTRATION
CEREZYME
®
is administered by intravenous infusion over 1-2 hours. Dosage should
be
individualized to each patient. Initial dosages range from 2.5 U/kg of
body weight 3 times a
week to 60 U/kg once every 2 weeks. 60 U/kg every 2 weeks is the
dosage for which the 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 decrease, based on achievement of
therapeutic goals as assessed by
routine comprehensive evaluations of the patient’s clinical
manifestations.
CEREZYME
should be stored at 2-8°C. After reconstitution,
CEREZYME
should be inspected
visually before use. Because this is a protein solution, slight
flocculation (described as thin
translucent fibers) occurs occasionally after dilution. The diluted
solution may be filtered
through an in-line low protein-binding 0.2 μm filter during
administration. Any vials exhibiting
opaque particles or discoloration should not be used. DO NOT USE
CEREZYME
after the
expiration date on the vial.
On the day of use, after the correct amount of
CEREZYME
to be administered to the patient has
been determined, the appropriate number of vials are each
reconstituted with Sterile Water for
Injection, USP. The final concentrations and administration volumes
are provided in the
following table:
400 UNIT VIAL
Sterile water for reconstitution
10.2 mL
Final volume of reconstituted product
10.6 mL
Concentration after reconstitution
40 U/m