Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3803
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Cerezyme (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:dosage |
Cerezyme'
(imiglucerase for injection) 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 (36-46��F). 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��m 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: A nominal 5.0 mL for the 200 unit vial (10.0 mL for the 400 unit
vial) is withdrawn from each vial. The appropriate amount of Cerezyme' for each patient is
diluted with 0.9% Sodium Chloride Injection, USP, to a final volume of
100���200 mL. Cerezyme' is administered by intravenous infusion
over 1-2 hours. Aseptic techniques should be used when diluting the
dose. Since Cerezyme' does
not contain any preservative, after reconstitution, vials should be
promptly diluted and not stored for subsequent use. Cerezyme', after reconstitution,
has been shown to be stable for up to 12 hours when storedat room
temperature (25��C) and at 2-8��C. Cerezyme', when diluted, has
been shown to be stable for up to 24 hours when stored at
2-8��C. Relatively low toxicity, combined with the extended time course
of response, allows small dosage adjustments to be made occasionally to
avoid discarding partially used bottles. Thus, the dosage administered
in individual infusions may be slightly increased or decreased to
utilize fully each vial as long as the monthly administered dosage
remains substantially unaltered.
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| dailymed-instance:activeIng... | |
| dailymed-instance:supply |
Cerezyme'
(imiglucerase for injection) is supplied as a sterile, non-pyrogenic,
lyophilized product. It is available as follows: 200 Units per Vial NDC
58468-1983-1400 Units per
Vial NDC 58468-4663-1 Store at 2-8��C (36-46��F). Rx only U.S. Patent Numbers:
5,236,8385,549,892 Cerezyme'
(imiglucerase for injection) is manufactured by:Genzyme Corporation500 Kendall StreetCambridge, MA 02142 USA Certain manufacturing operations may have been performed by other
firms.6743 (4/05)
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| dailymed-instance:genericDr... | |
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:genericMe... |
imiglucerase
|
| dailymed-instance:fullName |
Cerezyme (Injection, Powder, Lyophilized, For Solution)
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| dailymed-instance:indicatio... |
Cerezyme'
(imiglucerase for injection) is indicated for long-term enzyme
replacement therapy for pediatric and adult patients with a confirmed
diagnosis of Type 1 Gaucher disease that results in one or more of the
following conditions:
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Cerezyme
|