ELAPRASE SOLUTION FOR INTRAVENOUS INFUSION

Pajjiż: Malasja

Lingwa: Ingliż

Sors: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredjent attiv:

Idursulfase

Disponibbli minn:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN (Isem Internazzjonali):

Idursulfase

Unitajiet fil-pakkett:

5ml mL; 3 ml mL

Manifatturat minn:

GENZYME CORPORATION

Karatteristiċi tal-prodott

Elaprase Malaysia PI Update to US V8 2013 -06
ELAPRASE ® (idursulfase)
Solution for intravenous infusion
WARNING: RISK OF ANAPHYLAXIS
Life -threatening anaphylactic reactions have occurred in some patients during and up to 24 hours after
ELAPRASE infusions. Anaphylaxis, presenting as respiratory distress, hypoxia, hypotension, urticaria
and/or angioedema of throat or tongue have been rep orted to occur during and after ELAPRASE infusions,
regardless of duration of the course of treatment. Closely observe patients during and after ELAPRASE
administration and be prepared to manage anaphylaxis. Inform patients of the signs and symptoms of
an aphylaxis and have them seek immediate medical care should symptoms occur. Patients with
compromised respiratory function or acute respiratory disease may be at risk of serious acute exacerbation
of their respiratory compromise due to hypersensitivity reac tions, and require additional monitoring [see
Warnings and Precautions and Adverse Reactions ].
INDICATIONS AND USAGE
ELAPRASE is indicated for patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
ELAPRASE has been shown to improve walking capacity in these patients.
DOSAGE AND ADMINISTRATION
Recommended Dose
The recommended dosage regimen of ELAPRASE is 0.5 mg/kg of body weight administered once week ly
as an intravenous infusion.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit.
Preparation Instructions
Prepare and use ELAPRASE according to the following steps using aseptic technique: a. Determine the
total volume of ELAPRASE to be admin istered and the number of vials needed based on the patient’s
weight and the recommended dose of 0.5 mg/kg.
Patient’s weight (kg) x 0.5 mg per kg of ELAPRASE  2 mg per mL =
Total mL of ELAPRASE
Total mL of ELAPRASE  3 mL per vial = Total number of vials
Round up to the next whole vial to determine the number of vials ne eded . Remove the required number of
via