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AstraZeneca

Naglazyme
galsulfase

PACKAGE LEAFLET: INFORMATION FOR THE USER


Naglazyme 1 mg/ml concentrate for solution for infusion

Galsulfase


Read all of this leaflet carefully before you start using this medicine because it contains important information for you.


What Naglazyme looks like and contents of the pack


Naglazyme is supplied as a concentrate for solution for infusion. The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles. The solution must be diluted further before it can be infused.


Pack sizes: 1 and 6 vials. Not all package sizes may be marketed.


Marketing Authorization Holder BioMarin International Limited Shanbally, Ringaskiddy

County Cork, P43 R298 Ireland

Manufacturer

BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 Ireland


This leaflet was last revised in MM/YYYY


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The following information is intended for medical or healthcare professionals only:


Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below.


Each vial of Naglazyme is intended for single use only. The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique. It is recommended that the diluted Naglazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.


Any unused product or waste material is to be disposed of in accordance with local requirements.


Preparation of the Naglazyme Infusion (Use Aseptic Technique)


The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature.


Before dilution, each vial is to be inspected for particulate matter and discolouration. The clear to slightly opalescent and colourless to pale yellow solution must be free of visible particles.


A volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion is to be withdrawn and discarded from a 250 ml infusion bag equal to the total volume of Naglazyme to be added. 100 ml infusion bags should be considered for patients who are susceptible to fluid volume overload and weigh less than 20 kg; in this case the infusion rate (ml/min) should be decreased so that the total

duration remains no less than 4 hours. When using 100 ml bags, the volume of Naglazyme may be added directly to the infusion bag.


The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ml (0.9%) solution for infusion.


The solution is to be mixed gently for infusion.


The solution is to be visually inspected for particulate matter prior to use. Clear and colourless solutions without visible particles should be used.