What Naglazyme contains
- The active substance is galsulfase. One ml of Naglazyme contains 1 mg galsulfase. One vial of 5 ml contains 5 mg galsulfase. Galsulfase is recombinant human N-acetylgalactosamine 4-sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
- The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate, sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections.
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 Europe Limited
164 Shaftesbury Avenue
London, WC2H 8HL
Catalent UK Packaging Ltd.
Wingates Industrial Park,
Lancs, BL5 3XX
For any information about this medicine product, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgien BioMarin Europe Limited TélTel 00 800 2466 2746 biomarinfrbmrn.com LuxembourgLuxemburg BioMarin Europe Limited TélTel 00 800 2466 2746 biomarinfrbmrn.com
Magyarország BioMarin Europe Limited biomarinhubmrn.com BioMarin Europe Limited Te. 00 359 2 827 23 87 biomarinbgbmrn.com
eská republika BioMarin Europe Limited biomarincsbmrn.com Malta BioMarin Europe Limited biomarinenbmrn.com
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Eesti BioMarin Europe Limited biomarinetbmrn.com Österreich BioMarin Europe Limited Tel 00 800 2466 2746 biomarindebmrn.com
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Latvija BioMarin Europe Limited biomarinlvbmrn.com United Kingdom BioMarin Europe Limited Tel 00 800 2466 2746 biomarinenbmrn.com
BioMarin Europe Limited
This leaflet was last approved in
This medicine has been authorised under ?exceptional circumstances?.
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
<------------------------------------------------------------------------------------------------------------------------> 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.