ALDURAZYME Concentrate for solution for infusion Ref.[9232] Active ingredients: Laronidase

Aldurazyme treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases. Administration of Aldurazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.

Posology

The recommended dosage regimen of Aldurazyme is 100 U/kg body weight administered once every week.

Paediatric population

No dose adjustment is necessary for the paediatric population.

Elderly

The safety and efficacy of Aldurazyme in patients older than 65 years have not been established and no dosage regimen can be recommended in these patients.

Renal and hepatic impairment

The safety and efficacy of Aldurazyme in patients with renal or hepatic insufficiency have not been evaluated and no dosage regimen can be recommended in these patients.

Method of administration

Aldurazyme is to be administered as an intravenous infusion.

The initial infusion rate of 2 U/kg/h may be incrementally increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h. The total volume of the administration should be delivered in approximately 3-4 hours. For information on pre-treatment, see section 4.4.

For instruction on dilution of the medicinal product before administration, see section 6.6.

No case of overdose has been reported.

Shelf life

Unopened vials: 3 years.

Diluted solutions: From a microbiological safety point of view, the product should be used immediately. If not used immediately, in-use storage should not be longer than 24 hours at 2°C-8°C provided that dilution has taken place under controlled and validated aseptic conditions.

Store in a refrigerator (2°C–8°C).

For storage conditions after dilution of the medicinal product, see section 6.3.

5 ml concentrate for solution in a vial (type I glass) with a stopper (siliconised chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).

Pack sizes: 1, 10 and 25 vials.

Not all pack sizes may be marketed.

Each vial of Aldurazyme 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 Aldurazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.

Preparation of the Aldurazyme Infusion (Use Aseptic Technique):

• Determine the number of vials to be diluted based on the individual patient’s weight. Remove the required vials from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature (below 30˚C).
• Before dilution, visually inspect each vial for particulate matter and discoloration. The clear to slightly opalescent and colourless to pale yellow solution should be free of visible particles. Do not use vials exhibiting particles or discoloration.
• Determine the total volume of infusion based on the individual patient’s weight, either 100 ml (if body weight is less or equal than 20 kg) or 250 ml (if body weight is more than 20 kg) of sodium chloride 9 mg/ml (0.9%) solution for infusion.
• Withdraw and discard a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the infusion bag equal to the total volume of Aldurazyme to be added.
• Withdraw the required volume from the Aldurazyme vials and combine the withdrawn volumes.
• Add the combined volumes of Aldurazyme to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
• Mix the solution for infusion gently.
• Prior to use visually inspect the solution for particulate matter. Only clear and colourless solutions without visible particles should be used.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.