avenous infusion only.
Each vial is for single use only.
Instructions for reconstitution and administrationLamzede should be reconstituted and administrated by a healthcare professional.
Aseptic technique is to be used during preparation. Filter needles must not be used during preparation.
a) The number of vials to be used should be calculated based on the individual patient’s weight.
The recommended dose of 1 mg/kg is determined using the following calculation:
- Patient’s weight (kg) × dose (mg/kg) = Patient dose (in mg)
- Patient dose (in mg) divided by 10 mg/vial (content of one vial) = number of vials to
reconstitute. If the number of calculated vials includes a fraction, it should be rounded up
to the next whole number.
- Approximately 30 minutes prior to reconstitution, the required number of vials should be
removed from the refrigerator. The vials should reach ambient temperature (between
15°C and 25°C) prior to reconstitution.
Each vial is reconstituted by slowly injecting 5 mL of water for injections to the inside of thewall of each vial. Each mL of reconstituted solution contains 2 mg of velmanase alfa. Only thevolume corresponding to the recommended dose should be administered.
Example:
- Patient’s weight (44 kg) × dose (1 mg/kg) = Patient dose (44 mg)
- 44 mg divided by 10 mg/vial = 4.4 vials, therefore, 5 vials should be reconstituted.
- From the total reconstituted volume, only 22 mL (corresponding to 44 mg) should be
administered.
b) The powder should be reconstituted in the vial by a slow drop-wise addition of the water forinjections down the inside of the vial and not directly onto the lyophilised powder. Forcefullyejecting the water for injections from the syringe onto the powder should be avoided to
minimise foaming. The reconstituted vials should stand on the table for about 5-10 minutes.
Thereafter each vial should be tilted and rolled gently for 15-20 seconds to enhance the
dissolution process. The vial should not be inverted, swirled, or shaken.
c) An immediate visual inspection of the solution for particulate matter and discoloration shouldbe performed after reconstitution. The solution should be clear and not used if opaque
particles are observed or if the solution is discoloured. Due to the nature of the medicinal
product, the reconstituted solution may occasionally contain some proteinaceous particles in
form of thin white strands or translucent fibers which will be removed by the in-line filter
during infusion (see point e).
d) The reconstituted solution is to be slowly withdrawn from each vial with caution to avoid
foaming in the syringe. If the volume of the solution exceeds one syringe capacity, the requirednumber of syringes should be prepared in order to replace the syringe quickly during theinfusion.
e) The reconstituted solution should be administered using an infusion set equipped with a pumpand an in-line low protein-binding 0.22 μm filter.
The total volume of infusion is determined by the patient’s weight and should be administratedover a minimum of 50 minutes. For patients weighing less than 18 kg, and receiving less than9 mL reconstituted solution, the infusion rate should be calculated so that the infusion time is≥50 minutes. The maximum infusion rate is 25 mL/hour (see section 4.2). The infusion time canbe calculated from the following table:
Patient
weight
(kg)
Dose
(mL)
Maximum
infusion
rate
(mL/h)
Minimu |
