Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Sodium acetate trihydrate
Monosodium phosphate monohydrate
L-Arginine hydrochloride
Sorbitol
Polysorbate 20
Water for injections
6.2   Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

6.3   Shelf life

The expiry date of the product is indicated on the packaging material.
After dilution: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C – 8°C followed by up to 24 hours at 23°C – 27°C.

From a microbiological safety point of view, the diluted solution should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2°C – 8°C followed by up to 24 hours at 23°C – 27°C during administration.

6.4   Special precautions for storage

Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the original package in order to protect from light.

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

6.5   Nature and contents of container
Clear glass vial (Type I) with a butyl rubber stopper and a flip-off crimp seal (aluminium) with a plastic cap.

Pack sizes: 1 vial

6.6   Special precautions for disposal and other handling
Each vial of Vimizim is intended for single use only. Vimizim has to be diluted with sodium chloride 9 mg/ml (0.9 %) solution for infusion using aseptic technique. The diluted solution is administered to patients using an infusion set. An infusion set equipped with an in-line 0.2 μm filter can be used.

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


Preparation of the Vimizim infusion

Aseptic technique is to be used.

Vimizim must be diluted prior to administration.
The number of vials to be diluted is based on the individual patient's weight. The recommended dose is 2 mg per kg.

1. The number of vials to be diluted based on the individual patient’s weight and the recommended dose of 2 mg/kg is determined, using the following calculation: • Patient weight (kg) multiplied by 2 (mg/kg) = Patient dose (mg)
• Patient dose (mg) divided by 1 (mg/ml concentrate of Vimizim) = Total number of ml of Vimizim
• Total amount (ml) Vimizim divided by 5 ml per vial = Total number of vials      2. The calculated total number of vials is rounded up to the next whole vial. The appropriate number of vials is removed from the refrigerator. Do not heat or microwave vials. Do not shake vials.
3. An infusion bag containing sodium chloride 9 mg/ml (0.9 %) solution for infusion is obtained suitable for intravenous administration. The total volume of the infusion is determined by the patient’s body weight.
• Patients weighing less than 25 kg should receive a total volume of 100 ml.
• Patients weighing 25 kg or more should receive a total volume of 250 ml.
4. Before withdrawing Vimizim from the vial, each vial is visually inspected for particulate matter and discoloration. Because this is a protein solution, slight flocculation (thin translucent fibres) may occur. The Vimizim solution should be clear to slightly opalescent and colourless to pale yellow. Do not use if the solution is discoloured or if there is particulate matter in the solution.
5. A volume of the sodium chloride 9 mg/ml (0.9 %) solution for infusion is to be withdrawn and discarded from the infusion bag, equal to the volume of Vimizim concentrate to be added.
6. The calculated volume of Vimizim from the appropriate number of vials is slowly withdrawn using caution to avoid excessive agitation.
7. Vimizim is slowly added to the infusion bag using care to avoid agitation.
8. The infusion bag is gently rotated to ensure proper distribution of Vimizim. Do not shake the solution.
9. The diluted solution is administered to patients using an infusion set. An infusion set equipped with an in-line 0.2µm filter can be used.