Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Trisodium citrate dihydrate
Human serum albumin
Citric acid monohydrate
Water for injections

6.2    Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3    Shelf life

The expiry date of the product is indicated on the packaging materials.
After dilution: Chemical and physical in-use stability has been demonstrated for up to 24 hours at 2°C to 8°C, or up to 12 hours below 25°C.

From a microbiological point of view, the diluted solution should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, or up to 12 hours below 25°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4    Special precautions for storage

Store in a refrigerator (2°C to 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 siliconised butyl rubber stopper, and an aluminium seal with a plastic flip-off cap, containing 10 ml of concentrate.

Pack size: 1 vial

6.6   Special precautions for disposal and other handling
Each vial of KANUMA is intended for single use only. KANUMA has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
The diluted solution should be administered to patients using a low-protein binding infusion set equipped with an in-line, low-protein binding 0.2 μm filter, with a surface area of greater than 4.5 cm2 as available in order to avoid filter occlusion.

Preparation of the sebelipase alfa infusion

KANUMA should be prepared and used according to the following steps. Aseptic technique should be used.
a. The number of vials to be diluted for infusion should be determined based on the patient’s weight and prescribed dose.
b. The vials should not be frozen, heated or microwaved and should be protected from light.
c. The vials should not be shaken. Prior to dilution, the concentrate in the vials should be inspected visually; the concentrate should be clear to slightly opalescent, colourless to slightly coloured (yellow). Due to the proteinaceous nature of the medicinal product, slight flocculation (e.g., thin translucent fibres) may be present in the vial concentrate and is acceptable for use.
d. Do not use if the concentrate is cloudy, or if foreign particulate matter is present.
e. Up to 10 ml of concentrate should be slowly withdrawn from each vial and diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion. See Table 5 for recommended total infusion volumes by weight range. The solution should be mixed gently, and not be shaken.

Table 5: Recommended infusion volumes*
1 mg/kg dose                     3 mg/kg dose**
Weight range (kg)
Total infusion                   Total infusion volume (ml)                      volume (ml)
1-10                                10                               25 
11-24                               25                                 50 
25-49                               50                                100

50-99                               100                               250 
100-120                              250                               500 
* The infusion volume should be based on the prescribed dose and should be prepared to a final sebelipase alfa concentration of 0.1-1.5 mg/ml.
** For patients who do not achieve an optimal clinical response with a dose of 1 mg/kg.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7.    REGISTRATION NUMBER

157-74-34903