Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Mannitol
Sodium phosphate monobasic monohydrate
Sodium phosphate dibasic heptahydrate
Polysorbate 80

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, an immediate use is recommended. However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C when stored under protection from light.

6.4   Special precautions for storage

Store in a refrigerator (2°C – 8°C).
For storage conditions after dilution of the medicinal product, see section 6.3.
6.5   Nature and contents of container

50 mg of powder in a vial (Type 1 glass) with a stopper (siliconised butyl) and a seal (aluminium) with a flip-off cap (plastic). Pack sizes of 1, 10 or 25 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling
Myozyme has to be reconstituted with water for injections, then diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and then administered by intravenous infusion. Reconstitution and dilution should be performed in accordance with good practice rules, particularly for the respect of asepsis.

Due to the proteinaceous nature of the product, particle formation may occur in the reconstituted solution and final infusion bags. Therefore, a 0.2 micron low protein binding in-line filter should be used for administration. It was demonstrated that the use of a 0.2 micron in-line filter removes visible particles and does not result in an apparent loss of protein or activity.
Determine the number of vials to be reconstituted based on the individual patient’s dose regimen (mg/kg) and remove the required vials from the refrigerator in order to allow them to reach room temperature (approximately 30 minutes). Each vial of Myozyme is for single use only.

Use aseptic technique

Reconstitution
Reconstitute each 50 mg vial of Myozyme with 10.3 ml water for injections. Add the water for injections by slow drop-wise addition down the side of the vial and not directly onto the lyophilised cake. Tilt and roll each vial gently. Do not invert, swirl or shake the vial. The reconstituted volume is 10.5 ml containing 5 mg/ml, and appears as a clear, colourless to pale yellow solution which may contain particles in the form of thin white strands or translucent fibres. Perform an immediate inspection of the reconstituted vials for particulate matter and discoloration. If upon immediate inspection foreign particles other than those described above are observed, or if the solution is discoloured, do not use.
The pH of the reconstituted solution is approximately 6.2.

After reconstitution, it is recommended to promptly dilute the vials (see below).

Dilution
When reconstituted as above, the reconstituted solution in the vial contains 5 mg alglucosidase alfa per ml. The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 50 mg) from each vial. This should then be further diluted as follows: Slowly withdraw the reconstituted solution from each vial until the volume for the patient’s dose is obtained. The recommended final concentration of alglucosidase in the infusion bags ranges from 0.5 mg/ml to 4 mg/ml. Remove airspace within the infusion bag. Also remove an equal volume of sodium chloride 9 mg/ml (0.9%), solution for injection, that will be replaced with reconstituted Myozyme. Slowly inject the reconstituted Myozyme directly into the sodium chloride 9 mg/ml (0.9%) solution for injection. Gently invert or massage the infusion bag to mix the diluted solution. Do not shake or excessively agitate the infusion bag.

The final infusion solution should be administered as close to preparation time as possible.

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