Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients

Human albumin solution (containing, sodium caprylate and N- acetyl L tryptophan).
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

Unopened vials
The expiry date of the product is indicated on the packaging materials.
Stability of reconstituteddispersion in the vial

Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C in the original carton, protected from light.
Stability of the reconstituteddispersion in the infusion bag
Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C followed by 4 hours at 25°C, protected from light.

However, from a microbiological point of view, unless the method of reconstituting and filling of the infusion bags precludes the risks of microbial contamination, the product should be used immediately after reconstitution and filling of the infusion bags.

If not used immediately, in-use storage times and conditions are the responsibility of the user.

The total combined storage time of reconstituted medicinal product in the vial and in the infusion bag when refrigerated and protected from light is 24 hours. This may be followed by storage in the infusion bag for 4 hours below 25°C.


6.4   Special precautions for storage
Unopened vials
Keep the vial in the outer carton in order to protect from light. Store not above 25ºC. Neither freezing nor refrigeration adversely affects the stability of the product.

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

6.5   Nature and contents of container
50 ml vial (type 1 glass) with a stopper (butyl rubber), with an overseal (aluminium), containing 100 mg of paclitaxel formulated as albumin bound nanoparticles.

Pack size of one vial.

6.6   Special precautions for disposal and other handling
Preparation and administration precautions
Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane. The use of gloves, goggles and protective clothing is recommended. If thedispersion contacts the skin, the skin should be washed immediately and thoroughly with soap and water. If it contacts mucous membranes, the membranes should be flushed thoroughly with water. Abraxane should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents. Pregnant staff should not handle Abraxane.

Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during administration of the medicinal product. Limiting the infusion of Abraxane to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.

Reconstitution and administration of the product
Abraxane is supplied as a sterile lyophilised powder for reconstitution before use. After reconstitution, each ml ofdispersion contains 5 mg of paclitaxel formulated as albumin bound nanoparticles.

100 mg vial: Using a sterile syringe, 20 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion should slowly be injected into a vial of Abraxane over a minimum of 1 minute.
The solution should be directed onto the inside wall of the vial. The solution should not be injected directly onto the powder as this will result in foaming.

Once the addition is complete, the vial should be allowed to stand for a minimum of 5 minutes to ensure proper wetting of the solid. Then, the vial should gently and slowly be swirled and/or inverted for at least 2 minutes until complete redispersion of any powder occurs. The generation of foam must be avoided. If foaming or clumping occurs, the dispersionmust stand for at least 15 minutes until foam subsides.

The reconstituteddispersion should be milky and homogenous without visible precipitates. Some settling of the reconstituteddispersion may occur. If precipitates or settling are visible, the vial should be gently inverted again to ensure complete redispursion prior to use.

Inspect thedispersion in the vial for particulate matter. Do not administer the reconstituteddispersion if particulate matter is observed in the vial.

The exact total dosing volume of 5 mg/mldispersion required for the patient should be calculated and the appropriate amount of reconstituted Abraxane should be injected into an empty, sterile, PVC or non-PVC type intravenous bag.

The use of medical devices containing silicone oil as a lubricant (i.e. syringes and IV bags) to reconstitute and administer Abraxane may result in the formation of proteinaceous strands. Administer Abraxane using an infusion set incorporating a 15 µm filter to avoid administration of these strands. Use of a 15 µm filter removes strands and does not change the physical or chemical properties of the reconstituted product.

Use of filters with a pore size less than 15 µm may result in blockage of the filter.

The use of specialized di(2-ethylhexyl)phthalate (DEHP)-free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions.

Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose.

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