Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Dehydrated alcohol
Water for injections
Hydrochloric acid (for pH-adjustment)
Sodium hydroxide (for pH-adjustment)

6.2   Incompatibilities
In the absence of compatibility studies, 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.

In-use shelf life

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

Chemical and physical in-use stability of HALAVEN as an undiluted solution in a syringe has been demonstrated for up to 4 hours at 15-25°C and ambient lighting, or up to 24 hours at 2°C - 8°C.

Chemical and physical in-use stability of HALAVEN as a diluted solution (0.018 mg/ml to 0.18 mg/ml eribulin in sodium chloride 9 mg/ml (0.9%)) has been demonstrated for up to 72 hours at 2°C - 8°C.

6.4   Special precautions for storage

Store below 25ºC
For storage conditions after first opening or dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 ml of solution.

The pack sizes are cartons of 1 or 6 vials.

Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

HALAVEN is a cytotoxic anticancer medicinal product and, as with other toxic compounds, caution should be exercised in its handling. The use of gloves, goggles, and protective clothing is recommended.
If the skin comes into contact with the solution it should be washed immediately and thoroughly with soap and water. If it contacts mucous membranes, the membranes should be flushed thoroughly with water. HALAVEN should only be prepared and administered by personnel appropriately trained in handling of cytotoxic agents. Pregnant staff should not handle HALAVEN.

Using aseptic technique HALAVEN can be diluted up to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection. 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. It must not be mixed with other medicinal products and should not be diluted in glucose 5% infusion solution.

If using a spike to administer the product refer to the instructions provided from the device manufacturer.
HALAVEN vials have a 13mm stopper. The device selected should be compatible with small vial stoppers.

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


7.    REGISTRATION HOLDER AND IMPORTER
Eisai Israel Ltd., PO Box 3393, Petah Tikva, 4951600, Israel