Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

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

Unopened vial:
3 years.
Diluted solution:
Chemical and physical in-use stability has been demonstrated for the diluted medicinal product as follows:
- protected from light in polyethylene or polyvinylchloride infusion bag: for up to 6 days in a refrigerator (2°C-8°C) or for up to 24 hours at 25°C;
- exposed to light in polyethylene or polyvinylchloride infusion set for up to 1 hour at 25°C.
From a microbiological point of view, the product should be used immediately after dilution. 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, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Store in a refrigerator (2°C-8°C).
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 type I glass vials closed by a grey butyl or black chlorobutyl rubber stopper with aluminium flip-off seal with a bonnet. Each vial contains either 2 mL (50 mg vinflunine), 4 mL (100 mg vinflunine) or 10 mL (250 mg vinflunine) of concentrate for solution for infusion.

Pack size of 1 and 10 vials.

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

General precautions for preparation and administration.
Vinflunine is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Javlor. Procedure for proper handling and disposal of anticancer medicinal products should be considered. All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood. The use of gloves, goggles and protective clothing is recommended.
Javlor solution for infusion should only be prepared and administered by personnel appropriately trained in the handling of cytotoxic agents. Pregnant staff should not handle Javlor. Javlor is for single use only.
If the solution comes into contact with the skin, the skin should be washed immediately and thoroughly with soap and water. If it comes into contact with mucous membranes, the membranes should be flushed thoroughly with water .
Dilution of the concentrate
The volume of Javlor (concentrate) corresponding to the calculated dose of vinflunine should be mixed in a 100 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion. Glucose 50 mg/mL (5%) solution for infusion may also be used. The diluted solution should be protected from light until administration (see section 6.3).

Method of Administration
Javlor is for intravenous use ONLY.
Javlor is for single use only.
After dilution of the Javlor concentrate, the solution for infusion will be administered as follows: A venous access should be established for a 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for injection or glucose 50 mg/mL (5%) solution for infusion, on a large vein preferably in the upper part of the forearm or using a central venous line.
• The veins of the hand dorsum and those close to joints should be avoided • The intravenous infusion should be started with half of the 500 mL bag of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion, i.e.
250 mL, at a free flowing rate to flush the vein.
• The Javlor solution for infusion should be piggy-backed to the side injection port closest to the 500 mL bag to further dilute Javlor during administration.
• The Javlor solution for infusion should be infused over 20 minutes.
• The patency should be assessed frequently and extravasation precautions should be maintained throughout the infusion.
• After the infusion is completed, the remaining 250 mL from the sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for infusion bag should be run at a flowing rate of 300 mL/h. In order to flush the vein, administration of Javlor solution for infusion should always be followed by at least an equal volume of sodium chloride 9 mg/mL (0.9%) solution for infusion or of glucose 50 mg/mL (5%) solution for  infusion. Disposal

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