Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1       List of excipients
Lactose

6.2       Incompatibilities

The product precipitates when combined with heparin.


6.3       Shelf life

              The expiry date of the product is indicated on the packaging materials.

6.4    Special precautions for storage
Unreconstituted solution: Store below 250C.

Reconstituted solution: Use immediately after reconstitution.

6.5    Nature and contents of container
Colourless glass vial
Zavedos® 10mg Powder for Solution for Injection vials are available as single vials.

6.6    Special precautions for disposal and other handling

The following protective recommendations are given due to the toxic nature of this substance:
• This product should be handled only by personnel who have been trained in the safe handling of such preparations.
• Pregnant staff should be excluded from working with this drug.
• Personnel handling Zavedos® should wear protective clothing: goggles, gowns and disposable gloves and masks.
• All items used for administration or cleaning, including gloves, should be placed in high risk, waste disposal bags for high temperature incineration.
• The reconstituted solution is hypotonic and the recommended administration procedure described below must be followed.

Reconstitute with 10ml of Water for Injections to produce a 1mg/ml solution for injection (i.v.). The reconstituted solution is clear red-orange solution, essentially free from visible foreign matter, see section 6.4 also.

Intravenous administration: Zavedos®, as the reconstituted solution, must be administered only by the intravenous route. A slow administration over 5 to 10 minutes via the tubing of a freely running intravenous infusion of 0.9% sodium chloride, must be followed. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration, see section 4.4.


All cleaning materials should be disposed of as indicated previously. Accidental contact with the skin and eyes should be treated immediately by copious lavage with water or sodium bicarbonate solution, medical attention should be sought.
Discard any unused solution.