Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS

6.1     List of excipients

Sodium chloride, sodium acetate, acetic acid, glacial, sodium sulphate, water for injection 
6.2     Incompatibilities

Mitoxantrone should not be mixed with heparin in the same infusion since a precipitate may form.
Mitoxantrone should not be mixed with other drugs in the same infusion.
6.3     Shelf life

Unopened vial: the expiry date of the product is indicated on the packaging materials.
Shelf life after dilution:
The maximum storage time for the ready-to-use drug product infusion solution diluted with a 0.9% sodium chloride solution with a concentration of 0.02 to 2 mg/ml is 28 days when stored at 2-8°C.
From a microbiological point of view, the ready-to-use infusion solution should be used immediately. If the preparation is not used immediately, the user shall be responsible for the duration and the conditions of storage. If the ready-to-use preparation is not produced under controlled and validated aseptic conditions, it shall not be stored longer than 24 hours at 2-8°C.
The chemical and physical stability of the ready-to-use preparation for 24 hours at room temperature (20-25°C) has been demonstrated.

6.4     Special precautions for storage

Do not store above 25°C.
6.5     Nature and contents of container

Colourless glass vials (Type I) with a fluoropolymer-coated halobutyl rubber stopper with aluminium crimp cap.

Pack sizes: 1x5 ml, 1x10 ml.
Not all pack sizes may be marketed.
6.6     Instructions for use, handling, and disposal

Mitoxantron “Ebewe” should be diluted in at least 50 ml of one of the following intravenous infusions: Sodium chloride 0.9% or Glucose 5%. Administer the resulting solution over not less than 3 minutes via the tubing of freely running intravenous infusion of one of the above fluids.
Mitoxantrone should not be mixed with other drugs in the same infusion.
Care should be taken to avoid contact of mitoxantrone with the skin, mucous membranes or eyes.
Vials should be dispensed in the upright position in order to prevent drops of mitoxantrone collecting in the stopper during preparation and leading to potential aerosolisation of the solution.
If extravasations occur the administration should be stopped immediately and restarted in another vein. The non-vesicant properties of mitoxantrone minimise the possibility of severe local reaction following extravasations. As with other potentially cytotoxic compounds caution should be exercised when handling mitoxantrone (gloves, mask, overall). Contact with skin and mucous membranes should be avoided.

Spillage Disposal
The following clean-up procedure is recommended if mitoxantrone is spilled on equipment or environmental surfaces. Prepare a 50% solution of fresh concentrated bleach (any recognised proprietary brand containing either sodium or calcium hypochlorite) in water. Wet absorbent tissues in the bleach solution and apply the wetted tissues to the spillage. The spillage is deactivated when the blue colour has been fully discharged. Collect up the tissues with dry tissues. Wash the area with water and soak up the water with dry tissues. Appropriate protective equipment should be worn during the clean-up procedure.
All mitoxantrone contaminated items (e.g., syringes, needles, tissues, etc.) should be treated as toxic waste and disposed of accordingly. Incineration is recommended.
Observe guidelines for the handling of cytotoxic drugs.
Concentrate for solution for infusion must not be used undiluted.
• Cytotoxic drugs should be handled only by trained personnel and in a designated area.
• The work surface should be protected by disposable plastic-backed absorbent paper.
• Protective clothing (goggles, gowns and disposable gloves and masks) should be worn by staff handling parenteral mitoxantrone.
• Contact with skin and/or mucous membranes must be avoided.
• Cytotoxic preparations should not be handled by pregnant staff.
• All items used for reconstitution, administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
• Any spillage or waste material may be disposed of by incineration.