Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS

6.1    List of excipients
Sodium chloride
Hydrochloric acid or sodium hydroxide for pH adjustment
Water for injections

6.2    Incompatibilities

Doxorubicin must not be mixed with heparin, as this will result in precipitation. Until detailed compatibility information about miscibility is available, doxorubicin should not be mixed with other medicinal products than those mentioned under section 6.6.

Incompatibilities with the following products have been reported:
Aminophyllin, cephalotin, dexamethasone, fluorouracil, hydrocortisone.

6.3    Shelf life
Vial before opening
The expiry date of the product is indicated on the packaging materials.

After first opening
Use immediately after first opening.

After dilution
Chemical and physical in-use stability after dilution to a concentration of 0.5 mg/ml in 9 mg/ml (0.9%) sodium chloride solution for infusion or in 50 mg/ml (5%) glucose solution for infusion has been demonstrated for 7 days when stored protected from light at room temperature (15-25˚C) and at 2-8˚C.
After dilution to the concentration of 0.05 mg/ml, the diluted solution should be used immediately.

From a microbiological point of view, the product should be used immediately. 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 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4     Special precautions for storage

Store in a refrigerator (2-8°C).
Do not freeze.
For storage conditions of the diluted medicinal product, see section 6.3.

6.5    Nature and contents of container

Doxorubicin Teva concentrate for solution for infusion is supplied in vials of 5 ml (10 mg), 10 ml (20 mg), 25 ml (50 mg) or 100 ml (200 mg) containing a red, clear, sterile solution.


Primary packaging material: Vials are of colourless glass type I (Ph.Eur.), with a chlorobutyl rubber stopper with an inert fluoropolymer (PTFE) coating on the inner side and with an aluminium seal covered with a coloured polypropylene disc.

Trade package quantities: Boxes with one vial of 5, 10, 25 or 100 ml.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling
Doxorubicin can also be administered as intravenous infusion diluted in the concentration range of 0.05 mg/ml to 0.5 mg/ml in 9 mg/ml (0.9%) sodium chloride solution for infusion or in 50 mg/ml (5%) glucose solution for infusion using non-PVC infusion bags.

Personnel should be well trained for handling cytotoxic drugs. Pregnant staff should be excluded from working with this drug. Personnel handling this, and all cytotoxic drugs, should wear protective clothing: goggles, gowns and disposable gloves and masks.

If doxorubicin comes in contact with skin or mucous membranes, the exposed area should be thoroughly washed with soap and water. If the substance gets into the eyes, rinse with water or sterile physiological saline, whereupon an eye specialist should be consulted.

After use, bottles and injection materials, including gloves, should be destroyed according to the rules for cytostatics.
Any unused product or waste material should be disposed of in accordance with local requirements.

Inactivation of spilled or leaked drug can be obtained with 1% sodium hypochlorite solution or most simply with phosphate buffer (pH > 8) until solution is destained. All cleaning materials should be disposed of as indicated previously.

7.    LICENCE HOLDER AND MANUFACTURER

Teva Israel Ltd.,
124 Dvora HaNevi'a St., Tel Aviv 6944020, Israel.