Pharmaceutical particulars : מידע רוקחי

6       PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Polysorbate 80
Ethanol anhydrous
Citric acid anhydrous
Macrogol 300

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

Use immediately after opened.
After dilution

After dilution in sodium chloride 9 mg/mL (0.9%) solution for injection or 5% glucose chemical and physical in-use stability has been demonstrated for 4 hours when stored below 25 °C. From a microbiological point of view, the infusion preparation 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 °C to 8 °C unless dilution has taken place in controlled and validated aseptic conditions.

6.4     Special precautions for storage

Store below 25 ºC.
Keep the vial in the outer carton in order to protect from light.
For storage conditions of the diluted medicinal product, see section 6.3.
6.5     Nature and contents of container

2 mL, 8 mL or 16 mL in a vial (Type I clear glass with or without ONCO-TAIN® overwrap) with chlorobutyl elastomeric closures and aluminium seals with plastic flip-off cap.
Pack size: 1 x 2 mL, 1 x 8 mL or 1x 16 mL.
Not all pack sizes may be marketed.

6.6     Special precautions for disposal and other handling
Docetaxel is an antineoplastic agent and, as with other potentially toxic agents, caution should be exercised during handling and preparing solutions of this medicinal product.

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

Guidelines for the safe handling and disposal of antineoplastic agents 
Preparation

Local guidelines on safe preparation and handling should be consulted.
Cytotoxic agents should only be prepared and handled by personnel trained in the safe handling of such preparations. Pregnant personnel should not handle cytotoxic agents.

All personnel involved with handling cytotoxic agents should be adequately protected with appropriate personal protective equipment, including protective disposable gloves, eye shield, mask and long- sleeved gown. Preparation and manipulation of solutions should be performed in a designated handling area.

Contamination

In the event of skin contact, thoroughly wash the affected area with soap and water, taking care not to abrade the skin. A bland cream may be used to treat transient stinging of the skin. In the event of contact with the eyes, irrigate with copious amounts of water or sodium chloride 0.9%. Seek medical evaluation.


In the event of spillage, trained personnel wearing appropriate personal protective equipment should remove the maximum amount of material by use of a cytotoxic drug spill kit or designated absorbent materials. The area should be rinsed with copious amounts of water. All contaminated cleaning materials should be disposed of as described below.

Disposal

All contaminated waste materials (including sharps, containers, absorbent materials, unused solutions, etc.) should be placed in a designated sealed and labelled impervious waste disposal bag or rigid waste container, and incinerated in accordance with local procedures for destruction of hazardous waste.

Instructions for preparation

Refer to section 6.3 Shelf life.
Inspect visually prior to use. Only clear solutions without visible particles should be used. Must be diluted before use.

Contact of docetaxel solutions with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimise patient exposure to the plasticizer DEHP (di-2- ethylhexyl phthalate), which may be leached from PVC infusion bags or sets, all docetaxel solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.

Inject the required volume into a 250 mL infusion bag or bottle containing either: •    Sodium Chloride 9 mg/mL (0.9%) solution for injection
•    Glucose 50 mg/mL (5%)

If a dose greater than 200 mg of docetaxel is required, use a larger volume of the infusion vehicle so that a concentration of 0.74 mg/mL docetaxel is not exceeded.

Compatibility: It is not recommended to mix docetaxel with other drugs.

Administration: For instructions on administration see Section 4.2.