Pharmaceutical particulars : מידע רוקחי

6       PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Polysorbate 80
Ethanol anhydrous
Citric acid anhydrous
Water for injection

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. If not use immediately, in-use storage times and  conditions are the responsibility of the user.


After dilution (once added to the infusion bag)

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 in non-PVC bags for 6 hours when stored at 25 °C and for 48 hours at 2°C to 8°C. It should be used within 6 hours (including the one-hour infusion intravenous administration).

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.

Docetaxel infusion solution is supersaturated, therefore may crystallize over time. If crystals appear, the solution must no longer be used and shall be discarded.


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

1 mL, 4 mL or 8 mL in a vial (Type I clear glass) with bromo butyl flurocoated rubber plug with aluminium flip-off seal.
.
Pack size: 1 x 1 mL, 1 x 4 mL or 1x 8 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 (once added to the infusion bag)
DO NOT use other docetaxel medicinal products consisting of 2 vials
(concentrate and solvent) with this medicinal product (Docetaxel Venus Pharma 20 mg/1 mL, 80 mg/4 mL and 160 mg/8 mL concentrate for solution for infusion, which contains only 1 vial).

Docetaxel Venus Pharma 20 mg/1 mL, 80 mg/4 mL and 160 mg/8 mL concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.

Each vial is of single use and should be used immediately.

If the vials are stored under refrigeration, allow the required number of boxes of Docetaxel concentrate for solution for infusion to stand out of the refrigerator below 25°C for 5 minutes before use.

More than one vial of Docetaxel concentrate for solution for infusion may be necessary to obtain the required dose for the patient. Aseptically withdraw the required amount of Docetaxel concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.

In Docetaxel Venus Pharma 20 mg/1 mL, 80 mg/4 mL and 160 mg/8 mL vials the concentration of docetaxel is 20 mg/mL.
The required volume of Docetaxel concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag or bottle containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.

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.


If a dose greater than 190 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.
Mix the infusion bag or bottle manually using a rocking motion.

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

Administration: For instructions on administration see Section 4.2.


7. LICENSE HOLDER
Trustpharm Ltd., 50 Hakishon St., Tel-Aviv.