Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Polysorbate 80, Ethanol anhydrous, Citric Acid anhydrous

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.
After opening of the vial
Each vial is for single use and should be used immediately after opening. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Once added to the infusion bag
From a microbiological point of view, reconstitution/dilution must take place in controlled and aseptic conditions and the medicinal product should be used immediately. If not used immediately, in use storage times and conditions are the responsibility of the user.

Once added as recommended into the infusion bag (PP) or infusion bottle (PE), the docetaxel infusion solution, if stored below 25°C, is stable for 8 hours in infusion bottle or for 6 hours in infusion bag. It should be used within 6-8 hours (including the one hour infusion IV administration).

In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.

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

Do not store above 25ºC.
Store in the original package 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 colourless type-I glass vial, closed with a 13 mm grey chlorobutyl rubber stopper and a green flip-off seal consisting of an aluminium shell and a green plastic flip-off button. The rubber stopper is coated with a Teflon® barrier film.


Each box contains one vial with 1 ml fill volume
6 ml colourless type-I glass vial, closed with a 20 mm grey chlorobutyl rubber stopper and an orange flip- off seal consisting of an aluminium shell and an orange plastic flip-off button. The rubber stopper is coated with a Teflon® barrier film.

Each box contains one vial with 4 ml fill volume.

15 ml colourless type-I glass vial, closed with a 20 mm grey chlorobutyl rubber stopper and a red flip-off seal consisting of an aluminium shell and a red plastic flip-off button. The rubber stopper is coated with a Teflon® barrier film.

Each box contains one vial with 8 ml fill volume.
Not all pack sizes may be marketed.

6.6 Special precautions for disposal
Docetaxel Seacross 20 mg/ml is an antineoplastic agent and, as with other potentially toxic agents, caution should be exercised during handling and preparing solutions of Docetaxel Seacross 20 mg/ml.


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.


Preparation for the intravenous administration

Preparation of the infusion solution

DO NOT use other docetaxel medicinal products consisting of more than one vial (concentrate and solvent) with this medicinal product (Docetaxel Seacross 20 mg/ml concentrate for solution for infusion, which contains only 1 vial).


Docetaxel Seacross 20 mg/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.

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.

In Docetaxel Seacross 20 mg /ml vial the concentration of docetaxel is 20 mg/ml.

The required volume of Docetaxel concentrate for solution for infusion must be injected into a 250 ml infusion bag or bottle containing either glucose solution 50 mg/ml (5%) or sodium chloride 9 mg/ml (0.9%) solution for infusion.

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.

The infusion bag solution should be used within 6 hours below 25°C including the one hour infusion to the patient.

As with all parenteral products, Docetaxel infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

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