Pharmaceutical particulars : מידע רוקחי

6.     PHARMACEUTICAL PARTICULARS
6.1    List of excipients

Polysorbate 80
Ethanol anhydrous
Citric acid

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
2 years for a pack size of 20mg/1ml
3 years for a pack size of 80mg/4ml
3 years for a pack size of 160mg/8ml

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, the docetaxel infusion solution, if stored below 25°C, is stable for 6 hours. It should be used within 6 hours (including the one hour infusion intravenous 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 25 °C.
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

TAXOTERE 20 mg/1 ml concentrate for solution for infusion-7 ml clear glass (type I) vial with a green aluminium seal and a green plastic flip-off cap containing 1 ml of concentrate.

TAXOTERE 80 mg/4 ml concentrate for solution for infusion- 7 ml clear glass (type I) vial with a red aluminium seal and a magenta plastic flip-off cap containing 4 ml of concentrate.

TAXOTERE 160 mg/8 ml concentrate for solution for infusion- 15 ml clear glass (type I) vial with a blue aluminium seal and a blue plastic flip-off cap containing 8 ml of concentrate.

Each box contains one vial.
Not all pack sizes may be marketed.


6.6    Special precautions for disposal and other handling

TAXOTERE is an antineoplastic agent and, as with other potentially toxic compounds, caution should be exercised when handling it and preparing TAXOTERE solutions. The use of gloves is recommended.

If TAXOTERE concentrate or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If TAXOTERE concentrate or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.

Preparation for the intravenous administration

Preparation of the infusion solution
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (TAXOTERE 20mg/1 ml, 80mg/4ml or 160mg/8ml concentrate for solution for infusion, which contains only 1 vial).

TAXOTERE 20mg/1 ml, 80mg/4ml or 160mg/8ml 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 TAXOTERE concentrate for solution for infusion to stand below 25°C for 5 minutes before use.
More than one vial of TAXOTERE concentrate for solution for infusion may be necessary to obtain the required dose for the patient. Aseptically withdraw the required amount of TAXOTERE concentrate for solution for infusion using a calibrated syringe fitted with a 21G needle.

In TAXOTERE 20 mg/1 ml, 80mg/4ml or 160mg/8ml vial the concentration of docetaxel is 20 mg/ml.
The required volume of TAXOTERE 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.

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, TAXOTERE infusion solution should be visually inspected prior to use, solutions containing a precipitate should be discarded.

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

See below - PREPARATION GUIDE FOR USE WITH TAXOTERE 20 mg/1 ml, 80mg/4ml or 160mg/8ml CONCENTRATE FOR SOLUTION FOR INFUSION

7.    MARKETING AUTHORISATION HOLDER
 sanofi-aventis Israel ltd. P O Box 8090, Netanya 4250499