Pharmaceutical particulars : מידע רוקחי

6.      PHARMACEUTICAL PARTICULARS
6.1     List of excipients

None.

6.2     Incompatibilities
TEPADINA is unstable in acid medium.
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 reconstitution
Chemical and physical in-use stability after reconstitution has been demonstrated for 8 hours when stored at 2°C-8°C.

After dilution
Chemical and physical in-use stability after dilution has been demonstrated for 24 hours when stored at 2°C-8°C and for 4 hours when stored at 25°C.

From a microbiological point of view, the product should be used immediately after dilution. 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 the above mentioned conditions when dilution has taken place in controlled and validated aseptic conditions.

6.4     Special precautions for storage

Unopened vial
Store and transport refrigerated (2°C – 8°C).
Do not freeze.
After reconstitution and dilution
For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.

6.5     Nature and contents of container

Type I clear glass vial with a chlorobutyl stopper, containing 15 mg thiotepa.
Pack size of 1 vial.
6.6     Special precautions for disposal and other handling

Preparation of TEPADINA
Procedures for proper handling and disposal of anticancer medicinal products must be considered. All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.
As with other cytotoxic compounds, caution needs to be exercised in handling and preparation of TEPADINA solutions to avoid accidental contact with skin or mucous membranes. Topical reactions associated with accidental exposure to thiotepa may occur. In fact, the use of gloves is recommended in preparing the solution for infusion. If thiotepa solution accidentally contacts the skin, the skin must be immediately and thoroughly washed with soap and water. If thiotepa accidentally contacts mucous membranes, they must be flushed thoroughly with water.

Reconstitution
TEPADINA must be reconstituted with 1.5 ml of sterile water for injection.
Using a syringe fitted with a needle, aseptically withdraw 1.5 ml of sterile water for injection.
Inject the content of the syringe into the vial through the rubber stopper.
Remove the syringe and the needle and mix manually by repeated inversions.
Only colourless solutions, without any particulate matter, must be used. Reconstituted solutions may occasionally show opalescence; such solutions can still be administered.

Further dilution in the infusion bag
The reconstituted solution is hypotonic and must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection (1000 ml if the dose is higher than 500 mg) or with an appropriate volume of sodium chloride 9 mg/ml (0.9%) in order to obtain a final TEPADINA concentration between 0.5 and 1 mg/ml.

Administration
TEPADINA infusion solution should be inspected visually for particulate matter prior to administration.
Solutions containing a precipitate should be discarded.
Prior to and following each infusion, the indwelling catheter line should be flushed with approximately 5 ml sodium chloride 9 mg/ml (0.9%) solution for injection.
The infusion solution must be administered to patients using an infusion set equipped with a 0.2 µm in-line filter. Filtering does not alter solution potency.

Disposal
TEPADINA is for single use only.
Any unused product or waste material should be disposed of in accordance with local requirements.

7.   RIGHTS HOLDER AND MANUFACTURER
ADIENNE SA
Via Zurigo 46,
6900 Lugano, Switzerland