Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1   List of excipients
Ethanol absolute, polysorbate 80 (Tween 80), citric acid anhydrous, polyethylene glycol 300.
6.2   Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Plastic devices made of acrylic or ABS polymers have been reported to crack when used with undiluted etoposide solution for infusion 20 mg/ml. This effect has not been reported with etoposide after dilution of the solution for infusion according to instructions.

6.3   Shelf life
The expiry date of the product is indicated on the packaging materials.

Shelf life after dilution
The infusion has been shown to be physically and chemically stable for up to 120 hours at 25°C.
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. Dilution should take place in controlled and validated aseptic conditions.

Multi-dose use
Etoposide Teva concentrate for solution for infusion is stable for up to 72 hours (3 days) at 25°C following piercing of the rubber stopper. It is therefore suitable for multi-dose use.


6.4   Special precautions for storage
Store the undiluted product between 15-25°C. Do not refrigerate. Keep in the original package in order to protect from light.

Do not store the diluted product in a refrigerator (2-8°C) as this might cause precipitation.

For storage conditions after dilution and first opening of the medicinal product, see section 6.3.
6.5   Nature and contents of container
Clear, colorless glass vial, closed with chlorobutyl rubber stopper (coated with black teflon) held by an aluminum with pink snap cap with insert disc.

Vials containing 20 mg/ml of etoposide as follows:
100 mg of etoposide/5 ml,
200 mg of etoposide/10 ml,
1000 mg of etoposide/50 ml.

Pack sizes:
All presentations are packaged as individual vials.
Not all pack sizes may be marketed.
6.6   Special precautions for disposal and other handling

Procedures for proper handling and disposal of anti-cancer drugs should be followed.
Care must be taken whenever handling cytostatic products. Always take steps to prevent exposure. As with other potentially toxic compounds, caution should be exercised in handling and preparing Etoposide Teva solutions. Skin reactions associated with accidental exposure to Etoposide Teva may occur. The use of gloves is recommended. If etoposide should contact the skin or mucosa, immediately wash the skin with soap and water and flush the mucosa with water.

Etoposide Teva must be prepared under aseptic conditions.

Etoposide Teva must be diluted with either 5% dextrose solution for injection or 0.9% saline solution for injection, to give a final concentration of 0.2 mg/ml.

Solutions showing any signs of precipitation should not be used.

Etoposide Teva should not be physically mixed with any other medicinal product.
As with all cytotoxic preparations, the following special precautions should be taken for safe handling and disposal: 1. Trained personnel only should dilute the drug. Pregnant staff should not be involved in its handling.
2. Preparation of the drug should be performed in a designated area, ideally in a vertical laminar flow hood
(Biological Safety Cabinet - Class II). The work surfaces should be covered with disposable plastic-backed absorbent paper.
3. Adequate protective clothing should be worn, i.e., PVC gloves, safety glasses, disposable gowns and masks. In the event of contact with the eyes, wash with copious amounts of water or saline.
4. Luer-Lock fittings should be used on all syringes and sets. The possible formation of aerosols may be reduced by using large-bore needles and venting needles.
5. All unused material, needles, syringes, vials and other items which have come into contact with cytotoxic drugs should be segregated, placed in double-sealed polyethylene bags and incinerated at 1,000°C or more. Excreta should be similarly treated. Liquid waste should be flushed away with copious amounts of water.

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

7.   LICENCE HOLDER AND MANUFACTURER
Licence holder and Manufacturer:
Teva Israel Ltd., 124 Dvora HaNevi'a St., Tel Aviv, 6944020, Israel