Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Hydrochloric acid (10%) (for pH-adjustment)
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

The expiry date of the product is indicated on the packaging materials.
Stability after first opening:
Chemical and physical stability has been demonstrated for 28 days at 2°C - 8°C and at room temperature (15°C-25°C)with or without light protection.
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 and would normally not be longer than 24 hours at 2°C-8°C, unless opening has taken place in controlled and validated aseptic conditions.
Do not freeze.

Shelf lifer after dilution:
Chemical and physical in-use stability has been demonstrated for 28 days at 2°C-8°C and at room temperature (15°C -25°C ) in glucose 5% or sodium chloride 0.9% (1.0 mg/ml, 7.0 mg/ml and 25 mg/ml).
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 and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6.4   Special precautions for storage

Unopened vials: Store in a refrigerator (2°C-8°C). Do not freeze.
If the product is stored at the lower limit of 2°C-8°C range or slightly below (e.g. due to cold spots in the refrigerator), precipitation might occur. This precipitate dissolves quickly as soon as the product warms up, and there is no change to the product quality.
If the solution appears discoloured or contains visible particles, it should be discarded.
For storage conditions after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container

Colourless glass vial Type I (EP grade), closed with grey fluoropolymer coated rubber stopper (EP grade), with or without a protective plastic overwrap (Onco-Safe). “Onco-Safe” does not come into contact with the medicinal product and provides additional transport protection, which increases the safety for the medical and pharmaceutical personnel.


Pack sizes: carton containing a single vial containing 200 mg/5 ml, 1,000 mg/25 ml or 2,000 mg/ 50 ml gemcitabine.
Not all pack sizes may be marketed.

6.6   Special precautions for disposal and other handling

Parenteral medicinal products should be inspected visually for particulate matter and discolouration, prior to administration, whenever solution and container permit.
If the solution appears discoloured or contains visible particles, it should be discarded.

Gemcitabine “Ebewe” 40mg/ml concentrate for solution for infusion must be diluted before use (see section 4.2 and 4.4). It is recommended to use large veins for the infusion to prevent damage to the vessel and extravasation.

Transfer the required quantity of solution under aseptic conditions into a suitable infusion bag or bottle. The solution must be diluted with 0.9% sodium chloride solution or 5% glucose solution as appropriate. Mix the liquids thoroughly by rotating by hand.

For single use only.

Any unused solution should be discarded as described below.
Guidelines for the safe handling of cytotoxic medicinal products
Local guidelines on safe preparation and handling of cytotoxic medicinal products must be adhered to. Cytotoxic preparations should not be handled by pregnant staff. The preparation of injectable solutions of cytotoxic agents must be carried out by trained specialist personnel with knowledge of the medicines used. This should be performed in a designated area. The work surface should be covered with disposable plastic-backed absorbent paper.
Suitable eye protection, disposable gloves, face mask and disposable apron should be worn.
Precautions should be taken to avoid the medicinal product accidentally coming into contact with the eyes. If accidental contamination occurs, the eyes should be washed with water thoroughly and immediately.Syringes and infusion sets should be assembled carefully to avoid leakage (use of Luer lock fittings is recommended). Large bore needles are recommended to minimise pressure and the possible formation of aerosols. The latter may also be reduced by the use of a venting needle. Actual spillage or leakage should be mopped up wearing protective gloves. Excreta and vomit must be handled with care.
Disposal
Adequate care and precaution should be taken in the disposal of items used to dilute this medicinal product. Any unused product or contaminated materials should be placed in a high- risk waste bag. Sharp objects (needles, syringes, vials, etc.) should be placed in a suitable rigid container. Personnel concerned with the collection and disposal of this waste should be aware of the hazard involved. Waste material should be destroyed by incineration.

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