Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS

6.1     List of excipients
Sodium hydroxide
Hydrochloric acid or Sodium hydroxide for pH adjustment
Water for injections

6.2 Incompatibilities

Fluorouracil should only be diluted with normal saline or a 5% glucose solution.
Fluorouracil should not be mixed with other substances in the same I.V. injection or infusion, as a precipitate may form.

Incompatibilities with the following substances have been reported:
Cisplatin, cytarabine, doxorubicin, calcium folinate, methotrexate, vinorelbine, diazepam, droperidol, filgrastim, gallium nitrate, metoclopramide, morphine, ondansetron, parenteral nutrition solutions.

6.3 Shelf life

The expiry date of the product is indicated on the packaging materials.
Shelf life after first opening of the container and after preparation of the ready-to-use solution for infusion:

Once a dose is taken from the vial with a chemo-mini-spike, the shelf life will not exceed 72 hours at room temperature (no higher than 25°C) and protected from light, unless pricking or diluting took place under controlled and validated aseptic conditions.
Before use, the solution may be diluted with 0.9% sodium chloride solution or 5% glucose solution, if necessary.
After dilution of Fluorouracil Teva solution for injection in 5% glucose solution or in 0.9% sodium chloride solution, a chemical and physical shelf life was established of a minimum of 48 hours at room temperature (no higher than 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.


6.4 Special precautions for storage
Keep out of the reach and sight of children!

Fluorouracil Teva solution for injection should be stored in the original package, in order to protect from light and at a temperature of 15°C – 25°C. If stored as indicated, this medicinal product can be used until the date stated on the package.
Do not store in refrigerator or freezer. If a precipitate is formed as a result of exposure to low temperatures, this precipitate should be completely dissolved again before use, by heating up the injection vial to 60°C with vigorous shaking. Before use, the solution should be cooled off to body temperature.

Use only clear solutions.

For storage conditions of the diluted medicinal product after first opening of the container and after preparation of the ready-to-use solution for infusion, see section 6.3.

6.5 Nature and contents of container

1 vial containing 250 mg/5 mL solution for injection
1 vial containing 500 mg/10 mL solution for injection
1 vial containing 1,000 mg/20 mL solution for injection
1 vial containing 5,000 mg/100 mL solution for injection
Packs of 1 vial.
Not all package sizes may be marketed.

6.6 Special precautions for disposal and other instructions for handling 
Disposal regulations for cytostatic agents must be observed!

7.   LICENCE HOLDER AND MANUFACTURER
Teva Israel Ltd.,
124 Dvora HaNevi'a St., Tel Aviv 6944020, Israel.