Pharmaceutical particulars : מידע רוקחי

6.    PHARMACEUTICAL PARTICULARS
6.1   List of excipients

Sodium chloride
Sodium citrate dihydrate
Citric acid monohydrate
Polysorbate 80
Diethylenetriaminepentaacetic acid
Water for injections
Sodium hydroxide (for pH adjustment).

6.2   Incompatibilities
In the absence of compatibility studies, 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.
Solution for infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C – 8°C or 16 hours at room temperature (at or below 25°C). These time limits include storage of the infusion solution in the IV bag through the duration of infusion. From a microbiological point of view, the product must be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours at 2°C – 8°C or 16 hours at room temperature (at or below 25°C).

6.4   Special precautions for storage

Store in a refrigerator 2°C to 8°C. Do not freeze. Keep vial in the outer carton in order to protect from light.

For storage conditions after dilution of the medicinal product, see section 6.3.

6.5   Nature and contents of container
Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal.

Each carton contains one vial.

6.6   Special precautions for disposal and other handling
Preparation of diluted solution
•     Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution.
•     Inspect vial contents for discoloration and particulate matter prior to dilution. ZINPLAVA is a clear to moderately opalescent, colourless to pale yellow liquid. Do not use the vial if the solution is discoloured or contains visible particles.
•     Do not shake the vial.

•     Withdraw the required volume from the vial(s) based on the patient’s weight (in kg) and transfer into an IV bag containing either 0.9 % Sodium Chloride Injection, or 5 % Dextrose Injection, to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Mix diluted solution by gentle inversion.
•     Discard vial(s) and all unused contents.
•     If the diluted solution is refrigerated, allow the IV bag to come to room temperature prior to use.
•     Do not freeze the diluted solution.

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