p 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
• Preare 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.
7. Marketing authorisation holder
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
8. Marketing authorisation number(s)
EU/1/16/1156/001
9. Date of first authorisation/renewal of the authorisation
Date of first authorisation: 18 January 2017
10. Date of revision of the text
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