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Imfinzi

Imfinzi Caution For Usage

Manufacturer:

AstraZeneca

Distributor:

DKSH
Full Prescribing Info
Caution For Usage
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling:
IMFINZI does not contain a preservative. Administer infusion solution immediately once prepared. If infusion solution is not administered immediately and it needs to be stored, follow the following recommendations: Chemical and physical stability of the prepared solution for infusion, in the IV bag, has been demonstrated for up to 30 days at 2°C to 8°C and for up to 24 hours at room temperature (up to 25°C) from the time of preparation.
From a microbiological point of view, the prepared solution for infusion, in the IV bag, should be used immediately. If not used immediately, post-dilution storage times and conditions prior to use are the responsibility of the user and the product may be stored for a maximum of 30 days at 2°C to 8°C (36°F to 46°F) or 12 hours at room temperature. If dilution has taken place in controlled and validated aseptic conditions, the product may be stored for the time defined by the chemical and physical stability described previously.
Preparation of solution: IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.
Visually inspect the medicinal product for particulate matter and discolouration. IMFINZI is clear to opalescent, colourless to slightly yellow solution. Discard the vial if the solution is cloudy, discoloured or visible particles are observed. Do not shake the vial.
Withdraw the required volume from the vial(s) of IMFINZI and transfer into an IV bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or glucose 50 mg/mL (5%) solution for injection. Mix diluted solution by gentle inversion. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL. Do not freeze or shake the solution.
Care must be taken to ensure the sterility of prepared solutions.
Do not re-enter the vial after withdrawal of drug; only administer one dose per vial.
Discard any unused portion left in the vial.
Administration: Administer the infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron in-line filter.
Do not co-administer other medicinal products through the same infusion line.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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