Jemperli

Preparation/dilution Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.‍‍‍‍‍‍​​​‍​​​​​​ JEMPERLI is a slightly opalescent colourless to yellow solution. Discard the vial if visible particles are observed. JEMPERLI is compatible with an IV bag made of polyvinyl chloride (PVC) with or without di(2-ethylhexyl) phthalate (DEHP), ethylene vinyl acetate, polyethylene (PE), polypropylene (PP) or polyolefin blend (PP+PE), and a syringe made from PP. For the 500 mg dose, withdraw 10 mL of JEMPERLI from a vial and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9 %) solution for injection, or glucose 50 mg/mL (5 %) solution for injection. The final concentration of the diluted solution should be between 2 mg/mL and 10 mg/mL. The total volume of the infusion solution must not exceed 250 mL. This may require withdrawing a volume of diluent from the intravenous bag prior to adding a volume of JEMPERLI into the IV bag. - For example, if preparing a 500 mg dose in a 250 mL diluent intravenous bag, to achieve a 2 mg/mL concentration would require withdrawing 10 mL of diluent from the 250 mL intravenous bag. Then, 10 mL of JEMPERLI would be withdrawn from the vial and transferred into the intravenous bag. For the 1000 mg dose, withdraw 10 mL of JEMPERLI from each of two vials (withdraw 20 mL total) and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9 %) solution for injection, or glucose 50 mg/mL (5 %) solution for injection. The final concentration of the diluted solution should be between 4 mg/mL and 10 mg/mL. The total volume of the infusion solution must not exceed 250 mL. This may require withdrawing a volume of diluent from the IV bag prior to adding a volume of JEMPERLI into the intravenous bag. - For example, if preparing a 1000 mg dose in a 250 mL diluent intravenous bag, to achieve a 4 mg/mL concentration would require withdrawing 20 mL of diluent from the 250 mL intravenous bag. Then, 10 mL of JEMPERLI would be withdrawn from each of two vials, totaling 20 mL, and transferred into the intravenous bag. Mix diluted solution by gentle inversion. Do not shake the final infusion bag. Discard any unused portion left in the vial. Storage Store in the original carton until time of preparation in order to protect from light. The prepared dose may be stored either: - At room temperature up to 25 °C for no more than 6 hours from the time of dilution until the end of infusion. - Under refrigeration at 2 °C to 8 °C for no more than 24 hours from time of dilution until end of infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration. Administration JEMPERLI should be administered by intravenous infusion using an intravenous infusion pump over 30 minutes by a health care practitioner. Tubing should be made of PVC, platinum cured silicon or PP; fittings made from PVC or polycarbonate and needles made from stainless steel. A 0.2 or 0.22 micron in-line polyethersulfone (PES) filter must be used during administration of JEMPERLI. JEMPERLI must not be administered as an intravenous push or bolus injection. 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.