PERFUSION DOSAGE FORM

摘要

The present invention relates to a method for enabling hospitals or clinics to administer a dose of a drug to patients in need thereof while avoiding steps of manipulation, dilution, reconstitution, dispensing, sterilization, transfer, handling or compounding before intravenous administration.;The present invention further relates to a perfusion system comprising different sets of perfusion containers, each container comprising a ready-to-infuse, stable, sterile, aqueous perfusion solution of a drug, wherein the set of perfusion containers alone or in combination provides for direct intravenous administration of a desired dose of the drug to a patient in need thereof, such that the delivered dose is equal to or within ±5% of the calculated dose.

主权项

1. A method for enabling hospitals or clinics to administer a dose of a drug to patients in need thereof while avoiding steps of manipulation, dilution, reconstitution, dispensing, sterilization, transfer, handling or compounding before intravenous administration, the method comprising:
(a) manufacturing a first set of perfusion containers containing a ready-to-infuse, stable, sterile, aqueous perfusion solution of the drug at a first higher concentration, and a second set of top-up perfusion containers containing a ready-to-infuse, stable, sterile, aqueous perfusion solution of the drug at a second concentration and optionally a third set of top-up perfusion containers having a ready-to-infuse, stable, sterile, aqueous perfusion solution of the drug at a third concentration, the first concentration of drug being higher than the second and third concentrations, the containers within each set of perfusion containers ranging in volume from a lower to a higher volume, (b) calculating the dose to be administered to patients according to at least one patient parameter and providing instructions for selecting one or more perfusion container(s) from the first set and if required one or more top-up perfusion container(s) from the second or third set and for directly administering the drug from the selected perfusion containers such that the delivered dose is equal to or within ±5% of the calculated dose, (c) supplying to the distributors or hospitals or clinics, the first set of perfusion containers and second or third set of top-up containers along with the instructions.