Sterile flexible package with pressure compensator for the dosed reconstitution of fluid medicinal or nutritional substances to be administered to patients by infusion or injection

Abstract

The package comprises a sterile bag () filled with liquid diluent, a bottle () equipped with a pierceable cap () to contain a medicinal or nutritional substance and a tube () extending from the bag and ending with a coupling and perforation device () for the cap of the bottle. Said bag is housed in a flexible sterile sealed casing (), while the bottle and the coupling and perforation device are accommodated in a second flexible sterile sealed casing (). The tube () has a portion () between the first and second casing, housing a flow diverter () adjustable from a first position in which it impedes any communication between the bottle and the bag, to a second position in which it allows the bag to be put in communication with a sealed side opening () for a syringe (), or a third position in which it allows the bottle to be connected with said side opening. To another side opening () of the flow diverter a flexible tube () with hydrophobic filter () is attached, terminating into one and/or the other of said sterile sealed casings and serving as a pressure compensator().