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 (3) filled with liquid diluent, a bottle (9) equipped with a pierceable cap (26) to contain a medicinal or nutritional substance and a tube (12) extending from the bag and ending with a coupling and perforation device (16) for the cap of the bottle. Said bag is housed in a flexible sterile sealed casing (1), while the bottle and the coupling and perforation device are accommodated in a second flexible sterile sealed casing (2). The tube (12) has a portion (13) between the first and second casing, housing a flow diverter (18) 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 (19) for a syringe (22), or a third position in which it allows the bottle to be connected with said side opening. To another side opening (41) of the flow diverter a flexible tube (42) with hydrophobic filter (43) is attached, terminating into one and/or the other of said sterile sealed casings and serving as a pressure compensator(Fig. 1).

Dependencies are inferred from the claim text.