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

A package comprising:

• a sterile bag filled with liquid diluent;
• a bottle having a pierceable cap to contain a medicinal or nutritional substance in powder, gel, or liquid form;
• a tube extending from the bag and ending with a coupling and perforation device disposed at the cap of the bottle;
• a flexible sterile sealed first casing housing the bag;
• a flexible sterile sealed second casing housing the bottle and the coupling and perforation device, wherein the first and second casings are spatially separated by a distance, and the tube has a middle portion extending between the first casing and the second casing;
• an adjustable flow diverter disposed at the middle portion of the tube, wherein the flow diverter is configured to be adjusted to:
• a first position wherein the flow diverter impedes communication between the bottle and the bag,
• a second position wherein the flow diverter allows the bag to be in communication with a first side opening of the flow diverter, and the first side opening includes an openable and hermetically sealable cap for receiving a syringe, and
• a third position wherein the flow diverter allows the bottle to be in communication with the first side opening of the flow diverter;
• and
• a pressure compensator including a flexible tube with a hydrophobic filter, wherein the flexible tube of the pressure compensator is connected to a second side opening of the flow diverter and terminates in the first casing or the second casing.