Claims for Patent: 5,945,449

Summary for Patent: 5,945,449

Title:	Sterile bicarbonate concentrate
Abstract:	A sterile bicarbonate concentrate for use in the present invention relates to a sterile calcium-free bicarbonate concentrate for use in peritoneal dialysis, hemofiltration, cardiac bypass surgery and in electrolyte replacement therapy.
Inventor(s):	Purcell; Larry Joseph (Toronto, CA), Tobe; Sheldon William (North York, CA)
Assignee:	Dialysis Solutions Inc. (Toronto, CA)
Application Number:	08/961,778
Patent Claims:	1. A method for providing continuous renal replacement therapy to a patient comprising administering a calcium-free sterile dialysis solution comprising Na 140.+-.14 mmol/l, Mg 0.75.+-.0.07 mmol/l, Cl 106.5.+-.10 mmol/l, and HCO3 35.0.+-.3.5 mmol/l to a patient in need thereof. 2. A method for providing peritoneal dialysis to a patient comprising administering a calcium-free sterile dialysis solution comprising Na 140.+-.14 mmol/l, Mg 0.75.+-.0.07 mmol/l, Cl 106.5.+-.10 mmol/l, and HCO3 35.0.+-.3.5 mmol/l to a patient in need thereof. 3. A method according to claim 2 wherein the dialysis solution further comprises dextrose in a concentration of 2.5% w/v. 4. A method of reducing potassium levels and fluid volume during cardiopulmonary bypass surgery comprising administering a calcium-free sterile dialysis solution comprising Na 140.+-.14 mmol/l, Mg 0.75.+-.0.07 mmol/l, Cl 106.5.+-.10 mmol/l, and HCO3 35.0.+-.3.5 mmol/l to a patient in need thereof. 5. A method for hemofiltration comprising administering a calcium-free sterile infusate comprising Na 140.+-.14 mmol/l Mg 0.75.+-.0.07 mmol/l, Cl 106.5.+-.10 mmol/l, and HCO3 35.0.+-.3.5 mmol/l to a patient in need thereof. 6. A method of treating dysentery comprising administering a calcium-free sterile solution comprising 90 mMol/l sodium; 68.5 mMol/l chloride; 22 mMol/l bicarbonate; and 277 mMol/l glucose to a person in need thereof. 7. A kit for preparing a dialysis solution comprising (a) one 80 ml unit of a calcium-free concentrate comprising sodium chloride (NaCl) 86.87.+-.8.6 g/l, magnesium chloride (MgCl.sub.2) 2.05.+-.0.2 g/l, and sodium bicarbonate NaHCO.sub.3) 39.69.+-.3.9 g/l and (b) one litre of sterile water. 8. A kit for preparing a dialysis solution according to claim 7 further comprising (c) one litre of a 5% w/v dextrose solution in water and (d) a second 80 ml unit of a concentrate comprising sodium chloride (NaCl) 86.87.+-.8.6 g/l, magnesium chloride (MgCl.sub.2) 2.05.+-.0.2 g/l, and sodium bicarbonate NaHCO.sub.3) 39.69.+-.3.9 g/l. 9. A method of preparing a sterile dialysis solution comprising diluting a sterile, calcium free bicarbonate dialysis concentrate comprising sodium chloride (NaCl) 86.87.+-.8.6 g/l, magnesium chloride (MgCl.sub.2) 2.05.+-.0.2 g/l, and sodium bicarbonate (NaHCO.sub.3) 39.69.+-.3.9 g/l in a sufficient amount of water to prepare a dialysis solution comprising Na 140.+-.14 mmol/l, Mg 0.75.+-.0.07 mmol/l, Cl 106.5.+-.10 mmol/l, and HCO3 35.0.+-.3.5 mmol/l. 10. A method for providing continuous renal replacement therapy to a patient in need thereof comprising administering a sterile dialysis solution prepared according to the method of claim 9 to a patient in need thereof. 11. A method for providing peritoneal dialysis to a patient comprising administering a sterile dialysis solution prepared according to the method of claim 9 to a patient in need thereof. 12. A method of reducing potassium levels and fluid volume during cardiopulmonary bypass surgery comprising administering a sterile dialysis solution prepared according to the method of claim 9 to a patient in need thereof. 13. A method for treating acute renal failure in a critically ill patient without introducing calcium into the blood removed from the patient during dialysis comprising administering a sterile dialysis solution prepared according to the method of claim 9 to a patient in need thereof. 14. A method for treating acute renal failure in a critically ill patient without introducing calcium into the blood removed from the patient during dialysis comprising administering a calcium-free sterile dialysis solution comprising Na 140.+-.14 mmol/l, Mg 0.75.+-.0.07 mmol/l, Cl 106.5.+-.10 mmol/l, and HCO3 35.0.+-.3.5 mmol/l to a patient in need thereof. 15. A method according to claim 10 wherein the patient is a liver transplantation patient. 16. A method of preparing a sterile infusate comprising diluting a sterile, calcium free bicarbonate concentrate comprising sodium chloride (NaCl) 86.87.+-.8.6 g/l, magnesium chloride (MgCl.sub.2) 2.05.+-.0.2 g/l, and sodium bicarbonate (NaHCO.sub.3) 39.69.+-.3.9 g/l in a sufficient amount of water to prepare an infusate comprising Na 140.+-.14 mmol/l, Mg 0.75.+-.0.07 mmol/l, Cl 106.5.+-.10 mmol/l, and HCO3 35.0.+-.3.5 mmol/l. 17. A method for providing hemofiltration to a patient comprising administering a sterile infusate prepared according to the method of claim 16 to a patient in need thereof. 18. A method of preparing a sterile oral electrolyte solution for fluid replacement comprising diluting a sterile, calcium free bicarbonate concentrate comprising sodium chloride (NaCl) 86.87.+-.8.6 g/l, magnesium chloride (MgCl.sub.2) 2.05 .+-.0.2 g/l, and sodium bicarbonate (NaHCO.sub.3) 39.69.+-.3.9 g/l in a sufficient amount of water to prepare an electrolyte solution comprising Na 140.+-.14 mmol/l, Mg 0.75.+-.0.07 mmol/l, Cl 106.5.+-.10 mmol/l, and HCO3 35.0.+-.3.5 mmol/l.

Details for Patent 5,945,449

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2016-11-01