País: Canadá
Língua: inglês
Origem: Health Canada
POTASSIUM PHOSPHATE MONOBASIC; POTASSIUM PHOSPHATE DIBASIC
FRESENIUS KABI CANADA LTD
B05XA06
POTASSIUM PHOS INCL COMB W/0TH POT. SALTS
224MG; 236MG
SOLUTION
POTASSIUM PHOSPHATE MONOBASIC 224MG; POTASSIUM PHOSPHATE DIBASIC 236MG
INTRAVENOUS
15ML/50ML
Ethical
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0207483001; AHFS:
APPROVED
1998-07-02
Potassium Phosphates Injection, USP – Prescribing Information PAGE 1 OF 6 PRESCRIBING INFORMATION POTASSIUM PHOSPHATES INJECTION, USP (3 mmol Phosphorus / mL and 4.4 mEq Potassium / mL) 7.4 mOsmol / mL Sterile Solution For Intravenous Infusion After Dilution Electrolyte Solution ATC code: B05XA06 FRESENIUS KABI CANADA LTD. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Date of Preparation: November 24, 2020 Submission Control No: 235443 Potassium Phosphates Injection, USP – Prescribing Information PAGE 2 OF 6 PRESCRIBING INFORMATION POTASSIUM PHOSPHATES INJECTION, USP (3 mmol Phosphorus / mL and 4.4 mEq Potassium / mL) 7.4 mOsmol / mL DESCRIPTION Potassium Phosphates Injection, USP is a sterile, preservative free, nonpyrogenic, concentrated solution containing a mixture of mono- and dibasic potassium phosphate in Water for Injection. It must be diluted prior to administration. Each mL of the solution consists of two phosphate salts provided as follows: INGREDIENTS PHOSPHATE POTASSIUM Monobasic Potassium Phosphate – 224 mg 285 mg (3 mmol) 170 mg (4.4 mEq) Dibasic Potassium Phosphate – 236 mg The solution contains no bacteriostatic agent or other preservatives. The solution is intended to provide phosphate ion (PO 4 -3 ) for addition to large volume infusion fluids for intravenous use. Unused portions should be discarded. CLINICAL PHARMACOLOGY Phosphorus in the form of organic and inorganic phosphate has a variety of important biochemical functions in the body and is involved in many significant metabolic and enzyme reactions in almost all organs and tissues. It exerts a modifying influence on the steady state of calcium levels, a buffering effect on acid-base equilibrium and a primary role in the renal excretion of hydrogen ion. Phosphorus is present in plasma and other extracellular fluid, in cell membranes and intracellular fluid, as well as in collagen and bone tissues. Phosphate in the extracellular fluid is primarily in inorganic form, and plasma levels may vary somewhat with age. The ratio of disodiu Leia o documento completo