POTASSIUM PHOSPHATES INJECTION, USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

POTASSIUM PHOSPHATE MONOBASIC; POTASSIUM PHOSPHATE DIBASIC

Διαθέσιμο από:

FRESENIUS KABI CANADA LTD

Φαρμακολογική κατηγορία (ATC):

B05XA06

INN (Διεθνής Όνομα):

POTASSIUM PHOS INCL COMB W/0TH POT. SALTS

Δοσολογία:

224MG; 236MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

POTASSIUM PHOSPHATE MONOBASIC 224MG; POTASSIUM PHOSPHATE DIBASIC 236MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

15ML/50ML

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

REPLACEMENT PREPARATIONS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0207483001; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

1998-07-02

Αρχείο Π.Χ.Π.

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