MANNITOL INJECTION, USP SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

MANNITOL

Tilgjengelig fra:

FRESENIUS KABI CANADA LTD

ATC-kode:

B05BC01

INN (International Name):

MANNITOL

Dosering :

25%

Legemiddelform:

SOLUTION

Sammensetning:

MANNITOL 25%

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

50 ML

Resept typen:

Ethical

Terapeutisk område:

OSMOTIC DIURETICS

Produkt oppsummering:

Active ingredient group (AIG) number: 0103277001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-09-03

Preparatomtale

_Prescribing Information -Mannitol Injection, USP_
_Page 1 of 6_
PRESCRIBING INFORMATION
MANNITOL INJECTION, USP
12.5 g / 50 mL
1 372 mOsmol / L
Osmotic Diuretic
For Intravenous Infusion Only
FRESENIUS KABI CANADA LTD.
Date of Revision:
165 Galaxy Blvd, Suite 100
September 3, 2021
Toronto, ON M9W 0C8
Submission Control Number: 254881
_Prescribing Information -Mannitol Injection, USP_
_Page 2 of 6_
DESCRIPTION
Mannitol Injection, USP an osmotic diuretic, is a sterile,
nonpyrogenic solution of mannitol in
Water for Injection. It is a supersaturated solution at room
temperature.
Each mL contains: Mannitol 250 mg; Water for Injection q.s. The
osmolar concentration is
1 372 mOsmol / L (calc.). It contains no antimicrobial agents. The pH
of a 5% solution is
between 4.5 and 7.0.
CLINICAL PHARMACOLOGY
Mannitol is an osmotic diuretic. After intravenous injection, it is
confined to the extracellular
space, metabolized only slightly and excreted rapidly by the kidneys.
Approximately 80% of a
100 g dose appears in the urine in three hours. Mannitol is freely
filtered by the glomeruli with
less than 10% tubular reabsorption. It is not secreted by tubular
cells. It induces diuresis by
elevating the osmolarity of the glomerular filtrate and thereby
hinders tubular reabsorption of
water. Urinary output of water and excretion of sodium and chloride
are enhanced. Mannitol is
poorly absorbed from the gastrointestinal tract.
Mannitol Injection, USP is free of electrolytes and is used in urology
as a nonhemolytic irrigant.
The amount of mannitol absorbed intravascularly during transurethral
prostatic surgery is
variable and depends primarily on the extent of the surgery. Such
mannitol is excreted by the
kidneys and produces osmotic diuresis.
INDICATIONS AND USAGE
FOR INTRAVENOUS INJECTION
Mannitol Injection, USP is indicated for the following therapeutic
uses:

in the prophylaxis of oliguria in surgical procedures and traumatic
conditions involving
renal insult;

in the adjuvant treatment of oliguria or anuria;

the promotio