PENTASPAN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PENTASTARCH

Available from:

BRISTOL-MYERS SQUIBB CANADA

ATC code:

B05AA07

INN (International Name):

HYDROXYETHYLSTARCH

Dosage:

10G

Pharmaceutical form:

SOLUTION

Composition:

PENTASTARCH 10G

Administration route:

INTRAVENOUS

Units in package:

250/500 ML

Prescription type:

Prescription Recommended

Therapeutic area:

REPLACEMENT PREPARATIONS

Product summary:

Active ingredient group (AIG) number: 0152461001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2013-11-08

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PENTASPAN*
(10% PENTASTARCH IN 0.9% SODIUM CHLORIDE INJECTION)
INJECTION
PLASMA VOLUME EXPANDER
Bristol-Myers Squibb Canada
Montreal, Canada
*
TM auth. user
Date of Revision:
Bristol-Myers Squibb Canada
August 22, 2013
_ _
Control No.: 166295
2
PRODUCT MONOGRAPH
PENTASPAN
(10% PENTASTARCH IN 0.9% SODIUM CHLORIDE INJECTION)
Injection
THERAPEUTIC CLASSIFICATION
Plasma Volume Expander
ACTION AND CLINICAL PHARMACOLOGY
The colloidal properties of pentastarch render it useful as a plasma
volume expander.
Intravenous infusion of PENTASPAN (pentastarch) results in expansion
of the plasma volume in
excess of the volume infused. This expansion persists for
approximately 18 to 24 hours and is
expected to improve the hemodynamic status for 12 to 18 hours.
Pentastarch molecules below 50,000 molecular weight are rapidly
eliminated by renal excretion.
A single dose of approximately 500 mL of PENTASPAN results in
elimination in the urine of
approximately 70% of the dose within 24 hours, and approximately 80%
of the dose within one
week. The remaining percentage of the administered dose is presumed to
be eliminated at a
slower rate. Although this process is variable, it generally results
in an intravascular pentastarch
concentration below the level of detection by one week. The
hydroxyethyl group is not cleaved,
but remains intact and attached to glucose units when excreted.
INDICATIONS AND CLINICAL USE
PENTASPAN (pentastarch) is indicated when plasma volume expansion is
desired as an adjunct
in the management of shock due to hemorrhage, surgery, sepsis, burns
or other trauma. It is not a
substitute for red blood cells or coagulation factors in plasma.
CONTRAINDICATIONS
PENTASPAN (pentastarch) is contraindicated in patients with sepsis.
PENTASPAN is contraindicated in patients with severe liver disease.
PENTASPAN is contraindicated in patients with known hypersensitivity
to hydroxyethyl starch,
or with bleeding disorders, or with congestive heart failure where
volume overload is a potential
problem. PENTASPAN