PENTASPAN SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PENTASTARCH

Доступно од:

BRISTOL-MYERS SQUIBB CANADA

АТЦ код:

B05AA07

INN (Међународно име):

HYDROXYETHYLSTARCH

Дозирање:

10G

Фармацеутски облик:

SOLUTION

Састав:

PENTASTARCH 10G

Пут администрације:

INTRAVENOUS

Јединице у пакету:

250/500 ML

Тип рецептора:

Prescription Recommended

Терапеутска област:

REPLACEMENT PREPARATIONS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2013-11-08

Карактеристике производа

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