MANNITOL injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)

Tilgjengelig fra:

Hospira, Inc.

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Mannitol Intravenous (Mannitol Injection, USP) is indicated for the following purposes in adults and pediatric patients. - Reduction of intracranial pressure and brain mass. - Reduction of high intraocular pressure when the pressure cannot be lowered by other means. Measurement of glomerular filtration rate. - Well established anuria due to severe renal disease. - Severe pulmonary congestion or frank pulmonary edema. - Active intracranial bleeding except during craniotomy. - Severe dehydration. - Progressive heart failure or pulmonary congestion after institution of mannitol therapy. - Do not administer to patients with a known hypersensitivity to mannitol. To Open Tear outer wrap at notch and remove solution container. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will dimin

Produkt oppsummering:

Mannitol Intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows: NOTE: Crystals may form in mannitol solutions especially if the solutions are chilled. To dissolve crystals in the flexible container, warm the unit to 70°C with agitation. Heat solution by using a dry-heat cabinet with overwrap intact. The use of a water bath is not recommended. Cool to body temperature or less before administering. When infusing 20% mannitol, the administration set should include a filter. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Autorisasjon status:

New Drug Application

Preparatomtale

MANNITOL- MANNITOL INJECTION, SOLUTION
HOSPIRA, INC.
----------
MANNITOL INTRAVENOUS
MANNITOL INJECTION, USP
FLEXIBLE PLASTIC CONTAINER
Rx only
DESCRIPTION
Mannitol Intravenous (Mannitol Injection, USP) is a sterile,
nonpyrogenic solution of mannitol in water
for injection available in a concentration of 20% in flexible plastic
containers.
The content and characteristics of the available concentration is as
follows:
CONC. (%)
G/100 ML
MOS MOL/LITER
(CALC.)
PH
*
20
20
1098
6.3 (4.5 to 7.0)
The solution contains no bacteriostat, antimicrobial agent or added
buffer (except for pH adjustment) and
is intended only as a single-dose injection. When smaller doses are
required the unused portion should
be discarded.
Mannitol Injection, USP is a parenteral obligatory osmotic diuretic.
Mannitol, USP is chemically designated D-mannitol (C H O ), a white
crystalline powder or free-
flowing granules freely soluble in water. It has the following
structural formula:
Water for Injection, USP is chemically designated H O.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can
permeate from inside the container into the overwrap, but not in
amounts sufficient to affect the solution
significantly. Solutions in contact with the plastic container may
leach out certain chemical components
from the plastic in very small amounts; however, biological testing
was supportive of the safety of the
plastic container materials. Exposure to temperatures above
25°C/77°F during transport and storage will
lead to minor losses in moisture content. Higher temperatures lead to
greater losses. It is unlikely that
these minor losses will lead to clinically significant changes within
the expiration period.
CLINICAL PHARMACOLOGY
When administered intravenously mannitol is confined to the
extracellular space, only slightly
metabolized and rapidly excreted by the kidney. Approximately 80% of a
100 g dose appears in the
*
The 20% concentration may contain sodium bicarbonate for pH
adjustment.
6
14
6
2
urine in