SORBITOL-MANNITOL- sorbitol and mannitol irrigant

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R), MANNITOL (UNII: 3OWL53L36A) (MANNITOL - UNII:3OWL53L36A)

Предлага се от:

Hospira, Inc.

INN (Международно Name):

SORBITOL

Композиция:

SORBITOL 2.7 g in 100 mL

Начин на приложение:

URETHRAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Sorbitol-Mannitol Irrigation is indicated for use as a urologic irrigating fluid during transurethral prostatic resection and other transurethral surgical procedures. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. Do not use in patients with anuria.

Каталог на резюме:

Sorbitol-Mannitol Irrigation is supplied in single-dose 3000 mL flexible irrigation container (NDC No. 0409-7981-08). Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing.   Revised: May, 2009         Printed in USA                                                         EN-2127                                                                           Hospira, Inc., Lake Forest, IL 60045 USA

Статус Оторизация:

New Drug Application

Данни за продукта

SORBITOL-MANNITOL- SORBITOL AND MANNITOL IRRIGANT
HOSPIRA, INC.
----------
SORBITOL-MANNITOL IRRIGATION
_NONELECTROLYTIC IRRIGATING FLUID FOR TRANSURETHRAL SURGICAL_
_PROCEDURES_
FOR UROLOGIC IRRIGATION ONLY; NOT FOR INJECTION BY USUAL PARENTERAL
ROUTES.
FLEXIBLE IRRIGATION CONTAINER
Rx only
DESCRIPTION
Sorbitol-Mannitol Irrigation is a sterile, nonpyrogenic, hypotonic,
aqueous solution for urologic
nonelectrolyte irrigation during transurethral surgical procedures.
Each 100 mL contains sorbitol 2.70
g and mannitol 0.54 g in water for injection. The solution is
nonelectrolytic and hypotonic (178
mOsmol/liter calc.); pH 5.2 (4.0 to 7.0).
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is intended only for use as
a single-dose irrigation. When smaller volumes are required the unused
portion should be discarded.
Sorbitol-Mannitol Irrigation is a nonelectrolyte urologic irrigant.
Sorbitol, NF is chemically designated D-glucitol (C H O ), white
powder, granules or flakes very
soluble in water. It has the following structural formula:
Mannitol, USP is chemically designated D-mannitol (C H O ), 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 0.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. Water can
6
14
6
6
14
6
2
permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution
significantly.
The semi-rigid container is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The container requires no vapor barrier to
maintain the proper drug
concentration.
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
storag