SORBITOL-MANNITOL- sorbitol and mannitol irrigant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

ICU Medical Inc.

Administration route:

URETHRAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Sorbitol-Mannitol Irrigation is supplied in single-dose 3000 mL flexible irrigation container (NDC No. 0409-7981-08 / 0990-7981-08). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2018 EN-4664 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

Authorization status:

New Drug Application

Summary of Product characteristics

SORBITOL-MANNITOL- SORBITOL AND MANNITOL IRRIGANT
ICU MEDICAL INC.
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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:
6
14
6
6
14
6
Water for Injection, USP is chemically designated H 0.
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.
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