SORBITOL irrigant

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R)

Dostupno od:

B. Braun Medical Inc.

INN (International ime):

Sorbitol

Sastav:

Sorbitol 3.3 g in 100 mL

Administracija rute:

IRRIGATION

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

3.3% Sorbitol Irrigation is indicated for use as a urologic irrigation fluid. 3.3% Sorbitol Irrigation is not for injection. It is contraindicated in patients with anuria.

Proizvod sažetak:

3.3% Sorbitol Irrigation is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 2000 mL containers are packaged 8 per case and the 4000 mL containers are packaged 4 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).

Status autorizacije:

New Drug Application

Svojstava lijeka

SORBITOL- SORBITOL IRRIGANT
B. BRAUN MEDICAL INC.
----------
3.3% SORBITOL IRRIGATION
NONELECTROLYTE IRRIGATING FLUID FOR UROLOGIC IRRIGATION ONLY.
NOT FOR INJECTION.
DESCRIPTION
Each 100 mL contains:
Sorbitol (from Sorbitol Solution USP) 3.3 g
Water for Injection USP qs
pH: 5.3 (5.0–7.0)
Calculated Osmolarity: 185 mOsmol/liter, hypotonic
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULA
MOLECULAR WEIGHT
Sorbitol
182.17
Sorbitol is chemically designated D-glucitol (C H O ).
Sorbitol, an isomer of mannitol, is a hexitol naturally occurring in
many fruits, and is produced
commercially by the reduction of glucose.
3.3% Sorbitol Irrigation is a prediluted, sterile, nonpyrogenic
aqueous solution suitable for urologic
irrigation. The solution is slightly hypotonic.
The solution contains no antimicrobial or bacteriostatic agents or
added buffers.
The plastic container is a copolymer of ethylene and propylene
formulated and developed for parenteral
drugs. The copolymer contains no plasticizers and exhibits virtually
no leachability. The plastic
container is also virtually impermeable to vapor transmission and
therefore, requires no overwrap to
maintain the proper drug concentration. The safety of the plastic
container has been confirmed by
biological evaluation procedures. The material passes Class Vl testing
as specified in the U.S.
Pharmacopeia for Biological Tests — Plastic Containers. These tests
have shown that the container is
nontoxic and biologically inert.
The PIC Container is PVC-free and DEHP-free.
CLINICAL PHARMACOLOGY
In humans, sorbitol is nontoxic and rapidly metabolized. Sorbitol will
either be excreted in the urine by
the kidneys, or metabolized to carbon dioxide and dextrose.
When sorbitol is absorbed intravascularly in amounts which depend
primarily on the extent of the
surgery, it produces osmotic diuresis.
6
14
6
As a 3.3% solution, sorbitol is recommended for irrigation of the
urinary bladder and prostatic bed
during transurethral prostatectomy. Unlike dextrose solutions,
sor