GLYCINE irrigant

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C)

Dostopno od:

Hospira, Inc.

INN (mednarodno ime):

GLYCINE

Sestava:

GLYCINE 1.5 g in 100 mL

Pot uporabe:

IRRIGATION

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

1.5% Glycine Irrigation, USP is indicated for use as 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.

Povzetek izdelek:

1.5% Glycine Irrigation, USP is supplied in single-dose 3000 mL flexible irrigation container ( List No. 7974). Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: October 2004  ©Hospira 2004                                    EN-0577                                    Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Status dovoljenje:

New Drug Application

Lastnosti izdelka

GLYCINE- GLYCINE IRRIGANT
HOSPIRA, INC.
----------
1.5% GLYCINE IRRIGATION, USP
_NONELECTROLYTE IRRIGATING FLUID FOR TRANSURETHRAL SURGICAL_
_PROCEDURES._
FOR UROLOGIC IRRIGATION ONLY; NOT FOR INJECTION BY USUAL PARENTERAL
ROUTES
FLEXIBLE IRRIGATION CONTAINER
RX ONLY
DESCRIPTION
1.5% Glycine Irrigation, USP is a sterile, nonpyrogenic, hypotonic,
aqueous solution of glycine
intended only for urologic irrigation during transurethral surgical
procedures.
Each 100 mL contains 1.5 g of glycine in water for injection. The
solution is nonelectrolytic, hypotonic
and has an osmolarity of 200 mOsmol/liter (calc.); pH 6.0 (4.5 to
6.5).
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.
1.5% Glycine Irrigation is a urologic nonelectrolyte irrigant.
Glycine, USP is chemically designated aminoacetic acid (C H NO ), a
white crystalline powder freely
soluble in water. It has the following structural formula:
NH CH COOH
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.
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