GLYCINE irrigant

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

ICU Medical Inc.

Calea de administrare:

IRRIGATION

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

1.5% Glycine Irrigation, USP is supplied in single-dose 3000 mL flexible irrigation container 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. 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: November, 2022 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA IFU0000478

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

GLYCINE- GLYCINE IRRIGANT
ICU MEDICAL 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�