STERILE WATER- water irrigant

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)

可用日期:

B. Braun Medical Inc.

INN（国际名称）:

WATER

组成:

WATER 1 mL in 1 mL

给药途径:

IRRIGATION

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ). Not for injection.

產品總結:

Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in plastic irrigating containers. The 1000 mL and 500 mL containers are packaged 16 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).

授权状态:

New Drug Application

产品特点

STERILE WATER- WATER IRRIGANT
B. BRAUN MEDICAL INC.
----------
PACKAGE INSERT
PIC™ (PLASTIC IRRIGATION CONTAINERS)
STERILE WATER FOR IRRIGATION USP
RX ONLY
DESCRIPTION
Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic
irrigating fluid or
pharmaceutic aid (solvent) entirely composed of Sterile Water for
Injection USP. It is
prepared by distillation and contains no antimicrobial or
bacteriostatic agents or added
buffers. The pH is 5.7 (5.0–7.0)
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.
Not made with natural rubber Latex, PVC or DEHP.
CLINICAL PHARMACOLOGY
Sterile Water for Irrigation USP is utilized for a variety of clinical
indications. Because of
its low refractive index (1.3325), water provides excellent visibility
during endoscopic
urological procedures. It is also utilized as a pharmaceutic aid, as
well as in the
preparation of enteral nutrient products.
Water is hypotonic and will cause hemolysis and will be readily
absorbed by the tissues
during surgical procedures; therefore, its use under such conditions
is not
recommended.
INDICATIONS AND USAGE
Sterile Water for Irrigation USP is indicated for use as an irrigating
fluid or pharmaceutic
aid. Sterile Water may also be used as an adjunct in the preparation
of non-intravenously
administered nutrient mixtures (see DOSAGE AND ADMINISTRATION).
CONTRAINDICATIONS
Not for injection.
WARNINGS
Sterile Water for Irrigation USP is hypotonic and will cause
hemolysis,