RINGERS- sodium chloride, potassium chloride, and calcium chloride irrigant

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)

متاح من:

B. Braun Medical Inc.

INN (الاسم الدولي):

SODIUM CHLORIDE

تركيب:

SODIUM CHLORIDE 0.86 g in 100 mL

طريقة التعاطي:

IRRIGATION

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Ringer’s Irrigation USP is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

ملخص المنتج:

Ringer’s Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Containers). The 1000 mL containers are packaged 16 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).

الوضع إذن:

New Drug Application

خصائص المنتج

RINGERS- SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE
IRRIGANT
B. BRAUN MEDICAL INC.
----------
RINGER'S IRRIGATION USP
Package Insert
PIC™ (PLASTIC IRRIGATION CONTAINERS)
RINGER’S IRRIGATION USP
_FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES_
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES
SEMI-RIGID IRRIGATION CONTAINER
RX ONLY
DESCRIPTION
Ringer’s Irrigation USP is a sterile, nonpyrogenic, solution of
electrolytes in water for
injection intended only for sterile irrigation, washing and rinsing
purposes.
Each 100 mL contains:
Sodium Chloride USP 0.86 g; Potassium Chloride USP 0.03 g
Calcium Chloride Dihydrate USP 0.033 g; Water for Injection USP qs
pH: 5.8 (5.0-7.5). The solution is isotonic (310 mOsmol/liter, calc.)
and has the following
electrolyte content (mEq/liter): Na 147; K 4 Ca
4.5; Cl
156
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is
intended only for use as a single-dose or short procedure irrigation.
When smaller
volumes are required the unused portion should be discarded.
Ringer’s Irrigation USP
may be classified as a sterile irrigant, wash, rinse and
pharmaceutical vehicle.
The formulas of the active ingredients are:
INGREDIENTS
MOLECULAR FORMULAMOLECULAR WEIGHT
Sodium Chloride USP
NaCl
58.44
Potassium Chloride USP
KCl
74.55
Calcium Chloride Dihydrate USP
CaCl
•2H O
147.01
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
+
+
++
−
2
2
container is nontoxic and biologically inert.
Not made with natural rub