BALANCED SALT- sodium chloride, potassium chloride, calcium chloride, magnesium chloride, sodium acetate, and sodium citrate sol

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838), SODIUM ACETATE (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37), SODIUM CITRATE (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37)

متاح من:

B. Braun Medical Inc.

INN (الاسم الدولي):

Sodium Chloride

تركيب:

Sodium Chloride 6.4 mg in 1 mL

طريقة التعاطي:

IRRIGATION

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

ملخص المنتج:

Balanced Salt Solution Sterile Irrigating Solution is supplied in a glass bottle using a gray butyl stopper and Flip off closure to close it.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

BALANCED SALT- SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE,
MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE SOLUTION
B. BRAUN MEDICAL INC.
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BALANCED SALT SOLUTION
STERILE IRRIGATING SOLUTION
DESCRIPTION
Balanced Salt Solution Sterile Irrigating Solution is a sterile
balanced salt solution, each
mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl)
0.075%, calcium
chloride dihydrate (CaCl
·2H O) 0.048%, magnesium chloride hexahydrate (MgCl
·6H O)
0.03%, sodium acetate trihydrate (C H NaO ·3H O) 0.39%, sodium
citrate dihydrate
(C H Na O ·2H O) 0.17%, sodium hydroxide and/or hydrochloric acid (to
adjust pH),
and water for injection.
The pH is approximately 7.0.
The osmolality is approximately 300 mOsm/Kg.
CLINICAL PHARMACOLOGY
Balanced Salt Solution Sterile Irrigating Solution is an isotonic
solution for use in irrigating
tissues of the eyes.
INDICATIONS AND USAGE
For use as an extraocular and intraocular irrigating solution during
ocular surgical
procedure involving perfusion of the eye with an expected maximum
duration of less
than 60 minutes.
WARNINGS
NOT FOR INJECTION OR INTRAVENOUS INFUSION.
Do not use unless product is clear, seal is intact and container is
undamaged.
Do not use if product is discolored or contains a precipitate.
SINGLE patient use only. The contents of this bottle should not be
used in more than
one patient.
The use of additives with this solution may cause corneal
decompensation.
This solution contains no preservative, unused contents should be
discarded.
PRECAUTIONS
Open under aseptic conditions only.
Studies suggest that intraocular irrigating solutions which are
iso-osmotic with normal
aqueous fluids should be used with caution in diabetic patients
undergoing vitrectomy
since intraoperative lens changes have been observed.
2
2
2
2
2
3
2
2
6
5
3
7
2
There have been reports of corneal clouding or edema following ocular
surgery in which
Balanced Salt Solution Sterile Irrigating Solution was used as an
irrigating solution.
ADVERSE REACTIONS
Irriga