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

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

sodium chloride (UNII: 451W47IQ8X) (chloride ion - UNII:Q32ZN48698, sodium cation - UNII:LYR4M0NH37), potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152, chloride ion - UNII:Q32ZN48698), calcium chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB, chloride ion - UNII:Q32ZN48698), magnesium chloride (UNII: 02F3473H9O) (magnesium cation - UNII:T6V3LHY838, chloride ion - UNII:Q32ZN48698), sodium acetate (UNII: 4550K0SC9B) (acetate ion - UNII:569DQM74SC, sodium cation - UNI

Предлага се от:

Akorn

Начин на приложение:

OPHTHALMIC

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

Balanced Salt Solution ( Sterile Irrigating Solution) is supplied in a glass bottle using a grey butyl stopper and aluminum seal with a polypropylene flip-off cap. NDC 17478-921-95          500 mL in a 570 mL container. STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. DO NOT FREEZE. AKORN Manufactured for: Akorn, Inc. Lake Forest, IL 60045 Made in Austria BSA0N Rev. 10/16

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

BALANCED SALT- SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE,
MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE
SOLUTION
AKORN
----------
M080082/00 US
BALANCED SALT SOLUTION
SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM
CHLORIDE,
SODIUM ACETATE AND SODIUM CITRATE SOLUTION
DESCRIPTION
Balanced Salt Solution is a sterile physiological 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 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, vacuum is present
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.
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.
There have been reports of corneal clouding or edema following ocular
surgery in which
2
2
2
2
2
3
2
2
6
5
3
7
2
Balanced Salt Solution (Sterile Irrigating Solution) was used as an
irrigating solution.
ADVERSE REACTIONS
Irrigation