BALANCED SALT- calcium chloride, magnesium chloride, potassium chloride, sodium acetate, sodium chloride, sodium citrate solutio

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Calcium Chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB), Magnesium Chloride (UNII: 02F3473H9O) (magnesium cation - UNII:T6V3LHY838), Potassium Chloride (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152), Sodium Acetate (UNII: 4550K0SC9B) (SODIUM CATION - UNII:LYR4M0NH37), Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37), Sodium Citrate (UNII: 1Q73Q2JULR) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Akorn

INN (International Name):

Calcium Chloride

Composition:

Calcium Chloride 0.48 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

NDC 17478-920-19 18 mL bottle STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to excessive heat and do not allow to freeze. AKORN Manufactured by: Akorn, Inc. Lake Forest, IL 60045 BLA0N Rev. 10/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BALANCED SALT- CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM
CHLORIDE,
SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE SOLUTION
AKORN
----------
AKORN
BALANCED SALT SOLUTION
Rx only
DESCRIPTION
BALANCED SALT SOLUTION is a sterile physiological solution containing
calcium chloride
(CaCl
·2H O), magnesium chloride (MgCl
·6H O), potassium chloride (KCl), sodium
acetate (C H NaO ·3H O), sodium chloride (NaCl) and sodium citrate
(C H Na O ·2H O). This solution is isotonic to ocular tissue and
contains electrolytes
required for normal cellular metabolic functions. Each 1 mL contains:
Calcium Chloride
(MW 147.02)
0.48 mg
Magnesium Chloride
(MW 203.31)
0.30 mg
Potassium Chloride
(MW 74.56)
0.75 mg
Sodium Acetate
(MW 136.08)
3.90 mg
Sodium Chloride
(MW 58.44)
6.40 mg
Sodium Citrate
(MW 294.10)
1.70 mg
Hydrochloric Acid and/or Sodium Hydroxide added to adjust pH.
Water for Injection
7.0 pH and 300 mosm/kg osmolality.
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, 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.
2
2
2
2
2
3
2
2
6
5
3
7
2
PRECAUTIONS
Open under aseptic conditions only.
Prior to use, check the following: tip should be firmly in place,
irrigating needle should be
properly seated; squeeze out several drops before inserting into
anterior chamber. The
needle should be removed from the anterior chamber prior to releasing
pressure to
prevent suction.
Studies suggest that intraocular irrigating solutions which are
iso-osmotic with n