CALCIUM CHLORIDE injection, solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)

Beschikbaar vanaf:

American Regent, Inc.

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

10% calcium chloride injection is indicated for the treatment of hypocalcemia in those conditions requiring a prompt increase in plasma calcium levels. Calcium chloride is contraindicated for cardiac resuscitation in the presence of ventricular fibrillation or in patients with the risk of existing digitalis toxicity. Calcium chloride is not recommended in the treatment of asystole and electromechanical dissociation. None known.

Product samenvatting:

10% calcium chloride injection, USP is supplied in single-dose containers as follows: NDC No. Container Size Carton 0517-6710-10 Glass Vial 10 mL 10 Vials Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

CALCIUM CHLORIDE- CALCIUM CHLORIDE INJECTION, SOLUTION
AMERICAN REGENT, INC.
----------
10% CALCIUM CHLORIDE INJECTION, USP
10% CALCIUM CHLORIDE INJECTION, USP
1 GRAM (100 MG/ML)
Represents 27 mg (1.4 mEq) Ca
/mL
A HYPERTONIC SOLUTION IN A 10 ML SINGLE-DOSE VIAL FOR PROMPT
INTRAVENOUS INJECTION.
CAUTION: THIS SOLUTION MUST NOT BE INJECTED INTRAMUSCULARLY OR
SUBCUTANEOUSLY.
ADMINISTER ONLY BY SLOW INJECTION (NOT TO EXCEED 1 ML/MINUTE)
Rx only
DESCRIPTION
10% calcium chloride injection is a sterile, nonpyrogenic, hypertonic
solution. Each mL contains 100
mg (1.4 mEq/mL) of calcium chloride, dihydrate (1.4 mEq each of Ca
and Cl
) in water for injection. It
is provided in a 10 mL single-dose vial to facilitate prompt
intravenous injection. The solution contains
no bacteriostat, antimicrobial agent or added buffer and is intended
for use only as a single-dose
injection. The pH of 10% calcium chloride injection is 6.3 (5.5 to
7.5) when diluted with water for
injection to make a 5% solution. May contain hydrochloric acid and/or
sodium hydroxide for pH
adjustment. The osmolar concentration is 2.04 mOsmol/mL (calc.). 10%
calcium chloride injection is
oxygen sensitive.
Calcium chloride dihydrate is chemically designated CaCl
• 2H O (dihydrate) and is described as
white, odorless fragments or granules freely soluble in water.
CLINICAL PHARMACOLOGY
Calcium is the fifth most abundant element in the body and the major
fraction is in the bony structure.
Calcium plays important physiological roles, many of which are poorly
understood. It is essential for
the functional integrity of the nervous and muscular systems. It is
necessary for normal cardiac function
and is one of the factors that operates in the mechanisms involved in
the coagulation of blood.
Calcium chloride in water dissociates to provide calcium (Ca
) and chloride (Cl
) ions. They are
normal constituents of the body fluids and are dependent on various
physiological mechanisms for
maintenance of balance between intake and output. Approximately 80% of
body calcium i