CALCIUM CHLORIDE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Civica, Inc.

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

10% calcium chloride injection, USP is supplied in single-dose containers as follows: NDC No. Container Size Carton 72572-052-10 Glass Vial 10 mL 10 Vials Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

CALCIUM CHLORIDE- CALCIUM CHLORIDE INJECTION, SOLUTION
CIVICA, 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 is excrete