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:

HF Acquisition Co LLC, DBA HealthFirst

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 the following dosage forms: NDC 51662-1452-1 10% CALCIUM CHLORIDE INJECTION, USP 1000mg/10mL (100mg/mL) SYR HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms 10% Calcium Chloride Injection, USP is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

CALCIUM CHLORIDE- CALCIUM CHLORIDE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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10% CALCIUM CHLORIDE INJECTION, USP 1000MG/10ML (100MG/ML) SYR
SPL UNCLASSIFIED
1 Gram (100 mg/mL)
Represents 27 mg (1.4 mEq) Ca++/mL
Ansyr™ Plastic Syringe
A HYPERTONIC SOLUTION IN A 10 ML UNIT OF USE SYRINGE 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, USP 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 Unit
of Use Syringe 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, USP is 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, USP is oxygen sensitive.
Calcium Chloride, USP dihydrate is chemically designated CaCl2 •
2H2O (dihydrate) and
is described as white, odorless fragments or granules freely soluble
in water.
The plastic syringe is molded from a specially formulated
polypropylene. Water
permeates from inside the container at an extremely slow rate which
will have an
insignificant effect on solution concentration over the expected shelf
life. Solutions in
contact with the plastic container may leach out certain chemical
components from the
plastic in very small amounts; however, biological testing was
supportive of the safety of
the syringe material.
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