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:

Hospira, Inc.

INN (Nome Internazionale):

CALCIUM CHLORIDE

Composizione:

CALCIUM CHLORIDE 100 mg in 1 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Calcium Chloride Injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use The safety and effectiveness of Calcium Chloride Injection for long-term use has not been established. Calcium Chloride Injection is contraindicated in: Newborns (up to 28 days of age) if they require (or are expected to require) ceftriaxone intravenous treatment because of the risk of precipitation of ceftriaxone-calcium, regardless of whether these products would be received at different times or through separate intravenous lines [see Warnings and Precautions (5.1)] .       Risk Summary Administration of Calcium Chloride Injection for the treatment of acute symptomatic hypocalcemia during pregnancy is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with development of hypocalcemia during pregnancy (see Clinical Considerations) . Animal reproduction studies have n

Dettagli prodotto:

Calcium Chloride Injection, USP (clear solution) is supplied in single-dose syringes as follows: Unit of Sale and Product Description Strength NDC Bundle of 10 10 mL Ansyr® Plastic Syringe 10% (1,000 mg/10 mL) (100 mg/mL) 0409-1631-10 Bundle of 10 10 mL LifeShield® Abboject® Glass Syringe with Luer Lock Adapter and protected needle 10% (1,000 mg/10 mL) (100 mg/mL) 0409-4928-34 The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental calcium per mL of solution. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature.]

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

CALCIUM CHLORIDE- CALCIUM CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
REFERENCE LABEL SET ID: B0909F41-76D0-488E-95E8-D8755F0EEA4F
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE 10%
CALCIUM CHLORIDE
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
10% CALCIUM
CHLORIDE INJECTION.
CALCIUM CHLORIDE INJECTION, FOR INTRAVENOUS USE ONLY
INITIAL U.S. APPROVAL: 1938
INDICATIONS AND USAGE
Calcium Chloride Injection is a form of calcium indicated for the
treatment of adult and pediatric and
patients with acute symptomatic hypocalcemia. (1)
Limitations of Use:
The safety and effectiveness of Calcium Chloride Injection for
long-term use has not been established.
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Calcium Chloride Injection, USP (single-dose) is supplied as: (3)
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The 100 mg/mL concentration represents 27 mg or 1.4 mEq of elemental
calcium per mL of solution. (3)
CONTRAINDICATIONS
Calcium Chloride Injection is contraindicated in:
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WARNINGS AND PRECAUTIONS
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Administer Calcium Chloride Injection BY _SLOW_ INTRAVENOUS INFUSION
(NOT TO EXCEED 1
ML/MINUTE), _IN A CENTRAL OR DEEP VEIN_. (2.1)
Do not use intramuscularly or subcutaneously. (2.1)
Do not administer unless solution is clear and seal is intact. (2.1)
Stop the administration if the patient complains of any
administration-related discomfort, it may be
resumed when symptoms disappear. (2.1)
The recommended adult dose is from 200 mg to 1,000 mg. (2.2)
The recommended pediatric dose is from 2.7 to 5 mg/kg of calcium
chloride. (2.2)
Repeated injections may be required because of rapid calcium
excretion. (2.2)
See the full prescribing information for the recommended starting dose
in patients with renal
impairment. (2.3)
Do not mix Ca