EPINEPHRINE ABBOJECT NDC 0409-4933-01 Principal Display Panel (Epinephrine injection, USP ABBOJECT) | Pfizer Medical Information - US

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PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label

Epinephrine 1 mg/10 mL (0.1 mg/mL)

10 mL Single-dose
NDC 0409-4933-11
Discard Unused Portion

Epinephrine Injection, USP
1 mg/10 mL (0.1 mg/mL)

For Intravenous Use. Dosage: See insert.

Warning: Contains Sulfites. Sterile, nonpyrogenic.
Rx only

Hospira, Inc.
Lake Forest, IL 60045 USA
RL - 5135

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Label

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

10 mL
NDC 0409-4933-11
Rx only

Epinephrine
Injection, USP

1 mg/10 mL
(0.1 mg/mL)

For Intravenous Use
Warning: Contains Sulfites
Protect from light

ABBOJECT®
Unit of Use Syringe

with male luer lock
adapter and 20-Gauge
protected needle

Hospira

◀ PRESS AND PULL TO OPEN

PRINCIPAL DISPLAY PANEL - 10 mL Syringe Carton

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

EPINEPHRINE ABBOJECT NDC 0409-4933-01 Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...

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1 INDICATIONS AND USAGE

1.1 Hypotension associated with Septic Shock

Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is indicated to increase mean arterial blood...

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2 DOSAGE AND ADMINISTRATION

2.1 General Considerations

Inspect visually for particulate matter and discoloration prior to administration, whenever solution and...

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3 DOSAGE FORMS AND STRENGTHS

Injection solution: 10 mL clear glass vial containing 1 mg/10 mL (0.1 mg/mL) epinephrine in a sterile, nonpyrogenic, clear and colorless solution. Each vial is co-packaged with an injector, which...

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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Hypertension

Because individual response to epinephrine may vary significantly, monitor blood pressure frequently and titrate to avoid...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in labeling:

Hypertension [see Warnings and Precautions (5.1)]
...

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7 DRUG INTERACTIONS

7.1 Drugs Antagonizing Pressor Effects of Epinephrine

α-blockers, such as phentolamine
Vasodilators, such as nitrates
...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Limited published data...

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10 OVERDOSAGE

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema...

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11 DESCRIPTION

Epinephrine Injection USP, 1 mg/10 mL (0.1 mg/mL) is supplied as a sterile aqueous solution with a pH range of 2.3–3.5, that is clear, colorless, and nonpyrogenic. Each milliliter contains 0.1 mg epinephrine,...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Epinephrine acts on both alpha (α)- and beta (β)-adrenergic receptors. The mechanism of the rise in blood pressure...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate the carcinogenic potential of epinephrine have not...

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14 CLINICAL STUDIES

14.1 Hypotension associated with Septic Shock

Fourteen clinical studies from the literature documented that epinephrine increases the mean...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Epinephrine Injection 1 mg/10 mL (0.1 mg/mL) is a clear and colorless solution available in glass vials. Each vial is co-packaged with an injector, which together make a single-dose...

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

ABBOJECT...

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Report Adverse Event

Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.