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ERAXIS®Index Section (anidulafungin)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Candidemia and Other Forms of Candida Infections (Intra-abdominal Abscess and Peritonitis)

1.2 Esophageal Candidiasis

1.3 Limitations of Use

1.4 Usage

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage in Adults

2.2 Recommended Dosage in Pediatric Patients (1 Month of Age and Older)

2.3 Preparation for Administration

2.4 Dilution and Administration of the Infusion

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hepatic Adverse Reactions

5.2 Anaphylactic and Hypersensitivity Reactions

5.3 Risk of Neonatal Toxicity Associated with Polysorbates

5.4 Risk in Patients with Hereditary Fructose Intolerance (HFI)

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-marketing Experience

7 DRUG INTERACTIONS

7.1 Cyclosporine

7.2 Voriconazole

7.3 Tacrolimus

7.4 Rifampin

7.5 Amphotericin B Liposome for Injection

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Insufficiency

8.7 Renal Insufficiency

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Candidemia and Other Candida Infections (Intra-abdominal Abscess and Peritonitis)

14.2 Esophageal Candidiasis

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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