• Highlights
• Contents
• Indications and Usage
• Dosage and Administration
• Dosage Forms and Strengths
• Contraindications

• Warnings and Precautions
• Adverse Reactions
• Drug Interactions
• Use in Specific Populations
• Description

• Clinical Pharmacology
• Nonclinical Toxicology
• Clinical Studies
• References
• How Supplied/
  Storage and Handling

FULL PRESCRIBING INFORMATION:
CONTENTS*

1. 1 INDICATIONS AND USAGE
2. 2 DOSAGE AND ADMINISTRATION
   1. 2.1 Reconstitution of RECOTHROM
   2. 2.2 Application Techniques
3. 3 DOSAGE FORMS AND STRENGTHS
4. 4 CONTRAINDICATIONS
5. 5 WARNINGS AND PRECAUTIONS
6. 6 ADVERSE REACTIONS
   1. 6.1 Clinical Trials Experience
7. 7 DRUG INTERACTIONS
8. 8 USE IN SPECIFIC POPULATIONS
   1. 8.1 Pregnancy
   2. 8.4 Pediatric Use
   3. 8.5 Geriatric Use
9. 11 DESCRIPTION
10. 12 CLINICAL PHARMACOLOGY
11. 13 NONCLINICAL TOXICOLOGY
    1. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
    2. 13.2 Animal Toxicology and/or Pharmacology
    3. 13.3 Pharmacology
12. 14 CLINICAL STUDIES
    1. 14.1 Study Design and Objectives
    2. 14.2 Clinical Study Results
13. 15 REFERENCES
14. 16 HOW SUPPLIED/STORAGE AND HANDLING

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