Miscellaneous ePI Test, published by . This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-test/ and changes regularly. See the Directory of published versions
Example Bundle: Template of CLD Bundle
Composition category:
Composition status:
final
Narrative Text
Cover Page
1. INDICATIONS AND USAGE
2. DOSAGE AND ADMINISTRATION
2.1 Recommended Dose and Schedule
2.2 Dose Modification
3. DOSAGE FORMS AND STRENGTHS
5. WARNINGS AND PRECAUTIONS
5.1 Neutropenia
5.3 Embryo-Fetal Toxicity
6. ADVERSE REACTIONS
6.1 Clinical Studies Experience
6.2 Postmarketing Experience
7. DRUG INTERACTIONS
7.1 Agents that may Increase Palbociclib Plasma Concentrations
7.2 Agents that may Decrease Palbociclib Plasma Concentrations
7.3 Drugs that may have Their Plasma Concentrations Altered by Palbociclib
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Hepatic Impairment
8.7 Renal Impairment
9. OVERDOSAGE
10. DESCRIPTION
11. CLINICAL PHARMACOLOGY
11.1 Mechanism of Action
11.2 Pharmacodynamics
11.3 Pharmacokinetics
12 NONCLINICAL TOXICOLOGY
12.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13 CLINICAL STUDIES
14 HOW SUPPLIED/STORAGE AND HANDLING
15 PATIENT COUNSELING INFORMATION
Product Information
Combined pharmaceutical dose form: