Miscellaneous ePI Test
0.1.0 - CI Build

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

status:

Domain:

Combined pharmaceutical dose form:

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Clinical Information