1 Pregnant Women 11/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
5 1 INDICATIONS .............................................................................................................. 1 Pediatrics (<18 years of age) ...............................................................................
2 Geriatrics (≥ 65 years age) ................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX............................................................. 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 1 Dosing Considerations .........................................................................................
2 Recommended Dose and Dosage Adjustment ................................................... 3 Reconstitution ..................................................................................................... 4 Administration .....................................................................................................
5 Missed Dose ...................................................................................................... 10 5 OVERDOSAGE ...........................................................................................................
10 6 DOSAGE FORMS, STRENGHTS, COMPOSITION AND PACKAGING ................................ 10 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations ...........................................................................................
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics (<18 years of age) .............................................................................
4 Geriatrics (≥ 65 years of age) ............................................................................ 5 Hepatic insufficiency ......................................................................................... 6 Renal insufficiency.............................................................................................
16 8 ADVERSE REACTIONS ................................................................................................ 1 Adverse Reaction Overview .............................................................................. 2 Clinical Trial Adverse Reactions.........................................................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................... 5 Post-Market Adverse Reactions ........................................................................
24 9 DRUG INTERACTIONS................................................................................................ 2 Drug Interactions Overview .............................................................................. 4 Drug-Drug Interactions......................................................................................
5 Drug-Food Interactions ..................................................................................... 6 Drug-Herb Interactions ..................................................................................... 7 Drug-Laboratory Test Interactions ....................................................................
27 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ........................................................................................ 2 Pharmacodynamics ...........................................................................................
3 Pharmacokinetics .............................................................................................. 28 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 31 12 SPECIAL HANDLING INSTRUCTIONS ...........................................................................
32 PART II: SCIENTIFIC INFORMATION ...................................................................................... 33 13 PHARMACEUTICAL INFORMATION ............................................................................ 33 14 CLINICAL TRIALS........................................................................................................
1 Trial Design and Study Demographics ............................................................... 2 Study results ...................................................................................................... 37 15 MICROBIOLOGY ........................................................................................................
41 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 41 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................. 45 […]