BIAXIN

, Table 2. 2 Geriatrics Geriatrics (>65 years of age): Dosage adjustment should be considered in elderly patients with severe renal impairment. 4 Geriatrics. 2 CONTRAINDICATIONS • BIAXIN BID® and BIAXIN® are contraindicated in: o Patients with a known hypersensitivity to clarithromycin, erythromycin, other macrolide antibacterial agents or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

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Fatalities have been reported. Elderly patients may be more susceptible to drug-associated effects on the QT interval. , < 50 bpm), or when concomitantly taking with other medicinal products associated with QT prolongation, due to the risk for QT prolongation and torsades de pointes.

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; General 12/2024 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 ......................................................................

4 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 7 4 DOSAGE AND ADMINISTRATION ................................................................................. 10 5 OVERDOSAGE............................................................................................................

10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 11 7 WARNINGS AND PRECAUTIONS ................................................................................ 18 8 ADVERSE REACTIONS ................................................................................................

29 9 DRUG INTERACTIONS ................................................................................................ 42 10 CLINICAL PHARMACOLOGY .......................................................................................

43 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 56 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 56 PART II: SCIENTIFIC INFORMATION .......................................................................................

12/2024 7 WARNINGS AND PRECAUTIONS; General 12/2024 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 ......................................................................

4 1 INDICATIONS ............................................................................................................... 5 2 CONTRAINDICATIONS .................................................................................................

5