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#1.09B6 + SERUM PRESET PACKS FOR MAC FULL#
FULL PRESCRIBING INFORMATION: CONTENTS * WARNING: LEFT VENTRICULAR DYSFUNCTION AND EMBRYO-FETAL TOXICITY 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Doses and Schedules 2.2ĝose Modification or Important Dosing Considerations 2.3 Preparation for Administration 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Left Ventricular Dysfunction 5.2Ğmbryo-Fetal Toxicity 5.3 Infusion-Related Reactions 6 ADVERSE REACTIONS 6.1Ĝlinical Trials Experience 6.2 Immunogenicity 7 DRUG INTERACTIONS 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 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1Ĝarcinogenesis, Mutagenesis, and Impairment of Fertility 14 CLINICAL STUDIES 14.1 Metastatic Breast Cancer 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage 17 PATIENT COUNSELING INFORMATION * Sections or subsections omitted from the full prescribing information are not listed.