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CABAZITAXEL FOR is a brand name for Cabazitaxel, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 02/2023 7 WARNINGS AND PRECAUTIONS, 7.1.1 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…
Verbatim from this product's HC label. Tap a section to expand.
and 12 SPECIAL HANDLING INSTRUCTIONS). 1 Pediatrics (<18 years of age) There is no indication for the use of Cabazitaxel for Injection in the pediatric population. The safety and the efficacy of cabazitaxel in children have not been established (see 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions).
2 Clinical Trial Adverse Reactions, 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). 2 CONTRAINDICATIONS Cabazitaxel for Injection is contraindicated in patients with: • a history of severe hypersensitivity reactions to cabazitaxel or other drugs formulated with polysorbate 80, or to any ingredient in the formulation or component of the container.
For a complete listing, see
2 Clinical Trial Adverse Reactions, 10 CLINICAL PHARMACOLOGY, Special Populations and Conditions). 2 CONTRAINDICATIONS Cabazitaxel for Injection is contraindicated in patients with: • a history of severe hypersensitivity reactions to cabazitaxel or other drugs formulated with polysorbate 80, or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • neutrophil counts ≤ 1500 / mm3. • severe hepatic impairment (total bilirubin > 3 x Upper Limit of Normal (ULN)). • concomitant vaccination with yellow fever vaccine (see
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 ...........................................................................................................
Cabazitaxel for Injection is contraindicated in patients with: • a history of severe hypersensitivity reactions to cabazitaxel or other drugs formulated with polysorbate 80, or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • neutrophil counts ≤ 1500 / mm3. • severe hepatic impairment (total bilirubin > 3 x Upper Limit of Normal (ULN)). • concomitant vaccination with yellow fever vaccine (see 9 DRUG INTERACTIONS).
Cabazitaxel for Injection Page 6 of 53 Protected B / Protégé B
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 […]