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ZIRABEV is a brand name for Bevacizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between Zirabev (bevacizumab for injection) and the reference biologic drug Avastin. ZIRABEV (bevacizumab) is indicated for: • Metastatic Colorectal Cancer (mCRC) Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for first-line…
Verbatim from this product's HC label. Tap a section to expand.
5 Post-Market Adverse Reactions 03/2023 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 ........................................................ 4 1 INDICATIONS ............................................................................................................
1 Pediatrics ................................................................................................................. 2 Geriatrics .................................................................................................................
5 2 CONTRAINDICATIONS ............................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................... 5 4 DOSAGE AND ADMINISTRATION .........................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................... 3 Reconstitution .........................................................................................................
4 Administration ......................................................................................................... 5 Missed Dose.............................................................................................................
8 5 OVERDOSAGE .......................................................................................................... 8
5 Post-Market Adverse Reactions 03/2023 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 ........................................................ 4 1 INDICATIONS ............................................................................................................
1 Pediatrics ................................................................................................................. 2 Geriatrics .................................................................................................................
5 2 CONTRAINDICATIONS ............................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................... 5 4 DOSAGE AND ADMINISTRATION .........................................................................
1 Dosing Considerations ............................................................................................. 2 Recommended Dose and Dosage Adjustment ......................................................... 3 Reconstitution .........................................................................................................
4 Administration ......................................................................................................... 5 Missed Dose.............................................................................................................
8 5 OVERDOSAGE .......................................................................................................... 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 8 7 WARNINGS AND PRECAUTIONS ..........................................................................
4 Recommended Dose and Dosage Adjustment 09/2023
Zirabev is contraindicated in patients who are hypersensitive to this drug, Chinese hamster ovary cell products or other recombinant human or humanised antibodies or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). Zirabev is contraindicated in patients with untreated Central Nervous System (CNS) metastases (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bevacizumab in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
1 Special Populations ................................................................................................ 18 8 ADVERSE REACTIONS ......................................................................................... 1 Adverse Reaction Overview ...................................................................................
2 Clinical Trial Adverse Reactions ............................................................................. 3 Less Common Clinical Trial Adverse Reactions ...................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................
5 Post-Market Adverse Reactions ............................................................................. 59 9 DRUG INTERACTIONS .......................................................................................... 2 Drug Interactions Overview ...................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions ......................................................................... 62 10 CLINICAL PHARMACOLOGY ............................................................................... 1 Mechanism of Action .......................................................................................
2 Pharmacodynamics .......................................................................................... 3 Pharmacokinetics ............................................................................................. 63 11 STORAGE, STABILITY AND DISPOSAL .............................................................
65 12 SPECIAL HANDLING INSTRUCTIONS ................................................................ 65 PART II: SCIENTIFIC INFORMATION .............................................................................. 66 13 PHARMACEUTICAL INFORMATION ...................................................................
66 14 CLINICAL TRIALS .................................................................................................. 1 Clinical Trials by Indication ...............................................................................
67 15 MICROBIOLOGY ..................................................................................................... 85 16 NON-CLINICAL TOXICOLOGY ............................................................................. 85 17 SUPPORTING PRODUCT MONOGRAPHS .........................................................
87 PATIENT MEDICATION INFORMATION ......................................................................... 88 ZIRABEV (bevacizumab for injection) Page 4 of 98 Zirabev (bevacizumab for injection) is a biosimilar biologic drug to Avastin®.
A biosimilar is a biologic drug that was granted authorization based on a demonstration of similarity […]