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SANDOZ DIMETHYL FUMARATE is a brand name for Dimethyl Fumarate, supplied as a capsule (delayed release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: , 1.1 Pediatrics 05/2022
Verbatim from this product's HC label. Tap a section to expand.
2 Pharmacodynamics 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 .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................
4 Administration ....................................................................................................... 5 Missed Dose...........................................................................................................
6 5 OVERDOSAGE ............................................................................................................... 6
2 Pharmacodynamics 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 .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics ...............................................................................................................
2 Geriatrics ............................................................................................................... 4 2 CONTRAINDICATIONS ...................................................................................................
4 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations ........................................................................................... 2 Recommended Dose and Dosage Adjustment .......................................................
4 Administration ....................................................................................................... 5 Missed Dose...........................................................................................................
6 5 OVERDOSAGE ............................................................................................................... 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 6 7 WARNINGS AND PRECAUTIONS....................................................................................
11/2023 7 WARNINGS AND PRECAUTIONS, Hematologic 05/2022 7 WARNINGS AND PRECAUTIONS, Immune 05/2022
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dimethyl Fumarate 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 .............................................................................................. 1 Pregnant Women ................................................................................................ 2 Breast-feeding ....................................................................................................
3 Pediatrics ............................................................................................................ 4 Geriatrics ............................................................................................................
14 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 ........................................................................... 19 9 DRUG INTERACTIONS ................................................................................................. 2 Drug Interactions Overview .................................................................................
4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................ 25 10 CLINICAL PHARMACOLOGY.........................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
27 11 STORAGE, STABILITY AND DISPOSAL .......................................................................... 30 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................ 30 PART II: SCIENTIFIC INFORMATION ........................................................................................
31 13 PHARMACEUTICAL INFORMATION ............................................................................. 31 14 CLINICAL TRIALS .........................................................................................................
1 Clinical Trials by Indication ................................................................................... 3 Comparative Bioavailability Studies ..................................................................... 36 15 MICROBIOLOGY ..........................................................................................................
37 16 NON-CLINICAL TOXICOLOGY ....................................................................................... 37 17 SUPPORTING PRODUCT MONOGRAPHS ..................................................................... 39 PATIENT MEDICATION INFORMATION ...................................................................................
40 Sandoz Dimethyl Fumarate Page 4 of 47 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Sandoz Dimethyl Fumarate (dimethyl fumarate) is indicated as monotherapy for: • treatment of relapsing remitting multiple sclerosis (MS), to reduce the […]