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MAR-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 ............................................................................................................
5 5 OVERDOSAGE................................................................................................................ 5
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 ............................................................................................................
5 5 OVERDOSAGE................................................................................................................ 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.................................... 6 7 WARNINGS AND PRECAUTIONS .....................................................................................
, Immune 05/2022 7 WARNINGS AND PRECAUTIONS, Hematologic 11/2023
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 Pregnant Women ............................................................................................ 2 Breast-feeding ................................................................................................. 3 Pediatrics .........................................................................................................
4 Geriatrics ......................................................................................................... 11 8 ADVERSE REACTIONS ....................................................................................................
5 Post-Market Adverse Reactions ............................................................................ 16 9 DRUG INTERACTIONS .................................................................................................. 2 Drug Interactions Overview ...................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions ......................................................................................... 19 10 CLINICAL PHARMACOLOGY .........................................................................................
1 Mechanism of Action ....................................................................................... 2 Pharmacodynamics ......................................................................................... 3 Pharmacokinetics ............................................................................................
21 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................. 24 PART II: SCIENTIFIC INFORMATION .........................................................................................
25 13 PHARMACEUTICAL INFORMATION .............................................................................. 25 14 CLINICAL TRIALS ..........................................................................................................
1 Clinical Trials by Indication .............................................................................. 2 Comparative Bioavailability Studies……………………………………………………………… 30 15 MICROBIOLOGY ..........................................................................................................
32 16 NON-CLINICAL TOXICOLOGY ........................................................................................ 33 PATIENT MEDICATION INFORMATION ....................................................................................
34 MAR-DIMETHYL FUMARATE PM Page 4 of 38 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS MAR-DIMETHYL FUMARATE (dimethyl fumarate) is indicated as monotherapy for: • treatment of relapsing remitting multiple sclerosis (MS), to reduce the frequency of clinical exacerbations and to delay the progression of disability.
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