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RIVA LEUCOVORIN is a brand name for Leucovorin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: RIVA LEUCOVORIN (leucovorin calcium) is indicated for: • diminishing the toxicity and counteracting the effect of impaired methotrexate elimination. • treatment of megaloblastic anemias due to folate deficiency, as in sprue, nutritional deficiency, megaloblastic anemias of pregnancy and infancy. 1.1 Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 04/2023 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 ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................
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1 Adverse Reaction Overview Allergic sensitization, including anaphylactoid/anaphylactic reactions (including shock) and urticaria, has been reported following administration of leucovorin calcium. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
Leucovorin calcium in Combination with 5-fluorouracil (5-FU) In combination regimens, the toxicity profile of 5-FU is enhanced by leucovorin calcium. The most common manifestations are mucositis, stomatitis, leukopenia and/or diarrhea, which may be dose- limiting.
In clinical trials with this drug combination, these toxicities were found to be reversible with appropriate modification of 5-FU administration. RIVA LEUCOVORIN (leucovorin calcium) Page 11 of 24 Generally, the safety profile depends on the applied regimen of 5-fluorouracil due to enhancement of the 5-fluorouracil induced toxicities.
5 Post-Market Adverse Reactions Cases of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), some fatal, have been reported in patients receiving leucovorin calcium in combination with other agents known to be associated with these disorders.
A contributory role of leucovorin in these occurrences of SJS/TEN cannot be excluded. Fatalities have occurred as a result of gastrointestinal toxicity (predominantly mucositis and diarrhea) and myelosuppression. In patients with diarrhea, rapid clinical deterioration leading to death can occur.
4 Geriatrics 04/2023 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 ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 6 5 OVERDOSAGE..............................................................................................................
6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS .................................................................................. 9 8 ADVERSE REACTIONS ................................................................................................
11 9 DRUG INTERACTIONS ................................................................................................ 13 10 CLINICAL PHARMACOLOGY .......................................................................................
14 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 15 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 15 PART II: SCIENTIFIC INFORMATION .......................................................................................
RIVA LEUCOVORIN therapy is contraindicated in patients with: • Known hypersensitivity to the active substance or to any of the excipients. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Pernicious anemia or other megaloblastic anemias where Vitamin B12 is deficient.
A hematologic remission may occur while neurologic manifestations continue to progress.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Leucovorin 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.
16 13 PHARMACEUTICAL INFORMATION ............................................................................ 16 14 CLINICAL TRIALS ........................................................................................................
17 15 MICROBIOLOGY ........................................................................................................ 18 16 NON-CLINICAL TOXICOLOGY .....................................................................................
18 17 SUPPORTING PRODUCT MONOGRAPHS .................................................................... 18 PATIENT MEDICATION INFORMATION .................................................................................. 19 RIVA LEUCOVORIN (leucovorin calcium) Page 4 of 24 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS RIVA LEUCOVORIN (leucovorin calcium) is indicated for: • diminishing the toxicity and counteracting the effect of impaired methotrexate elimination.
• treatment of megaloblastic anemias due to folate deficiency, as in sprue, nutritional deficiency, megaloblastic anemias of pregnancy and infancy. 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; […]