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SANDOZ DEFERASIROX is a brand name for Deferasirox, supplied as a tablet for suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Deferasirox (deferasirox) dispersible tablets is indicated for: • the management of chronic iron overload in patients with transfusion-dependent anemias aged 6 years or older. • the management of chronic iron overload in patients with transfusion-dependent anemias aged two to five who cannot be adequately…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment 02/2023
2 Clinical Trial Adverse Reactions 02/2023 PATIENT MEDICATION INFORMATION, Children and adolescents (age 2 years to 16 years), Usual dose 02/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
3 Reconstitution ................................................................................................... 5 Missed Dose ......................................................................................................
11 5 OVERDOSAGE ............................................................................................................. 11 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 12 7 WARNINGS AND PRECAUTIONS ..................................................................................
1 Special Populations ............................................................................................ 20 8 ADVERSE REACTIONS ..................................................................................................
1 Adverse Reaction Overview................................................................................ 2 Clinical Trial Adverse Reactions .......................................................................... 3 Less Common Clinical Trial Adverse Drug Reactions ............................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ........................................................................................................ 5 Post-Market Adverse Reactions..........................................................................
29 9 DRUG INTERACTIONS.................................................................................................. 4 Drug-Drug Interactions ......................................................................................
3 Pediatrics (2 to 16 years of age) 02/2023
Sandoz Deferasirox is contraindicated in: • patients with estimated creatinine clearance <60 mL/min or serum creatinine >2 times the age-appropriate upper limit of normal. • high risk myelodysplastic syndrome (MDS) patients, any other MDS patient with a life expectancy < 1 year and patients with other hematological and non-hematological malignancies who are not expected to benefit from chelation therapy due to the rapid progression of their disease.
• patients with platelet counts < 50 x 109/L. • patients with hypersensitivity to the active substance, deferasirox, or to any of the excipients. For a complete listing of excipients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
PrSandoz® Deferasirox (deferasirox) Product Monograph Page 5 of 57
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Deferasirox 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.
5 Drug-Food Interactions ...................................................................................... 6 Drug-Herb Interactions ...................................................................................... 7 Drug-Laboratory Test Interactions ......................................................................
32 10 CLINICAL PHARMACOLOGY ......................................................................................... 1 Mechanism of Action ...................................................................................... 2 Pharmacodynamics ........................................................................................
3 Pharmacokinetics ........................................................................................... 33 11 STORAGE, STABILITY AND DISPOSAL ........................................................................... 35 12 SPECIAL HANDLING INSTRUCTIONS.............................................................................
35 PART II: SCIENTIFIC INFORMATION ........................................................................................ 36 13 PHARMACEUTICAL INFORMATION..............................................................................
36 14 CLINICAL TRIALS.......................................................................................................... 1 Clinical Trial by Indication ...............................................................................
37 15 MICROBIOLOGY .......................................................................................................... 46 16 NON-CLINICAL TOXICOLOGY .......................................................................................
46 17 SUPPORTING PRODUCT MONOGRAPHS...................................................................... 48 […]