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HADLIMA is a brand name for Adalimumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 01/2025 1 INDICATIONS, 1.1 Pediatrics (< 18 years of age) 01/2025 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 01/2025 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 01/2025 7 WARNINGS AND PRECAUTIONS 01/2025 7 WARNINGS AND PRECAUTIONS, 7.1.3Pediatrics (< 18 years of age) 01/2025 8…
Verbatim from this product's HC label. Tap a section to expand.
3 Pharmacokinetics 01/2025 13 PHARMACEUTICAL INFORMATION 01/2025 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 3 TABLE OF CONTENTS ..............................................................................................................
3 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 6 1 INDICATIONS ..............................................................................................................
1 Pediatrics ..................................................................................................... 2 Geriatrics ..................................................................................................... 8 2 CONTRAINDICATIONS .................................................................................................
9 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 9 4 DOSAGE AND ADMINISTRATION............................................................................... 1 Dosing Considerations ................................................................................
2 Recommended Dose and Dosage Adjustment ............................................. 3 Reconstitution............................................................................................ 4 Administration ...........................................................................................
5 Missed Dose............................................................................................... 16 PrHADLIMA® adalimumab PrHADLIMA® PushTouch® adalimumab Page 4 of 147 Protected B / Protégé B 5 OVERDOSAGE ...........................................................................................................
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3 Pharmacokinetics 01/2025 13 PHARMACEUTICAL INFORMATION 01/2025 TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES............................................................................................ 3 TABLE OF CONTENTS ..............................................................................................................
3 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 6 1 INDICATIONS ..............................................................................................................
1 Pediatrics ..................................................................................................... 2 Geriatrics ..................................................................................................... 8 2 CONTRAINDICATIONS .................................................................................................
9 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 9 4 DOSAGE AND ADMINISTRATION............................................................................... 1 Dosing Considerations ................................................................................
2 Recommended Dose and Dosage Adjustment ............................................. 3 Reconstitution............................................................................................ 4 Administration ...........................................................................................
5 Missed Dose............................................................................................... 16 PrHADLIMA® adalimumab PrHADLIMA® PushTouch® adalimumab Page 4 of 147 Protected B / Protégé B 5 OVERDOSAGE ...........................................................................................................
3Pediatrics (< 18 years of age) 01/2025
• HADLIMA® and HADLIMA® PushTouch® are contraindicated in patients who are hypersensitive to this drug 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.
• Patients with severe infections such as sepsis, tuberculosis and opportunistic infections. See
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Adalimumab 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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 16 7 WARNINGS AND PRECAUTIONS ................................................................................ 1 Special Populations ....................................................................................
1 Pregnant Women ....................................................................................... 2 Breast-feeding............................................................................................ 3 Pediatrics ...................................................................................................
4 Geriatrics ................................................................................................... 25 8 ADVERSE REACTIONS ................................................................................................
1 Adverse Reaction Overview ........................................................................ 2 Clinical Trial Adverse Reactions................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ................................................
3 Less Common Clinical Trial Adverse Reactions............................................. 1 Less Common Clinical Trial Adverse Reactions – Pediatrics .......................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ......................................................................................................
5 Post-Market Adverse Reactions .................................................................. 63 9 DRUG INTERACTIONS................................................................................................ 1 Serious Drug Interactions ...........................................................................
2 Drug Interactions Overview ........................................................................ 3 Drug-Behavioural Interactions .................................................................... 4 Drug-Drug Interactions ...............................................................................
5 Drug-Food Interactions............................................................................... 6 Drug-Herb Interactions ............................................................................... 7 Drug-Laboratory Test Interactions ..............................................................
66 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action.................................................................................. 2 Pharmacodynamics ....................................................................................
3 Pharmacokinetics ....................................................................................... 67 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 70 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
70 PrHADLIMA® adalimumab PrHADLIMA® PushTouch® adalimumab Page 5 of 147 Protected B / Protégé B PART II: SCIENTIFIC INFORMATION ...................................................................................... 72 13 PHARMACEUTICAL INFORMATION............................................................................
72 14 CLINICAL TRIALS........................................................................................................ 5 Clinical Trials - Reference Biologic Drug […]