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AVSOLA is a brand name for Infliximab, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indications have been granted on the basis of similarity between AVSOLA™ and the reference biologic drug Remicade®. AVSOLA (infliximab) is indicated for: use in combination with methotrexate for the reduction in signs and symptoms, inhibition of the progression of structural damage and improvement in physical…
Verbatim from this product's HC label. Tap a section to expand.
2 Breast-feeding XX/XXXX 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........................................................................................... 5 2 CONTRAINDICATIONS.......................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................. 6 4 DOSAGE AND ADMINISTRATION...................................................................... 1 Dosing Considerations.......................................................................
2 Recommended Dose and Dosage Adjustment ................................... 3 Reconstitution.................................................................................... 4 Administration....................................................................................
5 Missed Dose.................................................................................... 10 5 OVERDOSAGE ................................................................................................. 10
, Infusion-Related Reactions). For patients receiving the 10 mg/kg dose, administration should still occur over a period of not less than 2 hours. 2 μm or less). Do not store any unused portion of the infusion solution for reuse. 5. Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit .
If visibly opaque particles, discolouration or other foreign particulates are observed, the solution should not be used. 6. No physical biochemical compatibility studies have been conducted to evaluate the co - administration of AVSOLA with other agents.
AVSOLA should not be infused concomitantly in the same intravenous line with other agents. 5 Missed Dose Patients who forget or miss an appointment to receive AVSOLA should be advised to make another appointment as soon as possible.
5 OVERDOSAGE Single doses up to 20 mg/kg have been administered without any direct toxic effect. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately .
For management of a suspected drug overdose, contact your regional poison control centre. AVSOLA® Page 11 of 116 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table 2. Dosage Forms, Strengths, Composition and Packaging AVSOLA (infliximab) is supplied as a sterile white to slightly yellow, lyophilized powder for concentrate for solution for intravenous infusion. Each vial contains 100 mg infliximab, dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose.
2 Breast-feeding XX/XXXX 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........................................................................................... 5 2 CONTRAINDICATIONS.......................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................. 6 4 DOSAGE AND ADMINISTRATION...................................................................... 1 Dosing Considerations.......................................................................
2 Recommended Dose and Dosage Adjustment ................................... 3 Reconstitution.................................................................................... 4 Administration....................................................................................
5 Missed Dose.................................................................................... 10 5 OVERDOSAGE ................................................................................................. 10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING..............
11 7 WARNINGS AND PRECAUTIONS .................................................................... 1 Special Populations ......................................................................... 1 Pregnant Women.............................................................................
Patients with severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections (see 7 WARNINGS AND PRECAUTIONS, General, Risk of Infections). 2 Clinical Trial Adverse Reactions, Congestive Heart Failure). Patients with a history of hypersensitivity to infliximab, to other murine proteins, or to any of the excipients.
For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Infliximab 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.
No preservatives are present. AVSOLA (infliximab) lyophilised concentrate for intravenous injection is supplied in individually boxed single-use vials in the following strength: 100 mg infliximab. Vial stopper is free of natural rubber latex.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General AVSOLA should be used by health professionals who have sufficient knowledge of rheumatoid arthritis and/or ankylosing spondylitis and/or Crohn’s disease, ulcerative colitis and/or psoriatic arthritis and/or plaque psoriasis and who have fully familiarized themselves with the efficacy/safety profile of AVSOLA.
In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file. Risk of infections Serious infections due to bacterial (including sepsis and pneumonia), invasive fungal, viral, and other opportunistic pathogens, have been reported in patients receiving TNF - blocking agents.
Some of these infections have been fatal. Many of the serious infections in patients treated with infliximab have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.
AVSOLA should not be given to patients with a clinically important, active infection, including tuberculosis. Caution should be exercised when considering the use of AVSOLA in patients with a chronic infection or a history of recurrent infection.
Patients should be monitored for signs and symptoms of infection while on or after treatment with Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Intravenous injection Powder for Solution / 100 mg/vial Dibasic sodium phosphate anhydrous, monobasic sodium phosphate monohydrate, polysorbate 80, sucrose AVSOLA® Page 12 of 116 AVSOLA.
New infections should be closely monitored. 2 Clinical Trial Adverse Reactions, Infections). Cases of histoplasmosis, coccidioidomycosis, blastomycosis, listeriosis, pneumocystosis, and tuberculosis have been observed in patients receiving infliximab.
For patients who have resided in or travelled to regions where histop lasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of infliximab treatment should be carefully considered before initiation or continuation of AVSOLA therapy.
Invasive fungal infections:
In patients treated with AVSOLA, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness. Invasive fungal infections may present as disseminated rather than localized disease, and antigen and antibody testing may be negative in some patients with active infection.
Appropriate empiric antifungal therapy should be considered while a diagnostic workup is being performed. The decision to administer empiric antifungal therapy should be made in consultation with a health professional with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy.
Tuberculosis:
Cases of active tuberculosis have occurred in patients treated with infliximab during and after treatment for latent tuberculosis. Patients receiving AVSOLA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment, including patients who tested negative for latent tuberculosis infection.
The possibility of undetected latent tuberculosis should be considered, especially in patients who have immigrated from or traveled to […]
2 Breast-feeding ................................................................................. 3 Pediatrics ........................................................................................ 4 Geriatrics.........................................................................................
20 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................................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.............................................................
5 Post-Market Adverse Reactions ....................................................... 45 9 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 .................................................... 47 10 CLINICAL PHARMACOLOGY...........................................................................
1 Mechanism of Action ....................................................................... 2 Pharmacodynamics ......................................................................... 3 Pharmacokinetics ............................................................................
49 11 STORAGE, STABILITY AND DISPOSAL .......................................................... 50 12 SPECIAL HANDLING INSTRUCTIONS ............................................................. 51 PART II: SCIENTIFIC INFORMATION .......................................................................
51 13 PHARMACEUTICAL INFORMATION ................................................................ 51 14 CLINICAL TRIALS ............................................................................................ 1 Clinical Trials by Indication...............................................................
2 Comparative Bioavailability Studies.................................................. 3 Immunogenicity ............................................................................... 4 Clinical Trials – Reference Biologic Drug ..........................................
55 16 NON-CLINICAL TOXICOLOGY – REFERENCE BIOLOGIC DRUG ................. 1 Comparative Non-Clinical Pharmacology And Toxicology ............... 1 Comparative Non-Clinical Pharmacodynamics ............................... 2 Comparative Toxicology.................................................................
105 SUPPORTING PRODUCT MONOGRAPHS ............................................................. 106 PATIENT MEDICATION INFORMATION ................................................................. 107 AVSOLA® Page 4 of 116 AVSOLA® (infliximab for injection) is a biosimilar biologic drug (biosimilar) to […]