Details for: APO-OLANZAPINE ODT


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Product description

Product name: APO-OLANZAPINE ODT

Company name: APOTEX INC

DIN: 02360616

Status: Marketed

Status date: 2011-11-16

Active ingredient(s) Strength
OLANZAPINE 5 MG

Resources

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For consumers
Resource Description
Consumer Information Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
Product Monograph

The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use.

The Product Monograph includes three sections:

  • Part I: Health Professional Information;
  • Part II: Scientific Information; and
  • Patient Medication Information
Summary Safety Review - Olanzapine - Assessing the Potential Risks of Syndrome of Inappropriate Secretion of Antidiuretic Hormone and Hyponatremia

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Report a side effect

Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.

All suspected side effects should be reported, especially those that are:

  • Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
  • Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
  • Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
For health care professionals
Resource Description
Consumer Information Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
Product Monograph

The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use.

The Product Monograph includes three sections:

  • Part I: Health Professional Information;
  • Part II: Scientific Information; and
  • Patient Medication Information
Summary Safety Review - Olanzapine - Assessing the Potential Risks of Syndrome of Inappropriate Secretion of Antidiuretic Hormone and Hyponatremia

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Report a serious adverse drug reaction (for hospitals)

Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.

This regulatory requirement only applies to hospitals.
For researchers
Resource Description
Product Monograph

The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use.

The Product Monograph includes three sections:

  • Part I: Health Professional Information;
  • Part II: Scientific Information; and
  • Patient Medication Information
Search Clinical Information After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes.
All resources
Resource Description
Consumer Information Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
Product Monograph

The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use.

The Product Monograph includes three sections:

  • Part I: Health Professional Information;
  • Part II: Scientific Information; and
  • Patient Medication Information
Summary Safety Review - Olanzapine - Assessing the Potential Risks of Syndrome of Inappropriate Secretion of Antidiuretic Hormone and Hyponatremia

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Search Clinical Information After Health Canada completes the regulatory review process for a product, the clinical information included in a submission is made publicly available for non-commercial purposes.
Report a side effect

Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.

All suspected side effects should be reported, especially those that are:

  • Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
  • Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
  • Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
Report a serious adverse drug reaction (for hospitals)

Section C.01.020.1 of the Food and Drug Regulations and section 62 of the Medical Devices Regulations, require hospitals to report to Health Canada all serious adverse drug reactions (ADRs) and medical device incidents (MDIs) within 30 days of being documented within the hospital.

This regulatory requirement only applies to hospitals.
Resource Description
Consumer Information Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
Product Monograph

The Product Monograph is a scientific document that describes the properties, claims, indications and conditions of use of the product and contains any other information that may be required for optimal, safe and effective use.

The Product Monograph includes three sections:

  • Part I: Health Professional Information;
  • Part II: Scientific Information; and
  • Patient Medication Information
Summary Safety Review - Olanzapine - Assessing the Potential Risks of Syndrome of Inappropriate Secretion of Antidiuretic Hormone and Hyponatremia

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.
Report a side effect

Side effects are troublesome symptoms or feelings that you may not expect that show up when you are taking a medicine.

All suspected side effects should be reported, especially those that are:

  • Unexpected, regardless of their severity, i.e., not consistent with product information or labelling; or
  • Serious, whether expected or not, i.e., that requires being admitted to the hospital, lengthened hospital stay, causes a birth defect, disability, is life-threatening or results in death;
  • Reactions to recently marketed health products (on the market for less than five years), regardless of their nature or severity.
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