Product description
Product name: ISENTRESS
Company name:
MERCK CANADA INC
DIN: 02301881
Status: Marketed
Status date: 2009-03-05
| Active ingredient(s) |
Strength |
| RALTEGRAVIR (RALTEGRAVIR POTASSIUM) |
400 MG
|
Resources
Click on a resource to visit a page with more information. You may be taken away from this page to a different Government of Canada website.
For consumers
| 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
|
| 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 |
| 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 Basis of Decision for Isentress ™ *
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
| 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
|
|
Summary Basis of Decision for Isentress ™ *
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
| 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 |
| 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 Basis of Decision for Isentress ™ *
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
| 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 |
| 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
|
| 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.
|
| 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
|
|
Summary Basis of Decision for Isentress ™ *
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
| 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. |
| 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
|
|
Summary Basis of Decision for Isentress ™ *
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
| 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. |
| 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
|
|
Summary Basis of Decision for Isentress ™ *
|
The Summary Basis of Decision explains why the product was approved for sale in Canada. The document includes regulatory, safety, effectiveness and quality (in terms of chemistry and manufacturing) considerations.
|
| 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.
|
