Product description
Product name: NALOXONE HYDROCHLORIDE INJECTION, USP
Company name:
EUGIA PHARMA INC.
DIN: 02534975
Status: Approved
Status date: 2023-02-06
| Active ingredient(s) |
Strength |
| NALOXONE HYDROCHLORIDE |
4 MG
/ 10 ML
|
Resources
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For consumers
| Resource |
Description |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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.
|
