Details for: SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE


Product description

Product name: SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE

Company name: FRESENIUS KABI CANADA LTD

DIN: 02501775

Status: Marketed

Status date: 2021-07-09

Active ingredient(s) Strength
ALANINE 0.92 G / 100 ML
ARGININE 0.79 G / 100 ML
DEXTROSE 8.5 G / 100 ML
FISH OIL 0.43 G / 100 ML
GLYCINE 0.72 G / 100 ML
HISTIDINE 0.2 G / 100 ML
ISOLEUCINE 0.33 G / 100 ML
LEUCINE 0.48 G / 100 ML
LYSINE (LYSINE ACETATE) 0.43 G / 100 ML
MEDIUM CHAIN TRIGLYCERIDES (MCT) 0.87 G / 100 ML
METHIONINE 0.28 G / 100 ML
OLIVE OIL 0.72 G / 100 ML
PHENYLALANINE 0.33 G / 100 ML
PROLINE 0.73 G / 100 ML
SERINE 0.43 G / 100 ML
SOYBEAN OIL 0.87 G / 100 ML
TAURINE 0.65 G / 100 ML
THREONINE 0.29 G / 100 ML
TRYPTOPHAN 0.13 G / 100 ML
TYROSINE 0.26 G / 100 ML
VALINE 0.41 G / 100 ML

Resources

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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
Regulatory Decision Summary for Smofkabiven Electrolyte Free, Smofkabiven extra Nitrogen Electrolyte Free

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.

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
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
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
Regulatory Decision Summary for Smofkabiven Electrolyte Free, Smofkabiven extra Nitrogen Electrolyte Free

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.

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
Regulatory Decision Summary for Smofkabiven Electrolyte Free, Smofkabiven extra Nitrogen Electrolyte Free

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.

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.