Regulatory Decision Summary for SmofKabiven
Review decision
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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this submission was to seek approval of SmofKabiven, a total parenteral nutrition (TPN) sterile injectable product consisting of amino acids, dextrose (D-Glucose) and injectable lipid emulsion.
Why was the decision issued?
Health Canada considers that the benefits of therapy with SmofKabiven outweigh the potential risks.
Benefits estimation:
The submission presented data that is typical of TPN products. The submitted studies did not specifically evaluate the efficacy of SmofKabiven as efficacy endpoints to specifically assess TPN are difficult to define. However, the safety and tolerability data submitted support the use of SmofKabiven in TPN.
Specifically, data from safety and tolerability studies showed that patients administered SmofKabiven could survive during the period of the study without other sources of nutrition. Also, no adverse events were reported that could be interpreted as worsening of health status due to insufficient nutrition.
Risks estimation:
Safety and tolerance of SmofKabiven were comparable to the safety and tolerance of the comparator (Kabiven). Data reviewed indicated that SmofKabiven was associated with a slightly higher number of adverse events than Kabiven. However, all serious adverse events reported in the SmofKabiven group were assessed as unlikely related to SmofKabiven.
The tolerance of SmofKabiven was also assessed by the Modified Maddox Scoring System (MMS) on a scale between 0 and 6. SmofKabiven was well tolerated as the MMS scores were low; no MMS rating >3 was observed within 4 hours after start of the study medication.
Data from post-market experience (between the first registration of SmofKabiven in 2007 up to September 2013) indicate that 8,900,347 units have been sold in 47 countries and approximately 1,780,000 patients have been treated with SmofKabiven. During this period, 52 adverse drug reactions (ADRs) in 38 patients were reported. Of these ADRs, 28 were serious (18 patients). However, most of these serious adverse events were assessed as not related to SmofKabiven. No actions relating to safety have been taken by regulatory authorities or the marketing authorization holder since the launch of this product in 2007.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| SMOFKABIVEN | 02440695 | FRESENIUS KABI CANADA LTD | ALANINE 0.71 G / 100 ML ARGININE 0.61 G / 100 ML CALCIUM CHLORIDE 0.028 G / 100 ML DEXTROSE 12.7 G / 100 ML FISH OIL 0.57 G / 100 ML GLYCINE 0.56 G / 100 ML HISTIDINE 0.15 G / 100 ML ISOLEUCINE 0.25 G / 100 ML LEUCINE 0.38 G / 100 ML LYSINE (LYSINE ACETATE) 0.34 G / 100 ML MAGNESIUM SULFATE 0.061 G / 100 ML MEDIUM CHAIN TRIGLYCERIDES (MCT) 1.14 G / 100 ML METHIONINE 0.22 G / 100 ML OLIVE OIL 0.95 G / 100 ML PHENYLALANINE 0.26 G / 100 ML POTASSIUM CHLORIDE 0.23 G / 100 ML PROLINE 0.57 G / 100 ML SERINE 0.33 G / 100 ML SODIUM ACETATE TRIHYDRATE 0.17 G / 100 ML SODIUM GLYCEROPHOSPHATE 0.21 G / 100 ML SOYBEAN OIL 1.14 G / 100 ML TAURINE 0.05 G / 100 ML THREONINE 0.22 G / 100 ML TRYPTOPHAN 0.1 G / 100 ML TYROSINE 0.02 G / 100 ML VALINE 0.31 G / 100 ML ZINC SULFATE HEPTAHYDRATE 0.00066 G / 100 ML |