SMOFKABIVEN EMULSION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FISH OIL; DEXTROSE; LYSINE (LYSINE ACETATE); PHENYLALANINE; LEUCINE; VALINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; HISTIDINE; SERINE; TAURINE; TYROSINE; SODIUM ACETATE TRIHYDRATE; POTASSIUM CHLORIDE; SODIUM GLYCEROPHOSPHATE; MAGNESIUM SULFATE; CALCIUM CHLORIDE; ZINC SULFATE HEPTAHYDRATE; SOYBEAN OIL; MEDIUM CHAIN TRIGLYCERIDES (MCT); OLIVE OIL

Verfügbar ab:

FRESENIUS KABI CANADA LTD

ATC-Code:

B05BA10

INN (Internationale Bezeichnung):

COMBINATIONS

Dosierung:

0.57G; 12.7G; 0.34G; 0.26G; 0.38G; 0.31G; 0.22G; 0.22G; 0.25G; 0.1G; 0.71G; 0.61G; 0.56G; 0.57G; 0.15G; 0.33G; 0.05G; 0.02G; 0.17G; 0.23G; 0.21G; 0.061G; 0.028G; 0.00066G; 1.14G; 1.14G; 0.95G

Darreichungsform:

EMULSION

Zusammensetzung:

FISH OIL 0.57G; DEXTROSE 12.7G; LYSINE (LYSINE ACETATE) 0.34G; PHENYLALANINE 0.26G; LEUCINE 0.38G; VALINE 0.31G; THREONINE 0.22G; METHIONINE 0.22G; ISOLEUCINE 0.25G; TRYPTOPHAN 0.1G; ALANINE 0.71G; ARGININE 0.61G; GLYCINE 0.56G; PROLINE 0.57G; HISTIDINE 0.15G; SERINE 0.33G; TAURINE 0.05G; TYROSINE 0.02G; SODIUM ACETATE TRIHYDRATE 0.17G; POTASSIUM CHLORIDE 0.23G; SODIUM GLYCEROPHOSPHATE 0.21G; MAGNESIUM SULFATE 0.061G; CALCIUM CHLORIDE 0.028G; ZINC SULFATE HEPTAHYDRATE 0.00066G; SOYBEAN OIL 1.14G; MEDIUM CHAIN TRIGLYCERIDES (MCT) 1.14G; OLIVE OIL 0.95G

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

986/1477/1970/2463ML

Verschreibungstyp:

Ethical

Therapiebereich:

REPLACEMENT PREPARATIONS

Produktbesonderheiten:

Active ingredient group (AIG) number: 2758251002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2015-05-06

Fachinformation

_ _
SmofKabiven and SmofKabiven XN – Product Monograph
Page 1 of 60
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SMOFKABIVEN
®
Amino acids with electrolytes, dextrose and lipid injectable emulsion
5.1% & 0.7% / 12.7% / 3.8%; w/v
SMOFKABIVEN
® EXTRA NITROGEN
Amino acids with electrolytes, dextrose and lipid injectable emulsion
6.5% & 0.7% / 8.5% / 2.9%; w/v
Emulsions for Intravenous Nutrition
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
July 9, 2020
Submission Control No: 230147
Fresenius Kabi, is a registered trademark of Fresenius SE, SmofKabiven
and SMOFlipid are registered
trademarks of Fresenius Kabi AG, and Biofine is a registered trademark
of Fresenius Medical Care.
_ _
SmofKabiven and SmofKabiven XN – Product Monograph
Page 2 of 60
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.......................................................................20
DOSAGE FORMS,