Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
DEXTROSE; SOYBEAN OIL; MEDIUM CHAIN TRIGLYCERIDES (MCT); OLIVE OIL; FISH OIL; LYSINE (LYSINE ACETATE); PHENYLALANINE; LEUCINE; VALINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; HISTIDINE; SERINE; TAURINE; TYROSINE
FRESENIUS KABI CANADA LTD
B05BA10
COMBINATIONS
8.5G; 0.87G; 0.87G; 0.72G; 0.43G; 0.43G; 0.33G; 0.48G; 0.41G; 0.29G; 0.28G; 0.33G; 0.13G; 0.92G; 0.79G; 0.72G; 0.73G; 0.2G; 0.43G; 0.65G; 0.26G
EMULSION
DEXTROSE 8.5G; SOYBEAN OIL 0.87G; MEDIUM CHAIN TRIGLYCERIDES (MCT) 0.87G; OLIVE OIL 0.72G; FISH OIL 0.43G; LYSINE (LYSINE ACETATE) 0.43G; PHENYLALANINE 0.33G; LEUCINE 0.48G; VALINE 0.41G; THREONINE 0.29G; METHIONINE 0.28G; ISOLEUCINE 0.33G; TRYPTOPHAN 0.13G; ALANINE 0.92G; ARGININE 0.79G; GLYCINE 0.72G; PROLINE 0.73G; HISTIDINE 0.2G; SERINE 0.43G; TAURINE 0.65G; TYROSINE 0.26G
INTRAVENOUS
15G/50G
Ethical
CALORIC AGENTS
Active ingredient group (AIG) number: 2163114001; AHFS:
APPROVED
2020-07-09
_ _ 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, Baca dokumen lengkap