SMOFKABIVEN EMULSION
देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
उत्पाद विशेषताएं
(SPC)
09-07-2020
अनुरोध भेजा।
सक्रिय संघटक:
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
थमां उपलब्ध:
FRESENIUS KABI CANADA LTD
ए.टी.सी कोड:
B05BA10
INN (इंटरनेशनल नाम):
COMBINATIONS
डोज़:
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
फार्मास्यूटिकल फॉर्म:
EMULSION
रचना:
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
प्रशासन का मार्ग:
INTRAVENOUS
पैकेज में यूनिट:
986/1477/1970/2463ML
प्रिस्क्रिप्शन प्रकार:
Ethical
चिकित्सीय क्षेत्र:
REPLACEMENT PREPARATIONS
उत्पाद समीक्षा:
Active ingredient group (AIG) number: 2758251002; AHFS:
प्राधिकरण का दर्जा:
APPROVED
प्राधिकरण की तारीख:
2015-05-06
उत्पाद विशेषताएं
_ _
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,
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