SMOFKABIVEN ELECTROLYTE FREE EMULSION

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
09-07-2020

유효 성분:

SOYBEAN OIL; MEDIUM CHAIN TRIGLYCERIDES (MCT); OLIVE OIL; FISH OIL; DEXTROSE; LYSINE (LYSINE ACETATE); PHENYLALANINE; LEUCINE; VALINE; THREONINE; METHIONINE; ISOLEUCINE; TRYPTOPHAN; ALANINE; ARGININE; GLYCINE; PROLINE; HISTIDINE; SERINE; TAURINE; TYROSINE

제공처:

FRESENIUS KABI CANADA LTD

ATC 코드:

B05BA10

INN (International Name):

COMBINATIONS

복용량:

1.14G; 1.14G; 0.95G; 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

약제 형태:

EMULSION

구성:

SOYBEAN OIL 1.14G; MEDIUM CHAIN TRIGLYCERIDES (MCT) 1.14G; OLIVE OIL 0.95G; 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

관리 경로:

INTRAVENOUS

패키지 단위:

986/1477/1970/2463ML

처방전 유형:

Ethical

치료 영역:

CALORIC AGENTS

제품 요약:

Active ingredient group (AIG) number: 2163114002; AHFS:

승인 상태:

APPROVED

승인 날짜:

2015-04-30

제품 특성 요약

                                _ _
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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