SMOFKABIVEN EXTRA NITROGEN ELECTROLYTE FREE EMULSION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

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

Inapatikana kutoka:

FRESENIUS KABI CANADA LTD

ATC kanuni:

B05BA10

INN (Jina la Kimataifa):

COMBINATIONS

Kipimo:

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

Dawa fomu:

EMULSION

Tungo:

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

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Ethical

Eneo la matibabu:

CALORIC AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 2163114001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2020-07-09

Tabia za bidhaa

_ _
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,