SMOFKABIVEN EXTRA NITROGEN EMULSION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

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

Sẵn có từ:

FRESENIUS KABI CANADA LTD

Mã ATC:

B05BA10

INN (Tên quốc tế):

COMBINATIONS

Liều dùng:

0.72G; 0.73G; 0.2G; 0.43G; 0.065G; 0.026G; 0.16G; 0.23G; 0.23G; 0.061G; 0.028G; 0.00066G; 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

Dạng dược phẩm:

EMULSION

Thành phần:

GLYCINE 0.72G; PROLINE 0.73G; HISTIDINE 0.2G; SERINE 0.43G; TAURINE 0.065G; TYROSINE 0.026G; SODIUM ACETATE 0.16G; POTASSIUM CHLORIDE 0.23G; SODIUM GLYCEROPHOSPHATE 0.23G; MAGNESIUM SULFATE 0.061G; CALCIUM CHLORIDE 0.028G; ZINC SULFATE HEPTAHYDRATE 0.00066G; 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

Tuyến hành chính:

INTRAVENOUS

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Ethical

Khu trị liệu:

REPLACEMENT PREPARATIONS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 2763115001; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-07-09

Đặc tính sản phẩm

_ _
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,