SMOFKABIVEN PERIPHERAL EMULSION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

SOYBEAN OIL; MEDIUM CHAIN TRIGLYCERIDES (MCT); MAGNESIUM SULFATE; CALCIUM CHLORIDE; ZINC SULFATE HEPTAHYDRATE; DEXTROSE; OLIVE OIL; FISH OIL; 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

Disponível em:

FRESENIUS KABI CANADA LTD

Código ATC:

B05BA10

DCI (Denominação Comum Internacional):

COMBINATIONS

Dosagem:

850MG; 850MG; 38MG; 18MG; 0.4MG; 7.1G; 700MG; 420MG; 210MG; 160MG; 230MG; 200MG; 140MG; 130MG; 160MG; 63MG; 440MG; 380MG; 350MG; 350MG; 93MG; 210MG; 32MG; 12MG; 110MG; 140MG; 130MG

Forma farmacêutica:

EMULSION

Composição:

SOYBEAN OIL 850MG; MEDIUM CHAIN TRIGLYCERIDES (MCT) 850MG; MAGNESIUM SULFATE 38MG; CALCIUM CHLORIDE 18MG; ZINC SULFATE HEPTAHYDRATE 0.4MG; DEXTROSE 7.1G; OLIVE OIL 700MG; FISH OIL 420MG; LYSINE (LYSINE ACETATE) 210MG; PHENYLALANINE 160MG; LEUCINE 230MG; VALINE 200MG; THREONINE 140MG; METHIONINE 130MG; ISOLEUCINE 160MG; TRYPTOPHAN 63MG; ALANINE 440MG; ARGININE 380MG; GLYCINE 350MG; PROLINE 350MG; HISTIDINE 93MG; SERINE 210MG; TAURINE 32MG; TYROSINE 12MG; SODIUM ACETATE TRIHYDRATE 110MG; POTASSIUM CHLORIDE 140MG; SODIUM GLYCEROPHOSPHATE 130MG

Via de administração:

INTRAVENOUS

Unidades em pacote:

4X1206/4X1448/4X1904ML

Tipo de prescrição:

Ethical

Área terapêutica:

REPLACEMENT PREPARATIONS

Resumo do produto:

Active ingredient group (AIG) number: 2758251001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2016-07-05

Características técnicas

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_Page 1 of 58_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SMOFKABIVEN
® PERIPHERAL
Amino acids WITH electrolytes, dextrose and lipid injectable emulsion
3.2 % & 0.4% / 7.1 % / 2.8 %; w/v
Emulsion for Intravenous Nutrition
FRESENIUS KABI CANADA LTD.
45 Vogel Rd, Suite 200
Richmond Hill, ON L4B 3P6
Date of Preparation:
July 4, 2016
Submission Control No: 177540
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.
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_Page 2 of 58_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
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
..............................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.......................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
..