PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
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. Date of Preparation:
165 Galaxy Blvd, Suite 100 July 4, 2016
Toronto, ON M9W 0C8
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.
SmofKabiven Peripheral – Product Monograph Page 1 of 58
, Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3
SUMMARY PRODUCT INFORMATION ........................................................................3
INDICATIONS AND CLINICAL USE ..............................................................................3
CONTRAINDICATIONS ...................................................................................................3
WARNINGS AND PRECAUTIONS ..................................................................................4
ADVERSE REACTIONS....................................................................................................7
DRUG INTERACTIONS ..................................................................................................12
DOSAGE AND ADMINISTRATION ..............................................................................12
OVERDOSAGE ................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY ............................................................14
STORAGE AND STABILITY ..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS .......................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................23
PART II: SCIENTIFIC INFORMATION ................................................................................28
PHARMACEUTICAL INFORMATION..........................................................................28
CLINICAL TRIALS ..........................................................................................................32
DETAILED PHARMACOLOGY .....................................................................................36
MICROBIOLOGY ............................................................................................................39
TOXICOLOGY .................................................................................................................39
REFERENCES ..................................................................................................................46
PATIENT MEDICATION INFORMATION ...........................................................................51
SmofKabiven Peripheral – Product Monograph Page 2 of 58
, PART I: HEALTH PROFESSIONAL INFORMATION
Pr
SmofKabiven® Peripheral
Amino acids WITH electrolytes, dextrose and lipid injectable emulsion
3.2 % & 0.4% / 7.1 % / 2.8 %; w/v
SUMMARY PRODUCT INFORMATION
Route of Dosage Form / Strength Clinically Relevant Non-medicinal
Administration Ingredients
Intravenous Injectable emulsion. Purified egg phospholipids
All-rac-α-tocopherol
SmofKabiven Peripheral
[Amino acids WITH
electrolytes, dextrose and For a complete listing see Dosage Forms,
lipid injectable emulsion Composition and Packaging section.
(3.2 % & 0.4 % / 7.1 % /
2,8 %); w/v]
INDICATIONS AND CLINICAL USE
SmofKabiven Peripheral (Amino acids WITH electrolytes, dextrose and lipid injectable
emulsion) is indicated for intravenous infusion into a peripheral or central vein as parenteral
nutrition for adult patients when oral or enteral nutrition is impossible, insufficient or
contraindicated.
SmofKabiven Peripheral is a three-component product. Each component is located in a separate
chamber. Before use, the seals between the chambers must be broken to mix the components.
Geriatrics:
SmofKabiven Peripheral can be used in adults including geriatrics (see WARNING and
PRECAUTIONS section).
CONTRAINDICATIONS
SmofKabiven Peripheral is contraindicated in patients with:
- Hypersensitivity to fish-, egg-, soybean- or peanut protein or to any of the active
ingredients or excipients
- Severe hyperlipidemia
- Severe liver insufficiency
SmofKabiven Peripheral – Product Monograph Page 3 of 58
, - Severe blood coagulation disorders
- Congenital errors of amino acid metabolism
- Severe renal insufficiency without access to hemofiltration or dialysis
- Acute shock
- Uncontrolled hyperglycemia
- Pathologically elevated serum levels of any of the included electrolytes
- General contraindications to infusion therapy: acute pulmonary edema, hyperhydration,
and decompensated cardiac insufficiency
- Hemophagocytoic syndrome
- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes
mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe
sepsis, hypotonic dehydration, and hyperosomolar coma)
WARNINGS AND PRECAUTIONS
General
The infusion must be stopped immediately if any signs or symptoms of allergic reactions (such
as fever, shivering, sweating, headache, skin rashes, or dyspnea) develop.
SmofKabiven Peripheral should be infused with caution in conditions of impaired lipid
metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis,
impaired liver function, hypothyroidism, and sepsis.
To avoid risks associated with too rapid delivery, it is recommended to use a continuous and
well-controlled infusion, if possible a volumetric pump.
Disturbances of the electrolyte and fluid balance (e.g. abnormally high or low serum levels of the
electrolytes) should be corrected before starting the infusion of SmofKabiven Peripheral.
SmofKabiven Peripheral should be given with caution to patients prone to retaining electrolytes.
Special monitoring is required at the beginning of any intravenous infusion. Should any
abnormal sign occur, the infusion must be stopped.
The amount of individual electrolytes to be added is determined by the clinical condition of the
patient and by frequent monitoring of serum levels.
Parenteral nutrition should be given with caution in metabolic acidosis, cellular hypoxia and
increased serum osmolarity.
Parenteral nutrition infusion may be accompanied by increased urinary excretion of the trace
elements, in particular copper and zinc. This should be considered in the dosing of trace
elements, especially during long-term parenteral nutrition. Amounts of zinc present in
SmofKabiven Peripheral should be taken into account.
SmofKabiven Peripheral – Product Monograph Page 4 of 58
INCLUDING PATIENT MEDICATION INFORMATION
Pr
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. Date of Preparation:
165 Galaxy Blvd, Suite 100 July 4, 2016
Toronto, ON M9W 0C8
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.
SmofKabiven Peripheral – Product Monograph Page 1 of 58
, Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION ..........................................................3
SUMMARY PRODUCT INFORMATION ........................................................................3
INDICATIONS AND CLINICAL USE ..............................................................................3
CONTRAINDICATIONS ...................................................................................................3
WARNINGS AND PRECAUTIONS ..................................................................................4
ADVERSE REACTIONS....................................................................................................7
DRUG INTERACTIONS ..................................................................................................12
DOSAGE AND ADMINISTRATION ..............................................................................12
OVERDOSAGE ................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY ............................................................14
STORAGE AND STABILITY ..........................................................................................17
SPECIAL HANDLING INSTRUCTIONS .......................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................23
PART II: SCIENTIFIC INFORMATION ................................................................................28
PHARMACEUTICAL INFORMATION..........................................................................28
CLINICAL TRIALS ..........................................................................................................32
DETAILED PHARMACOLOGY .....................................................................................36
MICROBIOLOGY ............................................................................................................39
TOXICOLOGY .................................................................................................................39
REFERENCES ..................................................................................................................46
PATIENT MEDICATION INFORMATION ...........................................................................51
SmofKabiven Peripheral – Product Monograph Page 2 of 58
, PART I: HEALTH PROFESSIONAL INFORMATION
Pr
SmofKabiven® Peripheral
Amino acids WITH electrolytes, dextrose and lipid injectable emulsion
3.2 % & 0.4% / 7.1 % / 2.8 %; w/v
SUMMARY PRODUCT INFORMATION
Route of Dosage Form / Strength Clinically Relevant Non-medicinal
Administration Ingredients
Intravenous Injectable emulsion. Purified egg phospholipids
All-rac-α-tocopherol
SmofKabiven Peripheral
[Amino acids WITH
electrolytes, dextrose and For a complete listing see Dosage Forms,
lipid injectable emulsion Composition and Packaging section.
(3.2 % & 0.4 % / 7.1 % /
2,8 %); w/v]
INDICATIONS AND CLINICAL USE
SmofKabiven Peripheral (Amino acids WITH electrolytes, dextrose and lipid injectable
emulsion) is indicated for intravenous infusion into a peripheral or central vein as parenteral
nutrition for adult patients when oral or enteral nutrition is impossible, insufficient or
contraindicated.
SmofKabiven Peripheral is a three-component product. Each component is located in a separate
chamber. Before use, the seals between the chambers must be broken to mix the components.
Geriatrics:
SmofKabiven Peripheral can be used in adults including geriatrics (see WARNING and
PRECAUTIONS section).
CONTRAINDICATIONS
SmofKabiven Peripheral is contraindicated in patients with:
- Hypersensitivity to fish-, egg-, soybean- or peanut protein or to any of the active
ingredients or excipients
- Severe hyperlipidemia
- Severe liver insufficiency
SmofKabiven Peripheral – Product Monograph Page 3 of 58
, - Severe blood coagulation disorders
- Congenital errors of amino acid metabolism
- Severe renal insufficiency without access to hemofiltration or dialysis
- Acute shock
- Uncontrolled hyperglycemia
- Pathologically elevated serum levels of any of the included electrolytes
- General contraindications to infusion therapy: acute pulmonary edema, hyperhydration,
and decompensated cardiac insufficiency
- Hemophagocytoic syndrome
- Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes
mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe
sepsis, hypotonic dehydration, and hyperosomolar coma)
WARNINGS AND PRECAUTIONS
General
The infusion must be stopped immediately if any signs or symptoms of allergic reactions (such
as fever, shivering, sweating, headache, skin rashes, or dyspnea) develop.
SmofKabiven Peripheral should be infused with caution in conditions of impaired lipid
metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis,
impaired liver function, hypothyroidism, and sepsis.
To avoid risks associated with too rapid delivery, it is recommended to use a continuous and
well-controlled infusion, if possible a volumetric pump.
Disturbances of the electrolyte and fluid balance (e.g. abnormally high or low serum levels of the
electrolytes) should be corrected before starting the infusion of SmofKabiven Peripheral.
SmofKabiven Peripheral should be given with caution to patients prone to retaining electrolytes.
Special monitoring is required at the beginning of any intravenous infusion. Should any
abnormal sign occur, the infusion must be stopped.
The amount of individual electrolytes to be added is determined by the clinical condition of the
patient and by frequent monitoring of serum levels.
Parenteral nutrition should be given with caution in metabolic acidosis, cellular hypoxia and
increased serum osmolarity.
Parenteral nutrition infusion may be accompanied by increased urinary excretion of the trace
elements, in particular copper and zinc. This should be considered in the dosing of trace
elements, especially during long-term parenteral nutrition. Amounts of zinc present in
SmofKabiven Peripheral should be taken into account.
SmofKabiven Peripheral – Product Monograph Page 4 of 58
