OLIMEL 4.4% EMULSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHIONINE; L-PHENYLALANINE; L-PROLINE; SERINE; L-THREONINE; TRYPTOPHAN; LYSINE (L-LYSINE ACETATE); ALANINE; L-ARGININE; L-ASPARTIC ACID; GLUTAMIC ACID; GLYCINE; HISTIDINE; L-ISOLEUCINE; L-LEUCINE; OLIVE OIL; SOYBEAN OIL; L-TYROSINE; L-VALINE; DEXTROSE

Available from:

BAXTER CORPORATION

ATC code:

B05BA10

INN (International Name):

COMBINATIONS

Dosage:

2.21G; 3.07G; 2.64G; 1.75G; 2.21G; 0.74G; 3.48G; 6.41G; 4.34G; 1.28G; 2.21G; 3.07G; 2.64G; 2.21G; 3.07G; 32G; 8G; 0.11G; 2.83G;

Pharmaceutical form:

EMULSION

Composition:

METHIONINE 2.21G; L-PHENYLALANINE 3.07G; L-PROLINE 2.64G; SERINE 1.75G; L-THREONINE 2.21G; TRYPTOPHAN 0.74G; LYSINE (L-LYSINE ACETATE) 3.48G; ALANINE 6.41G; L-ARGININE 4.34G; L-ASPARTIC ACID 1.28G; GLUTAMIC ACID 2.21G; GLYCINE 3.07G; HISTIDINE 2.64G; L-ISOLEUCINE 2.21G; L-LEUCINE 3.07G; OLIVE OIL 32G; SOYBEAN OIL 8G; L-TYROSINE 0.11G; L-VALINE 2.83G; DEXTROSE 154G

Administration route:

INTRAVENOUS

Units in package:

1000/1500/2000/2500ML

Prescription type:

Ethical

Therapeutic area:

CALORIC AGENTS

Product summary:

Active ingredient group (AIG) number: 2052745001; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-06-28

Summary of Product characteristics

1
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
OLIMEL 4.4%
Amino acids, dextrose, lipids
Injectable Emulsion
4.4% w /v, 14% w /v, 4% w /v
OLIMEL 5.7%
Amino acids, dextrose, lipids
Injectable Emulsion
5.7% w /v, 11% w /v, 4% w /v
OLIMEL 7.6%
Amino acids, dextrose, lipids
Injectable Emulsion
7.6% w /v, 7.3% w /v, 3.5% w /v
Intravenous Nutritive Supplements
Baxter Corporation
Mississauga, Ontario L5N 0C2
Canada
Date of Initial Approval:
Jun 28, 2010
Date of Revision:
April 19, 2021
Submission Control No: 245814
Baxter, Oliclinomel, Olimel, and Periolimel are trademarks of Baxter
International Inc.
RECENT MAJOR LABEL CHANGES
DOSAGE AND ADMINISTRATION, Recommended Dose
Dec, 2019
ADVERSE REACTIONS, Post-Market Adverse Drug Reactions
May, 2020
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES ................................................................................
2
TABLE OF CONTENTS .......................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION ....................................................... 4
1
INDICATIONS
............................................................................................................
4
1.1
Pediatrics
............................................................................................................
4
1.2
Geriatrics
............................................................................................................
4
2
CONTRAINDICATIONS
............................................................................................
4
3
DOSAGE AND ADMINISTRATION .........................................................................
5
3.1
Dosing Considerations
........................................................................................
5
3.2
Recommended Dose and Dosage
Adjustment....................................................... 5
3.3
Administration
....................................................................................................
9
3.