ESSEPNA SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

ALANINE; ARGININE; GLYCINE; HISTIDINE; ISOLEUCINE; LEUCINE; LYSINE (L-LYSINE ACETATE); METHIONINE; PHENYLALANINE; PROLINE; SERINE; TAURINE; THREONINE; TRYPTOPHAN; TYROSINE; VALINE

Доступна з:

FRESENIUS KABI CANADA LTD

Код атс:

B05BA01

ІПН (Міжнародна Ім'я):

AMINO ACIDS

Дозування:

1.4G; 1.2G; 1.1G; 0.3G; 0.5G; 0.74G; 0.66G; 0.43G; 0.51G; 1.12G; 0.65G; 0.1G; 0.44G; 0.2G; 0.04G; 0.62G

Фармацевтична форма:

SOLUTION

Склад:

ALANINE 1.4G; ARGININE 1.2G; GLYCINE 1.1G; HISTIDINE 0.3G; ISOLEUCINE 0.5G; LEUCINE 0.74G; LYSINE (L-LYSINE ACETATE) 0.66G; METHIONINE 0.43G; PHENYLALANINE 0.51G; PROLINE 1.12G; SERINE 0.65G; TAURINE 0.1G; THREONINE 0.44G; TRYPTOPHAN 0.2G; TYROSINE 0.04G; VALINE 0.62G

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

15G/50G

Тип рецепту:

Ethical

Терапевтична области:

CALORIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 1662682001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2020-12-30

Характеристики продукта

ESSEPNA
TM
10% w/v - Product Monograph
_ _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ESSEPNA
TM
Amino acids injection
Solution, 10% w/v, Intravenous
Intravenous Nutritive Supplement
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Initial Approval:
December 29, 2020
Submission Control No: 231585
Essepna is a trademark of Fresenius Kabi AG
Fresenius Kabi is a Registered Trademark of Fresenius SE and Biofine
is a Registered
Trademark of Fresenius Medical Care.
_ _
Essepna
TM
10% w/v - Product Monograph
Template date: June 2017
_ _
_Page 2 of 30_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 4
1
INDICATIONS
................................................................................................................
4
2
CONTRAINDICATIONS
...............................................................................................
4
3
DOSAGE AND ADMINISTRATION
...........................................................................
4
3.1
Dosing Considerations
.............................................................................................
4
3.2
Recommended Dose and Dosage Adjustment
......................................................... 5
3.3
Administration
.........................................................................................................
5
3.4
Missed Dose
.............................................................................................................
5
4.
OVERDOSAGE
...............................................................................................................
5
5.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .............. 6
6
WARNINGS AND PRECAUTIONS
.............................................................................
6
7.
ADVERSE REACTIONS
................................................................................................
8
7.1
Adverse Reaction Overview
...........................