MICRO PLUS 6 (CONCENTRATE) LIQUID

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ZINC (ZINC SULFATE); COPPER (CUPRIC SULFATE); MANGANESE (MANGANESE SULFATE); CHROMIUM (CHROMIC CHLORIDE); SELENIUM (SELENIOUS ACID); IODINE (SODIUM IODIDE)

Предлага се от:

SANDOZ CANADA INCORPORATED

АТС код:

B05XA31

INN (Международно Name):

ELECTROLYTES IN COMB WITH OTHER DRUGS

дозиране:

5MG; 1MG; 0.5MG; 10MCG; 60MCG; 75MCG

Лекарствена форма:

LIQUID

Композиция:

ZINC (ZINC SULFATE) 5MG; COPPER (CUPRIC SULFATE) 1MG; MANGANESE (MANGANESE SULFATE) 0.5MG; CHROMIUM (CHROMIC CHLORIDE) 10MCG; SELENIUM (SELENIOUS ACID) 60MCG; IODINE (SODIUM IODIDE) 75MCG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

10 X 10ML VIALS

Вид предписание :

Ethical

Терапевтична област:

REPLACEMENT PREPARATIONS

Каталог на резюме:

Active ingredient group (AIG) number: 0631329002; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2022-01-24

Данни за продукта

_MICRO + 6 CONCENTRATE (6 Trace Elements Injection)_
Page 1 of 25
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MICRO +6 CONCENTRATE
6 TRACE ELEMENTS FOR INJECTION
Zinc
5 mg/mL
Copper
300 mcg/mL
Manganese
55 mcg/mL
Chromium
10 mcg/mL
Selenium
60 mcg/mL
Iodide
75 mcg/mL
Manufacturer’s Standard
Intravenous
Combination of Electrolytes
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Initial Authorization:
JUN 18, 2021
Date of Revision:
JAN 19, 2022
Submission Control No: 253937
_MICRO +6 CONCENTRATE (6 Trace Elements Injection)_
Page 2 of 25
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions
11/2021
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
11/2021
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
PART I: HEALTH PROFESSIONAL INFORMATION
...............................................................3
1
INDICATIONS
............................................................................................................3
1.1 Pediatrics (≤ 18 years of age)
...................................................................................
3
1.2 Geriatrics (≥ 65 years of age)
...................................................................................
3
2
CONTRAINDICATIONS
...............................................................................................3
4
DOSAGE AND ADMINISTRATION
...............................................................................3
4.1 Dosing Considerations
.............................................................................................
3
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 4
4.3
Reconstitution........................................................................................................
6
4.4 Administration
.......................................................................................................
6
5
OVERDOSAGE
................