MICRO+6 CONCENTRATE SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

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

Dostępny od:

SANDOZ CANADA INCORPORATED

Kod ATC:

B05XA31

INN (International Nazwa):

ELECTROLYTES IN COMB WITH OTHER DRUGS

Dawkowanie:

5MG; 300MCG; 55MCG; 10MCG; 60MCG; 75MCG

Forma farmaceutyczna:

SOLUTION

Skład:

ZINC (ZINC SULFATE) 5MG; COPPER (CUPRIC SULFATE) 300MCG; MANGANESE (MANGANESE SULFATE) 55MCG; CHROMIUM (CHROMIC CHLORIDE) 10MCG; SELENIUM (SELENIUM DIOXIDE) 60MCG; IODINE (SODIUM IODIDE) 75MCG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Ethical

Dziedzina terapeutyczna:

REPLACEMENT PREPARATIONS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0631329007; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2020-11-10

Charakterystyka produktu

_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
................