MICRO+ TE PEDIATRIC SOLUTION

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

MANGANESE (MANGANESE SULFATE); IODIDE (SODIUM IODIDE); SELENIUM (SELENIOUS ACID); ZINC (ZINC SULFATE); COPPER (CUPRIC SULFATE)

Disponibbli minn:

SANDOZ CANADA INCORPORATED

Kodiċi ATC:

B05XA31

INN (Isem Internazzjonali):

ELECTROLYTES IN COMB WITH OTHER DRUGS

Dożaġġ:

1MCG; 1MCG; 2MCG; 250MCG; 20MCG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

MANGANESE (MANGANESE SULFATE) 1MCG; IODIDE (SODIUM IODIDE) 1MCG; SELENIUM (SELENIOUS ACID) 2MCG; ZINC (ZINC SULFATE) 250MCG; COPPER (CUPRIC SULFATE) 20MCG

Rotta amministrattiva:

INTRAVENOUS

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Ethical

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0564501001; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2023-03-15

Karatteristiċi tal-prodott

_ _
_Micro+_
_®_
_ TE Pediatric _ Product Monograph _
_Page 1 of 22_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MICRO+
® TE PEDIATRIC
5 Trace Elements for Injection
Solution (Concentrate for injection)
Intravenous use only
Zinc 250 mcg/mL
Copper 20 mcg/mL
Selenium 2 mcg/mL
Iodide 1 mcg/mL
Manganese 1 mcg/mL
Manufacturer’s Standard
Multi-Trace Elements
Sandoz Canada Inc.
110 de Lauzon Street
Boucherville, Quebec
J4B 1E6
Date of initial authorization
March 14, 2023
Submission Control No: 246125
_ _
_Micro+_
_®_
_ TE Pediatric _ Product Monograph _
_Page 2 of 22_
RECENT MAJOR LABEL CHANGES
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................
2
TABLE OF CONTENTS
..................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
1
INDICATIONS
......................................................................................................
3
1.1
PEDIATRICS
...................................................................................................
3
1.2
GERIATRICS
....................................................................................................
3
2
CONTRAINDICATIONS
.......................................................................................
3
3
DOSAGE AND ADMINISTRATION
.....................................................................
3
3.1
Recommended Dose and Dosage Adjustment
............................................ 3
3.2
Dilution for intravenous use
.........................................................................
4
3.3
Administration
..............................................................................................
5
4
OVERDOSAGE
....................................................................................................
6
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 7
6
WARNINGS AND PRECAUTIONS
....