Страна: Канада
Език: английски
Източник: Health Canada
MANGANESE (MANGANESE SULFATE); CHROMIUM (CHROMIC CHLORIDE); SELENIUM (SELENIOUS ACID); COPPER (CUPRIC SULFATE); ZINC (ZINC SULFATE)
SANDOZ CANADA INCORPORATED
B05XA31
ELECTROLYTES IN COMB WITH OTHER DRUGS
0.5MG; 10MCG; 60MCG; 1MG; 5MG
LIQUID
MANGANESE (MANGANESE SULFATE) 0.5MG; CHROMIUM (CHROMIC CHLORIDE) 10MCG; SELENIUM (SELENIOUS ACID) 60MCG; COPPER (CUPRIC SULFATE) 1MG; ZINC (ZINC SULFATE) 5MG
INTRAVENOUS
10ML
Ethical
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0531376001; AHFS:
APPROVED
2006-06-09
_MICRO +5 CONCENTRATE (5 Trace Elements Injection USP) _ _Page 1 of 18_ _ _ _ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION MICRO +5 CONCENTRATE 5 Trace Elements Injection Zinc, 5 mg/mL Copper, 1 mg/mL Manganese, 0.5 mg/mL Chromium, 10 mcg/mL Selenium, 60 mcg/mL USP Intravenous Combination of Electrolytes Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, (Québec), Canada J4B 1K6 Date of Initial Authorization: APR 25, 1994 Date of Revision: December 16, 2021 Control No.:250303 _MICRO +5 CONCENTRATE (5 Trace Elements Injection USP) _ _Page 2 of 18_ RECENT MAJOR LABEL CHANGES 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment (Pediatrics) 12/2021 7 WARNINGS AND PRECAUTIONS, General 12/2021 TABLE OF CONTENTS Sections of subsections that are not applicable at the time of authorization are not listed. PART I: HEALTH PROFESSIONAL INFORMATION ................................................................. 4 1 INDICATIONS .................................................................................................................... 4 1.1 P EDIATRICS ( ≤ 18 YEARS OF AGE ) ................................................................................. 4 1.2 G ERIATRICS (≥ 65 YEARS OF AGE ) .................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................... 4 4 DOSAGE AND ADMINISTRATION .................................................................................... 4 4.1 D OSING C ONSIDERATIONS ................................................................................................... 4 4.2 R ECOMMENDED D OSE AND D OSAGE A DJUSTMENT ............................................................... 5 4.3 R ECONSTITUTION ................................................................................................................ 6 4.4 A DMINISTRATION ............................................................................. Прочетете целия документ