Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
ZINC (ZINC SULFATE); COPPER (CUPRIC SULFATE); MANGANESE (MANGANESE SULFATE); CHROMIUM (CHROMIC CHLORIDE); SELENIUM (SELENIOUS ACID); IODINE (SODIUM IODIDE)
SANDOZ CANADA INCORPORATED
B05XA31
ELECTROLYTES IN COMB WITH OTHER DRUGS
5MG; 1MG; 0.5MG; 10MCG; 60MCG; 75MCG
LIQUID
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
INTRAVENOUS
10 X 10ML VIALS
Ethical
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0631329002; AHFS:
CANCELLED POST MARKET
2022-01-24
_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 ................ Baca dokumen lengkap