MICRO PLUS 6 (CONCENTRATE) LIQUID
देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
उत्पाद विशेषताएं
(SPC)
19-01-2022
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
ZINC (ZINC SULFATE); COPPER (CUPRIC SULFATE); MANGANESE (MANGANESE SULFATE); CHROMIUM (CHROMIC CHLORIDE); SELENIUM (SELENIOUS ACID); IODINE (SODIUM IODIDE)
थमां उपलब्ध:
SANDOZ CANADA INCORPORATED
ए.टी.सी कोड:
B05XA31
INN (इंटरनेशनल नाम):
ELECTROLYTES IN COMB WITH OTHER DRUGS
डोज़:
5MG; 1MG; 0.5MG; 10MCG; 60MCG; 75MCG
फार्मास्यूटिकल फॉर्म:
LIQUID
रचना:
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
प्रशासन का मार्ग:
INTRAVENOUS
पैकेज में यूनिट:
10 X 10ML VIALS
प्रिस्क्रिप्शन प्रकार:
Ethical
चिकित्सीय क्षेत्र:
REPLACEMENT PREPARATIONS
उत्पाद समीक्षा:
Active ingredient group (AIG) number: 0631329002; AHFS:
प्राधिकरण का दर्जा:
CANCELLED POST MARKET
प्राधिकरण की तारीख:
2022-01-24
उत्पाद विशेषताएं
_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
................
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