Страна: Канада
мова: англійська
Джерело: Health Canada
MAGNESIUM SULFATE
FRESENIUS KABI CANADA LTD
B05XA05
MAGNESIUM SULPHATE
500MG
SOLUTION
MAGNESIUM SULFATE 500MG
INTRAMUSCULAR
10/20/50ML
Ethical
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0105356002; AHFS:
APPROVED
2022-04-01
_ _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION MAGNESIUM SULFATE INJECTION, USP Magnesium sulfate heptahydrate Sterile Solution 500 mg / mL of Magnesium Sulfate heptahydrate 4.06 mEq / mL of Magnesium Sulfate anhydrous 2.03 mmol / mL of Magnesium Sulfate anhydrous 4060 mOsmol / L pH 5.5 - 7.0 when diluted to a concentration of 5% (w/v) For Intravenous Infusion or Intramuscular Use Only Electrolyte Solution Fresenius Kabi Canada Ltd. 165 Galaxy Blvd, Suite 100 Toronto, ON M9W 0C8 Date of Initial Authorization: OCT 31, 1994 Date of Revision: April 4, 2022 Submission Control Number: 255007 _Product Monograph _ _Magnesium Sulfate Injection, USP (Magnesium sulfate heptahydrate) _ _Page 2 of 17 _ RECENT MAJOR LABEL CHANGES 2 CONTRAINDICATIONS 04/2022 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 04/2022 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 04/2022 4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution 04/2022 7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding 04/2022 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. RECENT MAJOR LABEL CHANGES ........................................................................................... 2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics ................................................................................................................... 4 1.2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ...... Прочитайте повний документ