MAGNESIUM SULFATE INJECTION, USP SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

MAGNESIUM SULFATE

Disponible des:

FRESENIUS KABI CANADA LTD

Codi ATC:

B05XA05

Designació comuna internacional (DCI):

MAGNESIUM SULPHATE

Dosis:

500MG

formulario farmacéutico:

SOLUTION

Composición:

MAGNESIUM SULFATE 500MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

10/20/50ML

tipo de receta:

Ethical

Área terapéutica:

MISCELLANEOUS ANTICONVULSANTS

Resumen del producto:

Active ingredient group (AIG) number: 0105356002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2022-04-01

Fitxa tècnica

_ _
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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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