MAGNESIUM SULFATE INJECTION, USP SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

MAGNESIUM SULFATE

Disponible depuis:

FRESENIUS KABI CANADA LTD

Code ATC:

B05XA05

DCI (Dénomination commune internationale):

MAGNESIUM SULPHATE

Dosage:

500MG

forme pharmaceutique:

SOLUTION

Composition:

MAGNESIUM SULFATE 500MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

10/20/50ML

Type d'ordonnance:

Ethical

Domaine thérapeutique:

MISCELLANEOUS ANTICONVULSANTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2022-04-01

Résumé des caractéristiques du produit

_ _
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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