ARSENIC TRIOXIDE FOR INJECTION Solution

Pays: Canada

Langue: français

Source: Health Canada

Ingrédients actifs:

Trioxyde d'arsénic

Disponible depuis:

STERIMAX INC

Code ATC:

L01XX27

DCI (Dénomination commune internationale):

ARSENIC TRIOXIDE

Dosage:

1MG

forme pharmaceutique:

Solution

Composition:

Trioxyde d'arsénic 1MG

Mode d'administration:

Intraveineuse

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Numéro de groupe d'ingrédients actifs (GIA) :0108756003; AHFS:

Statut de autorisation:

APPROUVÉ

Date de l'autorisation:

2019-09-30

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ARSENIC TRIOXIDE FOR INJECTION
(arsenic trioxide)
Solution for Injection
10 mg/10 mL (1 mg/mL) vial
Antineoplastic
SteriMax Inc.
2770 Portland Drive
Oakville, Ontario L6H 6R4
Date of Revision:
August 11, 2023
Submission Control No: 274630
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Arsenic Trioxide for Injection Product Monograph Page 2 of 50
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
08/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
08/2023
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
3
SERIOUS WARNINGS AND PRECAUTIONS
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5
4
DOSAGE AND
ADMINISTRATION..................................................................................
6
4.1
Dosing Considerations
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6
4.2
Recommended Dose and Dosage Adjustment
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