SODIUM NITRITE INJECTION, USP SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

SODIUM NITRITE

Boleh didapati daripada:

HOPE PHARMACEUTICALS LTD

Kod ATC:

V03AB08

INN (Nama Antarabangsa):

SODIUM NITRITE

Dos:

30MG

Borang farmaseutikal:

SOLUTION

Komposisi:

SODIUM NITRITE 30MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

10ML

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTIDOTES

Ringkasan produk:

Active ingredient group (AIG) number: 0104384004; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2015-04-23

Ciri produk

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_Page 1 of 22_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
SODIUM NITRITE INJECTION, USP
30 MG/ML
ANTIDOTE FOR ACUTE CYANIDE POISONING
HEALTH CANADA HAS AUTHORIZED THE SALE OF THIS EXTRAORDINARY
USE NEW DRUG FOR THE TREATMENT OF CYANIDE POISONING THAT IS
JUDGED TO BE LIFE-THREATENING BASED ON LIMITED CLINICAL TESTING
IN HUMANS
Hope Pharmaceuticals Ltd.
552A Clarke Road, Suite 299
Coquitlam, BC V3J 0A3
Canada
Date of Preparation:
April 27, 2015
Submission Control No: <174143>
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_Page 2 of 22_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
................................................................................14
PHARMACEUTICAL INFORMATION
..................................................