SODIUM NITRITE INJECTION, USP SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

SODIUM NITRITE

Διαθέσιμο από:

HOPE PHARMACEUTICALS LTD

Φαρμακολογική κατηγορία (ATC):

V03AB08

INN (Διεθνής Όνομα):

SODIUM NITRITE

Δοσολογία:

30MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

SODIUM NITRITE 30MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

10ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTIDOTES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2015-04-23

Αρχείο Π.Χ.Π.

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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
..................................................