ATROPINE SULFATE INJECTION USP SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ATROPINE SULFATE

Dostupné z:

PFIZER CANADA ULC

ATC kód:

A03BA01

INN (Medzinárodný Name):

ATROPINE

Dávkovanie:

1MG

Forma lieku:

SOLUTION

Zloženie:

ATROPINE SULFATE 1MG

Spôsob podávania:

INTRAMUSCULAR

Počet v balení:

10ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTIMUSCARINICS ANTISPASMODICS

Prehľad produktov:

Active ingredient group (AIG) number: 0104748003; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2015-06-12

Súhrn charakteristických

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_ATROPINE SULFATE INJECTION USP (atropine sulfate) Product Monograph _
_Page 1 of 14_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ATROPINE SULFATE INJECTION USP
Atropine Sulfate
Solution, 0.1 mg/mL for injection
USP
Anticholinergic
Pfizer Canada ULC
17300 Trans Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
December 31, 1975
Date of Revision:
October 26, 2022
Submission Control Number: 264652
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_ATROPINE SULFATE INJECTION USP (atropine sulfate) Product Monograph _
_Page 2 of 14_
RECENT MAJOR LABEL CHANGES
No major label changes related to safety and efficacy have been made
within the past 24 months
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
..................................................................................................................
4
1.2
Geriatrics
..................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
...............................................