ORCIPRENALINE SYRUP

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ORCIPRENALINE SULFATE

Available from:

APOTEX INC

ATC code:

R03CB03

INN (International Name):

ORCIPRENALINE

Dosage:

2MG

Pharmaceutical form:

SYRUP

Composition:

ORCIPRENALINE SULFATE 2MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Product summary:

Active ingredient group (AIG) number: 0102598001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-09-17

Summary of Product characteristics

_ORCIPRENALINE _
_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ORCIPRENALINE
Orciprenaline Sulfate Syrup
Syrup, 2 mg/mL and Oral
Apotex Standard
Beta–Adrenergic Agonist
Bronchodilator
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Date of Initial Authorization:
April 10, 2014
Date of Revision:
September 17, 2021
Submission Control Number:
251291
_ _
_ORCIPRENALINE Product Monograph _
_ _
_ _
_Page 2 of 21_
RECENT MAJOR LABEL CHANGES
None
N/A
7 Warnings and Precautions
09/2021
TABLE OF CONTENTS
TABLE OF CONTENTS
...............................................................................................................2
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing Considerations
.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
5
OVERDOSAGE
...............................................................................................................5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
...................................6
7
WARNINGS AND PRECAUTIONS
....................................................................................6
7.1
Special Populations
..............................................................................................7
7.1.1
Pregnant Women
.....................................................................................