ORCIPRENALINE SYRUP

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ORCIPRENALINE SULFATE

Boleh didapati daripada:

APOTEX INC

Kod ATC:

R03CB03

INN (Nama Antarabangsa):

ORCIPRENALINE

Dos:

2MG

Borang farmaseutikal:

SYRUP

Komposisi:

ORCIPRENALINE SULFATE 2MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2021-09-17

Ciri produk

_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
.....................................................................................