ORCIPRENALINE SYRUP

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ORCIPRENALINE SULFATE

Saatavilla:

APOTEX INC

ATC-koodi:

R03CB03

INN (Kansainvälinen yleisnimi):

ORCIPRENALINE

Annos:

2MG

Lääkemuoto:

SYRUP

Koostumus:

ORCIPRENALINE SULFATE 2MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2021-09-17

Valmisteyhteenveto

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