ORCIPRENALINE SYRUP

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ORCIPRENALINE SULFATE

Disponible depuis:

APOTEX INC

Code ATC:

R03CB03

DCI (Dénomination commune internationale):

ORCIPRENALINE

Dosage:

2MG

forme pharmaceutique:

SYRUP

Composition:

ORCIPRENALINE SULFATE 2MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2021-09-17

Résumé des caractéristiques du produit

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