Land: Kanada
Sprache: Englisch
Quelle: Health Canada
ORCIPRENALINE SULFATE
APOTEX INC
R03CB03
ORCIPRENALINE
2MG
SYRUP
ORCIPRENALINE SULFATE 2MG
ORAL
100
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0102598001; AHFS:
APPROVED
2021-09-17
_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 ..................................................................................... Lesen Sie das vollständige Dokument