NRA-ARIPIPRAZOLE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
15-05-2023
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ARIPIPRAZOLE
Fáanlegur frá:
NORA PHARMA INC
ATC númer:
N05AX12
INN (Alþjóðlegt nafn):
ARIPIPRAZOLE
Skammtar:
15MG
Lyfjaform:
TABLET
Samsetning:
ARIPIPRAZOLE 15MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Vörulýsing:
Active ingredient group (AIG) number: 0152514003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2023-06-01
Vara einkenni
NRA-ARIPIPRAZOLE (Aripiprazole Tablets)
Page 1 of 74
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATIO N
PR
NRA-ARIPIPRAZOLE
Aripiprazole Tablets
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, Oral
USP
Antipsychotic agent
Nora Pharma Inc.
1565, boul. Lionel-Boulet
Varennes, Québec, Canada
J3X 1P7
Date of Initial Authorization:
January 19, 2018
Date of Revision:
May 15, 2023
Submission Control No: 270875
NRA-ARIPIPRAZOLE (Aripiprazole Tablets)
Page 2 of 74
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
05/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
...............................................................................................
2
TABLE OF CONTENTS
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................................
4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
....................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................... 5
4
DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................................................... 6
4.3
Administration
..........................................................................................................
6
4.4
Reconstitution
....
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