Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
GUANFACINE (GUANFACINE HYDROCHLORIDE)
JAMP PHARMA CORPORATION
C02AC02
GUANFACINE
1MG
TABLET (EXTENDED-RELEASE)
GUANFACINE (GUANFACINE HYDROCHLORIDE) 1MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0154470001; AHFS:
APPROVED
2022-01-06
_ _ _JAMP Guanfacine XR_ _ _ _(guanfacine extended-release tablets) _Page 1 of 44 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP GUANFACINE XR Guanfacine Extended-Release Tablets Extended-Release Tablets, 1 mg, 2 mg, 3 mg, and 4 mg of Guanfacine (as Guanfacine Hydrochloride) Oral House Standard Selective Alpha 2A -Adrenergic Receptor Agonist JAMP Pharma Corporation 1310, rue Nobel Boucherville, Quebec, J4B 5H3, Canada Date of Initial Authorization: December 20, 2021 Submission Control No: 251452 _ _ _JAMP Guanfacine XR_ _ _ _(guanfacine extended-release tablets) _Page 2 of 44 RECENT MAJOR LABEL CHANGES _None at the time of authorization._ TABLE OF CONTENTS RECENT MAJOR LABEL CHANGES………………………………………………………….2 TABLE OF CONTENTS ......................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 4 1 INDICATIONS............................................................................................................ 4 1.1 Pediatrics .......................................................................................................... 5 1.2 Adults ................................................................................................................ 5 1.3 Geriatrics........................................................................................................... 5 2 CONTRAINDICATIONS............................................................................................ 5 4 DOSAGE AND ADMINISTRATION ......................................................................... 5 4.1 Dosing Considerations ..................................................................................... 5 4.2 Recommended Dose and Dosage Adjustment ............................................... 6 4.2.1 Children (6-17 years old) .............................................................................. 6 4.2.2 R Belgenin tamamını okuyun