JAMP GUANFACINE XR TABLET (EXTENDED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

GUANFACINE (GUANFACINE HYDROCHLORIDE)

Mevcut itibaren:

JAMP PHARMA CORPORATION

ATC kodu:

C02AC02

INN (International Adı):

GUANFACINE

Doz:

4MG

Farmasötik formu:

TABLET (EXTENDED-RELEASE)

Kompozisyon:

GUANFACINE (GUANFACINE HYDROCHLORIDE) 4MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Ürün özeti:

Active ingredient group (AIG) number: 0154470004; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2022-01-06

Ürün özellikleri

_ _
_JAMP Guanfacine XR_
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_(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