AG-METFORMIN TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
28-11-2019
Niektoré dokumenty týkajúce sa tohto produktu nie sú momentálne k dispozícii, môžete poslať požiadavku na náš zákaznícky servis a my vás upozorníme hneď, ako ich dokážeme získať.
Poslať žiadosť.
Poslať žiadosť.
Aktívna zložka:
METFORMIN HYDROCHLORIDE
Dostupné z:
ANGITA PHARMA INC.
ATC kód:
A10BA02
INN (Medzinárodný Name):
METFORMIN
Dávkovanie:
850MG
Forma lieku:
TABLET
Zloženie:
METFORMIN HYDROCHLORIDE 850MG
Spôsob podávania:
ORAL
Počet v balení:
15G/50G
Typ predpisu:
Prescription
Terapeutické oblasti:
BIGUANIDES
Prehľad produktov:
Active ingredient group (AIG) number: 0101773002; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2019-12-02
Súhrn charakteristických
Page 1 of 40
Product
Monograph of
AG-Metformin
PRODUCT MONOGRAPH
Pr
AG-METFORMIN
MetforminHydrochloride Tablets, USP
500 mg, 850mg
Oral Antihyperglycemic Agent
Submission Control No.:
232222
J4B 5H3
Boucherville
,
Qu
e
bec
1310 rue Nobel
Angita Pharma Inc.
November 2
8
,2019
Date of
Revision
:
Page 2 of 40
Product
Monograph of
AG-Metformin
Table of Contents
PART I: HEALTH PROFESSIONAL IN FORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................3
CONTRAINDICATIONS...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
13
DRUG
INTERACTIONS..........................................................................................................
15
DOSAGE AND
ADMINISTRATION......................................................................................
18
OVERDOSAGE
.............................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
21
STORAGE AND STABILITY
.................................................................................................
22
DOSAGE FORMS, COMPOSITION AND
PACKAGING...................................................... 22
PAR T II: SCIENTIFIC
INFORMATION....................................................................................23
PHARMACEUTICAL INFORMATION
.................................................................................
23
CLINICAL TRIALS
...............................
Prečítajte si celý dokument
