OSENI TABLET
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
17-01-2014
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Trimite cerere.
Trimite cerere.
Ingredient activ:
ALOGLIPTIN (ALOGLIPTIN BENZOATE); PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE)
Disponibil de la:
TAKEDA CANADA INC
Codul ATC:
A10BD09
INN (nume internaţional):
PIOGLITAZONE AND ALOGLIPTIN
Dozare:
25MG; 30MG
Forma farmaceutică:
TABLET
Compoziție:
ALOGLIPTIN (ALOGLIPTIN BENZOATE) 25MG; PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 30MG
Calea de administrare:
ORAL
Unități în pachet:
30
Tip de prescriptie medicala:
Prescription
Zonă Terapeutică:
DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS
Rezumat produs:
Active ingredient group (AIG) number: 0255250005; AHFS:
Statutul autorizaţiei:
CANCELLED PRE MARKET
Data de autorizare:
2018-01-19
Caracteristicilor produsului
_OSENI_
_TM_
_ Product Monograph _
_Page 1 of 51_
PRODUCT MONOGRAPH
Pr
OSENI™
alogliptin (as alogliptin benzoate) and pioglitazone (as pioglitazone
hydrochloride)
12.5 mg/15 mg, 12.5 mg/30 mg, 12.5 mg/45 mg, 25 mg/15 mg, 25 mg/30 mg
and 25 mg/45 mg
tablets
Oral Antihyperglycemic Agent
DPP-4 Inhibitor + Thiazolidinedione
Incretin Enhancer
Takeda Canada Inc.
Oakville, Ontario L6M 4X8
Date of Preparation:
January 16, 2014
SUBMISSION CONTROL NO: 156813
_OSENI_
_TM_
_ Product Monograph _
_Page 2 of 51_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................22
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................32
SPECIAL HANDLING INSTRUCTIONS
.......................................................................32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................32
PART II: SCIENTIFIC INFORMATION
...............................................................................
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