CARBAGLU TABLET FOR SUSPENSION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

CARGLUMIC ACID

Dostupné z:

RECORDATI RARE DISEASES

ATC kód:

A16AA05

INN (Medzinárodný Name):

CARGLUMIC ACID

Dávkovanie:

200MG

Forma lieku:

TABLET FOR SUSPENSION

Zloženie:

CARGLUMIC ACID 200MG

Spôsob podávania:

ORAL

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

AMMONIA DETOXICANTS

Prehľad produktov:

Active ingredient group (AIG) number: 0156770001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2015-04-10

Súhrn charakteristických

_ _
_Carbaglu_
_®_
_ Product Monograph _
_Page 1 of 29_
PRODUCT MONOGRAPH
Pr
CARBAGLU
®
Carglumic acid dispersible tablets
200 mg
amino acids and derivatives
Recordati Rare Diseases
Immeuble Le Wilson
70 avenue du général de Gaulle
92800 Puteaux, France
Date of Revision:
November 06, 2020
Distributed by :
Recordati Rare Diseases Canada Inc.
Milton, ON, L9T 9L1
Control No: 227936
_Carbaglu_
_®_
_ Product Monograph _
_Page 2 of 29 _
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
....................................................................................................5
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
............................................................14
STORAGE AND STABILITY
..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................16
PART II: SCIENTIFIC INFORMATION
...............................................................................17
PHARMACEUTICAL INFORMATION
..........................................................................17
CLINICAL TRIALS
...............................................