HYPURIN NPH INSULIN ISOPHANE PORK SUSPENSION

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

INSULIN ISOPHANE INJECTION PORK

Доступно од:

WOCKHARDT UK LIMITED

АТЦ код:

A10AC03

INN (Међународно име):

INSULIN (PORK)

Дозирање:

100UNIT

Фармацеутски облик:

SUSPENSION

Састав:

INSULIN ISOPHANE INJECTION PORK 100UNIT

Пут администрације:

INTRAMUSCULAR

Јединице у пакету:

10

Тип рецептора:

Schedule D

Терапеутска област:

INSULINS

Резиме производа:

Active ingredient group (AIG) number: 0151573001; AHFS:

Статус ауторизације:

MARKETED

Датум одобрења:

2006-04-01

Карактеристике производа

PRODUCT MONOGRAPH
HYPURIN® NPH INSULIN, PORK
INSULIN INJECTION, ISOPHANE (PORCINE) PH EUR
SUSPENSION FOR INJECTION 100 IU/ML
ANTI-DIABETIC AGENT
SPONSOR: WOCKHARDT UK LTD 2000 ELLESMERE ROAD, UNIT 16 SCARBOROUGH, ONTARIO M1H 2W4
MANUFACTURER: WOCKHARDT UK LTD
ASH ROAD NORTH
WREXHAM, LL13 9UF
UNITED KINGDOM
CONTROL #:
204997
DATE OF
APPROVAL
:
JUNE 15
,
201
7
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................1
SUMMARY PRODUCT
INFORMATION........................................................................1
INDICATIONS AND CLINICAL
USE..............................................................................1
CONTRAINDICATIONS
....................................................................................................1
WARNINGS AND PRECAUTIONS
..................................................................................1
ADVSERSE REACTIONS
..................................................................................................5
DRUG
INTERACTIONS.....................................................................................................5
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
....................................................................................................................8
ACTION AND CLINICAL PHARMACOLOGY
.............................................................8
STORAGE AND STABILITY
............................................................................................9
SPECIAL HANDLING
INSTRUCTIONS.........................................................................9
DOSAGE FORMS, COMPOSITION AND PACKAGING
...........................................10
PART II: SCIENTIFIC INFORMATION
..........................................................................11
PHARMACEUTICAL
INFORMATION.........................................................................11
CLINICAL
TRIALS................................