PRIMENE 10% LIQUID
Држава: Канада
Језик: Енглески
Извор: Health Canada
Карактеристике производа
(SPC)
23-12-2019
Пошаљите упит.
Активни састојак:
L-ISOLEUCINE; L-PHENYLALANINE; HISTIDINE; L-THREONINE; L-CYSTEINE; METHIONINE; TRYPTOPHAN; TAURINE; L-TYROSINE; GLUTAMIC ACID; L-ARGININE; L-ALANINE; L-ASPARTIC ACID; SERINE; GLYCINE; L-PROLINE; L-ORNITHINE DIHYDROCHLORIDE; L-LEUCINE; L-LYSINE; L-VALINE
Доступно од:
BAXTER CORPORATION
АТЦ код:
B05BA01
INN (Међународно име):
AMINO ACIDS
Дозирање:
670MG; 420MG; 380MG; 370MG; 189MG; 240MG; 200MG; 60MG; 45MG; 1G; 840MG; 800MG; 600MG; 400MG; 400MG; 300MG; 318MG; 1G; 1.1G; 760MG
Фармацеутски облик:
LIQUID
Састав:
L-ISOLEUCINE 670MG; L-PHENYLALANINE 420MG; HISTIDINE 380MG; L-THREONINE 370MG; L-CYSTEINE 189MG; METHIONINE 240MG; TRYPTOPHAN 200MG; TAURINE 60MG; L-TYROSINE 45MG; GLUTAMIC ACID 1G; L-ARGININE 840MG; L-ALANINE 800MG; L-ASPARTIC ACID 600MG; SERINE 400MG; GLYCINE 400MG; L-PROLINE 300MG; L-ORNITHINE DIHYDROCHLORIDE 318MG; L-LEUCINE 1G; L-LYSINE 1.1G; L-VALINE 760MG
Пут администрације:
INTRAVENOUS
Јединице у пакету:
250ML
Тип рецептора:
Ethical
Терапеутска област:
CALORIC AGENTS
Резиме производа:
Active ingredient group (AIG) number: 2050895002; AHFS:
Статус ауторизације:
APPROVED
Датум одобрења:
2014-12-18
Карактеристике производа
PRODUCT MONOGRAPH
PRIMENE 10%
(AMINO ACID INJECTION 10% W/V)
PHARMACY BULK PACK (NOT FOR DIRECT INFUSION)
Intravenous Nutritive Supplement
BAXTER CORPORATION
MISSISSAUGA, ONTARIO, CANADA
L5N 0C2
Submission Control No: 232065
Date of Revision: December 23, 2019
Baxter and Primene are registered trademarks of Baxter International
Inc.
_ _
_PRIMENE 10% (Amino Acid Injection) _
_Page 2 of 26_
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
.......................................................................................................
11
DOSAGE AND ADMINISTRATION
..................................................................................
11
OVERDOSAGE
......................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 16
STORAGE AND STABILITY
..............................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 16
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL INFORMATION
.............................................................................
18
CLINICAL
TRIALS...............................................................................................................
22
TO
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