EXTRANEAL SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

SODIUM CHLORIDE; SODIUM LACTATE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; ICODEXTRIN

Dostopno od:

BAXTER CORPORATION

Koda artikla:

B05DA

INN (mednarodno ime):

ISOTONIC SOLUTIONS

Odmerek:

5.35G; 4.48G; 257MG; 51MG; 75G

Farmacevtska oblika:

SOLUTION

Sestava:

SODIUM CHLORIDE 5.35G; SODIUM LACTATE 4.48G; CALCIUM CHLORIDE 257MG; MAGNESIUM CHLORIDE 51MG; ICODEXTRIN 75G

Pot uporabe:

HAEMODIALYSIS (INTRAPERITONEAL)

Enote v paketu:

2/2.5/3L

Tip zastaranja:

Ethical

Terapevtsko območje:

HEMODIALYSIS SOLUTION

Povzetek izdelek:

Active ingredient group (AIG) number: 0538301002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

1999-09-17

Lastnosti izdelka

_ _
_EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium
chloride, magnesium chloride) _
_Page 1 of 29 _
PRODUCT MONOGRAPH
EXTRANEAL
Icodextrin, Sodium Chloride, Sodium Lactate, Calcium Chloride,
Magnesium Chloride
75 g/L Icodextrin
5.35 g/L Sodium Chloride
4.48 g/L Sodium Lactate
257 mg/L Calcium Chloride
51 mg/L Magnesium Chloride
Peritoneal Dialysis Solution
BAXTER CORPORATION
Mississauga, Ontario L5N 0C2
Control Number: 195522
Date of Revision:
September 27, 2016
Baxter, Extraneal, and Viaflex are trademarks of Baxter International
Inc.
_ _
_EXTRANEAL (icodextrin, sodium chloride, sodium lactate, calcium
chloride, magnesium chloride) _
_Page 2 of 29 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................4
SUMMARY PRODUCT INFORMATION
........................................................................4
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
...................................................................................................
9
PART III: PATIENT MEDICATION INFORMATION
.......................................................26
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION .................................