REGIOCIT SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

SODIUM CHLORIDE; SODIUM CITRATE

Fáanlegur frá:

BAXTER CORPORATION

ATC númer:

B05ZB

INN (Alþjóðlegt nafn):

HEMOFILTRATES

Skammtar:

5.03G; 5.29G

Lyfjaform:

SOLUTION

Samsetning:

SODIUM CHLORIDE 5.03G; SODIUM CITRATE 5.29G

Stjórnsýsluleið:

EXTRACORPOREAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Ethical

Lækningarsvæði:

HEMODIALYSIS SOLUTION

Vörulýsing:

Active ingredient group (AIG) number: 0262055001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2020-03-03

Vara einkenni

_REGIOCIT (sodium chloride and sodium citrate) solution _
_Page 1 of 19_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
REGIOCIT
Sodium chloride and sodium citrate solution
for hemofiltration and regional citrate anticoagulation (RCA) during
continuous renal
replacement therapy (CRRT)
sodium chloride 5.03 g/L, sodium citrate 5.29 g/L
Solution for Extracorporeal use only, Not for direct intravenous
infusion
Hemofiltrates, ATC code: B05ZB
Baxter Corporation
Mississauga, ON
Canada, L5N 0C2
Date of Initial Approval:
March 2, 2020
Submission Control No: 225953
_REGIOCIT (sodium chloride and sodium citrate) solution _
_Page 2 of 19_
RECENT MAJOR LABEL CHANGES
Not applicable
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES ......................................................................................2
TABLE OF CONTENTS ..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................4
1
INDICATIONS
......................................................................................................
4
1.1
Pediatrics
...................................................................................................
4
1.2
Geriatrics
...................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX ..................... NOT
APPLICABLE
4
DOSAGE AND ADMINISTRATION
.....................................................................
4
4.1
Dosing
Considerations...............................................................................
4
4.2
Recommended Dose and Dosage Adjustment
.......................................... 5
4.3
Administration
............................................................................................
5
4.4
Reconstitution
...........................