REGIOCIT SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

SODIUM CHLORIDE; SODIUM CITRATE

Доступна з:

BAXTER CORPORATION

Код атс:

B05ZB

ІПН (Міжнародна Ім'я):

HEMOFILTRATES

Дозування:

5.03G; 5.29G

Фармацевтична форма:

SOLUTION

Склад:

SODIUM CHLORIDE 5.03G; SODIUM CITRATE 5.29G

Адміністрація маршрут:

EXTRACORPOREAL

Одиниць в упаковці:

15G/50G

Тип рецепту:

Ethical

Терапевтична области:

HEMODIALYSIS SOLUTION

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2020-03-03

Характеристики продукта

_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
...........................