REGIOCIT SOLUTION FOR HAEMOFILTRATION

국가: 싱가포르

언어: 영어

출처: HSA (Health Sciences Authority)

유효 성분:

Sodium Chloride; Sodium Citrate

제공처:

VANTIVE PTE. LTD.

ATC 코드:

B05ZB

약제 형태:

SOLUTION, STERILE

구성:

Sodium Chloride 5.03 g/l; Sodium Citrate 5.29 g/l

관리 경로:

INTRAVENOUS

처방전 유형:

Prescription Only

Manufactured by:

Bieffe Medital S.p.A

승인 상태:

ACTIVE

승인 날짜:

2018-07-19

제품 특성 요약

BN, HK
MY, SG
Package Insert
....................................................................3
TW
使用說明書
..........................................................................7
07-19-00-1287
Regiocit,
Solution for haemofiltration
"百特"局部抗凝檸檬酸血液過濾用溶液
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 07-19-00-1287
Date: 26-NOV-2019
Proofread No.: 01
Designer: DEP
Page: 1 of 12
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Colour Reference:
DRAFT
THIS PAGE IS INTENTIONALLY LEFT BLANK
BAXTER CONFIDENTIAL - INTERNAL USE ONLY
Part Number: 07-19-00-1287
Date: 26-NOV-2019
Proofread No.: 01
Designer: DEP
Page: 2 of 12
BLACK
Colour Reference:
DRAFT
3
07-19-00-1287
SG
MY
HK
BN
PACKAGE INSERT
1. NAME OF THE MEDICINAL
PRODUCT
REGIOCIT Solution for
haemofiltration
2. QUALITATIVE AND
QUANTITATIVE
COMPOSITION
Composition:
Sodium chloride
5.03 g/l
Sodium citrate
5.29 g/l
Sodium, Na
+
140 mmol/l
Chloride, Cl
−
86 mmol/l
Citrate, C
6
H
5
O
7
3−
18 mmol/l
For the full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
Solution for haemofiltration
The solution is sterile, clear and
colourless and free from bacterial
endotoxins.
Theoretical osmolarity: 244 mOsm/l
pH ≈ 7.4
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
REGIOCIT solution is indicated as
replacement fluid before dialyzer
for continuous renal replacement
therapy (CRRT) using regional
citrate anticoagulation. Citrate is
particularly relevant when systemic
anticoagulation with heparin is con
-
traindicated, for example in patients
with increased bleeding risks.
In paediatric patients,
REGIOCIT so
-
lution is indicated in all age groups
provided that the equipment used is
adapted to the weight of the child.
4.2 POSOLOGY AND METHOD
OF ADMINISTRATION
POSOLOGY
The rate at which REGIOCIT solu
-
tion is administered depends on
the targeted citrate dose and the
prescribed blood flow rate (BFR).
The prescription of
REGIOCIT
solution must consider the flow
rates of the effluent and other
therapeutic fluids, the patient’s fluid
removal requirements, a