ACCUSOL 35 POTASSIUM 4 MMOL/L 4 mMol. Solution for Haemofiltration

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYDROUS

可用日期:

Baxter Healthcare Limited

INN（国际名称）:

SODIUM CHLORIDE CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE ANHYDROUS SODIUM BICARBONATE POTASSIUM CHLORIDE GLUCOSE ANHYD

剂量:

4 mMol.

药物剂型:

Solution for Haemofiltration

处方类型:

Product subject to prescription which may not be renewed (A)

授权状态:

Authorised

授权日期:

0000-00-00

资料单张

EMEA ARTWORK DESIGN CENTRE
ARTWORK APPROVAL
4TH DRAFT 
DATE  16 JAN 2014
RA TO APPROVE LAYOUT 
AND FORMAT
PLANT APPROVAL 
HALLE ONLY
COUNTRY
N/A
NAME
N/A
SIGNATURE
N/A
DATE
N/A
RA PROOFREADING CHECKLIST
PRODUCT INFORMATION PROOFREAD AS 
PER RA SOP CE-RAPV-009
PRODUCT NAME,STRENGTH,COMPOSITION 
(API & EXCIPIENTS)
COMPLIANCE WITH NATIONAL 
REGULATIONS
CONSISTENCY CHECK WITH ALL FIGURES 
CITED IN THE PRODUCT INFORMATION
BARCODES, SYMBOLS  AND RE-
IMBURSEMENT INFORMATION
STORAGE CONDITIONS AND SHELF-LIFE
CB-30-01-853
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACCUSOL 35 POTASSIUM 4 MMOL/L, SOLUTION FOR HAEMOFILTRATION, 
HAEMODIALYSIS AND HAEMODIAFILTRATION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT 
CONTAINS IMPORTANT INFORMATION FOR YOU:
•  Keep this leaflet. You may need to read it again.
•  If you have any further questions, ask your doctor.
•  If you get any side effects talk to your doctor. This includes
any
possible side effects not listed in this leaflet.
What is in this leaflet
1.  What ACCUSOL 35 Potassium 4 mmol/l is and what it is
used for
2.  What you need to know before you are given
ACCUSOL 35 Potassium 4 mmol/l
3.  How you will be given ACCUSOL 35 Potassium 4 mmol/l
4.  Possible side effects
5  How to store ACCUSOL 35 Potassium 4 mmol/l
6.  Contents of the pack and other information
1.  WHAT ACCUSOL 35 POTASSIUM 4 MMOL/L IS AND WHAT IT IS 
USED FOR
ACCUSOL 35 Potassium 4 mmol/l is a solution for haemofiltration,
haemodialysis
and haemodiafiltration.
ACCUSOL 35 Potassium 4 mmol/l is prescribed to you if you have
temporary or
permanent kidney failure.
It purifies your blood of waste products; it corrects the acidity or
alkalinity and
the level of salts in your blood. As a replacement fluid in
haemodiafiltration and
haemofiltration, it can also be used as a source of salts and water
for hydration.
ACCUSOL 35 solutions are supplied in a non-PVC bag with two chambers.
The
two chambers are separated by a long-seal (interchamber seal). Prio

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Accusol 35 Potassium 4 mmol/l
Solution for haemofiltration, haemodialysis and haemodiafiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Equivalent to the following ionic composition:
The 5000 ml of final solution results from the mixing of 3750 ml of solution ‘A’ with 1250 ml of solution ‘B’. 

The pH of the final solution is between 7.0 -7.5.
For the full list of excipients, see section 6.1.
The number “35” in the name specifies the buffer concentration of the solution (bicarbonate = 35 mmol/l).
3 PHARMACEUTICAL FORM
COMPOSITION
PER 1000 ML
ACCUSOL 35
LARGE CHAMBER ‘A’
Calcium chloride dihydrate
0.343 g
Magnesium chloride hexahydrate
0.136 g
Sodium chloride
Potassium chloride
Glucose monohydrate
7.52 g
0.398g
1.47g
SMALL CHAMBER ‘B’
Sodium bicarbonate
13.4 g
FINAL SOLUTION AFTER MIXING
PER 1000 ML
ACCUSOL 35
Calcium chloride dihydrate
0.257 g
Magnesium chloride hexahydrate
0.102 g
Sodium chloride
6.12 g
Sodium bicarbonate
Potassium chloride
Glucose anhydrous
2.94 g
0.298g
1.0g
IONIC COMPOSITION OF FINAL SOLUTION
PER 1000 ML
ACCUSOL 35
Calcium (Ca
++
)
1.75 mmol
Magnesium (Mg
++
)
0.5 mmol
Sodium (Na
+
)
140 mmol
Potassium (K
+)
Chloride (Cl
-
)
Glucose anhydrous
4mmol
113.3 mmol
5.55mmol
Bicarbonate (HCO
3
-
)
35 mmol
Theoretical Osmolarity
300 MOSM/L
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 09/07/2014_
_CRN 2130021_
_page number: 1_
Solution for haemofiltration, haemodialysis and haemodiafiltration.
Accusol 35 is a sterile, non pyrogenic, clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Accusol 35 is indicated for the treatment of acute and chronic renal failure, as substitution solution