ACCUSOL 35 POTASSIUM 2MMOL/L 2 mMol. Solution for Haemofiltration

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

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

Διαθέσιμο από:

Baxter Healthcare Limited

INN (Διεθνής Όνομα):

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

Δοσολογία:

2 mMol.

Φαρμακοτεχνική μορφή:

Solution for Haemofiltration

Τρόπος διάθεσης:

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

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

0000-00-00

Φύλλο οδηγιών χρήσης

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-30-01-852
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACCUSOL 35 POTASSIUM 2 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 2 mmol/l is and what it is
used for
2.  What you need to know before you are given
ACCUSOL 35 Potassium 2 mmol/l
3.  How you will be given ACCUSOL 35 Potassium 2 mmol/l
4.  Possible side effects
5  How to store ACCUSOL 35 Potassium 2 mmol/l
6.  Contents of the pack and other information
1.  WHAT ACCUSOL 35 POTASSIUM 2 MMOL/L IS AND WHAT IT IS 
USED FOR
ACCUSOL 35 Potassium 2 mmol/l is a solution for haemofiltration,
haemodialysis
and haemodiafiltration.
ACCUSOL 35 Potassium 2 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

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Accusol 35 Potassium 2 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 mixing 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 = 35mmol/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
7.52 g
Potassium chloride
0.199 g
Glucose monohydrate
1.47 g
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
Potassium chloride
0.149 g
Glucose anhydrous
1.0 g
Sodium bicarbonate
2.94 g
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
+
)
2 mmol
Chloride (Cl
-
)
111.3 mmol
Glucose Anhydrous
5.55 mmol
Bicarbonate (HCO
3
-
)
35 mmol
Theoretical Osmolarity
296 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