Accusol 35 Potassium 4 mmol/lSolution for haemofiltration, haemodialysis and haemodiafiltration

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Sodium chloride; Calcium chloride; Magnesium chloride; Sodium bicarbonate; Potassium chloride; Glucose anhydrous

MAH:

Nikkiso Belgium bvba

ATC_code:

B05ZB

INN:

Sodium chloride; Calcium chloride; Magnesium chloride; Sodium bicarbonate; Potassium chloride; Glucose anhydrous

dosage:

4 mmol/L

pharmaceutical_form:

Solution for haemodialysis/haemofiltration

prescription_type:

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

therapeutic_area:

Hemofiltrates

authorization_status:

Marketed

authorization_date:

2006-04-28

PIL

Accusol 35 Potassium 4 mmol/l
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. See section 4.
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). Prior to use, the two
chambers of Accusol 35 solutions
must first be mixed by activating the long-seal (interchamber seal),
followed by the activation of the
short SafetyMoon seal near the access port.
Accusol 35 Potassium 4 mmol/l may be given to you especially if you
have a low level of potassium.
Accusol 35 solutions must only be used by or under the direction of a
doctor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ACCUSOL 35 POTASSIUM 4
MMOL/L
Before starting the therapy, your doctor will ensure that you h

SPC

Health Products Regulatory Authority
30 November 2020
CRN00C23M
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Accusol 35 Potassium 4 mmol/lSolution for haemofiltration,
haemodialysis and haemodiafiltration
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
Equivalent to the following ionic composition:
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
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
Solution for haemofiltration, haemodialysis and haemodiafiltration.
Accusol 35 is a sterile, non pyrogenic, clear and colourless solution.
4 CLINICAL PARTICULARS
Health Products Regulatory Authority
30 November 2020
CRN00C23M
Page 2 of 5
4.1 THERAPEUTIC INDICATIONS
Accusol 35 is indicated for the treatment of acute and chronic renal
failure, as substitution solution in haemofiltration and
haemodiafiltration, and as dialysis solution in haemodialysis and
haemodiafiltration.
Accusol 35, Potassium4 mmol/l is primarily intended for usein patients
with hypokalaemia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
F