ACCUSOL 35 potassium 4 mmol/L haemofiltration solution for intravenous injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcium chloride dihydrate, Quantity: 1.286 g; magnesium chloride hexahydrate, Quantity: 0.51 g; sodium chloride, Quantity: 28.2 g; glucose monohydrate, Quantity: 5.512 g (Equivalent: glucose, Qty 4.987 g); potassium chloride, Quantity: 1.492 g

Available from:

AA-Med Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: water for injections; dibasic sodium phosphate dihydrate; dilute hydrochloric acid

Administration route:

Intravenous

Units in package:

5L x 2

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

A continuous renal replacement therapy (CRRT) replacement fluid used in intensive care units for the treatment of acute kidney injury.

Product summary:

Visual Identification: Sterile, pyrogen-free, clear and colourless solutions.; Container Type: Bag; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2019-06-12

Patient Information leaflet

ACCUSOL 35 haemofiltration solutions
1
ACCUSOL 35
ACCUSOL 35 POTASSIUM 2 MMOL/L
ACCUSOL 35 POTASSIUM 4 MMOL/L
_Contains the active ingredients calcium chloride dihydrate, glucose
monohydrate, magnesium chloride _
_hexahydrate, potassium chloride, sodium chloride, sodium bicarbonate_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACCUSOL 35
haemofiltration solution for injection.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or nurse.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
ACCUSOL 35 haemofiltration
solution for injection. It contains the
active ingredients calcium chloride,
glucose, magnesium chloride,
potassium chloride, sodium chloride
and sodium bicarbonate.
ACCUSOL 35 solutions are available
in 3 different strengths of potassium,
called potassium-free (K0),
potassium 2 mmol (K2) and
potassium 4 mmol (K4).
It is used in continuous renal
replacement therapy (CRRT) to treat
patients with serious kidney
malfunction. It is administered by
injection into the vein, using
specialised equipment in intensive
care units.
Your doctor or nurse are best
positioned to answer any questions
you may have about why
ACCUSOL 35 has been prescribed
for you.
_HOW IT WORKS _
ACCUSOL 35 solutions purify your
blood of waste products; they correct
the chemistry and mineral levels in
your blood.
As a replacement fluid, it can also be
used to provide adequate hydration
and mineral levels.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN _
_THIS MEDICINE _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE OR HAVE HAD
ANY OF THE FOLLOWING:
•
if you have a high level of
potassium in your b

Summary of Product characteristics

Australian Product Information
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION
ACCUSOL 35 HAEMOFILTRATION SOLUTION
ACCUSOL 35 POTASSIUM 2 MMOL/L HAEMOFILTRATION SOLUTION ACCUSOL 35 POTASSIUM 4 MMOL/L HAEMOFILTRATION SOLUTION
1. NAME OF THE MEDICINE
Calcium chloride dihydrate, Glucose monohydrate, Magnesium chloride
hexahydrate, Potassium chloride, Sodium
chloride and Sodium bicarbonate
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BEFORE MIXING, each 1000 mL ACCUSOL 35 solution contains:
TABLE 1: COMPOSITION OF ACCUSOL 35 SOLUTION BEFORE MIXING
ACCUSOL 35 K0
(Potassium-free)
ACCUSOL 35 K2
(Potassium 2 mmol/L)
ACCUSOL 35 K4
(Potassium 4 mmol/L)
LARGE (ELECTROLYTE) CHAMBER ‘A’
Glucose monohydrate
_equivalent to glucose * _
---
1.47 g
_1.33 g _
1.47 g
_1.33 g _
Calcium chloride dihydrate
0.343 g
0.343 g
0.343 g
Magnesium chloride hexahydrate
0.136 g
0.136 g
0.136 g
Sodium chloride
7.52 g
7.52 g
7.52 g
Potassium chloride
---
0.199 g
0.398 g
SMALL (BUFFER) CHAMBER ‘B’
Sodium bicarbonate
13.4 g
13.4 g
13.4 g
* In medical practice, glucose monohydrate is usually expressed as
glucose.
AFTER MIXING, 1000 mL of the ready-to-use ACCUSOL 35 solution
contains:
TABLE 2: COMPOSITION OF ACCUSOL 35 SOLUTION AFTER MIXING
ACCUSOL 35 K0
(Potassium-free)
ACCUSOL 35 K2
(Potassium 2 mmol/L)
ACCUSOL 35 K4
(Potassium 4 mmol/L)
Glucose
---
1.0 g
1.0 g
Calcium chloride dihydrate
0.257 g
0.257 g
0.257 g
Magnesium chloride hexahydrate
0.102 g
0.102 g
0.102 g
Sodium chloride
6.12 g
6.12 g
6.12 g
Potassium chloride
---
0.149 g
0.298 g
Sodium bicarbonate
2.94 g
2.94 g
2.94 g
The mixed solution is equivalent to the following ionic composition,
per 1000 mL:
TABLE 3: IONIC COMPOSITION OF THE MIXED SOLUTION
ACCUSOL 35 K0
(Potassium-free)
ACCUSOL 35 K2
(Potassium 2 mmol/L)
ACCUSOL 35 K4
(Potassium 4 mmol/L)
Glucose
0
5.55 mmol
5.55 mmol
Calcium (Ca
2+
)
1.75 mmol
1.75 mmol
1.75 mmol
Magnesium (Mg
2+
)
0.50 mmol
0.50 mmol
0.50 mmol
Australian Product Information
ACCUSOL 35
Page 2 of 11
ACCUSOL 35 K0
(Potassium-free)
ACCUSOL 35 K2
(Potassium 2 mmol/