AA-Med HAEMOFILTRATION REPLACEMENT FLUID 5000mL injection bag AHB7864

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcium chloride dihydrate,glucose,magnesium chloride hexahydrate,potassium chloride,sodium chloride,sodium lactate

Available from:

AA-Med Pty Ltd

Authorization status:

Registered

Patient Information leaflet

Haemofiltration Replacement Fluid (AHB7864)
1
HAEMOFILTRATION REPLACEMENT FLUID
(AHB7864) SOLUTION FOR INJECTION
_Contains the active ingredients calcium chloride dihydrate, glucose,
magnesium chloride hexahydrate, _
_potassium chloride, sodium chloride, sodium lactate_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Haemofiltration
Replacement Fluid (AHB7864). 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
Haemofiltration Replacement Fluid
(AHB7864). It contains the active
ingredients calcium chloride,
glucose, magnesium chloride,
potassium chloride, sodium chloride
and sodium lactate.
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 AHB7864
has been prescribed for you.
_HOW IT WORKS _
AHB7864 is used to purify your
blood of waste products and correct
the chemistry and mineral levels in
your blood.
As a replacement fluid, it can also be
used to improve the hydration status
of your blood.
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 low level of
potassium in your blood
•
if your body has trouble
metabolising lactate, such as due
to liver failure or heart failure
•
if the access to your veins and/or
arteries is not good.
•
if you have an excessive

Summary of Product characteristics

Australian Product Information
Page 1 of 7
AUSTRALIAN PRODUCT INFORMATION
HAEMOFILTRATION REPLACEMENT FLUID (AHB7864) SOLUTION FOR INJECTION
1. NAME OF THE MEDICINE
Calcium chloride dihydrate, Glucose, Magnesium chloride hexahydrate,
Potassium chloride, Sodium chloride and
Sodium lactate.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Haemofiltration Replacement Fluid (AHB7864) is a large volume solution
used undiluted as a replacement fluid in
continuous renal replacement therapy (CRRT), a therapeutic technique
that effects rapid corrections to fluid,
electrolyte and acid-base balance in patients with acute kidney
injury.
The composition of the solution is described in the following table.
TABLE 1: COMPOSITION OF THE SOLUTION
COMPOSITION
PER 1000 ML
PER 5000 ML
Glucose
1.96 g
9.8 g
Calcium chloride dihydrate
0.24 g
1.2 g
Magnesium chloride hexahydrate
0.152 g
0.76 g
Potassium chloride
0.074 g
0.37 g
Sodium chloride
5.52 g
27.6 g
Sodium lactate
5.1 g
25.5 g
Equivalent to the following ionic composition:
TABLE 2: IONIC COMPOSITION OF THE SOLUTION
IONIC COMPOSITION
PER 1000 ML
(Approx.)
PER 5000 ML
(Approx.)
Glucose
10.9 mmol
54 mmol
Sodium (Na
+
)
140 mmol
700 mmol
Calcium (Ca
2+
)
1.6 mmol
8 mmol
Magnesium (Mg
2+
)
0.8 mmol
4 mmol
Potassium (K
+
)
1 mmol
5 mmol
Chloride (Cl
-
)
100 mmol
500 mmol
Lactate _(endogenously converted to bicarbonate HCO_
_3_
_-_
_)_
46 mmol
230 mmol
Approximate Osmolarity (per 5000 mL)
300 mOsm/L
Approximate Kilojoules (per 5000 mL)
156 kJ
pH
5.0 – 6.5
For a full list of excipients, see 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Haemofiltration Replacement Fluid is a sterile, non-pyrogenic, clear
and colourless replacement fluid solution for
injection. It is a ready-to-use solution that is lactate-buffered and
contains no added antimicrobial preservative.
Australian Product Information
Page 2 of 7
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Haemofiltration Replacement Fluid is indicated as a replacement fluid
in Continuous Renal Replacement Therapy
(CRRT) in intensive care un