MULTIBIC potassium-free, Solution for Haemofiltration

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

magnesium chloride hexahydrate, Quantity: 0.1017 g/L; sodium bicarbonate, Quantity: 2.94 g/L; sodium chloride, Quantity: 6.136 g/L; glucose monohydrate, Quantity: 1.1 g/L (Equivalent: glucose, Qty 1 g/L); calcium chloride dihydrate, Quantity: 0.2205 g/L

Available from:

Fresenius Medical Care Australia Pty Ltd

Pharmaceutical form:

Solution, dialysis

Composition:

Excipient Ingredients: carbon dioxide; water for injections; hydrochloric acid; monobasic sodium phosphate dihydrate

Administration route:

Intravenous

Units in package:

2 x 5 L bag (after mixing)

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Replacement fluid, which is administered intravenously in patients with acute renal failure in intensive care units.

Product summary:

Visual Identification: Clear and colourless solution; Container Type: Bag; Container Material: Composite plastic laminate; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

2021-08-02

Patient Information leaflet

MULTIBIC potassium-free and 4 mmol/L potassium solutions for
haemofiltration v2.3
1
MULTIBIC POTASSIUM-FREE
AND
MULTIBIC 4 MMOL/L POTASSIUM
SOLUTIONS FOR HAEMOFILTRATION
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING MULTIBIC?
MULTIBIC solutions contain the active ingredients Potassium chloride
(MULTIBIC 4 mmol/L potassium only), Sodium chloride,
Sodium bicarbonate, Calcium chloride dihydrate, Magnesium chloride
hexahydrate and Glucose monohydrate. MULTIBIC is used
as a substitution solution in haemofiltration therapy.
For more information, see Section 1. Why am I using MULTIBIC? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MULTIBIC?
Do not use if you have ever had an allergic reaction to MULTIBIC or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
MULTIBIC? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MULTIBIC and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MULTIBIC?
Your doctor, nurse or pharmacist will tell you how much of this
medicine you should take. This will depend on your condition
and whether you are taking any other medicines. Do not stop taking
your medicine or change your dosage without first
checking with your doctor. More instructions can be found in Section
4. How do I use MULTIBIC? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MULTIBIC?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
MULTIBIC.
THINGS YOU
SHOULD NOT DO
•
Give this medicine to anyone else, even if their symptoms seem similar
to yours
•
Take your medicine to treat any other

Summary of Product characteristics

Product Information – Australia V 2.5
Page 1
MULTIBIC potassium-free and 4 mmol/L potassium Solution for
Haemofiltration
AUSTRALIAN PRODUCT INFORMATION
MULTIBIC
® POTASSIUM-FREE, SOLUTION FOR HAEMOFILTRATION
MULTIBIC
® 4 MMOL/L POTASSIUM, SOLUTION FOR HAEMOFILTRATION NAME OF THE MEDICINE
Potassium chloride (MULTIBIC 4 mmol/L potassium only)
Sodium chloride
Sodium bicarbonate
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Glucose monohydrate QUALITATIVE AND QUANTITATIVE COMPOSITION
MULTIBIC Haemofiltration (HF) solution is a solution comprised of
electrolytes needed for continuous renal
replacement therapies (CRRT). It is used as a substitution solution in
haemofiltration therapy.
MULTIBIC HF solution is provided in a two-compartment bag with 4.75 L
of an alkaline bicarbonate solution in
one compartment (Compartment B) and 0.25 L of an acidic electrolyte,
glucose solution in the other
compartment (Compartment A) to give a total volume of 5 L after
mixing.
BEFORE MIXING, each 1000 mL MULTIBIC solution contains:
TABLE 1: ACIDIC ELECTROLYTE, GLUCOSE SOLUTION (SMALL COMPARTMENT A)
MULTIBIC
potassium- free
MULTIBIC
4 mmol/L potassium
Unit
Potassium chloride
0
5.964
g
Calcium chloride dihydrate
4.410
4.410
g
Magnesium chloride
hexahydrate
2.033
2.033
g
Glucose anhydrous
20.00
20.00
g
as Glucose monohydrate
22.00
22.00
K
+
0
80
mmol
Ca
2+
30
30
mmol
Mg
2+
10
10
mmol
Cl
-
82
162
mmol
Glucose
111
111
mmol
TABLE 2: ALKALINE BICARBONATE SOLUTION (LARGE COMPARTMENT B)
MULTIBIC
potassium- free
MULTIBIC
4 mmol/L potassium
Unit
Sodium chloride
6.453
6.453
g
Sodium bicarbonate
3.104
3.104
g
Na
+
147
147
mmol
Cl
-
110
110
mmol
HCO
3
-
37
37
mmol
Product Information – Australia V 2.5
Page 2
MULTIBIC potassium-free and 4 mmol/L potassium Solution for
Haemofiltration
TABLE 3: AFTER MIXING, 1000 ML OF THE READY-TO-USE MULTIBIC SOLUTION
CONTAINS:
MULTIBIC
potassium- free
MULTIBIC
4 mmol/L potassium
Unit
Potassium chloride
0
0.2982
g
Sodium chloride
6.136
6.136
g
Sodium bicarbonate
2.940
2.940
g
Calcium chloride dihydra