PHYSIONEAL 40 Glucose 2.27% w/v Peritoneal Dialysis Solution Bag

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium bicarbonate, Quantity: 2.1 g/L; sodium lactate, Quantity: 1.68 g/L; magnesium chloride hexahydrate, Quantity: 51 mg/L; glucose monohydrate, Quantity: 25 g/L (Equivalent: glucose, Qty 22.7 g/L); calcium chloride dihydrate, Quantity: 0.184 g/L; sodium chloride, Quantity: 5.38 g/L

Available from:

Vantive Pty Ltd

INN (International Name):

calcium chloride dihydrate,glucose monohydrate,magnesium chloride hexahydrate,sodium bicarbonate,sodium chloride,sodium lactate

Pharmaceutical form:

Solution, dialysis

Composition:

Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide

Administration route:

Intraperitoneal

Units in package:

2500 mL, 5000 mL, 2000 mL, 1500 mL

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

Physioneal 40 is indicated for use in peritoneal dialysis in patients with acute or chronic renal failure.

Product summary:

Visual Identification: Clear solution contained in a dual compartment Clear Flex PL 17552 plastic bag with medication port, access system and hanger.; Container Type: Bag; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2005-05-31

Patient Information leaflet

1
CONSUMER MEDICINE INFORMATION
PHYSIONEAL 40 PERITONEAL DIALYSIS SOLUTION
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet in safe place. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

This medicine has been prescribed for you personally and you should
not pass it on to
others. It may harm them, even if their symptoms are the same as yours

IF YOU HAVE ANY CONCERNS ABOUT TAKING THE MEDICINE, ASK YOUR DOCTOR OR
RENAL
NURSE.
WHAT IS IN THIS LEAFLET?
What is PHYSIONEAL 40 and what is it used for?

Before you use PHYSIONEAL 40

How to take PHYSIONEAL 40

Possible side effects

Storing PHYSIONEAL 40
WHAT IS PHYSIONEAL 40 AND WHAT IT IS USED FOR?
PHYSIONEAL 40 is a solution for peritoneal dialysis. PHYSIONEAL 40 is
prescribed to
patients whose kidneys are either temporarily or permanently not
working. It removes water
and waste products from the blood and corrects abnormal blood levels
of salt. The higher the
glucose strength in the solution, the greater the amount of water that
can be removed from
the blood.
BEFORE YOU USE PHYSIONEAL 40:
DO NOT USE PHYSIONEAL 40: _ _
There are no times when PHYSIONEAL 40 is not suitable for use during
peritoneal dialysis.
However, there are several conditions in which special precautions
should be taken (see
Precautions section below).
TAKE SPECIAL CARE WITH PHYSIONEAL 40_ _
Your doctor will advise you about particular precautions as they apply
to you.
PHYSIONEAL 40 _is for intraperitoneal administration only_.
PRODUCT IS FOR SINGLE USE IN ONE PATIENT ONLY.
•
It is generally not advisable to use peritoneal dialysis in the
presence of serious
conditions affecting the abdominal wall (e.g. skin infections or
burns, recent surgery,
hernia) or abdominal cavity (e.g. blockage of the intestine, fibrous
bands causing
abnormal joining of internal surfaces (adhesions), bowel perforation,
problems with the
diaphragm, tumours and advanced pregnancy) and in severe breat

Summary of Product characteristics

Physioneal 40 Glucose
Version 1.0
1 of 15
AUSTRALIAN PRODUCT INFORMATION
PHYSIONEAL 40 GLUCOSE (%W/V) SOLUTION FOR PERITONEAL
DIALYSIS
1
NAME OF THE MEDICINE
Glucose, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate,
Sodium Chloride,
Sodium Lactate and Sodium Bicarbonate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
COMPOSITION:
COMPOSITION OF THE SOLUTION IN EACH COMPARTMENT BEFORE MIXING IN G/L
VIAFLEX BAG
CLEAR FLEX BAG
GLUCOSE
1.36%
GLUCOSE
2.27%
GLUCOSE
3.86%
GLUCOSE
1.36%
GLUCOSE
2.27%
GLUCOSE
3.86%
GLUCOSE BAG “A”
Glucose monohydrate
Calcium Chloride Dihydrate
Magnesium Chloride Hexahydrate
37.50
0.507
0.140
62.60
0.507
0.140
106.50
0.507
0.140
18.2
0.245
0.068
30.3
0.245
0.068
51.5
0.245
0.068
BUFFER BAG “B”
Sodium Chloride
Sodium Bicarbonate
Sodium Lactate
8.43
3.29
2.63
8.43
3.29
2.63
8.43
3.29
2.63
19.95
9.29
6.73
19.95
9.29
6.73
19.95
9.29
6.73
FINAL SOLUTION AFTER MIXING G/L
Glucose monohydrate
Sodium Chloride
Calcium Chloride Dihydrate
Magnesium Chloride Hexahydrate
Sodium Bicarbonate
Sodium Lactate
13.6
5.38
0.184
0.051
2.10
1.68
22.7
5.38
0.184
0.051
2.10
1.68
38.6
5.38
0.184
0.051
2.10
1.68
1000 mL of final solution after mixing corresponds to:
•
Viaflex Bag: 362.5 mL of solution A (Glucose) and 637.5 mL of solution
B (Buffer).
•
Clear Flex Bag: 750 mL of solution A (Glucose) and 250 mL of solution
B (Buffer).
•
The pH of the final solution is 7.4.
•
Hydrochloric acid (Solution A) and Sodium hydroxide (Solution B) are
used for pH
adjustment in the Clear Flex presentation.
Physioneal 40 Glucose
Version 1.0
2 of 15
COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L
GLUCOSE 1.36%
GLUCOSE 2.27%
GLUCOSE 3.86%
Glucose (C
6
H
12
O
6
)
Sodium (Na
+
)
Calcium (Ca
++
)
Magnesium (Mg
++
)
Chloride (Cl
-
)
Bicarbonate (HCO
3
-
)
Lactate (C
3
H
5
O
3
-
)
75.5
132
1.25
0.25
95
25
15
126
132
1.25
0.25
95
25
15
214
132
1.25
0.25
95
25
15
Osmolarity*
344 mOsmol/L
395 mOsmol/L
483 mOsmol/L
*Osmolarity is equivalent to osmolality in infinitively
diluted conditions, including total diss