STERISOL® PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 1,5% m/v; STERISOL® LOW SODIUM PERIDIASOL WITH 2% m/v DEXTROSE (DIALYSIS SOLUTION); STERISOL® PERIDIASOL WITH DEXTROSE 4,25% m/v (DIALYSIS SOLUTION)

INDICATIONS CONTRA-INDICATIONS DOSAGE SIDE-EFFECTS PREGNANCY OVERDOSE IDENTIFICATION PATIENT INFORMATION

STERISOL® PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 1,5% m/v
STERISOL® LOW SODIUM PERIDIASOL WITH 2% m/v DEXTROSE (DIALYSIS SOLUTION)
STERISOL® PERIDIASOL WITH DEXTROSE 4,25% m/v (DIALYSIS SOLUTION)

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

STERISOL^® PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 1,5% m/v
STERISOL^® LOW SODIUM PERIDIASOL WITH 2% m/v DEXTROSE (DIALYSIS SOLUTION)
STERISOL^® PERIDIASOL WITH DEXTROSE 4,25% m/v (DIALYSIS SOLUTION)

COMPOSITION:
{table modified for Internet presentation}

a. = STERISOL^® PERITONEAL DIALYSIS SOLUTION WITH DEXTROSE 1,5% m/v
b. = STERISOL^® LOW SODIUM PERIDIASOL WITH 2% m/v DEXTROSE (DIALYSIS SOLUTION)
c. = STERISOL^® PERIDIASOL WITH DEXTROSE 4,25% m/v (DIALYSIS SOLUTION)

Composition per 1000 mL:	a.	b.	c.
Dextrose anhydrous	15,0 g	-	-
Dextrose monohydrate	-	20,0 g	42,5 g
Sodium chloride	5,61 mg	5,2 g	5,6 g
Sodium lactate	5,04 g	4,6 g	5,0 g
Calcium chloride .2H₂0	-	260 mg	260 mg
Calcium chloride .6H₂0	363 mg	-	-
Magnesium chloride .6H₂0	150 mg	150 mg	150 mg
Approx. osmolarity mOsmol/L	373	368	504
Approx. pH	5,5	5,5	5,0
Approx. ionic concentration (mmol/L)	a.	b.	c.
Sodium	141	130	141
Calcium	1,7	1,8	1,8
Magnesium	0,7	0,74	0,7
Chloride	101	94	101
Lactate	45	41	45

The above dialysis solutions are sterile and pyrogen-free. They do not contain any preservatives or buffers.

PHARMACOLOGICAL CLASSIFICATION:
A 34 (Other).

PHARMACOLOGICAL ACTION:
Dialysis solutions allow the selective removal of toxic substances, electrolytes, and excessive body fluids from the blood (a function normally performed by the kidneys).
In peritoneal dialysis, the exchange of ions between the solution and the patient's blood is made across the membranes of the peritoneal cavity.

Fluid removal from the patient's plasma into the peritoneal cavity is improved by the hyperosmolarity of the peritoneal dialysis solutions, due to the presence of glucose in the formulations.

INDICATIONS:

a.	For peritoneal dialysis whenever haemodialysis is difficult or impossible.
b.	Acute pulmonary oedema with renal insufficiency rendering diuretics ineffective and haemodialysis dangerous.
c.	Cardiac anasarca (cardiac dropsy) resistant to the classic forms of treatment. The biochemical criteria for treatment is the same as for haemodialysis, but should also not be followed too blindly, for the main criterion is the clinical condition of the patient. An exception, however, is kalaemia, which should never exceed 7 meq/L. The urea level should not exceed 4 g/L and the total CO₂ level should remain above 10 meq/L

Sterisol^® Peritoneal Dialysis Solution with Dextrose 1,5% m/v –Indicated for patients with low blood pressure in need of dialysis.
Sterisol^® Low Sodium Peridiasol with 2% m/v Dextrose –Indicated for patients with slightly raised blood pressure or for overloaded diabetic patients.
Sterisol^® Peridiasol with Dextrose 4,25% m/v –Indicated for patients suffering from renal failure with sodium and water overload this will manifest by mass gain, oedema and cardiac failure. Even in these patients, Sterisol^® Peridiasol with Dextrose 4,25% m/v should only be used for alternate and not for successive exchanges. Excessive use can lead to hyperglycaemia, calorie overload and dehydration.

CONTRA-INDICATIONS:
To be avoided in pregnancy, excessive obesity and behavioural disturbances rendering co-operation of the patient impossible in a procedure requiring relative but prolonged restriction of movement.

WARNINGS:
Great care should be taken if the decision is made at all to choose peritoneal dialysis as the mode of therapy for patients with certain abdominal conditions such as generalised peritonitis, localised infectious processes of the abdomen, traumatic abdominal lesions, recent abdominal surgery, extensive adhesions, the presence of intra-abdominal masses greatly restricting the volume of the cavity e.g. tumours, polycystic kidneys and liver, bowel distention, undiagnosed abdominal disease, abdominal wall infection, hernias or burns, faecal fistula or colostomy, tense ascites. Care should also be taken if patients have recently undergone aortic graft replacement or suffered from severe pulmonary disease.
The weight of the patient must be carefully monitored by means of a fluid balance record to avoid over- or underhydration. Such conditions could result in severe complications including congestive heart failure, volume depletion or shock.
Sterisol^® Peridiasol with Dextrose 4,25% m/v should not be used excessively during peritoneal dialysis as this can result in excessive removal of fluid from the patient.
Stable patients on maintenance peritoneal dialysis must be evaluated periodically with regard to blood chemistries and haematological factors, as well as other indicators or patient status.
Plasma electrolyte concentrations of acute renal failure patients must be monitored regularly during the procedure.
These dialysis solutions are potassium-free, because dialysis may be performed to correct hyperkalaemia. The addition of potassium chloride (up to 4 meq/L) may therefore be indicated to prevent severe hypokalaemia in patients with normal potassium levels or hypokalaemia. This must be done under the direction of a physician and only after careful evaluation of serum and total body potassium. Monitoring of serum electrolytes must be done frequently.
Additives may be incompatible and this must be investigated before any additions are made. Use aseptic technique when introducing additives. Mix thoroughly and do not store. The relevant manufacturer's product information, for products considered as additives, should be referred to.
If the injection (additive port) is damaged, do not use the product if medication is to be added.
Check the bags for minute leaks by squeezing (after removal of the overpouch) the solution should be discarded if any leaks are found, as the sterility may have been impaired.
Do not use unless the solution is clear. Discard any unused portion.

DOSAGE AND DIRECTIONS FOR USE:
These solutions are intended for intraperitoneal administration only, and must be visually inspected before administration for particulate matter, discolouration and leaks.
The physician responsible for and supervising the treatment should decide on the mode of therapy (intermittent Peritoneal Dialysis (IPD) or Continuous Ambulatory Peritoneal Dialysis (CAPD), the frequency of the treatment, the formulation, exchange volume, duration of dwell, and the length of dialysis, suitable for the individual patient.
It is advisable to select the dialysis solution with the lowest level of osmolarity consistent with the fluid requirements for that exchange.
Discomfort and heat loss may be decreased by heating the dialysis solution (in the overpouch) to 37°C. This will also result in increased clearances when compared to the use of solutions at room temperature.
Additives may be incompatible. Do not use know incompatible additives. Use aseptic technique if, in the informed judgement of the physician, it is advisable to introduce additives. The dialysis solutions should be mixed thoroughly after the addition of additives. Do not store solutions containing additives.

Intermittent Peritoneal Dialysis (IPD)
For dialysis of acute renal failure patients and maintenance dialysis of chronic renal failure patients.
The cycle of instillation, dwell and removal of dialysis fluid is repeated sequentially over a period of hours (8 to 36 hours) as many times as indicated by the condition of the patient. For chronic renal failure patients, maintenance dialysis often uses periodic dialysis (3 to 5 times weekly) for shorter time periods (8 to 14 hours per session).

Continuous Ambulatory Peritoneal Dialysis (CAPD)
For maintenance dialysis of chronic renal failure patients.
Use as prescribed by a physician.

Directions for use:
Use aseptic technique.
Warming of the dialysis solutions, if required, should be done in the overpouch and only dry heat should be used. The solution should be at body temperature (37°C) to ensure patient comfort. Do not overheat. The solution container should be comfortably warm to the touch.
A solution temperature exceeding 45°C may be detrimental to the solution. The solution container should be checked frequently during the heating process and should be removed from the heat source when the container becomes warm to the touch.
To open: Tear the overpouch (along the) notches and remove solution container. Plastics may absorb moisture during the sterilisation process which may cause opacity of the plastic. This is normal and the quality or safety of the solution is not affected. It will be noted that the opacity will diminish gradually. If the use of additives have been instructed, follow directions below before preparing for administration.
Check the container for minute leaks by squeezing.
To add medication:
Additives may be incompatible.

1.	Prepare medication site.
2.	Using a syringe with a 25 mm long, 19 to 25 gauge needle, puncture the resealable colourless, semi-transparent injection/additive port and inject the medication.
3.	Position the dialysis solution container with ports up and evacuate injection/additive port by tapping and squeezing it.
4.	Mix the solution with the added medication thoroughly.

Preparation for administration:

1.	Place the dialysis solution container on a table or suspend from support (depending on technique).
2.	Remove the red protective cap from the safe-lock connector. If a continuous flow is noted, discard container.
3.	Attach the appropriate solution transfer set. Refer to the directions for use of the relevant transfer set.
4.	Discard any unused portion.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The possible risk of infection should be minimised by the use of aseptic techniques throughout the procedure and its termination. If peritonitis should occur, identification and sensitivity studies of the isolated organism(s) should be used where possible to determine the choice and dosage of antibiotics to be used. Broad-spectrum antibiotics may be indicated before the involved organism(s) have been identified.
Significant amounts of protein, amino acids and water soluble vitamins may be lost during peritoneal dialysis and replacement therapy should be provided as necessary.
Safety in pregnancy and lactation have not been established.
Do not administer unless the dialysis solution is clear and seal is intact.
Adverse reactions to peritoneal dialysis may be due to mechanical or solution related problems, contamination of equipment or improper technique in catheter placement. Complications of the procedure include abdominal pain, bleeding, peritonitis, subcultaneous infection around a chronic peritoneal catheter, catheter blockage, difficulty in fluid removal and ileus. Solution related adverse reactions may include fluid and electrolyte imbalances, hypovolaemia, hypervolaemia, hypotension, hypertension, disequilibruim syndrome and muscle cramping.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear, colourless to light straw coloured solution.

PRESENTATION:
Dialysis solutions in plastic containers with a red moulded safe-lock connector and a colourless, semi-transparent moulded injection/additive port are available in normal size containers with fill volumes and glucose concentrations as indicated below.

	PRESENTATION
	FILL VOLUME (mL)	CONTAINER SIZE (mL)
Sterisol^® Peritoneal Dialysis solution with Dextrose 1,5% m/v	1 000 1 000 2 000	1 000 2 000 3 000
Sterisol^® Low Sodium Peridiasol with 2% m/v Dextrose	1 000 1 000 2 000	1 000 2 000 3 000
Sterisol^® Peridiasol with Dextrose 4,25% m/v	1 000 1 000 2 000	1 000 2 000 3 000

STORAGE INSTRUCTIONS:
Store below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:

Sterisol^® Peritoneal Dialysis Solution with Dextrose 1,5% m/v	D/24/153
Sterisol^® Low Sodium Peridiasol with 2% m/v Dextrose	J/24/259
Sterisol^® Peridiasol with Dextrose 4,25% m/v	J/24/260

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
INTRAMED (Pty) Ltd
6 Gibaud Road
Port Elizabeth, 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
December 1993

	12-009/8-94
	Tradepak PE