Read all this product information carefully before you start taking this medicine. (DOWNLOAD)

• If you have any further questions, ask your health care provider.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please inform your health care provider.

In this leaflet:
1. What CAPD SOLUTION is and what it is used for
2. What you need to know before you use CAPD SOLUTION
3. How to use CAPD SOLUTION
4. Possible side effects
5. How to store CAPD SOLUTION
6. Contents of the pack and other information

1. WHAT CAPD SOLUTION IS AND WHAT IT IS USED FOR
Continuous Ambulatory Peritoneal Dialysis (CAPD) Solution is a sterile, nonpyrogenic solution for intraperitoneal administration only. CAPD Solution contains no bacteriostatic or antimicrobial agents or added buffers.

CAPD Solution is indicated for patients in acute or chronic renal failure when non-dialytic medical therapy is judged to be inadequate. It may also be indicated in the treatment of certain fluid and electrolyte disturbances, and for patients intoxicated with certain poisons and drugs. However, for many substances other methods of detoxification have been reported to be more effective than peritoneal dialysis.

2. WHAT YOU NEED TO KNOW BEFORE YOU USE CAPD SOLUTION CAPD Solution is contraindicated in patients with:

• Pre-existing severe lactic acidosis.
• Uncorrectable mechanical defects that prevent effective peritoneal dialysis or increase the risk of infection.
• Documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.

Warnings and precautions
Solutions containing dextrose should be used with caution in patients with a known allergy to corn or corn products. Hypersensitivity reactions such as those due to a corn starch allergy, including anaphylactic/anaphylactoid reactions, may occur. Stop the infusion immediately and drain the solution from the peritoneal cavity if any signs or symptoms of a suspected hypersensitivity reaction develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.

Patients with severe lactic acidosis should not be treated with lactate-based peritoneal dialysis solutions. It is recommended that patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension or sepsis that can be associated with acute renal failure, inborn errors of metabolism; treatment with drugs such as nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)] must be monitored for occurrence of lactic acidosis before the start of treatment and during treatment with lactate-based peritoneal dialysis solutions.

When prescribing the solution to be used for an individual patient, consideration should be given to the potential interaction between the dialysis treatment and therapy directed at other existing illnesses. Serum Potassium, Calcium and Magnesium levels should be monitored carefully in patients treated with cardiac glycosides.

Diabetics require careful monitoring of blood-glucose levels during and following dialysis
with dextrose (glucose)-containing solutions. Dosage of insulin or other treatments for
hyperglycemia should be adjusted.

The use of 5 liters of dialysis solution is not indicated in a single exchange. CAPD Solution is intended for intraperitoneal administration only. Not for intravenous administration.

Do not administer if the solution is discolored, cloudy, contains particulate matter or shows evidence of leakage or if seals are not intact.

The drainage fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.

Significant losses of protein, amino acids, water soluble vitamins, and other medicines may occur during peritoneal dialysis. Replacement therapy should be provided as necessary.

Peritoneal dialysis should be done with caution in patients with:

• Abdominal conditions, including disruption of the peritoneal membrane and diaphragm by surgery, from congenital anomalies or trauma until healing is complete, abdominal tumors, abdominal wall infection, hernias, fecal fistula, colostomy, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intra-abdominal cavity.
• Other conditions include aortic graft placement and severe pulmonary disease. When assessing peritoneal dialysis as the mode of therapy in these situations, the benefits to the patient must be weighed against the possible complications.

An accurate fluid balance record must be kept, and the weight of the patient carefully monitored to avoid over or under hydration with severe consequences such as congestive heart failure, volume depletion, or shock.

Excessive use of CAPD Solution with higher Dextrose during a peritoneal dialysis treatment can result in significant removal of water from the patient.

Serum electrolyte concentrations (particularly Bicarbonate, Potassium, Magnesium, Calcium and Phosphate), blood chemistry (including parathyroid hormone and lipid parameters) and hematological parameters should be evaluated periodically.

Over-infusion of CAPD Solution into the peritoneal cavity may be characterized by abdominal distension/abdominal pain and/or shortness of breath.

Treatment of CAPD Solution over-infusion is to drain CAPD Solution from the peritoneal cavity.

Use in Children: The safety and efficacy in children have not been established.

Improper clamping or priming sequence may result in infusion of air into the peritoneal cavity, which may result in abdominal pain and/or peritonitis.

Other medicines and CAPD SOLUTION
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors: vitamins, minerals, natural supplements, or alternative medicines.

The blood concentration of drugs that can be removed from the body using dialysis may be reduced by peritoneal dialysis.
If you are taking heart medicines known as cardiac glycosides (such as Digoxin), or insulin, your doctor will monitor you closely during treatment. Some drug additives may be incompatible with CAPD Solution

• Addition of Potassium
  Potassium is omitted from CAPD Solution because dialysis may be performed to correct hyperkalemia. In situations where there is a normal serum Potassium level or hypokalemia, the addition of Potassium chloride (up to a concentration of 4 mEq/L) may be indicated to prevent severe hypokalemia. The decision to add Potassium chloride should be made by the physician after careful evaluation of serum Potassium.
• Addition of Heparin
  No human drug interaction studies with heparin were conducted. In vitro studies demonstrated no evidence of incompatibility of heparin with CAPD SOLUTION
• Addition of Antibiotics
  No formal clinical drug interaction studies have been performed. It has been reported in the literature that, in vitro studies of the following anti-infectives have demonstrated stability with several different peritoneal dialysis formulations: Amphotericin B,
  Ampicillin, Azlocillin, Cefapirin, Cefazolin, Cefepime, Cefotaxime, Ceftazidime, Ceftriaxone, Ciprofloxacin, Clindamycin, Cotrimoxazole, Deferoxamine, Erythromycin,

Gentamicin, Linezolid, Mezlocillin, Miconazole, Moxifloxacin, Nafcillin, Ofloxacin, Penicillin G, Piperacillin, Teicoplanin, Ticarcillin, Tobramycin, and Vancomycin. However, aminoglycosides should not be mixed with penicillins due to chemical incompatibility.

Pregnancy and breast-feeding
Peritoneal Dialysis Solutions can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, CAPD Solutions should not be used during pregnancy and lactation.

Driving and using machines
Before doing tasks, which require special attention, wait until you know how you respond to CAPD Solution. Do not drive or operate machinery if you experience weakness, blurred vision, or dizziness.

3. HOW TO TAKE CAPD SOLUTION

• Detailed instructions and training on the peritoneal dialysis exchange procedure will be given to you, in a specialized training center, before you use CAPD SOLUTION at home.
• You should practice infection free technique throughout the bag change procedure.
• Examine the bag before use and discard the package if it is broken, damaged, or the solution is discoloured, cloudy or any solids are floating in the solution.
• To make using CAPD Solution more comfortable, you can warm it to 37 ̊C (98.6 ̊F) before use. This should only be done using dry heat, such as a heating pad or cycler warming plate. To avoid increased risk of infection, do not place CAPD SOLUTION in
  water to heat the bags. Do not microwave.
• Tear the over pouch down the side at the slit and remove the solution container. The container should be squeezed firmly to check for leaks. If leaks are found, discard the bag.

If you receive more CAPD SOLUTION than you should
There is a potential for overdose resulting in hypervolemia, hypovolemia, electrolyte disturbances or hyperglycemia. Excessive use of CAPD Solution with 4.25% Dextrose during peritoneal dialysis treatment can result in significant removal of water from the
patient.

Management of Overdose
Hypervolemia may be managed by using hypertonic peritoneal dialysis solutions and fluid restriction. Hypovolemia may be managed by fluid replacement either orally or intravenously, depending on the degree of dehydration.

Electrolyte disturbances may be managed according to the specific electrolyte disturbance verified by blood testing. The most probable disturbance, hypokalemia, may be managed by the oral ingestion of Potassium or by the addition of Potassium chloride in the peritoneal dialysis solution prescribed by the treating physician (see Incompatibilities section).

Hyperglycemia in diabetic patients may be managed by adjusting the insulin dose or adjusting other treatments for hyperglycemia.

For management of a suspected drug overdose, contact your regional Poison Control Centre immediately.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild or moderate and often disappear after a short time.
These are not all the possible side effects you may feel when using Peritoneal Dialysis Solution. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Rash, itching
• Vomiting, nausea, diarrhea, constipation
• Abdominal pain, distention and/or discomfort
• Muscle pain/cramps

If any of these affects you severely, tell your doctor, nurse, or pharmacist. Sometimes too much Peritoneal Dialysis Solution can get into your peritoneal cavity. If you experience abdominal distention, feeling of fullness and/or shortness of breath, contact
your doctor, nurse, pharmacist or peritoneal dialysis unit.

Encapsulating peritonitis Sclerosis (EPS) is a rare but serious side effect that happens to patients using Peritoneal Dialysis Solution. In EPS the bowels become blocked due to the growth of a thick layer of fibrin within the peritoneum. Symptoms include fever,
abdominal discomfort, constipation, nausea, vomiting or lack of appetite, lack or decreased bowel movements or of passing gas. If this happens to you seek immediate medical help.

Serious Side Effects, How Often They Happen, and What to Do About Them

Symptom/effect	Talk with your doctor, nurse or pharmacis	Talk with your doctor, nurse or pharmacis	Seek immediate medical help
-	Only if severe	In all cases	-
Allergic Reaction: rash, hives, swelling of the face, difficulty swallowing or breathing lips, tongue or throat,			X
Dehydration: dizziness, weakness, fainting, thirst, dry mouth, constipation, muscle cramps	X
Catheter Blockage/ Infection: Redness, pus, swelling or pain around exit			X
Peritonitis (infection in the peritoneal cavity): cloudy or bloody drained fluid, abdominal pain, fever, redness, nausea, upset stomach, vomiting, lack of appetite, weight loss, constipation		X
Edema: Swollen ankles or legs, swelling of the eyes or face	X
Steven-Johnson Syndrome: painful red or purple rash, blisters on your skin, mouth, nose, eyes and genitals			X
High Blood Pressure: headaches, vision problems, dizziness, shortness of breath	X
Shortness of breath or chest pain		X
Abnormal Bleeding		X
Increased Blood Sugar: frequent urination, thirst, and hunger	X
Electrolyte Imbalance: weakness, drowsiness, muscle pain or cramps, irregular heartbeat		X

5. HOW TO STORE CAPD SOLUTION

• Keep this medicine out of the sight and reach of children.
• Store below 30°C.
• Do not use CAPD SOLUTION after the expiry date which is stated on the carton and label after ‘EXP’. The expiry date refers to the last day of that month.

6. FURTHER INFORMATION.
What CAPD 1.5% SOLUTION contains
Each 1000ml of CAPD 1.5% SOLUTION contains:
Dextrose monohydrate 16.5g
Sodium Chloride 5.786g
Sodium Lactate 3.925g
Calcium Chloride 0.2573g
Magnesium Chloride 0.05g
What CAPD 2.5% SOLUTION contains
Each 1000ml of CAPD 2.5% SOLUTION contains:
Dextrose monohydrate 27.5g
Sodium Chloride 5.786g
Sodium Lactate 3.925g
Calcium Chloride 0.2573g
Magnesium Chloride 0.05g

What CAPD SOLUTION looks like and contents of the pack
2000ml transparent, clear liquid in an infusion bag