Special Warning : אזהרת שימוש

4.4       Special warnings and precautions for use
Patient conditions requiring caution of use
Peritoneal dialysis should be done with caution in patients with:
1) 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, faecal fistula, colostomy or iliostomy, frequent episodes of diverticulitis, inflammatory or ischemic bowel disease, large polycystic kidneys, or other conditions that compromise the integrity of the abdominal wall, abdominal surface, or intra- abdominal cavity.
2) other conditions including recent aortic graft replacement and severe pulmonary disease.

Encapsulating Peritoneal Sclerosis (EPS)
Encapsulating Peritoneal Sclerosis (EPS) is considered to be a known, rare complication of peritoneal dialysis therapy. EPS has been reported in patients using peritoneal dialysis solutions including some patients using PHYSIONEAL 40 as part of their PD therapy.

Peritonitis
If peritonitis occurs, the choice and dosage of antibiotics should be based upon the results of identification and sensitivity studies of the isolated organism(s) when possible. Prior to identification of the involved organism(s), broad-spectrum antibiotics may be indicated.

Hypersensitivity
Solutions containing glucose derived from hydrolysed maize starch should be used with caution in patients with a known allergy to maize or maize products.
Hypersensitivity reactions such as those due to a maize 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.

Use in patients with elevated lactate levels
Patients with elevated lactate levels should use lactate-containing peritoneal dialysis solutions with caution. It is recommended that patients with conditions known to increase the risk of lactic acidosis [e.g., severe hypotension, sepsis, acute renal failure, inborn errors of metabolism, treatment with drugs such as metformin and 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.

General monitoring
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 levels should be monitored carefully in patients treated with cardiac glycosides.

An accurate fluid balance record must be kept and the body weight of the patient must carefully be monitored to avoid over- or underhydration with severe consequences including congestive heart failure, volume depletion and shock.
Protein, amino acids, water soluble vitamins and other medicines may be lost during peritoneal dialysis and may require replacement.

Serum electrolyte concentrations (particularly bicarbonate, potassium, magnesium, calcium and phosphate), blood chemistry (including parathyroid hormone and lipid parameters) and haematological parameters should be monitored periodically.

Secondary hyperparathyroidism
In patients with secondary hyperparathyroidism, the benefits and risks of the use of a solution with 1.25 mmol/l calcium, such as PHYSIONEAL 40, should be carefully considered as it might worsen hyperparathyroidism.
Metabolic alkalosis
In patients with plasma bicarbonate level above 30 mmol/l, the risk of possible metabolic alkalosis should be weighed against the benefits of treatment with this product.


Overinfusion
Overinfusion of PHYSIONEAL 40 solutions into the peritoneal cavity may be characterised by abdominal distension/abdominal pain and/or shortness of breath.

Treatment of PHYSIONEAL 40 overinfusion is to drain the solution from the peritoneal cavity.

Use of higher glucose concentrations
Excessive use of PHYSIONEAL 40 peritoneal dialysis solution with a higher dextrose (glucose) during a peritoneal dialysis treatment may result in excessive removal of water from the patient.
See section 4.9.

Addition of potassium
Potassium is omitted from PHYSIONEAL 40 solutions due to the risk of hyperkalemia.
In situations in which there is a normal serum potassium level or hypokalaemia, the addition of potassium chloride (up to a concentration of 4 mEq/l) may be indicated to prevent severe hypokalaemia and should be made after careful evaluation of serum and total body potassium, only under the direction of a physician.


Use in diabetic patients
In patients with diabetes, blood glucose levels should be monitored and the dosage of insulin or other treatment for hyperglycaemia should be adjusted.

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


In case of infusion of unmixed solution, the patient should immediately drain the solution and use a newly mixed bag.

Paediatric population
Safety and efficacy in paediatric patients have not been established.

Effects on Driving

4.7      Effects on ability to drive and use machines
End stage renal disease (ESRD) patients undergoing peritoneal dialysis may experience undesirable effects, which could affect the ability to drive or use machines.