Physioneal 40 Glucose

/ Teva

Administration:
– PHYSIONEAL 40 is intended for intraperitoneal administration only. Not for intravenous administration.
– Peritoneal dialysis solutions may be warmed to 37°C to enhance patient comfort.
However, only dry heat (for example, heating pad, warming plate) should be used.
Solutions should not be heated in water or in a microwave oven due to the potential for patient injury or discomfort.
– Aseptic technique should be employed throughout the peritoneal dialysis procedure.
– Do not administer if the solution is discoloured, cloudy, contains particulate matter, shows evidence of leakage between chambers or to the exterior, or if seals are not intact.
– The drained fluid should be inspected for the presence of fibrin or cloudiness, which may indicate the presence of peritonitis.
– For single use only.
– After removal of the overpouch, immediately break the interchamber frangible pin to mix the two solutions. Wait until the upper chamber has completely drained into the lower chamber. Mix gently by pushing with both hands on the lower chamber walls. The intraperitoneal solution must be infused within 24 hours after mixing.
– For further information on the use of the medicinal product see section 6.6 Instructions for use and handling.
Posology:
The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be selected by the physician.
Adults: patients on continuous ambulatory peritoneal dialysis (CAPD) typically perform 4 cycles per day (24 hours). Patients on automated peritoneal dialysis (APD) typically perform 4-5 cycles at night and up to 2 cycles during the day. The fill volume depends on body size, usually from 2.0 to 2.5 litres.
Elderly: as for adults.
Paediatric patients from pre-term newborn infants to adolescents: Paediatric patients have not been evaluated in clinical studies with PHYSIONEAL 40.
Therefore the clinical benefits of PHYSIONEAL 40 have to be balanced versus the risks of side effects in this patient category.
For pediatric patients >2 years old, 800 to 1400 mL/m² per cycle up to a maximum amount of 2000 mL, as tolerated, has been recommended. Fill volumes of 200 to 1000 mL/m² are recommended in children less than 2 years of age.
To avoid the risk of severe dehydration, hypovolaemia and to minimise the loss of proteins, it is advisable to select the peritoneal dialysis solution with the lowest osmolarity consistent with fluid removal requirements for each exchange.

Physioneal 40 is indicated whenever peritoneal dialysis is employed, including:
– Acute and chronic renal failure;
– Severe water retention;
– Severe electrolyte imbalance;
– Drug intoxication with dialysable substances, when a more adequate therapeutic alternative is not available.
Physioneal 40 bicarbonate/lactate based peritoneal dialysis solutions with a physiological pH are particularly indicated in patients in whom solutions based on lactate buffer only, with a low pH, cause abdominal inflow pain or discomfort.

PHYSIONEAL 40 should not be used in patients with:
– uncorrectable mechanical defects that prevent effective PD or increase the risk of infection,
– documented loss of peritoneal function or extensive adhesions that compromise peritoneal function.

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) 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.
– 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), broadspectrum antibiotics may be indicated.
– 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., 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.
– 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.
– Safety and effectiveness in paediatric patients has not been established.
– 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.
– 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.
– 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.
– Protein, amino acids, water soluble vitamins and other medicines may be lost during peritoneal dialysis and may require replacement.
– 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.
– 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.
– Potassium is omitted from PHYSIONEAL 40 solutions due to the risk of hyperkaelemia.
In situations in which there is a normal serum potassium level or hypokaelemia, the addition of potassium chloride (up to a concentration of 4 mEq/l) may be indicated to prevent severe hypokaelemia and should be made after careful evaluation of serum and total body potassium, only under the direction of a physician.
– 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.
– 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 patients with diabetes, blood glucose levels should be monitored and the dosage of insulin or other treatment for hyperglycaemia should be adjusted.

The most commonly reported Adverse Reaction from the controlled clinical trials with Physioneal 40 was alkalosis, occurring in approximately 10 % of patients. In most cases, it was based on serum bicarbonate values only and was usually not associated with clinical symptoms.
See prescribing information for full details.

Blood concentration of dialysable medicinal product may be reduced during dialysis. A possible compensation for losses must be taken into consideration.
Plasma levels of potassium in patients using cardiac glycosides must be carefully monitored as there is a risk of digitalis intoxication. Potassium supplements may be necessary.

There is no clinical experience with Physioneal 40 during pregnancy and lactation. No data are available from animal studies. The risk-benefit must be assessed.

Possible consequences of overdose include hypervolaemia, hypovolaemia, electrolyte disturbances or (in diabetic patients) hyperglycaemia.
Management of overdose: Hypervolaemia may be managed by using hypertonic peritoneal dialysis solutions and fluid restriction.
Hypovolaemia may be managed by fluid replacement either orally or intravenously, depending on the degree of dehydration.
Electrolyte disturbances shall be managed according to the specific electrolyte disturbance verified by blood test. The most probable disturbance, hypokalaemia, 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.
Hyperglycaemia (in diabetic patients) shall be managed by adjusting the insulin dose according to the insulin scheme prescribed by the treating physician.

Stability after mixing: The product, once removed from its overpouch and mixed, should be used within 24 hours.
Storage: Store below 25°C Do not store below 4°C.