PHYSIONEAL

Posology The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be selected by the physician. 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.

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.

5 litres. Elderly As for adults. Paediatric population The safety and efficacy of PHYSIONEAL 35 in paediatric patients have not been established. Therefore the clinical benefits of Physioneal 35 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. Method of administration Precautions to be taken before handling or administering the medicinal product • PHYSIONEAL 35 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. 6 Special precautions for disposal and other handling.

Adverse reactions (occurring in 1% of patients or more) from the clinical trials and post marketing are listed below. The adverse drug reactions listed in this section are given following the recommended frequency convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

System Organ Class Preferred Term Frequency BLOOD AND LYMPHATIC SYSTEM DISORDERS Eosinophilia Not known METABOLISM AND NUTRITION DISORDERS Hypokalaemia Fluid retention Hypercalcaemia Hypervolaemia Anorexia Dehydration Hyperglycaemia Lactic Acidosis Common Common Common Uncommon Uncommon Uncommon Uncommon Uncommon PSYCHIATRIC DISORDERS Insomnia Uncommo n NERVOUS SYSTEM DISORDERS Dizziness Headache Uncommon Uncommon VASCULAR DISORDERS Hypertension Hypotension Common Uncommon RESPIRATORY, THORACIC, AND MEDIASTINAL DISORDERS Dyspnoea Cough Uncommo n Uncommo n GASTROINTESTINA L DISORDERS Peritonitis Peritoneal membrane failure Abdominal pain Dyspepsia Flatulence Nausea Encapsulating peritoneal sclerosis Cloudy peritoneal effluent Common Uncommon Uncommon Uncommo n Uncommo n Uncommo n Not known Not known SKIN AND SUBCUTANEOUS TISSUE DISORDERS Angioedema Rash Not known Not known MUSCULOSKELET AL AND CONNECTIVE TISSUE DISORDERS Musculoskeletal pain Not known GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Oedema Asthenia Chills Facial oedema Hernia Malaise Thirst Pyrexia Common Common Uncommo n Uncommo n Uncommo n Uncommo n Uncommo n Not known INVESTIGATIONS Weight increased PCO2 increased Common Uncommo n Other undesirable effects of peritoneal dialysis related to the procedure: bacterial peritonitis, catheter site infection, catheter related complication.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.

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 35 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), broadspectrum 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. , 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.

1. PHYSIONEAL 35 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.