Description

DIANEAL_PD-Solutions-Datasheet

NAME OF THE MEDICINAL PRODUCT

Dianeal PD4 Glucose 1.36% w/v /13.6mg/ml

Dianeal PD4 Glucose 2.27% w/v /22.7mg/ml

Dianeal PD4 Glucose 3.86% w/v /38.6mg/ml

QUALITATIVE AND QUANTITATIVE COMPOSITION

Dianeal PD4 Glucose 1.36% w/v /13.6mg/ml

Dianeal PD4 Glucose 2.27% w/v /22.7mg/ml

Dianeal PD4 Glucose 3.86% w/v /38.6mg/ml

THERAPEUTIC INDICATIONS

Dianeal PD4 is indicated whenever peritoneal dialysis is employed, including: Acute and chronic renal failure; Severe water retention; Electrolyte disorders; Drug intoxication, when a more adequate therapeutic alternative is not available. Dianeal PD4 is particularly useful for the control of serum calcium and phosphate levels in renal failure patients receiving calcium or magnesiumcontaining phosphate binders.

DOSAGE AND ROUTE

Intraperitoneal administration only. The mode of therapy, frequency of treatment, exchange volume, duration of dwell and length of dialysis should be selected by the attending 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. Paediatric population (i.e., newborn to 18 years of age): 800 to 1400 ml/m2 per cycle up to a maximum amount of 2000 ml, as tolerated, is recommended. Fill volumes of 500 to 1000 ml/m2 are recommended in children less than 2 years of age. As the patient’s body weight becomes closer to the ideal dry weight, lowering the glucose concentration of Dianeal is recommended.

CONTRAINDICATIONS

Dianeal is contraindicated in patients with: hypersensitivity to the active substances or to any of the excipients listed in section 6.1; pre-existing severe lactic acidosis, 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.