BICAVERA Solution for peritoneal dialysis Ref.[50426] Active ingredients: Calcium chloride Glucose Magnesium chloride Sodium bicarbonate Sodium chloride

BicaVera 1.5% Glucose, 1.25 mmol/l Calcium may only be administered after careful benefit-risk assessment in:

• patients with loss of electrolytes due to vomiting and/or diarrhoea.
• patients with hypocalcaemia: It may be necessary to use a peritoneal dialysis solution with a higher calcium concentration either temporarily or permanently, in case an adequate enteral supply of calcium, by calcium-containing phosphate binders and/or vitamin D, is not possible.
• patients with hyperparathyroidism: The administration of calcium-containing phosphate binders and/or vitamin D may be considered to ensure adequate enteral calcium supply.
• patients receiving digitalis therapy: Regular monitoring of the serum potassium level is mandatory. Severe hypokalaemia may necessitate the use of a potassium-containing dialysis solution besides dietary counselling.
• patients with large polycystic kidneys.

The natural metabolic acidosis due to renal failure might not be totally compensated by the 34 mmol/l bicarbonate level of the final solution. Acidosis might be associated with undesirable effects e.g. malnutrition.

A loss of proteins, amino acids, and water-soluble vitamins occurs during peritoneal dialysis. To avoid deficiencies an adequate diet or supplementation should be ensured.

The transport characteristics of the peritoneal membrane may change during long-term peritoneal dialysis primarily indicated by a loss of ultrafiltration. In severe cases peritoneal dialysis must be stopped and haemodialysis commenced.

The monitoring of the following parameters is recommended:

• body weight for the early recognition of over- and dehydration,
• serum sodium, potassium, calcium, magnesium, phosphate, acid base status and blood proteins
• serum creatinine and urea,
• parathormone and other indicators of bone metabolism,
• blood sugar,
• residual renal function in order to adapt the peritoneal dialysis

Encapsulating peritoneal sclerosis is considered to be a known, rare complication of peritoneal dialysis therapy which can infrequently lead to fatal outcome.

Elderly patients

The increased incidence of hernia should be considered in elderly patients prior to the start of peritoneal dialysis.

The use of this peritoneal dialysis solution can lead to a loss of efficacy of other medicinal products if these are dialysable through the peritoneal membrane. A dose adjustment might become necessary.

A distinct reduction of the serum potassium level can increase the frequency of digitalis-associated adverse reactions. Potassium levels must be monitored particularly closely during concurrent digitalis therapy.

Special attention and monitoring is required in the case of secondary hyperparathyroidism. The therapy with calcium-containing phosphate binders and/or vitamin D may be required.

The use of diuretic agents may help maintain residual diuresis, but may also result in water and electrolyte imbalances.

In diabetic patients the daily dose of blood sugar reducing medication must be adjusted to the increased glucose load.

Fertility

No data available.

Pregnancy

There are no clinical data available from use of bicaVera solutions in pregnant women. Animal studies are insufficient with respect to reproductive and developmental toxicity (see section 5.3). bicaVera solution should only be used during pregnancy when the benefit to the mother clearly outweighs the potential risks to the fetus (see section 4.4).

Lactation

It is not known whether bicaVera solution ingredients are excreted in human milk.

bicaVera solution should only be used in lactating women, when the benefit to the mother clearly outweighs the potential risks to the infant.

BicaVera has no or negligible influence on the ability to drive and to use machines.

BicaVera 1.5% Glucose, 1.25 mmol/l Calcium is an electrolyte solution which composition is similar to blood.

In addition the physiological buffer bicarbonate is used.

Possible adverse reactions may result from the peritoneal dialysis itself or may be induced by the peritoneal dialysis solution.

The adverse drug reactions are ranked under the headings of reporting frequency, using the following 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.

Potential adverse reactions of the peritoneal dialysis solution:

Potential adverse reactions of the treatment mode:

Peritonitis

is indicated by a cloudy effluent. Later abdominal pain, fever, and general malaise may develop or, in very rare cases, sepsis. The patient should seek medical advice immediately. The bag with the cloudy effluent should be closed with a sterile cap and assessed for microbiological contamination and white blood cell count.

Skin exit site and tunnel infections

are indicated by redness, oedema, exudations, crusts and pain at the catheter exit site. In case of skin exit site and tunnel infections the attending physician should be consulted as soon as possible.

Disturbances in hydration

is indicated by a rapid decrease (dehydration) or increase (overhydration) in body weight. Severe dehydration might occur when using solutions of higher glucose concentration.

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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.