BICAVERA Solution for peritoneal dialysis (2022)

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Περιεχόμενα

1. Name of the medicinal product

BicaVera 1.5% Glucose, 1.25 mmol/l Calcium. Solution for peritoneal dialysis.

2. Qualitative and quantitative composition

BicaVera 1.5% Glucose, 1.25 mmol/l Calcium is delivered in a double chamber bag. One chamber contains the alkaline hydrogen carbonate solution, the other chamber contains the acidic glucose-based electrolyte ...

3. Pharmaceutical form

Solution for peritoneal dialysis. Clear and colourless solution. Theoretical osmolarity: 357 mOsm/l pH ≈ 7.4

4.1. Therapeutic indications

End-stage (decompensated) chronic renal failure of any origin treated with peritoneal dialysis.

4.2. Posology and method of administration

Posology BicaVera 1.5% Glucose, 1.25 mmol/l Calcium is exclusively indicated for the intraperitoneal use. The mode of therapy, frequency of administration, and dwell time required will be specified by ...

4.3. Contraindications

For this specific peritoneal dialysis solution BicaVera 1.5% Glucose, 1.25 mmol/l Calcium must not be used in patients with severe hypokalaemia and severe hypocalcaemia. This peritoneal dialysis solution ...

4.4. Special warnings and precautions for use

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: ...

4.5. Interaction with other medicinal products and other forms of interaction

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. ...

4.6. Fertility, pregnancy and lactation

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 ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

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 ...

4.9. Overdose

Any excess of dialysis solution infused in the peritoneal cavity can easily be drained in the drainage bag. In case of too frequent exchanges dehydration and/or electrolyte disturbances might result which ...

5.1. Pharmacodynamic properties

<b>Pharmacotherapeutic group:</b> Peritoneal dialytics, hypertonic solutions <b>ATC code:</b> B05DB The electrolyte profile of the solution is basically the same as that of physiological serum. It has ...

5.2. Pharmacokinetic properties

No animal studies have been performed with the intraperitoneal application of bicarbonate-containing bicaVera solutions. Clinical studies in patients on bicaVera have shown that dialysate bicarbonate equilibrates ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity and repeated dose toxicity. The electrolytes and glucose included in bicaVera ...

6.1. List of excipients

Hydrochloric acid Sodium hydroxide Carbon dioxide Water for injections

6.2. Incompatibilities

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

6.3. Shelf life

Shelf life within the container: 2 years. Shelf life of the ready-to-use solution prepared as described in section 6.6 and without any additional drugs: 24 hours.

6.4. Special precautions for storage

BicaVera stay safe/sleep safe: Do not store below 4°C. BicaVera sleep safe combo: Store at 5°C-30°C.

6.5. Nature and contents of container

Double-chamber bag One chamber contains the alkaline hydrogen carbonate solution; the other chamber contains the acidic glucose-based electrolyte solution. Mixing of both solutions (ratio 1:1) by opening ...

6.6. Special precautions for disposal and other handling

Disposal No special requirements for disposal. Handling Plastic containers may occasionally be damaged during transport or storage. This can result in a contamination with growth of microorganisms in the ...

7. Marketing authorization holder

Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg, Germany

8. Marketing authorization number(s)

PL 13689/0021

9. Date of first authorization / renewal of the authorization

26/10/2016

10. Date of revision of the text

06/12/2019

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