Source: Marketing Authorisation Holder Revision Year: 2022 Publisher: Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg, Germany
BicaVera 1.5% Glucose, 1.25 mmol/l Calcium.
Solution for peritoneal dialysis.
| Pharmaceutical Form |
|---|
|
Solution for peritoneal dialysis. Clear and colourless solution. Theoretical osmolarity: 357 mOsm/l |
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 solution. Mixing of both solutions by opening the median seam between the two chambers results in the ready-to-use solution.
1 litre of acidic glucose based electrolyte solution contains:
Active substances:
Calcium chloride dihydrate 0.3675 g
Sodium chloride 11.57 g
Magnesium chloride hexahydrate 0.2033 g
Glucose monohydrate 33.0 g
(equivalent to glucose) (30.0 g)
This corresponds to:
Ca2+ 2.5 mmol/l
Na+ 198 mmol/l
Mg2+ 1.0 mmol/l
Cl- 207 mmol/l
1 litre of alkaline hydrogen carbonate solution contains:
Active substances:
Sodium hydrogen carbonate 5.88 g
This corresponds to:
Na+ 70 mmol/l
HCO3- 70 mmol/l
1 litre of the ready-to-use solution contains:
Active substances:
Calcium chloride dihydrate 0.1838 g
Sodium chloride 5.786 g
Sodium hydrogen carbonate 2.940 g
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate 16.5 g
(equivalent to glucose) (15.0 g)
This corresponds to:
Ca2+ 1.25 mmol/l
Na+ 134 mmol/l
Mg2+ 0.5 mmol/l
Cl- 103.5 mmol/l
HCO3- 34 mmol/l
Glucose 83.25 mmol/l
For a full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Calcium chloride |
Calcium is the most abundant mineral in the body, and is an essential body electrolyte. Homeostasis is mainly regulated by the parathyroid hormone, by calcitonin, and by the activated form of vitamin D. Calcium is a structural component of bones and teeth. It is also required for blood clotting, neurotransmitter release, muscle contraction and normal heartbeat. |
|
| Glucose |
Glucose is frequently used in both adults and children to restore blood glucose concentrations in the treatment of hypoglycaemia resulting from insulin excess or from other causes. The metabolism of glucose is an energy source for the body. |
|
| Magnesium chloride |
|
|
| Sodium bicarbonate |
Sodium bicarbonate has antacid properties. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide. |
|
| Sodium chloride |
Sodium chloride is the principle salt involved in maintaining the osmotic tension of blood and tissues. Changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissue. |
| List of Excipients |
|---|
|
Hydrochloric acid |
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 the median seam between the two chambers results in the ready-touse solution.
The stay safe system is provided as a double bag system consisting of a doublechamber solution bag and a drainage bag, both with injection units, a transfer tubing system and a system connector. All components are based on polypropylene. The bags and tubings also contain synthetic elastomers. The solution bag is laminated in addition by polyester. The stay safe system is wrapped up in an outer bag made of polyolefins.
The sleep safe system is provided as a single bag system consisting of a doublechamber solution bag with an injection unit, a transfer tubing system and a bag connector. All components are based on polypropylene. The bags and tubings also contain synthetic elastomers. Further materials of the solution bag are polyester and polyamide. The sleep safe system is wrapped up in an outer bag made of polyolefines.
The sleep safe combo system is bicaVera sleep safe additionally provided with a disinfection cap and a sleep safe Set Plus for the application to the patient.
Pack sizes:
| Stay safe | sleep safe |
| 4 bags of 2000 ml | 4 bags of 3000 ml |
| 4 bags of 2500 ml | 2 bags of 5000 ml |
Sleep safe combo:
2 bags of 5000 ml + disinfection cap + sleep safe Set Plus
Not all pack sizes may be marketed.
Fresenius Medical Care Deutschland GmbH, Else-Kröner-Straße 1, 61352 Bad Homburg, Germany
PL 13689/0021
26/10/2016
| Drug | Countries | |
|---|---|---|
| BICAVERA | Austria, Cyprus, Estonia, Spain, Finland, France, Croatia, Poland |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
