BICA VERA 4.25 % GLUCOSE 1.75 MMOLL CALCIUM

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

CALCIUM CHLORIDE DIHYDRATE; CALCIUM CHLORIDE DIHYDRATE; GLUCOSE AS MONOHYDRATE; GLUCOSE MONOHYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; MAGNESIUM CHLORIDE HEXAHYDRATE; SODIUM CHLORIDE; SODIUM CHLORIDE; SODIUM HYDROGEN CARBONATE; SODIUM HYDROGEN CARBONATE

Commercializzato da:

FRESENIUS MEDICAL CARE ISRAEL P.B., LTD.

Codice ATC:

B05XA30

Forma farmaceutica:

SOLUTION FOR PERITONEAL DIALYSIS

Composizione:

SODIUM CHLORIDE 11.57 G/L; CALCIUM CHLORIDE DIHYDRATE 0.5145 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.2033 G/L; GLUCOSE AS MONOHYDRATE 93.50 G/L; GLUCOSE MONOHYDRATE 46.75 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.1017 G/L; CALCIUM CHLORIDE DIHYDRATE 0.2573 G/L; SODIUM HYDROGEN CARBONATE 2.940 G/L; SODIUM CHLORIDE 5.786 G/L; SODIUM HYDROGEN CARBONATE 5.880 G/L

Via di somministrazione:

PERITONEAL DIALYSIS

Tipo di ricetta:

Required

Prodotto da:

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH, GERMANY

Gruppo terapeutico:

COMBINATIONS OF ELECTROLYTES

Area terapeutica:

COMBINATIONS OF ELECTROLYTES

Indicazioni terapeutiche:

End-stage (decompensated ) chronic renal failure of any origin treated with peritoneal dialysis.17/10/2017 בקשה לשינוי משטר מינון שינוי משטר מינון בהתאם למאושר באירופה

Data dell'autorizzazione:

2020-03-31

Foglio illustrativo

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Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BICA VERA_ _4.25% GLUCOSE, 1.75 MMOL/L CALCIUM,
SOLUTION FOR PERITONEAL DIALYSIS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bica Vera 4.25% Glucose, 1.75 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.
BEFORE RECONSTITUTION
1 liter of acidic glucose based electrolyte solution contains:
active substances:
Calcium chloride dihydrate
0.5145 g
Sodium chloride
11.57 g
Magnesium chloride hexahydrate 0.2033 g
Glucose monohydrate
93.5 g
(equivalent to glucose) 85.0 g
This corresponds to
Ca
2+
3.5 mmol/l
Na
+
198.0 mmol/l
Mg
2+
1.0 mmol/l
Cl
-
209.0 mmol/l
1 liter of alkaline hydrogen carbonate solution contains:
active substances:
Sodium hydrogen carbonate
5.88 g
This corresponds to
Na
+
70.0 mmol/l
HCO
3
-
70.0 mmol/l
AFTER RECONSTITUTION
1 liter of the ready-to-use solution contains:
active substances:
Calcium chloride dihydrate
0.2573 g
Sodium chloride
5.786 g
Sodium hydrogen carbonate
2.940 g
Magnesium chloride hexahydrate 0.1017 g
Glucose monohydrate
46.75 g
(equivalent to glucose) 42.5 g
This corresponds to
Ca
2+
1.75 mmol/l
Na
+
134 mmol/l
Mg
2+
0.5 mmol/l
Cl
-
104.5 mmol/l
HCO
3
-
34 mmol/l
Glucose
235.9 mmol/l
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis
Clear and colourless solution
Theoretical osmolarity: 511 mOsm/l
pH

7.40
4.
CLINICAL PARTICULARS
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
Bica Vera
_ _
4.25% Glucose, 1.75 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 the
attending phys