BICA VERA 1.5 % GLUCOSE 1.75 MMOLL CALCIUM

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

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

Available from:

FRESENIUS MEDICAL CARE ISRAEL P.B., LTD.

ATC code:

B05XA30

Pharmaceutical form:

SOLUTION FOR PERITONEAL DIALYSIS

Composition:

SODIUM CHLORIDE 11.57 G/L; CALCIUM CHLORIDE DIHYDRATE 0.5145 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.2033 G/L; SODIUM CHLORIDE 5.786 G/L; GLUCOSE MONOHYDRATE 33.0 G/L; GLUCOSE MONOHYDRATE 16.5 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.1017 G/L; CALCIUM CHLORIDE DIHYDRATE 0.2573 G/L; SODIUM HYDROGEN CARBONATE 2.940 G/L; SODIUM HYDROGEN CARBONATE 5.880 G/L

Administration route:

PERITONEAL DIALYSIS

Prescription type:

Required

Manufactured by:

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH, GERMANY

Therapeutic area:

COMBINATIONS OF ELECTROLYTES

Therapeutic indications:

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

Authorization date:

2020-03-31

Patient Information leaflet

كيدي لسغإ ⇐ .)سيكلا ةملاس ،لولحملا
ءافص ،ةيحلاصلا ءاهتنإ خيرات ،ةقصلملا(
لامعتسلإا لبق لولحملا
طلتخي .ىطسولا ةزردلا حتفنت نأ ىلإ
ةيولعلا هفارطأ دحأ نم سيكلا جرحد ⇐
.ميثارجلل داضم نوباص ةطساوب
يلفسلا ثلثملا ةزرد حتفنت ىتح يولعلا
فرطلا نم سيكلا جرحد ،كلذ دعب ⇐ .
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ايئاقلت نيترجحلا يف نيلولحملا
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اروف لامعتسلإل زهاجلا لولحملا لامعتسإ
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ىلع لولحملا سيك ق
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لع ⇐
دوماعل يلفسلا كساملا ىلع فيرصتلا سيك ق
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كسيد�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BICA VERA 1.5% GLUCOSE, 1.75 MMOL/L CALCIUM
SOLUTION FOR PERITONEAL DIALYSIS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bica Vera 1.5% 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 litre 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
33.0
g
(equivalent to glucose)
30.0
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 litre 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 litre 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
16.5
g
(equivalent to glucose)
15.0
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
83.25
mmol/l
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis
Clear and colourless solution
Theoretical osmolarity: 358 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 1.5% 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 physician.
_