BICA VERA 2.3 % GLUCOSE 1.75 MMOLL CALCIUM

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

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

Disponibil de la:

FRESENIUS MEDICAL CARE ISRAEL P.B., LTD.

Codul ATC:

B05XA30

Forma farmaceutică:

SOLUTION FOR PERITONEAL DIALYSIS

Compoziție:

SODIUM CHLORIDE 11.57 G/L; CALCIUM CHLORIDE DIHYDRATE 0.5145 G/L; MAGNESIUM CHLORIDE HEXAHYDRATE 0.2033 G/L; GLUCOSE MONOHYDRATE 25.0 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; GLUCOSE MONOHYDRATE 50.00 G/L

Calea de administrare:

PERITONEAL DIALYSIS

Tip de prescriptie medicala:

Required

Produs de:

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH, GERMANY

Grupul Terapeutică:

COMBINATIONS OF ELECTROLYTES

Zonă Terapeutică:

COMBINATIONS OF ELECTROLYTES

Indicații terapeutice:

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 de autorizare:

2020-03-31

Prospect

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 ⇐ .
ً
ايئاقلت نيترجحلا يف نيلولحملا
!طلخلا دعب رثكلأا ىلع ةعاس 24 قاطن يف
نكل ،
ً
اروف لامعتسلإل زهاجلا لولحملا لامعتسإ
بجي⇐ .
ً
امامت
سايكلأا لادبتسإ زيهجت
.2
كسيدلا عضو ،لولحملا سيك بيبانأ ةيوستب
مق ،بيرستلا دوماع ىلع يولعلا كساملا
ىلع لولحملا سيك ق
ِّ
لع ⇐
دوماعل يلفسلا كساملا ىلع فيرصتلا سيك ق
ّ
لع ،فيرصتلا سيك بيبانأ ةيوست دعب .م
ّ
ظنملا لخاد )DISC(
ءاطغلا لزأو كيدي م
ّ
قع ⇐ .م
ّ
ظ
َ
نملا لخاد يف رطثقلا ق
ّ
سنم ز
ّ
كر ⇐.م
ّ
ظنملا لخاد ميقعتلا ءاطغ عضو بيرستلا
.كسيدلل رطثقلا ق
ّ
سنم لص ⇐ .كسيدلل يقاولا
)OUTFLOW( فيرصتلا
.3
● ةلاح ⇐ .فيرصتلا أدبي .رطثقلا )clamp(
كبشم حتفإ ⇐
)FLUSH( لسغلا .4
●● ةلاح ⇐ .)
ٍ
ناوث 5
ً
ابيرقت( جزاط لولحمب فيرصتلا سيك لسغإ ⇐
)INFLOW( لخادلا ىلإ قفدتلا .5
○◑● ةلاح ⇐ رطثقلا عم لولحملا سيك
ليصوتب مق ⇐
ناملأا ةلحرم .6
●●●● ةلاح ⇐ .)PIN( سوبد لاخدإ ةطساوب
رطثقلا ق
ّ
سنم قلغأ ⇐
لصفلا
.7
.رطثقلا ق
ّ
سنمل ديدجلا ميقعتلا ءاطغ ةبلولب مقو
كسيدلا نم رطثقلا ق
ّ
سنم عزنإ ⇐
كسيد�

Caracteristicilor produsului

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