CAPD 2 PERITONEAL DIALYSIS SOLUTION

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

CALCIUM CHLORIDE; GLUCOSE AS MONOHYDRATE; LACTIC ACID AS SODIUM; MAGNESIUM CHLORIDE; SODIUM CHLORIDE

MAH:

FRESENIUS MEDICAL CARE ISRAEL P.B. LTD

ATC_code:

B05XA30

pharmaceutical_form:

SOLUTION FOR PERITONEAL DIALYSIS

composition:

MAGNESIUM CHLORIDE 0.1017 G/L; SODIUM CHLORIDE 5.786 G/L; CALCIUM CHLORIDE 0.2573 G/L; GLUCOSE AS MONOHYDRATE 16.5 G/L; LACTIC ACID AS SODIUM 3.925 G/L

administration_route:

INTRA-PERITONEAL

prescription_type:

Required

manufactured_by:

FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH, GERMANY

therapeutic_group:

COMBINATIONS OF ELECTROLYTES

therapeutic_area:

COMBINATIONS OF ELECTROLYTES

therapeutic_indication:

For use in patients with end-stage (decompensated) chronic renal failure of any origin being maintained on peritoneal dialysis.

authorization_date:

2022-11-30

PIL

־ ו״משתה )םירישכת( םיחקורה תונקת יפל
וכרצל ןולע
1986
ה
הפורת
יפ לע תקוושמ
אפור םשרמ
דבלב
CAPD 2
תיקפצ הזילאידל הסימת
CAPD 3
תיקפצ הזילאידל הסימת
CAPD 4
תיקפצ הזילאידל הסימת
הסימת
הזילאידל
תיקפצ
בכרה
:
כ
ל
רטיל
ליכמ הסימת לש
:
CAPD 2
CAPD 3
CAPD 4
CALCIUM CHLORIDE
DIHYDRATE
0.2573 g
0.2573 g
0.2573 g
םויצלק
דירולכ
טארדיהיד
SODIUM CHLORIDE
5.786 g
5.786 g
5.786 g
םוידוס
דירולכ
SODIUM-(S)-LACTATE
SOLUTION
(Sodium-(S)-lactate(
7.85 g
(3.925 g)
7.85 g
(3.925 g)
7.85 g
(3.925 g)
תסימת
םוידוס
-
(
S
)
-
טטקל
)
םוידוס
-
(
S
)
-
טטקל
(
MAGNESIUM CHLORIDE
HEXAHYDRATE
0.1017 g
0.1017 g
0.1017 g
םויזנגמ
דירולכ
טארדיהאסקה
GLUCOSE MONOHYDRATE
(Glucose)
(Fructose, up to)
16.5 g
(15.0 g)
(0.75 g)
46.75 g
(42.5 g)
(2.1 g)
25.0 g
(22.73 g)
(1.1 g)
זוקולג
טארדיהונומ
)
זוקולג
(
)
זוטקורפ
,
דע
ל
-
(
CA
2+
1.75 mmol/l
1.75 mmol/l
1.75 mmol/l
ינוי
ןדיס
NA
+
134 mmol/l
134 mmol/l
134 mmol/l
ינוי
ןרתנ
MG
2+
0.5 mmol/l
0.5 mmol/l
0.5 mmol/l
ינוי
םויזנגמ
CL
-
103.5 mmol/l
103.5 mmol/l
103.5 mmol/l
ינוי
דירולכ
(S)-LACTATE
35 mmol/l
35 mmol/l
35 mmol/l
(
S
)
-
טטקל
GLUCOSE
83.2 mmol/l
235.8 mmol/l
126.1 mmol/l
זוקולג
THEORETICAL
OSMOLARITY
358 mOsm/l
511 mOsm/l
401 mOsm/l
תוירלומסוא
תיטרואית
pH

5.5
םירמוח
יתלב
םיליעפ
םיינגרלאו
–
האר
ףיעס
6
עדימ״
״ףסונ
ףיעסו
2
שומישה ינפל״
״הפורתב
.
ארק
.הפורתב שמתשת םרטב ופוס דע ןולעה תא
ןויעב
ךל שי םא .הפורתה לע יתיצמת עדימ ליכמ הז
ןולע
אפורה לא הנפ ,תופסונ תולאש
חקורה ,
.תוחאה לא וא
המשרנ וז הפורת
רובע
כ ךל הארנ םא וליפא םהל קיזהל הלולע איה
.םירחאל הת�

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
CAPD 2 PERITONEAL DIALYSIS SOLUTION
CAPD 3 PERITONEAL DIALYSIS SOLUTION
CAPD 4 PERITONEAL DIALYSIS SOLUTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 litre contains:
CAPD 2
CAPD 3
CAPD 4
Calcium chloride dihydrate
0.2573 g
0.2573 g
0.2573 g
Sodium chloride
5.786 g
5.786 g
5.786 g
Sodium-(S)-lactate solution
sodium-(S)- lactate
7.85 g
(3.925 g)
7.85 g
(3.925 g)
7.85 g
(3.925 g)
Magnesium chloride
hexahydrate
0.1017 g
0.1017 g
0.1017 g
Glucose monohydrate
(Glucose)
הגבגבב
16.5 g
(15.0 g)
(up to 0.75 g fructose)
46.75 g
(42.5 g)
(up to 2.1 g fructose)
25.00 g
(22.73 g)
(up to 1.1 g fructose)
Ca
2+
1.75 mmol/l
1.75 mmol/l
1.75 mmol/l
Na
+
134 mmol/l
134 mmol/l
134 mmol/l
Mg
2+
0.5 mmol/l
0.5 mmol/l
0.5 mmol/l
CI
-
103.5 mmol/l
103.5 mmol/l
103.5 mmol/l
(S)-lactate
35 mmol/l
35 mmol/l
35 mmol/l
Glucose
83.2 mmol/l
235.8 mmol/l
126.1 mmol/l
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis
Clear, colourless to slightly yellow solution
For
CAPD 2
CAPD 3
CAPD 4
Theoretical osmolarity
358 mOsm/l
511 mOsm/l
401 mOsm/l
pH

5.5
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For use in patients with end-stage (decompensated) chronic renal
failure of any origin being maintained on
peritoneal dialysis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
CAPD 2/3/4 is exclusively indicated for intraperitoneal use.
The mode of therapy, frequency of administration, and dwell time
required will be specified by the attending
physician.
Continuous ambulatory peritoneal dialysis (CAPD)
ADULTS:
Unless otherwise prescribed, patients will receive 2000 ml solution
per exchange four times a day. After a
dwell time between 2 and 10 hours the solution will be drained.
Adjustment of dosage, volume and number of exchanges will be necessary
for individual patients.
If dilation pain occurs at the commencement of peritoneal dialysis
treatment, the solution volume per
exchange should be reduced to 500 - 1500 m