CAPD 18 SOLUTION FOR PERITONEAL DIALYSIS

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

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

Available from:

FRESENIUS MEDICAL CARE ISRAEL P.B. LTD

ATC code:

B05CB10

Pharmaceutical form:

SOLUTION FOR PERITONEAL DIALYSIS

Composition:

SODIUM CHLORIDE 5.786 G; LACTIC ACID AS SODIUM 3.925 G; GLUCOSE AS MONOHYDRATE 46.75 G; CALCIUM CHLORIDE 0.1838 G; MAGNESIUM CHLORIDE 0.1017 G

Administration route:

PERITONEAL DIALYSIS

Prescription type:

Required

Manufactured by:

FRESENIUS MEDICAL CARE DEUTSCHLAND GmbH

Therapeutic group:

COMBINATIONS

Therapeutic area:

COMBINATIONS

Therapeutic indications:

For use in patients with end-stage (decompensated )chronic renal failure of any origin which can be treated with peritoneal dealysis.17/10/2017 בקשה לשינוי משטר מינוןשינוי משטר מינון בהתאם למאושר באירופה

Authorization date:

2021-06-30

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986
The medicine is dispensed with a doctor’s prescription only
CAPD 17 SOLUTION FOR PERITONEAL DIALYSIS
CAPD 18 SOLUTION FOR PERITONEAL DIALYSIS
CAPD 19 SOLUTION FOR PERITONEAL DIALYSIS
COMPOSITION:
Each liter of solution contains:
CAPD 17
CAPD 18
CAPD 19
CALCIUM CHLORIDE DIHYDRATE
0.1838 g
0.1838 g
0.1838 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(
)Fructose, up to(
16.5 g
)15.0 g(
)0.75 g(
46.75 g
)42.5 g(
)2.1 g(
25 g
)22.73 g(
)1.1 g(
CA
2+
1.25 mmol/l
1.25 mmol/l
1.25 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
CL
-
102.5 mmol/l
102.5 mmol/l
102.5 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
THEORETICAL OSMOLARITY:
356 mOsm/l
509 mOsm/l
399 mOsm/l
pH ≈ 5.5
Inactive ingredients and allergens – see section 6 “Further
information” and section 2
“Before using the medicine”.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THE
MEDICINE. This leaflet
contains concise information about the medicine. If you have further
questions, refer to
the doctor, pharmacist or nurse.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them
even if it seems to you that their illness is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
For use in patients suffering from end-stage chronic renal failure who
are being treated
with peritoneal dialysis.
THERAPEUTIC GROUP: Peritoneal dialytics, hypertonic solutions
2. BEFORE USING THE MEDICINE:
DO NOT USE THE MEDICINE IF:
• You are sensitive )allergic( to the active ingredients or to any
of the additional
ingredients contained in the medicine.
• The level of potassium in your blood is very low.
• The level of calcium in your blood is very low.
• You suffer from di

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CAPD 17 SOLUTION FOR PERITONEAL DIALYSIS
CAPD 18 SOLUTION FOR PERITONEAL DIALYSIS
CAPD 19 SOLUTION FOR PERITONEAL DIALYSIS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 litre contains:
CAPD 17
CAPD 18
CAPD 19
Calcium chloride dihydrate 0.1838 g
0.1838 g
0.1838 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
16.5 g
(15.0 g anhydrous glucose)
up to 0.75 g fructose
46.75 g
(42.5 g anhydrous glucose)
up to 2.1 g fructose
25.0 g
(22.73 g anhydrous glucose)
up to 1.1 g fructose
Ca
2+
1.25 mmol/l
1.25 mmol/l
1.25 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
Cl
-
102.5 mmol/l
102.5 mmol/l
102.5 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
CAPD 17
CAPD 18
CAPD 19
Theoretical osmolarity:
356 mOsm/l
509 mOsm/l
399 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 which can be
treated with peritoneal dialysis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
CAPD 17/18/19 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)
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ADULTS:
Unless otherwise prescribed, patients will receive an infusion of 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
t