Physioneal 35 Glucose1.36%w/v/13.6mg/ml Clear-Flex solution for peritoneaal dialysis

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

CALCIUM CHLORIDE, GLUCOSE MONOHYDRATE, MAGNESIUM CHLORIDE, HEXAHYDRATE, SODIUM CHLORIDE, SODIUM HYDROGEN, CARBONATE, SODIUM LACTATE

Mevcut itibaren:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

ATC kodu:

B05DB

INN (International Adı):

CALCIUM CHLORIDE 0.343 g/l GLUCOSE MONOHYDRATE 20 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.068 g/l SODIUM CHLORIDE 5.67 g/l SODIUM HYDROGEN CARBONATE 9.29 g/l SODIUM LACTATE 4.48 g/l

Farmasötik formu:

SOLUTION FOR PERITONEAL DIALYSIS

Kompozisyon:

CALCIUM CHLORIDE 0.343 g/l GLUCOSE MONOHYDRATE 20 g/l MAGNESIUM CHLORIDE HEXAHYDRATE 0.068 g/l SODIUM CHLORIDE 5.67 g/l SODIUM HYDROGEN CARBONATE 9.29 g/l SODIUM LACTATE 4.48 g/l

Reçete türü:

POM

Terapötik alanı:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2014-10-02

Bilgilendirme broşürü

PAGE 1 OF 8
PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
PHYSIONEAL 35 GLUCOSE 1.36% W/V / 13.6 MG/ML CLEAR-FLEX, SOLUTION FOR
PERITONEAL DIALYSIS
PHYSIONEAL 35 GLUCOSE 2.27% W/V / 22.7 MG/ML CLEAR-FLEX, SOLUTION FOR
PERITONEAL DIALYSIS
PHYSIONEAL 35 GLUCOSE 3.86% W/V / 38.6 MG/ML CLEAR-FLEX, SOLUTION FOR
PERITONEAL DIALYSIS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What PHYSIONEAL 35 is and what it is used for
2.
What you need to know before you use PHYSIONEAL 35
3.
How to use PHYSIONEAL 35
4.
Possible side effects
5.
How to store PHYSIONEAL 35
6.
Contents of the pack and other information
1.
WHAT PHYSIONEAL 35 IS AND WHAT IT IS USED FOR
PHYSIONEAL 35 is a solution for peritoneal dialysis. It removes water
and waste products
from the blood. It also corrects abnormal levels of different blood
components. PHYSIONEAL
35 contains varying levels of glucose (1.36%, 2.27% or 3.86%). The
higher the strength of
glucose in the solution, the greater the amount of water that will be
removed from the blood.
PHYSIONEAL 35 may be prescribed to you if you have:
-
either temporary or permanent kidney failure;
-
severe water retention;
-
severe disturbances in the acidity or alkalinity (pH) and the level of
salts in your blood;
-
certain types of drug intoxication where no other treatments are
available.
PHYSIONEAL 35 solution has an acidity (pH) close to that of your
blood. Therefore it may be
particularly useful if you experience inflow pain or discomfort with
other more acidic Peritoneal
Dialysis solutions.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
PHYSIONEAL 35
Your doctor must supervise you the first time you use this product.
DO NOT USE PHYSIONEAL 35
-
If you

Ürün özellikleri

PAGE 1 OF 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
PHYSIONEAL 35 Glucose 1.36% w/v / 13.6 mg/ml Clear-Flex,
Solution for peritoneal dialysis.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Before mixing
1000 ML OF ELECTROLYTE SOLUTION (LARGE CHAMBER

A

) CONTAINS:
Active substances:
Glucose monohydrate
equivalent to Glucose anhydrous
Calcium chloride dihydrate
Magnesium chloride hexahydrate
20.0 g
18.2 g
0.343 g
0.068 g
1000 ML OF BUFFER SOLUTION (SMALL CHAMBER

B

) CONTAINS:
Active substances:
Sodium chloride
Sodium hydrogen carbonate
Sodium (S)-lactate solution
equivalent to sodium (S)-lactate
21.12 g
9.29 g
4.48 g
After mixing
1000 ML OF THE MIXED SOLUTION CONTAINS:
Active substances:
Glucose monohydrate
equivalent to Glucose anhydrous
Sodium chloride
Calcium chloride dihydrate
Magnesium chloride hexahydrate
Sodium hydrogen carbonate
Sodium (S)-lactate solution
equivalent to sodium (S)-lactate
15.0 g
13.6 g
5.67 g
0.257 g
0.051 g
2.10 g
1.12 g
1000 ml of final solution after mixing corresponds to 750 ml of
solution A and 250 ml of
solution B.
COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L
Glucose anhydrous (C
6
H
12
O
6
)
Na
+
Ca
++
Mg
++
Cl
-
HCO
3
-
C
3
H
5
O
3
-
75.5 mmol/l
132 mmol/l
1.75 mmol/l
0.25 mmol/l
101 mmol/l
25 mmol/l
10 mmol/l
For the full list of excipients, see section 6.1.
The number ‘35’ in the name specifies the buffer concentration of
the solution (10 mmol/l of
lactate + 25 mmol/l of hydrogen carbonate = 35 mmol/l).
PAGE 2 OF 11
3.
PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Sterile, clear, colourless solution.
The pH of the final solution is 7.4.
Osmolarity 345 mOsmol/l
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PHYSIONEAL 35 is indicated whenever peritoneal dialysis is employed,
including:
•
Acute and chronic renal failure;
•
Severe water retention;
•
Severe electrolyte imbalance;
•
Drug intoxication with dialysable substances, when a more adequate
therapeutic
alternative is not available.
PHYSIONEAL 35 hyd