Dianeal PD4 Glucose 2.27 % w/v (22.7 mg/ml), Solution for peritoneal dialysis

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Sodium chloride; Sodium lactate ; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose anhydrous ; Glucose monohydrate

Saatavilla:

Baxter Holding B.V.

ATC-koodi:

B05DB

INN (Kansainvälinen yleisnimi):

Sodium chloride; Sodium lactate ; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose anhydrous ; Glucose monohydrate

Annos:

2.27 percent weight/volume

Lääkemuoto:

Solution for peritoneal dialysis

Terapeuttinen alue:

Hypertonic solutions

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1993-06-03

Pakkausseloste

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DIANEAL PD4 GLUCOSE 1.36% W/V / 13.6 MG/ML
DIANEAL PD4 GLUCOSE 2.27% W/V / 22.7 MG/ML
DIANEAL PD4 GLUCOSE 3.86% W/V / 38.6 MG/ML
SOLUTIONS 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 DIANEAL PD4 is and what it is used for
2.
What you need to know before you use DIANEAL PD4
3.
How to use DIANEAL PD4
4.
Possible side effects
5.
How to store DIANEAL PD4
6.
Contents of the pack and other information
1.
WHAT DIANEAL PD4 IS AND WHAT IT IS USED FOR
DIANEAL PD4 is a solution for peritoneal dialysis.
It removes water and waste products from the blood. It also corrects
abnormal levels of different
blood components. DIANEAL PD4 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.
DIANEAL PD4 may be prescribed to you if you have:

either temporary or permanent kidney failure

severe water retention

severe disturbances in the acidity or alkalinity and the level of
salts in your blood

certain types of drug intoxication where no other treatments are
available.
DIANEAL PD4 is particularly indicated for the control of your serum
calcium and phosphate levels
if you receive calcium or magnesium containing phosphate binders.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DIANEAL PD4
DO NOT USE DIANEAL PD4

If you are allergic to active substances or any of the other
ingredients of this medicine (listed
in section 6).

If you have severe lactic acidosis (too much acid in the blood) before
you use this solution
for the first time.

If you have a surgically uncorrectable problem affe

Valmisteyhteenveto

HealthProductsRegulatoryAuthority
25February2019
CRN008KFL
Page1of6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
DianealPD4Glucose2.27%w/v(22.7mg/ml),Solutionforperitonealdialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
AnhydrousGlucose
2.27%
w/v
22.70
g/L
or
GlucoseMonohydrate
2.50%
w/v
25.00
g/L
SodiumChloride
0.538%
w/v
5.38
g/L
SodiumLactate
0.448%
w/v
4.48
g/L
CalciumChlorideDihydrate
0.0184%
w/v
184.00
mg/L
MagnesiumChlorideHexahydrate
0.0051%
w/v
51.00
mg/L
MMOL/L
Na
+
132.00
Ca
2+
1.25
Mg
2+
0.25
Cl
-
95.00
C
3
H
5
O
3
-
40.00
For afulllistofexcipients,seesection6.1.
3 PHARMACEUTICAL FORM
SolutionforPeritonealDialysis.
Aclearcolourlesstopaleyellow,solutioninPVCcontainers,whichmayhaveanintegraladministrationsetanddrainagebag.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DianealPD4isindicatedwheneverperitonealdialysisisemployed,including:
1. Acuteandchronicrenalfailure.
2. Severewaterretention.
3. Electrolytedisorders.
4.
Drugintoxication,whenamoreadequatetherapeuticalternativeisnotavailable.
DianealPD4isparticularlyusefulforthecontrolofserumcalciumandphosphatelevelsinrenalfailurepatientsreceiving
calciumormagnesium-containingphosphatebinders.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_:
Themodeoftherapy,frequencyoftreatment,exchangevolume,durationofdwellandlengthofdialysisshouldbeselectedby
theattendingphysician.
Adults
HealthProductsRegulatoryAuthority
25February2019
CRN008KFL
Page2of6
Patientsoncontinuousambulatoryperitonealdialysis(CAPD)typ