Dianeal PD4 Glucose 2.27% solution for peritoneal dialysis 2litre System 3 twin bags with spike connector

Land: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Download Vara einkenni (SPC)
16-06-2018

Virkt innihaldsefni:

Glucose anhydrous; Sodium chloride; Sodium lactate; Calcium chloride; Magnesium chloride

Fáanlegur frá:

Baxter Healthcare Ltd

ATC númer:

n/a

INN (Alþjóðlegt nafn):

Glucose anhydrous; Sodium chloride; Sodium lactate; Calcium chloride; Magnesium chloride

Skammtar:

22.7gram/1litre ; 5.38gram/1litre ; 4.48gram/1litre ; 184mg/1litre ; 51mg/1litre

Lyfjaform:

Solution for peritoneal dialysis

Stjórnsýsluleið:

Intraperitoneal

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Never Valid To Prescribe As A VMP

Vörulýsing:

BNF:

Vara einkenni

                                OBJECT 1
DIANEAL PD4 GLUCOSE 2.27% W/V / 22.7 MG/ML
Summary of Product Characteristics Updated 18-Aug-2016 | Baxter
Healthcare Ltd
1. Name of the medicinal product
Dianeal PD4 Glucose 2.27% w/v / 22.7 mg/ml
2. Qualitative and quantitative composition
Anhydrous Glucose
PhEur.
2.27% w/v
or
Glucose Monohydrate
PhEur.
2.50% w/v
Sodium chloride
PhEur.
0.538% w/v
Sodium Lactate
Ph.Fr. + internal specification
0.448% w/v
Calcium Chloride
PhEur.
0.0184% w/v
Magnesium Chloride
PhEur.
0.0051% w/v
3. Pharmaceutical form
Solution for peritoneal dialysis.
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.
Route of administration
Intraperitoneal administration only.
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
Patients on continuous ambulatory peritoneal dialysis (CAPD) typically
perform 4 cycles per day (24
hours). Patients on automated peritoneal dialysis (APD) typically
perform 4-5 cycles at night and up to 2
cycles during the day. The fill volume depends on body size, usually
from 2.0 to 2.5 litres.
Paediatric population (i.e., newborn to 18 years of age),
800 to 1400 ml/m2 per cycle up to a maximum amount of 2000 ml, as
tolerated, is recommended. Fill
volumes of 500 to 1000 ml/m2 are recommended in children less than 2
years of age.
As the patient's body weight becomes closer to the ideal dry weight,
lowering the glucose concentration
of DIANEAL is recommended.
To avoid the risk of severe dehydration, hypovolaemia and to minimise
the loss
                                
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