Extraneal (Icodextrin 7.5%) APD solution for peritoneal dialysis 2litre single bags with luer connector

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Icodextrin; Sodium chloride; Sodium lactate; Calcium chloride; Magnesium chloride

Διαθέσιμο από:

Icodextrin 7.5%) APD solution for peritoneal dialysis 2litre single bags with luer connector (Vantive Ltd

Φαρμακολογική κατηγορία (ATC):

n/a

INN (Διεθνής Όνομα):

Icodextrin; Sodium chloride; Sodium lactate; Calcium chloride; Magnesium chloride

Δοσολογία:

75gram/1litre ; 5.4gram/1litre ; 4.5gram/1litre ; 257mg/1litre ; 51mg/1litre

Φαρμακοτεχνική μορφή:

Solution for peritoneal dialysis

Οδός χορήγησης:

Intraperitoneal

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Never Valid To Prescribe As A VMP

Περίληψη προϊόντος:

BNF: ; GTIN: 05413760441870 55413760441875

Αρχείο Π.Χ.Π.

OBJECT 1
EXTRANEAL (ICODEXTRIN 7.5%) SOLUTION FOR
PERITONEAL DIALYSIS
Summary of Product Characteristics Updated 26-May-2016 | Baxter
Healthcare Ltd
1. Name of the medicinal product
EXTRANEAL (Icodextrin 7.5%)
Solution for peritoneal dialysis
2. Qualitative and quantitative composition
A sterile peritoneal dialysis fluid containing Icodextrin at a
concentration of 7.5% w/v in an electrolyte
solution.
Icodextrin
75
g/L
Sodium Chloride
5.4
g/L
Sodium S-Lactate
4.5
g/L
Calcium Chloride
0.257
g/L
Magnesium
Chloride
0.051
g/L
Theoretical osmolarity: 284 (milliosmoles per litre)
Theoretical osmolality: 301 (milliosmoles per kg)
Electrolyte solution content per 1000 ml:
Sodium
133
mmol/L
Calcium
1.75
mmol/L
Magnesium
0.25
mmol/L
Chloride
96
mmol/L
Lactate
40
mmol/L
pH = 5 to 6
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for peritoneal dialysis.
Extraneal is a sterile, clear, colorless solution.
4. Clinical particulars
4.1 Therapeutic indications
Extraneal is recommended as a once daily replacement for a single
glucose exchange as part of a
continuous ambulatory peritoneal dialysis (CAPD) or automated
peritoneal dialysis (APD) regimen for
the treatment of chronic renal failure, particularly for patients who
have lost ultrafiltration on glucose
solutions, because it can extend time on CAPD therapy in such
patients.
4.2 Posology and method of administration
Posology:
Extraneal is recommended for use during the longest dwell period, i.e.
in CAPD usually overnight and in
APD for the long daytime dwell.
• The mode of therapy, frequency of treatment, exchange volume,
duration of dwell and length of
dialysis should be initiated and supervised by the physician.
_Adults_
By intraperitoneal administration limited to a single exchange in each
24 hour-period, as part of a CAPD
or APD regimen.
The volume to be instilled should be given over a period of
approximately 10 to 20 minutes at a rate
which the patient finds comfortable. For adult patients of normal body
size the instilled volume should