EXTRANEAL Solution for peritoneal dialysis

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Icodextrin; Sodium chloride; Sodium (S) - lactate ; Calcium chloride; Magnesium chloride

Disponible depuis:

Baxter Holding B.V.

Code ATC:

B05DA

DCI (Dénomination commune internationale):

Icodextrin; Sodium chloride; Sodium (S) - lactate ; Calcium chloride; Magnesium chloride

forme pharmaceutique:

Solution for peritoneal dialysis

Domaine thérapeutique:

Isotonic solutions

Statut de autorisation:

Marketed

Date de l'autorisation:

1997-07-25

Résumé des caractéristiques du produit

Health Products Regulatory Authority
21 January 2022
CRN00CRW7
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
EXTRANEAL Solution for peritoneal dialysis
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
A sterile peritoneal dial y sis fluid containing Ic odextri n at a
concentration of 7 .5 % w/v in an electroly te solution.
Icodextrin
75
g/L
Sodium Chloride
5.4
g/L
Sodium S-Lactate
4.5
g/L
Calciu m Chloride
0.25 7g/L
Magnesiu m Chloride0.05 1g/L
Theoretical osm o larity : 284 (m illiosm oles per litre)
Theoretical osm o lality : 301 (m illiosm oles per kg)
Electroly te so lution co ntent per 100 0 m l:
Sodium
133 mmol/L
Calciu m
1.75mmol/L
Magnesiu m0.25mmol/L
Chloride
96
mmol/L
Lactate
40
mmol/L
pH = 5 to 6
For the full list of excipients, see se ction 6.1.
3 PHARMACEUTICAL FORM
Solution for peritoneal dialysis.
Extraneal is a sterile, clear, colourless 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.
Health Products Regulatory Authority
21 January 2022
CRN00CRW7
Page 2 of 11
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 norm