EXTRANEAL

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

ICODEXTRIN ; SODIUM CHLORIDE ; SODIUM LACTATE ; CALCIUM CHLORIDE DIHYDRATE ; MAGNESIUM CHLORIDE ANHYDROUS

から入手可能:

Baxter Healthcare Limited

ATCコード:

B05DA

INN（国際名）:

ICODEXTRIN ; SODIUM CHLORIDE ; SODIUM LACTATE ; CALCIUM CHLORIDE DIHYDRATE ; MAGNESIUM CHLORIDE ANHYDROUS

投薬量:

N/A

医薬品形態:

Solution for Dialysis

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Isotonic solutions

認証ステータス:

Marketed

承認日:

1997-07-25

情報リーフレット

CB-30-02-186
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
EXTRANEAL Solution for Peritoneal Dialysis
Read all of this leaflet carefully before you start using this
medicine.
–
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 EXTRANEAL is and what it is used for
2.
What you need to know before you use EXTRANEAL
3.
How to use EXTRANEAL
4.
Possible side effects
5.
How to store EXTRANEAL
6.
Contents of the pack and other information
1.
WHAT EXTRANEAL IS AND WHAT IT IS USED FOR
EXTRANEAL is a solution for peritoneal dialysis. The peritoneal cavity
is the
cavity in your abdomen (belly) between your skin and the peritoneum.
The
peritoneum is the membrane surrounding your internal organs such as
your
intestines and liver. The EXTRANEAL solution is placed into the
peritoneal cavity
where it removes water and waste products from the blood. It also
corrects
abnormal levels of different blood components.
EXTRANEAL may be prescribed for you if:
•
You are an adult with permanent kidney failure which needs peritoneal
dialysis.
•
Standard glucose peritoneal dialysis solutions alone cannot remove
sufficient water.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE EXTRANEAL
Your doctor must supervise you the first time you use this product.
Do NOT use EXTRANEAL
•
if you are allergic to icodextrin or starch derivatives (e.g. maize
starch)
or any of the other ingredients of EXTRANEAL
•
if you are intolerant to maltose or isomaltose (sugar coming from
starch)
•
if you have glycogen storage disease
•
if you already have severe lactic acidosis (too much acid in the
blood)
•
if you have a surgically uncorrectable problem affecting your
abdominal wall or cavity or uncorrectable problem that increases risk
of abdominal infections
•
if you have documented loss of peritoneal function due to severe
peritoneal sc

製品の特徴

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
EXTRANEAL 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.
Theoretical osmolarity: 284 (milliosmoles per litre)
Theoretical osmolality: 301 (milliosmoles per kg)
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, 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_
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
Sodium
133
mmol/L
Calcium
1.75
mmol/L
Magnesium
0.25
mmol/L
Chloride
96
mmol/L
Lactate
40
mmol/L
Electrolyte solution content per 1000 ml:
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