VIASPAN %v/v Solution for Organ Preservation

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

POLY(O-2-HYDROXYETHYL)STARCH, LACTOBIONIC ACID, POTASSIUM HYDROXIDE, SODIUM HYDROXIDE (40%), ADENOSINE, ALLOPURINOL, POTASSIUM PHOSPHATE MONOBASIC, MAGNESIUM SULFATE, RAFFINOSE, GLUTATHIONE

Saadav alates:

Bristol-Myers Squibb Pharmaceuticals Ltd

ATC kood:

V07AB

INN (Rahvusvaheline Nimetus):

POLY(O-2-HYDROXYETHYL)STARCH, LACTOBIONIC ACID, POTASSIUM HYDROXIDE, SODIUM HYDROXIDE (40%), ADENOSINE, ALLOPURINOL, POTASSIUM P

Annus:

%v/v

Ravimvorm:

Solution for Organ Preservation

Retsepti tüüp:

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

Terapeutiline ala:

Solvents and diluting agents, incl. irrigating solutions

Volitamisolek:

Authorised

Loa andmise kuupäev:

2001-12-03

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ViaSpan Solution for organ preservation
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 l Solution for organ preservation contains:
1)
MS = moles hydroxyethyl groups per moles anhydroglucose units
*German Patent Number 3,688,936.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for organ preservation.
Clear, yellow solution. The solution has an approximate osmolality of 320 mosmol/kg, sodium final
concentration of 29 mEq/l, potassium concentration of 125 mEq/l and pH of 7.4 at room temperature.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solution for the preservation of kidney, liver and pancreas. Not for continuous machine perfusion.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Perfusion and preservation of organs.
VIASPAN IS ONLY TO BE USED TO PREPARE BELZER UW COLD STORAGE SOLUTION. THE FOLLOWING CAN BE ADDED
ASEPTICALLY TO EACH LITRE OF VIASPAN IMMEDIATELY BEFORE USE:
16 MG DEXAMETHASONE
40 UNITS OF REGULAR INSULIN
200,000 UNITS OF PENICILLIN G
If desired, an additional 0.922g/l (3 mmol/l) freshly prepared reduced glutathione solution may be added
immediately prior to use.
Poly (0-2-hydroxyethyl) starch 0.40-0.50
MS
1)
(Pentafraction*)
50.0
g/l
Lactobionic Acid (as Lactone)
35.83
g/l
(105 mmol/l)
Potassium Hydroxide 56 %
14.5
g/l
(100 mmol/l)
Sodium Hydroxide 40 %
3.679
g/l
( 27 mmol/l)
Adenosine
1.34
g/l
(
5 mmol/l)
Allopurinol
0.136
g/l
(
1 mmol/l)
Potassium Dihydrogen Phosphate
3.4
g/l
( 25 mmol/l)
Magnesium Sulphate x 7H
2
O
1.23
g/l
(
5 mmol/l)
Raffinose x 5H
2
O
17.83
g/l
( 30 mmol/l)
Glutathione
0.922
g/l
(
3 mmol/l)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/11/2012_
_CRN 2118981_
_page number: 1_
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