Раствор медицинский для хирургии: жидкость для перфузии и хранения органов, предназначенных для трансплантации StoreProtect (объ

Valsts: Baltkrievija

Valoda: krievu

Klimata pārmaiņas: Министерством здравоохранения Республики (Центр экспертиз и испытаний в здравоохранении)

Pieejams no:

Carnamedica Sp. z o.o., ПОЛЬША

Klase:

изделия медицинского назначения

Ražojis:

Carnamedica Sp. z o.o. (контрактное производство в Польше)

Autorizācija datums:

2018-08-30

Produkta apraksts

INSTRUCTIONS FOR USE
EN
PlegiStore
®
Container with perfusion and preservation solution
for organs intended for transplantation
IfU/PLST/en/2020/01/07
CARNAMEDICA SP. Z O.O.
ul. Olszynki Grochowskiej 21 lok. U6
04-281 Warsaw, Poland
2
EN
INSTRUCTIONS FOR USE
Container contents: Solution for perfusion and cold storage
of organs for transplantation PlegiStore
®
Bretschneider’s Histidine – Tryptophan – Ketoglutarate Solution
STERILE AND NON-PYROGENIC SOLUTION FOR PERFUSION AND COLD STORAGE
OF ORGANS FOR TRANSPLANTATION
NOT INJECTABLE
Description: Composition: 1000 ml solution contains:
sodium chloride
0.8766 g
15.0 mmol/l
potassium chloride
0.6710 g
9.0 mmol/l
magnesium chloride · H
2
O
0.8132 g
4.0 mmol/l
histidine hydrochloride · H
2
O
3.7733 g
18.0 mmol/l
histidine
27.9289 g
180.0 mmol/l
tryptophan
0.4085 g
2.0 mmol/l
mannitol
5.4651 g
30.0 mmol/l
calcium chloride · H2O
0.0022 g
0.015 mmol/l
potassium hydrogen 2-oxopentandioate
0.1842 g
1.0 mmol/l
Potassium hydroxide 2N to pH adjustment
q.s.
Water for injection
q.s. 1.000 ml
Physical properties: pH: 7.02-7.20 at 25° C; 7.40-7.45 at 4° C;
Osmolality: 310 mOsm/kg
Type of device and mode of action: Electrolyte and amino acid aqueous
solution for organ perfusion and
preservation. Cardiac arrest by electromechanical decoupling. Organ
protection, preservation and conservation.
Surface cooling of organs (heart, kidney, liver, lung, pancreas).
Protection of vessel grafts.
Indications: In cardioplegia (multi organ protective irrigation) in
connection with heart surgery, organ protec-
tion during operations under ischemia (heart, kidney, liver),
preservation of organs for transplantation with
venous or arterial segments (heart, kidney, liver, lung, pancreas).
The solution should be used only by medical
healthcare staff, adequately trained, according to established
operating protocols.
Contraindications: None known at present.
Precautions and warnings: Histidine – Tryptophan – Ketoglutarate
solution is not intended for intravenous
or intraarterial administr