HEMOSOL B0 haemofiltration / haemodiafiltration solution bag

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

calcium chloride dihydrate, Quantity: 5.145 g/L; magnesium chloride hexahydrate, Quantity: 2.033 g/L; (S)-lactic acid, Quantity: 5.4 g/L

Предлага се от:

Vantive Pty Ltd

INN (Международно Name):

calcium chloride dihydrate,magnesium chloride hexahydrate,sodium bicarbonate,sodium chloride,(S)- Lactic acid

Лекарствена форма:

Solution, dialysis

Композиция:

Excipient Ingredients: water for injections

Начин на приложение:

Intravenous Infusion

Броя в опаковка:

5000 mL

Вид предписание :

Not scheduled. Not considered by committee

Терапевтични показания:

HEMOSOL B0 solution is used in the treatment of Acute Kidney Injury (AKI) as a substitution solution in continuous haemofiltration and continuous haemodiafiltration and as a dialysis solution in continuous haemodialysis and continuous haemodiafiltration.,HEMOSOL B0 solution may also be used in case of drug poisoning with dialysable or filterable substances.,In these patient groups, Hemosol B0 is indicated for those with a tendency to hyperkalaemia; see PRECAUTIONS

Каталог на резюме:

Visual Identification: Clear and colourless solution; Container Type: Bag; Container Material: Other composite material; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2016-12-14

Данни за продукта

HEMOSOL B0 (calcium chloride dihydrate, magnesium chloride
hexahydrate, (
_S_
)-lactic acid, sodium
bicarbonate, sodium chloride)
Version 1.0
1 of 13
AUSTRALIAN PRODUCT INFORMATION – HEMOSOL B0
(CALCIUM CHLORIDE DIHYDRATE, MAGNESIUM
CHLORIDE HEXAHYDRATE, (_S_)-LACTIC ACID, SODIUM
BICARBONATE, SODIUM CHLORIDE) SOLUTION FOR
DIALYSIS
1
NAME OF THE MEDICINE
Calcium
chloride
dihydrate,
magnesium
chloride
hexahydrate,
(
_S_
)-lactic
acid,
sodium
bicarbonate and sodium chloride.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
HEMOSOL B0 is a solution for haemodialysis and haemofiltration
consisting of a mixture of
the
following
five
active
ingredients:
calcium
chloride
dihydrate,
magnesium
chloride
hexahydrate, (
_S_
)-lactic acid, sodium bicarbonate and sodium chloride.
HEMOSOL B0 solution is clear and colourless when reconstituted as a
solution. It is contained
in
a
two
compartment
polyolefin
bag
containing
an
electrolyte
solution
in
the
small
compartment (compartment A) and a buffer solution in the large
compartment (compartment
B).
_BEFORE RECONSTITUTION _
1000 mL of electrolyte solution (small compartment A) contains:
active substances:
Calcium chloride dihydrate
Magnesium chloride hexahydrate
(S)-Lactic acid
5.145 g
2.033 g
5.4 g
1000 mL of buffer solution (large compartment B) contains:
active substances:
Sodium bicarbonate
Sodium chloride
_ _
3.09 g
6.45 g
_AFTER RECONSTITUTION _
The small and the large compartments are mixed to give a reconstituted
solution with the
following ionic composition:
ACTIVE SUBSTANCES
IN MMOL/L
IN MEQ/L
Sodium
Na
+
140
140
Calcium
Ca
2+
1.75
3.5
Magnesium
Mg
2+
0.5
1
Chloride
Cl
-
109.5
109.5
Hydrogen carbonate
HCO
3
-
32
32
Lactate
3
3
Theoretical Osmolarity: 287 mOsm/L
HEMOSOL B0 (calcium chloride dihydrate, magnesium chloride
hexahydrate, (
_S_
)-lactic acid, sodium
bicarbonate, sodium chloride)
Version 1.0
2 of 13
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Solution for dialysis.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HEMOS