Albumex 4

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Albumin 40 g/L (Albumin ex NZ)

Disponibbli minn:

CSL Behring (NZ) Ltd

INN (Isem Internazzjonali):

Albumin 40 g/L (Albumin ex NZ)

Dożaġġ:

4% w/v

Għamla farmaċewtika:

Solution for infusion

Kompożizzjoni:

Active: Albumin 40 g/L (Albumin ex NZ) Excipient: Octanoate ions Sodium Water for injection

Unitajiet fil-pakkett:

Vial, glass, bottle, 50 mL

Klassi:

General sale

Tip ta 'preskrizzjoni:

General sale

Manifatturat minn:

CSL Behring (Australia) Pty Ltd

Indikazzjonijiet terapewtiċi:

Hypovolaemia/shock; Preservation of an adequate circulating blood volume should be the primary aim of therapy. Albumex® 4 may be the initial plasma expander of choice if shock is associated with significant hypoalbuminaemia (albumin concentration less than 25 g/Litre), or if it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. Albumex® 4 may also be useful following initial resuscitation with crystalloid or synthetic colloid solutions in patients in whom extended support of the intravascular volume is required, such as seriously ill patients with multiple organ failure or the systemic capillary leak syndrome.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Vial, glass, bottle - 50 mL - 48 months from date of manufacture stored at or below 30°C protect from light - Vial, glass, bottle - 250 mL - 48 months from date of manufacture stored at or below 30°C protect from light - Vial, glass, bottle - 500 mL - 48 months from date of manufacture stored at or below 30°C protect from light

Data ta 'l-awtorizzazzjoni:

1995-06-14

Karatteristiċi tal-prodott

NEW ZEALAND DATA SHEET
Albumex 4 NZ DS 14.00
Page
1
of
11
1 PRODUCT NAME
Albumex
®
4 (4%) solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin
It is a 4% w/v human albumin solution.
Albumex
®
4 is manufactured from human plasma donated by New Zealand’s
voluntary and
non-remunerated donors. It is prepared by a combination of the Cohn
cold-ethanol fractionation
process and chromatographic techniques.
The nominal composition of Albumex
®
4 is as follows:
Human Albumin
40 g/L
Sodium
140 mmol/L
Chloride
128 mmol/L
Octanoate
6.4 mmol/L
Albumex
®
contains no preservatives.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for intravenous infusion.
Albumex
®
4 is a clear, slightly viscous liquid; it is almost colourless,
yellow, amber or green.
It has a nominal osmolality of 260 mOsm/kg, is approximately isotonic
and the pH is 6.7 to 7.3.
Albumex
®
4 is iso-oncotic with human serum.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPOVOLAEMIA/SHOCK
Preservation of an adequate circulating blood volume should be the
primary aim of therapy.
Albumex
®
4 may be the initial plasma expander of choice if shock is associated
with significant
hypoalbuminaemia (albumin concentration less than 25 g/L), or if it is
clinically desirable to avoid the
infusion of large volumes of crystalloid solutions. Albumex
®
4 may also be useful following initial
resuscitation with crystalloid or synthetic colloid solutions in
patients in whom extended support of
the intravascular volume is required, such as seriously ill patients
with multiple organ failure or the
systemic capillary leak syndrome.
NEW ZEALAND DATA SHEET
Albumex 4 NZ DS 14.00
Page
2
of
11
CARDIOPULMONARY BYPASS
Albumex
®
4 may be used for priming the pump for cardiopulmonary bypass surgery
for patients with
poor left ventricular function, and other complicating factors such as
long bypass time, anaemia or
repeat surgery. For post-operative hypovolaemia Albumex
®
4 may be used if further colloid is
required afte