Albumex 20

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Albumin 200 g/L (Albumin ex NZ)

Fáanlegur frá:

CSL Behring (NZ) Ltd

INN (Alþjóðlegt nafn):

Albumin 200 g/L (Albumin ex NZ)

Skammtar:

20% w/v

Lyfjaform:

Solution for infusion

Samsetning:

Active: Albumin 200 g/L (Albumin ex NZ) Excipient: Octanoate ions Sodium Water for injection

Einingar í pakka:

Vial, glass, bottle, 10 mL

Tegund:

General sale

Gerð lyfseðils:

General sale

Framleitt af:

CSL Behring (Australia) Pty Ltd

Ábendingar:

Hypoproteinaemia in the acutely ill patient; Albumex® 20 is administered when there are existing or anticipated clinical problems or complications from reduced oncotic pressure, and/or as an adjunct to diuretic therapy.

Vörulýsing:

Package - Contents - Shelf Life: Vial, glass, bottle - 10 mL - 4 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, bottle - 100 mL - 48 months from date of manufacture stored at or below 30°C protect from light

Leyfisdagur:

1995-08-25

Vara einkenni

NEW ZEALAND DATA SHEET
Albumex 20 NZ DS 16.00
Page
1
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12
1 PRODUCT NAME
Albumex
®
20 (20%) solution for infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human albumin
It is a 20% w/v human albumin solution.
Albumex
®
20 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 composition of Albumex
®
20 is as follows:
Human Albumin
200 g/L
Sodium
48 to 100 mmol/L
Octanoate
32 mmol/L
Albumex
®
contains no preservatives.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for intravenous infusion.
Albumex
®
20 is a clear, slightly viscous liquid; it is almost colourless,
yellow, amber or green.
It has a nominal osmolality of 130 mOsm/kg, is hypotonic and the pH is
6.7 to 7.3.
It is hyperoncotic and hypo-osmotic compared to human serum.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HYPOPROTEINAEMIA IN THE ACUTELY ILL PATIENT
Albumex
®
20 is administered when there are existing or anticipated clinical
problems or
complications from reduced oncotic pressure, and/or as an adjunct to
diuretic therapy.
SHOCK
Albumex
®
20 may be used for the resuscitation of patients in shock due to acute
loss of blood or
plasma, but 4% human albumin is preferred when available.
BURNS
Extensive burns are followed by sequential shifts in the distribution
of body water, salt and proteins
resulting in hypovolaemic shock and circulatory failure.
NEW ZEALAND DATA SHEET
Albumex 20 NZ DS 16.00
Page
2
of
12
Initially (during the first 24 hours) there is an increased vascular
permeability leading to loss of water
and proteins into the extravascular compartment, and
haemoconcentration. Large volumes of
crystalloid solutions should be infused to restore the constricted
intravascular fluid space, and smaller
amounts of Albumex
®
20 are required to maintain adequate plasma volume and colloid osmotic
pressure.
ADULT RESPIRATORY DISTRESS SYNDROME
The c