Albumex 20
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
19-04-2020
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Active ingredient:
Albumin 200 g/L (Albumin ex NZ)
Available from:
CSL Behring (NZ) Ltd
INN (International Name):
Albumin 200 g/L (Albumin ex NZ)
Dosage:
20% w/v
Pharmaceutical form:
Solution for infusion
Composition:
Active: Albumin 200 g/L (Albumin ex NZ) Excipient: Octanoate ions Sodium Water for injection
Units in package:
Vial, glass, bottle, 10 mL
Class:
General sale
Prescription type:
General sale
Manufactured by:
CSL Behring (Australia) Pty Ltd
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.
Product summary:
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
Authorization date:
1995-08-25
Summary of Product characteristics
NEW ZEALAND DATA SHEET
Albumex 20 NZ DS 16.00
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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
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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
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