ZENALB 20 HUMAN ALBUMIN SOLUTION 20% wv

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ALBUMIN (HUMAN)

Available from:

EURO ASIA MEDICO PTE. LTD.

ATC code:

B05AA01

Dosage:

20% w/v

Pharmaceutical form:

INJECTION

Composition:

ALBUMIN (HUMAN) 20% w/v

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

BIO PRODUCTS LABORATORY LIMITED

Authorization status:

ACTIVE

Authorization date:

1992-10-09

Patient Information leaflet

MyGPS Europe Limited  
Tel: [phone]
Job No: 1568
Project Name:
Zenalb 20 Leaflet Dual Malaysia / Singapore
Contact:
Wioletta Nisiobedzka
Client Order No.
P5520
Date:
23/05/2014
Proof No.
5
Operator:
Hema Joshi
Doc. Size:
150 x 220mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB
®

20
HUMAN ALBUMIN 20% SOLUTION
ABNMYSG1
1. 
NAME OF MEDICINAL PRODUCT

ZENALB
®
 20, Human Albumin 20% Solution.
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 ACTIVE 
INGREDIENTS
 Human 
albumin.
2.2 QUANTITATIVE 
COMPOSITION
 ZENALB
®
 20 is a clear, yellow to green, sterilised 
solution. It is a low salt solution containing 150-250g/L 
of plasma protein of which not less than 95% is albumin. 
The residual proteins are heat stable alpha- and beta- 
globulins. Zenalb
®
 20 is free from plasma proteins 
associated with the blood clotting mechanism and blood 
group antibodies.
3. PHARMACEUTICAL 
FORM

ZENALB
®
 20 is a low salt solution of albumin for 
intravenous use.
4. CLINICAL 
PARTICULARS
4.1 THERAPEUTIC 
INDICATIONS
 ZENALB
®
 20 is used for albumin replacement in patients 
with albumin and blood volume deficiency.
 ZENALB
®
 20 is indicated in:

i)  the clinical management of hypovolaemic shock 
associated with blood loss, trauma and surgical 
procedures,

ii)  the clinical management of burn injuries. It should be 
used as part of a recognised method of resuscitation 
and, depending upon the particular regimen being 
followed, may be the principal component of the 
intravenous fluid therapy or given as an adjunct to 
crystalloid infusions,

iii)  albumin replacement in patients with severe 
hypoalbuminaemia, to restore physiological oncotic 
balance.
 ZENALB
®
 20 has an aluminum content of not more than 
200ug/L and is therefore suitable for premature infants 
and patients undergoing dialysis, in compliance with the 
European Pharmacopoeia.
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION
 ZENALB
®
 20 is given by intravenous infusion.
4.2.1 POSOLOGY
 ZE

Summary of Product characteristics

Star Creative
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Text. Sizes:
Main Body Text 6pt
Line Spacing 7pt
Fonts used:
Helvetica Neue LT Std 55 Roman
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Project Name:
Zenalb 20 PIL Singapore ABSG5
Contact:
Laura Ambrose
Client Order No.
P73814
Date:
10/07/2023
Proof No.
3
Operator:
Hema Joshi
Doc. Size:
170 x 220mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB 20
HUMAN ALBUMIN 20% SOLUTION
ABSG5
COLOURS: PANTONE PROCESS BLACK
1.
NAME OF THE MEDICINAL PRODUCT
Zenalb 20
200 g/l solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zenalb 20 is a solution containing 200 g/l (20%) of total protein of
which at least 95% is human albumin.
A vial of 100 ml contains 20 g of human albumin.
Zenalb 20 has a mildly hyperoncotic effect.
Excipient with known effect:
Zenalb 20 contains approximately 50-120 mmol/l sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
A clear, slightly viscous liquid, it is almost colourless, yellow,
amber
or green.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zenalb 20 is indicated in all patients for the restoration and
maintenance of circulating blood volume where volume deficiency
has been demonstrated, and use of a colloid is appropriate.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The concentration of the albumin preparation, dosage and the
infusion-rate should be adjusted to the patient’s individual
requirements.
POSOLOGY
The dose required depends on the size of the patient, the severity
of trauma or illness and on continuing fluid and protein losses.
Measures of adequacy of circulating volume, and not plasma albumin
levels, should be used to determine the dose required.
If human albumin is to be administered, haemodynamic performance
should be monitored regularly; this may include:
–
arterial blood pressure and pulse rate
–
central venous pressure
–
pulmonary artery wedge pressure
–
urine output
–
electrolyte
–
haematocrit/haemoglobin
METHOD OF ADMINISTRATION
Human albumin can be directly ad