ZENALB 4.5 HUMAN ALBUMIN SOLUTION 4.5% 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:

4.5% w/v

Pharmaceutical form:

INJECTION

Composition:

ALBUMIN (HUMAN) 4.5% 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  
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Job No: 1567
Project Name:
Zenalb 4.5 Leaflet Dual Malaysia / Singapore
Contact:
Wioletta Nisiobedzka
Client Order No.
P5520
Date:
23/05/2014
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Hema Joshi
Doc. Size:
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB
®

4.5
HUMAN ALBUMIN 4.5% SOLUTION
ADNMYSG1
1. 
NAME OF MEDICINAL PRODUCT

ZENALB
®
 4.5, Human Albumin 4.5% Solution.
2. QUALITATIVE 
AND 
QUANTITATIVE 
COMPOSITION

2.1 ACTIVE 
INGREDIENTS
 Human 
albumin.
2.2 QUANTITATIVE 
COMPOSITION
 ZENALB
®
 4.5 is a clear, yellow to green, sterilised solution. 
It is a solution containing 40-50g/L of plasma protein of 
which not less than 95% is albumin. Zenalb
®
 4.5 is free 
from plasma proteins associated with the blood clotting 
mechanism and blood group antibodies.
3. PHARMACEUTICAL 
FORM

ZENALB
®
 4.5 is an isotonic solution for intravenous use.
4. CLINICAL 
PARTICULARS
4.1 THERAPEUTIC 
INDICATIONS
 ZENALB
®
 4.5 is used for albumin replacement in patients 
with albumin and blood volume deficiency.
 ZENALB
®
 4.5 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)  fluid replacement regimens in therapeutic plasma 
exchange. In the plasma exchange the volume of 
plasma removed may be replaced in whole or part by an 
equivalent volume of ZENALB
®
 4.5, but the volume of 
any anticoagulant given must be taken into account in 
calculating the albumin replacement volume,

iv)  the resuspension of recycled red blood cells during major 
surgical procedures, e.g. liver transplant.
  ZENALB
®
 4.5 has an aluminum content of not more than 
200ug/L

Summary of Product characteristics

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Project Name:
Zenalb 4.5 PIL Singapore ADSG5
Contact:
Laura Ambrose
Client Order No.
P75523
Date:
30/10/2023
Proof No.
1
Operator:
Hema Joshi
Doc. Size:
200 x 280mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB 4.5
HUMAN ALBUMIN 4.5% SOLUTION
ADSG5
1.
NAME OF THE MEDICINAL PRODUCT
Zenalb 4.5
45 g/l solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zenalb 4.5 is a solution containing 45 g/l (4.5%) of total protein of
which
at least 95% is human albumin.
A vial of 100 ml contains 4.5 g of human albumin.
Zenalb 4.5 has a mildly hypooncotic effect.
Excipient with known effect:
Zenalb 4.5 contains approximately 100-160 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 4.5 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 administered by the intravenous route.
The infusion rate should be