Zenalb 4.5, Human Albumin 4.5% Solution

Land: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

ALBUMIN HUMAN

Fáanlegur frá:

GERMAX SDN. BHD.

INN (Alþjóðlegt nafn):

ALBUMIN HUMAN

Einingar í pakka:

250ml mL; 500 ml mL; 100 ml mL; 50 ml mL

Framleitt af:

BIO PRODUCTS LABORATORY LIMITED

Vara einkenni

GPS Limited
Tel: [phone]
Job No: 18552
Text Sizes:
Main Body Text 7pt
Line Spacing 8pt
Fonts used:
Helvetica Neue
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Project Name:
Zenalb 4.5 PIL Malaysia ADMY5
Contact:
Laura Ambrose
Client Order No.
P53744
Date:
26/06/2020
Proof No.
4
Operator:
Hema Joshi
Doc. Size:
200 x 280mm
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB 4.5
HUMAN ALBUMIN 4.5% SOLUTION
ADMY5
1.
NAME OF THE MEDICINAL PRODUCT
Zenalb 4.5, Human Albumin 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 ra