ZENALB 4.5

Land: Ísrael

Tungumál: enska

Heimild: Ministry of Health

Virkt innihaldsefni:

ALBUMIN HUMAN

Fáanlegur frá:

KAMADA LTD, ISRAEL

ATC númer:

B05AA01

Lyfjaform:

SOLUTION FOR INFUSION

Samsetning:

ALBUMIN HUMAN 45 MG/ML

Stjórnsýsluleið:

I.V

Gerð lyfseðils:

Required

Framleitt af:

BIO PRODUCTS LABORATORY LIMITED, UK

Meðferðarhópur:

ALBUMIN

Lækningarsvæði:

ALBUMIN

Ábendingar:

For restoration and maintenance of circulation blood volume where volume deficiency has been demonstrated and use of a colloid, is appropriate.

Leyfisdagur:

2022-12-31

Vara einkenni

GPS Limited
Tel: [phone]
Job No: 17167
Text Sizes:
Main Body Text 7pt
Line Spacing 7.7pt
Fonts used:
Helvetica Neue
Regular
Project Name:
Zenalb 4.5 PIL Israel ADIS3SPC
Contact:
Laura Ambrose
Client Order No.
P32318
Date:
06/01/2017
Proof No.
1
Operator:
Hema Joshi
Doc. Size:
150 x 260mm
Colours: Black Pantone 5845
SUMMARY OF PRODUCT CHARACTERISTICS
ZENALB
® 4.5
HUMAN ALBUMIN SOLUTION
ADIS3SPC
1.
NAME OF THE MEDICINAL PRODUCT:
Zenalb
®
4.5, a 45 g/L of human albumin solution for
infusion (4.5% Solution).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Zenalb
®
4.5 contains 45 g/L and 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.
For 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
Restoration and maintenance of circulating
blood volume where volume deficiency has been
demonstrated and use of a colloid is appropriate.
The choice of albumin rather than artificial colloid will
depend on the clinical situation of the patient, based
on official recommendations.
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 dir