Zenalb 4.5% solution for infusion 50ml bottles

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Albumin solution human

Disponibbli minn:

Bio Products Laboratory Ltd

Kodiċi ATC:

B05AA01

INN (Isem Internazzjonali):

Albumin solution human

Dożaġġ:

45mg/1ml

Għamla farmaċewtika:

Solution for infusion

Rotta amministrattiva:

Intravenous

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 09020202; GTIN: 5019943000096

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZENALB
®
4.5
4.5% W/V SOLUTION FOR INFUSION
HUMAN ALBUMIN SOLUTION
ADL19
PLEASE READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START USING THIS MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
-
If any of the side effects become serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor.
IN THIS LEAFLET:
1. WHAT ZENALB
® 4.5 IS AND WHAT IT IS USED FOR
2.
BEFORE YOU ARE GIVEN ZENALB
® 4.5
3.
HOW YOU WILL BE GIVEN ZENALB
® 4.5
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ZENALB
® 4.5
6.
FURTHER INFORMATION
1. WHAT ZENALB
® 4.5 IS AND WHAT IT IS USED FOR
Zenalb 4.5
®
is a solution containing the active substance
called human albumin (a protein found naturally in your
blood which is needed for many different functions). Human
albumin is obtained from blood plasma from screened
donors selected from the USA.
Zenalb 4.5
®
is used to replace the blood or body fluids
that you have lost because of bleeding, surgery, or kidney
dialysis (blood “cleaning” by a machine). It contains a similar
amount of albumin as normal blood.
The product is given by injection into a vein (intravenous
infusion). It is only available on a doctor’s prescription.
This medicine is also suitable for premature babies and
patients on kidney dialysis as it contains only very small
quantities of aluminium.
2. BEFORE YOU ARE GIVEN ZENALB
® 4.5
DO NOT ALLOW ZENALB
® 4.5 TO BE GIVEN TO YOU IF YOU:
•
are allergic to albumin or any of the other ingredients
of Zenalb
®
4.5 _(see Section 6 and end of Section 2 _
_Important information about some of the ingredients of _
_Zenalb_
_®_
_ 4.5)._
TAKE SPECIAL CARE WITH ZENALB
® 4.5
You must tell your doctor before receiving Zenalb
®
4.5 if any
of the following conditions applies to you:
•
ALLERGIC or violent REACTION t

Karatteristiċi tal-prodott

OBJECT 1
ZENALB 4.5, A HUMAN ALBUMIN 4.5% SOLUTION
Summary of Product Characteristics Updated 28-Jan-2013 | Bio Products
Laboratory Limited
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 directly administered by the intravenous route.
The infusion rate should be adjusted according to the individual
circumstances and the indication.
In plasma exchange the infusion should be adjusted to the rate of
removal.
4.3 Contraindications
Hypersensitivity to albumin p