Albunorm 5% solution for infusion 500ml bottles

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Albumin solution human

Available from:

Octapharma Ltd

ATC code:

B05AA01

INN (International Name):

Albumin solution human

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09020202; GTIN: 5060237670105

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUNORM 5%
50 G/L, SOLUTION FOR INFUSION
Human albumin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See
section 4.
WHAT IS IN THIS LEAFLET:
1. What Albunorm 5% is and what it is used for
2. What you need to know before you use Albunorm 5%
3. How to use Albunorm 5%
4. Possible side effects
5. How to store Albunorm 5%
6. Contents of the pack and other information
1. WHAT ALBUNORM 5% IS AND WHAT IT IS USED FOR
Albunorm 5% belongs to the pharmacotherapeutic group: blood
substitutes and plasma protein fractions.
The product is given to patients to restore and maintain circulating
blood volume where a deficiency in volume has been demonstrated.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALBUNORM 5%
DO NOT USE ALBUNORM 5%
-
if you are allergic to human albumin preparations or any of the other
ingredients of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Albunorm 5%.
Take special care with Albunorm 5%
-
if you are at special risk from increased blood volume e.g. in case
of severe heart disorders, high blood pressure, dilated veins of the
oesophagus, fluid in the lung, bleeding disorders, severely lowered
red blood cell count or without urine output.
-
when
there
are
signs
for
increased
blood
volume
(headache,
breathing disorder, jugular vein congestion) or increased blood
pressure. The infusion should be stopped immediately.
-
when there are signs of an allergic reaction. The infusion should be
stopped immediately.
-
when it is used

Summary of Product characteristics

OBJECT 1
ALBUNORM5%, 50G/L, SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 16-Mar-2015 | Octapharma
Limited
1. Name of the medicinal product
Albunorm 5%, 50 g/l, solution for infusion
2. Qualitative and quantitative composition
Albunorm 5% is a solution containing 50 g/l of total protein of which
at least 96% is human albumin.
A bottle of 100 ml contains 5 g of human albumin.
A bottle of 250 ml contains 12.5 g of human albumin.
A bottle of 500 ml contains 25 g of human albumin.
Excipients:
Sodium (144-160 mmol/l)
Albunorm 5% is a mildly hypooncotic solution.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
The solution is a clear, slightly viscous liquid; it is 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 individual
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
Paediatric population
Data on the use of Albunorm 5% in children are limited; therefore, the
product should only be
administered to these individuals if the benefits clearly outweigh
potential risks.
Method of administration