Human Albumin Biotest 20% solution for infusion 100ml vials

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Albumin solution human

Διαθέσιμο από:

Biotest (UK

Φαρμακολογική κατηγορία (ATC):

B05AA01

INN (Διεθνής Όνομα):

Albumin solution human

Δοσολογία:

200mg/1ml

Φαρμακοτεχνική μορφή:

Solution for infusion

Οδός χορήγησης:

Intravenous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: ; GTIN: 04036124017934

Φύλλο οδηγιών χρήσης

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PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMAN ALBUMIN BIOTEST 20%, SOLUTION FOR INFUSION
Human albumin
READ THIS ENTIRE 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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Human Albumin Biotest 20% is and what it is used for
2. What you need to know before you are given Human Albumin Biotest
20%
3. How you are given Human Albumin Biotest 20%
4. Possible side effects
5. How to store Human Albumin Biotest 20%
6. Contents of the pack and other information
1. WHAT HUMAN ALBUMIN BIOTEST 20% IS AND WHAT IT IS USED FOR
Human Albumin Biotest 20% is a solution for infusion (into a vein).
1000 ml solution contains 200 g human
plasma protein of which at least 95% is human albumin.
Human Albumin Biotest 20% is used to restore and maintain circulating
blood volume where there is a low
blood volume and the use of a colloid, such as albumin, is required.
_ _
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN HUMAN ALBUMIN BIOTEST
20%
YOU WILL NOT RECEIVE HUMAN ALBUMIN BIOTEST 20% IF:

you are allergic to albumin preparations or to any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS:
Suspicion of allergic or anaphylactic type reactions requires an
immediate stop of the injection. In case of
shock, standard medical treatment for shock should be applied.
The infusion will also be stopped if you develop any of the following
conditions as a sign of cardiovascular
overload (hypervolaemia):

headache

dyspnoea (difficulties in breathing)

jugular vein congestion (a build u

Αρχείο Π.Χ.Π.

OBJECT 1
HUMAN ALBUMIN BIOTEST 20%
Summary of Product Characteristics Updated 16-Oct-2015 | Biotest (UK)
Ltd
1. Name of the medicinal product
Human Albumin Biotest 20%, solution for infusion
2. Qualitative and quantitative composition
Human albumin
Human Albumin Biotest 20% is a solution containing 200 g/l of total
protein of which at least 95% is
human albumin.
Each vial of 50 ml contains 10 g of human plasma protein of which at
least 95% is human albumin.
Each vial of 100 ml contains 20 g of human plasma protein of which at
least 95% is human albumin.
The product has a hyperoncotic effect.
Excipients with known effect:
1 litre of Human Albumin Biotest 20% contains 122 mmol sodium.
For the full list of excipients, see 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 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 or 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
• haemaotcrit / haemoglobin
METHOD OF ADMINISTRATION
Human albumin can be directly administered by the intravenous route,
or it can also be diluted