Human Albumin Biotest 5% solution for infusion 250ml vials

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Albumin solution human

Inapatikana kutoka:

Biotest (UK

ATC kanuni:

B05AA01

INN (Jina la Kimataifa):

Albumin solution human

Kipimo:

50mg/1ml

Dawa fomu:

Solution for infusion

Njia ya uendeshaji:

Intravenous

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: ; GTIN: 04036124017736

Taarifa za kipeperushi

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PACKAGE LEAFLET: INFORMATION FOR THE USER
HUMAN ALBUMIN BIOTEST 5%, 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. 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 5% is and what it is used for
2. What you need to know before you are given Human Albumin Biotest 5%
3. How you are given Human Albumin Biotest 5%
4. Possible side effects
5. How to store Human Albumin Biotest 5%
6. Contents of the pack and other information
1. WHAT HUMAN ALBUMIN BIOTEST 5% IS AND WHAT IT IS USED FOR
Human Albumin Biotest 5% is a solution for infusion (into a vein).
1000 ml solution contains 50 g human
plasma protein of which at least 95 % is human albumin.
Human Albumin Biotest 5% 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 5%
YOU WILL NOT RECEIVE HUMAN ALBUMIN BIOTEST 5% IF:

you are allergic to albumin preparations or to any of the other
ingredients of this medicine (listed in
section 6).
HUMAN ALBUMIN BIOTEST 5%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 congestio

Tabia za bidhaa

OBJECT 1
HUMAN ALBUMIN BIOTEST 5%
Summary of Product Characteristics Updated 16-Oct-2015 | Biotest (UK)
Ltd
1. Name of the medicinal product
Human Albumin Biotest 5%, solution for infusion
2. Qualitative and quantitative composition
Human albumin
Human Albumin Biotest 5% is a solution containing 50 g/l of total
protein of which at least 95% is human
albumin.
Each vial of 250 ml contains 12.5 g of human plasma protein of which
at least 95% is human albumin.
The product has a mildly hypooncotic effect.
Excipients with known effect:
1 litre of Human Albumin Biotest 5% contains 145 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.
The infusion rate should be adjusted according to the individual
circumstances and the indication.
In plasma exchange t