Uman Albumin 200g/l Solution for infusion (100ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ALBUMIN, HUMAN

Available from:

Kedrion S.p.A Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga - Lucca, Italy

ATC code:

B05AA01

INN (International Name):

ALBUMIN, HUMAN 20 g/100ml

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

ALBUMIN, HUMAN 20 g/100ml

Prescription type:

POM

Therapeutic area:

BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2005-09-02

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
UMAN ALBUMIN 200 G/L SOLUTION FOR INFUSION
Human albumin from human plasma
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, pharmacist or
nurse.
-
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 UMAN ALBUMIN is and what it is used for
2.
What you need to know before you use UMAN ALBUMIN
3.
How to use UMAN ALBUMIN
4.
Possible side effects
5.
How to store UMAN ALBUMIN
6.
Contents of the pack and other information
1.
WHAT UMAN ALBUMIN IS AND WHAT IT IS USED FOR
UMAN ALBUMIN contains albumin (an important human blood protein) and
belongs to a class of
medicinal products called “Plasma substitutes and plasma protein
fractions”. It is made from human
plasma collected from blood donors.
This product is used to restore and maintain the volume of circulating
blood in patients who have lost
blood and/or body fluids for some reason, and the use of a colloid
(substitute of plasma) is appropriate.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE UMAN ALBUMIN
DO NOT USE UMAN ALBUMIN
If you are allergic (hypersensitive) to human albumin or to any of the
other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using
UMAN ALBUMIN
.
If in the past you had signs of an allergic response
(hypersensitivity) to human albumin, inform your
doctor or nurse immediately.
Suspicion of allergic or anaphylactic type reactions requires
immediate discontinuation of the
infusion. In case of shock, standard medical treatment for shock must
be implemented.
Albumin must be used

Summary of Product characteristics

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_SUMMARY OF PRODUCT CHARACTERISTICS _
1
NAME OF THE MEDICINAL PRODUCT
UMAN ALBUMIN 200 g/l Solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
UMAN ALBUMIN
200 G/L
Solution containing total plasma proteins
to
20%
of which human albumin at least to
95%
a vial of 50 ml contains human albumin
equal to
10 g
a vial of 100 ml contains human albumin
equal to
20 g
The solution is
Hyperoncotic
Excipient with known effect:
This medicinal product contains up to 157 mg sodium per vial of 50 ml
and 314 mg per vial
of 100 ml.
For the full list of 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.
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
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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 _
The safety and efficacy of UMAN ALBUMIN in children have not been
established
by
controlled clinical trials and its use in paediatric population is
based only on estabilished
medical practice. For this reason, UMAN ALBUMIN must be used in
children only if clearly
necessary.
UMAN ALBUMIN can be