Albunorm Octapharma 5% solution for i/v infusion

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

albumin human

Dostopno od:

Octapharma Pharmazeutika Produktionsges. m.b.H.

Koda artikla:

B05AA01

INN (mednarodno ime):

albumin human

Odmerek:

50mg/ml

Farmacevtska oblika:

solution for i/v infusion

Enote v paketu:

100ml glass bottle, 250ml glass bottle, 500ml glass bottle

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2020-10-21

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUNORM OCTAPHARMA 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 Octapharma 5% is and what it is used for
2.
What you need to know before you use Albunorm Octapharma 5%
3.
How to use Albunorm Octapharma 5%
4.
Possible side effects
5.
How to store Albunorm Octapharma 5%
6.
Contents of the pack and other information
1.
WHAT ALBUNORM OCTAPHARMA 5% IS AND WHAT IT IS USED FOR
Albunorm Octapharma 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
OCTAPHARMA 5%
DO NOT USE ALBUNORM OCTAPHARMA 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
Octapharma 5%.
_-_
_-_
_ALBUNORM 5%_
_SOLUTION FOR INFUSION_
_1.3.1_
_COMMON - ENGLISH - PACKAGE LEAFLET_
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Take special care with Albunorm Octapharma 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

Lastnosti izdelka

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Albunorm Octapharma 5%
_, _
50 g/l,
_ _
solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Albunorm Octapharma 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.
Albunorm Octapharma 5% is a mildly hypooncotic solution.
Excipients with known effect:
Sodium (144-160 mmol/l)
For 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
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:
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arterial blood pressure and pulse rate
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central venous pressure
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pulmonary artery wedge pressure
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urine output
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electrolyte
-
haematocrit/haemoglobin
_Paediatric population _
Data on the use of Albunorm Octapharma 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
Human albumin can be directly administered by the intravenous route.
The infusion rate sh