Albunorm Octapharma 20% 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:

200mg/ml

Farmacevtska oblika:

solution for i/v infusion

Enote v paketu:

50ml and 100ml glass bottle

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2019-10-09

Navodilo za uporabo

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUNORM OCTAPHARMA 20%
200 G/L, SOLUTION FOR INFUSION
Human albumin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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 symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Albunorm Octapharma 20% is and what it is used for
2.
Before you use Albunorm Octapharma 20%
3.
How to use Albunorm Octapharma 20%
4.
Possible side effects
5.
How to store Albunorm Octapharma 20%
6.
Further information
1.
WHAT ALBUNORM OCTAPHARMA 20% IS AND WHAT IT IS USED FOR
Albunorm Octapharma 20% 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.
BEFORE YOU USE ALBUNORM OCTAPHARMA 20%
DO NOT USE ALBUNORM OCTAPHARMA 20%
-
if you are allergic (hypersensitive) to human albumin preparations or
any of the other
ingredients of Albunorm Octapharma 20%
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TAKE SPECIAL CARE WITH ALBUNORM OCTAPHARMA 20%
-
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 in patients with severe tra

Lastnosti izdelka

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INSTRUCTIONS FOR USE
(SUMMARY OF PRODUCT CHARACTERISTICS)
1
NAME OF THE MEDICINAL PRODUCT
Albunorm Octapharma 20%
_,_
200 g/l
_, _
solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Albunorm Octapharma 20% is a solution containing 200 g/l of total
protein of which at least
96% is human albumin.
A bottle of 50 ml contains 10 g of human albumin.
A bottle of 100 ml contains 20 g of human albumin.
Excipients:
Sodium (144-160 mmol/l)
Albunorm Octapharma 20% is a hyperoncotic 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
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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 _
Data on the use of Albunorm Octapharma 20% in children are limited;
therefore, the product
should only be administered to these individuals if the benefits
clearly outweigh potential
risks.