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, 250ml, 500ml glass bottle

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2019-10-09

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALBUNORM 5%
50 G/L, SOLUTION FOR INFUSION
Human albumin
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
- Keep this leafl et. 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 leafl et, please tell your doctor
or pharmacist.
IN THIS LEAFL ET:
1.
What Albunorm 5% is and what it is used for
2.
Before you use Albunorm 5%
3.
How to use Albunorm 5%
4.
Possible side effects
5.
How to store Albunorm 5%
6.
Further information
1.
WHAT ALBUNORM 5% IS AND WHAT IT IS USED FOR
Albunorm 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 defi ciency in volume has
been demonstrated.
2.
BEFORE YOU USE ALBUNORM 5%
DO NOT USE ALBUNORM 5%
-
if you are allergic (hypersensitive) to human albumin
preparations or any of the other ingredients of Albunorm 5%
TAKE SPECIAL CARE WITH ALBUNORM 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, fl uid 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 traumatic brain
injury.
6.
FURTHER INFORMATION
WHAT ALBUNORM 5% CONTAINS
-
The active substance is 50 g/l human albumin derived from
human plasma (bottle of 100, 250, 500 ml).
-
The other ingredients are sodium, pota

Lastnosti izdelka

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INSTRUCTIONS FOR USE
(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.
Excipients:
Sodium (144-160 mmol/l)
Albunorm Octapharma 5% is a mildly hypooncotic 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 5% in children are limited;
therefore, the product
should only be administered to these individ