ALBUREX 5, 50 g/l Solution for infusion (2018)
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Περιεχόμενα
1. Name of the medicinal product
Alburex 5, 50 g/l, solution for infusion.
2. Qualitative and quantitative composition
Alburex 5 is a solution containing 50 g/l of total protein of which at least 96% is human albumin. One vial of 100 ml contains 5 g of human albumin. One vial of 250 ml contains 12.5 g of human albumin. ...
3. Pharmaceutical form
Solution for infusion. A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.
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 ...
4.2. Posology and method of administration
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patients individual requirements. Posology The dose required depends on the size of the patient, the ...
4.3. Contraindications
Hypersensitivity to albumin preparations or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. In case of shock, standard medical treatment for shock should be implemented. Albumin should be ...
4.5. Interaction with other medicinal products and other forms of interaction
No specific interactions of human albumin with other medicinal products are known.
4.6. Fertility, pregnancy and lactation
Pregnancy No animal reproduction studies have been conducted with Alburex 5. Its safety for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be ...
4.7. Effects on ability to drive and use machines
No effects on the ability to drive and use machines have been observed.
4.8. Undesirable effects
Summary of the safety profile Mild reactions with human albumin solutions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed ...
4.9. Overdose
Hypervolaemia may occur if the dosage and infusion rate are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion) or increased blood pressure, raised ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> plasma substitutes and plasma protein fractions <b>ATC code:</b> B05AA01 Human albumin accounts quantitatively for more than half of the total protein in the plasma and ...
5.2. Pharmacokinetic properties
Distribution Under normal conditions, the total exchangeable albumin pool is 4–5 g/kg body weight, of which 40–45% is present intravascularly and 55–60% in the extravascular space. Increased capillary ...
5.3. Preclinical safety data
Human albumin is a normal constituent of human plasma and acts like physiological albumin. In animals, single dose toxicity testing is of little relevance and does not permit the evaluation of toxic or ...
6.1. List of excipients
Sodium N-acetyltryptophanate 4 mmol/l Sodium caprylate 4 mmol/l Sodium chloride q.s.to a sodium content of 4 mmol/l Water for injections q.s.to 1 litre
6.2. Incompatibilities
Human albumin must not be mixed with other medicinal products, whole blood and packed red cells.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
6.5. Nature and contents of container
100 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer). 250 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer). ...
6.6. Special precautions for disposal and other handling
The solution can be directly administered by the intravenous route. Albumin solutions must not be diluted with water for injections as this may cause haemolysis in recipients. If large volumes are administered, ...
7. Marketing authorization holder
CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
8. Marketing authorization number(s)
UK: PL 15036/0031 IE: PA 800/8/1
9. Date of first authorization / renewal of the authorization
UK: 07 January 2010 / 17 August 2012 IE: 13 June 2014 / 30 January 2019
10. Date of revision of the text
14 September 2018
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