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 Φάρμακα Α - Ζ  Συγχορήγηση  Μητρότητα

ALBUREX 20, 200g/l Solution for infusion (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Alburex 20, 200 g/l, solution for infusion.

Qualitative and quantitative composition

Alburex 20 is a solution containing 200 g/l of total protein of which at least 96% is human albumin. One vial of 50 ml contains 10 g of human albumin. One vial of 100 ml contains 20 g of human albumin. ...

Pharmaceutical form

Solution for infusion. A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green.

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 ...

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 ...

Contraindications

Hypersensitivity to albumin preparations or to any of the excipients listed in section 6.1.

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 ...

Interaction with other medicinal products and other forms of interaction

No specific interactions of human albumin with other medicinal products are known.

Fertility, pregnancy and lactation

Pregnancy No animal reproduction studies have been conducted with Alburex 20. Its safety for use in human pregnancy has not been established in controlled clinical trials and therefore it should only be ...

Effects on ability to drive and use machines

No effects on the ability to drive and use machines have been observed.

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 ...

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 ...

Pharmacodynamic properties

Pharmacotherapeutic group: plasma substitutes and plasma protein fractions ATC code: B05AA01 Human albumin accounts quantitatively for more than half of the total protein in the plasma and represents about ...

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 ...

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 ...

List of excipients

Sodium N-acetyltryptophanate 16 mmol/l Sodium caprylate 16 mmol/l Sodium chloride q.s.to a sodium content of 140 mmol/l Water for injections q.s. to 1 litre

Incompatibilities

Human albumin must not be mixed with other medicinal products, whole blood and packed red cells.

Shelf life

Shelf life: 3 years.

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.

Nature and contents of container

50 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer). 100 ml of solution in a single vial (glass type II) with a stopper (halogenated synthetic elastomer). ...

Special precautions for disposal and other handling

The solution can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 5% glucose or 0.9% sodium chloride). Albumin solutions must not be diluted with ...

Marketing authorization holder

CSL Behring GmbH, Emil-von-Behring-Strasse 76, 35041, Marburg, Germany

Marketing authorization number(s)

UK: PL 15036/0032 IE: PA 800/8/2

Date of first authorization / renewal of the authorization

UK: 07 January 2010 / 17 August 2012 IE: 13 June 2014 / 30 January 2019

Date of revision of the text

14 September 2018

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