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Ιατροφαρμακευτική πληροφόρηση για τον επαγγελματία υγείας

Φάρμακα Δραστικές ουσίες Συμπληρώματα διατροφής Έλεγχος συγχορήγησης Νόσοι ICD-10
Κλαύδιος Γαληνός
Είσοδος χρηστών
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Βιβλιογραφική αναφορά

Προτάσεις

SPC, UK: Alburex 5, 50 g/l and Alburex 20, 200 g/l, solution for infusion (2012)

Εκδότης

Εκδότης CSL Behring UK Limited
Διεύθυνση Hayworth House, Market Place, Haywards Heath, West Sussex, RH16 1DB, UK
Σφάλμα Για την προβολή της πλήρους καταχώρησης χρειάζεται να έχετε συνδρομή σε ισχύ (αγορά συνδρομής).
Ολοκληρώνοντας τη διαδικασία δωρεάν εγγραφής θα αποκτήσετε, χωρίς καμία δέσμευση εκ μέρους σας, συνδρομή διάρκειας 30 ημερών.

Περιεχόμενα

Name of the medicinal product

Alburex® 5, 50 g/l, solution for infusion. Alburex® 20, 200 g/l, solution for infusion.

Qualitative and quantitative composition

Alburex 5 is a solution containing 50 g/l of total protein of which at least 96% is human albumin. Alburex ...

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 ...

Posology and method of administration

The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the ...

Contraindications

Hypersensitivity to albumin preparations or to any of the excipients.

Special warnings and precautions for use

Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the infusion. ...

Interaction with other medicinal products and other forms of interaction

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

Pregnancy and lactation

The safety of Alburex for use in human pregnancy has not been established in controlled clinical trials. ...

Effects on ability to drive and use machines

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

Undesirable effects

Mild reactions such as flush, urticaria, fever and nausea occur rarely. These reactions normally disappear ...

Overdose

Hypervolaemia may occur if the dosage and infusion rate are too high. At the first clinical signs of ...

Pharmacodynamic properties

Pharmacotherapeutic group: plasma substitutes and plasma protein fractions ATC code: B05AA01 Human albumin ...

Pharmacokinetic properties

Under normal conditions, the total exchangeable albumin pool is 4–5 g/kg body weight, of which 40–45% ...

Preclinical safety data

Human albumin is a normal constituent of human plasma and acts like physiological albumin. In animals, ...

List of excipients

Sodium N-acetyltryptophanate Sodium caprylate Sodium chloride Water for injections

Incompatibilities

Human albumin must not be mixed with other medicinal products (except those mentioned in 6.6), whole ...

Shelf life

3 years. Once the vial has been opened, the contents should be used immediately.

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 ...

Nature and contents of container

Alburex 5: 100 ml of solution in a single vial (glass type II) with a stopper (chlorobutyl). 250 ml of ...

Special precautions for disposal and other handling

Alburex 5 only: The solution can be directly administered by the intravenous route. Alburex 20 only: ...

Marketing authorization holder

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

Marketing authorization number(s)

Alburex 5: PL 15036/0031 Alburex 20: PL 15036/0032

Date of first authorization / renewal of the authorization

07 January 2010

Date of revision of the text

12 August 2010
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.