ALBUNORM Solution for infusion (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Albunorm 5%, 50 g/l, solution for infusion.

2. Qualitative and quantitative composition

Albunorm 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. ...

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.

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 The dose required depends on the size of the patient, the ...

4.3. Contraindications

Hypersensitivity to albumin preparations or to any of the excipients.

4.4. Special warnings and precautions for use

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Suspicion of allergic or anaphylactic ...

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. Pregnancy and lactation

Pregnancy The safety of Albunorm 5% for use in human pregnancy has not been established in controlled clinical trials. However, clinical experience with albumin suggests that no harmful effects on the ...

4.7. Effects on ability to drive and use machines

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

4.8. Undesirable effects

Mild reactions such as flush, urticaria, fever, and nausea occur rarely. These reactions normally disappear rapidly when the infusion rate is slowed down or the infusion is stopped. Very rarely, severe ...

4.9. Overdose

Hypervolaemia may occur if the dosage and rate of infusion are too high. At the first clinical signs of cardiovascular overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure, ...

5.1. Pharmacodynamic properties

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

5.2. Pharmacokinetic properties

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 permeability will ...

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 chloride 7.7. g/l N-acetyl-DL-tryptophan 1 g/l Caprylic acid 0.6 g/l Water for injections ad 1000 ml Electrolytes: Sodium 144-160 mmol/l

6.2. Incompatibilities

Human albumin solution must not be mixed with other medicinal products (except those mentioned in 6.6) whole blood and packed red cells.

6.3. Shelf life

3 years. After the vial has been opened, the content should be used immediately.

6.4. Special precautions for storage

Do not store above +25°C. Store in the original container in order to protect from light. Do not freeze.

6.5. Nature and contents of container

100 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber). Pack size of 1 or 10. 250 ml of solution in infusion bottle (type II glass) with stopper (bromobutyl rubber). ...

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

Octapharma Ltd., The Zenith Building, 26 Spring Gardens, Manchester M2 1AB, United Kingdom

8. Marketing authorization number(s)

PL 10673/0030

9. Date of first authorization / renewal of the authorization

19/01/2014

10. Date of revision of the text

01/04/2020

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