ALBUMAN Solution for infusion (2021)
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Περιεχόμενα
1. Name of the medicinal product
Albuman 200 g/l solution for infusion.
2. Qualitative and quantitative composition
Albuman 200 g/l is a solution containing 200 g/l (20%) of total protein of which at least 95% is human albumin. A vial contains either 10 g/50 ml or 20 g/100 ml of human albumin. The solution is hyperoncotic. ...
3. Pharmaceutical form
Solution for infusion. The solution is clear, slightly viscous; 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. Albuman 200 g/l is indicated in adults.
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 the active substance or to any of the excipients listed in section 6.1.
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 Albuman 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 course ...
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
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
<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
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 ...
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 caprylate, sodium chloride, sodium hydroxide or hydrochloric acid, water for injections.
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products, whole blood and packed red cells (except the solutions mentioned in 6.6).
6.3. Shelf life
3 years. After first opening: the product should be used immediately.
6.4. Special precautions for storage
Store below 25°C. Do not freeze. Store in the original package in order to protect from light.
6.5. Nature and contents of container
50 ml or 100 ml of solution in a vial (glass type II) with stopper (bromobutyl); pack size of 1. Not all pack sizes may be marketed.
6.6. Special precautions for disposal and other handling
The preparation 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 ...
7. Marketing authorization holder
Sanquin Plasma Products B.V., Plesmanlaan 125, NL-1066 CX Amsterdam, The Netherlands
8. Marketing authorization number(s)
RVG 103595
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 15 June 2009 Date of last renewal: April 15, 2012
10. Date of revision of the text
April 12, 2021
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