País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Human albumin solution
CSL Behring GmbH
B05AA01
Human albumin solution
20, 200 gram(s)/litre
Solution for infusion
albumin
Not marketed
2020-07-31
CSL BEHRING HUMAN ALBUMIN CSL BEHRING PIL/IE/ENGLISH, REV.:18-SEP-2020/RMS DAY 20 POSITION CSL Behring Page 2 of 8 Human Albumin CSL Behring -IE-PIL_18-SEP-2020 PACKAGE LEAFLET: INFORMATION FOR THE USER HUMAN ALBUMIN CSL BEHRING, 200 G/L, SOLUTION FOR INFUSION Active substance: human albumin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Human Albumin CSL Behring is and what it is used for 2. What you need to know before you are given Human Albumin CSL Behring 3. How to use Human Albumin CSL Behring 4. Possible side effects 5. How to store Human Albumin CSL Behring 6. Contents of the pack and other information 1. WHAT _HUMAN ALBUMIN CSL BEHRING_ IS AND WHAT IT IS USED FOR _WHAT IS HUMAN ALBUMIN CSL BEHRING_ Human Albumin CSL Behring is a plasma substitute. _HOW HUMAN ALBUMIN CSL BEHRING WORKS_ Albumin stabilises the circulating blood volume. It is a carrier of hormones, enzymes, medicinal products and toxins. The albumin protein in Human Albumin CSL Behring is taken from human blood plasma. Therefore the albumin works exactly as if it was your own protein. _WHAT HUMAN ALBUMIN CSL BEHRING IS USED FOR_ Human Albumin CSL Behring is used to restore and stabilize the circulating blood volume. It is normally used under intensive care situations, when your blood volume has decreased critically. This may be the case e.g.: due to severe loss of blood after an injury _or_ due to a large surface burn The choice of using Human Albumin CSL Behring will be made by your doctor. It will depend on you Llegiu el document complet
Health Products Regulatory Authority 21 February 2022 CRN009XRV Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Human Albumin CSL Behring, 200 g/l, solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human Albumin CSL Behring is a solution containing 200 g/l of total protein of which at least 96 % is human albumin. A vial of 100 ml contains at least 19.2 g of human albumin. A vial of 50 ml contains at least 9.6 g of human albumin. The solution is hyperoncotic. Excipients with known effect: Sodium 125 mmol per litre. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. A clear, slightly viscous liquid; it is almost colourless, yellow, amber or green. 4 CLINICAL PARTICULARS 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 severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required. _ _ If human albumin is to be administered, haemodynamic performance should be monitored regularly; this may include: -arterial blood pressure and pulse rate -central venous pressure -pulmonary artery wedge pressure -urine output -electrolyte -haematocrit / haemoglobin _Paediatric Population_ The posology in children and adolescents (0-18 years) is not expected to be different from that of adults. Method of administration Human Albumin CSL Behring 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). For instructions on dilution of the medicinal product before administrati Llegiu el document complet