Country: Malta
Language: English
Source: Medicines Authority
ALBUMIN, HUMAN
Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium
B05AA01
ALBUMIN, HUMAN 200 g/l
SOLUTION FOR INFUSION
ALBUMIN, HUMAN 200 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2010-05-17
_Page 1 of 5 _ _ _ PACKAGE LEAFLET: INFORMATION FOR THE USER ALBUNORM 20% 200 G/L, SOLUTION FOR INFUSION Human albumin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Albunorm 20% is and what it is used for 2. What you need to know before you use Albunorm 20% 3. How to use Albunorm 20% 4. Possible side effects 5. How to store Albunorm 20% 6. Contents of the pack and other information 1. WHAT ALBUNORM 20% IS AND WHAT IT IS USED FOR Albunorm 20% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions. The product is given to patients to restore and maintain circulating blood volume where a deficiency in volume has been demonstrated. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALBUNORM 20% DO NOT USE ALBUNORM 20% - if you are allergic to human albumin preparations or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Albunorm 20%. Take special care with Albunorm 20% _Page 2 of 5 _ _ _ - if you are at special risk from increased blood volume e.g. in case of severe heart disorders, high blood pressure, dilated veins of the oesophagus, fluid in the lung, bleeding disorders, severely lowered red blood cell count or without urine output. - when there are signs for increased blood volume (headache, breathing disorder, jugular vein congestion) or increased blood pressure. The infusion should be stopped immediately. - when there are signs of an allergic reaction. The infusion Read the complete document
_Page 1 of 7 _ _ _ SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Albunorm 20% _,_ 200 g/l _, _ solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Albunorm 20% is a solution containing 200 g/l of total protein of which at least 96% is human albumin. A bottle of 50 ml contains 10 g of human albumin. A bottle of 100 ml contains 20 g of human albumin. Albunorm 20% is a hyperoncotic solution. Excipients with known effect: Sodium (144-160 mmol/l) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. Aclear, 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 _Page 2 of 7 _ _ _ - pulmonary artery wedge pressure - urine output - electrolyte - haematocrit/haemoglobin _ _ _Paediatric population _ Data on the use of Albunorm 20% in children are limited; therefore, the product should only be administered to these individuals if the benefits clearly outweigh potential risks. Method of administration Human albumin 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). The infusion rate should be adjusted according to the individual circumstances Read the complete document