Country: Malta
Language: English
Source: Medicines Authority
ALBUMIN, HUMAN
Sanquin Plesmanlaan 125, 1066 CX Amsterdam, Netherlands
B05AA01
ALBUMIN, HUMAN 40 g/l
SOLUTION FOR INFUSION
ALBUMIN, HUMAN 40 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Withdrawn
2010-03-02
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ALBUMAN 40 G/L SOLUTION FOR INFUSION ALBUMAN 200 G/L SOLUTION FOR INFUSION Human albumin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Albuman solution for infusion is and what it is used for 2. Before you use Albuman solution for infusion 3. How to use Albuman solution for infusion 4. Possible side effects 5. How to store Albuman solution for infusion 6. Further information 1. WHAT ALBUMAN SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR Albuman solution for infusion contains the human protein albumin and is administered into a vein. Human albumin is a normal constituent of human plasma and acts like albumin present in your body when given as a replacement therapy. Albumin stabilises circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. Albumin is used for restoration and maintenance of circulating blood volume in your body where volume deficiency has been demonstrated and your doctor considers replacement therapy appropriate. The product is provided in two different strengths: Albuman 40 g/l and Albuman 200 g/l. 2. BEFORE YOU USE ALBUMAN SOLUTION FOR INFUSION DO NOT USE ALBUMAN SOLUTION FOR INFUSION - if you are allergic (hypersensitive) to albumin preparations or any of the other ingredients Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Albuman 40 g/l solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Albuman 40 g/l is a solution containing 40 g/l (4%) of total protein of which at least 95% is human albumin. A vial contains either 4 g/100 ml or 10 g/250 ml or 16 g/400 ml of human albumin. The solution is mildly hypooncotic. This medicinal product contains 140 mmol/l of sodium (3,2 g/l). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. The solution is clear, slightly viscous; 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. The choice of albumin rather than artificial colloid will depend on the clinical situation of the individual patient, based on official recommendations. 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 Page 2 of 5 - electrolyte - haematocrit/haemoglobin This product is suitable for Read the complete document