Country: মাল্টা
ভাষা: ইংরেজি
সূত্র: Medicines Authority
ALBUMIN, HUMAN
Baxalta Innovations GmbH Industriestrasse 67, 1221, Vienna, Austria
B05AA01
ALBUMIN, HUMAN 200 g/l
SOLUTION FOR INFUSION
ALBUMIN, HUMAN 200 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2007-12-05
1 PACKAGE LEAFLET: INFORMATION FOR THE USER FLEXBUMIN 200 G/L SOLUTION FOR INFUSION Human albumin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANTINFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - 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 Flexbumin 200 g/l is and what it is used for 2. What you need to know before you use Flexbumin 200 g/l 3. How to use Flexbumin 200 g/l 4. Possible side effects 5. How to store Flexbumin 200 g/l 6. Contents of the pack and other information 1. WHAT FLEXBUMIN 200 G/L IS AND WHAT IT IS USED FOR Flexbumin 200 g/l is a solution of plasma protein and belongs to the pharmacotherapeutic group of plasma substitutes and plasma protein fractions. Plasma is the fluid in which blood cells are suspended. This medicine is used for restoration and maintenance of circulating blood volume when there is not enough blood volume. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE FLEXBUMIN 200 G/L DO NOT USE FLEXBUMIN 200 G/L - if you are allergic to human albumin or any of the other ingredients of this medicine (listed in section 6). WARNING AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Flexbumin 200 g/l. - If you get headache, difficulties in breathing or feeling faint during the treatment please tell your doctor or nurse. It can be an allergic reaction. - If you have: – decompensated heart failure – high blood pressure – oesophageal varices (swelled veins in the oesophagus) – pulmonary oedema (fluid in the lungs) – a tendency to spontaneous bleeding – severe anemia (lack of red blood cells) – decreased urine formation inform your doc সম্পূর্ণ নথি পড়ুন
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Flexbumin 200 g/l solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Flexbumin 200 g/l is a solution containing 200 g/l (20%) of total protein of which at least 95% is human albumin. A bag of 100 ml contains 20 g of human albumin. A bag of 50 ml contains 10 g of human albumin The solution is hyperoncotic. Excipients with known effect: Sodium 130-160 mmol/l 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. 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: 2 - arterial blood pressure and pulse rate - central venous pressure - pulmonary artery wedge pressure (PCW-pressure) - urine output - electrolyte - haematocrit/haemoglobin - clinical signs of cardiac/respiratory failure (e.g.dyspnoea) - clinical signs of increasing intra-cranial pressure (e.g. headache) Paediatric population The safety and efficacy of the use of Albumin (Human) solution in pediatric patients have not been established in company-sponsored clinical trials. Limited data on the use of Flexbumin 200 g/l in সম্পূর্ণ নথি পড়ুন