Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Plasma protein containing at least 95% human albumin
Baxalta Innovations GmbH
B05AA; B05AA01
Plasma protein containing at least 95% human albumin
50 gram(s)/litre
Solution for infusion
intravenous route
250 ml of solution in a vial, pack size of 1 or 24. 500 ml of solution in a vial, – pack size of 1 or 10
Product subject to prescription which may not be renewed (A)
plasma substitutes and plasma protein fractions
Blood substitutes and plasma protein fractions; albumin
Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate.
Marketed
2006-12-21
1 PACKAGE LEAFLET: INFORMATION FOR THE USER HUMAN ALBUMIN BAXALTA 50 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, 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 Human Albumin Baxalta 50 g/l is and what it is used for 2. What you need to know before you use Human Albumin Baxalta 50 g/l 3. How to use Human Albumin Baxalta 50 g/l 4. Possible side effects 5. How to store Human Albumin Baxalta 50 g/l 6. Contents of the pack and other information 1. WHAT HUMAN ALBUMIN BAXALTA 50 G/L IS AND WHAT IT IS USED FOR Human Albumin Baxalta 50 g/l contains a protein called albumin found in the liquid component of the blood (the plasma) and belongs to the group of medical products called “plasma substitutes and plasma protein fractions”. It is made from human blood collected from blood donors. A vial of 250 ml contains 12.5 g of human albumin. A vial of 500 ml contains 25 g of human albumin. Human albumin is used to restore and maintain blood volume in patients who have lost blood or fluid due to certain medical conditions. The choice of albumin rather than an artificial substitute and the dose needed will depend on the clinical situation of the individual patient. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE HUMAN ALBUMIN BAXALTA 50 G/L DO NOT USE HUMAN ALBUMIN BAXALTA 50 G/L: - if you are allergic to human albumin 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 Human Albumin Baxalta 50 g/l. - if you t Прочитать полный документ
Health Products Regulatory Authority 19 January 2022 CRN00CRS9 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Human Albumin Baxalta 50 g/l Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Human Albumin Baxalta 50 g/l is a solution containing 50 g/l of total protein of which at least 95% is human albumin. A vial of 250 ml contains 12.5 g of human albumin. A vial of 500 ml contains 25 g of human albumin. Human albumin 50 g/l is mildly hypooncotic. 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: - arterial blood pressure and pulse rate - central venous pressure - pulmonary artery wedge pressure - urine output - electrolyte concentration - haematocrit/haemoglobin - clinical signs of cardiac/respiratory failure (e.g., dyspnoea) - clinical signs of increasing intra-cranial pressure (e.g., headache) Method of administration Health Products Regulatory Authority 19 January 2022 CRN00CRS9 Page 2 of 6 Human Albumin Bax Прочитать полный документ