Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Human albumin solution
Instituto Grifols S.A.
B05AA01
Human albumin solution
50 gram(s)/litre
Solution for infusion
albumin
Not marketed
2021-10-08
PACKAGE LEAFLET: INFORMATION FOR THE USER ALBUTEIN 50 G/L, SOLUTION FOR INFUSION human albumin READ ALL THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE; 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 symptoms are the same as yours. - If you get any side effects tell your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Albutein 50 g/l is and what it is used for 2. What you need to know before you use Albutein 50 g/l 3. How to use Albutein 50 g/l 4. Possible side effects 5. How to store Albutein 50 g/l 6. Contents of the pack and other information 1. WHAT ALBUTEIN 50 G/L IS AND WHAT IT IS USED FOR Albutein 50 g/l is a solution for intravenous infusion containing proteins extracted from human plasma (plasma proteins), which is the liquid part of the blood. Each bottle/bag contains a solution of 50 g plasma protein/litre of which at least 95% is human albumin. This medicinal product belongs to a group of medicines known as plasma substitutes and plasma protein fractions. Albutein 50 g/l is used to restore and maintain the circulating blood volume where volume deficiency has been demonstrated and use of a plasma substitute is appropriate. Albutein can be used for all age groups. For children, see section 4. If you have any questions about the use of Albutein 50 g/l please ask your doctor. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALBUTEIN 50 G/L DO NOT USE ALBUTEIN 50 G/L - If you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before you start using Albutein 50 g/l. Special care should be taken with Albutein 50 g/l • If you have a special risk Lire le document complet
Health Products Regulatory Authority 16 January 2024 CRN00DJ8Z Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Albutein, 50 gram(s)/litre, solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Albutein 50 g/l is a solution containing 50 g/l (5%) of total protein of which at least 95% is human albumin. A bottle of 100 ml contains 5 g of human albumin. A bottle of 250 ml contains 12.5 g of human albumin. A bottle of 500 ml contains 25 g of human albumin. A bag of 100 ml contains 5 g of human albumin. A bag of 250 ml contains 12.5 g of human albumin. A bag of 500 ml contains 25 g of human albumin. Albutein 50 g/l has a mildly hypooncotic effect to normal plasma. Excipient(s) with known effect The solution contains between 130 - 160 mmol/l of sodium and less than 2 mmol/l of potassium. Produced from the plasma of human donors. For a 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. Albutein can be used for all age groups. For paediatric population, see section 4.4. 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 Health Products Regulatory Authority 16 January 202 Lire le document complet