Country: Malta
Language: English
Source: Medicines Authority
HUMAN ALBUMIN, SOLUTION
CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany
B05AA01
HUMAN ALBUMIN SOLUTION 200 g/l
SOLUTION FOR INFUSION
HUMAN ALBUMIN SOLUTION 200 g/l
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2019-02-01
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ALBUREX 5, 50 G/L, SOLUTION FOR INFUSION & ALBUREX 20, 200 G/L, SOLUTION FOR INFUSION Human albumin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 healthcare professional. • If you get any side effects, talk to your doctor or healthcare professional. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET: 1. What Alburex is and what it is used for 2. What you need to know before you are given Alburex 3. How to use Alburex 4. Possible side effects 5. How to store Alburex 6. Contents of the pack and other information 1. WHAT ALBUREX IS AND WHAT IT IS USED FOR WHAT ALBUREX IS Alburex is a plasma substitute. HOW ALBUREX WORKS Albumin stabilises the circulating blood volume. It is a carrier of hormones, enzymes, medicines and toxins. The albumin protein in Alburex is isolated from human blood plasma. Therefore the albumin works exactly as if it was your own protein. WHAT ALBUREX IS USED FOR Alburex is used to restore and stabilise the circulating blood volume. It is normally used under intensive care situations, when your blood volume has decreased critically. This may be the case e.g.: • due to severe loss of blood after an injury, _or_ • due to a large surface burn The choice of using Alburex will be made by your doctor. It will depend on your individual clinical situation. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALBUREX ➔ Read this section carefully. The information given should be taken into consideration by you and your doctor before you are given Alburex. DO NOT USE ALBUREX • If you are allergic (hypersensitive) to human albumin or any of the other ingredients of this medicine (listed in section 6). Page 2 of 6 WARNINGS AND PRECAUTIONS ➔ Talk to your doctor or healthcare professional before you are given Alburex. Which cir Read the complete document
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 7 1. NAME OF THE MEDICINAL PRODUCT Alburex 20, 200 g/l, solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Alburex 20 is a solution containing 200 g/l of total protein of which at least 96% is human albumin. One vial of 50 ml contains 10 g of human albumin. One vial of 100 ml contains 20 g of human albumin. Alburex 20 is hyperoncotic to normal plasma. Excipient with known effect: Alburex 20 contains approximately 3.2 mg sodium per ml of solution (140 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 Page 3 of 7 • pulmonary artery wedge pressure • urine output • electrolyte • haematocrit / haemoglobin _Paediatric population _ The posology in children and adolescents (0-18 years) should be adjusted to the patient’s individual requirements. Method of administration Human albumin can be directly administered by the intravenous route, or it can also b Read the complete document