देश: माल्टा
भाषा: अंग्रेज़ी
स्रोत: Medicines Authority
ALBUMIN, HUMAN
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
B05AA01
ALBUMIN, HUMAN 20 % (W/V)
SOLUTION FOR INFUSION
ALBUMIN, HUMAN 20 % (W/V)
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2011-06-08
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ALBIOMIN 20% (200 G/L), SOLUTION FOR INFUSION Human albumin READ ALL OF THE 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 or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Albiomin 20% (200 g/l) is and what it is used for 2. What you need to know before you use Albiomin 20% (200 g/l) 3. How to use Albiomin 20% (200 g/l) 4. Possible side effects 5. How to store Albiomin 20% (200 g/l) 6. Contents of the pack and other information 1. WHAT ALBIOMIN 20% (200 G/L) IS AND WHAT IT IS USED FOR Albiomin 20% (200 g/l) is a solution for infusion (into a vein). 1 litre solution contains 200 g human plasma protein of which at least 96% is human albumin. Albiomin 20% (200 g/l) is used to restore and maintain circulating blood volume where there is a low blood volume and the use of a colloid, such as albumin, is required. _ _ _ _ 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALBIOMIN 20% (200 G/L) DO NOT USE ALBIOMIN 20% (200 G/L): • if you are allergic to albumin preparations or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Suspicion of allergic or anaphylactic type reactions requires an immediate stop of the infusion. In case of shock, standard medical treatment for shock should be applied. The infusion will also be stopped if you develop any of the following conditions as a sign of cardiovascular overload (hypervolaemia): • headache • dyspnoea (difficulties in breathing) • jugular vein congestion (a build up of fluid in a neck vein) • increased blood pressure • raised venous pressure (increased pressure in the veins) • pulmonary oedema (water on the lungs) Page 2 of 6 TALK TO YOUR DOCTOR IF YOU SUFFER FROM ANY पूरा दस्तावेज़ पढ़ें
Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 . NAME OF THE MEDICINAL PRODUCT Albiomin 20% (200 g/l), solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Human albumin Albiomin 20% (200 g/l) is a solution containing 200 g/l of total protein of which at least 96% is human albumin. Each vial of 50 ml contains 10 g of human plasma protein of which at least 96% is human albumin. Each vial of 100 ml contains 20 g of human plasma protein of which at least 96% is human albumin. The product has a hyperoncotic effect. Excipients with known effect: One vial of 50 ml Albiomin 20% (200 g/l) contains approximately 140 mg sodium (6.1 mmol). One vial of 100 ml Albiomin 20% (200 g/l) contains approximately 280 mg sodium (12.2 mmol). For the full list of excipients, see 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. 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 or 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 • haemaotcrit / haemoglobin METHOD OF ADMINISTRATION Intravenous use Human albumin can be directly administered by the intravenous route, or it can also be diluted in an isotonic solution (e.g. 0.9% sodium chloride). The infusion rate s पूरा दस्तावेज़ पढ़ें