Country: Armenia
Bahasa: Inggeris
Sumber: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
albumin human
Octapharma Pharmazeutika Produktionsges. m.b.H.
B05AA01
albumin human
200mg/ml
solution for i/v infusion
50ml and 100ml glass bottle
Prescription
Registered
2019-10-09
_20190531_pil_666_AM_02.01_en _ _ _ _1 / 5 _ PACKAGE LEAFLET: INFORMATION FOR THE USER ALBUNORM OCTAPHARMA 20% 200 G/L, SOLUTION FOR INFUSION Human albumin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Albunorm Octapharma 20% is and what it is used for 2. Before you use Albunorm Octapharma 20% 3. How to use Albunorm Octapharma 20% 4. Possible side effects 5. How to store Albunorm Octapharma 20% 6. Further information 1. WHAT ALBUNORM OCTAPHARMA 20% IS AND WHAT IT IS USED FOR Albunorm Octapharma 20% belongs to the pharmacotherapeutic group: blood substitutes and plasma protein fractions. The product is given to patients to restore and maintain circulating blood volume where a deficiency in volume has been demonstrated. 2. BEFORE YOU USE ALBUNORM OCTAPHARMA 20% DO NOT USE ALBUNORM OCTAPHARMA 20% - if you are allergic (hypersensitive) to human albumin preparations or any of the other ingredients of Albunorm Octapharma 20% _20190531_pil_666_AM_02.01_en _ _ _ _2 / 5 _ TAKE SPECIAL CARE WITH ALBUNORM OCTAPHARMA 20% - if you are at special risk from increased blood volume e.g. in case of severe heart disorders, high blood pressure, dilated veins of the oesophagus, fluid in the lung, bleeding disorders, severely lowered red blood cell count or without urine output. - when there are signs for increased blood volume (headache, breathing disorder, jugular vein congestion) or increased blood pressure. The infusion should be stopped immediately. - when there are signs of an allergic reaction. The infusion should be stopped immediately. - when it is used in patients with severe tra Baca dokumen lengkap
_20190531_spc_666_AM_02.01_en_ _ _ _ _ _page 1 of 7 _ INSTRUCTIONS FOR USE (SUMMARY OF PRODUCT CHARACTERISTICS) 1 NAME OF THE MEDICINAL PRODUCT Albunorm Octapharma 20% _,_ 200 g/l _, _ solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Albunorm Octapharma 20% is a solution containing 200 g/l of total protein of which at least 96% is human albumin. A bottle of 50 ml contains 10 g of human albumin. A bottle of 100 ml contains 20 g of human albumin. Excipients: Sodium (144-160 mmol/l) Albunorm Octapharma 20% is a hyperoncotic solution. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. The solution is a clear, slightly viscous liquid; it is 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 _20190531_spc_666_AM_02.01_en_ _ _ _ _ _page 2 of 7 _ 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 - haematocrit/haemoglobin _Paediatric population _ Data on the use of Albunorm Octapharma 20% in children are limited; therefore, the product should only be administered to these individuals if the benefits clearly outweigh potential risks. Baca dokumen lengkap