Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
HUMAN PLASMA PROTEIN NOT CONTAINING LESS THAN 96% HUMAN ALBUMIN
Octapharma Limited
B05AA01
HUMAN PLASMA PROTEIN NOT CONTAINING LESS THAN 96% HUMAN ALBUMIN
50 g/l
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Blood substitutes and plasma protein fractions
Authorised
2009-06-25
_2131066.PA0521_016_001.e55af9e3-1f69-44b9-aa6c-_ _ea82c7344bc3_3_.20140205_pil_664_IE_03.02_tracked.140207 _ _ 1/5 _ PACKAGE LEAFLET: INFORMATION FOR THE USER ALBUNORM 5% 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 or pharmacist. - 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. IN THIS LEAFLET: 1. What Albunorm 5% is and what it is used for 2. What you need to know before you use Albunorm 5% 3. How to use Albunorm 5% 4. Possible side effects 5. How to store Albunorm 5% 6. Contents of the pack and other information 1. WHAT ALBUNORM 5% IS AND WHAT IT IS USED FOR Albunorm 5% 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. WHAT YOU NEED TO KNOW BEFORE YOU ALBUNORM 5% DO NOT USE ALBUNORM 5% if you are allergic to human albumin preparations or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS _2131066.PA0521_016_001.e55af9e3-1f69-44b9-aa6c-_ _ea82c7344bc3_3_.20140205_pil_664_IE_03.02_tracked.140207 _ _ 2/5 _ Talk to your doctor, pharmacist or nurse before using Albunorm 5%. Take special care with Albunorm 5% - if you are at special risk from Lue koko asiakirja
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Albunorm 5%, 50 g/l, solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Albunorm 5% is a solution containing 50 g/l of total protein of which at least 96% 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. Excipients: Sodium (144-160 mmol/l) Albunorm 5% is a mildly hypooncotic solution. For the 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 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 _________________________________________________________________________________________________________________ Lue koko asiakirja