Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
POLY(O-2-HYDROXYETHYL)STARCH, SODIUM CHLORIDE
Fresenius Kabi Limited
B05AA07
POLY(O-2-HYDROXYETHYL)STARCH, SODIUM CHLORIDE
6 %w/v
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Blood substitutes and plasma protein fractions
Authorised
2000-07-07
V006 • 4264-7 WHAT IS IN THIS LEAFLET: 1. What Voluven 6% is and what it is used for 2. What you need to know before you take Voluven 6% 3. How to take Voluven 6% 4. Possible side effects 5. How to store Voluven 6% 6. Contents of the pack and other information 1. WHAT VOLUVEN 6% IS AND WHAT IT IS USED FOR Voluven 6% is a plasma volume substitute that is used to restore the blood volume when you have lost blood when other products called crystalloids are not considered sufficient alone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VOLUVEN 6% DO NOT USE VOLUVEN 6% IF YOU: • are allergic to any of the active substances or any of the other ingredients of this medicine • suffer from serious generalised infection (sepsis) • suffer from burn injury • have kidney impairment or receive dialysis • suffer from bleeding in the brain (intracranial or cerebral bleeding) • are critically ill (e.g. you need to stay in an intensive care unit) • have too much fluid in your body and you have been told that you have a condition known as hyperhydration • have fluid in the lungs (pulmonary oedema) • are dehydrated • have been told that you have a severe increase of sodium or chloride in your blood • have severely impaired liver function PACKAGE LEAFLET: INFORMATION FOR THE USER VOLUVEN6% SOLUTION FOR INFUSION Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. Austria Voluven (HES 130/0,4) 6 % - Infusionslösung Belgium Voluven, 6% (60 mg/ml) oplossing vo Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1 NAME OF THE MEDICINAL PRODUCT Voluven 6% Solution for Infusion (Glass bottle) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml solution for infusion contain: Poly(O-2-hydroxyethyl)starch (Ph.Eur.) 60.0 g - Molar substitution_:_ 0.38 - 0.45 - Mean molecular weight: 130,000 Da (manufactured from waxy maize starch) Sodium chloride 9.00 g Na + 154 mmol Cl - 154 mmol Theoretical osmolarity 308 mosmol/l pH 4.0 - 5.5 Titratable acidity < 1 mmol NaOH/l For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for infusion A clear to slightly opalescent solution, colourless to slightly yellow. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient (see sections 4.2, 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous use as infusion_._ USE OF HES SHOULD BE RESTRICTED TO THE INITIAL PHASE OF VOLUME RESUSCITATION WITH A MAXIMUM TIME INTERVAL OF 24 H. The first 10-20 ml should be infused slowly and under careful monitoring of the patient so that any anaphylactic/anaphylactoid reaction can be detected as early as possible. The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of haemodynamics and on the haemodilution (dilution effect). The maximum daily dose is 30 ml/kg for Voluven 6%. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document