Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
POLY(O-2-HYDROXYETHYL)STARCH, SODIUM ACETATE TRIHYDRATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE HEXAHYDRATE
Fresenius Kabi Limited
B05AA07
POLY(O-2-HYDROXYETHYL)STARCH, SODIUM ACETATE TRIHYDRATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE HEXAHYDRATE
6 Per Cent
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Blood substitutes and plasma protein fractions
Authorised
2008-05-16
VOLUVEN ® 6% SOLUTION FOR INFUSION Hydroxyethyl starch (HES 130/0.4) in isotonic sodium chloride solution 068 3511/03 UK This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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. 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. WHAT IS IN THIS LEAFLET: 1. What Voluven ® 6% is and what it is used for 2. What you need to know before you use Voluven 6% 3. How to use 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. 1 PACKAGE LEAFLET: INFORMATION FOR THE USER 0683511_03_Voluven UK_PB 08.08.2017 08:29 Seite 1 2. WHAT YOU NEED TO KNOW BEFORE YOU USE 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 • hav Đọc toàn bộ tài liệu
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 Volulyte 6% Solution for Infusion. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1000 ml solution for infusion contain: Electrolytes: For a 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 Poly(O-2-hydroxyethyl)starch (Ph.Eur.) - Molar substitution 0.38 – 0.45 - Mean molecular weight = 130,000 Da (manufactred from waxy maize stach) 60.00 g Sodium acetate trihydrate 4.63 g Sodium chloride 6.02 g Potassium chloride 0.30 g Magnesium chloride hexahydrate 0.30 g Na + 137.0 mmol/l K + 4.0 mmol/l Mg ++ 1.5 mmol/l Cl - 110.0 mmol/l CH 3 COO - 34.0 mmol/l Theoretical osmolarity: 286.5 mosm/l Titrable acidity: < 2.5 mmol NaOH/l pH: 5.7 – 6.5 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _4_ _/_ _0_ _5_ _/_ _2_ _0_ _1_ _8_ _C_ _R_ _N_ _ _ _2_ _1_ _9_ _6_ _2_ _1_ _9_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ For intravenous u Đọc toàn bộ tài liệu