Kraj: Irlandia
Język: angielski
Źródło: 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
Sodium chloride 9 g Electrolytes: Na + 154 mmol/l Cl – 154 mmol/l Theoretical osmolarity: 308 mosml/l Titratable acidity: ⬍ 1.0 mmol NaOH/l pH: 4.0 – 5.5 OTHER INGREDIENTS: Sodium hydroxide, Hydrochloric acid, Water for injections WHAT VOLUVEN 6% LOOKS LIKE AND CONTENTS OF THE PACK Voluven 6% is a sterile, clear to slightly opalescent solution, colourless to slightly yellow. It is contained in: • flexible bags made either of polyolefin (FREE_flex_) or plasticized PVC bag • or in a glass bottle • in a Polyethylene bottle (KabiPac) Polyolefin bag (FREE_flex_) with overwrap: 1, 5, 10, 20, 30, 35, 40 x 250 ml; 1, 5, 10, 15, 20 x 500 ml Plasticized PVC bag with overwrap: 1, 5, 25 x 250 ml; 1, 5, 15 x 500 ml Colourless type II glass bottle with halobutyl rubber closure and aluminium cap: 1, 10 x 250 ml; 1, 10 x 500 ml Polyethylene bottle (KabiPac): 1, 10, 20, 30 x 250 ml; 1, 10, 20 x 500 ml Not all pack sizes may be marketed. MARKETING AUTHORISATION HOLDER AND MANUFACTURER Marketing Authorisation Holder: Fresenius Kabi Limited Cestrian Court, Eastgate Way, Manor Park, Runcorn, Cheshire, WA7 1NT, UK Manufacturers: Fresenius Kabi Deutschland GmbH Fresenius Kabi Polska Sp. z.o.o. 61346 Bad Homburg v.d.H. Wytwórnia Plynów Infuzyjnych Germany ul. Sienkiewicza 25 99-300 Kutno, Poland THIS MEDICINAL PRODUCT IS AUTHORISED IN THE MEMBER STATES OF THE EEA UNDER THE FOLLOWING NAMES: Austria: Voluven (HES 130/0,4) 6% – Infusionslösung Belgium: Voluven, 6% (60 mg/ml) oplossing voor infusie/solution pour perfusion/Infusionslösung Denmark: Voluven Finland: Voluven 60 mg/ml infuusioneste, liuos Germany: Voluven Fresenius 6% Infusionslösung Greece: Voluven 6% Διάλυµα για έγχυση Ireland: Voluven 6% Solution for Infusion Iceland: Voluven 6% Innrennslislyf, lausn Italy: Voluven Soluzione per infusione Luxembourg: Voluven Fresenius 6% Norway: Voluven 60 mg/ml infusjonsvæske, oppløsning Portugal: Voluven Fresenius 6% Sweden: Voluven, 60 mg/ml infusionsvätska, lösning The Netherlands: Voluven, 6% (60 mg Przeczytaj cały dokument
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 us Przeczytaj cały dokument