EN Official Journal of the European Union C 56/26

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2011 to 31 December 2011

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2) )

2012/C 56/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 16.12.2011 Dianeal, Extraneal, Nutrineal, Monosol and sodium chloride 0,9% solution for haemodialysis (Baxter) See Annex I See Annex I 19.12.2011





— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 3.11.2011 HIPRABOVIS PNEUMOS Emulsion for injection for cattle See Annex II See Annex II 7.11.2011

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State EU/EEA Marketing authorisation holder Invented name Strength Pharmaceutical form Route of administration Austria Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria EXTRANEAL - Peritonealdialyselösung 75 g/L solution for peritoneal dialysis intraperitoneal use Austria Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria Dianeal PD4 Glucose 1,36% w/v/13,6 mg/ml - Peritonealdialyselösung Anhydrous glucose 13,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L solution for peritoneal dialysis intraperitoneal use Austria Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria Dianeal PD4 Glucose 2,27% w/v/22,7 mg/ml - Peritonealdialyselösung Anhydrous glucose 22,7 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L solution for peritoneal dialysis intraperitoneal use Austria Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml - Peritonealdialyselösung Anhydrous glucose 38,6 g/L, sodium chloride 5,38 g/L, sodium-L(+) lactate 4,48 g/L, calcium chloride dihydrate 0,184 g/L, magnesium chloride hexahydrate 0,051 g/L solution for peritoneal dialysis intraperitoneal use Austria Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria Nutrineal PD4 mit 1,1 % Aminosäuren - Peritonealdialyselösung alanine 951 mg/L, arginine 1 071 mg/L, glycine 510 mg/L, histidine 714 mg/L, isoleucine 850 mg/L, leucine 1 020 mg/L, lysine hydrochloride 955 mg/L, methionine 850 mg/L, phenylalanine 570 mg/L, proline 595 mg/L, serine 510 mg/L, threonine 646 mg/L, tryptophan 270 mg/L, tyrosine 300 mg/L, valine 1 393 mg/L, sodium chloride 5 380 mg/L, calcium chloride dihydrate 184 mg/L, magnesium chloride hexahydrate 51 mg/L, sodium(s)-lactate 4 480 mg/L solution for peritoneal dialysis intraperitoneal use Austria Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria Monosol Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L solution for haemodialysis, haemodiafiltration and haemofiltration intraarterial use, intravenous use, hemodialysis Austria Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria Monosol-K mit 2mEq Kalium/l Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L, potassium chloride 0,149 g/L solution for haemodialysis, haemodiafiltration and haemofiltration intraarterial use, intravenous use, hemodialysis Austria Baxter Healthcare GmbH, Stella-Klein-Löw-Weg 15, A-1020 Wien Austria Monosol-K mit 4mEq Kalium/l Hämodialyse-, Hämodiafiltrations- und Hämofiltrationslösung Glucose monohydrate 1,1 g/L, sodium chloride 6,43 g/L, sodium lactate 3,36 g/L, calcium chloride dihydrate 0,257 g/L, magnesium chloride hexahydrate 0,152 g/L, potassium chloride 0,298 g/L solution for haemodialysis, haemodiafiltration and haemofiltration intraarterial use, intravenous use, hemodialysis Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium EXTRANEAL 7,5 %, solution pour dialyse péritonéale 75,00 g/l Icodextrine solution for peritoneal dialysis intraperitoneal use Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium Dianeal PD1 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale 13,60 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium Dianeal PD1 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale 22,7 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium Dianeal PD1 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale 38,6 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium Dianeal PD4 Glucose 1,36 % (13,6 mg/ml), solution pour dialyse péritonéale 13,6 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium Dianeal PD4 Glucose 2,27 % (22,7 mg/ml), solution pour dialyse péritonéale 22,7 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium Dianeal PD4 Glucose 3,86 % (38,6 mg/ml), solution pour dialyse péritonéale 38,6 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Belgium Baxter SA Boulevard R. Branquart 80 7680 Lessines Belgium Nutrineal Peritoneal Dialysis 4 à 1,1 % d’acides aminés, solution pour dialyse péritonéale 4 to 1,1% acides aminés solution for peritoneal dialysis intraperitoneal use Bulgaria BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana Slovenia Dianeal PD4 Glucose 1,36% w/v/ 13,6mg/ml 1,36% w/v/ 13,6mg/ml solution for peritoneal dialysis intraperitoneal use Bulgaria BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana Slovenia Dianeal PD4 Glucose 2,27% w/v/ 22,7mg/ml solution for peritoneal dialysis intraperitoneal use Bulgaria BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana Slovenia Dianeal PD4 Glucose 3,86% w/v/ 38,6mg/ml solution for peritoneal dialysis intraperitoneal use Bulgaria BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana Slovenia Extraneal 7,50% solution for peritoneal dialysis intraperitoneal use Bulgaria BAXTER d.o.o., Zelezna cesta 18, 1000 Ljubljana Slovenia Nutrineal PD 4 with 1,1% Amino Acids solution for peritoneal dialysis intraperitoneal use Czech Republic Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland EXTRANEAL 7,5 % 75 g / 1 000 ml solution for peritoneal dialysis peritoneal use Czech Republic Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland Dianeal PD4 Glucose 1,36 % w/v / 13,6 mg/ml 1,36 % w/v / 13,6 mg/ml solution for peritoneal dialysis peritoneal use Czech Republic Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland Dianeal PD4 Glucose 2,27 % w/v / 22,7 mg/ml 2,27 % w/v / 22,7 mg/ml solution for peritoneal dialysis peritoneal use Czech Republic Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland Dianeal PD4 Glucose 3,86 % w/v / 38,6 mg/ml 3,86 % w/v / 38,6 mg/ml solution for peritoneal dialysis peritoneal use Czech Republic Baxter Healthcare S.A. Moneen Road Castlebar, Co. Mayo Ireland NUTRINEAL PD4 WITH 1,1% AMINOACIDS 1,10% solution for peritoneal dialysis peritoneal use Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød Denmark Natriumklorid Baxter 9 mg/ml 9 mg/ml solution for infusion intravenous use Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød Denmark Dianeal PD4 med Glucos 13,6 mg/ml solution for peritoneal dialysis intraperitoneal use Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød Denmark Dianeal PD4 med Glucos 22,7 mg/ml solution for peritoneal dialysis intraperitoneal use Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød Denmark Dianeal PD4 med Glucos 38,6 mg/ml solution for peritoneal dialysis intraperitoneal use Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød Denmark Extraneal 75 mg/ml solution for peritoneal dialysis intraperitoneal use Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød Denmark Nutrineal PD4 med 1,1 % aminosyrer 1,1 %/1 000 ml solution for peritoneal dialysis intraperitoneal use Estonia Baxter OY P.O box 270, Valimotie 15A, Helsinki 00381 Finland EXTRANEAL 7,50% solution for peritoneal dialysis intraperitoneal use Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland Natriumklorid Baxter 9 mg/ml 9 mg/ml solution for infusion intravenous use Finland Baxter Oy Valimotie 15 A 00380 Helsinki Finland Extraneal 7,50% solution for peritoneal dialysis intraperitoneal use Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland Dianeal PD4 Glucose 13,6 mg/ml solution for peritoneal dialysis intraperitoneal use Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland Dianeal PD4 Glucose 22,7 mg/ml solution for peritoneal dialysis intraperitoneal use Finland Baxter Healthcare S.A. Moneen Road, Castlebar County Mayo Ireland Dianeal PD4 Glucose 38,6 mg/ml solution for peritoneal dialysis intraperitoneal use France Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France DIANEAL PD1 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche 1,36% solution for peritoneal dialysis intraperitoneal use France Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France DIANEAL PD1 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche 3,86% solution for peritoneal dialysis intraperitoneal use France Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche 3,86% solution for peritoneal dialysis intraperitoneal use France Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France DIANEAL PD1 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche 2,27% solution for peritoneal dialysis Intraperitoneal use France Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche 2,27% solution for peritoneal dialysis Intraperitoneal use France Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche 1,36% solution for peritoneal dialysis Intraperitoneal use France Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France EXTRANEAL, solution pour dialyse péritonéale 7,50% solution for peritoneal dialysis Intraperitoneal use France Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas 78310 Maurepas France NUTRINEAL PD4 A 1,1 % D'ACIDES AMINES, solution pour dialyse péritonéale 1,10% solution for peritoneal dialysis Intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PD1 Glucose 1,36% w/v 13,6 g / l 5,67 g / l 3,92 g / l 0,257 g / l 0,152 g / l solution for peritoneal dialysis Intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PD1 Glucose 2,27% w/v 22,7 g / l 5,67 g / l 3,92 g / l 0,257 g / l 0,152 g / l solution for peritoneal dialysis Intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PD1 Glucose 3,86% w/v 38,6 g / l 5,67 g / l 3,92 g / l 0,257 g / l 0,152 g / l solution for peritoneal dialysis Intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PD4 Glucose 1,36% w/v 13,6 g / l 5,4 g / l 4,5 g / l 0,184 g / l 0,051 g / l solution for peritoneal dialysis Intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PD4 Glucose 2,27% w/v 22,7 g / l 5,4 g / l 4,5 g / l 0,184 g / l 0,051 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PD4 Glucose 3,86% w/v 38,6 g / l 5,4 g / l 4,5 g / l 0,184 g / l 0,051 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PDG1 1,36 % 13,6 g / l 5,67 g / l 3,92 g / l 0,257 g / l 0,0152 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PDG1 2,27 % 22,7 g / l 5,67 g / l 3,92 g / l 0,257 g / l 0,0152 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PDG1 3,86 % 38,6 g / l 5,67 g / l 3,92 g / l 0,257 g / l 0,0152 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PDG4 1,36 % 13,6g / l 5,38 g / l 4,48 g/ l 0,184 g / l 0,051 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PDG4 2,27 % 22,7 g / l 5,38 g / l 4,48 g/ l 0,184 g / l 0,051 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Dianeal PDG4 3,86 % 38,6 g /l 5,38 g / l 4,48 g/ l 0,184 g / l 0,051 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Extraneal 75 g / l 5,4 g / l 4,5 g / l 0,257 g / l 0,051 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Nutrineal PD4 mit 1,1 % Aminosäuren 11,205 g / l 5,38 g / l 0,184 g / l 0,0508 g / l 4,48 g / l solution for peritoneal dialysis intraperitoneal use Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Monosol 1,1 g / l 6,43 g / l 0,257 g / l 0,152 g / l 3,36 g / l solution for haemodialysis hemodialysis Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Monosol-K mit 2 mmol Kalium/l 1,1 g / l 6,43 g / l 0,257 g / l 0,149 g / l 0,152 g / l 3,36 g / l solution for haemodialysis hemodialysis Germany Baxter Deutschland GmbH Edisonstr. 4 D-85716 Unterschleißheim Germany Monosol-K mit 4 mmol Kalium/l 1,1 g / l 6,43 g / l 0,257 g / l 0,298 g / l 0,152 g / l 3,36 g / l solution for haemodialysis hemodialysis Greece DIOPHAR S.A. Kifissias Avenue 368, Halandri, 152 33 Greece DIANEAL PD1 1,36% W/V 2,27% W/V 3,86% W/V solution for peritoneal dialysis Intraperitoneal use Greece DIOPHAR S.A. Kifissias Avenue 368, 152 33 Halandri, Greece DIANEAL PD4 1,36% 2,27% W/V 3,86% W/V solution for peritoneal dialysis intraperitoneal use Greece DIOPHAR S.A. Kifissias Avenue 368, 152 33 Halandri, Greece EXTRANEAL (7,5+0,54+0,45+0,0257+0,0051)% w/v solution for peritoneal dialysis intraperitoneal use Greece DIOPHAR S.A. Kifissias Avenue 368, 152 33 Halandri, Greece Nutrineal PD4 1,1% solution for peritoneal dialysis intraperitoneal use Hungary Baxter Hungary Kft. Népfürdő u. 22. 1138, Budapest Hungary EXTRANEAL peritoneális dializáló oldat 7,5% (icodextrin) solution for peritoneal dialysis intraperitoneal use Hungary Baxter Hungary Kft. Népfürdő u. 22. 1138, Budapest Hungary DIANEAL PD 1 Glucose 1,36% peritoneális dializáló oldat 1,36% solution for peritoneal dialysis intraperitoneal use Hungary Baxter Hungary Kft. Népfürdő u. 22. 1138, Budapest Hungary DIANEAL PD 1 Glucose 2,27% peritoneális dializáló oldat 2,27% solution for peritoneal dialysis intraperitoneal use Hungary Baxter Hungary Kft. Népfürdő u. 22. 1138, Budapest Hungary DIANEAL PD 1 Glucose 3,86% peritoneális dializáló oldat 3,86% solution for peritoneal dialysis intraperitoneal use Hungary Baxter Hungary Kft. Népfürdő u. 22. 1138, Budapest Hungary DIANEAL PD 4 Glucose 1,36% peritoneális dializáló oldat 1,36% solution for peritoneal dialysis intraperitoneal use Hungary Baxter Hungary Kft. Népfürdő u. 22. 1138, Budapest Hungary DIANEAL PD 4 Glucose 2,27% peritoneális dializáló oldat 2,27% solution for peritoneal dialysis intraperitoneal use Hungary Baxter Hungary Kft. Népfürdő u. 22. 1138, Budapest Hungary DIANEAL PD 4 Glucose 3,86% peritoneális dializáló oldat 3,86% solution for peritoneal dialysis intraperitoneal use Iceland Baxter Healthare SA Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 13,6 mg/ml solution for peritoneal dialysis intraperitoneal use Iceland Baxter Healthare SA Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 22,7 mg/ml solution for peritoneal dialysis intraperitoneal use Iceland Baxter Healthare SA Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 38,6 mg/ml solution for peritoneal dialysis intraperitoneal use Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Monosol, Solution for haemodialysis, haemodiafiltration and haemofiltration Glucose Monohydrate Ph. Eur.1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur., 0,257, Magnesium Chloride Hexahydrate Ph. Eur.0,152, Sodium Lactate Ph. Eur. 3,36 solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Monosol-K with 2 mEq Potassium/l, Solution for haemodialysis, haemodiafiltration and haemofiltration Glucose Monohydrate Ph. Eur. 1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur. 0,257, Magnesium Chloride Hexahydrate Ph. Eur. 0,152, Sodium Lactate Ph. Eur. 3,36, Potassium Chloride Ph. Eur. 0,149 solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Monosol-K with 4 mEq Potassium/l, Solution for haemodialysis, haemodiafiltration and haemofiltration Glucose Monohydrate Ph. Eur. 1,1, Sodium Chloride Ph. Eur. 6,43, Calcium Chloride Dihydrate Ph. Eur. 0,257, Magnesium Chloride Hexahydrate Ph. Eur. 0,152, Sodium Lactate Ph. Eur. 3,36, Potassium Chloride Ph. Eur. 0,298 solution for haemodialysis, haemodiafiltration and haemofiltration hemodialysis Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Dianeal PD1 Glucose 1,36% w/v (13,6mg/ml) Solution for Peritoneal Dialysis 1,36% w/v solution for peritoneal dialysis intraperitoneal use Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Dianeal PD1 Glucose 3,86% w/v (38,6 mg/ml) Solution for Peritoneal Dialysis 3,86% w/v (38,6 mg/ml) solution for peritoneal dialysis intraperitoneal use Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Dianeal PD1 Glucose 2,27% w/v (22,7 mg/ml) Solution for Peritoneal Dialysis 2,27% w/v (22,7 mg/ml) solution for peritoneal dialysis intraperitoneal use Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Dianeal PD4 Glucose 1,36 % w/v (13,6 mg/ml) Solution for peritoneal dialysis 1,36 % w/v (13,6 mg/ml) solution for peritoneal dialysis intraperitoneal use Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Dianeal PD4 Glucose 2,27 % w/v (22,7 mg/ml) Solution for peritoneal dialysis 2,27 % w/v (22,7 mg/ml) solution for peritoneal dialysis intraperitoneal use Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Dianeal PD4 Glucose 3,86 % w/v (38,6 mg/ml) Solution for peritoneal dialysis 3,86 % w/v (38,6 mg/ml) solution for peritoneal dialysis intraperitoneal use Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom Nutrineal Solution for Peritoneal Dialysis 4 with 1,1% Amino Acids solution for peritoneal dialysis intraperitoneal use Ireland Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk, IP24 3SE, United Kingdom EXTRANEAL Solution for peritoneal dialysis solution for peritoneal dialysis intraperitoneal use Italy Baxter SPA piazzale dell' industria 20 - 00144 Roma, Italy EXTRANEAL 7,5% solution for dialysis peritoneal intraperitoneal use Italy Baxter SPA piazzale dell' industria 20 – 00144 Roma, Italy NUTRINEAL PD4 1,1% solution for dialysis peritoneal intraperitoneal use Italy Baxter SPA piazzale dell' industria 20 – 00144 Roma, Italy SOLUZIONI PER DIALISI PERITONEALE BAXTER 4,95 g/l - 49,54 g/l; solution for dialysis peritoneal intraperitoneal use Latvia Baxter Oy Valimotie 15 A 00381 Helsinki Finland Extraneal solution for peritoneal dialysis 75g/L 5,4g/L 4,5g/L 0,257g/L 0,051g/L solution for peritoneal dialysis intraperitoneal use Latvia Baxter Healthcare S.A. Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 2,27% w/v//22,7 mg/ml solution for peritoneal dialysis 2,27 % w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v solution for peritoneal dialysis intraperitoneal use Latvia Baxter Healthcare S.A. Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 3,86 % w/v/38,6 mg/ml solution for peritoneal dialysis 3,86% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v solution for peritoneal dialysis intraperitoneal use Latvia Baxter Healthcare S.A. Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 1,36 % w/v/13,6 mg/ml solution for peritoneal dialysis 1,36% w/v 0,538% w/v 0,448% w/v 0,0184% w/v 0,0051% w/v solution for peritoneal dialysis intraperitoneal use Lithuania Baxter Healthcare S.A. Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051g/l solution for peritoneal dialysis intraperitoneal use Lithuania Baxter Healthcare S.A. Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051g/l solution for peritoneal dialysis intraperitoneal use Lithuania Baxter Healthcare S.A. Moneen Road Castlebar County Mayo Ireland Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051g/l solution for peritoneal dialysis intraperitoneal use Lithuania Baxter Oy, P.O. Box 270 Valimotie 15A 00381 Helsinki Finland EXTRANEAL 75g+5,4g+4,5g+0,257g+0,051g/1 000ml solution for peritoneal dialysis intraperitoneal use Luxembourg Baxter SA, Bd René Branquart 80, B-7860 Lessines Belgium Nutrineal PD4+A.A.1,1% 1,1% amino acids solution for peritoneal dialysis intraperitoneal use Luxembourg Baxter SA, Bd René Branquart 80, B-7860 Lessines Belgium Dianeal PD1 Glucose 1,36%/2,27%/3,86% dextrose anydre solution for peritoneal dialysis intraperitoneal use Luxembourg Baxter SA, Bd René Branquart 80, B-7860 Lessines Belgium Dianeal PD4 Glucose 1,36%/2,27%/3,86% dextrose anydre solution for peritoneal dialysis intraperitoneal use Luxembourg Baxter SA, Bd René Branquart 80, B-7860 Lessines Belgium Extraneal 75,00 g/l Icodextrine solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Extraneal (Icodextrin 7,5%) Icodextrin (75 g/l), Sodium chloride (5,4 g/l), Calcium chloride (0,257 g/l), Magnesium chloride (0,051 g/l), Sodium lactate solution (4,5 g/l) solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Nutrineal PD4 with 1,1% amino acids L-Tyrosine 0,300 g/l L-Tryptophan 0,270 g/l L-Phenylalanine 0,570 g/l L-Threonine 0,646 g/l L-Serine 0,510 g/l L-Proline 0,595 g/l Glycine 0,510 g/l L-Alanine 0,951 g/l L-Valine 1,393 g/l L-Methionine 0,850 g/l L-Isoleucine 0,850 g/l L-Leucine 1,020 g/l L-Lysine (chlorhydrate) 0,955 g/l L-Histidine 0,714 g/l L-Arginine 1,071 g/l Calcium chloride dihydrate 0,184 g/l Magnesium chloride hexahydrate 0,051 g/l Sodium Lactate 4,48 g/l Sodium Chloride 5,38 g/l Quantitative Composition of Sodium Lactate Lactic Acid 139 g Sodium Hydroxide 52,25 g Water for Injections to 100 ml solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Dianeal PD1 Glucose 1,36%w/v 13,6mg/ml Anhydrous Glucose Ph.Eur. 1,36 % w/v or Glucose Monohydrate Ph.Eur. 1,50 % w/v Sodium Chloride Ph.Eur. 0,57 % w/v Sodium Lactate Ph.Eur. 0,39 % w/v Calcium Chloride Ph.Eur. 0,0257 % w/v Magnesium Chloride Ph.Eur. 0,0152 % w/v solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Dianeal PD1 Glucose 2,27%w/v 22,7mg/ml Anhydrous Glucose Ph.Eur. 2,27 % w/v or Glucose Monohydrate Ph.Eur. 2,50 % w/v Sodium Chloride Ph.Eur. 0,57 % w/v Sodium Lactate Ph.Eur. 0,39 % w/v Calcium Chloride Ph.Eur. 0,0257 % w/v Magnesium Chloride Ph.Eur. 0,0152 % w/v solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Dianeal PD1 Glucose 3,86%w/v 38.6mg/ml Anhydrous Glucose Ph.Eur. 3,86 % w/v or Glucose Monohydrate Ph.Eur. 4,25 % w/v Sodium Chloride Ph.Eur. 0,57 % w/v Sodium Lactate Ph.Eur. 0,39 % w/v Calcium Chloride Ph.Eur. 0,0257 % w/v Magnesium Chloride Ph.Eur. 0,0152 % w/v solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Dianeal PD4 Glucose 1,36%w/v 13,6mg/ml Anhydrous Glucose Ph.Eur. 1,36 % w/v or Glucose Monohydrate Ph.Eur. 1,50 % w/v Sodium Chloride Ph.Eur. 0,538 % w/v Sodium Lactate Ph.Eur. 0,448 % w/v Calcium Chloride Ph.Eur. 0,0184 % w/v Magnesium Chloride Ph.Eur. 0,0051 % w/v solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Dianeal PD4 Glucose 2,27%w/v 22,7mg/ml Anhydrous Glucose Ph.Eur. 2,27 % w/v or Glucose Monohydrate Ph.Eur. 2,50 % w/v Sodium Chloride Ph.Eur. 0,538 % w/v Sodium Lactate Ph.Eur. 0,448 % w/v Calcium Chloride Ph.Eur. 0,0184 % w/v Magnesium Chloride Ph.Eur. 0,0051 % w/v solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Ltd., Caxton Way, Thetford, Norfolk, IP24 3SE United Kingdom Dianeal PD4 Glucose 3,86%w/v 38,6mg/ml Anhydrous Glucose Ph.Eur. 3,86 % w/v or Glucose Monohydrate Ph.Eur. 4,25 % w/v Sodium Chloride Ph.Eur. 0,538 % w/v Sodium Lactate Ph.Eur. 0,448 % w/v Calcium Chloride Ph.Eur. 0,0184 % w/v Magnesium Chloride Ph.Eur. 0,0051 % w/v solution for peritoneal dialysis intraperitoneal use Malta Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, UK Monosol Glucose Monohydrate 1,1 g/l, Sodium Chloride 6,43 g/l, Calcium Chloride Dihydrate 0,257 g/l, Magnesium Chloride Hexahydrate 0,152 g/l, Sodium Lactate 3,36 g/l solution for haemodialysis/haemofiltration intraarterial use, intravenous use Malta Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, UK Monosol-K with 2MEQ Potassium/L Glucose Monohydrate 1,1 g/l, Sodium Chloride 6,43 g/l, Calcium Chloride Dihydrate 0,257 g/l, Magnesium Chloride Hexahydrate 0,152 g/l, Potassium Chloride 0,149 g/l, Sodium Lactate 3,36 g/l solution for haemodialysis/haemofiltration intra-arterial use, intravenous use Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht The Netherlands Dianeal PD1 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeistof 13,6 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht The Netherlands Dianeal PD1 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeistof 22,7 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht The Netherlands Dianeal PD1 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeistof 38,6 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht The Netherlands Dianeal PD4 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeistof 13,6 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht The Netherlands Dianeal PD4 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeistof 22,7 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht The Netherlands Dianeal PD4 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeistof 38,6 g/l glucose anhydrate solution for peritoneal dialysis intraperitoneal use Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht The Netherlands Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeistof 11 g/l amino acids and 1,25 mmol/l Ca. solution for peritoneal dialysis intraperitoneal use Netherlands Baxter B.V., Kobaltweg 49, 3542 CE Utrecht The Netherlands EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse 75 g/l icodextrine solution for peritoneal dialysis intraperitoneal use Norway Baxter AS Gjerdrumsvei 11 0484 Oslo Norway Natriumklorid Baxter 9 mg/ml 9 mg/ml solution for infusion intravenous use Norway Baxter AS Gjerdrumsvei 11 0484 Oslo Norway Nutrineal PD4 amino Acids 1,1 % 1,10% solution for peritoneal dialysis intraperitoneal use Norway Baxter AS Gjerdrumsvei 11 0484 Oslo Norway Extraneal 75 mg/ml solution for peritoneal dialysis intraperitoneal use Poland Baxter Polska SP. z o.o. Kruczkowskiego 8 st., 00-380 Warszawa Poland Dianeal PD1 (glukoza 1,36%). Zestaw do dializy otrzewnowej 15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Poland Baxter Polska SP. z o.o. Kruczkowskiego 8 st., 00-380 Warszawa Poland Dianeal PD1 (glukoza 2,27%). Zestaw do dializy otrzewnowej 25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Poland Baxter Polska SP. z o.o. Kruczkowskiego 8 st., 00-380 Warszawa Poland Dianeal PD1 (glukoza 3,86%). Zestaw do dializy otrzewnowej 42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 2,57 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Poland Baxter Polska SP. z o.o. Kruczkowskiego 8 st., 00-380 Warszawa Poland Dianeal PD4 (glukoza 1,36%). Zestaw do dializy otrzewnowej 15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Poland Baxter Polska SP. z o.o. Kruczkowskiego 8 st., 00-380 Warszawa Poland Dianeal PD4 (glukoza 2,27%). Zestaw do dializy otrzewnowej 25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Poland Baxter Polska SP. z o.o. Kruczkowskiego 8 st., 00-380 Warszawa Poland Dianeal PD4 (glukoza 3,86%). Zestaw do dializy otrzewnowej 42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Poland Baxter Polska SP. z o.o. Kruczkowskiego 8 st., 00-380 Warszawa Poland Extraneal Zestaw do dializy otrzewnowej 75 mg/ml solution for peritoneal dialysis intraperitoneal use Poland Baxter Polska SP. z o.o. Kruczkowskiego 8 st., 00-380 Warszawa Poland Nutrineal PD4 (z 1,1% roztworem aminokwasów) 1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira – Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal Extraneal 75 mg/ml Icodextrin; 5,4 mg/ml Sodium Chloride; 4,5 mg/ml Sodium (S) - lactate solution; 0,051 mg/ml Magnesium Chloride; 0,257 mg/ml Calcium Chloride solution for peritoneal dialysis intraperitoneal use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira – Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal Dianeal Pd1 42,5 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 2,57 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira – Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal Dianeal Pd1 25 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Chloride Hexahydrate; 3,92 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira – Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal Dianeal Pd1 15 mg/ml Glucose Monohydrate; 5,67 mg/ml Sodium Chloride; 0,257 mg/ml Calcium Chloride Dihydrate; 0,152 mg/ml Magnesium Hydroxide; 3,92 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira – Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal Dianeal Pd4 42,5 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira – Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal Dianeal Pd4 25 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira – Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal Dianeal Pd4 15 mg/ml Glucose Monohydrate; 5,38 mg/ml Sodium Chloride; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 4,48 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Portugal Baxter Médico-Farmacêutica, Lda. Zona Industrial da Abrunheira – Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal Nutrineal PD4 1,071 mg/ml Arginine; 0,714 mg/ml Histine; 0,955 mg/ml Lysine hydrochloride; 1,02 mg/ml Leucine; 0,85 mg/ml Isoleucine; 0,85 mg/ml Methionine; 1,393 mg/ml Valine; 0,951 mg/ml Alanine; 0,51 mg/ml Glycine; 0,595 mg/ml Proline; 0,51 mg/ml Serine; 0,646 mg/ml Threonine; 0,57 mg/ml Phenylalanine; 0,27 mg/ml Tryptophan; 0,3 mg/ml Tyrosine; 0,184 mg/ml Calcium Chloride Dihydrate; 0,051 mg/ml Magnesium Chloride Hexahydrate; 5,38 mg/ml Sodium Chloride; 4,48 mg/ml Sodium Lactate solution for peritoneal dialysis intraperitoneal use Romania BAXTER HEALTHCARE Ltd., Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford, United Kingdom EXTRANEAL 75 mg/ml solution for peritoneal dialysis intraperitoneal use Romania BAXTER HEALTHCARE S.A. Moneen Road, Castelbar, County Mayo Ireland DIANEAL PD4 GLUCOSE 1,36% m/v (13,6 mg/ml), 13,6 mg/ml solution for peritoneal dialysis intraperitoneal use Romania BAXTER HEALTHCARE S.A. Moneen Road, Castelbar, County Mayo Ireland DIANEAL PD4 GLUCOSE 2,27% m/v (22,7 mg/ml) 22,7 mg/ml solution for peritoneal dialysis Intraperitoneal use Romania BAXTER HEALTHCARE S.A. Moneen Road, Castelbar, County Mayo Ireland DIANEAL PD4 GLUCOSE 3,86% m/v (38,6 mg/ml) 38,6 mg/ml solution for peritoneal dialysis intraperitoneal use Romania BAXTER d.o.o. Zelezna cesta 14, SI-1000 Ljubljana Slovenia NUTRINEAL PD4 cu 1,1% aminoacizi 1,1% solution for peritoneal dialysis intraperitoneal use Slovak Republic Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland Dianeal® PD1 glucose 1,36% w/v /13,6 mg/ml 13,6 mg/1 ml solution for peritoneal dialysis intraperitoneal use Slovak Republic Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland Dianeal® PD1 glucose 2,27% w/v /22,7 mg/ml 22,7 mg/1 ml solution for peritoneal dialysis intraperitoneal use Slovak Republic Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland Dianeal® PD1 glucose 3,86% w/v /38,6 mg/ml 38,6 mg/1 ml solution for peritoneal dialysis intraperitoneal use Slovak Republic Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland DIANEAL PD4 glucose 1,36 % w/v/13,6 mg/ ml 13,6 mg/1 ml solution for peritoneal dialysis intraperitoneal use Slovak Republic Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland DIANEAL PD4 glucose 2,27 % w/v/22,7 mg/ ml 22,7 mg/1 ml solution for peritoneal dialysis intraperitoneal use Slovak Republic Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland DIANEAL PD4 glucose 3,86 % w/v/38,6 mg/ ml 38,6 mg/1 ml solution for peritoneal dialysis intraperitoneal use Slovak Republic Baxter Healthcare Ltd. Caxton Way Thetford Norfolk IP24 3SE United Kingdom EXTRANEAL 7,5% solution for peritoneal dialysis intraperitoneal use Slovak Republic Baxter Healthcare SA Moneen Rd Castlebar, Co. Mayo Ireland Nutrineal PD4 with 1,1 % Amino Acids 1,1% solution for peritoneal dialysis intraperitoneal use Slovenia Baxter d.o.o., Zelezna cesta 18, SI-1000 Ljubljana, Slovenia Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo 75 mg/ml solution for peritoneal dialysis intraperitoneal use Slovenia Baxter d.o.o., Zelezna cesta 18, SI-1000 Ljubljana, Slovenia Nutrineal PD4 11 mg/ml amino kislin raztopina za peritonealno dializo 11 mg/ml solution for peritoneal dialysis intraperitoneal use Slovenia Baxter d.o.o., Zelezna cesta 18, SI-1000 Ljubljana, Slovenia Dianeal PD1 13,6 mg/ml glukoze raztopina za peritonelano dializo 13,6 mg/ml solution for peritoneal dialysis intraperitoneal use Slovenia Baxter d.o.o., Zelezna cesta 18, SI-1000 Ljubljana, Slovenia Dianeal PD1 22,7 mg/ml glukoze raztopina za peritonelano dializo 22,7 mg/ml solution for peritoneal dialysis intraperitoneal use Slovenia Baxter d.o.o., Zelezna cesta 18, SI-1000 Ljubljana, Slovenia Dianeal PD1 38,6 mg/ml glukoze raztopina za peritonelano dializo 38,6 mg/ml solution for peritoneal dialysis intraperitoneal use Slovenia Baxter d.o.o., Zelezna cesta 18, SI-1000 Ljubljana, Slovenia Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo 13,6 mg/ml solution for peritoneal dialysis intraperitoneal use Slovenia Baxter d.o.o., Zelezna cesta 18, SI-1000 Ljubljana, Slovenia Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo 22,7 mg/ml solution for peritoneal dialysis intraperitoneal use Slovenia Baxter d.o.o., Zelezna cesta 18, SI-1000 Ljubljana, Slovenia Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo 38,6 mg/ml solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia Valencia) 46394 Spain EXTRANEAL Solución para diálisis peritoneal 75 g/l; 5,4 g/l; 4,5 g/l; 0,257 g/l; 0,051 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Nutrineal PD4 con 1,1% de aminoácidos solución para diálisis peritoneal 951 mg/l; 1 071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1 020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 270 mg/l; 300 mg/l; 393 mg/l; 5 380 mg/l; 184 mg/l; 51 mg/l; 4 480 mg/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Nutrineal PD4 con 1,1% de aminoácidos con sistema de desconexión integrado solución para diálisis peritoneal 951 mg/l; 1 071 mg/l; 510 mg/l; 714 mg/l; 850 mg/l; 1 020 mg/l; 955 mg/l; 850 mg/l; 570 mg/l; 595 mg/l; 510 mg/l; 646 mg/l; 720 mg/l; 300 mg/l; 1 393 mg/l; 5 380 mg/l; 184 mg/l; 51 mg/l; 4 480 mg/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD1 Glucosa 1,36% solución para diálisis peritoneal 15 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD1 Glucosa 1,36% con sistema de desconexión integrado solución para diálisis peritoneal. 15 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD1 Glucosa 2,27% solución para diálisis peritoneal 25,0 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD1 Glucosa 2,27% con sistema de desconexión integrado solución para diálisis peritoneal 25,0 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD1 Glucosa 3,86% solución para diálisis peritoneal 42,50 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD1 Glucosa 3,86% con sistema de desconexión integrado solución para diálisis peritoneal 42,50 g/l; 5,67 g/l; 3,92 g/l; 0,257 g/l; 0,152 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD4 Glucosa 1,36% solución para diálisis peritoneal 15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD4 Glucosa 1,36% con sistema de desconexión integrado solución para diálisis peritoneal. 15,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD4 Glucosa 2,27% solución para diálisis peritoneal 25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD4 Glucosa 2,27% con sistema de desconexión integrado solución para diálisis peritoneal 25,0 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD4 Glucosa 3,86% solución para diálisis peritoneal 42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l solution for peritoneal dialysis intraperitoneal use Spain BAXTER S.L. Pouet de Camilo 2 Ribarroja del Turia (Valencia) 46394 Spain Dianeal PD4 Glucosa 3,86% con sistema de desconexión integrado solución para diálisis peritoneal 42,50 g/l; 5,38 g/l; 4,48 g/l; 0,184 g/l; 0,051 g/l solution for peritoneal dialysis intraperitoneal use Sweden Baxter Medical AB Box 63 164 94 Kista Sweden Natriumklorid Baxter 9 mg/ml 9 mg/ml solution for infusion intravenous use Sweden Baxter Healthare SA Moneen Road Castlebar County Mayo Ireland Dianeal PD4 med glucos 13,6 mg/ml 13,6 mg/ml solution for peritoneal dialysis intraperitoneal use Sweden Baxter Healthare SA Moneen Road Castlebar County Mayo Ireland Dianeal PD4 med glucos 22,7 mg/ml 22,7 mg/ml solution for peritoneal dialysis intraperitoneal use Sweden Baxter Healthare SA Moneen Road Castlebar County Mayo Ireland Dianeal PD4 med glucos 38,6 mg/ml 38,6 mg/ml solution for peritoneal dialysis intraperitoneal use Sweden Baxter Medical AB Box 63 164 94 Kista Sweden Extraneal 7,5% solution for peritoneal dialysis intraperitoneal use Sweden Baxter Medical AB Box 63 164 94 Kista Sweden Nutrineal PD4 1,1 % Aminosyror 1,10% solution for peritoneal dialysis intraperitoneal use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Monosol Calcium Chloride: 0,026% w/v. glucose 0,110%w/v; sodium lactate 0,336%w/v; sodium chloride 0,643%w/v; magnesium chloride 0,015%w/v solution for haemodialysis/haemofiltration intraarterial use, intravenous use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Monosol-K with 2MEQ Potassium/L sodium chloride 0,643%w/v; magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucoae 0,110%w/v; potassium chloride 0,015%w/v; sodium lactate 0,336%w/v solution for haemodialysis/haemofiltration intraarterial use, intravenous use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Monosol-K with 4MEQ Potassium/L magnesium chloride 0,015%w/v; potassium chloride 0,029%w/v; calcium chloride 0,026%w/v; sodium lactate 0,336%w/v; sodium chloride 0,643%w/v; glucose 0,110%w/v solution for haemodialysis/haemofiltration intraarterial use, intravenous use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Dianeal PD1 Glucose 1,36% w/v /13,6mg/ml magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucose 1,36%w/v; sodium lactate 0,39%w/v; sodium chloride 0,57%w/v solution for peritoneal dialysis intraperitoneal use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Dianeal PD1 Glucose 3.86% w/v /38,6mg/ml magnesium chloride 0,015%w/v; calcium chloride 0,026%w/v; glucose 3,86%w/v; sodium lactate 0,39%w/v; sodium chloride 0,57%w/v solution for peritoneal dialysis intraperitoneal use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Dianeal PD1 Glucose 2,27% w/v /22,7mg/ml sodium chloride 0,57%w/v; glucose 2,27%w/v; magnesium chloride 0,015%w/v; sodium lactate 0,39%w/v; calcium chloride 0,026%w/v solution for peritoneal dialysis intraperitoneal use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Dianeal PD4 Glucose 1,36% w/v /13,6mg/ml magnesium chloride 0,005%w/v; glucose 1,36%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v solution for peritoneal dialysis intraperitoneal use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Dianeal PD4 Glucose 2,27% w/v /22,7mg/ml magnesium chloride 0,005%w/v; glucose 2,27%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v solution for peritoneal dialysis intraperitoneal use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Dianeal PD4 Glucose 3,86% w/v /38,6mg/ml magnesium chloride 0,005%w/v; glucose 3,86%w/v; sodium lactate 0,45%w/v; calcium chloride 0,018%w/v; sodium chloride 0,54%w/v solution for peritoneal dialysis intraperitoneal use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Extraneal (Icodextrin 7,5%) Solution for peritoneal dialysis icodextrin 75g/l; sodium chloride 5,4g/l; calcium chloride 0,257g/l; magnesium chloride 0,051g/l; sodium s-lactate 4,5g/l solution for peritoneal dialysis intraperitoneal use United Kingdom Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE United Kingdom Nutrineal PD4 with 1,1% Amino Acids tyrosine 0,03%w/v; tryptophan 0,027%w/v; phenylalanine 0,057%w/v; threonine 0,064%w/v; L-serine 0,051%w/v; L-proline 0,058%w/v; glycine 0,.051%w/v; L-alanine 0,095%w/v; valine 0,139%w/v; methionine 0,085%w/v; isoleucine 0,085%w/v; leucine 0,102%w/v; lysine 0,095%w/v; histidine 0/071%w/v; arginine 0,107%w/v; calcium chloride 0,018%w/v; magnesium chloride 0,005%w/v; sodium chloride 0,538%w/v; sodium s-lactate 0,448%w/v solution for peritoneal dialysis intraperitoneal use