|
24.2.2012 |
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 |
|
EXTRANEAL - Peritonealdialyselösung |
75 g/L |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
EXTRANEAL 7,5 %, solution pour dialyse péritonéale |
75,00 g/l Icodextrine |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Dianeal PD4 Glucose 1,36% w/v/ 13,6mg/ml |
1,36% w/v/ 13,6mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Bulgaria |
|
Dianeal PD4 Glucose |
2,27% w/v/ 22,7mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Bulgaria |
|
Dianeal PD4 Glucose |
3,86% w/v/ 38,6mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Bulgaria |
|
Extraneal |
7,50% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Bulgaria |
|
Nutrineal PD 4 with 1,1% Amino Acids |
|
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Czech Republic |
|
EXTRANEAL |
7,5 % 75 g / 1 000 ml |
solution for peritoneal dialysis |
peritoneal use |
||||||
|
Czech Republic |
|
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 |
|
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 |
|
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 |
|
NUTRINEAL PD4 WITH 1,1% AMINOACIDS |
1,10% |
solution for peritoneal dialysis |
peritoneal use |
||||||
|
Denmark |
|
Natriumklorid Baxter 9 mg/ml |
9 mg/ml |
solution for infusion |
intravenous use |
||||||
|
Denmark |
|
Dianeal PD4 med Glucos |
13,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Denmark |
|
Dianeal PD4 med Glucos |
22,7 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Denmark |
|
Dianeal PD4 med Glucos |
38,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Denmark |
|
Extraneal |
75 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Denmark |
|
Nutrineal PD4 med 1,1 % aminosyrer |
1,1 %/1 000 ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Estonia |
|
EXTRANEAL |
7,50% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Finland |
|
Natriumklorid Baxter 9 mg/ml |
9 mg/ml |
solution for infusion |
intravenous use |
||||||
|
Finland |
|
Extraneal |
7,50% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Finland |
|
Dianeal PD4 Glucose |
13,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Finland |
|
Dianeal PD4 Glucose |
22,7 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Finland |
|
Dianeal PD4 Glucose |
38,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
France |
|
DIANEAL PD1 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche |
1,36% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
France |
|
DIANEAL PD1 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche |
3,86% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
France |
|
DIANEAL PD4 GLUCOSE 3,86 %, solution pour dialyse péritonéale en poche |
3,86% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
France |
|
DIANEAL PD1 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche |
2,27% |
solution for peritoneal dialysis |
Intraperitoneal use |
||||||
|
France |
|
DIANEAL PD4 GLUCOSE 2,27 %, solution pour dialyse péritonéale en poche |
2,27% |
solution for peritoneal dialysis |
Intraperitoneal use |
||||||
|
France |
|
DIANEAL PD4 GLUCOSE 1,36 %, solution pour dialyse péritonéale en poche |
1,36% |
solution for peritoneal dialysis |
Intraperitoneal use |
||||||
|
France |
|
EXTRANEAL, solution pour dialyse péritonéale |
7,50% |
solution for peritoneal dialysis |
Intraperitoneal use |
||||||
|
France |
|
NUTRINEAL PD4 A 1,1 % D'ACIDES AMINES, solution pour dialyse péritonéale |
1,10% |
solution for peritoneal dialysis |
Intraperitoneal use |
||||||
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
DIANEAL PD1 |
1,36% W/V 2,27% W/V 3,86% W/V |
solution for peritoneal dialysis |
Intraperitoneal use |
||||||
|
Greece |
|
DIANEAL PD4 |
1,36% 2,27% W/V 3,86% W/V |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Greece |
|
EXTRANEAL |
(7,5+0,54+0,45+0,0257+0,0051)% w/v |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Greece |
|
Nutrineal PD4 |
1,1% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Hungary |
|
EXTRANEAL peritoneális dializáló oldat |
7,5% (icodextrin) |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Hungary |
|
DIANEAL PD 1 Glucose 1,36% peritoneális dializáló oldat |
1,36% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Hungary |
|
DIANEAL PD 1 Glucose 2,27% peritoneális dializáló oldat |
2,27% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Hungary |
|
DIANEAL PD 1 Glucose 3,86% peritoneális dializáló oldat |
3,86% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Hungary |
|
DIANEAL PD 4 Glucose 1,36% peritoneális dializáló oldat |
1,36% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Hungary |
|
DIANEAL PD 4 Glucose 2,27% peritoneális dializáló oldat |
2,27% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Hungary |
|
DIANEAL PD 4 Glucose 3,86% peritoneális dializáló oldat |
3,86% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Iceland |
|
Dianeal PD4 Glucose |
13,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Iceland |
|
Dianeal PD4 Glucose |
22,7 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Iceland |
|
Dianeal PD4 Glucose |
38,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Ireland |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Nutrineal Solution for Peritoneal Dialysis 4 with 1,1% Amino Acids |
|
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Ireland |
|
EXTRANEAL Solution for peritoneal dialysis |
|
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Italy |
|
EXTRANEAL |
7,5% |
solution for dialysis peritoneal |
intraperitoneal use |
||||||
|
Italy |
|
NUTRINEAL PD4 |
1,1% |
solution for dialysis peritoneal |
intraperitoneal use |
||||||
|
Italy |
|
SOLUZIONI PER DIALISI PERITONEALE BAXTER |
4,95 g/l - 49,54 g/l; |
solution for dialysis peritoneal |
intraperitoneal use |
||||||
|
Latvia |
|
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 |
|
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 |
|
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 |
|
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 |
|
Dianeal PD4 Glucose |
13,6g+5,38g+4,48g+0,184g+0,051g/l |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Lithuania |
|
Dianeal PD4 Glucose |
22,7g+5,38g+4,48g+0,184g+0,051g/l |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Lithuania |
|
Dianeal PD4 Glucose |
38,6g+5,38g+4,48g+0,184g+0,051g/l |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Lithuania |
|
EXTRANEAL |
75g+5,4g+4,5g+0,257g+0,051g/1 000ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Luxembourg |
|
Nutrineal PD4+A.A.1,1% |
1,1% amino acids |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Luxembourg |
|
Dianeal PD1 Glucose |
1,36%/2,27%/3,86% dextrose anydre |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Luxembourg |
|
Dianeal PD4 Glucose |
1,36%/2,27%/3,86% dextrose anydre |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Luxembourg |
|
Extraneal |
75,00 g/l Icodextrine |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Malta |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Dianeal PD1 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeistof |
13,6 g/l glucose anhydrate |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Netherlands |
|
Dianeal PD1 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeistof |
22,7 g/l glucose anhydrate |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Netherlands |
|
Dianeal PD1 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeistof |
38,6 g/l glucose anhydrate |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Netherlands |
|
Dianeal PD4 Glucose 1,36%/13,6 mg/ml, peritoneaaldialysevloeistof |
13,6 g/l glucose anhydrate |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Netherlands |
|
Dianeal PD4 Glucose 2,27%/22,7 mg/ml, peritoneaaldialysevloeistof |
22,7 g/l glucose anhydrate |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Netherlands |
|
Dianeal PD4 Glucose 3,86%/38,6 mg/ml, peritoneaaldialysevloeistof |
38,6 g/l glucose anhydrate |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
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 |
|
EXTRANEAL 7,5 %, oplossing voor peritoneale dialyse |
75 g/l icodextrine |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Norway |
|
Natriumklorid Baxter 9 mg/ml |
9 mg/ml |
solution for infusion |
intravenous use |
||||||
|
Norway |
|
Nutrineal PD4 amino Acids 1,1 % |
1,10% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Norway |
|
Extraneal |
75 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Extraneal Zestaw do dializy otrzewnowej |
75 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
EXTRANEAL |
75 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Romania |
|
DIANEAL PD4 GLUCOSE 1,36% m/v (13,6 mg/ml), |
13,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Romania |
|
DIANEAL PD4 GLUCOSE 2,27% m/v (22,7 mg/ml) |
22,7 mg/ml |
solution for peritoneal dialysis |
Intraperitoneal use |
||||||
|
Romania |
|
DIANEAL PD4 GLUCOSE 3,86% m/v (38,6 mg/ml) |
38,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Romania |
|
NUTRINEAL PD4 cu 1,1% aminoacizi |
1,1% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovak Republic |
|
Dianeal® PD1 glucose 1,36% w/v /13,6 mg/ml |
13,6 mg/1 ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovak Republic |
|
Dianeal® PD1 glucose 2,27% w/v /22,7 mg/ml |
22,7 mg/1 ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovak Republic |
|
Dianeal® PD1 glucose 3,86% w/v /38,6 mg/ml |
38,6 mg/1 ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovak Republic |
|
DIANEAL PD4 glucose 1,36 % w/v/13,6 mg/ ml |
13,6 mg/1 ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovak Republic |
|
DIANEAL PD4 glucose 2,27 % w/v/22,7 mg/ ml |
22,7 mg/1 ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovak Republic |
|
DIANEAL PD4 glucose 3,86 % w/v/38,6 mg/ ml |
38,6 mg/1 ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovak Republic |
|
EXTRANEAL |
7,5% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovak Republic |
|
Nutrineal PD4 with 1,1 % Amino Acids |
1,1% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovenia |
|
Extraneal 75 mg/ml ikodekstrina raztopina za peritonealno dializo |
75 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovenia |
|
Nutrineal PD4 11 mg/ml amino kislin raztopina za peritonealno dializo |
11 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovenia |
|
Dianeal PD1 13,6 mg/ml glukoze raztopina za peritonelano dializo |
13,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovenia |
|
Dianeal PD1 22,7 mg/ml glukoze raztopina za peritonelano dializo |
22,7 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovenia |
|
Dianeal PD1 38,6 mg/ml glukoze raztopina za peritonelano dializo |
38,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovenia |
|
Dianeal PD4 13,6 mg/ml glukoze raztopina za peritonelano dializo |
13,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovenia |
|
Dianeal PD4 22,7 mg/ml glukoze raztopina za peritonelano dializo |
22,7 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Slovenia |
|
Dianeal PD4 38,6 mg/ml glukoze raztopina za peritonelano dializo |
38,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
Natriumklorid Baxter 9 mg/ml |
9 mg/ml |
solution for infusion |
intravenous use |
||||||
|
Sweden |
|
Dianeal PD4 med glucos 13,6 mg/ml |
13,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Sweden |
|
Dianeal PD4 med glucos 22,7 mg/ml |
22,7 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Sweden |
|
Dianeal PD4 med glucos 38,6 mg/ml |
38,6 mg/ml |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Sweden |
|
Extraneal |
7,5% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
Sweden |
|
Nutrineal PD4 1,1 % Aminosyror |
1,10% |
solution for peritoneal dialysis |
intraperitoneal use |
||||||
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
ANNEX II
LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
|
Member State EU/EEA |
Marketing authorisation holder |
Invented name |
Strength |
Pharmaceutical form |
Animal species |
||||
|
Austria |
|
HIPRABOVIS PNEUMOS - Emulsion zur Injektion für Rinder |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Belgium |
|
HIPRABOVIS PNEUMOS |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Czech Republic |
|
HIPRABOVIS PNEUMOS Injekční emulze pro skot |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Denmark |
|
HIPRABOVIS PNEUMOS |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
France |
|
HIPRABOVIS PNEUMOS EMULSION INJECTABLE POUR BOVINS |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Germany |
|
HIPRABOVIS PNEUMOS |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Greece |
|
HIPRABOVIS PNEUMOS |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Hungary |
|
HIPRABOVIS PNEUMOS vakcina A.U.V. |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Ireland |
|
HIPRABOVIS PNEUMOS Emulsion for injection for cattle |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Italy |
|
HIPRABOVIS PNEUMOS Emulsion for injection for cattle |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Poland |
|
HIPRABOVIS PNEUMOS emulsja do wstrzykiwań dla bydła |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Portugal |
|
HIPRABOVIS PNEUMOS Emulsão para injecção para bovinos |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Slovak Republic |
|
HIPRABOVIS PNEUMOS injekčná emulzia pre dobytok |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
Spain |
|
HIPRABOVIS PNEUMOS |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
The Netherlands |
|
HIPRABOVIS PNEUMOS |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |
||||
|
United Kingdom |
|
HIPRABOVIS PNEUMOS Emulsion for Injection for Cattle |
Mannheimia haemolytica Biotype A serotype A1, inactivated cell free suspension containing leukotoxoid Ph. Eur. Inactivated Histophilus somni Bailie strain |
Emulsion for injection |
Cattle from 2 months of age |