natgillin/translations-raw huggingface dataset:
Refusal of the marketing authorisation for Nerventra (laquinimod) EMA/311892/2014 
Odbijanje odobrenja za stavljanje u promet lijeka Nerventra (laquinimod) EMA/405462/2014
At the time of the initial recommendation, the CHMP had concerns about results from animal studies showing a higher occurrence of cancers after long-term exposure to the medicine and noted that a similar long-term cancer risk could not be excluded in humans, especially when considering that the way the medicine works in the body is unclear. 
U trenutku prve preporuke, CHMP je bio zabrinut zbog rezultata prikupljenih iz ispitivanja provedenih u životinja koja su pokazala veći broj rakova nakon dugoročnog izlaganja lijeku, te je zaključeno da sličan dugoročan rizik od raka ne može biti isključen u slučaju ljudi, posebice ako se uzme u obzir da nije jasan način na koji lijek djeluje u tijelu.
How is Nerventra expected to work? 
Kako je Nerventra trebao djelovati?
Nerventra is a medicine that contains the active substance laquinimod. 
Nerventra je lijek koji sadrži djelatnu tvar lakinimod.
Therefore the Committee concluded that the benefits of Nerventra at the dose studied were not sufficient to outweigh the potential risks in patients with relapsing remitting MS and maintained its recommendation that the medicine be refused marketing authorisation. 
Stoga je Povjerenstvo zaključilo da koristi od lijeka Nerventra u ispitanoj dozi nisu dostatne kako bi nadmašile potencijalne rizike u bolesnika s relapsno-remitirajućom multiplom sklerozom i održale svoju preporuku da se lijeku uskrati izdavanje odobrenja za stavljanje u promet.
Nerventra was expected to be used to treat multiple sclerosis (MS), a disease in which the immune system malfunctions, causing inflammation that destroys the protective sheath around the nerves in the brain and spinal cord. 
Nerventra se trebao koristiti za liječenje multiple skleroze, bolesti koja utječe na rad imunosnog sustava uzrokujući upalu koja uništava zaštitnu ovojnicu oko živaca u mozgu i kralježničku moždinu.
The CHMP noted that the risk could not be excluded with current data and that animal studies suggest that some of the harmful effects may be delayed and only seen later on in the child's life. 
CHMP je zaključio da se ne može isključiti rizik na temelju aktualnih podataka te da ispitivanja provedena na životinjama ukazuju da postoje određena štetna djelovanja koja se mogu odgoditi i uočiti tek kasnije tijekom života djeteta.
The company also provided results of two main studies in patients with relapsing-remitting MS. One of the studies involving 1,106 patients compared Nerventra with placebo (a dummy treatment), while the second study in 1,331 patients compared Nerventra with placebo and another medicine used to treat MS, interferon-beta 1a. 
Jedno od ispitivanja obuhvatilo je 1 106 bolesnika te je usporedilo lijek Nerventra s placebom (liječenjem bez djelatne tvari), dok je drugo ispitivanje obuhvatilo 1 331 bolesnika te je usporedilo lijek Nerventra s placebom i drugim lijekom korištenim za liječenje multiple skleroze, lijekom interferon-beta 1a.
The company informed the CHMP that there are a number of ongoing and planned clinical trials with Nerventra in patients with multiple sclerosis. 
Tvrtka je obavijestila CHMP da postoji niz kliničkih ispitivanja za lijek Nerventra koji su trenutno u tijeku ili su planirani u bolesnika oboljelih od multiple skleroze.
What was Nerventra expected to be used for? 
Za što se lijek Nerventra trebao koristiti?
Nerventra was to be used in the type of MS known as relapsing-remitting MS, when the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions). 
Nerventra se trebao koristiti za liječenje tipa multiple skleroze poznate pod nazivom relapsnoremitirajuća multipla skleroza, u slučaju kada bolesnici imaju izbijanje simptoma (relapse) nakon razdoblja oporavka (remisija).
control the inflammation and the damage to nerves, thus helping to reduce symptoms and the worsening of disability in patients with MS. 
Modulirajući imunosni sustav očekuje se da će pomoći pri kontroli upale i oštećenja živaca, te stoga pomaže pri smanjivanju simptoma i pogoršanju invalidnosti u bolesnika oboljelih od multiple skleroze.
The company that applied for authorisation is Teva Pharma GmbH. 
Teva Pharma GmbH je tvrtka koja je podnijela zahtjev za izdavanje odobrenja za stavljanje lijeka u promet.
What measures are being taken to ensure the safe and effective use of 
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita
What is Fexeric and what is it used for? 
Što je Fexeric i za što se koristi?
The maximum dose is 12 tablets per day. 
Maksimalna doza iznosi 12 tableta na dan.
Fexeric is available as 1 g tablets. 
Fexeric je dostupan kao 1 g tablete.
The full EPAR and risk management plan summary for Fexeric can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Fexeric nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Patients should keep to their prescribed low 
Bolesnici se trebaju pridržavati propisane dijete koja
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom crijevima i formira spoj koji se zatim eliminira u stolici.
Further information can be found in the summary of the risk management plan. 
Dodatne informacije možete pronaći usažetku plana upravljanja rizikom.
Other information about Fexeric 
Ostale informacije o lijeku Fexeric
The recommended starting dose is 3 to 6 tablets per day, taken in divided doses together with meals. 
Preporučena početna doza iznosi 3 do 6 tableta na dan, koje se uzimaju raspodjeljene u doze uz obrok.
Serious side effects were uncommon and mainly affected the gut and stomach. 
Ozbiljne nuspojave nisu bile česte i uglavnom su zahvaćale crijeva i želudac.
What are the risks associated with Fexeric? 
Koji su rizici povezani s lijekom Fexeric?
This is a summary of the European public assessment report (EPAR) for Fexeric. 
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Fexeric.
The overall safety profile was considered acceptable and comparable to other phosphate binders. 
Zaključeno je kako je cjelokupan sigurnosan profil prihvatljiv i usporediv s drugim sredstvima za vezivanje fosfata.
In the second study, 149 patients who were not on dialysis received either Fexeric or placebo for 3 months. 
U drugom ispitivanju, 149 bolesnika koji nisu primali dijalizu primalo je lijek Fexeric ili placebo tijekom 3 mjeseca.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Fexeric's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Fexeric nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
This prevents the phosphate from being absorbed into the body and helps to keep down the phosphate levels in the blood. 
Ovo sprječava apsorpciju fosfata u tijelu i pomaže pri održavanju niskih koncentracija fosfata u krvi.
A risk management plan has been developed to ensure that Fexeric is used as safely as possible. 
Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Fexeric.
Patients with severe kidney disease have difficulty eliminating phosphate from their bodies. 
Bolesnici s ozbiljnim oboljenjem bubrega ne mogu eliminirati fosfat iz svojeg tijela.
Both studies looked at the change in the amount of phosphate in the blood, measured in mg/dl. 
Oba su ispitivanja istražila promjenu u broju fosfata u krvi, izmjereno u mg/dl.
It is not intended to provide practical advice on how to use Fexeric. 
Svrha sažetka nije davati praktične savjete o primjeni lijeka Fexeric.
In addition, the company that markets Fexeric will carry out a study to gain further information on the long-term safety of Fexeric, particularly in older patients. 
Nadalje, tvrtka koja stavlja lijek Fexeric u promet provest će ispitivanje kako bi prikupila daljnje informacije o dugoročnoj sigurnoj primjeni lijeka Fexeric, posebice u starijih bolesnika.
A build-up of phosphate leads to hyperphosphataemia and in the long-term can cause complications such as heart 
Nakupljanje fosfata rezultira hiperfosfatemijom i dugoročno može uzrokovati komplikacije poput bolesti srca i kosti.
In the first study, Fexeric was as effective as sevelamer carbonate, an approved medicine, in lowering phosphate levels in 359 patients with long-term kidney disease: after 12 weeks both treatments resulted in a reduction in phosphate levels of around 2 mg/dl. 
U prvom ispitivanju, Fexeric je bio podjednako djelotvoran kao sevelamer karbonat, odobreni lijek, za potrebe snižavanja koncentracija fosfata u 359 bolesnika s dugoročnom bolesti bubrega: nakon 12 tjedana obje su terapije rezultirale smanjenjem koncentracija fosfata od otprilike 2 mg/dl.
Fexeric must not be used in patients with low blood-phosphate levels, patients who have severe problems with the stomach and gut (such as bleeding from the gut), and those with iron accumulation disorders such as haemochromatosis. 
Fexeric se ne smije koristiti u bolesnika s niskim koncentracijama fosfata u krvi, bolesnicima koji imaju ozbiljne probleme sa želucem i crijevima (poput krvarenja iz crijeva), i onima koji imaju poremećaj akumulacije željeza poput hemokromatoze.
The study showed that blood-phosphate levels fell on average by 0.7 mg/dl with Fexeric compared with 0.3 mg/dl with placebo. 
Ispitivanjem je utvrđeno da su koncentracije fosfata u krvi snižene prosječno za 0,7 mg/dl s lijekom Fexeric u usporedbi s 0,3 mg/dl s placebom.
What benefits of Fexeric have been shown in studies? 
Koje su koristi lijeka Fexeric utvrđene u ispitivanjima?
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fexeric, including the appropriate precautions to be followed by healthcare 
Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Fexeric nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici
The active substance in Fexeric, ferric citrate coordination complex, is a phosphate binder. 
Djelatna tvar lijeka Fexeric, koordinacijski kompleks željezovog citrata, je sredstvo za vezivanje fosfata.
The most common side effects with Fexeric (which may affect more than 1 in 10 people) are changes in bowel movements (diarrhoea or constipation) and discoloured faeces. 
Najčešće nuspojave lijeka Fexeric (koje su uočene kod više od na bolesnika) su promijene u radu crijeva (proljev ili zatvor) i promjena u boji izmeta.
Blood-phosphate levels should be monitored regularly during treatment. 
Tijekom liječenja treba redovito pratiti koncentracije fosfata u krvi.
For more information about treatment with Fexeric, read the package leaflet (also part of the EPAR) or contact 
Više informacija o terapiji lijekom Fexeric pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
When taken with meals, the iron contained in Fexeric binds to phosphate from food in the gut, forming a compound that is then eliminated in the stools. 
Kada se uzima uz obroke, željezo sadržano u lijeku Fexeric vezuje se na fosfat iz hrane u
Fexeric is a medicine used to control hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease. 
Fexeric je lijek koji se koristi za kontrolu hiperfosfatemije (visoke koncentracije fosfata u krvi) u odraslih osoba sa kroničnim oboljenjem bubrega.
The CHMP considered that Fexeric is effective at controlling blood-phosphate levels in patients with long-term kidney disease, whether they are on dialysis or not. 
CHMP je zaključio kako je Fexeric djelotvoran za kontroliranje koncentracija fosfata u krvi u bolesnika s dugoročnom bolesti bubrega, bez obzira nalaze li se na dijalizi ili ne.
It contains the active substance ferric citrate coordination 
koordinacijski kompleks željezovog citrata
Fexeric was shown to be effective at controlling blood-phosphate levels in 2 main studies in patients with long-term kidney disease and hyperphosphataemia. 
Dokazano je da je lijek Fexeric djelotvoran za kontroliranje koncentracija fosfata u krvi u 2 glavna ispitivanja u bolesnika s kroničnim oboljenjem bubrega i hiperfosfatemijom.
For practical information about using Fexeric, patients should read the package leaflet or contact their 
Praktične informacije o primjeni lijeka Fexeric pročitajte u uputi o lijeku, odnosno obratite se svojem
For the full list of all side effects reported with 
Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Fexeric
Budapest H-1138 Hungary 
Budapest H-1138
B. Braun Adria d.o.o Hondlova 2/9 
Braun Adria d.o.o Hondlova 2/9
B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, 
B-dul Theodor Pallady nr. 50, sector 3,
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States 
Popis naziva, farmaceutskih oblika, jačina lijekova, puteva primjene, nositelja odobrenja u državama članicama
Hydroksyetyloskro bia 200/0,5 Baxter 
Hydroksyetyloskrobia 200/0,5 Baxter
Strada Fânarului nr. 2A, 500464 Braşov, Romania 
Strada Fânarului nr. 2A, 500464 Braşov,
Baxter Hungary Kft Népfürdő u. 22. 
Madžarska Baxter Hungary Kft Népfürdő u.
Kruczkowskiego 8 00-380 Warszawa Poland 
Kruczkowskiego 8 00-380 Warszawa Poland hidroksietilškrob
S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A, 500464 Brasov, Romania 
Rumunjska S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A, 500464 Brasov,
FRESENIUS KABI HELLAS AE 
KABI HELLAS AE
Marina, 16-18-17 08005 Barcelona Spain 
Marina, 16-18-17
S.C. INFOMED FLUIDS S.R.L., 
Rumunjska S.C. INFOMED FLUIDS S.R.L.,
S.C. FRESENIUS KABI ROMÂNIA S.R.L. 
Rumunjska S.C. FRESENIUS KABI ROMÂNIA S.R.L.
FRESENIUS KABI ITALIA Srl 
KABI ITALIA Srl
0.450.55 AV. MW 200K, sodium chloride 
0,45 - 0,55 AV, MW 200K, natrijev klorid
S.C. INFOMED FLUIDS S.R.L. 
Rumunjska S.C. INFOMED FLUIDS S.R.L.
Baxter Polska Sp. z o.o. 
Baxter Polska Sp. z o.o. ul.
sodium chloride 
natrijev klorid
69007 Lyon France hydroxyethyl starch 200 
69007 Lyon France hidroksietilškrob 200
Polígono Industrial Sector 14 
Španjolska BAXTER S.L. Polígono Industrial Sector 14
B. Braun Melsungen A.G. 
Braun Melsungen A.G.
FRESENIUS KABI ESPAÑA S.A. 
KABI ESPAÑA S.A.
Hallesche Landstr. 
Serumwerk Bernburg AG Hallesche Landstr.
Box 1110 +1120 DE-34209 Melsungen Germany 
Braun Melsungen AG P.O. Box 1110 +1120 DE-34209 Melsungen Germany
FRESENIUS KABI FRANCE 
KABI FRANCE
BAXTER CZECH spol. 
BAXTER CZECH spol. s r.o.
60 g/l, 72 g/l, water ad 1000 ml 
60 g/l, 72 g/l, voda do 1000 ml
34212 Melsugen 
34212 Melsungen,
B.Braun Melsungen AG Carl Braun Strasse 1 Melsungen 
Madžarska B.Braun Melsungen AG Carl Braun Strasse 1
Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1 61352 Bad Homburg v.d.H. 
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1 613 52 Bad Homburg v.d.H.
00181 Helsinki, Finland 
08005 Barcelona
100 g/l, 9 g/l, water ad 1000 ml 
100 g/l, 9 g/l, voda do 1000 ml
Slovak Republic 
Slovačka
Fresenius Kabi AB, 751 74 Uppsala Sweden hydroxyethyl starch, 
Fresenius Kabi AB, Rapsgatan 7, SE-751 74 Uppsala, Sweden hidroksietilškrob , natrijev klorid, voda
60 g/l, 9 g/l, water ad 1000 ml 
60 g/l, 9 g/l, voda do 1000 ml
B. BRAUN MELSUNGEN AG 
Španjolska B. BRAUN MELSUNGEN AG
Fresenius Kabi Polska Sp. z o.o. 
Fresenius Kabi Polska Sp. z o.o. ul.
B. BRAUN MELSUNGEN AG, 
Rumunjska B. BRAUN MELSUNGEN AG,
Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (polymere 130/0.4) and sodium chloride 
Molenberglei 7 2627 Schelle Belgium djelatna tvar: hidroksietilškrob (Mr 130 000), natrijev klorid
Str.1, D34212 Melsungen, Germany 
D - 34212 Melsungen, Germany
60 g/l, 0,3 g/l, 0,3 g/l, 6,02 g/l, 4,63 g/l, water ad 1000 ml 
60 g/l, 0,3 g/l, 0,3 g/l, 6,02 g/l, 4,63 g/l, voda do 1000 ml
Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (MR 
Molenberglei 7 2627 Schelle Belgium djelatna tvar: hidroksietilškrob (Mr
B. Braun Melsungen AG Carl-Braun-Straße 1 34209 Melsungen Germany 
Braun Melsungen AG Carl-Braun-Straße 1 34209 Melsungen Germany
B. Braun Melsungen AG Carl-Braun-Str. 1 
Braun Melsungen AG Carl-Braun-Str.
0,134 g/l, 60 g/l, 0,4 g/l, 0,2 g/l, 6 g/l, 3,7 g/l, water ad 1000 ml 
0,134 g/l, 60 g/l, 0,4 g/l, 0,2 g/l, 6 g/l, 3,7 g/l, voda do 1000 ml
B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride, Magnesium chloride hexahydrate, sodium acetate, Malic acid 
Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany hidroksietilškrob, natrijev klorid, kalijev klorid, kalcijev klorid magnezijev klorid heksahidrat, natrijev acetat, malatna kiselina
Poly-(o-2-hydroxyethyl)starch (M.W 200000) + sodium acetate trihydrate + sodium chloride + potassium chloride + magnesium chloride hexahydrate 
Greece poli (O-2hidroksietil)škrob (Mr 200000) + natrijev acetat trihidrat, + natrijev klorid + kalijev klorid + magnezijev klorid heksahidrat
0,37 g/l, 100 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, water ad 1000 ml 
0,37 g/l, 100 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, voda do 1000 ml
0,37 g/l, 60 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, water ad 1000 ml 
0,37 g/l, 60 g/l, 0,3 g/l, 0,2 g/l, 6,25 g/l, 3,27 g/l, 0,67 g/l, 1,197 g/l, voda do 1000 ml
VOLULYTE SOLUTION FOR INFUSION 6% 
SOLUTION FOR INFUSION 6%
VOLULYTE 6% 60,0 g/l, 4,63 g/l, 
6% 60,0 g/l, 4,63 g/l,
Poli(O-2-hydroxyethyl) starch, Sodium chloride 
poli(O-2 hidroksietil)škrob, natrijev klorid
5, place du Marivel 92316 Sèvres Cedex France hydroxyethyl starch 130 
5, place du Marivel 92316 Sèvres Cedex France hidroksietilškrob 130
Hydroxyethyl Starch 130/0,42, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate 
hidroksietilškrob 130/0,42, natrijev klorid,kalijev klorid,kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat
Poly(O-2hydoxyethyl)starch 130/0.4, Sodium chloride, Sodium acetate trihydrate, Potassium chloride, Magnesium chloride hexahydrate 
poli(O-2 hidroksietil)škrob 130/0,4, natrijev klorid, natrijev acetat trihidrat, kalijev klorid, magnezijev klorid heksahidrat
United Kingdom poly (o-2hydroxyethyl)starch sodium chloride 
United Kingdom poli(O-2 hidroksietil)škrob, natrijev klorid
1753 Halden Norway 
1753 Halden Norway poli(O-2 hidroksietil)škrob, natrijev klorid
VOLULYTE 6 %, solution pour perfusion 
6 %, solution pour perfusion
Hydroxyethyl Starch + Sodium Acetate Trihydrate + Sodium Chloride + Potasium Chloride + Magnesium Chloride Hexahydrate 
hidroksietilškrob, + natrijev acetat trihidrat + natrijev klorid + kalijev klorid + magnezijev klorid heksahidrat
P.O. 
B.
0.37 g/l, 0.2g/l, 3.27 g/l, 0.67 g/l 
0,20 g/l, 3,27 g /l, 0,67 g/l
Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 250 
5, place du Marivel 92316 Sèvres Cedex France hidroksietilškrob 250
B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany hydroxyethyl starch, 
Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsugen Germany natrijev klorid, hidroksietilškrob
Poly(0-2hydroxyethyl)starch 130 kDa mol.substitution 0,42 , Sodium chloride 
poli(O-2 hidroksietil)škrob, 130 kDa mol.subst.
Luxembourg B.Braun Melsungen A.G. Carl-Braun-Straße 1 
Luksemburg B.Braun Melsungen A.G.
Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate + Malic Acid 
hidroksietilškrob, + natrijev klorid + kalijev klorid + kalcijev klorid dihidrat + + magnezijev klorid heksahidrat +natrijev acetat trihidrat + malatna kiselina
Poly-(o-2-hydroxyethyl)starch (MW 200000) + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate + 
Greece poli(O-2hidroksietil)škrob (Mr 200000) + natrijev klorid + kalijev klorid + kalcijev klorid dihidrat + magnezijev klorid heksahidrat + natrijev acetat trihidrat + malatna kiselina
Poly(0-2hydroxyethyl)starch 200 kDa mol.substitution 0,45-0,55, Sodium chloride 
D-34212 Melsungen poli(O-2 hidroksietil)škrob, 200 kDa mol.subst.
Hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Sodium chloride, Magnesium chloride 
hidroksietilškrob, natrijev acetat trihidrat, natrijev klorid, magnezijev klorid
Tetraspan 6 % 60g/l, 6,25g/l, 0,30 g/l, 0.37 g/l, 
Tetraspan 6 % 60g/l, 6,25g/l, 0,30 g/l, 0,37 g/l, 0,20 g/l,
B.Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany 
Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany
Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate, hydroxyethyl starch 130/0.42 
United Kingdom natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat, hidroksietilškrob 130 /
Poly(0-2hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride 
D-34212 Melsungen poli(O-2 hidroksietil)škrob, 130 kDa mol.subst.
Hidroxietil amidon, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, Calcium chloride dihydrate,Sodium acetate trihydrate, Malic acid 
Melsungen hidroksietilškrob, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat, malatna kiselina
B. Braun Melsungen AG Carl-Braun Strasse 1 34212 Melsungen Germany 
Braun Melsungen AG Carl-Braun Strasse 1 34212 Melsungen Germany
Belgium Fresenius Kabi NV Molenberglei 7 
Molenberglei 7
164 94 Kista Sweden hydroxyethyl starch, 
SE-751 74 Uppsala Sweden hidroksietilškrob, natrijev klorid, voda
D-34212 Melsungen 
Melsungen D-34212
Hydroxyethyl Starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate, 
hidroksietilškrob, natrijev acetat trihidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat,
B Braun Melsungen AG Carl-Braun-Strasse 1 Melsungen, D-34212 Germany 
Španjolska B. BRAUN MELSUNGEN AG Carl-Braun Strasse, 1 Melsungen D-34212
Hydroxyethyl Starch + Sodium Chloride + Potasium Chloride + Calcium Chloride Dihydrate + Magnesium Chloride Hexahydrate + Sodium Acetate Trihydrate 
Greece hidroksietilškrob + natrijev klorid + kalijev klorid + kalcijev klorid dihidrat + magnezijev klorid heksahidrat + natrijev acetat trihidrat
ul.Hrubieszowska 2 01-209 Warszawa, Poland 
Fresenius Kabi Polska Sp.zo.o. ul.Hrubieszowska 2 01-209 Warszawa, Poland poli(O-2 hidroksietil)škrob, natrijev klorid
Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal 
Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal natrijev acetat trihidrat + kalijev klorid + magnezijev klorid heksahidrat + hidroksietilškrob + kalcijev klorid dihidrat + natrijev klorid
Vitafusal 10 % 100g/l, 6 g/l, 0.4 g/l, 0.134 g/l, 0.2 g/l, 3.7 g/l 
Vitafusal 10 % 100g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l,
3.7 mg/ml + 0.4mg/ml + 0.2mg/ml + 60mg/ml + 0.134mg/ml + 6mg/ml 
PlasmaVolume Redibag 3,7 mg/ml,0,4 mg/ml,0,2 mg/ml, 60 mg/ml, 0,134 mg/ml, 6 mg/ml
Vitafusal 6 % 60 g/l, 6 g/l, 0.4 g/l, 0.134 g/l, 0.2 g/l, 3.7 g/l 
Vitafusal 6 % 60 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l,
Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 200 
5, place du Marivel 92316 Sèvres Cedex France hidroksietilškrob 200
hydroxyethyl starch, Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate 
hidroksietilškrob, natrijev acetat trihidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat
Vitakoll 10 % 100 g/l, 6 g/l, 0.4 g/l, 0.134 g/l, 0.2 g/l, 3.7 g/l 
Vitakoll 10 % 100 g/l, 6 g/l, 0,4 g/l, 0,134 g/l, 0,2 g/l,