natgillin/translations-raw huggingface dataset:
How is Nerventra expected to work?
Kako naj bi zdravilo Nerventra delovalo?
control the inflammation and the damage to nerves, thus helping to reduce symptoms and the worsening of disability in patients with MS.
Z uravnavanjem delovanja imunskega sistema naj bi pomagalo zmanjšati vnetje in poškodbe živcev, s čimer naj bi ublažilo simptome in upočasnilo napredovanje prizadetosti pri bolnikih z MS.
What measures are being taken to ensure the safe and effective use of
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe
The maximum dose is 12 tablets per day.
Največji odmerek je 12 tablet na dan.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom spojino, ki se izloči z blatom.
Other information about Fexeric
Druge informacije o zdravilu Fexeric
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.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Fexeric sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
In the second study, 149 patients who were not on dialysis received either Fexeric or placebo for 3 months.
V drugi študiji je 149 bolnikov, ki niso bili na dializi, tri mesece prejemalo zdravilo Fexeric ali placebo.
What is Fexeric and what is it used for?
Kaj je zdravilo Fexeric in za kaj se uporablja?
Serious side effects were uncommon and mainly affected the gut and stomach.
Resni neželeni učinki so bili občasni in so večinoma prizadeli črevo ter želodec.
This is a summary of the European public assessment report (EPAR) for Fexeric.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Fexeric.
A risk management plan has been developed to ensure that Fexeric is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Fexeric je bil pripravljen načrt obvladovanja tveganj.
What are the risks associated with Fexeric?
Kakšna tveganja so povezana z zdravilom Fexeric?
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 zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Fexeric večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
This prevents the phosphate from being absorbed into the body and helps to keep down the phosphate levels in the blood.
To preprečuje absorpcijo fosfatov v telesu in pomaga vzdrževati nizke ravni fosfatov v krvi.
Patients should keep to their prescribed low
Bolniki se morajo držati predpisane diete z
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.
Poleg tega bo družba, ki trži zdravilo Fexeric, izvedla študijo, s katero bo pridobila dodatne podatke o njegovi dolgoročni varnosti, predvsem pri starejših bolnikih.
Patients with severe kidney disease have difficulty eliminating phosphate from their bodies.
Bolniki s hudo ledvično boleznijo imajo težave z izločanjem fosfatov iz telesa.
What benefits of Fexeric have been shown in studies?
Kakšne koristi je zdravilo Fexeric izkazalo v študijah?
The overall safety profile was considered acceptable and comparable to other phosphate binders.
Splošni varnostni profil je bil sprejemljiv in primerljiv z
Both studies looked at the change in the amount of phosphate in the blood, measured in mg/dl.
V obeh študijah so opazovali spremembo količine fosfatov v krvi, izmerjeno v mg/dl.
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.
Najpogostejša neželena učinka zdravila Fexeric (ki lahko prizadeneta več kot 1 osebo od 10) sta spremenjeno delovanje črevesja (driska ali zaprtje) in obarvano blato.
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
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni
It is not intended to provide practical advice on how to use Fexeric.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
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.
V prvi študiji je bilo zdravilo Fexeric enako učinkovito kot sevelamerijev karbonat, ki je že odobreno zdravilo, pri zniževanju ravni fosfatov pri 359 bolnikih z dolgotrajno ledvično boleznijo: po 12 tednih so pri obeh oblikah zdravljenja ugotovili znižanje ravni fosfatov za približno 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.
Zdravilo Fexeric se ne sme uporabljati pri bolnikih z nizkimi ravnmi fosfatov v krvi, bolnikih, ki imajo hude težave z želodcem in črevesom (kot je krvavitev iz črevesa) ter bolnikih z motnjami kopičenja železa, kot je hemokromatoza.
A build-up of phosphate leads to hyperphosphataemia and in the long-term can cause complications such as heart
Kopičenje fosfatov povzroča hiperfosfatemijo, ki lahko dolgoročno vodi do zapletov, kot so bolezni srca in kosti.
For more information about treatment with Fexeric, read the package leaflet (also part of the EPAR) or contact
Za več informacij o zdravljenju z zdravilom Fexeric preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Blood-phosphate levels should be monitored regularly during treatment.
Med zdravljenjem je treba redno spremljati ravni fosfatov v krvi.
Fexeric is a medicine used to control hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease.
Fexeric je zdravilo, ki se uporablja za nadzorovanje hiperfosfatemije (visokih ravni fosfatov v krvi) pri odraslih z dolgotrajno ledvično boleznijo.
The active substance in Fexeric, ferric citrate coordination complex, is a phosphate binder.
Zdravilna učinkovina zdravila Fexeric, koordinacijski kompleks železovega citrata, je vezalec fosfatov.
For practical information about using Fexeric, patients should read the package leaflet or contact their
Za praktične informacije o uporabi zdravila Fexeric naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
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.
Menil je, da je zdravilo Fexeric učinkovito pri uravnavanju ravni fosfatov v krvi pri bolnikih z dolgotrajno ledvično boleznijo, ne glede na to, ali so na dializi ali ne.
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.
Pri jemanju ob obrokih se železo v zdravilu Fexeric veže na fosfate iz hrane v črevesu in tako ustvari
The recommended starting dose is 3 to 6 tablets per day, taken in divided doses together with meals.
Zdravilo Fexeric je na voljo v obliki tablet po 1 g. Priporočeni začetni odmerek je od 3 do 6 tablet na dan, ki se jemljejo v ločenih odmerkih ob obrokih.
It contains the active substance ferric citrate coordination
koordinacijski kompleks železovega citrata
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.
V njej so pokazali, da so se pri zdravilu Fexeric ravni fosfatov v krvi v povprečju znižale za 0,7 mg/dl,
Fexeric was shown to be effective at controlling blood-phosphate levels in 2 main studies in patients with long-term kidney disease and hyperphosphataemia.
V dveh glavnih študijah pri bolnikih z dolgotrajno ledvično boleznijo in hiperfosfatemijo so dokazali, da je zdravilo Fexeric učinkovito pri nadzorovanju ravni fosfatov v krvi.
EMA/23705/2010 EMEA/H/C/1102
20. januar 2009 EMA/139270/2010 EMEA/H/C/1102
It was to be available as tablets.
Na voljo naj bi bilo v tabletah.
The main measures of effectiveness were based on the amount of time the patients spent awake after they had first fallen asleep and improvements in the quality of sleep over the first four to 12 weeks of treatment.
Glavna merila učinkovitosti so temeljila na dolžini časa budnosti bolnikov od takrat, ko so prvič zaspali, ter na izboljšanju kakovosti spanja v prvih štirih do dvanajstih tednih zdravljenja.
The company presented results of four main studies involving over 3,000 adults who had difficulty staying asleep.
Družba je predložila rezultate štirih glavnih študij, v katere je bilo vključenih več kot 3 000 odraslih, ki so se med spanjem pogosto zbujali.
The effects of Sliwens were first tested in experimental models before being studied in humans.
Učinki zdravila Sliwens so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
There was also a lack of information comparing the long-term use of Sliwens with placebo.
Prav tako ni bilo na voljo podatkov o primerjavi dolgotrajne uporabe zdravila Sliwens s placebom.
The CHMP considered the effect of Sliwens on sleep to be small.
CHMP je menil, da so učinki zdravila Sliwens na spanec majhni.
Sliwens is a medicine that contains the active substance eplivanserin.
Sliwens je zdravilo, ki vsebuje zdravilno učinkovino eplivanserin.
The company informed the CHMP that there were no consequences for patients in clinical trials or compassionate use, since all ongoing clinical trials have been discontinued.
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe, ker so bila vsa klinična preskušanja v teku prekinjena.
The Committee was also concerned about the risk of diverticulitis (inflammation in little sacs or pouches in the intestines) in patients taking the medicine.
Odbor je izrazil tudi zadržke glede tveganja za pojav divertikulitisa (vnetja majhnih vrečk ali žepkov v črevesju) pri bolnikih, ki jemljejo to zdravilo.
On 18 December 2009, Sanofi-Aventis officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Sliwens, for use in adults with chronic (long-term) insomnia who have difficulty staying asleep.
Družba Sanofi-Aventis je dne 18. decembra 2009 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Sliwens, namenjenim zdravljenju bolnikov s kronično (dolgotrajno) nespečnostjo, ki se med spanjem pogosto zbujajo.
The active substance in Sliwens, eplivanserin, is a 5-hydroxytryptamine receptor antagonist.
Zdravilna učinkovina v zdravilu Sliwens, eplivanserin, je antagonist receptorjev 5-hidroksitriptamina.
Withdrawal of marketing authorisation application for Sliwens (eplivanserin) EMA/23705/2010
Umik vloge za pridobitev dovoljenja za promet z zdravilom Sliwens (eplivanserin) EMA/139270/2010
It blocks receptors in the brain called 5-hydroxytryptamine type 2 receptors, which are involved in regulating the daily cycle of being asleep and being awake.
Zavira receptorje v možganih, imenovane receptorji 5-hidroksitriptamina tipa 2, ki sodelujejo pri uravnavanju dnevnega cikla spanja in budnosti.
Withdrawal of marketing authorisation application for Sliwens (eplivanserin)
Umik vloge za pridobitev dovoljenja za promet z zdravilom Sliwens (eplivanserin)
Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Sliwens could not have been approved.
Na podlagi pregleda podatkov in odgovorov družbe na seznam vprašanj, ki jih zastavil CHMP, je v času umika vloge izrazil določene zadržke in je začasno menil, da zdravila Sliwens ni mogoče odobriti.
study involving 283 adults compared Sliwens with lormetazepam (another medicine used to treat insomnia) looked at how sleepy the patients were the morning after taking Sliwens.
V peti študiji, v katero je bilo vključenih 283 odraslih, so zdravilo Sliwens primerjali z lormetazepamom (drugim zdravilom za zdravljenje nespečnosti) in proučevali, kako zaspani so bili bolniki naslednje jutro po zaužitju zdravila Sliwens.
Sliwens was expected to be used in adults with long-term insomnia (difficulty sleeping).
Zdravilo Sliwens naj bi se uporabljalo pri odraslih z dolgotrajno nespečnostjo (težavo s spancem).
By blocking these receptors, eplivanserin was expected to modify the sleep-wake cycle, helping people with long-term insomnia to stay asleep.
Eplivanserin naj bi z zaviranjem teh receptorjev spremenil ta cikel ter ljudem z dolgotrajno nespečnostjo pomagal zaspati in se med spanjem ne zbujati.
The studies compared Sliwens with placebo (a dummy treatment).
V študijah so zdravilo Sliwens primerjali s placebom (zdravilom brez zdravilne učinkovine).
What was Sliwens expected to be used for?
Za kaj naj bi se zdravilo Sliwens uporabljalo?
It was to be used in patients who have difficulty staying asleep.
Zdravilo naj bi se uporabljalo pri bolnikih, ki se med spanjem pogosto zbujajo.
What is Sliwens?
Kaj je zdravilo Sliwens?
How was Sliwens expected to work?
Kako naj bi zdravilo Sliwens delovalo?
Baxter Hungary Kft Népfürdő u. 22.
Madžarska Baxter Hungary Kft Népfürdő u. 22.
Baxter MédicoFarmacêutica, Lda.
Portugalska Baxter MédicoFarmacêutica, Lda.
Luxembourg Baxter S.A. Boulevard René Branquart 80
Luksembourg Baxter S.A. Boulevard René Branquart 80
Hydroksyetyloskro bia 200/0,5 Baxter
Hydroksyetyloskrobi a 200/0,5 Baxter
0.450.55 AV. MW 200K, sodium chloride
0.45-0.55 AV. MW 200K, natrijev klorid
Annex I List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the Member States
Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
Baxter B.V.
Nizozemska Baxter B.V.
Fresenius Kabi Pharma Portugal, Lda Av. do Forte, 3
Portugalska Fresenius Kabi Pharma Portugal, Lda
PlasmaHES RedibagInfusionsloesung
PlasmaHES Redibag - Infusionsloesung
69007 Lyon France hydroxyethyl starch 200
69007 Lyon France hidroksietilškrob 200 000 PLASMOHES 6%, solution pour perfusion
B. Braun Melsungen A.G.
Luksembourg B.Braun Melsungen A.G.
Belgium B. Braun Melsungen AG Carl-Braun-Strasse 1
Češka republika B. Braun Melsungen AG Carl-Braun Strasse 1
Fresenius Kabi AB, 751 74 Uppsala Sweden hydroxyethyl starch,
Fresenius Kabi AB, Rapsgatan 7, SE-751 74 Uppsala, Sweden hidroksietilškrob (HES), natrijev klorid, voda
D-34212 Melsungen
D-34212 Melsungen Germany
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
B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany hidroksietilškrob, natrijev klorid, kalijev klorid, kalcijev klorid, magnezijev klorid heksahidrat, natrijev acetat, jabolčna kislina
Poli(O-2-hydroxyethyl) starch
poli(O-2-hidroksietil)škrob Volulyte
Poly-(o-2-hydroxyethyl)starch (M.W 200000) + sodium acetate trihydrate + sodium chloride + potassium chloride + magnesium chloride hexahydrate
Greece poli(O-2-hidroksietil)škrob (M.W 200000) + natrijev acetat trihidrat + natrijev klorid + kalijev klorid + magnezijev klorid heksahidrat
Sodium Chlorid, Hydroxyethyl starch
natrijev klorid, hidroksietilškrob
Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (MR
Fresenius Kabi NV Molenberglei 7 2627 Schelle Belgium hidroksietilškrob
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 130/0.42
Poly(0-2hydroxyethyl)starch 130 kDa mol.substitution 0,42 , Sodium chloride
poli(0-2-hidroksietil)škrob 130 kDa mol.substitucija natrijev klorid
United Kingdom poly (o-2hydroxyethyl)starch sodium chloride
United Kingdom poli(o-2-hidroksietil)škrob, natrijev klorid
Sodium Chloride, malic acid, Calcium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate
natrijev klorid, jabolčna kislina, kalcijev klorid, kalijev klorid, magnezijev klorid, natrijev acetat
ul.Hrubieszowska 2 01-209 Warszawa, Poland
ul.Hrubieszowska 2 01-209 Warszawa, Poland poli(O-2hidroksietil)škrob, natrijev klorid
Poli(O-2-hydroxyethyl) starch, Sodium chloride
poli(O-2hidroksietil)škrob, natrijev klorid
Hydroxyethyl Starch + Sodium Acetate Trihydrate + Sodium Chloride + Potasium Chloride + Magnesium Chloride Hexahydrate
hidroksietilškrob + natrijev acetat trihidrat + natrijev klorid + kalijev klorid + magnezijev klorid heksahidrat
Poly-(o-2-hydroxyethyl)starch (MW 200000) + Sodium Chloride + Potassium Chloride + Calcium Chloride Dihydrate +
Greece poli(O-2-hidroksietil)škrob (M.W 200000) + natrijev klorid + kalijev klorid + kalcijev klorid dihidrat + magnezijev klorid heksahidrat + natrijev acetat trihidrat + jabolčna kislina
B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany hydroxyethyl starch,
B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsugen Germany natrijev klorid, hidroksietilškrob
Belgium Fresenius Kabi NV Molenberglei 7
Madžarska Fresenius Kabi Deutschland GmbH Else-Kröner-Str. 1
Poly(0-2hydroxyethyl)starch 200 kDa mol.substitution 0,43-0,55, Sodium chloride
D-34212 Melsungen poli(0-2-hidroksietil)škrob 130 kDa mol.substitucija natrijev klorid
Fresenius Kabi Nederland B.V. Molenberglei 7 2627 Schelle Belgium active substance: hydroxyethyl starch (polymere 130/0.4) and sodium chloride
Fresenius Kabi EOOD 1 "Alexander Jendov" str. 6th floor, ap 37+Sofia 1113 Bulgaria poli(O-2hidroksietil)škrob, natrijev klorid
Sodium Chloride, Potassium Chloride, Magnesium Chloride, Sodium acetate, hydrochloric acid
natrijev klorid, kalijev klorid, magnezijev klorid, natrijev acetat, klorovodikova kislina
Czech Republic hydroxyethyl starch, Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate
Czech Republic hidroksietilškrob, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat
Poly(0-2hydroxyethyl)starch 130 kDa mol.substitution 0,38-0,45 , Sodium acetate trihydrate, sodium chloride, potassium chloride, magnesium chloride hexahydrate
poli(0-2-hidroksietil)škrob 130 kDa mol.substitucija natrijev acetat trihidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat
Poly(0-2hydroxyethyl)starch 130 kDa mol.substitution 0,42 , Sodium chloride, Potassium chloride, Calcium chloride trihydrate, Magnesium chloride hexahydrate, sodium acetate trihydrate
Belgium poli(0-2-hidroksietil)škrob 130 kDa mol.substitucija natrijev klorid kalijev klorid, kalcijev klorid trihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat
Refortan 10 % 9 g/l, 100 g/l
Refortan 10 % 9 g/l, 100 g/l raztopina za infundiranje
S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A, 500464 Brasov, Romania
S.C. Fresenius Kabi Romania S.R.L, strada Fanarului nr. 2A, 500464 Brasov, Romania hidroksietilškrob, natrijev acetat trihidrat, kalijev klorid, magnezijev klorid heksahidrat, natrijev klorid
Poly(0-2hydroxyethyl)starch 130 kDa mol.substitution 0,42 , Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, sodium acetate trihydrate, malic acid
D-34212 Melsungen poli(0-2-hidroksietil)škrob 130 kDa mol.substitucija natrijev klorid kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat, jabolčna kislina
HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate
HES, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat
Poly(0-2hydroxyethyl)starch 200 kDa mol.substitution 0,45-0,55, Sodium chloride
D-34212 Melsungen poli(0-2-hidroksietil)škrob 200 kDa mol.substitucija natrijev klorid
HES, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate, Malic Acid
HES, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat, jabolčna kislina
INFOHES 100 g/L 100 g/l, 9 g/l
INFOHES 100 g/L 100 g/l, 9 g/l raztopina za infundiranje
1753 Halden Norway
1753 Halden Norway poli(O-2-hidroksietil)škrob (HES), natrijev klorid
Poly(O-2-hydroxyethyl) starch (HES), Sodium acetate trihydrate, Sodium chloride, Potassium chloride, Magnesium chloride hexahydrate
poli(O-2hidroksietil)škrob, natrijev acetat trihidrat, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat
Hydroxyethyl starch (HES), sodium chloride, water
SE-751 74 Uppsala Sweden hidroksietilškrob (HES), natrijev klorid, voda
Hydroxyethyl Starch 130/0,42, Sodium Chloride, Potassium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Acetate Trihydrate
342 12 Melsungen hidroksietilškrob 130 000, natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat, L-jabolčna kislina
Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Magnesium chloride hexahydrate, Sodium acetate trihydrate
Italy hidroksietilškrob, natrijev klorid, kalijev klorid, magnezijev klorid heksahidrat, natrijev acetat trihidrat
100 g + 9 g/l
100 g/l + 9 g/l raztopina za infundiranje
5, place du Marivel 92316 Sèvres Cedex France hydroxyethyl starch 130
5, place du Marivel 92316 Sèvres Cedex France hidroksietilškrob 240 000 HESTERIL 10 %, solution pour perfusion
B. Braun Melsungen AG (Melsungen) Carl-Braun-Strasse 1 34212 Melsungen Germany active substance: hydroxyethyl starch (MR
B. Braun Melsungen AG Carl-Braun-Straße 1 34212 Melsungen Germany poli(O-2-hidroksietil)škrob (HES), natrijev klorid
Hydroxyethyl starch, Sodium Chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride hexahydrate, Sodium acetate trihydrate
hidroksietilškrob natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat
Infukoll HES 10 % 100 g/l, 9 g/l
Infukoll HES 10 % 100 g/l, 9 g/l raztopina za infundiranje
Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 250
5, place du Marivel 92316 Sèvres Cedex France hidroksietilškrob 250 000 LOMOL, solution injectable pour perfusion en poche
Poli(0-2hydroxyethyl)starch(HEK) , Sodium chloride, Potassium chloride, Calcium chloride dihydrate, Magnesium chloride heksahydrate, Sodium acetate trihydrate, Malic acid
IP24 3SE United Kingdom poli(O-2-hidroksietil)škrob (HES), natrijev klorid, kalijev klorid, kalcijev klorid dihidrat, magnezijev klorid heksahidrat, natrijev acetat trihidrat
Place du Marivel 5 92316 Sèvres Cedex France hydroxyethyl starch 200
5, place du Marivel 92316 Sèvres Cedex France hidroksietilškrob 240 000 HESTERIL 6 %, solution pour perfusion
This overview was last updated in 11-2019.
Povzetek je bil nazadnje posodobljen 11-2019.
Further information on Plegridy can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/plegridy.
Nadaljnje informacije o zdravilu Plegridy so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/plegridy.
What measures are being taken to ensure the safe and effective use of Plegridy?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Plegridy?