natgillin/translations-raw huggingface dataset:
2000, Study report [NP07760] 3 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study. 
2000, Poročilo o študiji [NP07760] 3 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
The PRAC considered that the use of fusafungine for oromucosal and nasal use is associated with serious adverse allergic reactions sometimes fatal. 
Odbor PRAC je presodil, da sta oromukozna in nazalna uporaba fuzafungina povezani z resnimi, včasih smrtnimi neželenimi alergijskimi učinki.
During the assessment, the PRAC also noted that the MAH stated that available data no longer support tonsillitis and laryngitis indications; the MAH also confirmed that all the available data have been provided and that they will not be able to provide any further data to demonstrate the clinical safety and benefit of fusafungine in the management of diseases of the upper respiratory airways. 
Imetnik dovoljenja za promet z zdravili je potrdil tudi, da so bili predloženi vsi razpoložljivi podatki in da za dokaz klinične varnosti in koristi fuzafungina pri zdravljenju bolezni zgornjih dihal ne bo mogel zagotoviti nobenih dodatnih podatkov.
The author's conclusion that the outcomes achieved by fusafungine are not relevant in clinical practice is supported by the PRAC. 
Odbor PRAC podpira avtorjev zaključek, da izidi, doseženi s fuzafunginom, v klinični praksi niso pomembni.
The MAH provided: - 5 clinical studies in adults including 3 pivotal studies in acute rhinopharyngitis (Chabolle, 19991, Eccles 20002 and Bouter, 20023) and 2 supportive randomized, double-blind, placebo controlled studies in rhinosinusitis (Cuénant 19884, Mösges 2002) and, - one study in children (a double-blind, placebo-controlled, randomized, in 515 children, aged 8-12 years, with acute rhinopharyngitis, Januszewicz 2002). 
- pet kliničnih študij pri odraslih, ki so obsegale tri osrednje študije pri akutnem rinofaringitisu (Chabolle, 19991, Eccles, 20002, in Bouter, 20023) in dve podporni, dvojno slepi, s placebom nadzorovani študiji pri rinosinuzitisu (Cuénant, 19884, Mösges, 2002), ter
• The PRAC noted that serious, life-threatening hypersensitivity (including allergic) reactions have been reported with fusafungine for oromucosal and nasal use, including fatal cases, with short time to onset (even at first dose). 
• odbor PRAC je ugotovil, da so pri fuzafunginu za oromukozno in nazalno uporabo poročali o življenjsko nevarnih preobčutljivostnih (tudi alergijskih) reakcijah, vključno s smrtnimi primeri, s kratkim časom do pojava (celo pri prvem odmerku);
The PRAC reviewed all the available data submitted with regards to the clinical efficacy and safety of fusafungine-containing products. 
Odbor PRAC je pregledal vse razpoložljive podatke, predložene v zvezi s klinično učinkovitostjo in varnostjo zdravil, ki vsebujejo fuzafungin.
The PRAC considered all the available data submitted with regards to the mechanism of action of fusafungine. 
Odbor PRAC je upošteval vse razpoložljive podatke o mehanizmu delovanja fuzafungina, ki so bili predloženi.
Further risk minimisation measures such as additional amendments to the product information (further restriction of the indication and contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were therefore also considered during the discussions. 
V razpravah so bili tako obravnavani tudi dodatni ukrepi za zmanjševanje tveganja, kot so dodatne spremembe informacij o zdravilu (nadaljnja omejitev indikacij in dodatne kontraindikacije, omejitev trajanja zdravljenja, dodane besede „ne vdihujte“ v posebnem opozorilu in previdnostnih ukrepih za uporabo, omejitev pomožnih snovi), komunikacijsko gradivo (neposredno obvestilo za zdravstvene delavce) in omejitev izdaje zdravil samo na recept.
• rash - 4.7% (2.1%), 
• izpuščaj - 4,7 % (2,1 %),
Further risk minimisation measures, as proposed by the MAH, such as additional amendments to the product information (further restriction of the indication and additional contra-indications, limitation of treatment duration, addition of the wording ‘do not inhale' in special warning and precautions for use, limitation of excipients), communication material (Direct Health Care Professional communication) and restriction to prescription only were also considered during the discussions. 
V razpravah so bili obravnavani tudi dodatni ukrepi za zmanjševanje tveganja, kot jih je predlagal imetnik dovoljenja za promet z zdravili, npr. dodatne spremembe informacij o zdravilu (nadaljnja omejitev indikacij in dodatne kontraindikacije, omejitev trajanja zdravljenja, dodane besede „ne vdihujte“ v posebnem opozorilu in previdnostnih ukrepih za uporabo, omejitev pomožnih snovi), komunikacijsko gradivo (neposredno obvestilo za zdravstvene delavce) in omejitev izdaje zdravil samo na recept.
Fusafungine , used in the form of a spray, is indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth. 
Fuzafungin, ki se uporablja v obliki pršila, je indiciran za lokalno protibakterijsko in protivnetno zdravljenje bolezni zgornjih dihal (sinuzitis, rinitis, rinofaringitis, angina, laringitis).
The PRAC reviewed all the available data submitted with regards to the clinical efficacy of fusafunginecontaining products. 
Odbor PRAC je pregledal vse razpoložljive podatke, predložene v zvezi s klinično učinkovitostjo zdravil, ki vsebujejo fuzafungin.
The PRAC reviewed all the available data submitted with regards to the clinical safety of fusafunginecontaining products. 
Odbor PRAC je pregledal vse razpoložljive podatke, predložene v zvezi s klinično varnostjo zdravil, ki vsebujejo fuzafungin.
Fusafungine is currently indicated in the local antibacterial and anti-inflammatory treatment of diseases in the upper respiratory airways (sinusitis, rhinitis, rhinopharyngitis, angina, laryngitis), inhaled in usual doses of 500 micrograms every 4 hours into each nostril or via the mouth. 
Fuzafungin je trenutno indiciran za lokalno protibakterijsko in protivnetno zdravljenje bolezni zgornjih dihal (sinuzitis, rinitis, rinofaringitis, angina, laringitis).
7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study. 
2000, Poročilo o študiji [NP07760] 7 Bouter K. 7-day treatment of acute infectious rhinopharyngitis with fusafungine (1.0 mg x 4 daily): a double-blind placebo-controlled parallel-group study.
a. the medicinal product is harmful, and, 
Imetnik dovoljenja za promet z zdravili je zagotovil:
Fusafungine was shown to be superior to placebo in the acute rhinopharyngitis indication regarding evolution of nasal symptom score after 4 days of treatment in adults in three pivotal studies Chabolle, 19995, Eccles 20006 and Bouter, 20027) and the pooled analysis of them (Grouin 20038). 
V treh osrednjih študijah (Chabolle, 19995, Eccles, 20006, in Bouter, 20027) ter v njihovi zbirni analizi (Grouin, 20038) se je po štirih dneh zdravljenja pri odraslih pokazalo, da pri akutnem rinofaringitisu fuzafungin nosne simptome lajša učinkoviteje od placeba.
*** fluorescent focus units 
*** fluorescentna fokusna enota.
Reassortant influenza virus* (live attenuated) of the following strains**: A/California/7/2009 (H1N1)pdm09-like strain (A/California/7/2009, MEDI 228029) 10 
Novi virus gripe* (živ oslabljen) naslednjih sevov**: A/California/7/2009 (H1N1)pdm09-podoben sev (A/California/7/2009, MEDI 228029)
10 sprayers 
10 pršilnikov
Nasal use sprayer (glass/PE) 0.2ml 
Nazalna uporaba pršilnik (steklo/PE)
Nasal spray, 
Pršilo za nos,
FFU*** ................................................................................................................................................per 0.2 ml dose 
FFE*** ............................................................................................................................................................. na 0,2 ml odmerek
The frequency of these reactions is considered not known (cannot be estimated from the available data). 
Pogostnost teh učinkov ni znana (ni je mogoče oceniti iz razpoložljivih podatkov).
Adopted at the 4-8 July 2016 PRAC 
Sprejeto na seji odbora PRAC med 4. in 8. julijem 2016
Tell your doctor before taking this medicine, if: 
Pred začetkom jemanja tega zdravila zdravnika obvestite, če:
• You are due to have a specific blood test (Chromogranin A) 
• ste naročeni na specifično preiskavo krvi (kromogranin A)
Tablets should be taken before meals or during meals, depending on gastrointestinal tolerance. 
Tablete je treba zaužiti pred ali med obrokom, odvisno od gastrointestinalne tolerance.
If you cannot follow this instruction or have difficulty swallowing, please contact your doctor. 
Če tega navodila ne morete upoštevati ali imate težave pri požiranju, se obrnite na zdravnika.
To avoid this interference, [Product name] treatment should be stopped for at least 5 days before CgA measurements (see section 5.1). 
Da bi to preprečili, je treba vsaj pet dni pred meritvami CgA prekiniti zdravljenje z zdravilom [ime zdravila] (glejte poglavje 5.1).
Ferrous sulfate - Mouth ulceration (EPITT no 18623) 
Železov(II) sulfat - razjede v ustih (št. EPITT 18623)
3 - How to take [Product name] Swallow the tablet whole with water. 
3 - Kako jemati zdravilo [ime zdravila] Tableto pogoltnite celo z vodo.
Proton pump inhibitors (PPIs): dexlansoprazole; esomeprazole; lansoprazole; omeprazole; pantoprazole; rabeprazole - Elevated circulating levels of Chromogranin A (EPITT no 18614) 
Zaviralci protonske črpalke: dekslansoprazol, esomeprazol, lansoprazol, omeprazol, pantoprazol, rabeprazol - zvišane ravni kromogranina A v obtoku (št. EPITT 18614)
Post-marketing: The following ADRs have been reported during post-marketing surveillance. 
Iz obdobja trženja: V okviru nadzora v obdobju trženja poročajo o naslednjih neželenih učinkih.
Not known (frequency cannot be estimated from the available data) Mouth ulceration (in case of incorrect use, when tablets are chewed, sucked or left in the mouth) Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects your mouth with your stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways. 
Neznana pogostnost (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov) Razjede v ustih (v primeru nepravilne uporabe, tj. kadar bolnik tablete žveči, sesa ali zadržuje v ustih) Pri starejših bolnikih in bolnikih, ki imajo težave s požiranjem, obstaja tudi tveganje za razjede grla, požiralnika ali sapnic (glavnih dihalnih poti v pljučih), če tableta pride v dihala.
Elderly patients and patients with deglutition disorders may also be at risk of oesophageal lesions or of bronchial necrosis, in case of false route. 
Pri starejših bolnikih in bolnikih z motnjami požiranja obstaja tudi tveganje za razjede požiralnika ali bronhialno nekrozo, kadar je pot uporabe napačna.
Do not suck, chew or keep the tablet in your mouth. 
Tablete ne sesajte, žvečite ali zadržujte v ustih.
The tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water. 
Tablet se ne sme sesati, žvečiti ali zadrževati v ustih, pač pa jih je treba pogoltniti cele z vodo.
Due to the risk of mouth ulceration and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth but swallowed whole with water. 
Zaradi tveganja za razjede v ustih in obarvanje zob se tablet ne sme sesati, žvečiti ali zadrževati v ustih, pač pa jih je treba pogoltniti cele z vodo.
Gastrointestinal disorders: mouth ulceration* * in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth. 
* pri nepravilnem dajanju, torej kadar bolnik tablete žveči, sesa ali zadržuje v ustih.
The application was withdrawn before ‘day 120'. 
Vloga je bila umaknjena pred „120.
This was then compared with results reported in the scientific literature. 
To so nato primerjali z rezultati, o katerih so poročali v znanstveni literaturi.
The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'. 
Dopis, s katerim družba Agencijo obvešča o umiku vloge, je na voljo pod zavihkom „All documents“ (Vsi dokumenti).
This means that Epostim was intended to be similar to a biological medicine that is already authorised in the European Union (also known as the ‘reference medicine') and contains the same active substance. 
To pomeni, da naj bi bilo zdravilo Epostim podobno biološkemu zdravilu, ki je že odobreno v Evropski uniji (znano tudi kot „referenčno zdravilo“) in vsebuje isto zdravilno učinkovino.
The effects of Epostim were first tested in experimental models before being studied in humans. 
Učinki zdravila Epostim so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Epostim was expected to be used in the following situations: 
Zdravilo Epostim naj bi se uporabljalo v naslednjih primerih:
The company informed the CHMP that here are no consequences for patients currently in clinical trials using Epostim. 
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Epostim.
This study is still ongoing and aims to show that Epostim has the same effect on maintaining haemoglobin levels as Eprex. 
Ta študija še poteka, z njo pa želijo pokazati, da ima zdravilo Epostim enak učinek na vzdrževanje ravni hemoglobina kot zdravilo Eprex.
The epoetin alfa in Epostim is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce it. 
Epoetin alfa v zdravilu Epostim se proizvaja z metodo, znano kot „tehnologija rekombinantne DNA“: tvori ga celica, ki je prejela gen (DNA), s katerim lahko tvori eritropoetin.
• to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce their need for blood transfusions; 
• za zdravljenje anemije pri odraslih, ki prejemajo kemoterapijo za določene vrste raka, in zmanjševanje njihove potrebe po transfuziji krvi;
In these cases, erythropoietin is used to replace the missing hormone or to increase red blood cell counts. 
V teh primerih se eritropoetin uporablja, da nadomesti manjkajoči hormon ali zviša raven rdečih krvnih celic.
• to treat anaemia (low red blood cell counts) that is causing symptoms in adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly); 
• za zdravljenje anemije (nizko število rdečih krvnih celic), ki povzroča simptome pri odraslih in otrocih s „kronično odpovedjo ledvic“ (dolgotrajno, napredujoče upadanje sposobnosti ledvic za pravilno delovanje);
On 15 March 2011, Reliance GeneMedix Plc officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Epostim to be used to treat anaemia and stimulate red blood cell production. 
Družba Reliance GeneMedix Plc je dne 15. marca 2011 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Epostim, namenjenim zdravljenju anemije in spodbujanju tvorjenja rdečih krvnih celic.
A second main study in 188 kidney patients compared Epostim with the reference medicine Eprex. 
V drugi glavni študiji so pri 188 bolnikih s težami z ledvicami primerjali zdravilo Epostim z referenčnim zdravilom Eprex.
• to increase the amount of blood that can be taken from patients who are going to need the blood after surgery (autologous blood transfusion); 
• za povečanje količine krvi, ki se lahko odvzame bolnikom, ki bodo potrebovali kri po operaciji (avtologna transfuzija krvi);
Withdrawal of the marketing authorisation application for Epostim (epoetin alfa) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Epostim (epoetin alfa)
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin. 
Pri bolnikih, ki prejemajo kemoterapijo, ali pri bolnikih s težavami z ledvicami lahko pomanjkanje eritropoetina ali nezadostna odzivnost telesa na eritropoetin povzroči anemijo.
Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss. 
Eritropoetin se uporablja tudi pred operacijami za povečanje števila rdečih krvnih celic in kot pomoč pri zmanjševanju posledic izgube krvi.
Epostim is a solution for injection that contains the active substance epoetin alfa. 
Zdravilo Epostim je raztopina za injiciranje, ki vsebuje zdravilno učinkovino epoetin alfa.
Epostim was developed as a ‘biosimilar' medicine. 
Zdravilo Epostim je bilo razvito kot „podobno biološko“zdravilo.
In a main study in 75 adults with anaemia caused by kidney problems, patients were treated with Epostim and their blood levels of haemoglobin (a protein in red blood cells) measured to see how much their anaemia improved. 
V glavni študiji je sodelovalo 75 odraslih bolnikov z anemijo zaradi težav z ledvicami, ki so jih zdravili z zdravilom Epostim in pri katerih so merili raven hemoglobina v krvi (beljakovina v rdečih krvnih celicah), da bi ugotovili, v kolikšni meri se je anemija pri njih pozdravila.
Erythropoietin is produced by the kidneys. 
Eritropoetin tvorijo ledvice.
The reference medicine for Epostim is Eprex. 
Referenčno zdravilo za zdravilo Epostim je zdravilo Eprex.
• to reduce the need for blood transfusions in non-iron deficient patients who are about to undergo major orthopaedic (bone) surgery. 
• za zmanjšanje potrebe po transfuziji krvi pri odraslih bolnikih brez pomanjkanja železa pred večjo ortopedsko operacijo (operacijo na kosteh).
A hormone called erythropoietin stimulates the production of red blood cells from the bone marrow. 
Hormon, imenovan eritropoetin, spodbuja tvorjenje rdečih krvnih celic v kostnem mozgu.
The active substance in Epostim, epoetin alfa, is a copy of human erythropoietin and was expected to work in exactly the same way as the natural hormone to stimulate red blood cell production. 
Zdravilna učinkovina v zdravilu Epostim, epoetin alfa, je kopija človeškega eritropoetina in naj bi pri spodbujanju tvorjenja rdečih krvnih celic delovala povsem enako kot naravni hormon.
What is Epostim? 
Kaj je zdravilo Epostim?
What was Epostim expected to be used for? 
Za kaj naj bi se zdravilo Epostim uporabljalo?
How is Epostim expected to work? 
Kako naj bi zdravilo Epostim delovalo?
Pharmaceutical Form Route of Administration 
Farmacevtska oblika pot uporabe
Invented name Strength 
Številka EU Izmišljeno ime Jakost
Packaging 
Subkutano
10 vials + 10 vials 
0,65 ml 10 vial + 10 vial
1 vial + 1 vial 
0,65 ml 1 viala + 1 viala
10 vials + 10 pre-filled syringes with attached needle 
0,65 ml 10 vial + 10 napolnjenih injekcijskih brizg z nameščenimi iglami
1 vial + 1 pre-filled syringe + 2 separate needles 
0,65 ml 1 viala + 1 napolnjena injekcijska brizga +2 nepritrjeni igli
1 vial + 1 pre-filled syringe + 1 separate needle 
0,65 ml 1 viala + 1 napolnjena injekcijska brizga + 1 nepritrjena igla
1 vial + 1 pre-filled syringe without needle 
0,65 ml 1 viala + 1 napolnjena injekcijska brizga brez igle
1 vial + 1 pre-filled syringe with attached needle 
0,65 ml 1 viala + 1 napolnjena injekcijska brizga z nameščeno iglo
06 March 2012 
6. marec 2012
The European Commission issued a decision on 06 March 2012. 
Evropska komisija je sklep izdala dne 6. marca 2012.
On 20 April 2011, Denmark referred the matter to the CHMP for arbitration. 
Dne 20. aprila 2011 je Danska zadevo napotila na CHMP v arbitražo.
Why was Norditropin reviewed? 
Zakaj je bilo zdravilo Norditropin pregledano?
The Committee looked at the study presented by the company to support the new indication. 
Odbor je pregledal študijo, ki jo je družba predložila v podporo novi indikaciji.
In May 2010, the company applied for an additional indication in Denmark and in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the 
Maja 2010 je družba predložila vlogo za dodatno indikacijo na Danskem in v naslednjih državah članicah: Avstrija, Belgija, Bolgarija, Ciper, Češka republika, Estonija, Finska, Francija, Nemčija, Grčija, Madžarska, Irska, Italija, Latvija, Litva,
Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom1. 
Luksemburg, Malta, Nizozemska, Poljska, Portugalska, Romunija, Slovaška, Slovenija, Španija, Švedska in Združeno kraljestvo1.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP agreed that the data were insufficient and that the study presented, which was an observational study, did not meet required methodological standards. 
CHMP se je po vrednotenju trenutno razpoložljivih podatkov in znanstveni razpravi v Odboru strinjal, da so podatki nezadostni in da predložena študija, ki je bila opazovalna, ne izpolnjuje zahtevanih metodoloških standardov.
The Member States cited methodological weaknesses in the study presented, the wide range of doses used and insufficient data (e.g. missing data on body composition measurements). 
Države članice so se sklicevale na metodološke pomanjkljivosti v predstavljeni študiji, širok razpon uporabljenih odmerkov in nezadostne podatke (npr. manjkajoče podatke o meritvah telesne sestave).
The company that makes the medicine is NovoNordisk. 
Družba, ki izdeluje zdravilo, je NovoNordisk.
1 In May 2011 the marketing authorisations of the concerned products were withdrawn in Estonia, and in June 2011 the marketing authorisations of the concerned products were withdrawn in Latvia. 
Dovoljenja za promet z zadevnimi zdravili so bila maja 2011 umaknjena v Estoniji in junija 2011 v Latviji.
Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates. 
Rastni hormon spodbuja rast v obdobju otroštva in adolescence ter vpliva na način, kako telo presnavlja beljakovine, maščobo in ogljikove hidrate.
The European Medicines Agency has completed an arbitration procedure for Norditropin and associated names. 
Evropska agencija za zdravila je zaključila arbitražni postopek za zdravilo Norditropin in povezana imena.
The CHMP therefore recommended that the new indication for Norditropin and associated names should not be granted in Denmark or in the concerned Member States. 
CHMP je zato priporočil, naj se nova indikacija za zdravilo Norditropin in povezana imena na Danskem ali v zadevnih državah članicah ne odobri.
Norditropin is authorised under a mutual recognition procedure based on an initial authorisation granted by Denmark. 
Zdravilo Norditropin je bilo odobreno v postopku z medsebojnim priznavanjem na podlagi prvotnega dovoljenja za promet, ki je bilo odobreno na Danskem.
Although somatropin medicines are already approved in EU Member States for use in Prader-Willi syndrome, the Member States were unable to reach agreement on whether to accept this indication for Norditropin. 
Čeprav so zdravila s somatropinom v državah članicah EU že odobrena za uporabo pri zdravljenju Prader-Willijevega sindroma, se države članice niso uspele dogovoriti glede tega, ali naj sprejmejo to indikacijo za zdravilo Norditropin.
What is Norditropin? 
Kaj je zdravilo Norditropin?