natgillin/translations-raw huggingface dataset:
Change from baseline Difference from glipizide + metformin c 
Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s kombinacijo glipizid + metformin
Skin and subcutaneous tissue disorders 
Bolezni jeter, žolčnika in žolčevodov motnje delovanja jeter hepatitis
For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin The recommended dose is one tablet twice daily. 
Bolniki, ki niso zadostno urejeni z metforminom v monoterapiji ali metforminom v kombinaciji z drugimi antidiabetiki, vključno z insulinom
OTHER 
Redki
Baseline (mean) Change from Baseline Difference from Placebo c 
Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom
The Committee retained its other concerns. 
Ohranil pa je druge zadržke.
International non-proprietary name (INN): idebenone 
Mednarodno nelastniško ime (INN): idebenon
It was to be available as tablets (150 mg). 
Na voljo naj bi bilo v tabletah (150 mg).
It is usually fatal in adulthood. 
V odrasli dobi je bolezen ponavadi smrtna.
The effectiveness of Sovrima was studied in one main study involving 48 patients. 
Učinkovitost zdravila Sovrima je bila ocenjena v eni glavni študiji, ki je vključevala 48 bolnikov.
However, during the re-examination of the opinion, the intended use of the medicine was restricted to children only. 
Vendar je bilo med ponovnim pregledom mnenja zdravilo namenjeno le za uporabo pri otrocih.
Questions and answers on recommendation for the refusal of the marketing authorisation for Sovrima 
Vprašanja in odgovori v zvezi s priporočilom za zavrnitev vloge za dovoljenje za promet z zdravilom Sovrima
In the initial application, it was intended for use in children and young adults, as well as in adults whose disease had been diagnosed within the past five years and in adults with cardiomyopathy (harm to the heart muscle). 
V prvotni vlogi je bilo namenjeno za uporabo pri otrocih in mladih odraslih kot tudi pri odraslih, pri katerih je bila bolezen ugotovljena v preteklih petih letih, ter pri odraslih z kardiomiopatijo (poškodbami srčne mišice).
Ref. EMEA/614926/2008 
: EMEA/421324/2009 Error!
After having considered the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 20 November 2008. 
Po proučitvi podlage za to zahtevo je CHMP ponovno pregledal prvotno mnenje in dne 20. novembra 2008 potrdil zavrnitev vloge za dovoljenje za promet.
There are no consequences on the use of idebenone in its existing indications, for which the balance of benefits and risks remains unchanged. 
Umik nima nobenih posledic za uporabo zdravila idebenon za odobreno indikacijo, pri kateri ostaja razmerje med koristmi in tveganji nespremenjeno.
Frataxin plays a role in building the energy-producing parts of cells. 
Frataksin pomaga pri tvorbi delov celic, ki proizvajajo energijo.
The active substance in Sovrima, idebenone, has been available in some countries in Europe since the 1990s for cognitive disorders (problems with thinking, learning and memory) and for Alzheimer's disease. 
Zdravilna učinkovina zdravila Sovrima idebenon je na voljo v nekaterih evropskih državah od leta 1990 za zdravljenje kognitivnih motenj (težave z razmišljanjem, učenjem in spominom) in Alzheimerjeve bolezni.
These highly reactive forms of oxygen damage cells in the brain, the spinal cord and nerves, as well as in the heart and pancreas, causing the symptoms of the disease. 
Te visoko reaktivne oblike kisika poškodujejo celice v možganih, hrbtenjači in živcih ter v srcu in trebušni slinavki, kar povzroča simptome te bolezni.
The company that applied for authorisation is Santhera Pharmaceuticals (Deutschland) GmbH. 
Vlogo za dovoljenje je predložila družba Santhera Pharmaceuticals (Deutschland) GmbH.
In addition, the supporting information from the scientific literature was weak and did not demonstrate a consistent clinical benefit of Sovrima for this disease. 
Poleg tega so bili podatki iz znanstvene literature, ki podpirajo študijo, šibki in niso dokazali stalne klinične koristi zdravila Sovrima za to bolezen.
It has a range of symptoms that gradually get worse, including difficulty walking, an inability to co-ordinate movements, muscle weakness, speech problems, damage to the heart muscle, and diabetes. 
Zanjo je značilna vrsta simptomov, ki postopoma napredujejo, vključno s težavami pri hoji, nesposobnostjo usklajevanja gibov, šibkostjo mišic, govornimi težavami, poškodbami srčne mišice in sladkorno boleznijo.
The effects of Sovrima were first tested in experimental models before being studied in humans. 
Učinki zdravila Sovrima so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
The CHMP noted that it would be useful to have more information on the effects of Sovrima on preventing heart disease getting worse in children. 
CHMP je navedel, da bi bilo koristno imeti več informacij o učinkih zdravila Sovrima pri preprečevanju slabšanja bolezni srca pri otrocih.
The main measure of effectiveness was the change in the level of a substance in the blood called deoxyguanosine, which is a marker of cell damage caused by highly reactive forms of oxygen. 
Glavno merilo učinkovitosti je bila sprememba koncentracije snovi v krvi, imenovane deoksigvanozin, ki je označevalec poškodb celic, ki jih povzročajo visoko reaktivne oblike kisika.
In July 2008, the CHMP was concerned that the effectiveness of Sovrima had not been demonstrated in the single study performed. 
Julija 2008 je CHMP izrazil zaskrbljenost, da učinkovitost zdravila Sovrima z eno samo opravljeno študijo ni bila dokazana.
On 24 July 2008, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sovrima 150 mg tablets, intended for the treatment of Friedreich's ataxia. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 24. julija 2008 priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Sovrima, 150 mg tablete, namenjenim za zdravljenje Friedreichove ataksije.
Sovrima is a medicine that contains the active substance idebenone. 
Sovrima je zdravilo, ki vsebuje zdravilno učinkovino idebenon.
What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Sovrima? 
Kakšne so posledice zavrnitve za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Sovrima?
The company informed the CHMP that there are no consequences for patients currently included in clinical trials. 
Družba je obvestila CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih.
It is expected to work by enhancing the production of energy within cells and possibly by neutralising the highly reactive forms of oxygen. 
Delovalo naj bi s povečanjem tvorbe energije v celicah ter po možnosti z nevtraliziranjem visoko reaktivnih oblik kisika.
When frataxin is missing, the production of energy is severely impaired and highly reactive and toxic forms of oxygen are produced. 
Ob pomanjkanju frataksina je tvorba energije resno okrnjena, nastajajo pa visoko reaktivne in toksične oblike kisika.
This was expected to protect cells from damage and to reduce the symptoms of Friedreich's ataxia. 
To naj bi zaščitilo celice pred poškodbami in ublažilo simptome Fridreichove ataksije.
Friedreich's ataxia is an inherited disease. 
Friedreichova ataksija je dedna bolezen.
What is happening with idebenone for cognitive disorders and Alzheimer's disease? 
Kakšne so posledice za zdravilo idebenon za zdravljenje kognitivnih motenj in Alzheimerjeve bolezni?
The study looked also at the effectiveness of Sovrima in controlling movements, as measured on standard scales for ataxia symptoms, at its impact on daily activities as measured using a questionnaire, and at its effect on heart function. 
V študiji so proučevali tudi učinkovitost zdravila Sovrima pri nadzoru gibov, ki je bila merjena s standardnimi lestvicami za simptome ataksije, vplive na vsakodnevne aktivnosti, ki so bili merjeni z vprašalnikom, in njegove vplive na delovanje srca.
Patients with Friedreich's ataxia do not have enough of a protein called frataxin. 
Bolnikom s Friedreichovo ataksijo primanjkuje beljakovine, imenovane frataksin.
What is Sovrima? 
Kaj je zdravilo Sovrima?
The CHMP also had concerns that there was no clear explanation for the fact that the intermediate dose of Sovrima seemed to be more effective than the higher dose. 
CHMP je imel zadržke tudi zaradi pomanjkanja jasne razlage dejstva, da se je zdel srednji odmerek zdravila Sovrima učinkovitejši od višjega odmerka.
Sovrima did not show a significant improvement compared with placebo, with respect to the main measure of effectiveness, as well as to other evaluated parameters. 
V primerjavi s placebom pri zdravljenju z zdravilom Sovrima ni bilo bistvenih izboljšanj niti pri merilu učinkovitosti niti pri drugih ocenjevanih parametrih.
In addition, the CHMP was concerned that the information provided by the company did not show that Sovrima was more effective in children than in the wider group of patients initially proposed. 
Poleg tega je bil zaskrbljen, da podatki, ki jih je priskrbela družba, niso potrdili, da je zdravilo Sovrima bolj učinkovito pri otrocih kot pa pri širši skupini bolnikov, kot je bilo prvotno predlagano.
In November 2008, following the re-examination, the CHMP removed its concern over the intermediate dose of Sovrima. 
Novembra 2008 je CHMP po ponovni proučitvi umaknil zadržke glede srednjega odmerka zdravila Sovrima.
Sovrima was designated as an orphan medicinal product on 8 March 2004 for Friedreich's ataxia. 
Zdravilo Sovrima je bilo dne 8. marca 2004 določeno kot zdravilo sirota za zdravljenje Friedreichove ataksije.
The company also informed the CHMP that there are no consequences for the named patient programmes or compassionate use programmes with Sovrima. 
Družba je CHMP obvestila tudi, da umik nima posledic za programe posamezno imenovanih bolnikov ali programe sočutne uporabe zdravila Sovrima.
The study compared the effectiveness of three different doses of Sovrima (5, 15 and 40 mg per kilogram body weight) with that of placebo (a dummy treatment) over six months. 
V študiji so primerjali učinkovitost treh različnih odmerkov zdravila Sovrima (5, 15 in 40 mg na
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Sovrima in the treatment of Friedreich's ataxia did not outweigh its risks. 
CHMP je takrat menil, da koristi zdravila Sovrima pri zdravljenju Friedreichove ataksije ne odtehtajo z njim povezanih tveganj.
The active substance in Sovrima, idebenone, is an antioxidant agent. 
Zdravilna učinkovina zdravila Sovrima idebenon je antioksidant.
What was Sovrima expected to be used for? 
Za kaj naj bi se zdravilo Sovrima uporabljalo?
Sovrima was expected to be used to treat Friedreich's ataxia. 
Zdravilo Sovrima naj bi se uporabljalo za zdravljenje Friedreichove ataksije.
How is Sovrima expected to work? 
Kako naj bi zdravilo Sovrima delovalo?
Hence, the CHMP recommended that Sovrima be refused marketing authorisation. 
Zato je priporočil zavrnitev dovoljenja za promet z zdravilom Sovrima.
If protection against Rabies is required: 
Če je potrebna zaščita pred steklino:
ATC vet code: QI07AI02. 
Oznaka ATC vet: QI07AI02.
EU/2/14/164/002 
EU/2/14/0164/001 EU/2/14/0164/002
VIAL (1 ML SUSPENSION) 
VIALA (1 ML SUSPENZIJA)
Date of last renewal: 08/04/2019. 
Datum zadnjega podaljšanja dovoljenja za promet: 08/04/2019.
The duration of immunity against CAV-2 was not established by challenge. 
Trajanje imunosti proti CAV-2 ni bilo določeno s preizkusom.
* Tissue culture infectious dose 50%. 
* 50 % infektivnega odmerka za tkivno kulturo.
Protective immune response against CAV-2 associated respiratory disease is considered to last at least 3 years. 
Imunski odziv za zaščito proti CAV-2 pridruženi bolezni dihal naj bi trajal vsaj 3 leta.
Pharmacotherapeutic group: Immunologicals for canidae, live viral and inactivated bacterial vaccines. 
Farmakoterapevtska skupina: Imunološka zdravila za pse (canidae) - živa virusna in inaktivirana bakterijska cepiva.
Suspension: whitish colour with fine sediment. 
Suspenzija: belkasto obarvana s finim sedimentom.
However, in field studies 10% of sero-negative dogs did not show seroconversion (>0.1 IU/ml) 3-4 weeks after single primary vaccination against rabies. 
Študije na terenu so pokazale, da pri 10 % serološko negativnih psov ne pride do serološke konverzije (> 0,1 i.e./ml) 3-4 tedne po enkratnem cepljenju proti steklini.
However, in a minority of animals pain was observed at the injection site immediately after administration of a 10-fold overdose of the vaccine. 
Pri manjšem številu živali so opazili bolečino na mestu injiciranja takoj po dajanju 10- krat prevelikega odmerka cepiva.
Annual re-vaccination is required for Parainfluenza and Leptospira components, therefore a single dose of compatible vaccine Versican Plus Pi/L4 can be used annually as required. 
Vsako leto je treba ponoviti cepljenje proti virusu parainfluence in komponentam Leptospire, za kar se lahko letno uporabi enkratni odmerek kompatibilnega cepiva Versican Plus Pi/L4.
EXPIRY DATE EXP {month/year} 
EXP { mesec/leto }
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07/05/2014. 
Datum pridobitve dovoljenja za promet: 07/05/2014.
1.8-2.2 mg. For the full list of excipients, see section 6.1. 
Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Clinical signs of immune-mediated diseases, such as haemolytic anaemia, thrombocytopenia or polyarthritis have been reported in very rare cases. 
Klinični znaki imunsko pogojenih bolezni kot so hemolitična anemija, trombocitopenija ali poliartritis so bili opaženi v zelo redkih primerih.
In case of need, dogs younger than 8 weeks can be vaccinated as safety of Versican Plus DHPPi/L4R has been demonstrated in 6 weeks old dogs. 
Če je potrebno, lahko cepimo pse, mlajše od 8 tednov, saj je bila varnost cepiva Versican Plus DHPPi/L4R dokazana pri psih, starih 6 tednov.
The vaccine is intended for the active immunisation of healthy puppies and dogs against diseases caused by canine distemper virus, canine parvovirus, canine adenovirus type 1 and 2, canine parainfluenza virus, Leptospira interrogans serogroup Australis serovar Bratislava, Leptospira interrogans serogroup Canicola serovar Canicola, Leptospira kirschneri serogroup Grippotyphosa serovar Grippotyphosa and Leptospira interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae. 
Cepivo je namenjeno aktivni imunizaciji zdravih pasjih mladičev in odraslih psov proti boleznim, ki jih povzročajo virus pasje kuge, pasji parvovirus, pasji adenovirus tipa 1 in 2, virus pasje parainfluence, Leptospira interrogans serološka skupina Australis serovar Bratislava, Leptospira interrogans serološka skupina Canicola serovar Canicola, Leptospira kirschneri serološka skupina Grippotyphosa serovar Grippotyphosa in Leptospira interrogans serološka skupina Icterohaemorrhagiae serovar Icterohaemorrhagiae.
EXP {month/year} Once reconstituted, use immediately. 
EXP {mesec/leto} Rekonstituirano zdravilo uporabite takoj.
A single dose of Versican Plus DHPPi/L4 should be given every 3 years. 
Enkratni odmerek Versican Plus DHPPi/L4 je potrebno dati vsaka 3 leta.
At least one year following the primary vaccination course for canine parainfluenza virus and Leptospira components. 
Vsaj eno leto po osnovnem cepljenju proti virusu pasje parainfluence in Leptospira komponentam.
The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination. 
Vakcinalni sev CPV-2b ni bil preizkušen na drugih mesojedih (z izjemo psov in domačih mačk), ki so dovzetni za pasje parvoviruse,
Adjuvant: Aluminium hydroxide 
aluminijev hidroksid
− 4 weeks after the completion of primary course for Leptospira components. 
- 4 tedne po zaključku osnovnega cepljenja proti komponentam Leptospira.
Special precautions to be taken by the person administering the veterinary medicinal product to animals: In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. 
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo V primeru nenamernega samo-injiciranja se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
Potassium chloride Potassium dihydrogen phosphate Disodium phosphate dodecahydrate Water for injection 
Suspenzija: natrijev klorid kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat voda za injekcije
Reconstituted vaccine: pinkish or yellowish colour with slight opalescence. 
Rekonstituirano cepivo: rožnate ali rumenkaste barve, rahlo opalescentno.
Second dose: Versican Plus DHPPi/L4R 3-4 weeks later but not before 12 weeks of age. 
Drugi odmerek: Versican Plus DHPPi/L4R 3-4 tedne kasneje, vendar ne pred starostjo 12 tednov.
Type I glass vial containing 1 ml of suspension closed with a chlorobutyl rubber stopper and aluminium cap. 
Viala iz stekla tipa I, ki vsebuje 1 ml suspenzije, zaprta z zamaškom iz klorobutilne gume in aluminijasto zaporko.
First dose: Versican Plus DHPPi/L4 from 8-9 weeks of age. 
Prvi odmerek: Versican Plus DHPPi/L4 pri starosti 8-9 tednov.
− to prevent clinical signs and reduce infection and urinary excretion caused by L. kirschneri serogroup Grippotyphosa serovar Grippotyphosa. 
- za preprečevanje kliničnih znakov, zmanjšanje okužbe in izločanja virusa z urinom, ki jih povzroča L. kirschneri, serološka skupina Grippotyphosa, serovar Grippotyphosa.
− 3 weeks after the first vaccination for CDV, CAV, CPV, 
Nastop imunosti: - 3 tedne po prvem cepljenju proti CDV, CAV, CPV, - 3 tedne po zaključku osnovnega cepljenja proti CpiV in
Lyophilisate: Trometamol Edetic Acid Sucrose Dextran 70 
Liofilizat: trometamol saharoza edetna kislina dekstran 70
L. kirschneri serovar Grippotyphosa 
L. kirschneri serovar Grippotyphosa titer ALR ≥ 1:40
− to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus, 
- za preprečevanje kliničnih znakov, levkopenije in izločanja virusa, ki jih povzroča pasji parvovirus,
103.6 TCID50* 105.3 TCID50 Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10 
Pasji parvovirus tipa 2b, sev CPV-2b Bio 12/B
− to prevent mortality and clinical signs caused by canine distemper virus, 
- za preprečevanje smrtnosti in kliničnih znakov, ki jih povzroča virus pasje kuge,
Primary vaccination scheme: Two doses of Versican Plus DHPPi/L4 3-4 weeks apart from 6 weeks of age. 
Osnovno cepljenje: Dva odmerka cepiva DHPPi/L4 v razmaku 3-4 tednov od starosti 6 tednov naprej.
− to prevent clinical signs and urinary excretion and reduce infection caused by L. interrogans serogroup Canicola serovar Canicola and L. interrogans serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, and 
- za preprečevanje kliničnih znakov, izločanja virusa z urinom in zmanjšanje okužb, ki jih povzroča L.interrogans, serološka skupina Canicola,serovar Canicola ter L. interrogans, serološka skupina Icterohaemorrhagiae, serovar Icterohaemorrhagiae,
PACKAGE LEAFLET: Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs 
Versican Plus DHPPi/L4 liofilizat in suspenzija za suspenzijo za injiciranje za pse
Pregnancy lactation: 
Osnovno cepljenje:
− to prevent mortality and clinical signs caused by canine adenovirus type 1, 
- za preprečevanje smrtnosti in kliničnih znakov, ki jih povzroča pasji adenovirus tipa 1, - za preprečevanje kliničnih znakov in zmanjšanje izločanja virusa, ki jih povzroča pasji adenovirus tipa 2,
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 lyophilisate and suspension for suspension for injection for dogs 
NAVODILO ZA UPORABO Versican Plus DHPPi/L4 liofilizat in suspenzija za suspenzijo za injiciranje za pse
− to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus, 
- za preprečevanje kliničnih znakov (izcedek iz smrčka in oči) in zmanjšanje izločanja virusa, ki jih povzroča virus pasje parainfluence, - za preprečevanje kliničnih znakov, okužbe in izločanja virusa z urinom, ki jih povzroča L.
No other adverse effects other than those mentioned under section 6 (Adverse reactions) have been observed after administration of a 10-fold overdose of the vaccine. 
Po dajanju 10-krat prevelikega odmerka cepiva ni bilo opaziti drugih neželenih učinkov, razen tistih, navedenih v poglavju »Neželeni učinki«.
Suspension (inactivated): L. interrogans serovar Icterohaemorrhagiae 
L. interrogans serovar Icterohaemorrhagiae titer ALR ≥ 1:51
No other adverse reactions other than those mentioned in section 4.6 were observed after administration of a 10-fold overdose of the vaccine. 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi), (če je potrebno) Po dajanju 10- krat prevelikega odmerka cepiva ni bilo opaziti neželenih učinkov, razen tistih, navedenih v poglavju 4.6.
Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 103.1 TCID50* 105.1 TCID50 Suspension (inactivated): 
Virus pasje parainfluence tipa 2, sev CPiV-2 Bio 15
NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi/L4 suspension for dogs 
Versican Plus DHPPi/L4 suspenzijaza pse
EXPIRY DATE 
EXP{ mesec/leto }
VIALS (1 DOSE LYOPHILISATE) 
VIALA (1 ODMEREK LIOFILIZATA) IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
The company withdrew before the European Commission had issued a decision on this opinion. 
Družba je umaknila vlogo še preden je Evropska komisija izdala odločbo o mnenju.
The summary of opinion of the Committee for Orphan Medicinal Products for Oncophage is available here. 
Povzetek mnenja Odbora za zdravila sirote o zdravilu Oncophage je na voljo na tukaj.
What documentation did the company present to support its application to the Agency? 
Katero dokumentacijo je družba predložila Agenciji v podporo svoji vlogi?
The Commitee also noted that the company had provided insufficient information on the contents of the medicine and on the manufacturing process. 
Odbor je menil tudi, da družba ni predložila zadostnih informacij o vsebnosti zdravila in proizvodnem postopku.
The effects of Oncophage were first tested in experimental models before being studied in humans. 
Učinki zdravila Oncophage so bili najprej preizkušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Autologous means that it is derived from the cells in the patient's own body. 
Avtologni pomeni, da je izdelano iz celic iz bolnikovega telesa.
What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Oncophage? 
Kakšne so posledice umika za bolnike, ki sodelujejo v kliničnih preskušanjih ali programih sočutne uporabe zdravila Oncophage?
The company presented results of a study involving 818 adults with localised renal cell carcinoma that had been surgically removed and who had a high risk of the cancer coming back. 
Družba je predstavila rezultate študije, ki je zajela 818 odraslih bolnikov z lokaliziranim karcinomom ledvičnih celic, ki je bil kirurško odstranjen, in so imeli veliko tveganje ponovitve raka.
Since the proteins in vitespen are similar to proteins on the cancer cells, it was expected that the immune system would also attack the cancer cells, preventing the recurrence or the spread of the original tumour. 
Ker so beljakovine v vitespenu podobne beljakovinam na rakavih celicah, so pričakovali, da bo imunski sistem napadel tudi rakave celice, kar bi preprečilo pojav ali širjenje prvotnega tumorja.
The main measure of effectiveness was how long the patients lived without the cancer coming back. 
Glavno merilo učinkovitosti je bilo trajanje preživetja bolnikov brez ponovitve raka.