natgillin/translations-raw huggingface dataset:
Condition considered essential for the safe and effective use of the medicinal product including pharmacovigilance 
Pogoji, ki so bistveni za varno in učinkovito uporabo zdravila, vključno s farmakovigilanco
a prospective observational study aimed to evaluate the prescription recommendations of Mifepristone Linepharma for early pregnancy termination mentioned in the opinion should be performed. 
izvedba prospektivne opazovalne študije z namenom oceniti priporočila za predpisovanje zdravila Mifepristone Linepharma za zgodnjo prekinitev nosečnosti.
The National Competent Authorities coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH: 
Pristojni nacionalni organi, ki jih usklajuje referenčna država članica, morajo zagotoviti, da imetnik dovoljenja za promet z zdravilom izpolni naslednje pogoje:
Condition of the marketing authorisations 
Pogoji dovoljenja za promet z zdravilom
The way it works in this disease is not completely understood. 
Njen način delovanja pri tej bolezni ni v celoti znan.
Treatment is divided into 2 phases: induction and consolidation. 
Zdravljenje je razdeljeno na dve stopnji: indukcijsko in konsolidacijsko.
Further information on Arsenic trioxide Accord can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord. 
Nadaljnje informacije o zdravilu Arzenov trioksid Accord so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/arsenic-trioxide-accord.
• Patients with APL whose disease has not responded to previous treatment with a retinoid and cancer medicines, or when their disease has come back after this type of treatment. 
• bolnikih z akutno promielocitno levkemijo, katerih bolezen se ni odzvala na predhodno zdravljenje z retinoidi in zdravili za zdravljenje raka ali kadar se je bolezen po taki vrsti zdravljenja ponovila.
The infusion should last 1 to 2 hours, but it may need to be given for longer if the patient has certain side effects. 
Infuzija mora trajati od ene do dveh ur, če se pri bolniku pojavijo določeni neželeni učinki, pa jo bo morda treba dajati tudi dlje.
During the consolidation phase, Arsenic trioxide Accord is given on 5 days each week but the length of breaks between courses and how long it is given for depends on whether patients have received previous treatment or not. 
Med konsolidacijsko stopnjo se zdravilo Arzenov trioksid Accord daje pet dni na teden, vendar sta dolžina prekinitev med cikli in trajanje zdravljenja odvisna od tega, ali so bili bolniki predhodno zdravljeni ali ne.
The European Medicines Agency concluded that, in accordance with EU requirements, Arsenic trioxide Accord has been shown to be comparable to Trisenox. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Arzenov trioksid Accord primerljivo z zdravilom Trisenox.
Arsenic trioxide Accord is used to treat adults (aged 18 years or over) with acute promyelocytic leukaemia (APL), a rare form of leukaemia (cancer of the white blood cells) caused by a genetic ‘translocation' (when there is a swap of genes between two chromosomes). 
Zdravilo Arzenov trioksid Accord se uporablja za zdravljenje odraslih (starejših od 18 let) z akutno promielocitno levkemijo (APL), tj. redko obliko levkemije (raka belih krvnih celic), ki jo povzroča genetska „translokacija“ (zamenjava genov med dvema kromosomoma).
Because Arsenic trioxide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Arzenov trioksid Accord generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Trisenox, and do not need to be repeated for Arsenic trioxide Accord. 
Študije o koristih in tveganjih učinkovine pri odobrenih načinih uporabe so že bile izvedene z referenčnim zdravilom Trisenox, zato jih ni treba ponoviti za zdravilo Arzenov trioksid Accord.
During the induction phase, Arsenic trioxide Accord is given every day until there are signs that the treatment is working (when the bone marrow does not contain any leukaemia cells). 
Med indukcijsko stopnjo se zdravilo Arzenov trioksid Accord daje vsak dan, dokler se ne pojavijo znaki, da zdravljenje deluje (kostni mozeg ne vsebuje več levkemičnih celic).
The translocation affects the way the white blood cells grow, and as a result they lack the ability to use retinoic acid (vitamin A). 
Translokacija vpliva na to, kako rastejo bele krvne celice, zaradi česar ne morejo uporabljati retinojske kisline (vitamina A).
What measures are being taken to ensure the safe and effective use of Arsenic trioxide Accord? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Arzenov trioksid Accord?
As for every medicine, the company provided studies on the quality of Arsenic trioxide Accord. 
Tako kot za vsako zdravilo je podjetje predložilo študije o kakovosti zdravila Arzenov trioksid Accord.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Arsenic trioxide Accord have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Arzenov trioksid Accord upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Side effects reported with Arsenic trioxide Accord are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Arzenov trioksid Accord, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
This means that Arsenic trioxide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Trisenox. 
To pomeni, da vsebuje enako učinkovino in deluje na enak način kot „referenčno zdravilo“, ki je že odobreno v EU in se imenuje Trisenox.
An overview of Arsenic trioxide Accord and why it is authorised in the EU 
Pregled zdravila Arzenov trioksid Accord in zakaj je odobreno v EU
For more information about using Arsenic trioxide Accord, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Arzenov trioksid Accord glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Arsenic trioxide Accord can only be obtained with a prescription and its use should be supervised by a doctor who has experience in the management of patients with acute leukaemias. 
Predpisovanje in izdaja zdravila Arzenov trioksid Accord je le na recept, njegovo uporabo pa mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z akutnimi oblikami levkemije.
The active substance in the medicine, arsenic trioxide, has been used in medicines for many years, including for the treatment of leukaemia. 
Učinkovina v zdravilu Arzenov trioksid Accord, arzenov trioksid, se v zdravilih uporablja že mnogo let, tudi pri zdravljenju levkemije.
Arsenic trioxide Accord is used in: 
Zdravilo Arzenov trioksid Accord se uporablja pri:
As for all medicines, data on the use of Arsenic trioxide Accord are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Arzenov trioksid Accord stalno spremljajo.
• Patients with newly diagnosed low or intermediate risk APL where it is used together with the medicine all-trans-retinoic acid. 
• bolnikih z na novo diagnosticirano akutno promielocitno levkemijo z nizkim do srednjim tveganjem, pri kateri se uporablja v kombinaciji z vse-trans-retinojsko kislino (ATRA);
There was no need for ‘bioequivalence' studies to investigate whether Arsenic trioxide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. 
Izvedba študije „bioekvivalence“, s katero bi raziskali, ali se zdravilo Arzenov trioksid Accord absorbira podobno kot referenčno zdravilo in tako doseže enako raven učinkovine v krvi, ni bila potrebna.
What are the benefits and risks of Arsenic trioxide Accord? 
Kakšne so koristi in tveganja, povezani z zdravilom Arzenov trioksid Accord?
The recommended dose of Arsenic trioxide Accord depends on the patient's weight. 
Priporočeni odmerek zdravila Arzenov trioksid Accord je odvisen od bolnikove telesne mase.
Arsenic trioxide Accord contains the active substance arsenic trioxide and is a ‘generic medicine'. 
Zdravilo Arzenov trioksid Accord vsebuje učinkovino arzenov trioksid in je „generično zdravilo“.
Other information about Arsenic trioxide Accord 
Druge informacije o zdravilu Arzenov trioksid Accord
Arsenic trioxide Accord (arsenic trioxide) 
Arzenov trioksid Accord (arzenov trioksid)
This is because Arsenic trioxide Accord is given by infusion into a vein, so the active substance is delivered straight into the bloodstream. 
Zdravilo Arzenov trioksid Accord se namreč daje z infundiranjem v veno, tako da učinkovina vstopa neposredno v krvni obtok.
Why is Arsenic trioxide Accord authorised in the EU? 
Zakaj je bilo zdravilo Arzenov trioksid Accord odobreno v EU?
What is Arsenic trioxide Accord and what is it used for? 
Kaj je zdravilo Arzenov trioksid Accord in za kaj se uporablja?
It is given as an infusion (drip) into a vein. 
Zdravilo se daje z infundiranjem (kapalno infuzijo) v veno.
Therefore, the Agency's view was that, as for Trisenox, the benefits of Arsenic trioxide Accord outweigh the identified risks and it can be authorised for use in the EU. 
Zato je menila, da koristi zdravila Arzenov trioksid Accord enako kot pri zdravilu Trisenox odtehtajo znana tveganja in da se zdravilo lahko odobri v EU.
How does Arsenic trioxide Accord work? 
Kako zdravilo Arzenov trioksid Accord deluje?
How has Arsenic trioxide Accord been studied? 
Kako je bilo zdravilo Arzenov trioksid Accord raziskano?
How is Arsenic trioxide Accord used? 
Kako se zdravilo Arzenov trioksid Accord uporablja?
The European Commission granted a marketing authorisation valid throughout the European Union for Insulatard on 7 October 2002. 
Evropska komisija je dovoljenje za promet z zdravilom Insulatard, veljavno po vsej Evropski uniji, odobrila 7. oktobra 2002.
The full EPAR for Insulatard 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) za zdravilo Insulatard je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
What measures are being taken to ensure the safe and effective use of Insulatard? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Insulatard?
Other information about Insulatard 
Druge informacije o zdravilu Insulatard
It can be given once or twice a day, with or without a fast-acting insulin (given at meal times), according to the doctor's recommendation. 
Daje se lahko enkrat ali dvakrat dnevno skupaj s hitrodelujočim insulinom ali brez njega (v času obroka) v skladu s priporočili zdravnika.
This is a summary of the European public assessment report (EPAR) for Insulatard. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Insulatard.
The CHMP decided that Insulatard's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Insulatard večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
What benefit has Insulatard shown during the studies? 
Kakšne koristi je zdravilo Insulatard izkazalo med študijami?
A risk management plan has been developed to ensure that Insulatard is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Insulatard je bil pripravljen načrt obvladovanja tveganj.
For more information about treatment with Insulatard, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Insulatard preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Insulatard has been studied in four main clinical trials, which included a total of 557 patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 81 patients), or type 2 diabetes, when the body is unable to use insulin effectively (two studies involving 476 patients). 
Zdravilo Insulatard so preučili v štirih glavnih kliničnih preskušanjih, v katere je bilo vključenih skupno 557 bolnikov s sladkorno boleznijo tipa 1, pri kateri trebušna slinavka ne more tvoriti insulina (dve študiji, 81 bolnikov), in s sladkorno boleznijo tipa 2, pri kateri telo ne more učinkovito izrabiti insulina (dve študiji, 476 bolnikov).
The most common side effect with Insulatard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels). 
Najpogostejši neželeni učinek zdravila Insulatard (opažen pri več kot 1 bolniku od 10) je hipoglikemija (nizka raven glukoze v krvi).
In most patients, Insulatard was compared with other types of human insulin or insulin analogues. 
Pri večini bolnikov so zdravilo Insulatard primerjali z drugimi vrstami humanega insulina ali analogi insulina.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Insulatard, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Insulatard in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Insulatard. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Insulatard, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The studies measured the levels of fasting blood glucose or glycosylated haemoglobin (HbA1c, the haemoglobin in the blood that has glucose attached). 
V študijah so merili raven glukoze v krvi na tešče ali glikoziliranega hemoglobina (HbA1c, hemoglobina v krvi, na katerega se je vezala glukoza).
Insulatard contains insulin mixed with another substance, protamine, in an ‘isophane' form which is absorbed much more slowly during the day. 
V zdravilu Insulatard je insulin zmešan z drugo snovjo, tj. protaminom, v obliki „izofan“, ki se čez dan absorbira mnogo počasneje.
What is the risk associated with Insulatard? 
Kakšna tveganja so povezana z zdravilom Insulatard?
The active substance in Insulatard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin. 
Zdravilna učinkovina v zdravilu Insulatard, humani insulin, se proizvaja z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri se v celice kvasovk vstavi gen (DNK), ki jim daje sposobnost tvorjenja insulina.
Insulatard was effective for both type 1 and type 2 diabetes, and when using a standard injection or one of the pre-filled pens. 
Zdravilo Insulatard se je izkazalo kot učinkovito tako pri sladkorni bolezni tipa 1 kot pri sladkorni bolezni tipa 2, in sicer pri uporabi običajne injekcijske brizge ali enega od napolnjenih peresnikov.
Insulatard led to a decrease in the level of HbA1c, indicating that blood sugar levels had been controlled to a similar level to that seen with other human insulins. 
Zdravilo Insulatard je privedlo do znižanja ravni HbA1c, kar kaže, da so bile ravni glukoze v krvi uravnane na podobno raven kakor pri drugih humanih insulinih.
Insulatard is used to treat diabetes. 
Zdravilo Insulatard se uporablja za zdravljenje sladkorne bolezni.
Insulatard is a suspension for injection that contains the active substance human insulin. 
Zdravilo Insulatard je suspenzija za injiciranje, ki vsebuje zdravilno učinkovino humani insulin.
Why has Insulatard been approved? 
Zakaj je bilo zdravilo Insulatard odobreno?
It is available as vials, cartridges (Penfill), or pre-filled pens (InnoLet or FlexPen). 
Na voljo je v vialah, injekcijskih vložkih (Penfill) ali napolnjenih injekcijskih peresnikih (InnoLet ali FlexPen).
Insulatard is a replacement insulin which is very similar to the insulin made by the pancreas. 
Zdravilo Insulatard je nadomestni insulin, ki je zelo podoben insulinu, ki ga proizvaja trebušna slinavka.
Insulatard is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder). 
Zdravilo Insulatard se injicira v podkožje stegna, trebušne stene (sprednjega dela trebuha), glutealnega predela (zadnjice) ali deltoidnega predela (ramena).
Further studies were also carried out in 225 patients comparing injecting Insulatard using a syringe, or using a pre-filled pen (InnoLet or FlexPen). 
V dodatnih študijah zdravila Insulatard, ki so jih opravili na 225 bolnikih, so injiciranje zdravila Insulatard z injekcijsko brizgo primerjali z injiciranjem tega zdravila z napolnjenim peresnikom (InnoLet ali FlexPen).
Insulatard is a long-acting insulin. 
Zdravilo Insulatard je dolgodelujoči insulin.
How has Insulatard been studied? 
Kako je bilo zdravilo Insulatard raziskano?
What is Insulatard used for? 
Za kaj se zdravilo Insulatard uporablja?
How does Insulatard work? 
Kako zdravilo Insulatard deluje?
This gives Insulatard a longer duration of action. 
To podaljša čas delovanja zdravila Insulatard.
How is Insulatard used? 
Kako se zdravilo Insulatard uporablja?
What is Insulatard? 
Kaj je zdravilo Insulatard?
These other medicines may include: 
Ta druga zdravila lahko vključujejo:
•Final report of study results: December 2038 
• Končno poročilo o rezultatih študije: december 2038
Date of first authorisation: 23 August 2018 
Datum prve odobritve: 23. avgust 2018
Other outcomes were consistent with those of the mITT population. 
Ostali izidi so bili skladni z izidi pri populaciji mITT.
It will not be given to you again. 
Ne boste ga prejeli ponovno.
This can take 3 to 6 hours and may need to be repeated. 
To lahko traja od 3 do 6 ur; morda bo treba postopek ponoviti.
Annual safety reports and 5-yearly interim reports 
Letno poročilo o varnosti in 5-letna vmesna poročila
If not improving, manage as Grade 4 (below). 
Če ni izboljšanja, ravnajte kot pri 4. stopnji (spodaj).
Your doctor or nurse will check carefully that this medicine is yours. 
Zdravnik ali medicinska sestra bo skrbno preveril/a, da je to zdravilo vaše.
• Check if you had a vaccination in the previous 6 weeks or are planning to have one in the next few months. 
• preveril, ali ste bili v predhodnih 6 tednih cepljeni in ali se nameravate cepiti v naslednjih nekaj mesecih.
HBV reactivation 
Reaktivacija HBV
You may be given medicines to help prevent the condition. 
Morda boste dobili zdravila za preprečevanje tega stanja.
An impact of these antibodies on efficacy or safety was not discernible. 
Vpliv teh protiteles na učinkovitost ali varnost ni bil opazen.
As this medicine will be given by qualified healthcare professionals, they are responsible for the correct disposal of the product. 
Ker vam bodo to zdravilo dali usposobljeni zdravstveni delavci, so za pravilno odstranitev zdravila odgovorni oni.
- have had a stem cell transplant in the last 4 months. 
- če ste v zadnjih 4 mesecih imeli presaditev matičnih celic.
One out of 111 patients did not receive the product due to manufacturing failure. 
Eden od 111 bolnikov zdravila ni prejel zaradi napake v izdelavi.
• Check your lungs, heart and blood pressure. 
• pregledal vaša pljuča, srce in krvni tlak.
Do not try to treat your symptoms with other medicines on your own. 
Simptomov ne poskušajte sami zdraviti z drugimi zdravili.
Verify patient ID. 
Preverite ID bolnika.
Availability of tocilizumab and site qualification 
Razpoložljivost tocilizumaba in usposobljenost mesta
Your doctor will regularly check your blood counts as the number of blood cells and other blood components may decrease. 
Zdravnik bo redno preverjal vaša števila krvnih celic, saj se lahko število krvnih celic in drugih sestavin krvi zmanjša.
Efficacy was consistent with the overall treated patient population. 
Učinkovitost je bila skladna z učinkovitostjo pri splošni populaciji zdravljenih bolnikov.
• You will be given a pregnancy test before treatment starts. 
• Pred začetkom zdravljenja boste opravili test nosečnosti.
• After treatment while the immune system is recovering. 
• Po zdravljenju, ko vaš imunski sistem okreva.
If this happens to you, do not drive or use heavy machines until at least 8 weeks after infusion or until your doctor tells you that you have completely recovered. 
Če se vam to zgodi, ne vozite in ne upravljajte težkih strojev še vsaj 8 tednov po infundiranju ali dokler vam zdravnik ne pove, da ste povsem okrevali.
Median duration of response and median overall survival have not been reached (Table 5). 
Mediana trajanja odziva in mediana celokupnega preživetja nista bili doseženi (preglednica 5).
Active uncontrolled infection. 
Aktivna neobvladana okužba.
It is used to treat these conditions when other available medicines have stopped working for you. 
Uporablja se za zdravljenje teh bolezni, ko druga razpoložljiva zdravila pri vas več ne učinkujejo.
A summary of the patient demographics is provided in Table 4. 
Povzetek demografskih značilnosti bolnikov je v preglednici 4.
Serious adverse reactions occurred in 56% of patients. 
Resni neželeni učinki so se pojavili pri 56 % bolnikov.
Patient Educational program 
Izobraževalni program za bolnika
Hence, traditional toxicology studies used for drug development were not performed. 
Zato tradicionalnih toksikoloških študij, ki se uporabljajo za razvoj zdravil, niso izvedli.
Response and survival after treatment with available standard-of-care therapy was evaluated. 
Ocenili so odziv in preživetje po zdravljenju z razpoložljivo standardno oskrbo.
If the bag is compromised, follow the local guidelines (or immediately contact Kite). 
Če je vreča poškodovana, upoštevajte lokalne smernice (ali pa takoj poklicati Kite).
If your temperature is high, see your doctor immediately. 
Če je temperatura zvišana, pojdite takoj k zdravniku.
•Update reports: 
• Posodobitev poročil:
CR rates were 75% and 56%, respectively. 
Stopnja CR je bila 75 % oziroma 56 %.
Limit to a maximum of 3 doses in a 24 hour period; maximum total of 4 doses if no clinical improvement in the signs and symptoms of CRS. 
Omejitev na največ 3 odmerke v 24-urnem obdobju; skupaj največ 4 odmerki, če ni kliničnega izboljšanja znakov in simptomov CRS.
Effects on male and female fertility have not been evaluated in animal studies. 
Učinkov na sposobnost razmnoževanja pri moških in ženskah niso ugotavljali v študijah na živalih.
• Place the infusion bag inside a second sterile bag or per local guidelines. 
• Infuzijsko vrečo položite v drugo sterilno vrečo ali v skladu z lokalnimi smernicami.
YESCARTA is intended solely for autologous use and must not be administered to other patients. 
Zdravilo YESCARTA je namenjeno izključno za avtologno uporabo in se ne sme dajati drugim bolnikom.
This is the equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult. 
To ustreza 15 % priporočenega največjega dnevnega vnosa natrija s hrano za odraslo osebo.
Repeat tocilizumab every 8 hours as needed if not responsive to intravenous fluids or increasing supplemental oxygen. 
Po potrebi se dajanje tocilizumaba ponovi vsakih 8 ur, če ni odziva na intravenske tekočine ali povečano dodajanja kisika.
• Check if your cancer is getting worse. 
• preveril, ali se vaša rakava bolezen slabša.
ORR (%) [95% CI] CR (%) 
ORR (%) [95-% IZ] CR (%)