natgillin/translations-raw huggingface dataset:
At the time of triggering the referral, the UK considered that the benefit-risk analysis for the acne indication was not favourable based on insufficient data on the efficacy of the combination in the acne indication, an unacceptable safety profile, in particular regarding to the risk of venous thromboembolic events (VTE) and the fact that the target population covered by the abovementioned indication is broad and would unnecessarily expose women to a treatment with limited efficacy and to a potential higher risk of VTE when alternative and safer options for the treatment of acne are available. 
Ob sprožitvi napotitve je Združeno kraljestvo ocenilo, da analiza razmerja med tveganji in koristmi za indikacijo aken ni ugodna, in sicer na podlagi nezadostnih podatkov o učinkovitosti kombinacije pri indikaciji aken, nesprejemljivega varnostnega profila, zlasti glede tveganja za vensko trombembolijo in dejstva, da je ciljna populacija, ki jo zajema zgornja indikacija, široka in bi bile ženske po nepotrebnem izpostavljene zdravljenju z omejeno učinkovitostjo in morebitnemu povišanemu tveganju za vensko trombembolijo, kadar so na voljo druge in varnejše možnosti zdravljenja aken.
However, the CHMP noted that there were no cases of VTE in the phase III studies and the safety data provided by MAHs does not raise any new safety concern. 
Odbor CHMP je opozoril, da v študijah III. faze ni bilo primerov venske trombembolije, in tudi podatki o varnosti, ki so jih predložili imetniki dovoljenj za promet z zdravilom, ne vzbujajo novih pomislekov o varnosti.
• The CHMP noted that the risk of VTE with dienogest containing combined hormonal contraceptive is not yet fully characterised. 
• odbor CHMP je opozoril, da tveganje za vensko trombembolijo s kombiniranimi hormonskimi kontraceptivi, ki vsebujejo dienogest, še ni v celoti ovrednoteno.
• The CHMP also noted that the initial acne indication was too broad and would unnecessarily expose women to a treatment with a potential higher risk of VTE when alternative and safer options for the treatment of acne are available. 
• odbor CHMP je opozoril tudi, da je bila prvotna indikacija za akne preširoka in bi z njo po nepotrebnem izpostavili ženske zdravljenju s potencialno večjim tveganjem za vensko trombembolijo, kadar so na voljo druge in varnejše možnosti zdravljenja aken.
• The CHMP agreed that patients treated for acne should be assessed 3-6 months after starting treatment and periodically thereafter. 
• odbor CHMP se je strinjal, da je treba bolnice, ki se zdravijo zaradi aken, oceniti po 36 mesecih zdravljenja in nato v rednih časovnih presledkih.
• The CHMP considered the totality of the available clinical studies, published literature and postmarketing experience, including responses from marketing authorisation holders (MAHs) on the efficacy of DNG/EE in the treatment of acne, and on the safety of these medicines, in particular regarding the risk of venous thromboembolic events (VTE) and arterial thromboembolic events (ATE). 
• odbor CHMP je preučil vse razpoložljive klinične študije, objavljeno literaturo in izkušnje iz obdobja trženja, vključno z odgovori imetnikov dovoljenj za promet z zdravilom o učinkovitosti dienogesta/etinilestradiola pri zdravljenju aken in o varnosti teh zdravil, zlasti v zvezi s tveganjem za vensko trombembolijo in arterijsko trombembolijo;
• The CHMP considered that the efficacy of medicines containing dienogest 2 mg and ethinylestradiol 0.03 mg in the treatment of moderately severe acne in women in whom topical treatment or oral antibiotic was ineffective is well supported by phase III clinical trial data and further supported by a Cochrane review of combined oral contraceptive pills for treatment of acne. 
• odbor CHMP je ocenil, da je učinkovitost zdravil, ki vsebujejo dienogest 2 mg in etinilestradiol 0,03 mg, pri zdravljenju zmerno hudih aken pri ženskah, pri katerih je bilo zdravljenje s topičnim zdravilom ali peroralnim antibiotikom neučinkovito, dobro podprta s podatki iz kliničnih preskušanj III. faze, nadalje pa tudi s Cochranovim pregledom kombiniranih peroralnih kontracepcijskih tablet za zdravljenje aken;
• The CHMP is of the opinion that the benefits of dienogest/ethinylestradiol containing medicinal products continue to outweigh the risks in the second-line treatment of moderate acne in women who elect to use an oral contraceptive, provided that the medicinal products are only used after suitable topical therapies or oral antibiotic treatments have failed. 
• odbor CHMP meni, da koristi zdravil, ki vsebujejo dienogest/etinilestradiol, še vedno odtehtajo tveganja kot druga izbira zdravljenja zmernih aken pri ženskah, ki se odločijo za uporabo peroralnega kontraceptiva, pod pogojem, da se ta zdravila uporabijo šele, kadar zdravljenje z ustreznimi topičnimi zdravili ali peroralnim antibiotikom ni bilo uspešno.
In view of the most prominent effect on acne seen after 6 months of treatment, paired with the still to be quantified risk of VTE, women should be assessed 3-6 months after initiating treatment and periodically thereafter to review the need for continuation of treatment. 
Na podlagi najočitnejšega učinka na akne, vidnega po šestih mesecih zdravljenja, skupaj s tveganjem za vensko trombembolijo, ki ga je še treba ovrednotiti, je treba ženske oceniti po 3-6 mesecih zdravljenja, potem pa v rednih časovnih presledkih, da se preuči potreba po nadaljevanju zdravljenja.
The CHMP also noted that in order to avoid unnecessarily exposing women to a treatment with a potential higher risk of VTE when alternative and safer options for the treatment of acne are available that the indication should be restricted to women who elect contraception, and that a conscious and wellconsidered decision needs to be made when choosing this COC. 
Odbor CHMP je prav tako opozoril, da je treba v izogib nepotrebnemu izpostavljanju žensk zdravilu s potencialno večjim tveganjem za vensko trombembolijo, kadar so na voljo druge in varnejše možnosti zdravljenja aken, indikacijo omejiti na ženske, ki se odločijo za kontracepcijo, in da je pri odločitvi za ta kombinirani peroralni kontraceptiv potreben zavesten in dobro pretehtan razmislek.
Therefore, the benefit-risk relationship of DNG/EE is considered favourable for a second-line treatment of women with moderate acne. 
Zato je razmerje med tveganji in koristmi dienogesta/etinilestradiola ugodno kot zdravljenje druge izbire za ženske z zmernimi aknami.
Therefore the CHMP recommends the variation to the terms of the marketing authorisations for dienogest/ethinylestradiol containing medicinal products indicated in acne. 
Zato priporoča spremembo pogojev dovoljenj za promet z zdravili, ki vsebujejo dienogest/etinilestradiol, za indikacijo aken.
The CHMP, as a consequence, considers that the benefit-risk balance of dienogest/ethinylestradiol containing medicinal products indicated in acne remains favourable subject to the amendments to the product information described above. 
Odbor CHMP posledično meni, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo dienogest/etinilestradiol, še naprej ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
In view of the above, the CHMP concluded that the benefit-risk balance of dienogest/ethinylestradiol containing products indicated in acne is favourable subject to changes to the product information as described above. 
Z upoštevanjem zgoraj navedenega je odbor CHMP zaključil, da je razmerje med tveganji in koristmi zdravil, ki vsebujejo dienogest/etinilestradiol, ugodno, pod pogojem, da se upoštevajo zgoraj opisane spremembe informacij o zdravilu.
Asparaginase is an enzyme that has been used to treat cancer for many years, and is already approved under various trade names in the EU. 
Asparaginaza je encim, ki se že dolga leta uporablja za zdravljenje raka in je v EU odobren pod različnimi tržnimi imeni.
it can cause allergic reactions, but by enclosing it in red blood cells the risk of allergy is expected to be reduced. 
povzroča alergijske reakcije, z vključitvijo v rdeče krvne celice pa naj bi se tveganje za alergijo zmanjšalo.
Withdrawal of the marketing authorisation application for Graspa (eryaspase) EMA/817193/2016 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Graspa (eriaspaza) EMA/817193/2016
In addition, the company had changed the way the asparaginase in the medicine was made, and the Committee asked for supportive information to show that this would not affect the effectiveness of the product. 
Poleg tega je družba spremenila način izdelave asparaginaze v zdravilu, zato je odbor zaprosil za podporne informacije za dokazovanje, da to ne vpliva na učinkovitost zdravila.
On 14 November 2016, Erytech Pharma SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Graspa, for the treatment of acute lymphoblastic leukaemia. 
Družba Erytech Pharma SA je 14. novembra 2016 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Graspa, namenjenim zdravljenju akutne limfoblastne levkemije.
Because asparaginase is a protein, 
Ker je asparaginaza beljakovina, lahko
The company provided data on Graspa, including the results of a main study involving 80 patients with ALL whose disease had come back after initial treatment or who had not responded to initial treatment, some of whom had an allergy to other products containing asparaginase. 
Družba je predložila podatke o zdravilu Graspa, vključno z rezultati glavne študije, ki je vključevala 80 bolnikov z ALL, pri katerih se je bolezen po začetnem zdravljenju ponovila ali ki se niso odzvali na začetno zdravljenje, med njimi pa so imeli nekateri alergijo na druga zdravila, ki vsebujejo asparaginazo.
The CHMP was concerned about the way the effectiveness of the medicine had been measured in the main study, and whether the results of this study could be extended to patients taking other combinations of cancer medicines. 
Odbor CHMP je izrazil zaskrbljenost zaradi načina merjenja učinkovitosti zdravila v glavni študiji in vprašanja, ali se rezultati te študije lahko uporabijo tudi pri bolnikih, ki uporabljajo druge kombinacije zdravil za zdravljenje raka.
Graspa was expected to be used in combination with other cancer medicines to treat adults and children over 1 year of age who have acute lymphoblastic leukaemia (ALL), a cancer of white blood cells. 
Zdravilo Graspa naj bi se uporabljalo v kombinaciji z drugimi zdravili za zdravljenje raka, in sicer za zdravljenje odraslih in otrok, starejših od enega leta, ki imajo akutno limfoblastno levkemijo (ALL), vrsto raka belih krvnih celic.
Withdrawal of the marketing authorisation application for Graspa (eryaspase) 
Umik vloge za pridobitev dovoljenja za promet z zdravilom Graspa (eriaspaza)
The medicine was intended for use in patients whose cancer was classed ‘Philadelphia chromosome negative' and had not responded to initial treatment, or had come back after treatment. 
Uporabljalo naj bi se pri bolnikih, pri katerih je rak negativen za kromosom Philadelphia in ki se niso odzvali na začetno zdravljenje oziroma so se po zdravljenju vrnili.
The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Graspa. 
Družba je odbor CHMP obvestila, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Graspa.
Graspa was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 October 2006 for ALL. 
Zdravilo Graspa je bilo 26. oktobra 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje ALL.
Cancer cells need this amino acid to grow and multiply, and so its reduction in the blood causes the cells to die. 
Rakave celice to aminokislino potrebujejo za rast in razmnoževanje, zato upad njene ravni v krvi povzroči odmrtje teh celic.
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing the application because the additional data the CHMP considered necessary to support the application could not be obtained in the time available. 
Družba je v dopisu, s katerim je agencijo obvestila o umiku vloge, navedla, da umika vlogo, ker dodatnih podatkov, ki so po mnenju odbora CHMP potrebni za podporo vlogi, ne more pridobiti v razpoložljivem času.
Graspa is a cancer medicine that contains the active substance eryaspase (a version of the enzyme asparaginase enclosed in red blood cells compatible with the patient's blood group). 
Graspa je zdravilo za zdravljenje raka, ki vsebuje zdravilno učinkovino eriaspazo (različico encima asparaginaze, vključeno v rdeče krvne celice, ki so združljive z bolnikovo krvno skupino).
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the company had not provided enough data to support the application for Graspa. 
Zato je odbor CHMP ob umiku vloge menil, da družba ni predložila zadostnih podatkov v podporo vlogi za zdravilo Graspa.
Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Graspa could not have been approved for the treatment of ALL. 
Odbor CHMP je na podlagi pregleda podatkov ob umiku vloge izrazil določene zadržke in je začasno menil, da zdravila Graspa ni mogoče odobriti za zdravljenje ALL.
The asparaginase in Graspa is enclosed in red blood cells with the intention of helping protect the enzyme from being broken down in the body. 
Asparaginaza v zdravilu Graspa je vključena v rdeče krvničke, ki encim ščitijo pred razgradnjo v telesu.
The asparaginase in Graspa works by breaking up and reducing the blood levels of the amino acid asparagine. 
Asparaginaza v zdravilu Graspa deluje tako, da razgrajuje aminokislino asparagin in zmanjšuje njeno koncentracijo v krvi.
* efavirenz / emtricitabine / tenofovir disoproxil (as fumarate) 
* efavirenz / emtricitabin / tenofovirdizoproksil (v obliki fumarata)
600 mg/200 mg/245 mg * 600 mg/200 mg/245 mg * 
600 mg/200 mg/245 mg * Filmsko obložena tableta Peroralna uporaba Steklenička (HDPE/alu) 30 filmsko obloženih tablet
Atripla Atripla 
Ovojnina
3 x 30 film-coated tablets 
600 mg/200 mg/245 mg * Filmsko obložena tableta Peroralna uporaba Steklenička (HDPE/alu) 3 x 30 filmsko obloženih tablet
The full EPAR for Docetaxel Accord 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 Docetaxel Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Docetaxel Accord is given as a one-hour infusion every three weeks. 
Zdravilo Docetaxel Accord se daje kot enourna infuzija vsake tri tedne.
For more information on generic medicines, see the question-and-answer document here. 
Za več informacij o generičnih zdravilih si oglejte dokument z vprašanji in odgovori tukaj.
Docetaxel Accord is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3). 
Zdravilo Docetaxel Accord se uporablja le, kadar je število nevtrofilcev (raven vrste belih krvnih celic) normalno (vsaj 1 500 celic/mm3).
This is a summary of the European public assessment report (EPAR) for Docetaxel Accord. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Docetaxel Accord.
• prostate cancer, when the cancer does not respond to hormonal treatment. 
• raka prostate, kadar se ta ne odziva na hormonsko zdravljenje.
With the skeleton still in place, the cells cannot divide and they eventually die. 
Dokler je ogrodje postavljeno, se celice ne morejo deliti in sčasoma odmrejo.
The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Accord on 22 May 2012. 
Evropska komisija je dovoljenje za promet z zdravilom Docetaxel Accord, veljavno po vsej Evropski uniji, odobrila dne 22. maja 2012.
This means that Docetaxel Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Taxotere. 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Taxotere.
Because Docetaxel Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's. 
Ker je zdravilo Docetaxel Accord generično zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The CHMP concluded that, in accordance with EU requirements, Docetaxel Accord has been shown to be comparable to Taxotere. 
CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Docetaxel Accord primerljivo z zdravilom Taxotere.
Docetaxel Accord docetaxel 
Docetaxel Accord docetaksel
• head and neck cancer in patients whose cancer is locally advanced (a cancer that has grown but has not spread). 
• raka glave in vratu pri bolnikih, pri katerih je rak lokalno napredoval (rakava tvorba je zrasla, vendar se še ni razširila po telesu).
For more information about treatment with Docetaxel Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Docetaxel Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
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 Docetaxel Accord. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Docetaxel Accord, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Docetaxel Accord is used to treat the following types of cancer: 
Zdravilo Docetaxel Accord se uporablja za zdravljenje naslednjih vrst raka:
What are the benefits and risks of Docetaxel Accord? 
Kakšne so koristi in tveganja, povezani z zdravilom Docetaxel Accord?
An anti-inflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Docetaxel Accord infusion. 
Bolniku je treba dati tudi protivnetno zdravilo, kot je na primer deksametazon, in sicer dan pred infuzijo zdravila Docetaxel Accord.
Docetaxel Accord can be used on its own after other treatments have failed. 
Zdravilo Docetaxel Accord se lahko uporablja kot samostojno zdravilo, kadar druge oblike zdravljenja niso bile uspešne.
It can also be used with other anticancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated; 
Prav tako se lahko uporablja sočasno z drugimi zdravili proti raku (doksorubicinom, ciklofosfamidom, trastuzumabom ali kapecitabinom) pri bolnikih, ki se še niso zdravili proti raku ali pri katerih so bile druge oblike zdravljenja neuspešne, odvisno od vrste in stadija raka dojke, ki se zdravi;
The Committee recommended that Docetaxel Accord be given marketing authorisation. 
Odbor je priporočil, da se za zdravilo Docetaxel Accord odobri dovoljenje za promet.
Docetaxel Accord is used with cisplatin and 5-fluorouracil. 
Zdravilo Docetaxel Accord se uporablja v kombinaciji s cisplatinom in 5-fluorouracilom.
Docetaxel Accord should be used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy. 
Zdravilo Docetaxel Accord se sme uporabljati samo na specializiranih oddelkihza kemoterapijo (uporabo zdravil za zdravljenje raka) in le pod nadzorom zdravnika, usposobljenega za uporabo kemoterapije.
Other information about Docetaxel Accord 
Druge informacije o zdravilu Docetaxel Accord
Docetaxel Accord is a ‘generic medicine'. 
Zdravilo Docetaxel Accord je „generično zdravilo“.
• gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer. 
• adenokarcinoma želodca (vrste raka na želodcu) pri bolnikih, ki se zaradi raka še niso zdravili.
Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects. 
Docetaksel učinkuje tudi na nerakave celice, kot sokrvne celice, kar lahko povzroči neželene učinke.
The active substance in Docetaxel Accord, docetaxel, belongs to the group of anticancer medicines known as the taxanes. 
Zdravilna učinkovina v zdravilu Docetaxel Accord, docetaksel, spada v skupino zdravil proti raku, imenovani taksani.
Docetaxel Accord is used with cisplatin and 5-fluorouracil (other anticancer medicines); 
Zdravilo Docetaxel Accord se uporablja v kombinaciji s cisplatinom in 5-fluorouracilom (drugima zdraviloma za zdravljenje raka);
Docetaxel Accord is a medicine that contains the active substance docetaxel. 
Docetaxel Accord je zdravilo, ki vsebuje zdravilno učinkovino docetaksel.
The company also showed that the Docetaxel Accord solution for infusion has comparable quality to that of Taxotere. 
Poleg tega je predstavila tudi dokaze o tem, da je kakovost raztopine za infundiranje Docetaxel Accord primerljiva z zdravilom Taxotere.
Docetaxel Accord is used with prednisone or prednisolone (anti-inflammatory medicines); 
Zdravilo Docetaxel Accord se uporablja sočasno s prednizonom ali prednizolonom (protivnetnima zdraviloma);
Why has Docetaxel Accord been approved? 
Zakaj je bilo zdravilo Docetaxel Accord odobreno?
No additional studies were needed as Docetaxel Accord is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Taxotere. 
Ker je zdravilo Docetaxel Accord generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Taxotere, niso bile potrebne nobene dodatne študije.
How has Docetaxel Accord been studied? 
Kako je bilo zdravilo Docetaxel Accord raziskano?
What is Docetaxel Accord? 
Kaj je zdravilo Docetaxel Accord?
How does Docetaxel Accord work? 
Kako zdravilo Docetaxel Accord deluje?
What is Docetaxel Accord used for? 
Za kaj se zdravilo Docetaxel Accord uporablja?
How is Docetaxel Accord used? 
Kako se zdravilo Docetaxel Accord uporablja?
Annually within the annual reassessment 
Letno v okviru letne ponovne ocene
One, five, ten vials 
ena, pet, deset vial
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 11 November 2015 
Datum prve odobritve: 11. november 2015
Your doctor will also check if the bleeding is adequately controlled. 
Preveril bo tudi, ali je krvavitev zadostno obvladovana.
Before starting reconstitution you will need the following: 
Preden začnete rekonstitucijo, morate pripraviti naslednje:
The length of treatment depends on clinical judgement. 
Trajanje zdravljenja je odvisno od klinične presoje.
The educational programme is aimed to minimize the risk of dose dispensing errors. 
Cilj izobraževalnega programa je zmanjšati tveganja za napake pri izdajanju odmerkov.
Initial Phase 
Začetna faza
Those with pre-existing cardiovascular disease and the elderly are at particular risk. 
Še posebej so ogroženi bolniki z obstoječim kardiovaskularnimi boleznimi in starejše osebe.
In case of shock, standard medical treatment for shock should be implemented. 
V primeru šoka je treba upoštevati standardno medicinsko zdravljenje šoka.
Use in children and adolescents 
Otroci in mladostniki
500 U 
500 e.
Frequencies have been evaluated according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data). 
Pogostnosti so bile ocenjene v skladu z naslednjim dogovorom: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1000), zelo redki (<1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
The maximum blood FVIII activity must not exceed 200%. 
Največja aktivnost faktorja VIII v krvi ne sme preseči 200 %.