natgillin/translations-raw huggingface dataset:
On 31 January 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Doxolipad, intended for the treatment of breast and ovarian cancer. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je v svojem negativnem mnenju z dne 31. januarja 2019 priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom Doxolipad, namenjenim zdravljenju raka dojk in jajčnikov.
This means that Doxolipad was intended to be similar to a ‘reference medicine' already authorised in the European Union called Adriamycin. 
To pomeni, da naj bi bilo podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji, in sicer zdravilu Adriamycin.
Doxolipad was developed as a ‘hybrid medicine'. 
Zdravilo Doxolipad je bilo razvito kot „hibridno zdravilo“.
Because Doxolipad was developed as a hybrid medicine, the company also presented the results of a study carried out to investigate whether it is ‘bioequivalent' to Caelyx. 
Ker je bilo zdravilo Doxolipad razvito kot hibridno zdravilo, je podjetje predložilo tudi rezultate študije, ki je bila opravljena za proučitev, ali je zdravilo „biološko enakovredno“ zdravilu Caelyx.
The liposomes reduce the rate at which the active substance is broken down, allowing it to circulate in the blood for longer. 
Liposomi upočasnijo razgrajevanje učinkovine in podaljšajo čas njenega kroženja v krvi.
Although the reference medicine for Doxolipad is Adriamycin, this could not be used in the bioequivalence study because it contains doxorubicin in a different form (not enclosed in pegylated liposomes). 
Čeprav je referenčno zdravilo za zdravilo Doxolipad zdravilo Adriamycin, tega ni bilo mogoče uporabiti v študiji biološke enakovrednosti, saj vsebuje doksorubicin v drugačni obliki (ni vključen v pegilirane liposome).
The results of the bioequivalence study showed that Doxolipad is comparable to Caelyx in terms of ‘liposome-encapsulated doxorubicin', but failed to show that the amount of ‘free doxorubicin' is the same for the two medicines. 
Rezultati študije biološke enakovrednosti so pokazali, da je zdravilo Doxolipad primerljivo z zdravilom Caelyx v smislu „v liposome vključenega doksorubicina“, vendar niso dokazali, da je količina „prostega doksorubicina“ pri obeh zdravilih enaka.
The company that applied for authorisation is TLC Biopharmaceuticals B.V. 
Vlogo za pridobitev dovoljenja za promet z zdravilom je predložilo podjetje TLC Biopharmaceuticals B.V.
On that basis, the CHMP recommended that Doxolipad be refused marketing authorisation. 
Na tej podlagi je odbor CHMP priporočil, da se dovoljenje za promet z zdravilom Doxolipad zavrne.
Therefore, the CHMP was of the opinion that there was insufficient evidence to show that Doxolipad was bioequivalent to Caelyx, and it was not possible to establish that the benefits of Doxolipad outweigh its risks. 
Zato je odbor CHMP menil, da ni dovolj dokazov, da je zdravilo Doxolipad biološko enakovredno zdravilu Caelyx, in da ni mogoče zaključiti, da koristi zdravila Doxolipad odtehtajo njegova tveganja.
What is Doxolipad? 
Kaj je zdravilo Doxolipad?
Doxolipad is a cancer medicine that contains the active substance doxorubicin. 
Doxolipad je zdravilo za zdravljenje raka, ki vsebuje učinkovino doksorubicin.
What was Doxolipad expected to be used for? 
Za kaj naj bi se zdravilo Doxolipad uporabljalo?
The difference between the products is that in Doxolipad the active substance doxorubicin is enclosed in tiny fatty spheres called liposomes (see below for more details). 
Razlika med zdraviloma je v tem, da je učinkovina zdravila Doxolipad vključena v majhne maščobne kroglice, imenovane liposomi (za več podrobnosti glejte spodaj).
How does Doxolipad work? 
Kako zdravilo Doxolipad deluje?
The active substance in Doxolipad, doxorubicin, is a cytotoxic medicine that belongs to the group ‘anthracyclines'. 
Učinkovina v zdravilu Doxolipad, doksorubicin, je citotoksično zdravilo, ki spada v skupino „antraciklinov“.
In Doxolipad, it is enclosed in ‘pegylated liposomes' (tiny fatty spheres that are coated with a chemical called polyethylene glycol). 
V zdravilu Doxolipad je doksorubicin vključen v „pegilirane liposome“ (majhne maščobne kroglice, prevlečene s kemično snovjo, imenovano polietilenglikol).
The recommended dose is one 150 microgram capsule, once a day at the same time each day. 
Priporočeni odmerek je ena 150-mikrogramska kapsula, ki se jo vzame enkrat na dan ob istem času.
This causes the muscles of the airways to relax, helping to keep the airways open and allowing the patient to breathe more easily. 
To povzroči, da se mišice dihalnih poti sprostijo, kar jih pomaga ohranjati odprte in omogoča bolniku, da lažje diha.
The main measure of effectiveness was based on changes in the patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second) after 12 weeks. 
Glavno merilo učinkovitosti je bila sprememba forsiranega ekspiracijskega volumna (FEV1- največja količina zraka, ki jo oseba lahko izdihne v eni sekundi) pri bolnikih po 12 tednih.
The full EPAR for Oslif Breezhaler 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 Oslif Breezhaler je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
It works by attaching to beta-2 receptors that are found in the muscle cells of many organs and that cause the muscles to relax. 
Deluje tako, da se veže na receptorje beta-2, ki se nahajajo v mišičnih celicah številnih organov in povzročajo sprostitev mišic.
To receive a dose, the patient places a capsule into the inhaler and breathes the powder in through the mouth. 
Da vzame odmerek, bolnik položi kapsulo v inhalator in skozi usta vdihne prašek.
European Commission granted a marketing authorisation valid throughout the European Union for Oslif Breezhaler on 30 November 2009. 
Evropska komisija je dovoljenje za promet z zdravilom Oslif Breezhaler, veljavno po vsej Evropski uniji, izdala 30. novembra 2009.
COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty breathing. 
KOPB je dolgotrajna bolezen, pri kateri so dihalne poti in zračni mešički v pljučih poškodovani ali blokirani, zaradi česar je dihanje oteženo.
Therefore, the Agency decided that Oslif Breezhaler's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Zato je zaključila, da so koristi zdravila Oslif Breezhaler večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
This is a summary of the European public assessment report (EPAR) for Oslif Breezhaler. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Oslif Breezhaler.
Overall, the effects of the 150 and 300 microgram doses of Oslif Breezhaler were similar, but the results showed that the 300 microgram dose may provide better relief in patients with more severe disease. 
V celoti so bili učinki 150- in 300-mikrogramskih odmerkov zdravila Oslif Breezhaler podobni, vendar pa rezultati kažejo, da je 300-mikrogramski odmerek pri bolnikih s hujšimi oblikami bolezni zagotovil večje olajšanje.
Other common side effects include chest pain, cough and muscle cramps. 
Drugi neželeni učinki vključujejo bolečine v prsih, kašelj in mišične krče.
Oslif Breezhaler capsules, which contain a powder for inhalation, are only used with a Oslif Breezhaler inhaler and must not be swallowed. 
Kapsule zdravila Oslif Breezhaler, ki vsebujejo prašek za inhaliranje, se uporabljajo samo z inhalatorjem Oslif Breezhaler in se jih ne sme pogoltniti.
Oslif Breezhaler is used for maintenance (regular) treatment. 
Zdravilo Oslif Breezhaler se uporablja za vzdrževalno (redno) zdravljenje.
On average, the increase in FEV1 in patients who received Oslif Breezhaler was between 150 to 190 ml, while for patients who received placebo the change in FEV1 ranged from a decrease of 10 ml to an increase of 20 ml. 
Pri bolnikih, ki so prejeli zdravilo Oslif Breezhaler, je izboljšanje FEV1 v povprečju znašalo med 150 in 190 ml, medtem ko je pri bolnikih, ki so prejeli placebo, sprememba FEV1 segala od poslabšanja za 10 ml do izboljšanja za 20 ml.
The most common side effects with Oslif Breezhaler (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat) and upper respiratory tract infection (infection of the nose and throat). 
Najpogostejša neželena učinka zdravila Oslif Breezhaler (ki se lahko pojavita pri več kot 1 bolniku od 10) sta nazofaringitis (vnetje nosu in žrela) in okužba zgornjih dihal (okužba nosu in grla).
What measures are being taken to ensure the safe and effective use of Oslif Breezhaler? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Oslif Breezhaler?
In three main studies involving over 4,000 patients with COPD, Oslif Breezhaler was compared with placebo (a dummy treatment), tiotropium or formoterol (other inhaled medicines used to treat COPD). 
V treh glavnih študijah, ki so vključevale več kot 4 000 bolnikov s KOPB, so zdravilo Oslif Breezhaler primerjali s placebom (zdravilom brez zdravilne učinkovine), tiotropijem ali formoterolom (drugima inhalacijskima zdraviloma, ki se uporabljata za zdravljenje KOPB).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Oslif Breezhaler have been included in the summary of product characteristics and the package leaflet. 
Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Oslif Breezhaler upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about treatment with Oslif Breezhaler, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Oslif Breezhaler preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The Agency also noted that there were no major safety concerns with Oslif Breezhaler, with side effects being manageable and similar to other beta-2 adrenergic receptor agonist medicines. 
Ugotovila je tudi, da ni večjih pomislekov glede njegove varnosti, saj so njegovi neželeni učinki obvladljivi in podobni kot pri drugih agonistih adrenergičnih receptorjev beta-2.
Oslif Breezhaler is a medicine that is used to keep the airways open in adults with chronic obstructive pulmonary disease (COPD). 
Zdravilo Oslif Breezhaler se uporablja za vzdrževanje odprtih dihalnih poti pri odraslih bolnikih s kronično obstruktivno pljučno boleznijo (KOPB).
The European Medicines Agency concluded that Oslif Breezhaler was shown to be effective at improving the lung function in COPD. 
Evropska agencija za zdravila je zaključila, da je zdravilo Oslif Breezhaler dokazano učinkovito pri izboljševanju delovanja pljuč pri KOPB.
The active substance in Oslif Breezhaler, indacaterol, is a beta-2 adrenergic receptor agonist. 
Zdravilna učinkovina v zdravilu Oslif Breezhaler, indakaterol, je agonist adrenergičnih receptorjev beta2.
For practical information about using Oslif Breezhaler, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Oslif Breezhaler naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
For the full list of all side effects and restrictions with Oslif Breezhaler, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Oslif Breezhaler glejte navodilo za uporabo.
When Oslif Breezhaler is inhaled, indacaterol reaches the receptors in the airways and activates them. 
Ko bolnik vdihne zdravilo Oslif Breezhaler, indakaterol doseže receptorje v dihalnih poteh in jih aktivira.
Other information about Oslif Breezhaler 
Druge informacije o zdravilu Oslif Breezhaler
What is Oslif Breezhaler and what is it used for? 
Kaj je zdravilo Oslif Breezhaler in za kaj se uporablja?
What benefits of Oslif Breezhaler have been shown in studies? 
Kakšne koristi je zdravilo Oslif Breezhaler izkazalo v študijah?
What are the risks associated with Oslif Breezhaler? 
Kakšna tveganja so povezana z zdravilom Oslif Breezhaler?
Oslif Breezhaler was more effective than placebo at improving how well the lungs work in patients with COPD. 
Zdravilo Oslif Breezhaler je bilo pri izboljšanju delovanja pljuč bolnikov s KOPB učinkovitejše od placeba.
Why is Oslif Breezhaler approved? 
Zakaj je bilo zdravilo Oslif Breezhaler odobreno?
It is not intended to provide practical advice on how to use Oslif Breezhaler. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
How is Oslif Breezhaler used? 
Kako se zdravilo Oslif Breezhaler uporablja?
How does Oslif Breezhaler work? 
Kako zdravilo Oslif Breezhaler deluje?
The full European Public Assessment Report for Ceprotin 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 Ceprotin je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
As the CHMP was evaluating the initial documentation provided by the company, it had not yet made any recommendations. 
Ker je CHMP ocenjeval začetno dokumentacijo, ki jo je predložila družba, še ni podal nobenih priporočil.
There are no consequences on the use of Ceprotin in its authorised indication. 
Umik nima nobenih posledic za uporabo zdravila Ceprotin pri odobreni indikaciji.
Results from a retrospective study based on medical records of 94 children with congenital or acquired protein C deficiency were also provided. 
Prav tako je predložil rezultate retrospektivne študije, ki je temeljila na zdravstvenih kartotekah 94 otrok s prirojenim ali pridobljenim pomanjkanjem proteina C.
The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes. 
Družba je odbor CHMP obvestila, da zavrnitev nima nobenih posledic za bolnike v kliničnih preskušanjih ali programih sočutne uporabe.
The application was withdrawn while CHMP was still evaluating the initial documentation provided by the company. 
Vlogo so umaknili, medtem ko je odbor CHMP še vedno ocenjeval začetno dokumentacijo, ki jo je predložila družba.
On 22 October 2014, Baxter AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Ceprotin to treat acquired protein C deficiency. 
Predlagatelj, družba Baxter AG, je dne 22. oktobra 2014 uradno obvestil Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za novo indikacijo za zdravilo Ceprotin za zdravljenje pridobljenega pomanjkanja proteina C.
Ceprotin contains the active substance human protein C. It has been authorised in the EU since July 
Zdravilo Ceprotin vsebuje zdravilno učinkovino humani protein C. V EU je odobreno od julija 2001.
In its letter notifying the Agency of the withdrawal of application, the company stated that it withdrew the application because in its preliminary assessment the CHMP was requesting additional clinical data to support the claim that Ceprotin is also effective in patients with acquired protein C deficiency. 
Družba je v dopisu, s katerim Agencijo obvešča o umiku vloge, navedla, da je vlogo umaknila zato, ker je odbor CHMP v predhodni oceni zahteval dodatne klinične podatke, ki bi podprli trditev, da je zdravilo Ceprotin učinkovito tudi pri bolnikih s pridobljenim pomanjkanjem proteina C.
The applicant presented data from 2 main studies involving a total of 52 children with protein C deficiency due to severe infection, where Ceprotin was compared with placebo (a dummy treatment). 
Predlagatelj je predložil podatke iz dveh glavnih študij, v katerih je sodelovalo skupno 52 otrok s pomanjkanjem proteina C zaradi hude okužbe in v katerih so zdravilo Ceprotin primerjali s placebom (zdravilom brez zdravilne učinkovine).
Ceprotin contains human protein C, extracted and purified from human plasma (the liquid part of the blood). 
Zdravilo Ceprotin vsebuje humani protein C, ki je bil pridobljen in prečiščen iz človeške plazme (tekočega dela krvi).
What is Ceprotin? 
Kaj je zdravilo Ceprotin?
What was Ceprotin expected to be used for? 
Za kaj naj bi se zdravilo Ceprotin uporabljalo?
In the body, protein C controls the generation of thrombin, one of the proteins involved in blood clotting. 
Protein C v telesu nadzoruje nastajanje trombina, tj. ene od beljakovin, ki sodelujejo pri strjevanju krvi.
Protein C slows down the production of thrombin, and therefore slows down clotting. 
Protein C upočasni nastajanje trombina in tako upočasni strjevanje krvi.
An injection of Ceprotin produces an immediate but temporary increase in levels of protein C, controlling clotting problems in protein C-deficient patients. 
Injekcija zdravila Ceprotin takoj, vendar le za kratek čas zviša ravni proteina C, s čimer pomaga nadzorovati težave s strjevanjem krvi pri bolnikih s pomanjkanjem proteina C.
What is happening with Ceprotin for the treatment of patients with severe congenital protein C deficiency? 
Kakšne so posledice za zdravilo Ceprotin, indicirano za zdravljenje hudega prirojenega pomanjkanja proteina C?
How is Ceprotin expected to work? 
Kako naj bi zdravilo Ceprotin delovalo?
‘Acquired' means that the disease is not inherited but develops during the patient's life and may occur for different reasons such as severe infection, liver disease or vitamin K deficiency. 
Zdravilo Ceprotin naj bi se uporabljalo tudi pri bolnikih s „pridobljenim“ pomanjkanjem proteina C. „Pridobljeno“ pomeni, da bolezen ni dedna, ampak se pri bolniku razvije kasneje v življenju in se lahko pojavi zaradi različnih razlogov, kot so huda okužba, bolezen jeter ali pomanjkanje vitamina K.
Ceprotin is a medicine that is used to treat patients with severe congenital (hereditary) protein C deficiency and for the short-term prevention of blood clotting in patients with severe congenital protein C deficiency. 
Ceprotin je zdravilo, ki se uporablja za zdravljenje bolnikov s hudim prirojenim (dednim) pomanjkanjem proteina C in za kratkotrajno preprečevanje strjevanja krvi pri bolnikih s hudim prirojenim pomanjkanjem proteina C. Podrobne informacije o odobreni uporabi zdravila Ceprotin v Evropski uniji (EU) so na voljo tukaj.
Pack size syringes (multipack) 
6 (3 x 2) napolnjenih injekcijskih peresnikov (skupno pakiranje)
1 pre-filled pen pens (multipack) 
1 napolnjen injekcijski peresnik
EU-Number 
Številka EU
Invented name Strength Pharmaceutical Form Route of administration Packaging Content (concentration) Package size 
zaščiteno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija)
Your body's response to Repaglinide Accord may change if you take other medicines, especially these: 
Odziv na zdravilo Repaglinide Accord se lahko spremeni, če jemljete še druga zdravila, še posebej:
This depolarises the β-cell and leads to an opening of the calcium channels. 
To depolarizira celico  in povzroči odprtje kalcijevih kanalov.
30 tablets 90 tablets 120 tablets 180 tablets 270 tablets 
30 tablet 90 tablet 120 tablet 180 tablet 270 tablet
• If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent) and even death. 
• Dolgotrajna nezdravljena huda hipoglikemija lahko povzroči (prehodno ali trajno) okvaro možganov in celo smrt.
100 tablets in a HDPE bottle. 
100 tablet v HDPE steklenici.
Repaglinide Accord may not be suitable for you. 
Zdravljenje z zdravilom Repaglinide Accord pri vas morda ni primerno.
Date of latest renewal: 19th September 2016 
Datum prve odobritve: 22. december2011 Datum zadnjega podaljšanja: 19. september 2016
• If you take other medicines or suffer from liver or kidney problems (see other sections of 2. 
• če uporabljate druga zdravila ali imate težave z jetri ali ledvicami (glejte ostale dele poglavja
Immune system disorders Allergic reactions* 
Bolezni imunskega sistema alergijske reakcije*
Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%). 
Za farmakokinetiko repaglinida je značilna 63 % povprečna absolutna biološka uporabnost (CV 11 %).
This leaflet was last revised in. 
Navodilo je bilo nazadnje revidirano:
No clinical studies have been conducted in patients >75 years of age. 
Klinične študije pri bolnikih, starejših od 75 let, niso bile izvedene.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije o tem zdravilu so dosegljive na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
The amount of Repaglinide Accord, food or exercise may need to be adjusted. 
Morda bo treba prilagoditi odmerek zdravila Repaglinide Accord, količino zaužite hrane ali stopnjo telesne dejavnosti.
What Repaglinide Accord is and what it is used for What you need to know before you take Repaglinide Accord How to take Repaglinide Accord Possible side effects 
Kaj je zdravilo Repaglinide Accord in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Repaglinide Accord Kako jemati zdravilo Repaglinide Accord Možni neželeni učinki
• If you are allergic to repaglinide or any of the other ingredients in this medicine (listed in section 
• ste alergični na repaglinid ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
What Repaglinide Accord is and what it is used for 
Kaj je zdravilo Repaglinide Accord in za kaj ga uporabljamo
Do not take more Repaglinide Accord than your doctor has recommended. 
Ne jemljite večjega odmerka zdravila Repaglinide Accord, kot vam ga je predpisal zdravnik.
What you need to know before you take Repaglinide Accord). 
Kaj morate vedeti, preden boste vzeli zdravilo Repaglinide Accord).
• Oral contraceptives (birth control pills) 
• peroralne kontraceptive (tablete za nadzorovanje rojstev),
4.7 Effects on ability to drive and use machines Repaglinide Accord has no direct influence on the ability to drive and use machines but may cause hypoglycaemia. 
Zdravilo Repaglinide Accord nima neposrednega vpliva na sposobnost vožnje in upravljanja s stroji, vendar pa lahko povzroči hipoglikemijo.
Type 2 diabetes is a disease in which your pancreas does not make enough insulin to control the sugar in your blood or where your body does not respond normally to the insulin it produces. 
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka (pankreas) ne tvori dovolj insulina, da bi uravnal koncentracijo sladkorja v krvi ali pa se telo ne odziva normalno na insulin, ki ga sam proizvaja.
• If you have an infection or a fever 
• če imate okužbo ali zvišano telesno temperaturo,
• Hypersensitivity to repaglinide or to any of the excipients listed in section 6.1. 
• Preobčutljivost za repaglinid ali katero koli pomožno snov navedeno v poglavju 6.1.
The most frequent side effect is hypoglycaemia which may affect up to 1 in 10 patients (see If you get a hypo in section 2). 
Hipoglikemija je najpogostejši neželeni učinek, ki se lahko pojavi pri največ 1 od 10 bolnikov (glejte odstavek V primeru pojava hipe v poglavju 2).
North Harrow, Middx HA1 4HF United Kingdom 
North Harrow, Middlesex HA1 4HF Velika Britanija