natgillin/translations-raw huggingface dataset:
The proposal of the applicant/MAH to include five pharmacovigilance safety concerns in the Risk Management Plan is endorsed (two relate specifically to the unique Vantas formulation while the other three are classified as class effects: expulsions, cellulitis, flare, osteoporosis and QT prolongation). 
Sprejet je bil predlog vlagatelja/imetnika dovoljenja za promet z zdravilom, da v načrt za obvladovanje tveganja vključi pet vprašanj o varnosti z vidika farmakovigilance (dve se nanašata zlasti na edinstveno formulacijo zdravila Vantas, medtem ko ostala tri spadajo med učinke razreda: izključitve, celulitis, začetni dvig koncentracije testosterona (flare), osteoporoza in podaljšanje QT intervala).
The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure. 
Veljavni Povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so zadnje različice, ki so bile pripravljene v postopku koordinacijske skupine.
The achievement of castrate levels of testosterone is an acceptable surrogate endpoint in hormone sensitive advanced prostate cancer which can be translated into less pain from bone metastases, improvement in urinary flow, and in some cases slowing of tumour progression, although a clear-cut survival benefit has not been demonstrated. 
Doseganje ravni testosterona, ki so enake kot po kastraciji, je sprejemljiva nadomestna končna točka pri zdravljenju na hormone občutljivega raka prostate v naprednem stadiju in ki se lahko izrazi kot manj bolečin zaradi kostnih metastaz, izboljšanje pretoka urina in v nekaterih primerih tudi upočasnitev napredovanja tumorja, čeprav jasnega izboljšanja stopnje preživetja ni bilo mogoče dokazati.
The safety database seems limited, but no unexpected safety issues have occurred nor in the American post marketing surveillance neither in the trials. 
Zbirka podatkov o varnosti je na prvi pogled omejena, vendar pa niti nadzor po uvedbi zdravila na trg v Ameriki niti preizkušanja niso razkrila nobenih nepričakovanih varnostnih zadržkov.
The CHMP has recommended the granting of the Marketing Authorisation for which the Summary of Product Characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure as mentioned in Annex III for Vantas. 
CHMP je priporočil odobritev dovoljenja za promet z zdravilom, za katerega so bile končne različice Povzetka glavnih značilnosti zdravila, označevanja in Navodila za uporabo dosežene med postopkom koordinacijske skupine, kot je omenjeno v Dodatku III za zdravilo Vantas.
For the last two decades, injection of long-acting luteinizing hormone-releasing hormone agonists (LH-RHas) has been used to achieve androgen ablation. 
V zadnjih dveh desetletjih so ablacijo moškega spolnega hormona dosegali z vbrizgavanjem dolgo delujočih agonistov hormona za sproščanje luteinizirajočega hormona (LH-RHa-ji).
The data from the Long Term Extension Study 301 concerning efficacy and safety are in support for both long-term efficacy and safety for patients, receiving palliative treatment of advanced prostate cancer with histrelin implant for two or more years. 
Podatki dolgotrajnega podaljška študije 301, ki se nanašajo na učinkovitost in varnost, podpirajo tako dolgotrajno učinkovitost kot varnost pri bolnikih, ki prejemajo paliativno zdravljenje raka prostate v napredovalem stadiju s histrelinskimi vsadki že dve leti ali dlje.
The CHMP requests the inclusion, as proposed by the Applicant/MAH, of the five pharmacovigilance safety concerns in the Risk Management Plan as mentioned above. 
CHMP zahteva vključitev petih vprašanj varnosti z vidika farmakovigilance v načrt za obvladovanje tveganja, kot je predlagal vlagatelj/imetnik dovoljenja za promet z zdravilom in kot so opisana zgoraj.
The data of the Long Term Extension of Study 301 support long-term safety for patients treated with Vantas for two or more years. 
Podatki iz dolgotrajnega podaljška študije 301 govorijo v prid varnosti na dolgi rok pri bolnikih, ki se z zdravilom Vantas zdravijo že dve leti ali dlje.
ANNEX III SUMMARY OF PRODUCT CHARACHTERITICS, LABELLING AND PACKAGE LEAFLET 
DODATEK III POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJE IN NAVODILO ZA UPORABO
Late in the clinical course, it is androgen independent, and is refractory to hormonal therapy. 
Kasneje v kliničnem poteku postane pri svojem razvoju neodvisen od androgena in neodziven na hormonsko zdravljenje.
The safety of androgen suppression is well known and further information is not necessary for this product. 
Varnost supresije moškega spolnega hormona je dobro znana, tako da nadaljnje informacije o varnosti zdravila niso potrebne.
Another LHRH agonist could be used, but this is superfluous considering the meta-analysis presented by Applicant, orchidectomy is not acceptable when reversible methods are available, DES is obsolete and non-steroidal anti-androgens may have inferior efficacy when used as monotherapy. 
Orhidektomija ni sprejemljiva, če so na voljo reverzibilne metode, metoda z DES je zastarela, nesteroidni antiandrogen pa je lahko manj učinkovit, če se ga uporablja kot monoterapijo.
However, even in the androgenindependent state, prostate cancer is likely to contain subpopulations of cells that are androgen dependent. 
Vendar pa rak prostate tudi v stadiju, ko je neodvisen od moškega spolnega hormona, po vsej verjetnosti vsebuje podskupine celic, ki ostajajo odvisne od tega hormona.
United Kingdom 
Združeno kraljestvo (Velika Britanija)
Early in its natural cycle, prostate cancer is androgen dependent. 
V svojih zgodnjih stadijih je rak prostate odvisen od androgena, moškega spolnega hormona.
Furthermore, reduction of testosterone to castrate levels has been accepted as a valid surrogate for clinical efficacy in advanced prostate cancer by the CHMP in 2004 as part of scientific advice from the SAWP. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je poleg tega po znanstvenem priporočilu Delovne skupine za znanstveno svetovanje (SAWP) sprejel zmanjšanje ravni testosterona na enake kot pri kastriranih osebah za veljaven nadomestek za klinično učinkovitost pri napredovalem stadiju raka prostate.
On the basis of these limited data, continued androgen suppression in men with androgenindependent prostate cancer (AIPC) is the current standard of care. 
Na osnovi teh omejenih podatkov je trenutno veljaven standard zdravljenja pri raku prostate, ki ni odvisen od moškega spolnega hormona, neprekinjena supresija moškega spolnega hormona.
Member State 
Predlagatelj
Annex I List of the names, pharmaceutical form, strength of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States 
Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila,
In addition, 81% of these bleeding episodes required only a single treatment with Advate. 
Poleg tega je 81 % od omenjenih epizod krvavitev zahtevalo le eno zdravljenje z zdravilom Advate.
Hypersensitivity (allergic) reactions have been reported and may in some cases become severe. 
Poročali so o preobčutljivostnih (alergijskih) reakcijah, ki lahko v nekaterih primerih postanejo hude.
The European Commission granted a marketing authorisation valid throughout the EU for Advate on 2 March 2004. 
Evropska komisija je dovoljenje za promet z zdravilom Advate, veljavno po vsej Evropski uniji, izdala 2. marca 2004.
Advate is intended for either short-term or long-term use. 
Zdravilo Advate je namenjeno za kratkotrajno ali dolgotrajno uporabo.
The effectiveness of Advate was rated as ‘excellent' or ‘good' in 86% of 510 new bleeding episodes. 
Učinkovitost zdravila Advate je bila ocenjena kot „odlična“ ali „dobra“ v 86 % od 510 novih epizod krvavitev.
What measures are being taken to ensure the safe and effective use of Advate? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Advate?
The full EPAR for Advate 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 Advate je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Other information about Advate 
Druge informacije o zdravilu Advate
The additional studies confirmed Advate's effectiveness, including in children under 6 years of age. 
Dodatne študije so potrdile učinkovitost zdravila Advate tudi pri otrocih, mlajših od 6 let.
This is a summary of the European public assessment report (EPAR) for Advate. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Advate.
Advate is similar to another medicine approved in the EU called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine. 
Zdravilo Advate je podobno drugemu zdravilu, ki je že odobreno v EU, imenovanemu Recombinate, vendar je pripravljeno na drugačen način, tako da v zdravilu ni nobenih beljakovin humanega ali živalskega izvora.
It is not intended to provide practical advice on how to use Advate. 
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
The Agency decided that Advate's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Agencija je sklenila, da so koristi zdravila Advate večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
What are the risks associated with Advate? 
Kakšna tveganja so povezana z zdravilom Advate?
Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of 6 years. 
V treh dodatnih študijah so proučevali uporabo zdravila pri preprečevanju krvavitev in med kirurškim posegom pri bolnikih s hudo ali zmerno hudo hemofilijo A, vključno z eno študijo pri 53 otrocih, mlajših od 6 let.
The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use. 
Predloženi podatki o indukciji imunske tolerance pri bolnikih z zaviralci niso bili zadostni za odobritev zdravila za to specifično uporabo.
What benefits of Advate have been shown in studies? 
Kakšne koristi je zdravilo Advate izkazalo v študijah?
Patients or their carers may be able to administer Advate themselves at home once they have been trained appropriately. 
Bolniki ali njihovi negovalci lahko po ustreznem usposabljanju zdravilo Advate dajejo sami doma.
Why is Advate approved? 
Zakaj je bilo zdravilo Advate odobreno?
The dose and duration of treatment depend on whether Advate is used to treat or prevent bleeding or during surgery, as well as on the patient's factor VIII levels, the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition and bodyweight. 
Odmerek in trajanje zdravljenja sta odvisna od tega, ali se zdravilo uporablja za zdravljenje ali preprečevanje krvavitev ali med kirurškim posegom, ter od ravni faktorja VIII, resnosti hemofilije, obsega in mesta krvavitve ter bolnikovega stanja in telesne mase.
Octocog alfa is made by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce it. 
Proizvaja se z metodo, imenovano „tehnologija rekombinantne DNK“, pri kateri ga izdelajo celice, ki so prejele gen (DNK), kar jim omogoča njegovo tvorjenje.
Advate octocog alfa 
Oktokog alfa
For more information about treatment with Advate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Advate preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Advate 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 Advate upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
The Agency concluded that Advate has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile. 
Zaključila je, da se je zdravilo Advate izkazalo za učinkovito pri zdravljenju in preprečevanju krvavitev pri bolnikih s hemofilijo A in ima sprejemljiv varnostni profil.
Common side effects with Advate (affecting between 1 and 10 patients in 100) are headache and pyrexia (fever). 
Pogosta neželena učinka zdravila Advate (ki se lahko pojavita pri 1 do 10 bolnikih od 100) sta glavobol in pireksija (povišana telesna temperatura).
For practical information about using Advate, patients should read the package leaflet or contact their doctor or pharmacist. 
Za praktične informacije o uporabi zdravila Advate naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients. 
Zdravila Advate ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) humani koagulacijski faktor VIII, mišje ali hrčkove beljakovine ali katero koli drugo sestavino zdravila.
What is Advate and what is it used for? 
Kaj je zdravilo Advate in za kaj se uporablja?
Patients with haemophilia A lack factor VIII, and this causes blood clotting problems, such as bleeding in the joints, muscles or internal organs. 
Bolnikom s hemofilijo A primanjkuje faktorja VIII, kar povzroča težave s strjevanjem krvi, kot so krvavitve v sklepe, mišice ali notranje organe.
Advate is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). 
Advate je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih vseh starosti s hemofilijo A (dedno motnjo strjevanja krvi, ki jo povzroča pomanjkanje faktorja VIII).
Advate is available as a powder and solvent that are mixed together to make a solution for injection into a vein. 
Zdravilo Advate je na voljo v obliki praška in vehikla, ki se zmešata za pripravo raztopine za injiciranje v veno.
The active substance in Advate, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot. 
Zdravilna učinkovina zdravila Advate, oktokog alfa (humani koagulacijski faktor VIII), je snov, ki pomaga pri strjevanju krvi.
For the full list of all side effects reported with Advate, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Advate, glejte navodilo za uporabo.
Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A. 
Da bi ugotovili, ali sta zdravili Advate in Recombinate enakovredni, so ju primerjali v eni glavni študiji, v katero je bilo vključenih 111 bolnikov s hemofilijo A.
Advate is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder. 
Zdravilo Advate se uporablja za odpravo pomanjkanja faktorja VIII z nadomeščanjem manjkajočega faktorja VIII, kar zagotovi začasno obvladovanje motnje strjevanja krvi.
It contains the active substance octocog alfa (human coagulation factor VIII). 
Zdravilo vsebuje zdravilno učinkovino oktokog alfa (humani koagulacijski faktor VIII).
Advate can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia and with resuscitation equipment available in case of severe allergic reaction (anaphylaxis). 
Predpisovanje in izdaja zdravila Advate je le na recept, zdravljenje z njim pa mora uvesti zdravnik z izkušnjami z zdravljenjem hemofilije, ki ima na razpolago opremo za oživljanje v primeru resne alergijske reakcije (anafilaksije).
Advate given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective. 
Proučevali so, ali je zdravilo Advate, dano v velikih odmerkih, učinkovito pri odstranjevanju protiteles proti faktorju VIII iz krvi (postopek, znan kot indukcija imunske tolerance), tako da zdravljenje s faktorjem VIII ostane učinkovito.
How is Advate used? 
Kako se zdravilo Advate uporablja?
Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control. 
Pri nekaterih bolnikih se lahko pojavijo zaviralci faktorja VIII, tj. protitelesa (beljakovine), ki jih proizvede imunski sistem proti faktorju VIII in lahko izničijo delovanje zdravila in tako povzročijo izgubo nadzora nad krvavitvijo.
There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control. 
Pri zdravilih s faktorjem VIII obstaja tveganje, da se bodo pri nekaterih bolnikih pojavili zaviralci (protitelesa) faktorja VIII, ki bodo izničili delovanje zdravila ter tako povzročili izgubo nadzora nad krvavitvijo.
The study went on to look at the number of bleeding episodes and rated Advate's effectiveness in stopping bleeding on a scale from ‘none' to ‘excellent' in 107 patients, all of whom received Advate. 
V študiji so pri 107 bolnikih, ki so prejemali zdravilo Advate, proučevali tudi število epizod krvavitev in ocenili učinkovitost zdravila Advate pri prekinitvi krvavitve na lestvici od „brez“ do „odlična“.
For full details, see the package leaflet. 
Za več informacij glejte navodilo za uporabo.
• Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure). 
• Opozorilo o uporabi pri starejših glede na s starostjo povezana tveganja (zlasti za rak mehurja, zlome in srčno popuščanje).
Date of first authorisation: 16 November 2015 
Datum prve odobritve: 16. november 2015
Subjects with mean daily insulin dose reduction of at least 10% (%) 
Preiskovanci z znižanjem povprečnega dnevnega odmerka insulina za vsaj 10 % (%)
All randomised patients who took at least one dose of double-blind study medicinal product during the short-term double-blind period. 
Vsi randomizirani bolniki, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem.
Bristol-Myers Squibb Company Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy 
Bristol-Myers Squibb Company Contrada Fontana delCeraso IT-03012 Anagni (FR) Italija
More information is given below under ‘Other medicines and Ebymect'. 
Več informacij najdete v poglavju "Druga zdravila in zdravilo Ebymect", spodaj.
The safety and efficacy of Ebymect in patients with type 1 diabetes have not been established and Ebymect should not be used for treatment of patients with type 1 diabetes. 
Varnost in učinkovitost zdravila Ebymect pri bolnikih s sladkorno boleznijo tipa 1 nista ugotovljeni in zdravila Ebymect se ne sme uporabljati za zdravljenje takšnih bolnikov.
Treatment with dapagliflozin may be restarted when the ketone values are normal and the patient's condition has stabilised. 
Zdravljenje z zdravilom Ebymect je mogoče znova uvesti, ko so vrednosti ketonov normalne in se bolnikovo stanje stabilizira.
To avoid overdose, do not continue taking dapagliflozin and metformin tablets, if you are taking Ebymect. 
Da boste preprečili preveliko odmerjanje, ne nadaljujte jemanja tablet dapagliflozina in metformina, če jemljete zdravilo Ebymect.
If Fournier's gangrene is suspected, Ebymect should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted. 
Če obstaja sum na Fournierjevo gangreno, je treba zdravilo Ebymect ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes. 
Metformin Prospektivna randomizirana študija (UKPDS) je ugotovila dolgoročne koristi intenzivnega obvladovanja glukoze v krvi pri sladkorni bolezni tipa 2.
• At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
Posodobljen RMP je treba predložiti: na zahtevo Evropske agencije za zdravila; ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Patients should be alerted to the risk of hypoglycaemia when this medicinal product is used in combination with other glucoselowering medicinal products known to cause hypoglycaemia. 
Bolnike je treba opozoriti na tveganje za hipoglikemijo, če je to zdravilo uporabljeno v kombinaciji z drugimi antidiabetiki za katere je znano, da povzročajo hipoglikemijo.
This may be another medicine taken by mouth and/or a medicine given by injection, such as insulin or a GLP-1 receptor agonist (helps your body to increase the production of insulin when your blood sugar is high). 
To je lahko neko drugo zdravilo, ki ga zaužijete, ali ga dobite z injekcijo, kot na primer insulin ali agonist receptorjev GLP-1 (pomaga telesu, da lahko poveča tvorbo insulina, kadar so vrednosti krvnega sladkorja visoke).
• Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) Ebymect may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”). 
• Laktacidoza, ki se pojavi zelo redko (pojavi se lahko pri največ 1 od 10.000 bolnikov) Zdravilo Ebymect lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Opozorila in previdnostni ukrepi").
For patients insufficiently controlled on metformin monotherapy or metformin in combination with other medicinal products for the treatment of diabetes 
Bolniki, ki niso zadostno urejeni z metforminom v monoterapiji ali metforminom v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni
Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and nonsteroidal anti-inflammatory drugs [NSAIDs]) should be initiated with caution in metformin-treated patients. 
Zdravila, ki lahko akutno okvarijo delovanje ledvic (kot so antihipertenzivi, diuretiki in nesteroidna protivnetna zdravila), je treba pri bolnikih, ki se zdravijo z metforminom, uvesti previdno.
Ebymect has no or negligible influence on the ability to drive and use machines. 
Zdravilo Ebymect nima vpliva ali ima le zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Ebymect is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise: 
Zdravilo Ebymect je indicirano pri odraslih za zdravljenje sladkorne bolezni tipa 2 kot dodatek dieti in telesni dejavnosti:
At 1 year, mean eGFR was slightly lower, and at 4 years, mean eGFR was slightly higher in the dapagliflozin group compared with the placebo group. 
1 letu je bil eGFR v skupini z dapagliflozinom rahlo nižji, po 4 letih pa rahlo višji v primerjavi s skupino s placebom.