FrancophonIA/ELRC3.0 huggingface dataset:
English: Avalox is indicated for the treatment of: - Community acquired pneumonia (CAP) - Complicated skin and skin structure infections (cSSSI) Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Slovenian: Moksifloksacin se lahko uporablja le, ko uporaba protibakterijskih učinkovin, ki se navadno priporočajo za začetno zdravljenje teh okužb, ni primerna.
English: Treatment of cSSI
Slovenian: Interakcije z zdravili
English: Local reactions may increase slightly following the second dose, in this case lasting up to 15 days.
Slovenian: Lokalne reakcije so lahko pogostejše po drugem odmerku, v tem primeru pa lahko trajajo do 15 dni.
English: Cattle may show a temporary increase in body temperature (no more than 2.7 °C) in the 48 hours following vaccination.
Slovenian: Do 48 ur po cepljenju se lahko pri govedu pojavi prehodno povišanje telesne temperature (ki ne presega 2,7 °C).
English: Local reactions at the injection site are common and normally resolve within 4 weeks.
Slovenian: Na mestu injiciranja se pogosto pojavijo lokalne reakcije, ki običajno izzvenijo v štirih tednih.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Slovenian: Karenca je časovno obdobje, ki mora preteči po uporabi zdravila, preden se lahko žival zakolje in meso ali mleko uporabi za prehrano ljudi.
English: The vaccine is used to prevent viraemia (the presence of viruses in the blood) in cattle from three months of age.
Slovenian: Cepivo se uporablja za preprečevanje viremije (prisotnosti virusa v krvi) pri govedu, starejšemu od treh mesecev.
English: In 2013 the CVMP considered that the submitted data were adequate for the authorisation of Zulvac 1+8 Bovis to convert to a normal status.
Slovenian: Leta 2013 je CVMP menil, da predloženi podatki zadostujejo, da dovoljenje za promet s cepivom Zulvac 1+8 Bovis pridobi običajen status.
English: Another laboratory study in cattle looked at how long the vaccine was able to protect against bluetongue infection.
Slovenian: V dodatni laboratorijski študiji pri govedu so preučevali, kako dolgo je cepivo ščitilo pred okužbo z virusom modrikastega jezika.
English: Zulvac 1+8 Bovis was studied in calves in four main studies carried out in a laboratory.
Slovenian: Zdravilo Zulvac 1+8 Bovis je bilo raziskano pri teletih v štirih glavnih študijah, ki so bile opravljene v laboratoriju.
English: Zulvac 1+8 Bovis was initially authorised under ‘exceptional circumstances'.
Slovenian: Cepivo Zulvac 1+8 Bovis je prvotno pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: The studies looked at the strength of vaccine required to protect against bluetongue infection, and at the safety of the vaccine.
Slovenian: V študijah so preučevali jakost cepiva, ki je potrebna za zaščito pred okužbo z virusom modrikastega jezika, in njegovo varnost.
English: A field study was also conducted investigating the safety of the vaccine in dairy cows, including pregnant and lactating cows.
Slovenian: Izvedena je bila tudi terenska študija, v kateri so proučevali varnost cepiva pri kravah molznicah, vključno z brejimi kravami in kravami v obdobju laktacije.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zulvac 1+8 Bovis on 08/03/2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zulvac 1+8 Bovis, veljavno po vsej Evropski uniji, odobrila dne 8. marca 2012.
English: The studies showed that the vaccine is safe and that it prevents viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age.
Slovenian: Študije so pokazale, da je cepivo varno za uporabo in da preprečuje viremijo pri govedu, starejšemu od treh mesecev, ki jo povzročata serotipa 1 in 8 virusa bolezni modrikastega jezika.
English: The CVMP concluded that the benefits of Zulvac 1+8 Bovis exceed the risks for prevention of viraemia caused by bluetongue virus serotypes 1 and 8 in cattle from three months of age and recommended that Zulvac 1+8 Bovis be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Zulvac 1+8 Bovis za preprečevanje viremije, ki jo povzročata serotipa 1 in 8 virusa bolezni modrikastega jezika, pri govedu, starejšemu od treh mesecev, večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Other information about Zulvac 1+8 Bovis:
Slovenian: Druge informacije o zdravilu Zulvac 1+8 Bovis:
English: immune system recognises the viruses as ‘foreign' and makes antibodies against them.
Slovenian: Ko govedo prejme cepivo, imunski sistem viruse prepozna kot „tujke“ in proti njim razvije protitelesa.
English: Zulvac 1+8 Bovis is a vaccine.
Slovenian: Zdravilo Zulvac 1+8 Bovis je cepivo.
English: The field study showed that the vaccine can be used safely in pregnant and lactating cows.
Slovenian: Terenske študije so pokazale tudi, da se cepivo lahko uporablja pri brejih kravah in kravah v obdobju laktacije.
English: What benefit has Zulvac 1+8 Bovis shown during the studies?
Slovenian: Kakšne koristi je zdravilo Zulvac 1+8 Bovis izkazalo med študijami?
English: The withdrawal period for Zulvac 1 + 8 Bovis for meat and milk is zero days.
Slovenian: Karenca za cepivo Zulvac 1+8 Bovis za meso in mleko je nič dni.
English: Zulvac 1+8 Bovis is used in cattle to protect them against bluetongue disease, an infection caused by the bluetongue virus which is transmitted by midges.
Slovenian: Cepivo Zulvac 1+8 Bovis se uporablja pri govedu za zaščito pred boleznijo modrikastega jezika, tj. okužbo, ki jo povzroča virus bolezni modrikastega jezika, prenašajo pa jo trzače.
English: Zulvac 1+8 Bovis contains bluetongue viruses that have been inactivated so that they cannot cause the disease.
Slovenian: Cepivo Zulvac 1+8 Bovis vsebuje inaktivirane viruse bolezni modrikastega jezika, ki ne povzročajo bolezni.
English: Zulvac 1+8 Bovis is a vaccine that contains inactivated (killed) bluetongue serotypes 1 and 8 viruses as the active substance.
Slovenian: Zdravilo Zulvac 1+8 Bovis je cepivo, ki kot zdravilno učinkovino vsebuje inaktivirana (uničena) serotipa 1 in 8 virusa bolezni modrikastega jezika.
English: What is the risk associated with Zulvac 1+8 Bovis?
Slovenian: Kakšna tveganja so povezana z zdravilom Zulvac 1+8 Bovis?
English: Why has Zulvac 1+8 Bovis been approved?
Slovenian: Zakaj je bilo zdravilo Zulvac 1+8 Bovis odobreno?
English: Inactivated adjuvanted vaccine against bluetongue disease virus, serotypes 1 and 8
Slovenian: Zulvac 1+8 Bovis inaktivirano cepivo z adjuvansom proti virusu bolezni modrikastega jezika, serotipa 1 in 8
English: What is Zulvac 1+8 Bovis?
Slovenian: Kaj je zdravilo Zulvac 1+8 Bovis?
English: How has Zulvac 1+8 Bovis been studied?
Slovenian: Kako je bilo zdravilo Zulvac 1+8 Bovis raziskano?
English: The virus exists in several forms (serotypes) throughout the world; the types used in Zulvac 1+8 Bovis are serotypes 1 and 8.
Slovenian: Tipa, uporabljena v cepivu Zulvac 1+8 Bovis, sta serotipa 1 in 8.
English: How does Zulvac 1+8 Bovis work?
Slovenian: Kako zdravilo Zulvac 1+8 Bovis deluje?
English: This means that it was not possible at the time of the initial authorisation to obtain complete information about Zulvac 1+8 Bovis.
Slovenian: To pomeni, da ob prvotni izdaji dovoljenja za promet ni bilo mogoče pridobiti vseh podatkov o njem.
English: What is Zulvac 1+8 Bovis used for?
Slovenian: Za kaj se zdravilo Zulvac 1+8 Bovis uporablja?
English: What is the withdrawal period?
Slovenian: Kaj je karenca?
English: The studies also looked at the number of organ rejections that occurred within one year of the transplant.
Slovenian: V študijah so proučevali tudi število zavrnitev organov, ki so se pojavile v enem letu po presaditvi.
English: Further doses are given at the end of weeks 8 and 12.
Slovenian: Nadaljnji odmerki se dajo ob koncu 8. in 12. tedna po presaditvi.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nulojix on 17 June 2011.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Nulojix, veljavno po vsej Evropski uniji, izdala 17. junija 2011.
English: T cells must be ‘activated' before they work.
Slovenian: Limfociti T morajo biti pred začetkom učinkovanja „aktivirani“.
English: The full EPAR for Nulojix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Nulojix je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: In the initial phase it is given at a dose of 10 mg per kilogram body weight on day 1 (day of transplantation or the day before) and then again on days 5, 14 and 28.
Slovenian: V začetnem obdobju zdravljenja se daje odmerek 10 mg na kilogram telesne mase na 1. dan (dan presaditve ali dan pred presaditvijo) in nato ponovno na 5., 14. in 28. dan.
English: The most common serious side effects of Nulojix seen in more than 2% of patients are: urinary tract infection (infection of the structures that carry urine), cytomegalovirus infection, pyrexia (fever), increased blood creatinine (a marker of kidney problems), pyelonephritis (kidney infection), diarrhoea, gastroenteritis (diarrhoea and vomiting), poor functioning of the transplanted kidney, leucopenia (low white blood cell counts), pneumonia (infection of the lungs), basal cell carcinoma (a cancer), anaemia (low red blood cell counts), dehydration.
Slovenian: Najpogostejši neželeni učinki zdravila Nulojix, opaženi pri več kot 2 % bolnikov, so: okužba sečil (okužba struktur za odvajanje urina), okužba s citomegalovirusom, pireksija (povišana telesna temperatura), povišana vrednost kreatinina v krvi (znak težav z ledvicami), pielonefritis (okužba ledvic), driska, gastroenteritis (driska in bruhanje), slabo delovanje presajene ledvice, levkopenija (nizko število belih krvnih celic), pljučnica (okužba pljuč), bazalnocelični karcinom (rak), anemija (nizko število rdečih krvnih celic) in dehidracija.
English: This is a summary of the European public assessment report (EPAR) for Nulojix.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Nulojix.
English: What measures are being taken to ensure the safe and effective use of Nulojix?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Nulojix?
English: For more information about treatment with Nulojix, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Nulojix preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Other information about Nulojix
Slovenian: Druge informacije o zdravilu Nulojix
English: Doses are calculated using the patient's weight.
Slovenian: Odmerki se izračunajo na podlagi bolnikove telesne mase.
English: It contains the active substance belatacept.
Slovenian: Vsebuje zdravilno učinkovino belatacept.
English: A risk management plan has been developed to ensure that Nulojix is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Nulojix je bil pripravljen načrt obvladovanja tveganj.
English: 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 Nulojix.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z zdravilom in priporočila glede pogojev uporabe zdravila Nulojix.
English: Overall, the benefits of Nulojix compared well with the comparator medicine.
Slovenian: Na splošno so koristi zdravila Nulojix primerljive s koristmi primerjalnega zdravila.
English: Although the studies showed more acute rejections after one year of treatment with Nulojix compared with cyclosporine A, this did not lead to reduced patient and organ survival after three years.
Slovenian: Čeprav so študije pokazale akutnejše zavrnitve organa po enem letu zdravljenja z zdravilom Nulojix v primerjavi s ciklosporinom A, to ni pomenilo manjšega števila preživelih bolnikov in organov po treh letih.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nulojix, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The main measures of effectiveness were the proportion of patients who survived with their transplanted kidneys intact and how well their kidneys functioned.
Slovenian: Glavno merilo učinkovitosti sta bila delež bolnikov, ki so preživeli brez sprememb na presajeni ledvici, in uspešnost delovanja ledvic pri teh bolnikih.
English: In addition, the company that makes Nulojix will include an alert card in each medicine's pack to increase awareness of the benefits and risks with Nulojix.
Slovenian: Poleg tega bo družba, ki izdeluje zdravilo Nulojix, vsaki embalaži zdravila priložila opozorilno kartico o koristih in tveganjih jemanja tega zdravila.
English: It is used with corticosteroids and a mycophenolic acid (other medicines used to prevent organ rejection).
Slovenian: Uporablja se skupaj s kortikosteroidi in mikofenolno kislino (drugimi zdravili za preprečevanje zavrnitve organov).
English: The CHMP therefore concluded that Nulojix's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor je tako zaključil, da so koristi zdravila Nulojix večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: Intensive Nulojix treatment with a longer initial phase of six months produced similar results to treatment with a three-month initial phase.
Slovenian: Intenzivno zdravljenje z zdravilom Nulojix z daljšim začetnim šestmesečnim obdobjem je imelo podobne rezultate kot zdravljenje z začetnim trimesečnim obdobjem.
English: After the initial phase, which lasts three months, Nulojix is given at a maintenance dose of 5 mg/kg every four weeks starting from the end of the week 16.
Slovenian: Po začetnem obdobju, ki traja tri mesece, se zdravilo Nulojix daje z vzdrževalnim odmerkom 5 mg/kg vsake štiri tedne, s pričetkom konec 16. tedna po presaditvi.
English: What benefit has Nulojix shown during the studies?
Slovenian: Kakšne koristi je zdravilo Nulojix izkazalo med študijami?
English: Nulojix must not be used in patients who have not been exposed to the Epstein-Barr virus or in whom previous exposure is uncertain.
Slovenian: Zdravila Nulojix ne smejo uporabljati bolniki, ki še niso bili izpostavljeni virusu Epstein-Barr ali za katere ni znano, ali so bili izpostavljeni temu virusu.
English: Belatacept has been designed to attach to two of these molecules called CD80 and CD86.
Slovenian: Do tega pride, kadar se določene molekule vežejo na receptorje na površini limfocitov T. Belatacept se veže na dve od teh molekul, imenovani CD80 in CD86.
English: In two main studies involving 1,209 patients who underwent a kidney transplant, Nulojix was compared with cyclosporine A (another medicine used to prevent organ rejection).
Slovenian: V dveh glavnih študijah, v katerih je sodelovalo 1 209 bolnikov s presajeno ledvico, so zdravilo Nulojix primerjali s ciklosporinom A (drugim zdravilom, ki se uporablja za preprečevanje zavrnitve organa).
English: The CHMP noted that Nulojix does not have the toxic effects on the kidneys seen with other immunosuppressive medicines commonly used in transplantation.
Slovenian: Odbor CHMP je menil, da zdravilo Nulojix nima toksičnih učinkov na ledvice, opaženih pri uporabi drugih zdravil za zaviranje imunske odzivnosti, ki se običajno uporabljajo pri presaditvah.
English: It suppresses the activity of ‘T cells', immune system cells that can become involved in organ rejection.
Slovenian: Zavira delovanje limfocitov T, tj. celic imunskega sistema, ki lahko vplivajo na zavrnitev organa.
English: Nulojix should only be prescribed and supervised by a doctor who has experience in the management of kidney transplant patients.
Slovenian: Zdravljenje z zdravilom Nulojix lahko predpiše in nadzira le zdravnik, ki ima izkušnje z zdravljenjem bolnikov po presaditvi ledvice.
English: This stops them activating the T cells, helping to prevent organ rejection.
Slovenian: To ustavi aktivacijo limfocitov T in pomaga pri preprečevanju zavrnitve organa.
English: Nulojix is given as an infusion into a vein over 30 minutes.
Slovenian: Zdravilo Nulojix se daje kot infuzija v veno, ki traja 30 minut.
English: In the second study, 89% (155 out of 175) of patients on Nulojix and 85% (157 out 184) of those on cyclosporine A survived with their kidneys intact.
Slovenian: V drugi študiji je 89 % (155 od 175) bolnikov, ki so prejemali zdravilo Nulojix, in 85 % (157 od 184) bolnikov, ki so prejemali ciklosporin A, preživelo brez sprememb na ledvici.
English: Nulojix was shown to improve patient and organ survival following kidney transplantation.
Slovenian: Za zdravilo Nulojix so dokazali, da izboljšuje preživetje bolnikov in organa po presaditvi ledvice.
English: What is the risk associated with Nulojix?
Slovenian: Kakšna tveganja so povezana z zdravilom Nulojix?
English: Some patients were given intensive Nulojix treatment which involved a longer initial phase of six months.
Slovenian: Nekatere bolnike so zdravili z intenzivno terapijo z zdravilom Nulojix, pri kateri je bilo začetno obdobje daljše in je trajalo šest mesecev.
English: This is because patients treated with Nulojix who have had no previous exposure to the virus are at higher risk of getting a type of cancer known as post-transplant lymphoproliferative disorder.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Nulojix in ki predhodno niso bili izpostavljeni temu virusu, namreč obstaja večje tveganje za razvoj raka, imenovanega potransplantacijska limfoproliferativna bolezen.
English: All patients were also treated with corticosteroids, mycophenolic acid, and basiliximab (an interleukin-2 receptor antagonist) during the first week after transplantation.
Slovenian: Vse bolnike so prvi teden po presaditvi zdravili tudi s kortikosteroidi, mikofenolno kislino in baziliksimabom (antagonistom receptorja za interlevkin-2).
English: The proportion of patients who had an episode of organ rejection within one year was 17% for Nulojix and 7% for cyclosporine A.
Slovenian: Delež bolnikov, pri katerih je v enem letu po presaditvi prišlo do zavrnitve organa, je bil pri zdravilu Nulojix 17 %, pri ciklosporinu A pa 7 %.
English: For the full list of all side effects reported with Nulojix, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Nulojix, glejte navodilo za uporabo.
English: Nulojix is used in adults to prevent the body from rejecting a transplanted kidney.
Slovenian: Zdravilo Nulojix se uporablja pri odraslih za preprečevanje zavrnitve ledvice po presaditvi.
English: The active substance in Nulojix, belatacept, is an immunosuppressive medicine.
Slovenian: Zdravilna učinkovina zdravila Nulojix, belatacept, je zdravilo za zaviranje imunske odzivnosti.
English: The proportion of patients with impaired kidney function was 77% in patients on Nulojix and 85% in patients on cyclosporine A. Around 18% of patients on Nulojix had an episode of organ rejection within one year compared with 14% of patients on cyclosporine A.
Slovenian: Delež bolnikov z okvaro ledvice je bil 77 % pri bolnikih, ki so prejemali zdravilo Nujolix, in 85 % pri tistih, ki so prejemali ciklosporin A. Pri okoli 18 % bolnikov, ki so jemali Nulojix, je v enem letu po presaditvi prišlo do epizode zavrnitve organa v primerjavi s 14 % bolnikov, ki so jemali ciklosporin A.
English: Nulojix is a powder that is made up into a solution for infusion (drip into a vein).
Slovenian: Zdravilo Nulojix je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: Why has Nulojix been approved?
Slovenian: Zakaj je bilo zdravilo Nulojix odobreno?
English: An interleukin-2 receptor antagonist medicine should also be used with Nulojix during the first week after the kidney transplant.
Slovenian: V prvem tednu po presaditvi ledvice je treba z zdravilom Nulojix uporabljati še antagonist receptorja za interlevkin-2.
English: In the first study, 97% of patients receiving Nulojix treatment survived with their kidneys intact (218 out of 226) compared with 93% of patients receiving cyclosporine A (206 out 221).
Slovenian: V prvi študiji je 97 % (218 od 226) bolnikov, ki so prejemali zdravilo Nulojix, preživelo brez sprememb na ledvici , v primerjavi s 93 % (206 od 221) bolnikov, ki so prejemali ciklosporin A. Okoli 54 % bolnikov, ki so prejemali zdravilo Nulojix, in 78 % tistih, ki so prejemali ciklosporin A, je imelo okvaro ledvic.
English: How has Nulojix been studied?
Slovenian: Kako je bilo zdravilo Nulojix raziskano?
English: What is Nulojix used for?
Slovenian: Za kaj se zdravilo Nulojix uporablja?
English: How does Nulojix work?
Slovenian: Kako zdravilo Nulojix deluje?
English: How is Nulojix used?
Slovenian: Kako se zdravilo Nulojix uporablja?
English: What is Nulojix?
Slovenian: Kaj je zdravilo Nulojix?
English: After the initial doses, it is usually given once every 8 weeks.
Slovenian: Po začetnih odmerkih se običajno daje enkrat na vsakih osem tednov.
English: This means that it is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Slovenian: To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
English: Further information on Zessly can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Več informacij o zdravilu Zessly je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zessly (infliximab)
Slovenian: Zessly (infliksimab)
English: What measures are being taken to ensure the safe and effective use of Zessly?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zessly?
English: A similar proportion of patients achieved a 20% reduction with the two medicines (around 61.1% with Zessly and 63.5% with Remicade).
Slovenian: Do 20-odstotnega zmanjšanja je prišlo pri podobnem deležu bolnikov pri obeh zdravilih (približno 61,1 % z zdravilom Zessly in 63,5 % z zdravilom Remicade).
English: For Crohn's disease and ulcerative colitis, it is also used in children from 6 years of age.
Slovenian: Pri Crohnovi bolezni in ulceroznem kolitisu se uporablja tudi pri otrocih, starejših od šest let.
English: An overview of Zessly and why it is authorised in the EU
Slovenian: Pregled zdravila Zessly in zakaj je odobreno v EU
English: What benefits of Zessly have been shown in studies?
Slovenian: Kakšne koristi zdravila Zessly so se pokazale v študijah?
English: What is Zessly and what is it used for?
Slovenian: Kaj je zdravilo Zessly in za kaj se uporablja?
English: Why is Zessly authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Zessly odobreno v EU?
English: Zessly is used mainly in adults, usually when other medicines or treatments have failed or cannot be used.
Slovenian: Zdravilo Zessly se uporablja večinoma pri odraslih, običajno takrat, ko druga zdravila ali načini zdravljenja niso bili uspešni oziroma jih ni mogoče uporabiti.
English: What are the risks associated with Zessly?
Slovenian: Kakšna tveganja so povezana z zdravilom Zessly?