FrancophonIA/ELRC3.0 huggingface dataset:
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 Myfenax.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Myfenax, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Because Myfenax is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Myfenax generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so koristi in tveganja enaki kot pri referenčnem zdravilu.
English: Myfenax is a ‘generic medicine'.
Slovenian: Myfenax je „generično zdravilo“.
English: The CHMP concluded that, in accordance with EU requirements, Myfenax has been shown to have comparable quality and to be bioequivalent to CellCept.
Slovenian: CHMP je zaključil, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Myfenax primerljivo raven kakovosti kot zdravilo Cellcept ter da mu je biološko enakovredno.
English: Myfenax treatment should be initiated and maintained by a qualified transplant specialist.
Slovenian: Zdravljenje z zdravilom Myfenax mora uvesti in voditi zdravnik specialist za presaditve.
English: The Committee recommended that Myfenax be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Myfenax odobri dovoljenje za promet.
English: Myfenax is used to prevent the body from rejecting a transplanted kidney, heart or liver.
Slovenian: Zdravilo Myfenax se uporablja za preprečevanje zavrnitve ledvic, srca in jeter po presaditvi.
English: For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to 1.5 g Myfenax twice a day as soon as it can be tolerated.
Slovenian: Pri odraslih bolnikih s presajenimi jetri se mofetilmikofenolat prve štiri dni po presaditvi daje kot infuzija (kapalna infuzija v veno), ko je bolnik sposoben požirati, pa preide na jemanje 1,5 g zdravila Myfenax dvakrat na dan.
English: Myfenax mycophenolate mofetil
Slovenian: Myfenax mofetilmikofenolat
English: Other information about Myfenax
Slovenian: Druge informacije o zdravilu Myfenax:
English: Because Myfenax is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, CellCept.
Slovenian: Ker je zdravilo Myfenax generično zdravilo, so bile študije omejene na preskuse za ugotavljanje, ali je biološko enakovredno referenčnemu zdravilu CellCept.
English: By preventing the production of new DNA, Myfenax reduces the rate at which the lymphocytes multiply.
Slovenian: Zdravilo Myfenax s preprečevanjem tvorbe nove DNK zmanjša hitrost razmnoževanja limfocitov.
English: Myfenax is a medicine containing the active substance mycophenolate mofetil.
Slovenian: Myfenax je zdravilo, ki vsebuje zdravilno učinkovino mofetilmikofenolat.
English: Why has Myfenax been approved?
Slovenian: Zakaj je bilo zdravilo Myfenax odobreno?
English: The active substance in Myfenax, mycophenolate mofetil, is an immunosuppressive medicine.
Slovenian: Zdravilna učinkovina v zdravilu Myfenax, mofetilmikofenolat, je zaviralec imunske odzivnosti.
English: What is Myfenax?
Slovenian: Kaj je zdravilo Myfenax?
English: How has Myfenax been studied?
Slovenian: Kako je bilo zdravilo Myfenax raziskano?
English: What is Myfenax used for?
Slovenian: Za kaj se zdravilo Myfenax uporablja?
English: How does Myfenax work?
Slovenian: Kako zdravilo Myfenax deluje?
English: How is Myfenax used?
Slovenian: Kako se zdravilo Myfenax uporablja?
English: The referral started on 15 May 2013.
Slovenian: Napotitveni postopek se je začel 15. maja 2013.
English: Written explanations were provided by some of the applicants and marketing authorisation holders by 30 September 2013 and 3 February 2014.
Slovenian: Nekateri predlagatelji in imetniki dovoljenja za promet so pisna pojasnila predložili 30. septembra 2013 in 3. februarja 2014.
English: The Committee appointed C. Muñoz Madero as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Slovenian: Odbor je imenoval Cristino Muñoz Madero za poročevalko in Michaela Holzhauser-Albertija za soporočevalca.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II together with the amendments in the summaries of product characteristics, labelling and package leaflets in Annex III.
Slovenian: Seznam zadevnih imen zdravil je naveden v Prilogi I. Znanstveni zaključki so navedeni v Prilogi II, skupaj s spremenjenim povzetkom glavnih značilnosti zdravila, označevanjem in navodilom za uporabo v Prilogi III.
English: The CVMP was requested to consider what indications, dosage regimens and durations of treatments should be applied for the products concerned in order to ensure efficacy and target animal safety and to minimise the development of antimicrobial resistance, taking into account the available data.
Slovenian: Odbor CVMP so prosili, naj na podlagi razpoložljivih podatkov določi indikacije, režime odmerjanja in trajanje zdravljenja, ki naj se uporabljajo za zadevna zdravila, da bi zagotovili učinkovitost in varnost ciljnih živalskih vrst ter čim bolj zmanjšali razvoj odpornosti proti protimikrobnim zdravilom.
English: The CVMP was also requested to consider what withdrawal periods should be applied to the concerned products for each target species.
Slovenian: Odbor so prosili tudi, naj preveri, kakšne karence naj se uporabljajo za zadevna zdravila pri posameznih ciljnih vrstah.
English: On 22 April 2013, Spain presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products.
Slovenian: Španija je 22. aprila 2013 agenciji predložila obvestilo o napotitvi v skladu s členom 35 Direktive 2001/82/ES za zdravila Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje, Baytril 10 % raztopina za injiciranje in povezana imena ter z njimi povezana zdravila za uporabo v veterinarski medicini.
English: Opinion following an Article 351 referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 351 za zdravilo Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje, Baytril 10 % raztopina za injiciranje in povezana imena ter z njimi povezana zdravila za uporabo v veterinarski medicini
English: 1 Article 35 of Directive 2001/82/EC, as amended 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Slovenian: 1 Člen 35 Direktive 2001/82/ES, kakor je bila spremenjena.
English: Opinion following an Article 350F referral for Baytril 2.5% injectable, Baytril 5% injectable, Baytril 10% injectable and associated names, and related veterinary medicinal products
Slovenian: Mnenje v zvezi z napotitvijo v skladu s členom 350F za zdravilo Baytril 2,5 % raztopina za injiciranje, Baytril 5 % raztopina za injiciranje, Baytril 10 % raztopina za injiciranje in povezana imena ter z njimi povezana zdravila za uporabo v veterinarski me EMA/597438/2014
English: 8 May 2018
Slovenian: 8. maj 2018
English: Outcome of a procedure under Article 34 of Directive 2001/82/EC (EMEA/V/A/122)
Slovenian: Izid postopka v skladu s členom 34 Direktive 2001/82/ES (EMEA/V/A/122)
English: The European Commission issued a decision on 8 May 2018.
Slovenian: Evropska komisija je sklep izdala 8. maja 2018.
English: Girolan (and its associated name Apralan) is marketed in Denmark, France, Germany, Ireland, Italy, The Netherlands, Portugal, Spain and the United Kingdom.
Slovenian: Zdravilo Girolan (in povezano ime Apralan) se trži na Danskem, v Franciji, Nemčiji, na Irskem, v Italiji, na Nizozemskem, Portugalskem, v Španiji in Združenem kraljestvu.
English: Girolan is authorised in the EU via national procedures.
Slovenian: Zdravilo Girolan je bilo v EU odobreno po nacionalnih postopkih.
English: The amended product information is available on the 'All documents' tab.
Slovenian: Popravljene informacije o zdravilu so na voljo pod zavihkom„Vsi dokumenti“.
English: Questions and answers on Girolan and its associated name Apralan EMA/295529/2018
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Girolan in povezanim imenom Apralan EMA/295529/2018
English: Spain noted that there are divergences across Member States in the way the veterinary medicinal product can be used, as seen in the differences in the product information in the countries where Girolan (and its associated name Apralan) is marketed.
Slovenian: Španija je opozorila, da med državami članicami obstajajo razlike v načinu, kako se zdravilo za uporabo v veterinarski medicini lahko uporablja, kar se odraža v razlikah med informacijami o zdravilu v državah, v katerih se zdravilo Girolan (in povezano ime Apralan) trži.
English: Why was Girolan and its associated name Apralan reviewed?
Slovenian: Zakaj sta bila zdravilo Girolan in povezano ime Apralan pregledana?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that there is a need to harmonise the product information [summary of product characteristics (SPC), labelling and package leaflet] for the aforementioned product in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) pri agenciji je zaključil, da je treba uskladiti informacije o zdravilu (povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo) za omenjeno zdravilo v Evropski uniji (EU).
English: Questions and answers on Girolan and its associated name Apralan
Slovenian: Vprašanja in odgovori v zvezi z zdravilom Girolan in povezanim imenom Apralan
English: On 15 February 2018, the European Medicines Agency (the Agency) completed a review of Girolan and its associated name, Apralan.
Slovenian: Evropska agencija za zdravila (v nadaljnjem besedilu: agencija) je 15. februarja 2018 zaključila pregled zdravila Girolan in povezanega imena Apralan.
English: Girolan is a veterinary medicinal product available as a powder for use in drinking water/milk containing apramycin sulfate as the active substance.
Slovenian: Zdravilo Girolan je zdravilo za uporabo v veterinarski medicini, ki je na voljo v obliki praška za dajanje v vodo/mleko za pitje, ki kot učinkovino vsebuje apramicinijev sulfat.
English: enterica serovar Dublin (Salmonella Dublin) in pre-ruminant calves; treatment of colibacillosis caused by Escherichia coli in chickens and treatment and metaphylaxis of bacterial enteritis caused by Escherichia coli in rabbits.
Slovenian: enterica serovar Dublin (Salmonella Dublin) pri teletih, ki še ne prežvekujejo; zdravljenje kolibaciloze, ki jo pri piščancih povzroča bakterija Escherichia coli, ter zdravljenje in metafilakso bakterijskega enteritisa, ki ga pri kuncih povzroča bakterija Escherichia coli.
English: What is Girolan and its associated name Apralan?
Slovenian: Kaj sta zdravilo Girolan in povezano ime Apralan?
English: Girolan is indicated for the treatment of bacterial enteritis caused by Escherichia coli in pigs; treatment of bacterial enteritis caused by Escherichia coli and clinical outbreaks due to Salmonella enterica subsp.
Slovenian: Zdravilo Girolan je indicirano za zdravljenje bakterijskega enteritisa, ki ga pri prašičih povzroča bakterija Escherichia coli; zdravljenje bakterijskega enteritisa, ki ga povzroča bakterija Escherichia coli, in kliničnih izbruhov zaradi bakterije Salmonella enterica subsp.
English: Based on the evaluation of the currently-available data, the CVMP concluded by majority that the product information for Girolan and its associated name Apralan should be harmonised across the EU.
Slovenian: Odbor CVMP je na podlagi vrednotenja trenutno razpoložljivih podatkov zaključil, da je treba informacije o zdravilu za zdravilo Girolan in povezano ime Apralan uskladiti po vsej EU.
English: On 24 June 2016, Spain referred the matter to the CVMP in order to harmonise the product information for Girolan (and its associated name Apralan) in the EU.
Slovenian: Španija je za uskladitev informacij o zdravilu za zdravilo Girolan (in povezano ime Apralan) v EU 24. junija 2016 zadevo napotila na odbor CVMP.
English: Immediate use is then recommended.
Slovenian: Nato se priporoča takojšnja uporaba.
English: c: Remission is defined as DAS < 1.6.
Slovenian: c: Remisija je definirana kot DAS < 1,6.
English: • Wash your hands with soap and hot water.
Slovenian: • Roke si umijte z milom in vročo vodo.
English: • Educational materials will be constantly updated for further improvements
Slovenian: • izobraževalno gradivo se bo redno posodabljalo z nadaljnjimi izboljšavami;
English: During the injection you will hear 2 loud clicks.
Slovenian: Med injiciranjem boste slišali 2 glasna klika.
English: Caregivers and healthcare professionals only:
Slovenian: Samo za negovalce in zdravstvene delavce:
English: Frequency Not Known (Cannot be Estimated from Available Data)
Slovenian: neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: DO NOT USE
Slovenian: NE UPORABLJAJTE
English: • Free lines for adding additional information:
Slovenian: • prazne črte za vnos dodatnih informacij:
English: Erelzi is also prescribed for the treatment of the following diseases in children and adolescents:
Slovenian: Zdravilo Erelzi se predpisuje tudi za zdravljenje naslednjih bolezni pri otrocih in mladostnikih:
English: • Information regarding the need for evaluation on tuberculosis (TB)
Slovenian: • podatke o potrebnem pregledu glede tuberkuloze (TB);
English: Use in adult patients (aged 18 years or over)
Slovenian: Uporaba pri odraslih bolnikih (starih 18 let ali več)
English: 0.8 †, ϕ a: Patients who did not complete 12 months in the study were considered to be non-responders.
Slovenian: 0,8†,φ a: Bolniki, ki v študiji niso sodelovali 12 mesecev, so bili obravnavani kot neodzivni.
English: Erelzi can be taken with or without food or drink.
Slovenian: Zdravilo Erelzi se lahko uporablja skupaj s hrano ali pijačo ali brez njiju.
English: • Listen for the 2nd click.
Slovenian: • Počakajte na 2. klik.
English: • Patient´s name, Doctor´s name and phone number
Slovenian: • ime bolnika, ime in telefonska številka zdravnika.
English: 164 n = 193 n = 196 n = 196 n = 46 n = 96 n = 90
Slovenian: n = 164 n = 193 n = 196 n = 196 n = 46 n = 96 n = 90
English: • if you or the child have an infection of any kind.
Slovenian: • če imate vi ali otrok kakršnokoli okužbo.
English: The same information is also available on www.erelzi.eu and through the code below.
Slovenian: Te informacije so na voljo tudi na www.erelzi.eu in s spodnjo kodo.
English: The specific activity of etanercept is 1.7 x 106 units/mg.
Slovenian: Specifična aktivnost etanercepta je 1,7 x 106 enot/mg.
English: • Any core educational materials for HCPs are subject to country-specific adaptation according to local regulatory requirements
Slovenian: • vse osnovno izobraževalno gradivo, namenjeno zdravstvenim delavcem, je predmet prilagoditev po posameznih državah v skladu z lokalnimi uredbenimi zahtevami;
English: This indicates the injection is almost complete.
Slovenian: Ta pomeni, da je injiciranje skoraj končano.
English: It is important not to try to inject yourself until you have been trained by your doctor, nurse or pharmacist.
Slovenian: Pomembno je, da si ne poskušate zdravila injicirati sami, dokler vas tega ne nauči zdravnik, medicinska sestra ali farmacevt.
English: • Your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before and during treatment with Erelzi.
Slovenian: • Zdravnik vam bo izročil tudi opozorilno kartico za bolnika, ki vsebuje pomembne podatke o varnosti, s katerimi morate biti seznanjeni pred zdravljenjem z zdravilom Erelzi in med zdravljenjem z njim.
English: In all these cases, return the entire product pack to the pharmacy.
Slovenian: V vseh navedenih primerih vrnite celotno pakiranje zdravila v lekarno.
English: It is important that you tell the baby's doctors and other healthcare professionals about the use of Erelzi during pregnancy before the baby receives any vaccine (for more information see section 2, “Vaccinations”).
Slovenian: Pomembno je, da o uporabi zdravila Erelzi med nosečnostjo obvestite dojenčkovega zdravnika in ostale zdravstvene delavce, preden dojenček prejme katerokoli cepivo (za več informacij glejte poglavje 2 “Cepljenja”).
English: Several seconds later a 2nd click will indicate that the injection is almost finished.
Slovenian: Nekaj sekund kasneje boste slišali 2. klik, ki pomeni, da je injiciranje skoraj končano.
English: For the safety and health of you and others, needles and used syringes must never be re-used.
Slovenian: Iz varnostnih razlogov in za vašo zaščito ter zaščito zdravja drugih ljudi nikoli ne smete ponovno uporabiti že uporabljenih igel in brizg.
English: Erelzi is a medicine that is made from two human proteins.
Slovenian: Zdravilo Erelzi je pridobljeno iz dveh človeških beljakovin.
English: • Sandoz staff will be trained on the correct use of Erelzi in order to support HCPs in case of questions
Slovenian: • osebje podjetja Sandoz bo usposobljeno za pravilno uporabo zdravila Erelzi, da bodo v primeru vprašanj lahko pomagali zdravstvenim delavcem.
English: Erelzi should only be used during pregnancy if clearly needed.
Slovenian: Zdravilo Erelzi lahko med nosečnostjo uporabljamo le, če je to nujno potrebno.
English: In evaluating patients for infections, the patient's risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered.
Slovenian: Pri pregledovanju bolnikov glede okužb je treba upoštevati bolnikovo tveganje za relevantne oportunistične okužbe (npr. izpostavljenost endemičnim mikozam).
English: Treatment with etanercept should continue until remission is achieved, for up to 24 weeks.
Slovenian: Zdravljenje z etanerceptom je treba nadaljevati, dokler se ne doseže remisije, vendar največ 24 tednov.
English: Other medicines and Erelzi
Slovenian: Druga zdravila in zdravilo Erelzi
English: Educational materials
Slovenian: Izobraževalno gradivo
English: • Information that Erelzi can increase risk for getting serious infection:
Slovenian: • podatek, da lahko zdravilo Erelzi poveča tveganje za resno okužbo:
English: Other etanercept products with appropriate dosage forms for children are available.
Slovenian: Na voljo so druga zdravila z etanerceptom z ustreznimi oblikami odmerkov za otroke.
English: Check the green indicator fills the window:
Slovenian: Preglejte, ali je zeleni indikator zapolnil okence:
English: Administration of live vaccines to infants for 16 weeks after the mother's last dose of Erelzi is generally not recommended.
Slovenian: Uporaba živih cepiv v prvih 16 tednih po tem, ko so matere dojenčkov prejele zadnji odmerek zdravila Erelzi, pri dojenčkih običajno ni priporočljiva.
English: The known side effects of Erelzi include the following in groups of decreasing frequency:
Slovenian: Znani neželeni učinki zdravila Erelzi so v nadaljevanju navedeni v skupinah po padajoči pogostnosti:
English: Before starting treatment with Erelzi, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Slovenian: Pred začetkom zdravljenja z zdravilom Erelzi je treba vse bolnike pregledati tako glede aktivne kot tudi glede neaktivne ('latentne') tuberkuloze.
English: An educational program is developed in order to assist in training and educating HCPs for proper use of Erelzi:
Slovenian: Oblikovan je izobraževalni program za pomoč pri usposabljanju in izobraževanju zdravstvenih delavcev o pravilni uporabi zdravila Erelzi:
English: This is intended to aid in the protection of healthcare professionals, patients who self-inject doctor-prescribed medicines and individuals who assist self-injecting patients from accidental needle stick injuries.
Slovenian: To je namenjeno zaščiti zdravstvenih delavcev, bolnikov, ki si sami injicirajo zdravila, ki jim jih predpiše zdravnik, in oseb, ki bolnikom pomagajo pri samoinjiciranju, pred poškodbami zaradi nehotenega vboda z iglo.
English: If you received Erelzi during pregnancy, your baby may have a higher risk of getting an infection.
Slovenian: Če ste med nosečnostjo prejeli zdravilo Erelzi, lahko pri vašem dojenčku obstaja povečano tveganje za razvoj okužbe.
English: • Check the green indicator fills the window and has stopped moving.
Slovenian: • Opazujte, kdaj zeleni indikator zapolni okence in se neha premikati.
English: What Erelzi is and what it is used for
Slovenian: Kaj je zdravilo Erelzi in za kaj ga uporabljamo
English: A-6336 Langkampfen Austria
Slovenian: A-6336 Langkampfen Avstrija
English: A-6336 Langkampfen AUSTRIA
Slovenian: A-6336 Langkampfen AVSTRIJA
English: Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ.
Slovenian: Kakovost življenja bolnikov s psoriatičnim artritisom je bila ocenjena v vsaki časovni točki z uporabo indeksa invalidnosti po HAQ.
English: Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor.
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo (vključno z anakinro, abataceptom ali sulfasalazinom), tudi če ste ga dobili brez recepta.
English: PASI 50 14 58* 70 74* 77 9
Slovenian: PASI 50 14 58* 70 74* 77 9 PASI 75 4 34* 44 49* 59 3 DSGAb,
English: Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during Erelzi therapy and for three weeks after discontinuation of therapy.
Slovenian: Ženske v rodni dobi morajo razmisliti o uporabi ustrezne kontracepcije za preprečitev nosečnosti med zdravljenjem z zdravilom Erelzi in še tri tedne po prenehanju zdravljenja.
English: Some children and teenage patients who have received Erelzi or other medicines that work the same way as Erelzi have developed cancers, including unusual types, which sometimes resulted in death.
Slovenian: Pri nekaterih otrocih in mladostnikih, ki so prejemali zdravilo Erelzi ali druga podobna zdravila z enakim načinom delovanja kot zdravilo Erelzi, se je razvil rak, vključno z neobičajnimi oblikami, ki se je včasih končal s smrtjo.
English: What Erelzi is and what it is used for What you need to know before you use Erelzi How to use Erelzi
Slovenian: Kaj je zdravilo Erelzi in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Erelzi Kako uporabljati zdravilo Erelzi
English: • if you, or the child you are caring for, are allergic to etanercept or any of the other ingredients of Erelzi (listed in section 6).
Slovenian: • če ste vi ali otrok, za katerega skrbite, alergični na etanercept ali katerokoli sestavino tega zdravila Erelzi (navedeno v poglavju 6).
English: Treatment with etanercept 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5).
Slovenian: Z zdravljenjem s 25 mg etanercepta so dosegli bistveno izboljšanje pri 12 mesecih - približno 44 % bolnikov je doseglo normalen rezultat HAQ (manj kot 0,5).
English: If you forget to inject Erelzi
Slovenian: Če ste si pozabili injicirati zdravilo Erelzi
English: The primary measure of efficacy (ASAS 20) was a ≥ 20% improvement in at least 3 of the 4
Slovenian: Primarno merilo učinkovitosti (ASAS 20) je bilo ≥ 20 % izboljšanje pri vsaj 3 od 4 domen lestvice
English: This appearance is normal for Erelzi.
Slovenian: Tak izgled je normalen za zdravilo Erelzi.
English: Erelzi is administered by subcutaneous injection (see section 6.6).
Slovenian: Zdravilo Erelzi se daje s subkutano injekcijo (glejte poglavje 6.6).