FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits seen with Ilaris outweigh its risks and recommended that it be authorised in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Ilaris večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: Other information about Ilaris
Slovenian: Druge informacije o zdravilu Ilaris
English: − hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD);
Slovenian: − sindroma hiperimunoglobulinemije D (HIDS)/pomanjkanja mevalonske kinaze (MKD);
English: Ilaris treatment also allowed patients to reduce the amount of steroids they take to control inflammation.
Slovenian: Zdravljenje z zdravilom Ilaris je bolnikom tudi omogočilo znižanje količine steroidov, ki so jih jemali za obvladovanje vnetja.
English: The main risk with this medicine is infection, mostly affecting the nose and throat.
Slovenian: Glavno tveganje pri jemanju tega zdravila je okužba, ki najpogosteje prizadene nos in grlo.
English: Gouty arthritis
Slovenian: Protinski artritis
English: For information on doses and dose adjustments, see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij o odmerkih in prilagajanju odmerka glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Ilaris must not be used in patients with active or severe infection.
Slovenian: Zdravilo se ne sme uporabljati pri bolnikih z aktivnimi ali resnimi okužbami.
English: Ilaris canakinumab
Slovenian: Ilaris kanakinumab
English: By attaching to interleukin-1 beta, canakinumab blocks its activity, helping to reduce inflammation thereby relieving the symptoms of the diseases.
Slovenian: Kanakinumab z vezavo na interlevkin1 beta zavre njegovo delovanje in tako pomaga zmanjšati vnetje, s tem pa ublažiti simptome bolezni.
English: Ilaris is a medicine for treating the following inflammatory conditions:
Slovenian: Zdravilo Ilaris se uporablja za zdravljenje naslednjih vnetnih stanj:
English: The active substance in Ilaris, canakinumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a messenger molecule or ‘cytokine' in the body called interleukin-1 beta.
Slovenian: Zdravilna učinkovina v zdravilu Ilaris, kanakinumab, je monoklonsko protitelo, vrsta beljakovine, ki je bila zasnovana tako, da v telesu prepozna snov sporočilno molekulo ali citokin, imenovano interlevkin-1 beta, in se veže nanjo.
English: The company that markets Ilaris will provide doctors who will use Ilaris with educational material containing the prescribing information, the patient reminder card and information for doctors containing important safety information about Ilaris, including precautions to be taken when using the medicine.
Slovenian: Družba, ki trži zdravilo Ilaris, bo zdravnikom, ki bodo predpisovali to zdravilo, priskrbela izobraževalno gradivo o predpisovanju zdravila, opozorilno kartico za bolnike in informacije za zdravnike s pomembnimi podatki o njegovi varnosti, vključno s previdnostnimi ukrepi, ki jih je treba upoštevati pri njegovi uporabi.
English: After proper training, patients or their caregivers may inject Ilaris themselves if the doctor deems it appropriate (for gouty arthritis the medicine should always be given by a healthcare professional).
Slovenian: Bolniki ali njihovi negovalci lahko zdravilo Ilaris injicirajo sami, potem ko so bili ustrezno usposobljeni in če zdravnik meni, da je to ustrezno (pri protinskem artritisu mora zdravilo vedno injicirati zdravstveni delavec).
English: Because of the similarities between childhood Still's disease and the adult form (adult-onset Still's disease, AOSD), Ilaris is expected to have similar benefits in adults.
Slovenian: Zaradi podobnosti med otroško Stillovo boleznijo in odraslo obliko bolezni (Stillovo boleznijo z začetkom v odrasli dobi - AOSD) se pričakuje, da bo zdravilo Ilaris imelo podobne učinke pri odraslih.
English: In patients taking Ilaris, after 3 days, the pain level was reduced from 74 to 25 (on a standard rating scale from 0 to 100), whereas in patients taking the comparator the pain level was reduced from 74 to 35.
Slovenian: Pri bolnikih, ki so jemali zdravilo Ilaris, se je stopnja bolečine po treh dneh zmanjšala s 74 na 25 (na standardni ocenjevalni lestvici od 0 do 100), medtem ko se je pri bolnikih, ki so jemali primerjalna zdravila, ta stopnja znižala s 74 na 35.
English: What benefits of Ilaris have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ilaris izkazalo v študijah?
English: • Gouty arthritis, painful inflammation of the joints caused by deposit of urate crystals (in adults).
Slovenian: • protinskega artritisa, tj. bolečega vnetja sklepov, ki ga povzročajo skupki kristalov urata (pri odraslih).
English: What is Ilaris and what is it used for?
Slovenian: Kaj je zdravilo Ilaris in za kaj se uporablja?
English: − cryopyrin-associated periodic syndromes (CAPS);
Slovenian: − s kriopirinom povezanih periodičnih sindromov (CAPS);
English: Ilaris is given as a single injection under the skin every 8 weeks for CAPs and every 4 weeks for the other periodic fever syndromes (TRAPS, HIDS/MKD and FMF) and Still's disease.
Slovenian: Zdravilo Ilaris se daje kot enkratna podkožna injekcija vsakih osem tednov pri s kriopirinom povezanih periodičnih sindromih ter vsake štiri tedne pri drugih periodičnih vročičnih sindromih (TRAPS, HIDS/MKD in FMF) in Stillovi bolezni.
English: Why is Ilaris approved?
Slovenian: Zakaj je bilo zdravilo Ilaris odobreno?
English: It is not intended to provide practical advice on how to use Ilaris.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: • 4 types of periodic fever syndromes (diseases marked by recurring inflammation and fever) in adults and children aged 2 and above:
Slovenian: • štirih vrst periodičnih vročičnih sindromov (obolenj, za katere sta značilna ponavljajoče se vnetje in povišana telesna temperatura) pri odraslih in otrocih, starejših od dveh let:
English: What are the risks associated with Ilaris?
Slovenian: Kakšna tveganja so povezana z zdravilom Ilaris?
English: The risk of developing a new gouty arthritis attack was also reduced with Ilaris (17% with Ilaris versus 37% with triamcinolone acetonide).
Slovenian: Tveganje za ponovni napad protinskega artritisa je bilo tudi nižje ob jemanju zdravila Ilaris (17 % z zdravilom Ilaris v primerjavi s 37 % pri jemanju triamcinolon acetonida).
English: Studies have shown that Ilaris is effective at reducing symptoms or relapses in patients with periodic fever syndromes, Still's disease and gouty arthritis.
Slovenian: Študije so pokazale, da je zdravilo Ilaris učinkovito pri zmanjševanju simptomov ali zagonov bolezni pri bolnikih s periodičnimi vročičnimi sindromi, Stillovo boleznijo in protinskim artritisom.
English: For more information about treatment with Ilaris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ilaris preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In patients with gouty arthritis, a single injection is given on-demand to treat gouty arthritis attacks.
Slovenian: Pri bolnikih s protinskim artritisom se enkratno injiciranje po potrebi uporabi za zdravljenje napadov protinskega artritisa.
English: A study in 84 patients with childhood Still's disease (also known as systemic juvenile idiopathic arthritis, SJIA) found that Ilaris was more effective than placebo at reducing symptoms of arthritis: around 84% of patients who received Ilaris achieved the required reduction in symptoms, compared with about 10% of patients who received placebo.
Slovenian: V prvi študiji, v katero je bilo vključenih 84 bolnikov z otroško Stillovo boleznijo (znano tudi kot sistemski juvenilni idiopatski artritis - SJIA), je bilo ugotovljeno, da je bilo zdravilo Ilaris učinkovitejše od placeba pri zmanjševanju simptomov artritisa: pri okoli 84 % bolnikov, ki so prejemali zdravilo Ilaris, je bilo doseženo potrebno zmanjšanje simptomov v primerjavi z okoli 10 % bolnikov, ki so prejemali placebo.
English: For practical information about using Ilaris, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ilaris naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: − tumour necrosis factor receptor associated periodic syndrome (TRAPS);
Slovenian: − periodičnega sindroma, povezanega z receptorjem za tumorje nekrotizirajoči faktor (TRAPS);
English: Still's disease
Slovenian: Stillova bolezen
English: A fourth study in 181 patients with other periodic fever syndromes found that Ilaris was more effective than placebo in achieving a response (symptoms resolved with no new flare ups).
Slovenian: V četrti študiji, v katero je bilo vključenih 181 bolnikov z drugimi periodičnimi vročičnimi sindromi, je bilo ugotovljeno, da je bilo zdravilo Ilaris učinkovitejše od placeba pri doseganju odziva (simptomi so izzveneli brez novega zagona bolezni).
English: In a second study in childhood Still's disease (177 patients), the risk of experiencing a disease flare was reduced by 64% with Ilaris, compared with placebo.
Slovenian: V drugi študiji otroške Stillove bolezni, ki je vključevala 177 bolnikov, se je tveganje za zagon bolezni zmanjšalo za 64 % pri uporabi zdravila Ilaris v primerjavi s placebom.
English: Injections are usually given in the upper thigh, upper arm, abdomen or buttocks.
Slovenian: Zdravilo se običajno injicira v zgornji del stegna, nadlaket, trebuh ali zadnjico.
English: The response rates with Ilaris and placebo were 46% and 8%, respectively in patients with TRAPS, 35% and 6% in patients with HIDS/MKD, and 61% and 6% in patients with FMF.
Slovenian: Stopnji odziva pri jemanju zdravila Ilaris oziroma placeba sta bili 46 % oziroma 8 % pri bolnikih s periodičnim sindromom, povezanim z receptorjem za tumorje nekrotizirajoči faktor, 35 % oziroma 6 % pri bolnikih s sindromom hiperimunoglobulinemije D/pomanjkanjem mivalonske kinaze ter 61 % oziroma 6 % pri bolnikih z družinsko mediteransko vročico.
English: For the full list of all side effects reported with Ilaris, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ilaris, glejte navodilo za uporabo.
English: In the two other CAPS studies, which did not compare Ilaris with any other treatment, 85% of patients on Ilaris had no relapses at all.
Slovenian: V drugih dveh študijah tega obolenja, v katerih zdravila Ilaris niso primerjali z nobenim drugim zdravilom, pri 85 % bolnikov, ki so jemali to zdravilo, ni prišlo do nobenega novega zagona.
English: Two studies involving 454 patients with gouty arthritis showed that Ilaris was more effective than another anti-inflammatory medicine triamcinolone acetonide at reducing pain.
Slovenian: V dveh študijah, v kateri je bilo vključenih 454 bolnikov s protinskim artritisom, je bilo dokazano, da je bilo zdravilo Ilaris pri zmanjševanju bolečine učinkovitejše od drugega protivnetnega zdravila triamcinolon acetonida.
English: This messenger is involved in causing inflammation and is found in high levels in patients with periodic fever syndromes, Still's disease and gouty arthritis.
Slovenian: Ta sporočilna molekula sodeluje pri povzročitvi vnetja in je v velikih količinah prisotna pri bolnikih s periodičnimi vročičnimi sindromi, Stillovo boleznijo ali protinskim artritisom.
English: Three studies involving 220 adults and children 2 years and older showed that Illaris was effective at reducing relapses of CAPS symptoms after a 24-week treatment period.
Slovenian: V treh študijah, v katere je bilo vključenih 220 odraslih in otrok, starejših od dveh let, je bilo dokazano, da je zdravilo Ilaris po 24-tedenskem zdravljenju učinkovito pri zmanjševanju zagonov s kriopirinom povezanih periodičnih sindromov.
English: How does Ilaris work?
Slovenian: Kako zdravilo Ilaris deluje?
English: Serious infections have been observed in patients taking Ilaris.
Slovenian: Pri bolnikih, ki so jemali zdravilo Ilaris, so bile opažene resne okužbe.
English: Ilaris can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Ilaris je le na recept.
English: • Still's disease, a rare disease causing inflammation of joints as well as rash and fever (in adults and children aged 2 and above);
Slovenian: • Stillove bolezni, tj. redne bolezni, ki povzroča vnetje sklepov, izpuščaj in povišano telesno temperaturo (pri odraslih in otrocih, starejših od dveh let);
English: How is Ilaris used?
Slovenian: Kako se zdravilo Ilaris uporablja?
English: Ilaris contains the active substance canakinumab.
Slovenian: Zdravilo Ilaris vsebuje zdravilno učinkovino kanakinumab.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ilaris have also been included in the summary of product characteristics and the package leaflet.
Slovenian: V povzetek glavnih značilnosti zdravila in navodilo za uporabo so bili vključeni tudi priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo tega zdravila upoštevati zdravstveni delavci in bolniki.
English: In one of the studies, none of the patients with CAPS who received Ilaris during the 24-week treatment period had a relapse, compared with 81% of patients who received placebo (a dummy treatment).
Slovenian: V prvi študiji pri nobenem od 15 bolnikov s tem obolenjem, ki so 24 tednov prejemali zdravilo Ilaris, ni prišlo do zagona bolezni, se je pa to zgodilo pri 81 % (13 od 16) bolnikov, ki so prejemali placebo (zdravilo brez zdravilne učinkovine).
English: Doctors and patients must be aware of this possibility.
Slovenian: Zdravniki in bolnice se morajo zavedati te možnosti.
English: The main measure of effectiveness was the number of eggs collected.
Slovenian: Glavno merilo učinkovitosti je bilo število zbranih jajčec.
English: This means that Bemfola is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Slovenian: To pomeni, da je podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bemfola on 27 March 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Bemfola, veljavno po vsej Evropski uniji, izdala 27. mareca 2014.
English: What measures are being taken to ensure the safe and effective use of Bemfola?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bemfola?
English: Bemfola follitropin alfa
Slovenian: Bemfola folitropin alfa
English: It is not intended to provide practical advice on how to use Bemfola.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Previously, the FSH used in medicines was extracted from urine.
Slovenian: V preteklosti so hormon FSH, uporabljen v zdravilih, pridobivali iz urina.
English: The full EPAR and risk management plan summary for Bemfola 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) in povzetek načrta obvladovanja tveganj za zdravilo Bemfola sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Slovenian: Najpogostejši neželeni učinki zdravila Bemfola (ki lahko prizadenejo več kot 1 osebo od 10) so reakcije na mestu injiciranja (bolečina, rdečina, modrice, oteklina ali razdraženost).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Bemfola has been shown to have a comparable quality, safety and effectiveness to GONAL-f.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Bemfola po kakovosti, varnosti in učinkovitosti primerljivo zdravilu GONAL-f.
English: • women who do not produce eggs and who do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
Slovenian: • žensk, ki ne proizvajajo jajčec in se ne odzivajo na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja jajčnike, da proizvajajo jajčeca);
English: The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems
Slovenian: Izdaja zdravila je le na recept, zdravljenje z njim pa se sme uvesti samo pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem težav s plodnostjo.
English: A risk management plan has been developed to ensure that Bemfola is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Bemfola je bil pripravljen načrt obvladovanja tveganj.
English: Bemfola was compared with GONAL-f in one main study involving 372 women who were undergoing assisted reproductive techniques.
Slovenian: Zdravilo Bemfola so primerjali z zdravilom GONAL-f v eni glavni študiji, v kateri je sodelovalo 372 žensk, ki so se zdravile s postopki asistirane reprodukcije.
English: What benefits of Bemfola have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Bemfola izkazalo v študijah?
English: Other information about Bemfola
Slovenian: Druge informacije o zdravilu Bemfola
English: This is a summary of the European public assessment report (EPAR) for Bemfola.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bemfola.
English: What are the risks associated with Bemfola?
Slovenian: Kakšna tveganja so povezana z zdravilom Bemfola?
English: Why is Bemfola approved?
Slovenian: Zakaj je bilo zdravilo Bemfola odobreno?
English: It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons.
Slovenian: Ne sme se uporabljati pri bolnikih, ki se ne morejo učinkovito odzvati na zdravljenje, na primer pri bolnikih, katerih jajčniki ali moda ne delujejo, ali pri ženskah, ki ne smejo zanositi iz zdravstvenih razlogov.
English: What is Bemfola and what is it used for?
Slovenian: Kaj je zdravilo Bemfola in za kaj se uporablja?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Bemfola, 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 Bemfola in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: The study showed that Bemfola was as effective as GONAL-f at stimulating the ovaries during assisted reproductive techniques, as an average of 11 eggs were retrieved with both medicines.
Slovenian: Študija je pokazala, da je zdravilo Bemfola prav tako učinkovito kot zdravilo GONAL-f pri spodbujanju jajčnikov med postopki asistirane reprodukcije, saj so pri uporabi obeh zdravil v povprečju zabeležili 11 jajčec.
English: For more information about treatment with Bemfola, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Bemfola preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: • women who are undergoing assisted reproductive techniques (fertility treatment) such as in vitro fertilisation.
Slovenian: • žensk, ki se zdravijo s postopki asistirane reprodukcije (zdravljenje neplodnosti), kot je oploditev in vitro.
English: The reference medicine for Bemfola is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here.
Slovenian: Referenčno zdravilo za zdravilo Bemfola je zdravilo GONAL-f. Za več informacij o podobnih bioloških zdravilih si oglejte dokument z vprašanji in odgovori, ki je na voljo tukaj.
English: The Committee recommended that Bemfola be given marketing authorisation.
Slovenian: Priporočil je, da se za zdravilo Bemfola izda dovoljenje za promet.
English: The follitropin alfa in Bemfola, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce human FSH.
Slovenian: Folitropin alfa v zdravilu Bemfola in referenčnem zdravilu GONAL-f pa proizvajajo z metodo, znano kot „tehnologija rekombinantne DNK“, pri kateri so v celice vstavili gen (DNK), s katerim lahko te tvorijo humani FSH.
English: Bemfola is given to stimulate the ovaries to produce more than one egg at a time;
Slovenian: Zdravilo Bemfola se daje za spodbujanje jajčnikov k proizvodnji več kot enega jajčeca naenkrat;
English: Bemfola has been shown to be comparable to the reference medicine, GONAL-f.
Slovenian: Zdravilo Bemfola se je izkazalo za primerljivo z referenčnim zdravilom GONAL-f.
English: The active substance in Bemfola, follitropin alfa, is a copy of the natural hormone FSH.
Slovenian: Zdravilna učinkovina v zdravilu Bemfola, folitropin alfa, je kopija naravnega hormona FSH.
English: Bemfola must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Slovenian: Zdravila Bemfola ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) folitropin alfa, FSH ali katero koli drugo sestavino zdravila.
English: For practical information about using Bemfola, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Bemfola naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: In the body, FSH controls reproductive function: in women, it stimulates the production of eggs in the ovaries; in men, it stimulates the production of sperm in the testicles.
Slovenian: Hormon FSH v telesu nadzoruje funkcijo reprodukcije: pri ženskah spodbuja nastajanje jajčec v jajčnikih, pri moških pa nastajanje semenčic v modih.
English: It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Slovenian: Prav tako se ne sme uporabljati pri bolnikih s tumorji hipofize ali hipotalamusa ali z rakom na dojkah, maternici ali jajčnikih.
English: Bemfola is a medicine that contains the active substance follitropin alfa.
Slovenian: Bemfola je zdravilo, ki vsebuje zdravilno učinkovino folitropin alfa.
English: In women, Bemfola must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina.
Slovenian: Pri ženskah se zdravilo Bemfola ne sme uporabljati ob povečanih jajčnikih ali prisotnosti cist, ki niso posledica sindroma policističnih jajčnikov, ali pri nepojasnjenem krvavenju iz nožnice.
English: Bemfola is used together with human chorionic gonadotrophin (hCG) therapy to stimulate sperm production.
Slovenian: Zdravilo Bemfola se uporablja skupaj z zdravljenjem s humanim horionskim gonadotropinom (hCG) za spodbujanje nastanka sperme.
English: Bemfola is available as a solution for injection in a prefilled pen.
Slovenian: Zdravilo Bemfola je na voljo v obliki raztopine za injiciranje v napolnjenem injekcijskem peresniku.