natgillin/translations-raw huggingface dataset:
In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Pri multipli sklerozi se imunski sistem (naravna obramba telesa) ne odziva normalno in napada dele osrednjega živčevja (možgane, hrbtenjačo in optični živec [živec, ki pošilja signale iz očesa v možgane]) ter povzroča vnetje, ki poškoduje živce in zaščitno ovojnico okrog njih.
Extavia can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Predpisovanje in izdaja zdravila Extavia je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
Extavia contains the active substance interferon beta-1b.
Zdravilo Extavia vsebuje učinkovino interferon beta-1b.
For the full list of side effects and restrictions with Extavia, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Extavia glejte navodilo za uporabo.
Extavia has also been studied in 1,657 patients in two studies involving secondary progressive MS patients who were able to walk, where it was compared with placebo.
Zdravilo Extavia so proučevali tudi v okviru dveh študij, ki sta vključevali 1 657 bolnikov s sekundarno progresivno multiplo sklerozo, sposobnih hoje, pri čemer so ga primerjali s placebom.
Extavia treatment should be stopped in patients whose condition does not improve.
Pri bolnikih, pri katerih se stanje ne izboljša, je treba zdravljenje prekiniti.
It is used when the patient is considered to be at high risk of developing MS. Before using Extavia, doctors need to exclude other causes for the symptoms;
Pred njegovo uporabo morajo zdravniki izključiti druge možne vzroke simptomov;
Extavia was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where its effectiveness was compared with placebo (a dummy treatment).
Zdravilo Extavia so proučevali dve leti pri 338 bolnikih z recidivno-remitentno multiplo sklerozo, sposobnih hoje brez pomoči, pri čemer so učinkovitost zdravila primerjali z učinkovitostjo placeba (zdravila brez učinkovine).
Extavia is a medicine used to treat adults who have multiple sclerosis (MS).
Zdravilo Extavia je namenjeno za zdravljenje odraslih bolnikov z multiplo sklerozo.
How is Extavia used?
Kako se zdravilo Extavia uporablja?
How does Extavia work?
Kako zdravilo Extavia deluje?
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 22 March 2017
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati dne 22. marca 2017.
Some infections were unusual or opportunistic infections due to reduced white blood cell levels.
Nekatere okužbe so bile nenavadne ali oportunistične zaradi znižanih ravni belih krvnih celic.
− familial mediterranean fever (FMF);
− družinske mediteranske vročice (FMF);
Periodic fever syndromes
Periodični vročični sindromi
Ilaris was originally authorised under ‘exceptional circumstances', because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Ilaris je prvotno pridobilo dovoljenje v „izjemnih okoliščinah“, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
The European Commission granted a marketing authorisation valid throughout the European Union for Ilaris on 23 October 2009.
Evropska komisija je dovoljenje za promet z zdravilom Ilaris, veljavno po vsej Evropski uniji, izdala 23. oktobra 2009.
The proportion of patients with no relapse was lower (around 57%) for children aged 2 to 4 years.
Delež bolnikov, pri katerih ni prišlo do zagona, je bil nižji (okoli 57 %) pri otrocih, starih od dveh do štirih let.
What measures are being taken to ensure the safe and effective use of Ilaris?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ilaris?
The full EPAR for Ilaris 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 Ilaris je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The most common infections were of the nose and throat.
Najpogostejše okužbe so bile okužbe nosu in grla.
This is a summary of the European public assessment report (EPAR) for Ilaris.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ilaris.
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.
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.
Other information about Ilaris
Druge informacije o zdravilu Ilaris
− hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD);
− sindroma hiperimunoglobulinemije D (HIDS)/pomanjkanja mevalonske kinaze (MKD);
Ilaris treatment also allowed patients to reduce the amount of steroids they take to control inflammation.
Zdravljenje z zdravilom Ilaris je bolnikom tudi omogočilo znižanje količine steroidov, ki so jih jemali za obvladovanje vnetja.
The main risk with this medicine is infection, mostly affecting the nose and throat.
Glavno tveganje pri jemanju tega zdravila je okužba, ki najpogosteje prizadene nos in grlo.
Gouty arthritis
Protinski artritis
For information on doses and dose adjustments, see the summary of product characteristics (also part of the EPAR).
Za več informacij o odmerkih in prilagajanju odmerka glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
Ilaris must not be used in patients with active or severe infection.
Zdravilo se ne sme uporabljati pri bolnikih z aktivnimi ali resnimi okužbami.
By attaching to interleukin-1 beta, canakinumab blocks its activity, helping to reduce inflammation thereby relieving the symptoms of the diseases.
Kanakinumab z vezavo na interlevkin1 beta zavre njegovo delovanje in tako pomaga zmanjšati vnetje, s tem pa ublažiti simptome bolezni.
Ilaris is a medicine for treating the following inflammatory conditions:
Zdravilo Ilaris se uporablja za zdravljenje naslednjih vnetnih stanj:
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
What benefits of Ilaris have been shown in studies?
Kakšne koristi je zdravilo Ilaris izkazalo v študijah?
• Gouty arthritis, painful inflammation of the joints caused by deposit of urate crystals (in adults).
• protinskega artritisa, tj. bolečega vnetja sklepov, ki ga povzročajo skupki kristalov urata (pri odraslih).
What is Ilaris and what is it used for?
Kaj je zdravilo Ilaris in za kaj se uporablja?
− cryopyrin-associated periodic syndromes (CAPS);
− s kriopirinom povezanih periodičnih sindromov (CAPS);
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.
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.
Why is Ilaris approved?
Zakaj je bilo zdravilo Ilaris odobreno?
It is not intended to provide practical advice on how to use Ilaris.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
• 4 types of periodic fever syndromes (diseases marked by recurring inflammation and fever) in adults and children aged 2 and above:
• 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:
What are the risks associated with Ilaris?
Kakšna tveganja so povezana z zdravilom Ilaris?
The risk of developing a new gouty arthritis attack was also reduced with Ilaris (17% with Ilaris versus 37% with triamcinolone acetonide).
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).
Studies have shown that Ilaris is effective at reducing symptoms or relapses in patients with periodic fever syndromes, Still's disease and gouty arthritis.
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.
For more information about treatment with Ilaris, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
In patients with gouty arthritis, a single injection is given on-demand to treat gouty arthritis attacks.
Pri bolnikih s protinskim artritisom se enkratno injiciranje po potrebi uporabi za zdravljenje napadov protinskega artritisa.
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.
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.
For practical information about using Ilaris, patients should read the package leaflet or contact their doctor or pharmacist.
Za praktične informacije o uporabi zdravila Ilaris naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
− tumour necrosis factor receptor associated periodic syndrome (TRAPS);
− periodičnega sindroma, povezanega z receptorjem za tumorje nekrotizirajoči faktor (TRAPS);
Still's disease
Stillova bolezen
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).
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).
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.
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.
Injections are usually given in the upper thigh, upper arm, abdomen or buttocks.
Zdravilo se običajno injicira v zgornji del stegna, nadlaket, trebuh ali zadnjico.
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.
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.
For the full list of all side effects reported with Ilaris, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Ilaris, glejte navodilo za uporabo.
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.
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.
Two studies involving 454 patients with gouty arthritis showed that Ilaris was more effective than another anti-inflammatory medicine triamcinolone acetonide at reducing pain.
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.
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.
Ta sporočilna molekula sodeluje pri povzročitvi vnetja in je v velikih količinah prisotna pri bolnikih s periodičnimi vročičnimi sindromi, Stillovo boleznijo ali protinskim artritisom.
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.
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.
How does Ilaris work?
Kako zdravilo Ilaris deluje?
Serious infections have been observed in patients taking Ilaris.
Pri bolnikih, ki so jemali zdravilo Ilaris, so bile opažene resne okužbe.
Ilaris can only be obtained with a prescription.
Predpisovanje in izdaja zdravila Ilaris je le na recept.
• Still's disease, a rare disease causing inflammation of joints as well as rash and fever (in adults and children aged 2 and above);
• Stillove bolezni, tj. redne bolezni, ki povzroča vnetje sklepov, izpuščaj in povišano telesno temperaturo (pri odraslih in otrocih, starejših od dveh let);
How is Ilaris used?
Kako se zdravilo Ilaris uporablja?
Ilaris contains the active substance canakinumab.
Zdravilo Ilaris vsebuje zdravilno učinkovino kanakinumab.
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.
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.
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).
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).
Doctors and patients must be aware of this possibility.
Zdravniki in bolnice se morajo zavedati te možnosti.
The main measure of effectiveness was the number of eggs collected.
Glavno merilo učinkovitosti je bilo število zbranih jajčec.
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).
To pomeni, da je podobno biološkemu zdravilu (t. i. „referenčnemu zdravilu“), ki je že odobreno v Evropski uniji (EU).
The European Commission granted a marketing authorisation valid throughout the European Union for Bemfola on 27 March 2014.
Evropska komisija je dovoljenje za promet z zdravilom Bemfola, veljavno po vsej Evropski uniji, izdala 27. mareca 2014.
What measures are being taken to ensure the safe and effective use of Bemfola?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Bemfola?
It is not intended to provide practical advice on how to use Bemfola.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
Previously, the FSH used in medicines was extracted from urine.
V preteklosti so hormon FSH, uporabljen v zdravilih, pridobivali iz urina.
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.
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.
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).
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).
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.
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.
• 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);
• žensk, ki ne proizvajajo jajčec in se ne odzivajo na zdravljenje s klomifen citratom (drugim zdravilom, ki spodbuja jajčnike, da proizvajajo jajčeca);
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
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.
A risk management plan has been developed to ensure that Bemfola is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Bemfola je bil pripravljen načrt obvladovanja tveganj.
Bemfola was compared with GONAL-f in one main study involving 372 women who were undergoing assisted reproductive techniques.
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.
What benefits of Bemfola have been shown in studies?
Kakšne koristi je zdravilo Bemfola izkazalo v študijah?
Other information about Bemfola
Druge informacije o zdravilu Bemfola
This is a summary of the European public assessment report (EPAR) for Bemfola.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Bemfola.
What are the risks associated with Bemfola?
Kakšna tveganja so povezana z zdravilom Bemfola?
Why is Bemfola approved?
Zakaj je bilo zdravilo Bemfola odobreno?
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.
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.
What is Bemfola and what is it used for?
Kaj je zdravilo Bemfola in za kaj se uporablja?
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.
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.
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.
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.
For more information about treatment with Bemfola, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
• women who are undergoing assisted reproductive techniques (fertility treatment) such as in vitro fertilisation.
• žensk, ki se zdravijo s postopki asistirane reprodukcije (zdravljenje neplodnosti), kot je oploditev in vitro.
The reference medicine for Bemfola is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here.
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.
The Committee recommended that Bemfola be given marketing authorisation.
Priporočil je, da se za zdravilo Bemfola izda dovoljenje za promet.