natgillin/translations-raw huggingface dataset:
• mantle cell lymphoma in patients whose disease does not respond to or has come back after previous treatment;
• limfomom plaščnih celic pri bolnikih, pri katerih se bolezen ne odziva ali se je ponovila po predhodnem zdravljenju;
The average time before patients died or the disease got worse was 15 months with Imbruvica versus 6 months with temsirolimus.
Povprečen čas do smrti bolnikov ali poslabšanja bolezni je bil 15 mesecev pri jemanju zdravila Imbruvica v primerjali s šestimi meseci pri jemanju temsirolimusa.
A second study in 280 such patients compared Imbruvica with another cancer medicine, temsirolimus.
V drugi študiji pri 280 bolnikih so zdravilo Imbruvica primerjali z drugim zdravilom za zdravljenje raka, temsirolimusom.
For patients with mantle cell lymphoma the dose is 560 mg once a day, for patients with chronic lymphocytic leukaemia or Waldenström's macroglobulinaemia the usual dose of Imbruvica is 420 mg once a day.
Za bolnike z limfomom plaščnih celic je odmerek 560 mg enkrat na dan, za bolnike s kronično limfocitno levkemijo ali Waldenströmovo makroglobulinemijo pa 420 mg enkrat na dan.
The active substance in Imbruvica, ibrutinib, works against cancerous B lymphocytes, a type of white blood cells.
Učinkovina v zdravilu Imbruvica, ibrutinib, deluje proti rakavim limfocitom B, tj. vrsti belih krvnih celic.
The company that markets Imbruvica needs to provide further data on the benefits of Imbruvica in the treatment of chronic lymphocytic leukaemia from follow-up of previously treated patients.
Podjetje, ki trži zdravilo Imbruvica, mora posredovati dodatne podatke o koristih zdravila Imbruvica pri zdravljenju kronične limfocitne levkemije na podlagi spremljanja predhodno zdravljenih bolnikov iz prve študije.
Response to treatment was measured as a reduction in the blood levels of the protein IgM, which is present in high levels in patients with Waldenström's disease.
Merilo odziva na zdravljenje je bilo znižanje v krvi ravni beljakovine IgM, ki je v visoki koncentraciji prisotna pri bolnikih z Waldenströmovo makroglobulinemijo.
By blocking Btk, ibrutinib decreases survival and migration of B lymphocytes, thereby delaying progression of the cancer.
Ibrutinib z zaviranjem encima Btk zmanjša stopnjo preživetja in preselitve limfocitov B, s čimer zadržuje napredovanje raka.
St. John's wort (a herbal remedy used for depression and anxiety) must not be used in patients treated with Imbruvica.
Šentjanževka (zeliščni pripravek, ki se uporablja proti depresiji in tesnobi) se ne sme uporabljati pri bolnikih, ki se zdravijo z zdravilom Imbruvica.
• chronic lymphocytic leukaemia (CLL) in both previously treated and untreated patients;
• kronično limfocitno levkemijo (KLL) pri predhodno zdravljenih in predhodno nezdravljenih bolnikih;
In addition, Imbruvica was effective in patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, a group of patients with poor prognosis and few other treatment options.
Učinkovito je bilo tudi pri bolnikih z limfomom plaščnih celic, ki se ni odzval na predhodno zdravljenje ali se je po njem ponovil, tj. v skupini s slabo prognozo in malo drugimi možnostmi zdravljenja.
In addition Imbruvica was shown to be effective in patients with Waldenström's macroglobulinaemia..
Zdravilo Imbruvica je izkazalo učinkovitost tudi pri bolnikih z Waldenströmovo makroglobulinemijo.
Imbruvica was shown to be effective at delaying progression of chronic lymphocytic leukaemia, both in untreated patients and in those who had received treatment previously.
Zdravilo Imbruvica se je izkazalo kot učinkovito pri upočasnitvi napredovanja kronične limfocitne levkemije pri predhodno nezdravljenih in tudi predhodno zdravljenih bolnikih.
In a study in 111 patients with mantle cell lymphoma that did not respond to or had come back after previous treatment, 21% of patients taking Imbruvica had complete response (i.e. disappearance of all signs of cancer) and 47% had partial response (i.e. the patient improved but some signs of the disease remained).
V glavni študiji, v kateri je sodelovalo 111 bolnikov z limfomom plaščnih celic, ki se ni odzval na predhodno zdravljenje ali se je po njem ponovil, je 21 % bolnikov, ki so jemali zdravilo Imbruvica imelo popoln odziv na zdravilo (tj. popolno izginotje znakov raka), 47 % pa delen odziv ( tj. bolnikovo stanje se je izboljšalo, a nekateri znaki raka so ostali) na zdravljenje.
In one main study involving 63 patients who had previously received another treatment for Waldenström's macroglobulinaemia, the disease responded to treatment with Imbruvica in 87% of patients.
V glavni študiji, ki je vključevala 63 bolnikov, ki so se predhodno zdravili z drugim zdravilom za zdravljenje Waldenströmove makroglobulinemije, se je 87 % bolnikov odzvalo na zdravljenje z zdravilom Imbruvica.
In a study involving 150 patients with Waldenström's macroglobulinaemia, after 26 months, death or signs that the cancer was progressing occurred in 19% of patients who took Imbruvica together with rituximab compared with 56% of patients who took only rituximab.
V študiji, v katero je bilo vključenih 150 bolnikov z Waldenströmovo makroglobulinemijo, je po 26 mesecih prišlo do smrti ali znakov, da je rak napredoval pri 19 % bolnikov, ki so zdravilo Imbruvica jemali skupaj z rituksimabom, v primerjavi s 56 % bolnikov, ki so jemali samo rituksimab.
Imbruvica contains the active substance ibrutinib.
Zdravilo Imbruvica vsebuje učinkovino ibrutinib.
How is Imbruvica used?
Kako se zdravilo Imbruvica uporablja?
In a study in 578 patients whose disease had not responded to or had come back after previous treatment, death or signs that the cancer was progressing occurred in 19% of patients (56 of 289) who took Imbruvica together with the cancer medicines bendamustine and rituximab compared with 63% (183 of 289) in those who took bendamustine and rituximab without Imbruvica.
V študiji pri 578 bolnikih, pri katerih se bolezen ni odzvala na predhodno zdravljenje ali se je po njem ponovila, je prišlo do smrti ali znakov napredovanja raka pri 19 % (56 od 289) bolnikov, ki so zdravilo Imbruvica jemali skupaj z zdraviloma za zdravljenje raka bendamustinom in rituksimabom, v primerjavi s 63 % (183 od 289) bolnikov, ki so jemali bendamustin in rituksimab brez zdravila Imbruvica.
How does Imbruvica work?
Kako zdravilo Imbruvica deluje?
The side effects of the medicine were considered acceptable.
Neželeni učinki zdravila so šteli za znosne in obvladljive.
• Waldenström's macroglobulinaemia (also known as lymphoplasmacytic lymphoma) Imbruvica can be taken alone but can also be taken with bendamustine and rituximab or with obinutuzumab in certain patients with CLL and with rituximab in patients with Waldenström's macroglobulinaemia.
Zdravilo Imbruvica se lahko jemlje samostojno ali v kombinaciji z bendamustinom in rituksmabom ali obinutuzumabom pri nekaterih bolnikih s KLL in z rituksimabom pri bolnikih z Waldenströmovo makroglobulinemijo.
For the full list of side effects of Imbruvica, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Imbruvica, glejte navodilo za uporabo.
In one study in 391 patients whose disease did not respond to or had come back after previous treatment, 66% of patients receiving Imbruvica were still alive after one year with their disease not having progressed compared with around 6% of patients receiving another cancer medicine, ofatumumab.
V študiji pri 391 bolnikih, pri katerih se bolezen ni odzvala na predhodno zdravljenje ali se je po njem ponovila, je bilo 66 % bolnikov, ki so prejemali zdravilo Imbruvica, po enem letu še živih in brez napredovanja bolezni, v primerjavi s 6 % bolnikov, ki so prejemali drugo zdravilo za zdravljenje raka, ofatumumab.
In a study in 229 previously untreated patients, after 31 months, 79% of patients treated with Imbruvica and obinutuzumab were alive with their disease not having progressed compared with 36% of patients who took chlorambucil and obinutuzumab.
V študiji pri 229 predhodno nezdravljenih bolnikih je bilo po 31 mesecih približno 79 % bolnikov, ki so prejemali zdravilo Imbruvica in obinutuzumab še živih, njihova bolezen pa ni napredovala, v primerjavi s 36 % bolnikov, ki so jemali klorambucil in obinutuzumab.
In a study involving 269 patients who had not been treated before, around 90% of patients receiving Imbruvica were still alive with their disease not having progressed after 1.5 years of treatment compared with around 52% of patients receiving a cancer medicine called chlorambucil.
V študiji, ki je vključevala 269 predhodno nezdravljenih bolnikov, je bilo približno 90 % bolnikov, ki so prejemali zdravilo Imbruvica, po letu in pol še živih in brez napredovanja bolezni, v primerjavi s približno 52 % bolnikov, ki so prejemali zdravilo za zdravljenje raka, imenovano klorambucil.
27 February 2012
27. februar 2012
The European Commission issued a decision on 27 February 2012.
Evropska komisija je odločbo izdala dne 27. februarja 2012.
What are the recommendations for patients and healthcare professionals?
Kakšna so priporočila za bolnike in zdravstvene delavce?
Outcome of procedures under Article 20 of Regulation (EC) No 726/2004 and Article 107 of Directive 2001/83/EC
Izid postopkov v skladu s členom 20 Uredbe (ES) št. 726/2004 in členom 107 Direktive 2001/83/ES
What is somatropin?
Kaj je somatropin?
• Patients or their carers who have any questions should speak to their doctor or pharmacist.
• Bolniki ali njihovi negovalci, ki imajo kakršna koli vprašanja, naj se pogovorijo z zdravnikom ali farmacevtom.
• The maximum recommended daily dose should not be exceeded.
• Največji priporočeni dnevni odmerek se ne sme preseči.
It looked at data on 10,000 adults who started treatment between 1985 and 1996, using a mandatory national registry.
Proučevala je podatke o 10 000 odraslih, ki so začeli zdravljenje med letoma 1985 in 1996, pri čemer je bil uporabljen obvezen državni register.
The risk appeared to be highest when doses higher than the ones approved were used.
Najvišje tveganje se je pokazalo, ko so bili uporabljeni odmerki, višji od odobrenih.
Why was somatropin reviewed?
Zakaj je bil somatropin pregledan?
In particular, an increased risk of mortality due to bone tumours and cardiovascular events (such as bleeding in the brain) was seen.
Zlasti pa so opazili povečano tveganje umrljivosti zaradi kostnih tumorjev in srčno-žilnih dogodkov (kot so krvavitve v možganih).
1 Procedure numbers: EMEA/H/A-107/1287; EMEA/H/000607/A-20/0021; EMEA/H/C/000315/A-20/0040; and EMEA/H/C/000602/A-20/0008.
1 Številke postopka: EMEA/H/A-107/1287; EMEA/H/000607/A-20/0021; EMEA/H/C/000315/A-20/0040 in EMEA/H/C/000602/A-20/0008.
However, the Committee noted that the available data on the long-term effects of somatropin treatment are very limited.
Vendar pa je ugotovil, da so razpoložljivi podatki o dolgoročnih učinkih zdravljenja s somatropinom zelo omejeni.
Somatropin is a copy of naturally occurring human growth hormone, produced by a method known as ‘recombinant DNA technology'.
Somatropin je kopija naravnega človeškega rastnega hormona in se proizvaja z metodo, imenovano "tehnologija rekombinantne DNK".
Medicines containing somatropin are given by injection.
Zdravila, ki vsebujejo somatropin, se dajejo z injiciranjem.
• Patients and healthcare professionals are reminded that the benefits of somatropin continue to outweigh its risks in the approved indications.
• Bolnike in zdravstvene delavce je treba opozoriti, da so koristi somatropina še naprej večje od njegovih tveganj pri odobrenih indikacijah.
The CHMP concluded that the French SAGhE study had significant methodological limitations and that the results could not be considered robust.
Odbor CHMP je zaključil, da je imela francoska študija SAGhE pomembne metodološke omejitve in da rezultatov ni mogoče obravnavati kot trdne.
• Somatropin must not be used in patients with any evidence of tumour activity.
• Somatropin se ne sme uporabljati pri bolnikih s kakršnimi koli simptomi tumorske dejavnosti.
Growth hormone promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fats and carbohydrates.
Rastni hormon spodbuja rast v otroštvu in mladosti ter vpliva tudi na to, kako telo presnavlja beljakovine, maščobe in ogljikove hidrate.
They have been authorised in the EU since the 1980s through centralised or national procedures.2 The approved indications vary for the different somatropin-containing medicines: they may be used as hormone replacement therapy, and to correct short stature (height) in children with certain genetic diseases (Turner syndrome or Prader Willi syndrome), children who have long-standing kidney problems and children born small for their gestational age.
V EU so bila odobrena v osemdesetih letih prejšnjega stoletja na podlagi centraliziranega ali nacionalnega postopka.2 Odobrene indikacije se razlikujejo glede na različna zdravila, ki vsebujejo somatropin: lahko se uporabljajo kot hormonsko nadomestno zdravljenje in za izboljšanje rasti (višine) pri otrocih z nekaterimi genskimi boleznimi (Turnerjev sindrom ali Prader-Willijev sindrom), pri otrocih, ki imajo dolgotrajne težave z ledvicami, in pri otrocih, ki so se rodili majhni za svojo gestacijsko starost.
In particular, the harmonised wording will emphasise that somatropin must not be used if there is any evidence of tumour activity, and that the maximum recommended daily dose should not be exceeded.
Usklajeno besedilo bo predvsem vsebovalo opozorilo, da se somatropin ne sme uporabljati, če obstajajo kakršni koli simptomi tumorske dejavnosti, in da se največji priporočeni dnevni odmerek ne sme preseči.
Further mortality data from the European SAGhE study will be available by the end of 2012, and the CHMP considered an analysis of these results to be essential to address any concerns raised by the French study.
Več podatkov o umrljivosti iz evropske študije SAGhE bo na voljo do konca leta 2012, Odbor pa je menil, da je analiza teh rezultatov bistvena za obravnavo zadržkov, ki jih je sprožila francoska študija.
The nationally authorised medicines are Genotropin, Humatrope, Maxomat, Norditropin, Saizen and Zomacton.
Zdravila, ki so odobrena po nacionalnem postopku, so Genotropin, Humatrope, Maxomat, Norditropin, Saizen in Zomacton.
The CHMP also looked into additional data from the unpublished French SAGhE study.
Prav tako je proučil dodatne podatke iz neobjavljene francoske študije SAGhE.
Consequently, in December 2010 the French agency asked the CHMP to issue an opinion on the impact of these data on the benefit-risk balance of somatropin-containing medicines, and on whether the marketing authorisation for these medicines should be maintained, varied, suspended or withdrawn across the EU.
Zato je decembra 2010 francoska agencija zaprosila odbor CHMP, da izda mnenje o vplivu teh podatkov na razmerje med koristmi in tveganji za zdravila, ki vsebujejo somatropin, in o tem, ali je treba dovoljenje za promet s temi zdravili v EU ohraniti, spremeniti, začasno preklicati ali umakniti.
What are the conclusions of the CHMP?
Do kakšnih zaključkov je prišel odbora CHMP?
In December 2010, the French medicines regulatory agency was made aware of preliminary results of a long-term population-based study in France of patients treated during childhood with somatropincontaining medicines.
Decembra 2010 je francoska regulativna agencija za zdravila prejela predhodne rezultate dolgoročne, populacijsko usmerjene francoske študije z bolniki, ki so bili v otroštvu zdravljeni z zdravili, ki vsebujejo somatropin.
An analysis in approximately 7,000 of those patients who were treated for growth hormone deficiency and for gestational or idiopathic short stature showed a possible increased risk of mortality with somatropin compared with the general population.
Analiza približno 7 000 tistih bolnikov, ki so se zdravili zaradi pomanjkanja rastnega hormona in zaradi gestacijske ali idiopatske nizke rasti, je pokazala morebitno povečano tveganje umrljivosti pri bolnikih, ki so se zdravili s somatropinom, v primerjavi s splošno populacijo.
The CHMP reviewed the available data on the safety of somatropin-containing medicines, including data from clinical trials, registries, and observational studies, as well as reports of side effects from post-marketing surveillance.
Odbor CHMP je pregledal razpoložljive podatke o varnosti zdravil, ki vsebujejo somatropin, vključno s podatki iz kliničnih preskušanj, registrov in opazovalnih študij, kot tudi poročil o neželenih učinkih iz nadzora v obdobju trženja.
The European Medicines Agency has completed a review of the safety and effectiveness of somatropincontaining medicines, following the results of a French study which suggested an increased risk of mortality in patients treated with somatropin compared with the general population.
Evropska agencija za zdravila je zaključila pregled v zvezi z varnostjo in učinkovitostjo zdravil, ki vsebujejo somatropin, na podlagi rezultatov francoske študije, ki kažejo na povečano tveganje umrljivosti pri bolnikih, ki so se zdravili s somatropinom, v primerjavi s splošno populacijo.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefit-risk balance of somatropin-containing medicines remains positive when used in the approved indications at the approved doses.
Na podlagi ocene trenutno razpoložljivih podatkov in znanstvene razprave v Odboru je CHMP zaključil, da ostaja razmerje med koristmi in tveganji za zdravila, ki vsebujejo somatropin, pozitivno, kadar se uporabljajo v odobrenih indikacijah in v odobrenih odmerkih.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of somatropin continue to outweigh its risks, but recommended changes to the product information to ensure that somatropin-containing medicines are used appropriately.
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi somatropina še naprej večje od z njim povezanih tveganj, vendar priporoča spremembo informacij o zdravilu, da bi se tako zdravila, ki vsebujejo somatropin, pravilno uporabljala.
After assessing all other available safety data on somatropin, the CHMP concluded that the potential signal of an increased risk of mortality seen in the French study is not corroborated by any other data, and that the benefit-risk balance of somatropincontaining medicines has not changed.
Po presoji vseh drugih razpoložljivih podatkov o varnosti somatropina je Odbor zaključil, da možno znamenje za povečano tveganje umrljivosti, ki je bilo opaženo v francoski študiji, ni podprto z drugimi podatki in da se razmerje med koristmi in tveganji zdravil, ki vsebujejo somatropin, ni spremenilo.
However, to ensure that somatropin-containing medicines are used appropriately, the CHMP recommended that specific wording be included in the product information of all somatropin-containing medicines.
Za ustrezno uporabo zdravil, ki vsebujejo somatropin, pa je kljub temu priporočil, da se v informacije o zdravilu za vsa zdravila, ki vsebujejo somatropin, vključi posebno besedilo.
At the same time, the European Commission requested the CHMP to carry out the same assessment for the centrally authorised somatropin-containing medicines.
Hkrati je Evropska komisija zaprosila Odbor, da izvede enako oceno za zdravila, ki vsebujejo somatropin in so bila odobrena po centraliziranem postopku.
2 The centrally authorised somatropin-containing medicines are NutropinAq, Omnitrope and Valtropin.
2 Zdravila, ki vsebujejo somatropin in so bila odobrena po centraliziranem postopku, so NutropinAq, Omnitrope in Valtropin.
The study, called ‘Santé Adulte GH Enfant' (SAGhE) study, was initiated in October 2007 and aimed at improving knowledge on the safety and appropriateness of somatropin
Študija se je imenovala "Santé Adulte GH Enfant" (SAGhE) in se je začela
10 ml (3.5mg/ml) 5 vials
3 ml (3,5 mg/ml) 1 pre-filled pen viala (steklena) 10 ml (3,5 mg/ml) 1 viala viala (steklena) 10 ml (3,5 mg/ml) 5 vial
It must not be given to pregnant women.
Ne sme se dajati nosečnicam.
What measures are being taken to ensure the safe and effective use of Mvasi?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Mvasi?
This means that Mvasi 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 dose is between 5 and 15 mg per kilogram body weight every two or three weeks, depending on the type of cancer being treated and the other cancer medicines being used.
Odmerek zdravila znaša med 5 in 15 mg na kilogram telesne mase vsaka dva do tri tedne, odvisno od vrste raka, ki se zdravi, in drugega uporabljenega zdravila za zdravljenje raka.
The full EPAR for Mvasi 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 Mvasi je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The cancer responded to treatment in 39% of those given Mvasi (128 of 328 patients) and 42% of those given Avastin (131 of 314).
Rak se je odzval na zdravljenje pri 39 % (128 od 328) bolnikov, ki so prejemali zdravilo Mvasi, in pri 42 % (131 od 314) bolnikov, ki so prejemali zdravilo Avastin.
What benefits of Mvasi have been shown in studies?
Kakšne koristi je zdravilo Mvasi izkazalo v študijah?
The first infusion of Mvasi should last 90 minutes, but subsequent infusions may be given more quickly if the first infusion is tolerated well.
Prva infuzija zdravila Mvasi naj traja 90 minut, poznejše infuzije pa so lahko krajše, če je bolnik prvo infuzijo dobro prenesel.
The doctor may decide to interrupt or stop treatment if the patient develops certain side effects.
Zdravnik se lahko odloči zdravljenje prekiniti ali ukiniti, če se pri bolniku pojavijo določeni neželeni učinki.
This is a summary of the European public assessment report (EPAR) for Mvasi.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Mvasi.
What are the risks associated with Mvasi?
Kakšna tveganja so povezana z zdravilom Mvasi?
Other information about Mvasi
Druge informacije o zdravilu Mvasi
It is not intended to provide practical advice on how to use Mvasi.
Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
What is Mvasi and what is it used for?
Kaj je zdravilo Mvasi in za kaj se uporablja?
The treatment is continued until the patient no longer benefits from it.
Zdravljenje traja tako dolgo, dokler še koristi bolniku.
Why is Mvasi approved?
Zakaj je bilo zdravilo Mvasi odobreno?
Mvasi is a cancer medicine that is used to treat adults with the following cancers:
Mvasi je zdravilo proti raku, ki se uporablja za zdravljenje odraslih z naslednjimi vrstami raka:
Mvasi can be used in non-small cell lung cancer unless it orginates in cells of a particular type (called squamous cells);
Zdravilo Mvasi se lahko uporablja pri nedrobnoceličnem raku pljuč, razen če ta ne izvira v celicah posebnega tipa (imenovanih skvamozne celice);
Mvasi is used in combination with other cancer medicines, depending on the nature of any previous treatments or the presence of mutations (genetic changes) in the cancer that affect its sensitivity to particular medicines.
Zdravilo Mvasi se uporablja v kombinaciji z drugimi zdravili za zdravljenje raka, odvisno od narave predhodnih zdravljenj ali prisotnosti mutacij (genskih sprememb) pri raku, kar vpliva na občutljivost za določeno zdravilo.
For more information about treatment with Mvasi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Mvasi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.