FrancophonIA/ELRC3.0 huggingface dataset:
English: A second study involved 51 children under 12 years of age previously treated with other factor VIII products, who also had 3.8 bleeds per year on average during treatment with Iblias (mostly related to injuries).
Slovenian: Druga študija je vključevala 51 otrok, mlajših od 12 let, ki so se predhodno zdravili z drugimi zdravili s faktorjem VIII in so med zdravljenjem z zdravilom Iblias prav tako doživeli 3,8 krvavitve na leto (večinoma v povezavi s poškodbami).
English: Iblias can only be obtained with a prescription and treatment should be under the supervision of a doctor who has experience in the treatment of haemophilia.
Slovenian: Izdaja zdravila Iblias je le na recept, zdravljenje z njim pa mora biti pod nadzorom zdravnika z izkušnjami z zdravljenjem hemofilije.
English: There is also a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Slovenian: Pri zdravilih s faktorjem VIII obstaja tudi tveganje, da se bodo pri nekaterih bolnikih pojavili zaviralci (protitelesa) faktorja VIII, ki bodo izničili njegovo delovanje ter tako povzročili izgubo nadzora nad krvavitvijo.
English: Iblias is available as a powder and solvent used to make a solution for injection.
Slovenian: Zdravilo Iblias je na voljo kot prašek in vehikel za pripravo raztopine za injiciranje.
English: The effectiveness of Iblias in preventing and treating bleeding has been shown in a main study involving 62 patients aged 12 years or older with severe haemophilia A who were previously treated with other factor VIII products.
Slovenian: Učinkovitost zdravila Iblias pri preprečevanju in zdravljenju krvavitev so dokazali v glavni študiji, ki je vključevala 62 bolnikov, starejših od 12 let, s hudo obliko hemofilije A, ki so se predhodno zdravili z drugimi zdravili s faktorjem VIII.
English: The active substance in Iblias, octocog alfa, works in the body in the same way as human factor VIII.
Slovenian: Zdravilna učinkovina zdravila Iblias, efmoroktokog alfa, deluje v telesu enako kot humani faktor VIII.
English: Iblias is a medicine used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of a clotting protein called factor VIII).
Slovenian: Iblias je zdravilo, ki se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih s hemofilijo A (prirojeno motnjo strjevanja krvi zaradi pomanjkanja koagulacijske beljakovine, imenovane faktor VIII).
English: Hypersensitivity (allergic) reactions are uncommon with Iblias, affecting from 1 patient in 1,000 to less than 1 patient in 100.
Slovenian: Občasno so pri zdravilu Iblias opazili preobčutljivostne (alergijske) reakcije, ki prizadenejo med 1 osebo od 1 000 in manj kot 1 osebo od 100.
English: In addition, the company that markets Iblias will complete studies to investigate the safety and efficacy of the medicine in patients who have not previously been treated with other factor VIII products, and to provide further evidence of the safety and efficacy of long-term treatment with Iblias in children.
Slovenian: Poleg tega bo podjetje, ki trži zdravilo Iblias, izvedlo študije, s katerimi bodo proučili varnost in učinkovitost zdravila pri bolnikih, ki se predhodno niso zdravili z drugimi zdravili s faktorjem VIII, in zagotovili dodatne dokaze o varnosti in učinkovitosti dolgotrajnega zdravljenja z zdravilom Iblias pri otrocih.
English: For the full list of all side effects and restrictions with Iblias, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Iblias glejte navodilo za uporabo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Iblias, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Patients with haemophilia A lack factor VIII, a protein needed for normal clotting of the blood, and as a result, they bleed readily and may have problems such as bleeding into the joints, muscles and internal organs.
Slovenian: Bolnikom s hemofilijo A primanjkuje faktorja VIII, tj. beljakovine, ki je potrebna za normalno strjevanje krvi, zato hitreje zakrvavijo in imajo lahko težave, kot so krvavitve v sklepe, mišice in notranje organe.
English: For more information about treatment with Iblias, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Iblias preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Iblias, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Iblias naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: About 70% of the bleeding events that occurred were managed with a single injection of Iblias, and about another 15% responded to a second injection; the response was considered good or excellent in around 80% of cases.
Slovenian: Približno 70 % krvavitev, ki so se pojavile, so obvladali z enkratno injekcijo zdravila Iblias , naslednjih 15 % pa se je odzvalo na drugo injekcijo.
English: The number of bleeds that occurred during Iblias treatment was calculated as 3.8 bleeds per year on average (mostly into joints).
Slovenian: Število krvavitev med zdravljenjem z zdravilom Iblias so z izračunom pretvorili v povprečno 3,8 krvavitve na leto (večinoma v sklepe).
English: Further evidence of effectiveness and safety in patients previously untreated with factor VIII medicines, and further data on long-term use in children should be provided by ongoing studies.
Slovenian: Potekajoče študije bodo morale prinesti dodatne dokaze o učinkovitosti in varnosti pri bolnikih, ki se predhodno niso zdravili z zdravili s faktorjem VIII, in nadaljnje podatke o dolgoročni uporabi pri otrocih.
English: How does Iblias work?
Slovenian: Kako zdravilo Iblias deluje?
English: How is Iblias used?
Slovenian: Kako se zdravilo Iblias uporablja?
English: This overview was last updated in 12-2019.
Slovenian: Povzetek je bil nazadnje posodobljen 12-2019.
English: In addition, the safety of the medicine was considered acceptable.
Slovenian: Poleg tega je bila varnost zdravila ocenjena kot sprejemljiva.
English: Further information on Zydelig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zydelig.
Slovenian: Nadaljnje informacije za zdravilo Zydelig so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/zydelig.
English: Zydelig received a marketing authorisation valid throughout the EU on 18 September 2014.
Slovenian: Za zdravilo Zydelig je bilo 18. septembra 2014 izdano dovoljenje za promet, veljavno po vsej EU.
English: The Agency therefore concluded that Zydelig's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Agencija je zato zaključila, da so koristi zdravila Zydelig večje od z njim povezanih tveganj, in priporočila, da se odobri za uporabo v EU.
English: What measures are being taken to ensure the safe and effective use of Zydelig?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Zydelig?
English: Other information about Zydelig
Slovenian: Druge informacije o zdravilu Zydelig
English: If the patient has severe side effects, treatment must be stopped and can be restarted at a lower dose of 100 mg twice a day.
Slovenian: Če se pri bolniku pojavijo resni neželeni učinki, je treba zdravljenje prekiniti in ponovno začeti z manjšim odmerkom 100 mg dvakrat na dan.
English: Why is Zydelig authorised in the EU?
Slovenian: Zakaj je zdravilo Zydelig odobreno v EU?
English: Patients should also be monitored for infection and have regular blood tests to measure the level of white blood cells.
Slovenian: Poleg tega je treba bolnike spremljati zaradi okužbe in pri njih redno opravljati krvne preiskave za merjenje števila belih krvnih celic.
English: Zydelig is available as 100 mg and 150 mg tablets.
Slovenian: Zdravilo Zydelig je na voljo v obliki 100- in 150-miligramskih tablet.
English: As for all medicines, data on the use of Zydelig are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Zydelig stalno spremljajo.
English: What is Zydelig and what is it used for?
Slovenian: Kaj je zdravilo Zydelig in za kaj se uporablja?
English: The recommended dose is 150 mg twice a day, and treatment should be continued for as long as the patient improves or remains stable and the side effects are tolerable.
Slovenian: Priporočeni odmerek je 150 mg dvakrat na dan, zdravljenje pa se mora nadaljevati, dokler se bolnikovo stanje izboljšuje ali ostaja stabilno, neželeni učinki pa so znosni.
English: What benefits of Zydelig have been shown in studies?
Slovenian: Kakšne koristi zdravila Zydelig so se pokazale v študijah?
English: An overview of Zydelig and why it is authorised in the EU
Slovenian: Pregled zdravila Zydelig in zakaj je odobreno v EU
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zydelig have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Zydelig upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: This enzyme plays a role in the growth, migration and survival of white blood cells but is overactive in blood cancers, where it enables the survival of the cancer cells.
Slovenian: Ta encim sodeluje pri rasti, migraciji in preživetju belih krvnih celic, vendar je preveč dejaven pri krvnem raku, kjer omogoča preživetje rakavih celic.
English: Side effects reported with Zydelig are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Zydelig, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: What are the risks associated with Zydelig?
Slovenian: Kakšna tveganja so povezana z zdravilom Zydelig?
English: Zydelig should not be started in patients with any generalised infection (infection that has spread with symptoms affecting the whole body, such as fever and chills).
Slovenian: Zdravilo Zydelig se ne sme uporabljati pri bolnikih s kakršno koli generalizirano okužbo (okužbo, ki se je razširila, s simptomi, ki vplivajo na celotno telo, kot so povišana telesna temperatura in mrzlica).
English: The European Medicines Agency noted that data from the main studies showed high response rates with Zydelig in patients with chronic lymphocytic leukaemia and follicular lymphoma.
Slovenian: Evropska agencija za zdravila je ugotovila, da so podatki iz glavnih študij pokazali visoke stopnje odziva na zdravilo Zydelig pri bolnikih s kronično limfocitno levkemijo in folikularnim limfomom.
English: For more information about using Zydelig, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Zydelig glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Zydelig can only be obtained with a prescription and it should be prescribed by a doctor experienced in using cancer medicines.
Slovenian: Predpisovanje in izdaja zdravila Zydelig je le na recept, zdravljenje z njim pa mora predpisati zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
English: By targeting this enzyme and blocking its effects, idelalisib causes death of the cancer cells, thereby delaying or stopping the progression of the cancer.
Slovenian: Idelalisib z delovanjem na ta encim in zaviranjem njegovih učinkov povzroči odmrtje rakavih celic, s čimer se upočasni ali zaustavi napredovanje raka.
English: Zydelig was effective, with 54% of patients with follicular lymphoma having either a complete or partial response to treatment.
Slovenian: Zdravilo Zydelig je bilo učinkovito, saj je pri 54 % bolnikov s folikularnim limfomom prišlo bodisi do popolnega bodisi delnega odziva na zdravljenje.
English: The active substance in Zydelig, idelalisib, blocks the effects of an enzyme called PI3K-delta.
Slovenian: Učinkovina v zdravilu Zydelig, idelalisib, zavira učinke encima, imenovanega PI3K-delta.
English: Zydelig was also more effective than placebo in patients who had a specific genetic mutation in their cancer cells that makes them unsuitable for certain other therapies.
Slovenian: Zdravilo Zydelig je bilo učinkovitejše od placeba tudi pri bolnikih, ki so imeli posebno gensko mutacijo v rakavih celicah, zaradi česar niso primerni za nekatere druge vrste zdravljenj.
English: The most common side effects with Zydelig (which may affect more than 1 in 10 people) are infections (including lung infection caused by Pneumocystis jirovecii, and cytomegalovirus infections), neutropenia (low levels of neutrophils, a type of white blood cell), lymphocytosis (increased levels of lymphocytes, another type of white blood cell), diarrhoea, blood tests showing changes in the liver, rash, fever and increased blood fat levels.
Slovenian: Najpogostejši neželeni učinki zdravila Zydelig (ki se lahko pojavijo pri več kot 1 od 10 bolnikov) so okužbe (vključno z okužbo pljuč, ki jo povzroča bakterija Pneumocystis jirovecii, in okužbe s citomegalovirusi), nevtropenija (nizke ravni nevtrofilcev, tj. vrste belih krvnih celic), limfocitoza (povečane ravni limfocitov, tj. druge vrste belih krvnih celic), driska, rezultati krvnih preiskav, ki kažejo spremembe na jetrih, izpuščaj, povišana telesna temperatura in povišane ravni maščob v krvi.
English: For the full list of side effects and restrictions of Zydelig, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zydelig glejte navodilo za uporabo.
English: How is Zydelig used?
Slovenian: Kako se zdravilo Zydelig uporablja?
English: In a main study of 220 patients with previously treated CLL, Zydelig was more effective at treating the cancer than placebo (a dummy treatment) when both were given in combination with rituximab: 75% of patients taking Zydelig had an improvement in their disease compared with 15% of patients receiving placebo.
Slovenian: V glavni študiji pri 220 bolnikih s predhodno zdravljeno kronično limfocitno levkemijo je bilo zdravilo Zydelig učinkovitejše pri zdravljenju raka kot placebo (zdravilo brez učinkovine), pri čemer sta bila oba dana v kombinaciji z rituksimabom: do izboljšanja bolezenskega stanja je prišlo pri 75 % bolnikov, ki so prejemali zdravilo Zydelig, v primerjavi s 15 % bolnikov, ki so prejemali placebo.
English: In a study of 261 previously treated CLL patients, it took over 16 months on average before the disease got worse in patients treated with Zydelig plus ofatumumab, compared with 8 months in those treated with ofatumumab alone.
Slovenian: V študiji, v kateri je sodelovalo 261 predhodno zdravljenih bolnikov s kronično limfocitno levkemijo, se je bolezen v povprečju poslabšala po več kot 16 mesecih v primerjavi z 8 meseci pri bolnikih, ki so jih zdravili samo z ofatumumabom.
English: In follicular lymphoma, Zydelig is used on its own in patients whose disease has not improved with two previous treatments.
Slovenian: Pri folikularnem limfomu se zdravilo Zydelig uporablja kot samostojno zdravilo pri bolnikih, katerih bolezen se po dveh predhodnih zdravljenjih ni izboljšala.
English: Another main study evaluated Zydelig in patients with different lymphomas, including 72 patients with follicular lymphoma that had failed two previous treatments.
Slovenian: V drugi glavni študiji so proučevali zdravilo Zydelig pri bolnikih z različnimi limfomi, vključno z 72 bolniki s folikularnim limfomom, pri katerih sta bili dve predhodni zdravljenji neuspešni.
English: Zydelig was also effective in chronic lymphocytic leukaemia patients whose cancer cells have the 17p deletion or TP53 mutation, who usually have a poor outcome.
Slovenian: Zdravilo Zydelig je bilo učinkovito tudi pri bolnikih s kronično limfocitno levkemijo, katerih rakave celice imajo delecijo 17p ali mutacijo TP53, pri katerih je izid zdravljenja običajno slab.
English: Zydelig is a cancer medicine that is used to treat chronic lymphocytic leukaemia (CLL, a cancer of a type of white blood cells called B lymphocytes) and follicular lymphoma (another cancer that affects B lymphocytes).
Slovenian: Zydelig je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje kronične limfocitne levkemije (KLL, raka vrste belih krvnih celic, imenovanih limfociti B) in folikularnega limfoma (druge vrste raka, ki prizadene limfocite B).
English: In CLL, Zydelig is used in combination with another medicine (rituximab or ofatumumab) in patients who have received at least one previous treatment and in patients whose cancer cells have genetic mutations (changes) called 17p deletion or TP53 mutation and who cannot be treated with any other therapy.
Slovenian: Pri kronični limfocitni levkemiji se zdravilo Zydelig uporablja v kombinaciji z drugim zdravilom (rituksimabom ali ofatumumabom) pri bolnikih, ki so prejemali vsaj eno predhodno zdravljenje, in pri bolnikih, ki imajo v rakavih celicah genske mutacije (spremembe), imenovane delecija 17p ali mutacija TP53, in katerih ni mogoče zdraviti z nobenim drugim zdravljenjem.
English: How does Zydelig work?
Slovenian: Kako zdravilo Zydelig deluje?
English: Zydelig contains the active substance idelalisib.
Slovenian: Zdravilo Zydelig vsebuje učinkovino idelalisib.
English: Zydelig with ofatumumab was more effective than ofatumumab alone in the treatment of CLL.
Slovenian: Zdravilo Zydelig v kombinaciji z ofatumumabom je bilo pri zdravljenju kronične limfocitne levkemije učinkovitejše od ofatumumaba kot samostojnega zdravila.
English: All patients treated with Zydelig should also be given preventive medication against the lung infection Pneumocystis jirovecii pneumonia, and this should be continued for up to 6 months after stopping treatment with Zydelig.
Slovenian: Vsi bolniki, zdravljeni z zdravilom Zydelig, morajo prejemati tudi preventivno zdravilo proti okužbi pljuč s pljučnico, ki jo povzroča bakterija Pneumocystis jirovecii.
English: Wash your hands.
Slovenian: Umijte si roke.
English: • At the request of the European Medicines Agency.
Slovenian: • na zahtevo Evropske agencije za zdravila;
English: Please read the instructions carefully and follow them step by step.
Slovenian: Pozorno preberite navodila in jih upoštevajte korak za korakom.
English: General information:
Slovenian: Splošne informacije:
English: Then start the rotation again.
Slovenian: Potem ponovno začnite krožiti.
English: Lay out everything you need in advance.
Slovenian: Vnaprej si pripravite vse, kar potrebujete.
English: It is important to have your hands and the items you use as clean as possible.
Slovenian: Pomembno je, da so vaše roke in vse, kar boste uporabili, kar najbolj čisti.
English: This makes it easier to remember it.
Slovenian: Na ta način si boste to lažje zapomnili.
English: 1 ml contains:
Slovenian: 1 ml vsebuje:
English: 2 years.
Slovenian: 3 meseci.
English: The dose will depend on your condition.
Slovenian: Odmerek je odvisen od vašega stanja.
English: No fertility studies have been performed (see section 5.3).
Slovenian: Plodnost Študij plodnosti niso izvedli (glejte poglavje 5.3).
English: Always double-check the dose.
Slovenian: Odmerek vedno dvakrat preverite.
English: Your doctor will be able to explain this to you.
Slovenian: Vaš zdravnik vam bo to lahko pojasnil.
English: This half-life may vary from patient to patient.
Slovenian: Razpolovni čas se lahko od bolnika do bolnika razlikuje.
English: Let the skin air-dry.
Slovenian: Koža naj se posuši na zraku.
English: All patients used antiviral medicine.
Slovenian: Vsi bolniki so uporabljali protivirusna zdravila.
English: No re-infection was observed.
Slovenian: Ponovnih okužb niso opazili.
English: No other non-clinical trials have been carried out.
Slovenian: Druga neklinična preskušanja niso bila izvedena.
English: Please note that alcohol swabs and needles are not contained in the pack and you need to supply them yourself.
Slovenian: Upoštevajte, da alkoholne krpice in igle niso vsebovane v pakiranju in si jih morate priskrbeti sami.
English: In most cases you will be given the injection by your doctor or nurse.
Slovenian: V večini primerov vam bo injekcijo dal vaš zdravnik ali medicinska sestra.
English: Your doctor will explain you how to use it.
Slovenian: Vaš zdravnik vam bo razložil, kako ga uporabljajte.
English: Rotating sites means starting at one site and using all other sites before going back to the first site you used.
Slovenian: Krožiti z mesti injiciranja pomeni, da začnete na enem mestu in uporabite vsa druga možna mesta, preden se vrnete na mesto, ki ste ga uporabili najprej.
English: All other patients should be observed for at least 20 minutes after administration.
Slovenian: Vse druge bolnike je treba opazovati najmanj 20 minut po dajanju zdravila.
English: An updated RMP should be submitted
Slovenian: Posodobljen RMP je treba predložiti:
English: The individual treatment duration per patient was planned to be up to 24 weeks after transplantation.
Slovenian: Načrtovano trajanje zdravljenja posameznega bolnika je bilo 24 tednov po presaditvi.
English: For your own safety you will be monitored for antibody levels regularly.
Slovenian: Za vašo lastno varnost bodo pri vas redno spremljali raven protiteles.
English: True hypersensitivity reactions are rare.
Slovenian: Prave preobčutljivostne reakcije so redke.
English: Before the injection:
Slovenian: Pred injiciranjem:
English: For safety information with respect to transmissible agents, see section 4.4.
Slovenian: Za informacije o varnosti glede prenosljivih povzročiteljev bolezni glejte poglavje 4.4.
English: Inject beneath the skin as you have been shown by the doctor or nurse.
Slovenian: Injicirajte pod kožo kot vam je pokazal zdravnik ali medicinska sestra.
English: Try to take the injection at the same time of day.
Slovenian: Poskusite si dati injekcijo vedno ob istem času dneva.
English: It's important to change (rotate) the injection sites.
Slovenian: Pomembno je, da spreminjate (krožite) mesta injiciranja.
English: Avoid surgical scars.
Slovenian: Izogibajte se kirurškim brazgotinam.
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru pojava šoka je treba uvesti standardno zdravljenje šoka.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
English: This is very rare and may result in allergic reactions.
Slovenian: To je zelo redko in lahko vodi v alergijsko reakcijo.
English: 4.6 Fertility, pregnancy and lactation
Slovenian: 4.6 Plodnost, nosečnost in dojenje Nosečnost
English: IgG and IgG-complexes are broken down in the reticuloendothelial system.
Slovenian: Biotransformacija IgG in kompleksi IgG se razgradijo v retikuloendotelijskem sistemu.
English: This will help the skin stay supple and help the medicine be absorbed evenly.
Slovenian: To pomaga ohranjati kožo prožno in pomaga pri enakomerni absorpciji zdravila.
English: Possible interference with blood tests
Slovenian: Možni vplivi na krvne preiskave
English: Do not inject into a blood vessel.
Slovenian: Ne injicirajte ga v krvno žilo.
English: Zutectra might affect the results of certain blood tests (serological tests).
Slovenian: Zdravilo Zutectra lahko vpliva na izide nekaterih krvnih preiskav (seroloških testov).
English: Fatigue, tiredness
Slovenian: srbenje, sopenje,