natgillin/translations-raw huggingface dataset:
What benefits of Zydelig have been shown in studies? 
Kakšne koristi zdravila Zydelig so se pokazale v študijah?
An overview of Zydelig and why it is authorised in the EU 
Pregled zdravila Zydelig in zakaj je odobreno v EU
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. 
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.
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. 
Ta encim sodeluje pri rasti, migraciji in preživetju belih krvnih celic, vendar je preveč dejaven pri krvnem raku, kjer omogoča preživetje rakavih celic.
Side effects reported with Zydelig are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Zydelig, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What are the risks associated with Zydelig? 
Kakšna tveganja so povezana z zdravilom Zydelig?
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). 
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).
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. 
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.
For more information about using Zydelig, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Zydelig glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Zydelig can only be obtained with a prescription and it should be prescribed by a doctor experienced in using cancer medicines. 
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.
By targeting this enzyme and blocking its effects, idelalisib causes death of the cancer cells, thereby delaying or stopping the progression of the cancer. 
Idelalisib z delovanjem na ta encim in zaviranjem njegovih učinkov povzroči odmrtje rakavih celic, s čimer se upočasni ali zaustavi napredovanje raka.
Zydelig was effective, with 54% of patients with follicular lymphoma having either a complete or partial response to treatment. 
Zdravilo Zydelig je bilo učinkovito, saj je pri 54 % bolnikov s folikularnim limfomom prišlo bodisi do popolnega bodisi delnega odziva na zdravljenje.
The active substance in Zydelig, idelalisib, blocks the effects of an enzyme called PI3K-delta. 
Učinkovina v zdravilu Zydelig, idelalisib, zavira učinke encima, imenovanega PI3K-delta.
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. 
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.
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. 
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.
For the full list of side effects and restrictions of Zydelig, see the package leaflet. 
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Zydelig glejte navodilo za uporabo.
How is Zydelig used? 
Kako se zdravilo Zydelig uporablja?
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. 
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.
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. 
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.
In follicular lymphoma, Zydelig is used on its own in patients whose disease has not improved with two previous treatments. 
Pri folikularnem limfomu se zdravilo Zydelig uporablja kot samostojno zdravilo pri bolnikih, katerih bolezen se po dveh predhodnih zdravljenjih ni izboljšala.
Another main study evaluated Zydelig in patients with different lymphomas, including 72 patients with follicular lymphoma that had failed two previous treatments. 
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.
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. 
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.
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). 
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).
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. 
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.
How does Zydelig work? 
Kako zdravilo Zydelig deluje?
Zydelig contains the active substance idelalisib. 
Zdravilo Zydelig vsebuje učinkovino idelalisib.
Zydelig with ofatumumab was more effective than ofatumumab alone in the treatment of CLL. 
Zdravilo Zydelig v kombinaciji z ofatumumabom je bilo pri zdravljenju kronične limfocitne levkemije učinkovitejše od ofatumumaba kot samostojnega zdravila.
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. 
Vsi bolniki, zdravljeni z zdravilom Zydelig, morajo prejemati tudi preventivno zdravilo proti okužbi pljuč s pljučnico, ki jo povzroča bakterija Pneumocystis jirovecii.
Wash your hands. 
Umijte si roke.
• At the request of the European Medicines Agency. 
• na zahtevo Evropske agencije za zdravila;
Please read the instructions carefully and follow them step by step. 
Pozorno preberite navodila in jih upoštevajte korak za korakom.
General information: 
Splošne informacije:
Then start the rotation again. 
Potem ponovno začnite krožiti.
Lay out everything you need in advance. 
Vnaprej si pripravite vse, kar potrebujete.
It is important to have your hands and the items you use as clean as possible. 
Pomembno je, da so vaše roke in vse, kar boste uporabili, kar najbolj čisti.
This makes it easier to remember it. 
Na ta način si boste to lažje zapomnili.
1 ml contains: 
1 ml vsebuje:
2 years. 
3 meseci.
The dose will depend on your condition. 
Odmerek je odvisen od vašega stanja.
No fertility studies have been performed (see section 5.3). 
Plodnost Študij plodnosti niso izvedli (glejte poglavje 5.3).
Always double-check the dose. 
Odmerek vedno dvakrat preverite.
Your doctor will be able to explain this to you. 
Vaš zdravnik vam bo to lahko pojasnil.
This half-life may vary from patient to patient. 
Razpolovni čas se lahko od bolnika do bolnika razlikuje.
Let the skin air-dry. 
Koža naj se posuši na zraku.
All patients used antiviral medicine. 
Vsi bolniki so uporabljali protivirusna zdravila.
No re-infection was observed. 
Ponovnih okužb niso opazili.
No other non-clinical trials have been carried out. 
Druga neklinična preskušanja niso bila izvedena.
Please note that alcohol swabs and needles are not contained in the pack and you need to supply them yourself. 
Upoštevajte, da alkoholne krpice in igle niso vsebovane v pakiranju in si jih morate priskrbeti sami.
In most cases you will be given the injection by your doctor or nurse. 
V večini primerov vam bo injekcijo dal vaš zdravnik ali medicinska sestra.
Your doctor will explain you how to use it. 
Vaš zdravnik vam bo razložil, kako ga uporabljajte.
Rotating sites means starting at one site and using all other sites before going back to the first site you used. 
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.
All other patients should be observed for at least 20 minutes after administration. 
Vse druge bolnike je treba opazovati najmanj 20 minut po dajanju zdravila.
An updated RMP should be submitted 
Posodobljen RMP je treba predložiti:
The individual treatment duration per patient was planned to be up to 24 weeks after transplantation. 
Načrtovano trajanje zdravljenja posameznega bolnika je bilo 24 tednov po presaditvi.
For your own safety you will be monitored for antibody levels regularly. 
Za vašo lastno varnost bodo pri vas redno spremljali raven protiteles.
True hypersensitivity reactions are rare. 
Prave preobčutljivostne reakcije so redke.
Before the injection: 
Pred injiciranjem:
For safety information with respect to transmissible agents, see section 4.4. 
Za informacije o varnosti glede prenosljivih povzročiteljev bolezni glejte poglavje 4.4.
Inject beneath the skin as you have been shown by the doctor or nurse. 
Injicirajte pod kožo kot vam je pokazal zdravnik ali medicinska sestra.
Try to take the injection at the same time of day. 
Poskusite si dati injekcijo vedno ob istem času dneva.
It's important to change (rotate) the injection sites. 
Pomembno je, da spreminjate (krožite) mesta injiciranja.
Avoid surgical scars. 
Izogibajte se kirurškim brazgotinam.
In case of shock, standard medical treatment for shock should be implemented. 
V primeru pojava šoka je treba uvesti standardno zdravljenje šoka.
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
This is very rare and may result in allergic reactions. 
To je zelo redko in lahko vodi v alergijsko reakcijo.
4.6 Fertility, pregnancy and lactation 
4.6 Plodnost, nosečnost in dojenje Nosečnost
IgG and IgG-complexes are broken down in the reticuloendothelial system. 
Biotransformacija IgG in kompleksi IgG se razgradijo v retikuloendotelijskem sistemu.
This will help the skin stay supple and help the medicine be absorbed evenly. 
To pomaga ohranjati kožo prožno in pomaga pri enakomerni absorpciji zdravila.
Possible interference with blood tests 
Možni vplivi na krvne preiskave
Do not inject into a blood vessel. 
Ne injicirajte ga v krvno žilo.
Zutectra might affect the results of certain blood tests (serological tests). 
Zdravilo Zutectra lahko vpliva na izide nekaterih krvnih preiskav (seroloških testov).
Fatigue, tiredness 
srbenje, sopenje,
For subcutaneous use only. 
Samo za subkutano uporabo.
However, if your antibody levels are sufficient and you have a fixed dose regimen, you or your caregiver may be trained to carry out the injection at home (see below). 
Če pa je raven vaših protiteles zadostna in imate ustaljeno odmerno shemo, se lahko vi ali vaše negovalno osebje naučite dajati injekcijo doma (glejte spodaj).
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose. 
V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
This can be an allergic reaction or a serious allergic reaction (anaphylactic shock). 
To je lahko alergijska reakcija ali resna alergijska reakcija (anafilaktični šok).
Interference with serological testing 
Vpliv na serološko testiranje
Carefully push the plunger in until the air bubbles have disappeared. 
Previdno potiskajte bat, dokler vsi zračni mehurčki ne izginejo.
This medicine must not be mixed with other medicines. 
Zdravila ne smete mešati z drugimi zdravili.
Dispose of all used items 
Zavrzite vse uporabljene stvari
All patients included in this study had to run through a training period of at least 29 days and home self-administration could start on day 36 at the earliest. 
Vsi bolniki, vključeni v študijo, so morali opraviti obdobje usposabljanja, ki je trajalo vsaj 29 dni, samoinjiciranje pa se je lahko najprej začelo šele
This also applies to unknown or emerging viruses and other pathogens. 
To velja tudi za neznane ali pojavljajoče se viruse in druge povzročitelje bolezni.
If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time. 
Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
Consequences of an overdose are not known. 
Posledice prevelikega odmerjanja niso znane.
The doctor or his/her assistant will teach you the process of administration. 
Zdravnik ali njegov asistent vas bo naučil izpeljati postopek injiciranja.
There is no data about efficacy in post-exposure prophylaxis. 
O učinkovitosti zdravila pri postekspozicijski profilaksi ni podatkov.
You may have to wait at least 3 months after the last injection of Zutectra before you can have live attenuated vaccines. 
Morda boste morali počakati najmanj 3 mesece po zadnji injekciji zdravila Zutectra, preden boste lahko opravili cepljenja z živim oslabljenimi cepivi.
The mean anti-HBs serum level before switching was 393 ± 139 IU/l. 
Srednja raven anti-HB v serumu pred zamenjavo je bila 393±139 i.e./l.
It should be clear and contain no particles. 
Biti mora bistra in brez delcev.
Tell your doctor or healthcare professional if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali zdravstvenega delavca, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
The effects were grouped by system organ classes under relevant medical headings. 
Učinki so bili razporejeni po skupinah glede na organske sisteme pod ustreznimi medicinskimi nazivi.
Do not attempt to inject Zutectra until you are sure that you understand how to prepare the injection solution and give the injection. 
Ne poskušajte injicirati, dokler niste prepričani, da ste razumeli, kako pripraviti injekcijsko raztopino in kako dati injekcijo.
SPCare Especialidades Farmacêuticas, Lda Rua Luciano Cordeiro, nº 123, 1º dto. 
Rua Luciano Cordeiro, nº 123, 1º dto.
If the solution is discoloured, cloudy or contains particles, discard it and start again with a new syringe. 
Če je raztopina razbarvana, motna ali vsebuje delce, jo zavrzite in ponovno začnite z novo injekcijsko brizgo.
The physician must therefore weigh the benefit of treatment with Zutectra against the potential risk of hypersensitivity reactions. 
Zdravnik mora zato pretehtati korist zdravljenja z zdravilom Zutectra v primerjavi z možnim tveganjem za pojav preobčutljivostnih reakcij.
After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing. 
Po injiciranju imunoglobulinov lahko prehodno zvišanje različnih pasivno prenesenih protiteles v bolnikovi krvi vodi v zavajajoče pozitivne rezultate serološkega testiranja.
The starting material or what Zutectra is made from is human blood plasma (this is the liquid part of the blood). 
Izhodiščni material za izdelavo zdravila Zutectra je človeška krvna plazma (to je tekoči del krvi).
If you have an allergic reaction to Zutectra, the injection will be stopped immediately. 
Če boste imeli alergijsko reakcijo na zdravilo Zutectra, bodo injiciranje takoj ustavili.
Zutectra contains a small quantity of IgA. 
Zdravilo Zutectra vsebuje majhno količino IgA.
Information on the starting material of Zutectra and the possibility of transmission of infectious agents: 
Informacija o izhodiščnem materialu za zdravilo Zutectra in možnosti prenosa povzročiteljev nalezljivih bolezni:
No patient prematurely discontinued the study due to lack of feasibility of home self-treatment. 
Noben od bolnikov ni predčasno prenehal sodelovati v študiji, ker samoinjiciranje doma ne bi bilo mogoče.
Choose the area where you will make the injection and make a note of it in the diary. 
Izberite predel, kamor boste injicirali zdravilo, in ga zabeležite v dnevnik.
A failure rate of 0 % was also found for the facultative extension phase (week 24) (95 % CI: [0, 20.6 %]) 
Stopnja osipa je tudi v fakultativni podaljšani fazi (teden 24) (95-% IZ: [0; 20,6 %]) znašala 0 %.
With the exception of 6 patients who withdrew prior to day 36, all patients achieved complete hospital and home self-administration. 
36. dan. Z izjemo 6 bolnikov, ki so pred 36. dnem prenehali sodelovati, so vsi bolniki končali uporabo v bolnišnici in samoinjiciranje doma.
This recommendation applies also for documentation in the treatment diary during self-administration of the medicinal product in a home treatment. 
Ta priporočila veljajo tudi za dokumentiranje v dnevniku zdravljenja ob samoinjiciranju zdravila pri zdravljenju na domu.
Patients must be monitored for serum anti-HBs antibody levels regularly. 
Pri bolnikih je treba redno spremljati serumske ravni protiteles proti HBs.
Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected. 
Klinične izkušnje z imunoglobulini nakazujejo, da ni pričakovati škodljivih vplivov na potek nosečnosti, na plod in na novorojenčka.
The contents of one syringe are intended for use once only. 
Vsebina ene injekcijske brizge je namenjena samo za enkratno uporabo.
The administration in thighs is shown as an example in the following pictures: 
Dajanje zdravila v stegno je kot primer prikazano z naslednjimi sličicami:
You should inject Zutectra into the fatty layer between the skin and muscle (about 8 to 12 mm under the skin). 
Zdravilo Zutectra morate injicirati v maščobni sloj med kožo in mišico (približno od 8 do 12 mm pod površino kože).
The following instructions are intended to explain how to inject Zutectra. 
Naslednja navodila so namenjena razlagi, kako injicirate zdravilo Zutectra.
Zutectra has a half-life of about 3-4 weeks. 
Izločanje Razpolovni čas zdravila Zutectra je približno 3-4 tedne.
Patients should be HBsAg negative before treatment start. 
Bolniki morajo biti pred začetkom zdravljenja HBsAg-negativni.
No hepatitis B reinfection was reported and no patient was tested HBsAg positive during the treatment period of 48 weeks. 
Niso poročali o ponovni okužbi s hepatitisom B in noben bolnik ni imel pozitivnih testov na HBsAg med 48-tedenskim obdobjem zdravljenja.
Open each syringe only when you are ready for an injection. 
Vsako injekcijsko brizgo odprite šele, ko ste pripravljeni za injiciranje.
You may be allergic to immunoglobulins (antibodies) without knowing it, even if you have tolerated previous treatments with human immunoglobulins. 
Možno je, da ste alergični na imunoglobuline (protitelesa), ne da bi to vedeli, celo če ste predhodna zdravljenja s humanimi imunoglobulini dobro prenašali.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to human immunoglobulins. 
Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali na humane imunoglobuline.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or healthcare professional for advice before taking this medicine. 
Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali zdravstvenim delavcem, preden vzamete to zdravilo.
Talk to the doctor or healthcare professional about these or any other unusual conditions you may find. 
Z zdravnikom ali strokovnim zdravstvenim delavcem se pogovorite o vsakem neobičajnem stanju, ki ga opazite.
At the time of transplantation 21 patients (42.9%) were tested positive for HDV, patients with a positive HIV or HCV test were excluded from study participation. 
Ob času presaditve je imelo 21 bolnikov (42,9 %) pozitiven rezultat testa za HDV, medtem ko so bolnike s pozitivnim rezultatom testa za HIV ali HCV izključili iz študije.
Gently pinch the skin together around the disinfected injection site (to raise it up a little) and push the needle into the skin with a rapid, confident movement at an angle of 45 to 90 degrees. 
Nežno stisnite kožo okrog dezinficiranega mesta (in jo nekoliko privzdignite) ter iglo potisnite v kožo s hitrim, odločnim gibom pod kotom od 45 do 90 stopinj.
Distribution of IgG subclasses: IgG1: 
Porazdelitev podrazredov IgG: IgG1:
Injection into a vein or a blood vessel may result in allergic shock. 
Injiciranje v veno ali krvno žilo lahko povzroči alergijski šok.
If the recipient is a carrier of HBsAg, there is no benefit in administering this medicinal product. 
Če je prejemnik zdravila nosilec HBsAg, od dajanja tega zdravila ne bo nobene koristi.
Abdomen (stomach): Do not use the area within one inch around the navel. 
Abdomen (trebuh): Ne uporabljajte predela v širini enega palca (2,5 cm) okrog popka.