natgillin/translations-raw huggingface dataset:
The patient's condition should be evaluated continuously. 
Bolnikovo stanje je treba stalno ocenjevati.
Slowly move your thumb back 
Počasi odmaknite palec nazaj
• if you have had cancer. 
• Če ste kdaj imeli raka.
The majority (94.6%) of patients were female. 
Večina vključenih (94,6 %) bolnikov je bila žensk.
Efficacy was evaluated in 448 patients. 
Učinkovitost so ocenili pri 448
28 February 
28. februar
This could increase your risk of a serious infection. 
To vam lahko poveča tveganje za resno okužbo.
Symptoms of PML include: 
Med simptomi PML so:
It is normal to see one or more air bubbles in the solution. 
Normalno je, da v raztopini vidite enega ali več zračnih mehurčkov.
This medicine is not intended for use in children younger than 5 years of age. 
To zdravilo ni namenjeno uporabi pri otrocih, mlajših od 5 let.
Take a dose on the new day (even if it is less than a week since your last dose). 
Uporabite odmerek na novi dan (tudi če je to manj kot en teden od zadnjega odmerka).
In both studies the primary efficacy endpoint was evaluated at 52 weeks. 
V obeh študijah so primarni opazovani dogodek učinkovitosti ocenili po 52 tednih.
Gently swirl the vial for 60 seconds. 
Vialo nežno vrtite 60 sekund.
• Do not inject into the exact same site each time. 
• Ne injicirajte vsakič na isto mesto.
Continue with the new weekly schedule from that day. 
Nadaljujte z novim tedenskim urnikom od tega dne naprej.
This is important so that you can confirm a complete dose. 
To je pomembno, da boste lahko potrdili injiciranje celotnega odmerka.
A risk for indirect reduction of CYP activity by belimumab cannot be excluded. 
Tveganja za posredno zmanjšanje aktivnosti CYP z belimumabom ni mogoče izključiti.
If you already had these symptoms before you started treatment with Benlysta: Tell your doctor immediately if you notice any changes in these symptoms. 
Če ste te simptome imeli, že preden ste začeli zdravljenje z zdravilom Benlysta: Zdravnika nemudoma obvestite, če opazite kakršno koli spremembo teh simptomov.
If you experience these symptoms, particularly if you get two or more of them together: 
Če se vam pojavijo ti simptomi, še zlasti, če se vam pojavita dva ali več skupaj:
The majority did not necessitate drug discontinuation. 
Večina jih ni zahtevala prenehanja uporabe zdravila.
second “click” 
Drugi “klik”
Adults and children (5 years of age and older) 
Odrasli in otroci (stari 5 let in več)
Increased risk of brain infection 
Večje tveganje za okužbo možganov
If you get any of the following symptoms of an infection: 
Če se vam pojavi kateri od naslednjih simptomov okužbe:
The injection may take up to 15 seconds to complete. 
Injiciranje lahko traja do 15 sekund, preden je končano.
BLISS-76 was conducted primarily in North America and Western Europe. 
Študija BLISS-76 je bila izvedena predvsem v severni Ameriki in zahodni Evropi.
**Applies to subcutaneous formulation only. 
**Velja le za subkutano obliko.
No formal studies have been conducted. 
Formalnih študij niso izvedli.
You will see the purple indicator start to move through the inspection window. 
Videli boste, da se bo vijoličasti kazalnik začel premikati skozi okence za ogled.
Data on patients ≥65 years are limited to <1.8% of the studied population. 
starih 65 let in več, so omejeni na < 1,8 % raziskovane populacije.
No suicide was reported in either group. 
V nobeni skupini niso poročali o samomoru.
The needle will automatically rise up into the needle guard. 
Igla se bo samodejno dvignila v ščitnik igle.
The expiry date refers to the last day of that month. 
Uporabno do. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
You will be checked closely and if you do have any reactions these will be treated. 
Natančno vas bodo nadzirali; če bi se vam pojavila kakšna reakcija, jo bodo zdravili.
For example, do not warm it in a microwave oven, hot water or direct sunlight. 
Ne segrevajte ga na primer v mikrovalovni pečici, vroči vodi ali na neposredni sončni svetlobi.
• pain in hands or feet 
• bolečine v dlaneh ali stopalih,
It is not necessary to administer two doses on the same day. 
Uporaba dveh odmerkov na isti dan ni potrebna.
Allow the skin to air dry. 
Pustite, da se koža posuši.
Component of a multipack. 
Sestavina skupnega pakiranja.
Reconstitution and dilution must be carried out under aseptic conditions. 
Rekonstitucija in redčenje morata biti opravljena v aseptičnih pogojih.
The safety data presented include data beyond Week 52 in some patients. 
Predstavljeni podatki o varnosti pri nekaterih bolnikih vključujejo podatke preko 52. tedna.
Exp: Month - Year 
Exp: Mesec- Leto
Inject the missed dose as soon as you remember. 
Injicirajte pozabljeni odmerek, čim se spomnite.
In particular tell your doctor if you are being treated with medicines that affect your immune system: 
Še zlasti morate zdravnika obvestiti, če se zdravite z zdravili, ki vplivajo na imunski sistem:
The SLE Responder Index measures improvement in SLE disease activity, without worsening in any organ system, or in the patient's overall condition. 
Indeks odziva SLE meri izboljšanje aktivnosti SLE brez poslabšanja v kateremkoli organskem sistemu ali bolnikovem splošnem stanju.
Depression can affect up to 1 in 10 people, suicidal thoughts and suicide attempts can affect up to 1 in 100 people. 
Depresija se lahko pojavi pri največ 1 od 10 bolnikov, samomorilne misli in poskusi samomora pa se lahko pojavijo pri največ 1 od 100 bolnikov.
• if you are allergic to belimumab or any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na belimumab ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
Some infections were severe or fatal. 
Nekatere okužbe so bile hude ali s smrtnim izidom.
Response, n (%) 
Odziv, n (%)
Following subcutaneous administration the bioavailability of belimumab was approximately 74%. 
Po subkutani uporabi je bila biološka uporabnost belimumaba približno 74 %.
If you experience new or worsening symptoms at any time: 
Če se vam kadarkoli pojavijo novi ali poslabšani simptomi:
The risk of using Benlysta in patients with active or latent tuberculosis is unknown. 
Tveganje uporabe zdravila Benlysta pri bolnikih z aktivno ali latentno tuberkulozo ni znano.
Safety data in children younger than 12 years of age (n=10) are limited. 
Na voljo so omejeni podatki o varnosti pri otrocih, mlajših od 12 let (n=10).
Keeping hold of the syringe, slowly move your thumb back, allowing the plunger to rise up (Figure 9). 
Medtem ko brizgo še držite, počasi odmaknite palec, tako da se bo bat lahko dvignil (Slika 9).
• swelling of the face, lips, mouth or tongue 
• oteklost obraza, ustnic, ust ali jezika,
• low white blood cell count (can be seen in blood tests) 
• majhno število belih krvnih celic (razvidno iz krvnih preiskav),
Psychiatric disorders also includes data from a post-marketing study. 
Psihiatrične motnje vključujejo tudi podatke študije iz obdobja trženja.
In patients who experience such symptoms, treatment discontinuation should be considered. 
Pri bolnikih, pri katerih se pojavijo takšni simptomi, je treba razmisliti o prenehanju zdravljenja.
Your doctor or nurse will also tell you what signs and symptoms to look out for when using Benlysta, because serious allergic reactions can occur (see ‘Allergic reactions' in section 4). 
Zdravnik ali medicinska sestra vam bosta tudi povedala, na katere znake in simptome morate biti pozorni med uporabo zdravila Benlysta, kajti pojavijo se lahko resne alergijske reakcije (glejte "Alergijske reakcije" v 4. poglavju).
Age and race 
Starost in rasa
Tell your doctor. 
Obvestite zdravnika.
There is insufficient knowledge to determine whether premedication could diminish the frequency or severity of infusion reactions. 
Ni dovolj znanja, da bi lahko ugotovili, ali premedikacija zmanjša pogostnost ali izrazitost infuzijskih reakcij.
* All patients received standard therapy 
* Vsi bolniki so prejeli standardno zdravljenje
Percent of patients with reduction in SELENASLEDAI ≥4 
Odstotek bolnikov z zmanjšanjem SELENASLEDAI ≥ 4
Make sure the gold needle guard is flat on the skin. 
Preverite, da je zlati ščitnik igle plosko na koži.
first “click” 
Prvi “klik”
• Keep refrigerated until 30 minutes before use. 
• Zdravilo shranjujte v hladilniku do 30 minut pred uporabo.
Supplies you need for the injection 
Pribor, ki ga potrebujete za injiciranje
There are insufficient data to draw conclusions regarding response to other vaccines. 
Za sklepanje o odzivu na druga cepiva ni dovolj podatkov.
• Hold the syringe in one hand. 
• Držite injekcijsko brizgo v eni roki.
In one study in paediatric patients (6 to 17 years of age) the pharmacodynamic response was consistent with the adult data. 
V študiji pri pediatričnih bolnikih (starih od 6 do 17 let) je bil farmakodinamični odziv skladen s podatki pri odraslih.
You will be given Benlysta as well as your usual treatment for lupus. 
Dobili boste tako zdravilo Benlysta kot svoja običajna zdravila proti lupusu.
Your doctor will decide on the correct dose depending on your body weight. 
Zdravnik bo določil za vas pravi odmerek na podlagi vaše telesne mase.
Because of its mechanism of action, belimumab may interfere with the response to immunisations. 
Zaradi svojega mehanizma delovanja lahko belimumab ovira odziv na imunizacije.
If you wish to change your dosing day: 
Če želite zamenjati dan uporabe zdravila:
Patient median age was 15 years (range 6 to 17 years). 
Mediana starost bolnikov je bila 15 let (razpon: od 6 do 17 let).
Any unused solution in the vials must be discarded. 
Vso neporabljeno raztopino v vialah je treba zavreči.
When injecting in the same region, patients should be advised to use a different injection site each week; injections should never be given into areas where the skin is tender, bruised, red, or hard. 
V primeru injiciranja v isti predel je treba bolnika opozoriti, naj vsak teden uporabi drugo mesto injiciranja; zdravila ne sme nikdar injicirati v predele, kjer je koža občutljiva, podpluta, pordela ali zatrdela.
• if you are planning to have a vaccination or have had a vaccination within the last 30 days. 
• Če načrtujete cepljenje ali ste bili cepljeni pred kratkim (v zadnjih 30 dneh).
Data from post-marketing reports are also included. 
Vključeni so tudi podatki iz poročil med obdobjem trženja.
• Find a comfortable, well-lit and clean surface and place the following supplies within reach: 
• Najdite praktično, dobro osvetljeno in čisto površino in nanjo v dosegljivem obsegu razvrstite naslednje:
Lupus is a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation and organ damage. 
Lupus je bolezen imunskega sistema (sistema, ki premaguje okužbe), pri kateri imunski sistem napade vaše lastne celice in tkiva ter povzroči vnetje in okvaro organov.
In the case of inadvertent overdose, patients should be carefully observed and supportive care administered, as appropriate. 
V primeru naključnega prevelikega odmerjanja je treba bolnike natančno opazovati in jim zagotoviti podporno oskrbo, kot je ustrezno.
BMI-dependent changes in exposure did not lead to corresponding changes in efficacy. 
Od ITM odvisne spremembe izpostavljenosti niso povzročile ustreznih sprememb učinkovitosti.
All patients received standard therapy. 
Vsi bolniki so prejeli standardno zdravljenje.
Reconstitution is typically complete within 10 to 15 minutes after the water has been added, but it may take up to 30 minutes. 
Rekonstitucija je praviloma dokončana v 10 do 15 minutah po dodatku vode, vendar lahko traja do 30 minut.
Physicians should be particularly alert to symptoms suggestive of PML that patients may not notice (e.g., cognitive, neurological or psychiatric symptoms or signs). 
Zdravniki morajo biti posebej pozorni na simptome, ki nakazujejo PML, a jih bolniki lahko ne opazijo (npr. kognitivni, nevrološki ali psihiatrični simptomi ali znaki).
This medicinal product must not be mixed with other medicinal products except those mentioned in section 
Zdravila se ne sme mešati z drugimi zdravili razen s tistimi, ki so navedena v poglavju 6.6.
… purple indicator stops moving 
…se vijoličasti kazalnik ne neha premikati
• if you have, or have had, hepatitis B or C 
• Če imate ali ste imeli hepatitis B ali C.
If you feel depressed, have thoughts about harming yourself or other distressing thoughts, or if you are depressed and notice that you feel worse or develop new symptoms: 
Če ste depresivni, razmišljate o samopoškodovanju ali imate druge stisko povzročujoče misli oziroma če ste depresivni in opazite slabše počutje ali se vam pojavijo novi simptomi:
Do not give Benlysta as a subcutaneous injection to children or adolescents younger than 18 years of age. 
Zdravila Benlysta v obliki podkožne injekcije ne dajajte otrokom in mladostnikom, mlajšim od 18 let.
For information on infections observed in paediatric patients see Paediatric population section below. 
Za informacije o okužbah, ki so jih opažali pri pediatrični populaciji glejte razdelek spodaj Pediatrična populacija
• hypogammaglobulinaemia (IgG <400 mg/dl) or IgA deficiency (IgA <10 mg/dl) 
• hipogamaglobulinemijo (IgG < 400 mg/dl) ali pomanjkanjem IgA (IgA < 10 mg/dl),
Tell your doctor immediately if you have any of these symptoms, or similar problems that have lasted over several days. 
Nemudoma obvestite zdravnika, če imate katerega od teh simptomov, ali če imate podobne težave, ki trajajo nekaj dni.
The syringe or pen must be protected from light, and discarded if not used within the 12 hour period. 
Brizga ali peresnik mora biti zaščiten/a pred svetlobo in se jo/ga mora zavreči, če se je/ga ne uporabi znotraj obdobja 12 ur.
• Obligation to complete post-authorisation measures 
• Obveznosti izvedbe ukrepov po pridobitvi dovoljenja za promet
Memory cells increased initially and slowly declined toward baseline levels by Week 52. 
Število spominskih celic se je sprva povečalo in se je do 52. tedna počasi zmanjšalo na izhodiščno raven.
Tell your doctor if you are taking any other medicines, if you have recently taken or might take any other medicines. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
Of the anti-phospholipid antibodies, only anti-cardiolipin antibody was measured. 
Od antifosfolipidnih protiteles so merili samo antikardiolipinska protitelesa.
• Do not use if dropped onto a hard surface. 
• Ne uporabljajte ga, če je padel na trdo površino.
Some infections can be severe and can uncommonly cause death. 
Nekatere okužbe so lahko hude in lahko v občasnih primerih povzročijo smrt.
Benlysta is not usually recommended if you are pregnant. 
Zdravilo Benlysta ponavadi ni priporočljivo, če ste noseči.
See ‘Important information about the contents of Benlysta' in section 2 for further information. 
Glejte podpoglavje “Pomembne informacije o sestavi zdravila Benlysta“ v poglavju 2 za nadaljnje informacije.
The package leaflet should be available to the patient. 
Navodilo za uporabo tega zdravila mora biti na voljo bolniku.
Reductions in naïve and transitional B cells, as well as the SLE B cell subset were observed as early as Week 8. 
Zmanjšanje števila naivnih in tranzicijskih celic B ter podskupine SLE celic B so opazili že po 8 tednih.
The maximum serum concentration was 313 µg/ml (range: 173-573 µg/ml) based on simulating the concentration time profile using the typical parameter values of the population pharmacokinetic model. 
Največja koncentracija v serumu je bila 313 µg/ml (razpon: 173-573 µg/ml) na podlagi simulacije poteka koncentracije skozi čas z uporabo tipičnih vrednosti parametrov populacijskega farmakokinetičnega modela.
Percent of patients with no worsening by BILAG index 
Odstotek bolnikov brez poslabšanja indeksa BILAG
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP oz.
No carcinogenicity studies or fertility studies (male or female) have been performed. 
Študij kancerogenosti in študij plodnosti (samcev ali samic) niso izvedli.
It is unknown whether Benlysta is excreted in human milk or is absorbed systemically after ingestion. 
Ni znano, ali se zdravilo Benlysta izloča v človeškem mleku in ali se po zaužitju sistemsko absorbira.
Immunomodulatory medicinal products, including Benlysta, may increase the risk of malignancy. 
Imunomodulirajoča zdravila, vključno z zdravilom Benlysta, lahko povečajo tveganje za malignome.
The recommended dose is 10 mg for each kilogram (kg) of your body weight. 
Priporočeni odmerek je 10 mg na kilogram (kg) telesne mase.
If PML is suspected, further dosing must be suspended until PML has been excluded. 
V primeru suma na PML je treba nadaljnje zdravljenje prekiniti, dokler PML ni izključen.
The MAH shall also provide a data report on a long-term controlled safety registry where all patients are followed for a minimum of 5 years, based on a protocol agreed with CHMP. 
Imetnik dovoljenja za promet bo predložil tudi poročilo o podatkih dolgoročnega preglednega registra varnosti, v katerem bodo vse bolnike spremljali vsaj 5 let na podlagi protokola, oblikovanega v soglasju s CHMP.
Benlysta is not compatible with 5% glucose. 
Zdravilo Benlysta ni kompatibilno s 5 % glukozo.
Read the information ‘Increased risk of brain infection' in section 4 of this leaflet. 
Preberite informacije pod naslovom "Večje tveganje za okužbo možganov" v 4. poglavju tega navodila.
There may be a small amount of blood at the injection site. 
Na mestu injiciranja se lahko pojavi malo krvi.
Patients were on a stable SLE treatment regimen (standard of care) and had similar inclusion criteria as the adult studies. 
Bolniki so bili na stabilni shemi zdravljenja SLE (standardna oskrba); merila za vključitev so bila podobna kot v študijah pri odraslih.
These may include a type of medicine called an anti-histamine and a medicine to prevent a high temperature. 
Med takšnimi so zdravila, imenovana antihistaminiki, in zdravila za preprečevanje visoke telesne temperature.
Instructions for use and handling - reconstitution, dilution and administration In order to improve traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded. 
Navodila za uporabo in ravnanje - pripravo, redčenje in dajanje Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
Your doctor or nurse will show you or your caregiver how to inject Benlysta. 
Zdravnik ali medicinska sestra bosta vam ali vašemu negovalcu pokazala, kako injicirati zdravilo Benlysta.
The differences between the treatment groups were apparent by Week 16 and sustained through Week 52 (Figure 1). 
Razlika med terapevtskima skupinama se je pokazala do 16. tedna in se je ohranila do 52. tedna (Slika
Effects on male and female fertility have not been formally evaluated in animal studies (see section 5.3). 
Vpliva na plodnost samcev in samic v študijah na živalih niso formalno ocenili (glejte poglavje 5.3).
An informal assessment of menstrual cycling in females demonstrated no belimumab-related changes. 
Neformalna ocena menstruacijskih ciklusov pri samicah ni pokazala z belimumabom povezanih sprememb.
Gently invert the bag or bottle to mix the solution. 
Nežno obračajte vrečko ali steklenico, da boste premešali raztopino.
The two studies were similar in design except that BLISS-76 was a 76-week study and BLISS-52 was a 52-week study. 
Študiji sta bili po načrtu podobni, le da je bila študija BLISS-76 76-tedenska študija in študija BLISS-52 52tedenska.
Proportion of patients with at least 30% improvement in 3 of 5 components* and no more than one of the remaining worsening more than 30% 
Delež bolnikov z vsaj 30-% izboljšanjem 3 od 5 komponent* in s poslabšanjem ne več kot ene od preostalih za več kot 30 %
There was no significant impact on efficacy and safety based on weight. 
Masa ni pomembno vplivala na učinkovitost in varnost.
There is 1 vial in each pack. 
V enem pakiranju je 1 viala.
Percent of patients with no worsening by PGA 
Odstotek bolnikov brez poslabšanja po PGA
If patients wish to change their weekly dosing day, a new dose can be given on the newly preferred day of the week. 
Če bolnik želi spremeniti dan dajanja zdravila v tednu, lahko nov odmerek uporabi na novoizbrani dan v tednu.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
• Redno posodobljena poročila o varnosti zdravila (PSUR) Zahteve glede predložitve PSUR za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah,
Because maternal antibodies (IgG) are excreted in breast milk, it is recommended that a decision should be made whether to discontinue breast-feeding or to discontinue Benlysta therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Materina protitelesa (IgG) se izločajo v materinem mleku, zato se je priporočljivo odločiti za prenehanje dojenja ali za prekinitev zdravljenja z zdravilom Benlysta, upoštevaje korist dojenja za otroka in korist zdravljenja za žensko.
Physicians should advise patients (and caregivers where appropriate) to contact their health care provider about new or worsening psychiatric symptoms. 
Zdravniki morajo svetovati bolnikom (in njihovim skrbnikom, kjer je to potrebno), naj se obrnejo na svojega zdravnika v primeru novega pojava ali poslabšanja psihiatričnih simptomov.
If this happens, immediately contact your doctor or nurse, who will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary. 
Če se to zgodi, se nemudoma posvetujte z zdravnikom ali medicinsko sestro, ki vas bosta nadzorovala glede morebitnih znakov ali simptomov neželenih učinkov ter bosta takšne simptome zdravila, če bo treba.
After this, Benlysta is usually given once every 4 weeks. 
Pozneje se zdravilo ponavadi daje enkrat na 4 tedne.
The B cell and IgG response to long term treatment with intravenous Benlysta was assessed in an uncontrolled extension study. 
Odziv celic B in IgG na dolgotrajno zdravljenje z intravenskim zdravilom Benlysta so ocenili v nekontrolirani podaljšani študiji.
• Hold the pen comfortably so that you can view the inspection window. 
• Injekcijski peresnik držite udobno, tako da boste lahko videli okence za ogled.
IgG1 molecules such as belimumab are catabolised by widely distributed proteolytic enzymes, which are not restricted to hepatic tissue and changes in hepatic function are unlikely to have any effect on the elimination of belimumab. 
Molekule IgG1, kakršna je belimumab, se razgradijo s široko porazdeljenimi proteolitičnimi encimi, ki niso omejeni na jetrno tkivo, in ni verjetno, da bi spremembe delovanja jeter vplivale na odstranjevanje belimumaba.
Due to overlap in signs and symptoms, it is not possible to distinguish between hypersensitivity reactions and infusion reactions in all cases. 
Zaradi prekrivanj znakov in simptomov preobčutljivostnih in infuzijskih reakcij v vseh primerih ni mogoče razločiti.
A nurse or doctor will give you Benlysta through a drip in your vein (intravenous infusion) over one hour. 
Medicinska sestra ali zdravnik vam bo dal zdravilo Benlysta kapalno v veno (intravenska infuzija) v obdobju ene ure.
Then continue with your normal weekly schedule as usual or start a new weekly schedule starting from the day you inject the missed dose. 
Nato nadaljujte z običajnim tedenskim urnikom, kot po navadi, ali pa začnite nov tedenski urnik z dnem, ko si injicirate pozabljeni odmerek.
The relative contribution of BLyS levels to the pathophysiology of SLE is not fully understood. 
Relativni prispevek koncentracije BLyS k patofiziologiji SLE ni povsem razjasnjen.
• if you are HIV positive or have low immunoglobulin levels 
• Če ste HIV pozitivni ali imate majhno koncentracijo imunoglobulinov.