natgillin/translations-raw huggingface dataset:
• Risk Management Plan (RMP) 
ZDRAVILA • Načrt za obladovanje tveganja (RMP)
In one study in 6 to 17-year-old paediatric patients (n=53), none of the patients developed anti-belimumab antibodies. 
V študiji pri pediatričnih bolnikih, starih od 6 do 17 let (n=53), ni noben bolnik razvil protiteles proti belimumabu.
• After the needle is completely inserted, release the pinched skin. 
• Ko je igla povsem zabodena, izpustite stisnjeno kožo.
Benlysta should not be used during pregnancy unless the potential benefit justifies the potential risk to the foetus. 
Zdravila Benlysta se med nosečnostjo ne sme uporabljati, razen če možna korist upravičuje možno tveganje za plod.
Therefore, Benlysta should be administered in an environment where resources for managing such reactions are immediately available. 
Benlysta dajati v okolju, kjer je nemudoma na voljo vse potrebno za obvladanje takšnih reakcij.
Remove the ring cap. 
Odstranite okrogli pokrovček.
Using such medicines in combination with Benlysta may make your immune system less effective. 
Uporaba takšnih zdravil v kombinaciji z zdravilom Benlysta lahko zmanjša učinkovitost imunskega sistema.
If possible show them the pack, or this leaflet. 
Če je mogoče, jima pokažite škatlo zdravila ali to navodilo.
It is recommended that you make a note of this information in case you are asked for it in the future. 
Priporočljivo je, da si to informacijo zapišete, v primeru, da vas bodo kdaj povprašali po njej.
Although proteinuria (≥2 g/day) increased belimumab clearance and decreases in creatinine clearance decreased belimumab clearance, these effects were within the expected range of variability. 
Proteinurija (≥ 2 g/dan) je očistek belimumaba povečala, zmanjšanje očistka kreatinina pa ga je zmanjšalo, toda ta učinka sta bila znotraj pričakovanega razpona variabilnosti.
These severe reactions are more likely to happen on the day of your first or second treatment with Benlysta, but can be delayed and occur several days afterwards. 
Te reakcije so verjetnejše na dan, ko zdravilo Benlysta prejmete prvič ali drugič, lahko pa so tudi zapoznele in se pojavijo nekaj dni kasneje.
• nose, throat or stomach infection 
• okužba nosu, žrela ali želodca,
Limited data suggest that Benlysta does not significantly affect the ability to maintain a protective immune response to immunisations received prior to administration of Benlysta. 
Maloštevilni podatki kažejo, da zdravilo Benlysta ne vpliva pomembno na sposobnost za vzdrževanje zaščitnega imunskega odziva na imunizacije, izvedene pred uporabo zdravila Benlysta.
However, in a small study evaluating the response to a 23-valent pneumococcal vaccine, overall immune responses to the different serotypes were similar in SLE patients receiving Benlysta compared with those receiving standard immunosuppressive treatment at the time of vaccination. 
Toda v majhni študiji, ki je ocenjevala odziv na 23-valentno pnevmokokno cepivo, so bili na splošno imunski odzivi na različne serotipe pri bolnikih s SLE, ki so prejemali zdravilo Benlysta, podobni kot pri tistih, ki so ob času cepljenja prejemali standardno imunosupresivno zdravljenje.
5% glucose intravenous solutions are incompatible with Benlysta and must not be used. 
5 % intravenske raztopine glukoze niso kompatibilne z zdravilom Benlysta in se jih ne sme uporabljati.
The MAH shall complete, within the stated timeframe, the below measures: 
Imetnik dovoljenja za promet z zdravilom mora v spodaj navedenem časovnem okviru izvesti naslednje ukrepe:
Adverse reactions reported in association with cases of overdose have been consistent with those expected for belimumab. 
Neželeni učinki, o katerih so poročali v povezavi s primeri prevelikega odmerjanja, so bili v skladu s pričakovanimi za belimumab.
• a history of, or current, hepatitis B or C 
• anamnezo ali trenutnim hepatitisom B ali C,
Proportion of SRI responders by visit 
Delež bolnikov, odzivnih glede na SRI, po obiskih
This leaflet was last revised in 
Navodilo je bilo nazadnje revidirano dne:
Few patients with ADA reported serious/severe AEs. 
Malo bolnikov z ADA je navedlo resne/hude neželene učinke.
Effects on male and female fertility in monkeys were assessed in the 6-month repeat dose toxicology studies of belimumab at doses up to and including 50 mg/kg. 
Vplive na plodnost opičjih samcev in samic so ocenili v 6-mesečnih toksikoloških študijah ponavljajočih se odmerkov belimumaba v odmerkih do in vključno s 50 mg/kg.
Patient median age was 37 years (range: 18 to 77 years), and the majority (94%) were female. 
let (razpon: od 18 do 77 let) in večina (94 %) je bila žensk.
3) How to dilute the solution for infusion 
3) Kako razredčiti raztopino za infundiranje
In a substudy, a small group of patients who had previously received either tetanus, pneumococcal or influenza vaccinations were found to maintain protective titres after treatment with Benlysta. 
V eni podštudiji je majhna skupina bolnikov, ki so predhodno prejeli cepiva proti tetanusu, pnevmokokom ali gripi, po zdravljenju z zdravilom Benlysta ohranila zaščitne titre.
Prepare for the injection 
Pripravite se za injiciranje
Steadystate exposure was reached after approximately 11 weeks of subcutaneous administration. 
Izpostavljenost v stanju dinamičnega ravnovesja je bila dosežena po približno 11 tednih subkutane uporabe.
(not included) 
(ni priložen v pakiranju)
You may hear a first “click” at the start of the injection. 
Na začetku injiciranja lahko najprej zaslišite "klik".
If you do not notice that you have missed a dose until it is already time for your next dose, then just inject this next dose as planned. 
Če opazite, da ste pozabili odmerek, šele takrat, ko je že čas za naslednji odmerek, potem zgolj injicirajte ta naslednji odmerek, kot je načrtovano: ni treba, da si injicirate dva odmerka na isti dan.
Therefore, no dose adjustment is recommended. 
Zato odmerka ni treba prilagoditi.
Therefore, the use of Benlysta in elderly patients is not recommended unless the benefits are expected to outweigh the risks. 
Zato zdravila Benlysta ni priporočljivo uporabljati pri starejših bolnikih, razen če pričakovane koristi odtehtajo tveganja.
Tell your doctor or nurse immediately. 
→ Nemudoma obvestite zdravnika ali medicinsko sestro.
• cough, breathing problems 
• kašelj, težave z dihanjem,
For instructions on reconstitution, dilution, and storage of the medicinal product before administration, see section 6.6. 
Za navodila glede rekonstitucije, redčenja in shranjevanja zdravila pred dajanjem glejte poglavje 6.6.
If you use more Benlysta than you should 
Če ste uporabili večji odmerek zdravila Benlysta, kot bi smeli
• if you have a current or long-term infection or if you often get infections. 
• Če imate trenutno prisotno ali kakšno kronično okužbo, ali če se vam pogosto pojavljajo okužbe.
Patients have been reported to develop symptoms of acute hypersensitivity several hours after the infusion has been administered. 
Opisan je bil pojav simptomov akutne preobčutljivosti nekaj ur po infundiranju.
This will insert the needle and start the injection. 
To bo povzročilo vbod igle v kožo in začetek injiciranja.
• Do not use if left out at room temperature for more than 12 hours. 
• Zdravila ne puščajte na sobni temperaturi več kot 12 ur.
• The active ingredient is belimumab. 
• Učinkovina je belimumab.
Tell your doctor or nurse. 
→ Obvestite zdravnika ali medicinsko sestro.
Thereafter the patient should continue with the new weekly schedule from that day, even if the dosing interval may be temporarily less than a week. 
Potem mora nadaljevati z novim tedenskim urnikom od tistega dne naprej, tudi če je presledek med odmerkoma enkrat krajši od enega tedna.
There are no data on the effects of belimumab on human fertility. 
Podatkov o vplivu belimumaba na plodnost pri človeku ni.
Serum belimumab concentrations declined in a bi-exponential manner, with a distribution half-life of 1.75 days and terminal half-life 19.4 days. 
Koncentracija belimumab v serumu se je zmanjševala bieksponentno, z razpolovnim časom porazdelitve 1,75 dneva in končnim razpolovnim časom 19,4 dneva.
If you forget to use Benlysta 
Če ste pozabili uporabiti zdravilo Benlysta
Belimumab is a protein for which the expected metabolic pathway is degradation to small peptides and individual amino acids by widely distributed proteolytic enzymes. 
Belimumab je beljakovina in pričakovana pot njegove presnove je razgradnja v majhne peptide in posamezne aminokisline s široko porazdeljenimi proteolitičnimi encimi.
Patients had active SLE disease, defined as a SELENA-SLEDAI score ≥6 and positive autoantibodies at screening as described in the adult trials. 
Bolniki so imeli aktivno bolezen SLE, opredeljeno kot rezultat SELENASLEDAI ≥ 6 in pozitivna avtoprotitelesa ob presejanju, kot je opisano za preskušanja pri odraslih.
• Do not perform the injection if you do not have all the supplies listed. 
• Ne injicirajte zdravila, če nimate vsega naštetega.
As belimumab is a monoclonal antibody no genotoxicity studies have been conducted. 
Ker je belimumab monoklonsko protitelo, študij genotoksičnosti niso izvedli.
Patients who had severe active lupus nephritis, severe active CNS lupus, primary immunodeficiency, IgA deficiency or acute or chronic infections requiring management were excluded from the study. 
Bolniki s hudim aktivnim lupusnim nefritisom, hudim aktivnim lupusom osrednjega živčevja (CŽS), primarno imunsko pomanjkljivostjo, pomanjkanjem IgA ali akutnimi ali kroničnimi okužbami, ki zahtevajo nadzor, so bili izključeni iz študije.
Other possible side effects: Very common side effects 
Drugi možni neželeni učinki: Zelo pogosti neželeni učinki
These are very common and may affect more than 1 in 10 people. 
Okužbe so zelo pogoste in se lahko pojavijo pri več kot 1 od 10 bolnikov.
• if your lupus affects your kidneys or nervous system 
• Če vam lupus prizadene ledvice ali živčevje.
There are a limited amount of data from the use of Benlysta in pregnant women. 
Podatkov o uporabi zdravila Benlysta pri nosečnicah je malo.
Maximum serum concentrations of belimumab were generally observed at, or shortly after, the end of the infusion. 
Največjo koncentracijo belimumaba v serumu so praviloma ugotovili na koncu infundiranja ali kmalu po koncu infundiranja.
Infusion reactions occurred more frequently during the first two infusions and tended to decrease with subsequent infusions (see section 4.8). 
Infuzijske reakcije so se pogosteje pojavile med prvima dvema infundiranjema; med nadaljnjimi infundiranji se je njihova pogostnost zmanjševala (glejte poglavje 4.8).
Patients were randomised in a 2:1 ratio to receive belimumab 200 mg or placebo subcutaneously once weekly for 52 weeks. 
Bolniki so bili za 52 tednov v razmerju 2:1 randomizirani na prejemanje 200 mg belimumaba ali placeba subkutano enkrat na teden.
The safety and efficacy of Benlysta administered intravenously have been studied in black patients. 
Varnost in učinkovitost zdravila Benlysta, uporabljenega intravensko, so preučevali pri bolnikih črncih.
This was consistent with the findings from the adult intravenous clinical trials. 
To se sklada z izsledki kliničnih preskušanj intravenske uporabe pri odraslih.
The response for the individual components of the endpoint were consistent with that of the SRI (Table 3). 
Odziv po posameznih elementih cilja študije se je skladal z odzivom po SRI (Preglednica 3).
SRI response rate (excluding complement and anti-dsDNA changes) at week 52 (%) 
Delež odziva po SRI (izključujoč spremembe komplementa in anti-dvDNK) po 52 tednih
Infusion or injection-related systemic reactions and hypersensitivity: Infusion or injection-related systemic reactions and hypersensitivity were generally observed on the day of administration, but acute hypersensitivity reactions may also occur several days after dosing. 
Z infundiranjem ali injiciranjem povezane sistemske reakcije in preobčutljivost: Z infundiranjem ali injiciranjem povezane sistemske reakcije in preobčutljivost so na splošno opažali na dan uporabe, toda akutne preobčutljivostne reakcije se lahko pojavijo tudi nekaj dni po uporabi.
Continue to hold the pen down until the purple indicator has stopped moving. 
Še naprej držite injekcijski peresnik pritisnjen navzdol, dokler se vijoličasti kazalnik ne neha premikati.
The safety registry will evaluate the incidence of all-cause mortality and adverse events of special interest in patients with systemic lupus erythematosus. 
Register varnosti bo ocenil incidenco umrljivosti zaradi vseh vzrokov in neželenih učinkov posebnega interesa pri bolnikih s sistemskim eritematoznim lupusom.
This study was conducted in the US, South America, Europe and Asia. 
Ta študija je bila izvedena v ZDA, Južni Ameriki, Evropi in Aziji.
If a dose is missed, it should be administered as soon as possible. 
V primeru izpuščenega odmerka je treba zdravilo uporabiti čim prej.
For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po pripravi in redčenju zdravila glejte poglavje 6.3.
Then add the required volume of the reconstituted Benlysta solution into the infusion bag or bottle. 
Potem dodajte potrebno količino pripravljene raztopine zdravila Benlysta v infuzijsko vrečko ali steklenico.
The total time from reconstitution of Benlysta to completion of infusion should not exceed 8 hours. 
Celotni čas od rekonstitucije zdravila Benlysta do konca infundiranja ne sme preseči 8 ur.
In the subcutaneous study where serum samples from more than 550 patients with SLE were tested, no antibelimumab antibodies were detected during or after treatment with belimumab 200 mg subcutaneously. 
V študiji subkutane uporabe, v kateri so testirali vzorce seruma več kot 550 bolnikov s SLE, niso odkrili protiteles proti belimumabu ne med zdravljenjem z 200 mg belimumaba subkutano ne po zdravljenju.
Depression and suicide 
Depresija in samomorilnost
Belimumab is a human IgG1λ monoclonal antibody specific for soluble human B Lymphocyte Stimulator protein (BLyS, also referred to as BAFF and TNFSF13B). 
Belimumab je človeško monoklonsko protitelo IgG1λ, specifično za topno humano B-limfocite stimulirajočo beljakovino (BLyS, ki jo označujejo tudi BAFF in TNFSF13B).
• Choose an injection site (abdomen or thigh) as seen in Figure 4. 
• Izberite mesto injiciranja (trebuh ali stegno), kot prikazuje Slika 4.
Besides an expected pharmacological effect i.e. reduction of B cells, animal studies in monkeys do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 
Poleg pričakovanega farmakološkega učinka (tj. zmanjšanja števila celic B) študije na opicah ne kažejo neposrednih ali posrednih toksičnih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
Paediatric population: The pharmacokinetic parameters are based on individual parameter estimates from a population pharmacokinetic analysis of 53 patients from a study in paediatric patients. 
Farmakokinetični parametri temeljijo na ocenah posameznih parametrov v populacijski farmakokinetični analizi 53 bolnikov iz študije pri pediatričnih bolnikih.
The maximum serum concentration (Cmax) of belimumab at steady state was 108 µg/ml. 
Največja koncentracija belimumaba v serumu (Cmax) v stanju dinamičnega ravnovesja je bila 108 µg/ml.
It can affect almost any organ in the body, and is thought to involve a type of white blood cells called B cells. 
Prizadene lahko skoraj vsak organ v telesu in domnevno je v njegov nastanek vpletena vrsta belih krvnih celic, ki jih imenujemo celice B. Zdravilo Benlysta vsebuje belimumab (monoklonsko protitelo).
However, belimumab was detected in the milk from female monkeys administered 150 mg/kg every 2 weeks. 
Vendar pa so belimumab odkrili v mleku opičjih samic, ki so prejemale 150 mg/kg na 2 tedna.
Rarely, less severe delayed reactions to Benlysta can also occur, usually 5 to 10 days after an injection. 
Redkeje se lahko pojavijo tudi manj hude, zapoznele reakcije na zdravilo Benlysta, po navadi od 5 do 10 dni po injiciranju.
Transition from intravenous to subcutaneous administration 
Prehod z intravenske na subkutano uporabo
Based on simulations with population PK parameters the steady-state average belimumab concentrations for 200 mg subcutaneous every week were similar to 10 mg/kg intravenous every 4 weeks. 
Na podlagi simulacij s populacijskimi FK parametri je bila povprečna koncentracija belimumaba v stanju dinamičnega ravnovesja med uporabo 200 mg subkutano vsak teden podobna kot med uporabo 10 mg/kg intravensko na 4 tedne.
Medicine given before an infusion 
Zdravila, uporabljena pred infundiranjem
The mechanism of action of belimumab could increase the risk for the development of infections, including opportunistic infections. 
Zaradi svojega mehanizma delovanja lahko belimumab poveča tveganje za razvoj okužb, vključno z oportunističnimi okužbami.
No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of Benlysta with other agents. 
Študij fizikalne ali biokemične kompatibilnosti za oceno soapliciranja zdravila Benlysta z drugimi zdravili niso izvedli.
The primary efficacy endpoint was the SLE Responder Index (SRI) at Week 52 as described in the adult intravenous trials. 
Primarni cilj študije učinkovitosti je bil indeks odziva SLE (SRI-SLE Responder Index) po 52 tednih, kot je opisano za preskušanja intravenske uporabe pri odraslih.
After 7 and a half years of treatment (including the 72-week parent study), a substantial and sustained decrease in various B cell subsets was observed leading to 87% median reduction in naïve B cells, 67% in memory B cells, 99% in activated B cells, and 92% median reduction in plasma cells after more than 7 years of treatment. 
Po sedmih letih in pol (vključno z 72 tedni v matični študiji) so opažali bistveno in dolgotrajno zmanjšanje števila različnih podskupin celic B, ki je povzročilo 87 %mediano zmanjšanje števila naivnih celic B, 67 % spominskih celic B, 99 % aktiviranih celic B in 92 % mediano zmanjšanje števila plazmatk po več kot 7 letih zdravljenja.
• If needed, firm the injection site by pulling or stretching the skin. 
• Če je treba, utrdite mesto injiciranja tako, da kožo potegnete ali napnete.
There were no serious depression-related events or suicides reported in either group. 
V nobeni skupini niso poročali o resnih dogodkih, povezanih z depresijo ali samomorih.
Patients with malignant neoplasm within the last 5 years have not been studied, with the exception of those with basal or squamous cell cancers of the skin, or cancer of the uterine cervix, that has been fully excised or adequately treated. 
Bolniki, ki so imeli v zadnjih 5 letih maligno novotvorbo niso raziskani; izjema so bolniki z bazalnoceličnim ali ploščatoceličnim rakom kože ali rakom materničnega vratu, ki je bil v celoti izrezan ali ustrezno zdravljen.
Push the plunger all the way down 
Potisnite bat čisto do konca navzdol
It is likely that Benlysta can pass into breast milk. 
Zdravilo Benlysta verjetno lahko prehaja v materino mleko.
The proportion of black patients achieving an SRI-S2K response was higher in patients receiving Benlysta but the difference was not statistically significant compared with placebo. 
Delež bolnikov črncev, ki so dosegli odziv SRI-S2K, je bil večji pri bolnikih, ki so prejemali zdravilo Benlysta, toda razlika v primerjavi s placebom ni bila statistično značilna.
Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. 
Zdravljenje z zdravilom Benlysta mora uvesti in nadzorovati usposobljen zdravnik, ki ima izkušnje pri diagnosticiranju in zdravljenju SLE.
Contents of the pack and other information What Benlysta contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Benlysta
• When the injection is complete, lift the pen from the injection site. 
• Ko je injiciranje končano, dvignite injekcijski peresnik z mesta injiciranja.
BLISS-52 was conducted in South America, Eastern Europe, Asia, and Australia. 
Študija BLISS-52 je bila izvedena v južni Ameriki, vzhodni Evropi, Aziji in Avstraliji.
If you feel depressed or have thoughts of harming yourself or committing suicide, you may find it helpful to tell a relative or close friend and ask them to read this leaflet. 
Če ste depresivni ali razmišljate o samopoškodovanju ali samomoru, bi morda bilo koristno, da poveste sorodniku ali dobremu prijatelju in ga prosite, da prebere to navodilo za uporabo.
If a patient is being transitioned from Benlysta intravenous administration to subcutaneous administration, the first subcutaneous injection should be administered 1 to 4 weeks after the last intravenous dose (see section 5.2). 
Če bolnik prehaja z intravenske na subkutano uporabo zdravila Benlysta, je treba prvo subkutano injekcijo dati od 1 do 4 tedne po zadnjem intravenskem odmerku (glejte poglavje 5.2).
• Look in the inspection window to check that the Benlysta solution is colourless to slightly yellow in colour. 
• Poglejte skozi okence za ogled in preverite, da je raztopina zdravila Benlysta brezbarvna ali rahlo rumenkasta.
Of these patients, 64.5% had SELENA SLEDAI scores ≥ 10 at baseline. 
64,5 % teh bolnikov je imelo izhodiščno rezultat SELENA SLEDAI ≥ 10.
Live vaccines should not be given for 30 days before, or concurrently with Benlysta, as clinical safety has not been established. 
V 30 dneh pred uporabo zdravila Benlysta in sočasno z njegovo uporabo se ne sme uporabljati živih cepiv, ker klinična varnost ni ugotovljena.
You are usually given Benlysta on the first day of treatment then again 14 and 28 days later. 
Zdravilo Benlysta se ponavadi uporablja tako, da ga dobite prvi dan zdravljenja ter nato čez 14 in čez 28
Your doctor will discuss with you whether you should stop treatment with Benlysta while you are breast-feeding, or if you should stop breast-feeding. 
Zdravnik se bo z vami pogovoril o tem, ali naj med obdobjem dojenja prenehate zdravljenje z zdravilom Benlysta ali naj prenehate dojiti.
Patients should be instructed to seek immediate medical attention if they experience any of these symptoms. 
Bolnikom je treba naročiti, naj v primeru, če se jim pojavi kateri od teh simptomov, nemudoma poiščejo zdravniško pomoč.
After reconstitution with water for injections, the reconstituted solution, if not used immediately, should be protected from direct sunlight, and stored refrigerated at 2°C to 8°C. 
Po rekonstituciji z vodo za injekcije je treba pripravljeno raztopino - če ni uporabljena takoj - zaščititi pred neposredno sončno svetlobo in shraniti v hladilniku pri temperaturi od 2 do 8 °C.
• severe active lupus nephritis (see section 5.1) 
• hudim aktivnim lupusnim nefritisom (glejte poglavje 5.1),
Data presented below are pooled from the intravenous clinical studies (10 mg/kg intravenous dose only) and the subcutaneous clinical study. 
Spodaj predstavljeni podatki so kumulativni podatki kliničnih študij z intravensko uporabo (samo intravenski odmerek 10 mg/kg) in klinične študije s subkutano uporabo.
Two doses up to 20 mg/kg administered 21 days apart by intravenous infusion have been given to humans with no increase in incidence or severity of adverse reactions compared with doses of 1, 4, or 10 mg/kg. 
Dva odmerka do 20 mg/kg, uporabljena pri ljudeh v intravenski infuziji v presledku 21 dni, nista bila povezana z večjo incidenco neželenih učinkov kot odmerki 1, 4 ali 10 mg/kg.
B cell numbers recovered after the cessation of belimumab treatment by about 1 year post-partum in adult monkeys and by 3 months of life in infant monkeys; IgM levels in infants exposed to belimumab in utero recovered by 6 months of age. 
Število celic B se je po prenehanju zdravljenja z belimumabom popravilo v obdobju do približno 1 leta postpartalno pri odraslih opicah in do 3 mesecev življenja pri opičjih mladičih; Koncentracija IgM pri dojenčkih, in utero izpostavljenih belimumabu, se je popravila do 6. meseca starosti.
The healthcare professional must provide proper training in subcutaneous technique and education about signs and symptoms of hypersensitivity reactions (see section 4.4). 
Zdravnik mora bolnika ustrezno usposobiti za podkožno injiciranje in ga seznaniti z znaki in simptomi preobčutljivostnih reakcij (glejte poglavje 4.4).