natgillin/translations-raw huggingface dataset:
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.
• 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.