natgillin/translations-raw huggingface dataset:
There are no adequate and well-controlled data from studies in pregnant women, 
Za nosečnice ni zadostnih in dobro nadzorovanih podatkov iz študij.
95.1%b CI (−3.2%, 24.3%) a 
95,1 %b IZ (−3,2 %, 24,3 %) a
Key results from all four studies are summarised in Table 6. 
Ključni rezultati vseh štirih preskušanj so povzeti v preglednici 6.
This is usually given every 3 weeks up to 8 times. 
Ta se po navadi daje na 3 tedne, do osemkrat.
- CI = confidence interval. 
IZ = interval zaupanja.
• What to do if you think you might be getting an infection. 
• Kaj storite, če menite, da imate morda okužbo
Survival Time (Months) 
Čas preživetja (meseci)
Similar effects have been observed in animal studies (see section 5.3). 
Podobne učinke so opažali v študijah na živalih (glejte poglavje 5.3).
Complete remission at 12 and 18 months 
Popolna remisija po 12 in 18 mesecih
Proportion of patients with no erosive change 
Delež bolnikov brez erozivnih sprememb
Three cases had no reported adverse event. 
V treh primerih niso poročali o nobenem neželenem dogodku.
It is important that you keep this Alert Card and show it to your partner or caregiver. 
Pomembno je, da to kartico hranite pri sebi in da jo pokažete vašemu partnerju ali skrbniku.
The final efficacy analysis included all patients randomised to both parts of the study. 
Končna analiza učinkovitosti je vključevala vse bolnike, ki so bili randomizirani v oba dela študije.
These cases occurred in non-approved indications and the majority of patients were HIV positive. 
Ti primeri so se pojavili pri neodobrenih indikacijah, večina bolnikov je bila HIV-pozitivna.
Read this leaflet carefully before you start taking this medicine because it contains important information for you. 
Pred začetkom jemanja zdravila natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
This card tells you: 
V tej kartici je opisano:
Two patients were re-treated twice in the study. 
Dva bolnika sta bila v študiji dvakrat ponovno zdravljena.
* at end of maintenance/observation; final analysis results based on median follow-up of 73 months. 
* ob koncu vzdrževalnega zdravljenja/spremljanja; rezultati končne analize temeljijo na mediani spremljanja 73 mesecev.
• Keep this card with you all the timesuch as in your wallet or purse. 
• Kartico imejte vedno ob sebi, na primer v denarnici ali torbici.
Your doctor may change this, depending on how you respond to the medicine. 
Zdravnik lahko to spremeni, odvisno od tega, kako se odzovete na zdravilo.
From a microbiological point of view, the prepared infusion solution should be used immediately. 
Z mikrobiološkega stališča je treba pripravljeno infuzijsko raztopino uporabiti takoj.
- * Worst case imputation a Non-inferiority was demonstrated since the lower bound (−3.2%) was higher than the pre-determined non-inferiority margin (− 20%). 
* Imputacija za najslabši primer a Neinferiornost je bila dokazana, ker je bila spodnja meja (−3,2 %) višja od vnaprej opredeljene meje neinferiornosti (−20 %).
When these symptoms go away, or improve, the infusion can be continued. 
Ko ti simptomi izginejo ali se izboljšajo, se lahko infuzija nadaljuje.
Most side effects are mild to moderate but some may be serious and require treatment. 
Večina neželenih učinkov je blagih do zmernih, a nekateri so lahko resni in zahtevajo zdravljenje.
Standard tests to investigate mutagenicity have not been carried out, since such tests are not relevant for this molecule. 
Standardni testi za raziskovanje mutagenosti niso bili izvedeni, kajti tovrstni testi za to molekulo niso relevantni.
The syndrome frequently manifests itself within one or two hours of initiating the first infusion. 
Sindrom se pogosto pokaže v eni do dveh urah po začetku prve infuzije.
20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republic of Korea 
20 Academy-ro 51 beon-gil Yeonsu-gu, Incheon, 22014, Republika Koreja
Do not have Ritemvia if you have an active infection or a serious problem with your immune system. 
Zdravila Ritemvia ne smete prejeti, če imate aktivno okužbo ali resno težavo s svojim imunskim sistemom.
Look out for the following possible signs of infection: 
Bodite pozorni na naslednje znake okužbe:
The median follow up of patients was 53 months. 
Mediana spremljanja bolnikov je bila 53 mesecev.
These patients should be very closely monitored throughout the first infusion. 
Te bolnike moramo v celotnem teku prve infuzije natančno opazovati.
Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped. 
Nemudoma povejte osebi, ki vam daje infuzijo, če se pri vas pojavi kateri od teh simptomov, ker bo morda treba infuzijo upočasniti ali jo ustaviti.
Care must be taken to ensure the sterility of prepared solutions. 
Treba je paziti, da zagotovimo sterilnost pripravljene raztopine.
Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of. 
Bolnikom je treba naročiti, naj o svojem zdravljenju obvestijo partnerja ali skrbnike, ker bodo morda ti opazili simptome, ki se jih bolniki ne zavedajo.
The incidence of serious infections was similar in both arms (approximately 12%). 
Pojavnost resnih okužb je bila v obeh skupinah podobna (približno 12%).
Primary efficacy 
Primarna učinkovitost
b The 95.1% confidence level reflects an additional 0.001 alpha to account for an interim efficacy analysis. 
b 95,1-% interval zaupanja vključuje dodatni 0,001 alfa na račun vmesne analize učinkovitosti.
Ritemvia may also cause changes in laboratory tests carried out by your doctor. 
Zdravilo Ritemvia lahko vpliva tudi na spremembe laboratorijskih preiskav, ki jih naroči vaš zdravnik.
Patients should receive Ritemvia for at least 24 months after achievement of remission (absence of clinical signs and symptoms). 
Bolniki morajo zdravilo Ritemvia prejemati vsaj 24 mesecev po doseženi remisiji (odsotnost kliničnih znakov in simptomov).
This will be administered 1 year and 18 months after the initial treatment and then every 6 months as needed or your doctor may change this, depending on how you respond to the medicine. 
Tega boste dobili 1 leto in 18 mesecev po začetnem zdravljenju in nato vsakih 6 mesecev, če bo treba, a zdravnik vam lahko ta razpored spremeni, odvisno od tega, kako se odzovete na zdravilo.
Post-hoc retrospective laboratory evaluation 
Post-hoc retrospektivna laboratorijska ocena
Tell your doctor immediately if you have any of these symptoms. 
Nemudoma povejte svojemu zdravniku, če se pri vas pojavi kateri od teh simptomov.
p-value (Wald test, not adjusted) 
p-vrednost (test Wald, ni prilagojen)
The alert card contains important safety information for patients regarding potential increased risk of infections, including PML. 
Opozorilna kartica vsebuje za bolnika pomembne podatke o varnosti glede možnega povečanega tveganja za okužbe, vključno s PML.
The gender-related pharmacokinetic differences are not considered to be clinically relevant and dose adjustment is not required. 
S spolom povezane razlike v farmakokinetiki ne štejemo za klinično pomembne in prilagajanje odmerkov ni potrebno.
4 Includes observations collected as part of routine laboratory monitoring. 
4Vključujejo opažanja zbrana v okviru rutinskega laboratorijskega spremljanja.
7 includes fatal cases 
7 Vključujejo smrtne primere.
B cell counts returned to normal in these animals within 6 months of birth and did not compromise the reaction to immunisation. 
Število celic B se je pri teh živalih vrnilo na normalno raven v 6 mesecih po rojstvu in ni ogrožalo reakcije na imunizacijo.
CD20 does not circulate in the plasma as a free antigen and, thus, does not compete for antibody binding. 
CD20 ne kroži v plazmi kot prosti antigen in zato ne tekmuje za vezavo na protitelo.
Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Ireland 
Block 7, City North Business Campus, Stamullen, Co. Meath K32 YD60, Irska
If you can get pregnant, you and your partner must use an effective method of contraception while using Ritemvia. 
Če bi lahko zanosili, morate vi in vaš partner med uporabo zdravila Ritemvia uporabljati učinkovito kontracepcijsko zaščito.
You may require additional treatment such as an antihistamine or paracetamol. 
Morda boste potrebovali dodatno zdravljenje z zdravili, kot so antihistaminiki ali paracetamol.
Your doctor may decide to stop your Ritemvia treatment if these reactions are serious. 
Zdravnik se lahko odloči za prenehanje zdravljenja z zdravilom Ritemvia, če so te reakcije resne.
9.32 years 
9,32 let
The safety and efficacy of Ritemvia in children below 18 years has not been established. 
Varnost in učinkovitost zdravila Ritemvia pri otrocih do 18 leta starosti nista dokazani.
• The need for close supervision during administration in an environment where full resuscitation facilities are immediately available 
• informacije o nujnosti skrbnega nadzora med aplikacijo v okolju, kjer so vsi pripomočki za oživljanje nemudoma na voljo,
Your doctor may decide to treat you longer with Ritemvia (up to 5 years), depending on how you respond to the medicine. 
Zdravnik se lahko odloči, da vas bo z zdravilom Ritemvia zdravil dlje (do 5 let), odvisno od tega, kako se odzovete na zdravilo.
• Show this card to any doctor, nurse or dentist you see - not just the specialist who prescribes your Ritemvia. 
• Pokažite jo vsem zdravnikom, medicinskim sestram in zobozdravnikom, ki jih obiščete - ne samo specialistu, ki vam predpiše zdravilo Ritemvia.
Since the medicinal product does not contain any anti-microbial preservative or bacteriostatic agents, aseptic technique must be observed. 
Ker zdravilo ne vsebuje antimikrobnih ali bakteriostatičnih zaščitnih sredstev, je treba upoštevati aseptično tehniko.
• if you have ever taken medicines which affect your immune system - such as chemotherapy or immune-suppressive medicines. 
• če ste kdaj jemali zdravila, ki vplivajo na imunski sistem - na primer kemoterapijo ali imunosupresivna zdravila.
Kaplan-Meier estimate of median time to event (months) 
Kaplan-Meierjeva ocena mediane časa do dogodka (meseci)
Of 356 patients evaluated for anti-drug antibody (ADA), 1.1% (4 patients) were positive. 
Od 356 bolnikov, pri katerih so ocenjevali prisotnost protiteles proti zdravilu (anti-drug antibody -ADA), so bili pozitivni 4 bolniki (1,1%).
It remains unknown if early detection of PML and suspension of rituximab therapy may lead to similar stabilisation or improved outcome. 
Ni znano, ali lahko zgodnje odkritje PML in ukinitev zdravljenja z zdravilom rituksimab doseže podobno stabilizacijo ali izboljšanje izida.
• you have a weak immune system 
• imate oslabel imunski sistem;
Exploratory analyses of the benefit of maintenance treatment showed a less pronounced effect in elderly patients (> 70 years of age), however sample sizes were small. 
Eksplorativne analize koristi vzdrževalnega zdravljenja so pokazale manj izrazit učinek pri starejših bolnikih (> 70 let), vendar je bil vzorec majhen.
Ritemvia will be given to you by a doctor or nurse who is experienced in the use of this treatment. 
Zdravilo Ritemvia vam bo dal zdravnik ali medicinska sestra, ki ima izkušnje z uporabo takšnih zdravil.
Final analysis (median FU: 9.0 years) 
Končna analiza (mediana spremljanja: 9,0 let)
Population pharmacokinetic analysis revealed that BSA and gender were the most significant covariates to explain inter-individual variability in pharmacokinetic parameters. 
Populacijska farmakokinetična analiza je pokazala, da sta bila telesna površina in spol najbolj pomembni so-spremenljivki za razlago variabilnosti v farmakokinetičnih parametrih med posamezniki.
Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection. 
Bolnike, ki so kdaj imeli okužbo z virusom hepatitisa B, bo zdravnik skrbno spremljal glede znakov te okužbe;
Complete remission All Patients Newly diagnosed Relapsing 
Popolna remisija Vsi bolniki Novoodkriti Ponovitev
Name:_______________________ Doctor's 
Datum zadnjega infundiranja:____________ Datum prvega infundiranja:______________ Bolnikovo ime: _______________________ Zdravnikovo ime:______________________ Zdravnikov telefon:____________________
Before you are given Ritemvia, you will be given other medicines (pre-medication) to prevent or reduce possible side effects. 
Preden boste dobili zdravilo Ritemvia, boste dobili druga zdravila (to imenujemo premedikacija) za preprečitev ali zmanjšanje možnih neželenih učinkov.
In order to improve traceability of biological medicinal products, the tradename and batch number of the administered product should be clearly recorded (or stated) in the patient file. 
Za izboljšanje sledljivosti bioloških zdravil je treba lastniško ime in številko serije uporabljenega zdravila jasno zabeležiti (navesti) v bolnikovo kartoteko.
• if you think you may have an infection, even a mild one like a cold. 
• če menite, da bi lahko imeli okužbo, četudi blago, kot je prehlad.
After adjusting for BSA, male subjects had a larger volume of distribution and a faster clearance than female subjects. 
Po prilagoditvi za telesno površino so imeli moški večji volumen distribucije in večji očistek kot ženske.
When should I not have Ritemvia? 
Kdaj ne smete prejeti zdravila Ritemvia?
The pre-specified non-inferiority margin for the treatment difference was 20%. 
Vnaprej opredeljena meja neinferiornosti za razliko zdravljenj je bila 20%.
Secondary efficacy 
Sekundarna učinkovitost
Rarely, some of these reactions have been fatal. 
Redko so bili nekateri od teh neželenih učinkov smrtni.
The primary endpoint was the proportion of patients who achieved an ACR20 response at week 24. 
Primarni cilj študije je bil ugotoviti delež bolnikov, ki so po 24 tednih dosegli odziv ACR20.
Patients were followed beyond week 24 for long-term endpoints, including radiographic assessment at 56 weeks and at 104 weeks. 
Bolnike so od 24. tedna spremljali za dolgoročne cilje študije in naredili tudi radiološko oceno po 56 tednih ter 104 tednih.
Note: Patients were censored at month 28 if they had no event. 
Opomba: Podatki so bili krnjeni, če so bili bolniki ob 28. mesecu brez dogodka.
Ritemvia will be given to you once a week for 4 weeks. 
ga boste prejeli enkrat na teden 4 tedne.
Your doctor will check if you should have any vaccines before you receive Ritemvia. 
Vaš zdravnik bo preveril, ali bi morali biti cepljeni, preden boste dobili zdravilo Ritemvia.
Outcome† 
Izid†
5 Includes fatal cases 
5Vključujejo smrtne primere.
Contraception in males and females 
Kontracepcija za moške in ženske
You must tell your doctor or nurse if you are pregnant, think that you might be pregnant or are planning to become pregnant. 
Nosečnost in dojenje Zdravniku ali medicinski sestri morate povedati, če ste noseči, menite, da ste noseči, ali načrtujete zanositev.
Risk Reduction 
Zmanjšanje tveganja
Patients were between 19 and 79 years of age and had not received prior therapies for pemphigus. 
Bolniki so bili stari od 19 do 79 let in predhodno niso prejemali zdravljenja za pemfigus.
For patients randomised to the maintenance phase of the trial, the median observation time was 28 months from maintenance randomisation. 
Za bolnike, randomizirane v vzdrževalni del preskušanja, je bil mediani čas opazovanja 28 mesecev od randomizacije na vzdrževanje.
These findings were replicated at Week 48, where autoantibody seropositivity also significantly increased the probability of achieving ACR70. 
Ti izsledki so se ponovili 48. teden, ko je seropozitivnost prav tako značilno povečala verjetnost za doseganje odziva ACR70.
Physical function and quality of life outcomes 
Funkcijska zmogljivost in vpliv na kakovost življenja
The physician should be particularly alert to symptoms suggestive of PML that the patient may not notice (e.g. cognitive, neurological or psychiatric symptoms). 
Zdravnik mora biti še posebno pozoren na simptome, ki nakazujejo na PML in jih bolniki sami morda ne opazijo (npr. kognitivne, nevrološke ali psihiatrične).
Rituximab was detectable in the serum of patients 3 - 6 months after completion of last treatment. 
Rituksimab je bilo mogoče zaznati v serumu bolnikov 3 do 6 mesecev po zaključku zadnjega zdravljenja.
For these reasons rituximab should not be administered to pregnant women unless the possible benefit outweighs the potential risk. 
Zato nosečnice ne smejo prejemati zdravila rituksimab, razen če je pričakovana korist večja od možnega tveganja.
The incidence of IRR symptoms was highest during or after the first infusion (9%) and decreased with subsequent infusions (< 4%). 
Pojavnost simptomov IRR je bila največja med prvo infuzijo ali po njej (9%) in se je ob nadaljnjih infuzijah zmanjšala (< 4%).
Tell your doctor or nurse if you are taking or have previously taken medicines which may affect your immune system this includes chemo-therapy. 
Zdravniku ali medicinski sestri povejte, če jemljete ali ste jemali zdravila, ki lahko vplivajo na vaš imunski sistem, kar vključuje tudi kemoterapijo.
Across all development studies the treatment benefit was similar in patients independent of age, gender, body surface area, race, number of prior treatments or disease status. 
V vseh razvojnih študijah je bila korist zdravljenja pri bolnikih podobna, ne glede na starost, spol, telesno površino, raso, število predhodnih zdravljenj ali stanje bolezni.
Further treatment of patients after complete resolution of signs and symptoms has rarely resulted in repeated severe cytokine release syndrome. 
Nadaljnje zdravljenje bolnikov je po popolnem izginotju znakov in simptomov redko povzročilo ponoven hud sindrom sproščanja citokinov.
Before giving a subsequent course of rituximab treatment, patients should be re-evaluated for any potential risk for infections. 
Pred dajanjem nadaljnjega cikla zdravila rituksimab je treba bolnike ponovno oceniti glede možnega tveganja za okužbe.
Of 67 patients evaluated for human anti-mouse antibody (HAMA), no responses were noted. 
Pri 67 bolnikih, pri katerih so analizirali prisotnost humanih protimišjih protiteles (human anti-mouse antibody - HAMA), teh niso opazili.
A maintenance infusion of 500 mg IV should be administered at months 12 and 18, and then every 6 months thereafter if needed, based on clinical evaluation. 
Vzdrževalno infuzijo 500 mg intravensko je treba uporabiti v 12. in 18. mesecu in nato vsakih 6 mesecev, če je treba na podlagi klinične ocene.
Granulomatosis with polyangiitis and microscopic polyangiitis are two forms of inflammation of the blood vessels which mainly affects the lungs and kidneys, but may affect other organs as well. 
Granulomatoza s poliangiitisom in mikroskopski poliangiitis sta dve obliki vnetja krvnih žil, ki večinoma prizadeneta pljuča in ledvice, a lahko prizadeneta tudi druge organe.
Therefore, patients with a history of cardiac disease and/or cardiotoxic chemotherapy should be monitored closely. 
Zato je treba bolnike z anamnezo srčne bolezni in/ali kardiotoksične kemoterapije skrbno nadzorovati.
If you respond well to treatment, you may be given Ritemvia as a maintenance treatment. 
Če se boste na zdravilo dobro odzvali, boste lahko zdravilo Ritemvia prejemali kot vzdrževalno zdravljenje.
The risk of disease progression was reduced by 46% and the risk of relapse by 51%. 
Tveganje za napredovanje bolezni je bilo manjše za 46 %, tveganje za ponovitev bolezni pa za 51%.
Initial treatment, in combination with chemotherapy 
Začetno zdravljenje v kombinaciji s kemoterapijo
The Physician information and Patient information must be agreed with the National Competent Authorities prior to distribution and Patient Alert Card should be included as part of inner packaging. 
Besedilo informacij za zdravnike in informacij bolnike mora biti pred razdelitvijo dogovorjeno z nacionalnim organom, pristojnim za zdravila, opozorilna kartica za bolnika pa mora biti vključena med notranjo ovojnino.
A slight but not significant improvement in overall survival was reported in the R-FC compared to the FC arm. 
Poročali so o rahlem, vendar ne pomembnem izboljšanju celokupnega preživetja v skupini R-FC v primerjavi s skupino FC.
Eligible patients had active rheumatoid arthritis, diagnosed according to the criteria of the American College of Rheumatology (ACR). 
Vključeni bolniki so imeli aktiven revmatoidni artritis, diagnosticiran po merilih Ameriškega revmatološkega združenja (ACR, American College of Rheumatology).
• painful joints or back 
boleči sklepi ali hrbet,
In general, the proportion of patients experiencing any infusion reaction was higher following the first infusion than following the second infusion of any treatment course. 
Na splošno je bil delež bolnikov, pri katerih se je pojavila katerakoli z infuzijo povezana reakcija, višji po prvi infuziji kot po drugi infuziji kateregakoli cikla zdravljenja.
In the event of relapse, patients may receive 1000 mg IV. 
V primeru recidiva lahko bolniki dobijo 1.000 mg intravensko.
This medicinal product contains sodium. 
To zdravilo vsebuje natrij.
Not known (it is not known how often these side effects happen): 
Neznana pogostnost (kako pogosto se pojavijo naslednji neželeni učinki, ni znano):
This analysis suggests that dose adjustment of rituximab with any of the tested covariates is not expected to result in a meaningful reduction in its pharmacokinetic variability. 
Te analize kažejo, da prilagoditev odmerka rituksimaba s katerokoli od testiranih spremenljivk verjetno ne bo pomembno zmanjšala njegove farmakokinetične variabilnosti.
The cells that are affected by Ritemvia help to fight infection and you should wait until the infection has passed before you are given Ritemvia. 
Celice, ki jih zdravilo Ritemvia uniči, pomagajo pri borbi proti okužbam, zato morate počakati, da se okužba pozdravi, preden prejmete zdravilo Ritemvia.
Ritemvia is indicated in adults for the following indications: 
Zdravilo Ritemvia je pri odraslih indicirano za naslednje indikacije:
Data in approximately 180 patients pre-treated with rituximab have demonstrated clinical benefit (including CR) and are supportive for rituximab re-treatment. 
Podatki, pridobljeni pri približno 180 bolnikih, ki so bili predhodno zdravljeni z rituksimabom, dokazujejo klinično korist (vključno s CR) in podpirajo ponovno zdravljenje z rituksimabom.
Immunomodulatory medicinal products may increase the risk of malignancy. 
Imunomodulirajoča zdravila lahko povečajo tveganje za razvoj malignih bolezni.
 Cardiovascular events, see section 4.4. 
• kardiovaskularni dogodki, glejte poglavje 4.4.
In contrast, three patients (1.5%) had cerebrovascular events in the CHOP group, all of which occurred during the follow-up period. 
Nasprotno pa so se cerebrovaskularni dogodki pojavili pri treh bolnikih (1,5%) v skupini CHOP, vsi med obdobjem spremljanja.
Clinical manifestations of anaphylaxis may appear similar to clinical manifestations of the cytokine release syndrome (described above). 
Klinična manifestacija anafilakse je lahko podobna manifestaciji sindroma sproščanja citokinov (opisano zgoraj).
Rituximab was given in combination with intravenous glucocorticoids which may reduce the incidence and severity of these events. 
Rituksimab so dajali v kombinaciji z intravenskimi glukokortikoidi, ki lahko zmanjšajo incidenco in izrazitost teh učinkov.
Efficacy was observed both for patients with newly diagnosed disease and for patients with relapsing disease (Table 17). 
Učinkovitost so ugotovili tako pri bolnikih z novoodkrito boleznijo kot pri bolnikih s ponovitvijo bolezni (preglednica 17).
The most frequently reported events were tachycardia (4%) and atrial fibrillation (3%) (see section 4.4). 
Najpogosteje opisana neželena učinka sta bila tahikardija (4%) in atrijska fibrilacija (3 %) (glejte poglavje 4.4).
They will watch you closely while you are being given this medicine. 
Med dajanjem tega zdravila vas bodo skrbno nadzorovali.
This will be administered as 2 separate infusions which are given 2 weeks apart, followed by 1 infusion every 6 months for at least 2 years. 
Tega boste dobili v 2 ločenih infuzijah v presledku 2 tednov, nadaljevalo pa se bo z 1 infuzijo vsakih 6 mesecev najmanj 2 leti.