natgillin/translations-raw huggingface dataset:
This should be a final volume of 100 mL.
To mora biti končni volumen (100 ml).
Week 52
52. teden
Ninety three percent (93%; n=271) of patients had no progression between week 52 and week 104.
Pri 93 % (n = 271) bolnikov ni bilo napredovanja med 52. in 104. tednom.
Study V RADIATE
Študija V RADIATE
DATE OF FIRST AUTHORISATION/DATE OF LATEST RENEWAL Date of first authorisation: 16 January 2009
Datum prve odobritve: 16. januar 2009
If appropriate, the dose of concomitant MTX and/or other medications should be modified or dosing stopped and tocilizumab dosing interrupted until the clinical situation has been evaluated.
Če je primerno, je treba odmerek sočasno uporabljenega metotreksata in/ali drugih zdravil prilagoditi ali uporabo ustaviti ter odmerjanje tocilizumaba prekiniti, dokler klinično stanje ni ocenjeno.
The TNF antagonist therapy was discontinued prior to randomisation.
Zdravljenje z zaviralcem TNF je bilo prekinjeno pred randomizacijo.
• Do not inject through clothing covering the skin
• Ne uporabljate je skozi obleko, ki prekriva kožo.
Depending on your response, your doctor may decrease your dose to 4 mg/kg then increase back to 8 mg/kg when appropriate.
Odvisno od vašega odziva vam lahko zdravnik zmanjša odmerek na 4 mg/kg in ga nato spet poveča na 8 mg/kg, ko je primerno.
Glucocorticoids should be given according to medical judgement and practice guidelines.
Uporabiti je treba glukokortikoide v skladu z zdravnikovo presojo in smernicami za zdravljenje.
• red swollen areas in the mouth
• rdeči, otekli predeli v ustih,
In a separate analysis of the patients who received escape prednisone to treat GCA flare during the first 52 weeks, the cumulative prednisone dose varied greatly.
V ločeni analizi bolnikov, ki so prejeli rešilni prednizon za zdravljenje poslabšanja GCA v prvih 52 tednih, se je kumulativni odmerek prednizona zelo razlikoval.
Patient advice regarding hypersensitivity reactions (also known as anaphylaxis, if severe)
Nasvet bolniku glede preobčutljivostnih reakcij (znanih tudi kot anafilaksa, če so hude)
When clinically indicated, other liver function tests including bilirubin should be considered.
Glede na klinično stanje je treba razmisliti tudi o drugih testih delovanja jeter, vključno z bilirubinom.
The green cap contains a loose fitting metal tube.
Zelen pokrovček vsebuje ohlapno kovinsko vzmet.
Immunomodulatory medicinal products may increase the risk of malignancy.
Imunomodulirajoča zdravila lahko povečajo tveganje za malignome.
In study WA28119, the SF-36 results were separated into the physical and mental component summary scores (PCS and MCS, respectively).
V študiji WA28119 so rezultate SF-36 razdelili na celokupni oceni telesne in duševne komponente (PCS [telesna] in MCS [duševna]).
These proportions were highly significantly different (p<0.0001).
Ta deleža sta bila občutno signifikantno različna (p < 0,0001).
A study in animals has shown an increased risk of spontaneous abortion/embryo-foetal death at a high dose (see section 5.3).
Študije na živalih so pokazale, da pri večjih odmerkih obstaja večje tveganje spontanega splava ali embrio-fetalne smrti (glejte poglavje 5.3).
It is very important to use RoActemra exactly as prescribed by the doctor.
Zelo pomembno je, da uporabite zdravilo RoActemra natančno tako, kot vam je predpisal zdravnik.
RoActemra can reduce pain and swelling in the arteries and veins in your head, neck and arms.
Zdravilo RoActemra lahko zmanjša bolečino ter otekanje arterij v glavi, vratu in rokah.
Combination with TNF antagonists
Kombinacija z zaviralci TNF
Maintain dose.
Ohranite odmerek.
Physicians should be vigilant for symptoms potentially indicative of new-onset central demyelinating disorders.
Zdravniki morajo biti pozorni na simptome, ki bi lahko pomenili novonastalo centralno demielinizacijsko motnjo.
The percentage of patients achieving sustained remission at week 52, are shown in the Table 4.
Odstotek bolnikov, ki so po 52 tednih dosegli trajno remisijo, je prikazan v preglednici 4.
• children and adolescents, aged 2 years and over, with active polyarticular juvenile idiopathic arthritis (pJIA).
• otrok in mladostnikov, starih 2 leti in več, ki imajo aktivni poliartikularni juvenilni idiopatski artritis (pJIA).
Table 5: Efficacy Results for Study VI (WA19924)
Rezultati učinkovitosti za študijo VI (WA19924)
Cardiovascular risk
Srčno-žilno tveganje
There is limited data for patients above 100 kg (n=7).
Podatkov za bolnike s telesno maso nad 100 kg je malo (n = 7).
The interval between live vaccinations and initiation of RoActemra therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
Presledek med živimi cepivi in začetkom zdravljenja z zdravilom RoActemra mora biti v skladu z veljavnimi smernicami za cepljenje za imunosupresive.
Efficacy for the treatment of macrophage activation syndrome has not been investigated.
Učinkovitosti za zdravljenje sindroma aktivacije makrofagov niso proučevali.
Mean haemoglobin levels increased by week 2 and remained within normal range through to week 24.
Povprečna koncentracija hemoglobina se je povečala do 2. tedna in je ves čas do 24. tedna ostala v normalnem območju.
• If the Window area is not filled by the purple indicator then:
• Če vijolični indikator ne izpolni okenca:
In this study, ACR/EULAR remission (Boolean and Index) were also analysed as pre-specified exploratory endpoints, with higher responses observed in the tocilizumab groups.
V tej študiji so analizirali tudi remisijo glede na ACR/EULAR (na osnovi Boolean in Index definicije), ki sta bila vnaprej določena eksplorativna cilja - v skupinah s tocilizumabom so opazili večje odzive.
There was no clear relationship between decreases in neutrophils below 1 x 109/L and the occurrence of serious infections.
Jasne povezave med zmanjšanjem števila nevtrofilcev pod 1 x 109/l in pojavom resnih okužb ni bilo.
• Risk of serious infections
• tveganje za resne okužbe:
Tocilizumab normalises expression of these enzymes.
Tocilizumab normalizira ekspresijo teh encimov.
The frequency category was estimated as the upper limit of the 95% confidence interval calculated on the basis of the total number of patients exposed to TCZ in clinical trials.
Skupina pogostnosti je bila ocenjena kot zgornja meja 95-odstotnega intervala zaupanja, izračunana na podlagi skupnega števila bolnikov, izpostavljenih tocilizumabu v kliničnih preskušanjih.
Based upon the chronic nature of GCA, treatment beyond 52 weeks should be guided by disease activity, physician discretion, and patient choice.
Glede na kronično naravo GCA je treba pri zdravljenju, daljšem od 52 tednov, upoštevati aktivnost bolezni, zdravnikovo presojo in bolnikove želje.
Patients were considered responders if CRS resolved within 14 days of the first dose of tocilizumab, if no more than 2 doses of RoActemra were needed, and no drugs other than RoActemra and corticosteroids were used for treatment.
Bolniki so bili ocenjeni kot odzivni, če je CRS izzvenel v 14 dneh po prvem odmerku tocilizumaba, če nista bila potrebna več kot dva odmerka zdravila RoActemra in če za zdravljenje niso uporabili drugih zdravil kot zdravilo RoActemra in kortikosteroide.
The median time from start of CRS to first dose of tocilizumab was 3 days (range, 0-18 days).
Mediani čas od pojava CRS do prvega odmerka tocilizumaba je bil 3 dni (razpon: 0 - 18 dni).
One event (angioedema) was considered serious and life-threatening, and the patient was discontinued from study treatment.
(angioedem) so smatrali za resen ter življenje ogrožajoč in bolniku so študijsko zdravilo ukinili.
This patient did not develop a hypersensitivity reaction or injection site reaction.
Ta bolnik ni imel preobčutljivostne reakcije ali reakcije na mestu injiciranja.
Approximately one-third of the patients in the GCA study had moderate renal impairment at baseline (estimated creatinine clearance of 30-59 mL/min).
Približno tretjina bolnikov v študiji GCA je imela izhodiščno zmerno okvaro ledvic (ocenjeni očistek kreatinina od 30 do 59 ml/min).
• The product must not be given to patients with active or suspected infection
• Zdravila se ne sme dajati bolnikom z aktivno okužbo ali pri sumu na okužbo.
ap value is adjusted for region and duration of RA for all endpoints and additionally baseline value for all continuous endpoints.
a p vrednost je prilagojena glede na regijo in trajanje revmatoidnega artritisa za vse končne cilje ter dodatno za začetno vrednost pri vseh nadaljnjih končnih ciljih.
The accumulation ratio was higher for Cmin (2.49), which was expected based on the non-linear clearance contribution at lower concentrations.
Delež je bil večji za Cmin (2,49), kar je pričakovano glede na nelinearen prispevek očistka pri nižjih koncentracijah.
The incidence of anti-tocilizumab antibody formation might be underestimated because of interference of tocilizumab with the assay and higher drug concentration observed in children compared to adults.
Incidenca nastanka protiteles proti tocilizumabu je lahko podcenjena zaradi interference tocilizumaba z analizo in višje koncentracije zdravila, opažene pri otrocih v primerjavi z odraslimi.
• If you have cardiovascular risk factors such as raised blood pressure and raised cholesterol levels, tell your doctor.
• Če imate srčno-žilne dejavnike tveganja, npr. zvišan krvni tlak ali zvišano koncentracijo holesterola, morate to povedati svojemu zdravniku.
All efficacy comparisons vs Placebo + MTX.
Vse primerjave glede učinkovitosti so opravili s placebom + MTX.
Of the 4009 patients in this population, 3577 received treatment for at least 6 months, 3296 for at least one year, 2806 received treatment for at least 2 years and 1222 for 3 years.
Od 4009 bolnikov v tej populaciji jih je 3577 zdravilo prejemalo vsaj 6 mesecev, 3296 vsaj 1 leto, 2806 vsaj 2 leti ter 1222 3 leta.
> 3 to 5 x ULN (confirmed by repeat testing, see section 4.4).
> 3- do 5-kratna ZMN (potrjeno s ponovnim testiranjem, glejte poglavje 4.4).
The percent of patients achieving JIA ACR 30, 50, 70 and 90 responses are shown in Table 7.
Odstotki bolnikov, ki so dosegli odzive JIA ACR 30, 50, 70 in 90 so prikazani v preglednici 7.
A place to prepare your supplies: • Find a well-lit, clean, flat surface such as a table
Poiščite dobro osvetljeno, čisto in ravno površino, kot je miza.
The safety of subcutaneous RoActemra has been studied in one Phase III study (WA28119) with 251 GCA patients.
Varnost subkutano uporabljenega zdravila RoActemra so raziskali v eni študiji III. faze (WA28119) pri 251 bolnikih z GCA.
Higher scores signal improvement in both FACIT-Fatigue and EQ5D.
Višje ocene pomenijo izboljšanje tako po vprašaniku FACIT-Fatigue kot po vprašalniku EQ5D.
• If you have moderate to severe kidney function problems, your doctor will monitor you.
• Če imate zmerne do hude težave z ledvičnim delovanjem, vas bo zdravnik nadzoroval.
RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Zdravilo RoActemra je indicirano za zdravljenje gigantoceličnega arteriitisa (GCA) pri odraslih bolnikih.
• Do not speed up the warming process in any way, such as using the microwave or placing the pre-filled pen in warm water.
• Na noben način ne pospešujte postopka ogrevanja in ga ne dajajte v mikrovalovno pečico ali toplo vodo.
If you still experience difficulty, you should consult your healthcare provider.
Če imate še vedno težave, se posvetujte s svojim zdravstvenim delavcem.
Approximately 20% of patients had received prior treatment with DMARDs other than MTX.
Približno 20 % bolnikov je prejelo predhodno zdravljenje z DMARD, z izjemo metotreksata.
Patients achieving a JIA ACR70 response were permitted corticosteroid dose reduction.
Bolnikom, ki so dosegli odziv JIA ACR 70, so lahko zmanjšali odmerek kortikosteroida.
Side effects in children and adolescents with sJIA or pJIA are generally similar to those in adults.
Neželeni učinki pri otrocih in mladostnikih s sJIA ali pJIA so na splošno podobni tistim pri odraslih.
Do not throw away used syringes or the puncture resistant container in household trash and do not recycle them.
Ne zavrzite napolnjenih injekcijskih brizg ali zabojnika za ostre predmete v hišne smeti in jih ne reciklirajte.
Restart with 4 mg/kg or 8 mg/kg, as clinically appropriate
Ponovno začnite s 4 mg/kg ali 8 mg/kg, kot je klinično ustrezno.
• Serious hypersensitivity reactions and their management
• resne preobčutljivostne reakcije in njihovo obvladovanje,
The duration of glucocorticoid therapy during screening and before RoActemra (or placebo) was initiated, was similar in all 4 treatment groups (see Table 3).
Trajanje zdravljenja z glukokortikoidi med presejanjem in pred uporabo zdravila RoActemra (ali placeba) je bilo podobno v vseh 4 zdravljenih skupinah (glejte preglednico 3).
Pack sizes of 1 and 4 vials.
Pakiranja z 1 in 4 vialami.
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with RoActemra should be made taking into account the benefit of breast-feeding to the child and the benefit of RoActemra therapy to the woman.
Pri odločitvi za nadaljevanje ali prekinitev dojenja oz. za nadaljevanje ali prekinitev zdravljenja z zdravilom RoActemra je treba upoštevati korist dojenja za otroka in korist zdravljenja z zdravilom RoActemra za žensko.
• Never reattach the green cap after removal.
• Zelenega pokrovčka po odstranitvi nikoli ne nameščajte ponovno.
In GCA patients, higher exposure was observed in patients with lower body weight.
Pri bolnikih z GCA so zabeležili večjo izpostavljenost zdravilu pri bolnikih z manjšo telesno maso.
IL-6 is a pleiotropic pro-inflammatory cytokine produced by a variety of cell types including T- and B-cells, monocytes and fibroblasts.
IL-6 je pleiotropen proinflamatoren citokin, ki nastaja v različnih vrstah celic, med drugim v celicah T in B, monocitih in fibroblastih.
Cases of opportunistic infections have also been reported.
Opisani so bili tudi primeri oportunističnih okužb.
Effects can include strokes and blindness.
Zapleta bolezni sta lahko možganska kap in slepota.
PK differences are not accompanied by marked differences in PD parameters and so the clinical relevance is unknown.
Farmakokinetičnih razlik ne spremljajo izrazite razlike farmakodinamičnih parametrov in tako klinični pomen ni znan.
After 12 weeks or at the time of switching to RoActemra, due to disease worsening, patients were treated in the open label extension phase.
Po 12. tednih ali ob prehodu na zdravilo RoActemra zaradi poslabšanja bolezni so bolnike zdravili v odprti, podaljšani fazi.
• eye infection (conjunctivitis)
• okužba oči (konjunktivitis),
• Watch the purple indicator until it stops moving to be sure the full dose of medication is injected.
• Spremljajte vijolični indikator, dokler se ne ustavi, da se prepričate, da ste injicirali celoten odmerek zdravila.
• If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for approximately 10 seconds.
• Če na injekcijskem mestu opazite kapljice krvi, lahko nanj pritisnite sterilno vato ali gazo in držite približno 10 sekund.
If no clinical improvement in the signs and symptoms of CRS occurs after the first dose, up to 3 additional doses of RoActemra may be administered.
Če po prvem odmerku ne pride do kliničnega izboljšanja znakov in simptomov CRS, je mogoče uporabiti do 3 dodatne odmerke zdravila RoActemra.
Important: Do not touch the needle shield which is located at the tip of the pre-filled pen below the Window area (see Figure A), to avoid accidental needle stick injury.
Pomembno: Ne dotikajte se zaščite za iglo, ki se nahaja na konici napolnjenega injekcijskega peresnika pod okencem (glejte sliko A), da se izognete naključni poškodbi z iglo.
• Return any remaining pre-filled pens in the box to the refrigerator.
• Vse preostale napolnjene injekcijske peresnike v škatli vrnite v hladilnik.
• You may hear a second “click” during the injection but you should continue to hold the pre filled pen firmly against your skin until the purple indicator stops moving.
• Med injiciranjem lahko slišite drugi klik, vendar morate napolnjeni injekcijski peresnik še naprej trdno držati na koži, dokler se vijolični indikator ne ustavi.
The Patient's Global Assessment of disease activity was assessed on a 0-100mm Visual Analogue Scale (VAS).
Bolnikovo celotno oceno aktivnosti bolezni so ocenili s pomočjo vizualne analogne lestvice (Visual Analogue Scale, VAS) od 0 do 100 mm.
In study II, 65% of patients achieved a DAS28 < 2.6 at week 104 compared to 48% at 52 weeks and 33% of patients at week 24.
V študiji II je 65 % bolnikov doseglo DAS28 < 2,6 po 104 tednih v primerjavi z 48 % bolnikov po 52 tednih ter 33 % bolnikov po 24 tednih.
b Non-responder Imputation used for missing data.
b Za manjkajoče podatke so uporabili imputacijo za neodzivne bolnike.
Patients would be monitored for liver function tests.
Bolniki bodo opravljali teste delovanja jeter.
• increased bilirubin shown by blood tests
• zvišanje vrednosti bilirubina v krvi, ki ga pokažejo preiskave krvi,
Serious hepatic injury occurred between 2 weeks to more than 5 years after initiation of RoActemra.
Resna okvara jeter se je pojavila od 2 tednov do več kot 5 let po začetku zdravljenja z zdravilom RoActemra.
Available non-clinical data demonstrated the effect of IL-6 on malignant progression and apoptosis resistance to various cancer types.
Razpoložljivi neklinični podatki so pri več različnih vrstah raka pokazali učinek IL-6 na napredovanje malignoma in odpornosti proti apoptozi.
Like all medicines, RoActemra can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo RoActemra neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
• There may be a little bleeding at the injection site.
• Na mestu injiciranja se lahko pojavi manjša krvavitev.
The efficacy population for the tisagenlecleucel cohort included 28 males and 23 females (total 51 patients) of median age 17 years (range, 3-68 years).
Populacija, v kateri so spremljali učinkovitost, je v kohorti s tisagenlecleucelom vključevala 28 moških in 23 žensk (skupaj 51 bolnikov) povprečne starosti 17 let (razpon: 3 - 68 let).
Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Preden boste prejeli to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Patient advice regarding early recognition and treatment to limit risk of a serious infection
Nasvet bolniku glede resnih okužb (zgodnjega prepoznavanja in zdravljenja za zmanjšanje tveganja njihovega nastanka)
• Risk of gastrointestinal perforations especially in patients with history of diverticulitis or intestinal ulcerations
• tveganje za perforacije v prebavilih, posebno pri bolnikih z anamnezo divertikulitisa ali črevesnih ulceracij,
• low white blood cell counts shown by blood tests (neutropenia, leucopenia)
• majhno število belih krvnih celic, ki ga pokažejo preiskave krvi (nevtropenija, levkopenija),
The all control population includes all patients from the double-blind phases of each core study from randomization until either the first change in the treatment regimen, or two years is reached.
Vsa kontrolna populacija je vključila vse bolnike iz dvojno slepih faz vsake osnovne študije od randomizacije do dosežene prve spremembe v režimu zdravljenja ali do preteka dveh let.
You must press the plunger all the way down to ensure that you get the full dose of medication and to ensure the trigger fingers are completely pushed to the side.
Bat morate pritisniti do konca, da boste zagotovo prejeli celoten odmerek zdravila in da bosta sprostitveni sponki popolnoma potisnjeni navzven.
Before you use the RoACTEMRA pre-filled pen for the first time, make sure your healthcare provider shows you the right way to use it.
Preden prvič uporabite napolnjeni injekcijski peresnik zdravila RoACTEMRA, poskrbite, da vam zdravstveni delavec pokaže pravi način uporabe.
What RoActemra is and what it is used for
Kaj je zdravilo RoActemra in za kaj ga uporabljamo
Give the injection
Dajte injekcijo
At week 52 and week 104 the co-primary endpoints were prevention of joint damage and improvement in physical function.
Po 52 tednih ter 104 tednih sta bila dodatna primarna cilja preprečitev okvare sklepov in izboljšanje funkcijske zmogljivosti.
The results from study SC-I is shown in Table 2.
Rezultati iz študije SC-I so prikazani v preglednici 2.
Do not use the pre-filled pen if the box looks like it has already been opened.
Ne uporabite napolnjenega injekcijskega peresnika, če je videti, da je bila škatla že odprta.
• headache, dizziness, high blood pressure
• glavobol, omotica, visok krvni tlak,
No adverse reactions were observed.
Opazili niso nobenih neželenih učinkov.
Allow the syringe to adjust to room temperature
Pustite, da se napolnjena injekcijska brizga ogreje do sobne temperature
• 1 Sterile cotton ball or gauze
• 1 sterilna bombažna kroglica ali gaza
• If you don't keep the needle-shield completely pushed against the skin, the green Activation button will not work.
• Če zaščite za iglo popolnoma ne potisnete na kožo, se zeleni gumb za aktivacijo ne bo sprožil.
There are no adequate data from the use of tocilizumab in pregnant women.
Ni zadostnih podatkov o uporabi tocilizumaba pri nosečnicah.
Reductions in corticosteroids continued, with 44 patients off oral corticosteroids at week 44, while maintaining JIA ACR responses.
Zmanjšanja odmerkov kortikosteroidov so se nadaljevala, v 44. tednu peroralnih kortikosteroidov ni prejemalo 44 bolnikov, ki so ohranili odziv JIA ACR.
• allergic (hypersensitivity) reactions
• alergijske (preobčutljivostne) reakcije,
Your healthcare provider should show you how to prepare and inject properly before you use the RoActemra syringe for the first time.
Vaš zdravstveni delavec vam bo pokazal, kako ustrezno pripraviti in injicirati zdravilo, preden boste napolnjeno injekcijsko brizgo z zdravilom RoActemra prvič uporabili.
Study WA28119 was a randomized, multi-center, double-blind placebo-controlled Phase III superiority study conducted to assess the efficacy and safety of RoActemra in patients with GCA.
Študija WA28119 je bila randomizirana, multicentrična, dvojno slepa, s placebom kontrolirana študija superiornosti III. faze za oceno učinkovitosti in varnosti zdravila RoActemra pri bolnikih s GCA.
The extent varies with the patient's body weight (increased in light body weight patients and decreased in heavy body weight patients) but clinical outcome is consistent with that observed in intravenous treated patients.
Obseg se razlikuje glede na bolnikovo telesno maso (večji pri bolnikih z manjšo telesno maso in manjši pri bolnikih z večjo telesno maso), klinični izid pa je skladen z opaženim pri bolnikih, zdravljenih z intravensko obliko.
It should be clear and colorless to pale yellow.
Biti mora bistra in brezbarvna do bledo rumena.
If you notice any of these, tell your doctor as soon as possible.
Če opazite kar koli od naštetega, čim prej obvestite svojega zdravnika.
There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes.
Po prihodu zdravila na trg so poročali o intersticijski bolezni pljuč (vključno s pnevmonitisom in pljučno fibrozo), v nekaterih primerih s smrtnim izidom.
Severe neutropenia may be associated with an increased risk of serious infections, although there has been no clear association between decreases in neutrophils and the occurrence of serious infections in clinical trials with RoActemra to date.
Huda nevtropenija je lahko povezana s povečanim tveganjem za hude okužbe, čeprav do sedaj v kliničnih preskušanjih z zdravilom RoActemra ni bilo jasne povezave med zmanjšanjem števila nevtrofilcev ter pojavom hudih okužb.
RoActemra can affect the way some medicines work, and the dose of these may require adjustment.
RoActemra lahko vpliva na delovanje nekaterih zdravil in morda bo treba njihove odmerke prilagoditi.