natgillin/translations-raw huggingface dataset:
Concomitant stable doses of aminosalicylates, corticosteroids, and / or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of these medications.
Dovoljena je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ali imunomodulacijskih zdravil; 80 % bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
PGA-F clear / minimal and ≥ 2-grade improvement (%)
PGA-F čisto/minimalno in ≥ izboljšanje za dva razreda (%)
TIME (WEEKS)
ČAS (TEDNI)
Concomitant stable doses of one non-biologic immunosuppressant were permitted.
Sočasni, stalni odmerki enega nebiološkega imunosupresiva so bili dovoljeni.
Your symptoms may return upon stopping treatment.
Vaši simptomi se lahko po prenehanju zdravljenja povrnejo.
Clinical results were assessed for induction of remission at week 8 and for maintenance of remission at week 52.
Klinične rezultate so ocenili glede indukcije remisije 8. teden in glede ohranitve remisije 52. teden.
Component of a multipack, cannot be sold separately.
Sestavni del večkratnega pakiranja, ni za posamično prodajo.
If you have Crohn's disease you will first be given other medicines.
Če imate Crohnovo bolezen, boste najprej dobili druga zdravila.
Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests.
Nekateri neželeni učinki, ki so bili opaženi pri adalimumabu, nimajo simptomov in se jih lahko odkrije le pri krvnih testih.
The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomized design.
Na interpretacijo podatkov lahko vplivajo metodološke omejitve raziskave, vključno z majhno velikostjo vzorca in nerandomizirano zasnovo raziskave.
Significant response was first observed at week 2 and maintained through 24 weeks (table 13).
Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (preglednica 13).
Adalimumab should only be used during pregnancy if clearly needed.
Adalimumab se med nosečnostjo lahko uporablja samo, če je brez dvoma potrebno.
No dose adjustment is required.
Prilagoditev odmerka ni potrebna.
• high blood sugar;
• visok krvni sladkor;
Side effects may occur up to 4 months or more after the last Hefiya injection.
Neželeni učinki se lahko pojavijo do 4 mesece ali več po zadnji injekciji zdravila Hefiya.
• It is important to tell your doctor if you have had or have a serious heart condition.
• Pomembno je, da zdravniku poveste, če ste imeli ali imate kakšno resno bolezen srca.
Monoclonal antibodies are proteins that attach to a specific target in the body.
Monoklonska protitelesa so beljakovine, ki se vežejo na specifične tarče v telesu.
Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Bolniki iz študij UC-I in UC-II so imeli možnost nadaljevati v odprti, dolgoročni podaljšani študiji (UC III).
Most side effects are mild to moderate.
Večina neželenih učinkov je blagih do zmernih.
73 % of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
73 % bolnikov, vključenih v študiji pri psoriazi I in II, je predhodno dobivalo sistemsko zdravljenje ali fototerapijo.
You and your doctor should pay special attention to signs of infection while you are being treated with Hefiya.
Vi sami in vaš zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Hefiya.
The primary endpoint of the study was clinical remission at week 26, defined as PCDAI score ≤ 10.
Primarni cilj študije je bila klinična remisija v 26. tednu, definirana kot vrednost PCDAI ≤ 10.
If you have any questions, please talk to a doctor, pharmacist or nurse who is familiar with Hefiya.
Če imate kakršna koli vprašanja, se pogovorite z zdravnikom, farmacevtom ali medicinsko sestro, ki so seznanjeni z zdravilom Hefiya.
Impaired lung function may increase the risk for developing infections.
Okvarjena pljučna funkcija lahko zveča tveganje za razvoj okužbe.
Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability.
Pri peroralnem dajanju so imunoglobulini G podvrženi intestinalni proteolizi in imajo nizko biološko razpoložljivost.
There is little experience from re-administration after more than 8 weeks since the previous dose.
Izkušenj s ponovno uporabo po več kot 8 tednih od prejšnjega odmerka je malo.
The predicted exposures indicate that in the absence of methotrexate, a loading dose may lead to an initial increase in systemic exposure.
Napovedane izpostavljenosti nakazujejo, da lahko polnilni odmerek v odsotnosti metotreksata povzroči začetno povečanje sistemske izpostavljenosti.
Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Dolgotrajno zdravljenje z adalimumabom 40 mg na teden, ki je trajalo 96 tednov, ni dalo nobenih novih ugotovitev o varnosti.
efficacy outcomes double blind 32 weeks adalimumab / MTX (N =38)
rezultati učinkovitosti dvojno slepa 32 tednov adalimumab/MTX (N = 38)
Figure B: items not included in the carton
Slika B: Predmeti, ki niso priloženi v škatli
See “8.
Glejte točko „8.
8 to 12 years
8 do 12 let
None of these patients experienced rebound during the withdrawal period.
Nobenemu od teh bolnikov se med obdobjem prenehanja uporabe ni pojavil povratni odziv.
Among those, 109 subjects (63.7 %) were reported to be in remission at 10 years.
Med temi je bilo 109 oseb (63,7 %) po 10 letih v stanju remisije.
With current data it is not known if adalimumab treatment influences the risk for developing dysplasia or colon cancer.
Glede na trenutne podatke ni znano, ali zdravljenje z adalimumabom vpliva na tveganje za nastanek displazije ali raka kolona.
13 to 17 years
13 do 17 let
Patients taking TNF-antagonists are more susceptible to serious infections.
Bolniki, ki uporabljajo antagoniste TNF, so bolj dovzetni za resne okužbe.
In rare cases, these infections may be life-threatening.
V redkih primerih so te okužbe lahko smrtno nevarne.
Scarring may also occur in affected areas.
Na prizadetih področjih se lahko pojavijo tudi brazgotine.
Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.
Nato uporabite naslednji odmerek, kot bi ga uporabili po prvotnem urniku injiciranja, če ne bi pozabili odmerka.
• if you have a severe infection, including tuberculosis, sepsis (blood poisoning) or other opportunistic infections (unusual infections associated with a weakened immune system).
• če imate hudo okužbo, vključno s tuberkulozo, sepso (zastrupitev krvi) ali drugo oportunistično okužbo (neobičajne okužbe, povezane z oslabljenim imunskim sistemom).
Radiographic changes were assessed in the psoriatic arthritis studies.
Rentgenografske spremembe so ocenjevali v študijah psoriatičnega artritisa.
• Tell your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.
• Zdravniku povejte, če ste imeli v preteklosti ponavljajoče se okužbe ali druge bolezni, ki zvečujejo tveganje za okužbe.
The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
Drugi primeri so obsegali številne različne malignome, med njimi redke malignome, ki so po navadi povezani z imunosupresijo.
Concomitant antibiotic use was not allowed during the study.
Sočasno jemanje antibiotikov med trajanjem študije ni bilo dovoljeno.
Subcutaneous use.
Subkutana uporaba.
During the injection you will hear 2 loud clicks: o The 1st click indicates that the injection has started.
Med injiciranjem boste zaslišali 2 glasna klika: o 1. klik pomeni, da se je injiciranje začelo.
Serious haematological, neurological and autoimmune reactions have also been reported.
Poročali so tudi o resnih hematoloških, nevroloških in avtoimunskih reakcijah.
Among the 250 subjects who completed the open-label extension study, improvements in physical function were maintained through 10 years of treatment.
Med 250 osebami, ki so zaključile podaljšano odprto študijo, se je izboljšanje telesne funkcije ohranilo skozi 10 let zdravljenja.
4 to 7 years
4 do 7 let
It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).
Pomembno je, da zdravniku poveste, če ste imeli ali imate kakšno resno bolezen srca (glejte "Opozorila in previdnostni ukrepi").
You must keep holding your pen firmly against your skin until you see a green indicator fill the window and stop moving.
Še naprej trdno pritiskajte injekcijski peresnik ob kožo, dokler zeleni kazalnik ne napolni okenca in se neha premikati.
In the open label period of the study, PASI 75 and PGA clear or minimal responses were maintained for up to an additional 52 weeks with no new safety findings.
V odprtem obdobju študije so se odzivi PASI 75 in PGA čisto ali minimalno ohranili še do dodatnih 52 tednov brez novih varnostnih ugotovitev.
Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Klinični odziv (CR-100) se je ohranil pri 102 od prvih in 233 od drugih bolnikov.
• reduction in blood platelets which increases risk of bleeding or bruising;
• zmanjšanje števila krvnih ploščic, kar poveča tveganje krvavitev ali podplutb;
20 weeks
20 tednov
Touching them may cause the needle guard to be activated too early.
Če se jih dotaknete, se ščitnik za iglo lahko prezgodaj aktivira.
Hefiya can also be given alone.
Zdravilo Hefiya se lahko daje tudi samo.
• In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding.
• Pri nekaterih bolnikih telo ne ustvari dovolj krvnih celic, ki premagujejo okužbo ali pomagajo pri ustavitvi krvavitve.
The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Študija ni vključila primarno neodzivnih bolnikov in ti tako niso bili dodatno ocenjeni.
The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64 %.
Povprečna absolutna biološka uporabnost adalimumaba, ocenjena iz treh študij po enem 40 mg odmerku subkutano, je 64 %.
The safety and efficacy of adalimumab in children aged 4-17 years have not yet been established.
Varnost in učinkovitost adalimumaba pri otrocih, starih 4-17 let, ni bila potrjena.
Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1 % to 1 % of the maternal serum level.
Omejeni podatki iz objavljene literature kažejo, da se adalimumab izloča v materino mleko v zelo nizkih koncentracijah, s prisotnostjo adalimumaba v človeškem mleku v koncentraciji 0.1 % do 1 %
• be careful not to touch the needle guard wings before use.
• sta pazljivi, da se pred uporabo ne dotaknete krilc ščitnika za iglo.
• severe allergic reaction with shock;
• huda alergijska reakcija s šokom;
After 32 weeks or at disease flare, patients were eligible to enrol into the open label extension phase (table 12).
Po 32 tednih ali v primeru zagona bolezni so bili bolniki primerni za vključitev v odprto podaljšano fazo (preglednica 12).
After single intravenous doses ranging from 0.25 to 10 mg / kg, concentrations were dose proportional.
Po enem samem intravenskem odmerku od 0,25 do 10 mg/kg so bile koncentracije sorazmerne odmerku.
Do not use if any particulates and / or discolorations are observed.
Ne uporabite je, če opazite prisotnost delcev in/ali obarvanost.
• If you are over 65 years you may be more susceptible to infections while taking Hefiya.
• Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Hefiya.
An asterisk (*) appears in the SOC column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
V koloni organski sistem se pojavi znak zvezdica (*), če so v zvezi s tem vključene dodatne informacije v poglavjih 4.3, 4.4 in 4.8.
Keep this Patient Reminder Card with you during your treatment and for 4 months after your (or your child's) last injection of Hefiya.
To opozorilno kartico za bolnika imejte pri sebi med zdravljenjem in še štiri mesece po svoji zadnji injekciji (ali zadnji injekciji vašega otroka) zdravila Hefiya.
>32 weeks
> 32 tednov
• On rare occasions, treatment with Hefiya could result in lupus-like syndrome.
• V redkih primerih zdravljenje z zdravilom Hefiya povzroči lupusu podoben sindrom.
Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Adalimumab je rekombinantno humano monoklonsko protitelo, proizvedeno v celicah jajčnika kitajskega hrčka.
a HR of adalimumab vs placebo from proportional hazards regression with treatment as factor.
RT adalimumaba v primerjavi s placebom iz regresije proporcionalnih tveganj z zdravljenjem kot faktorjem.
Figure C: Safety Checks before injection
Slika C: Varnostno preverjanje pred injiciranjem
Quality of life
Kakovost življenja
If you have psoriasis, you should NOT inject directly into areas with psoriasis plaques.
Če imate luskavico, si NE injicirajte neposredno v predele s psoriatičnimi plaki.
Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Razpoložljivi podatki kažejo, da je adalimumab po ponovni uvedbi, ki je sledila prekinitvi za 70 dni ali več, dosegel enako velik klinični odziv in je imel podobne varnostne značilnosti kot pred prekinitvijo.
Adalimumab binds specifically to TNF and neutralises the biological function of TNF by blocking its interaction with the p55 and p75 cell surface TNF receptors.
Adalimumab se specifično veže na TNF in nevtralizira njegovo biološko delovanje, ker zavre njegovo interakcijo z receptorji p55 in p75 za TNF na površini celic.
Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Rezultati glede klinične remisije so ostali razmeroma stalni, ne glede na prejšnje prejemanje antagonistov TNF.
Subjects may also have previously lost response or been intolerant to infliximab.
Bolniki so lahko pred tem tudi postali neodzivni ali so imeli intoleranco na infliksimab.
After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Po korekciji za razlike v teži se je izkazalo, da spol in starost po vsem sodeč minimalno vplivata na očistek adalimumaba.
Patients may first be given other disease-modifying medicines, such as methotrexate.
Bolniki lahko najprej prejmejo druga imunomodulirajoča zdravila, npr. metotreksat.
If you accidentally inject Hefiya more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Če pomotoma injicirate zdravilo Hefiya pogosteje, kot bi smeli, se morate posvetovati z zdravnikom ali s farmacevtom in mu pojasniti, da ste uporabili večji odmerek, kot ga potrebujete.
The patients in HS-I and HS-II had Hurley Stage II or III disease with at least 3 abscesses or inflammatory nodules.
Bolniki v študijah HS-I in HS-II imajo po Hurleyevi razvrstitvi bolezen v stadiju II ali III z vsaj tremi abscesi ali inflamatornimi noduli.
Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of 0.1-0.2 nM).
Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in ICAM-1 z IK50 0,1-0,2 nM).
• impotence;
• impotenca;
If re-treatment with adalimumab is indicated, the above guidance on dose and treatment duration should be followed.
Če je indicirano vnovično zdravljenje z adalimumabom, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
Rates of discontinuation of corticosteroids or immunomodulators are presented in table 27.
Stopnja prenehanja zdravljenja s kortikosteroidi ali imunomodulatorji je predstavljena v preglednici 27.
For the safety and health of you and others, needles and used syringes must never be re-used.
Zaradi varnosti in zdravja vas in drugih oseb igel in uporabljenih injekcijskih brizg nikoli ne smete ponovno uporabiti.
BCVA was either improved or maintained (< 5 letters deterioration) in 88.4 % of the eyes at week 78.
Najboljša korigirana ostrina vida se je ali izboljšala ali pa ohranila (poslabšanje ostrine vida < 5 črk) pri 88,4 % očeh v 78. tednu.
In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.
V redkih primerih, zlasti če uporabljate druga zdravila, ki zavirajo imunski sistem, je reaktivacija okužbe s HBV lahko smrtno nevarna.
This medicine is subject to additional monitoring.
Za to zdravilo se izvaja dodatno spremljanje varnosti.
The response for the two monotherapy arms was similar (p = 0.447).
V obeh krakih z monoterapijo je bil odziv podoben (p = 0,447).
Hefiya in combination with methotrexate, is indicated for:
Zdravilo Hefiya je v kombinaciji z metotreksatom indicirano za:
10 A-6250 Kundl Austria
10 A-6250 Kundl Avstrija
The decision to stop using Hefiya should be discussed with your doctor.
O odločitvi, da bi prenehali uporabljati zdravilo Hefiya, se morate posvetovati s svojim zdravnikom.
In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNF-α was seen.
Pri bolnikih s Crohnovo boleznijo so opazili tudi zmanjšanje števila celic, ki izražajo vnetne označevalce v kolonu, vključno z bistvenim zmanjšanjem ekspresije TNFα.
Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Poročila so vključevala primere pljučne in zunajpljučne (tj. diseminirane)
Travel / recurrent infection
Potovanje/ponavljajoče se okužbe
Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Bolnike s kliničnim odzivom (znižanje CDAI ≥ 70) 4. teden so stratificirali in analizirali ločeno od bolnikov brez kliničnega odziva 4. teden.
In all situations described below, the benefit / risk balance of therapy should be very carefully considered.
V vseh spodaj opisanih okoliščinah je treba korist in tveganje zdravljenja z zdravilom Hefiya zelo natančno pretehtati.
These patients also had objective evidence of inflammation in the sacroiliac joints or spine on MRI or elevated hs-CRP.
Ti bolniki so imeli tudi objektivne znake vnetja sakroiliakalnih sklepov ali hrbtenice na MRI ali povišan hs-CRP.
One hundred patients (n = 100) from the Paediatric CD Study continued in an open-label long-term extension study.
Sto bolnikov (n = 100) iz študije Crohnove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
• You may see a drop of liquid at the end of the needle.
• Na koncu igle lahko opazite kapljico tekočine.
Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in table 26.
Stopnja klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15 točk od začetne vrednosti) sta predstavljena v preglednici 26.
Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week 8.
Klinično remisijo (opredeljeno kot ocena Mayo ≤ 2 in nobena podocena > 1) so ocenili 8. teden.
40 mg every other week in combination with methotrexate
40 mg vsak drugi teden v kombinaciji z metotreksatom
Injection site reactions generally did not necessitate discontinuation of the medicinal product.
Zaradi reakcij na injekcijskem mestu uporabe zdravila praviloma ni bilo treba prekiniti.
• Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Hefiya in case they cause infections.
• Določena cepiva lahko vsebujejo žive, vendar oslabljene oblike bakterij ali virusov, ki povzročajo bolezen, in teh cepiv se med zdravljenjem z zdravilom Hefiya ne sme uporabljati, da ne bi povzročila okužb.
Table 21 efficacy results at 12 weeks, HS studies I and II
Preglednica 21: rezultati učinkovitosti v 12. tednu, HS študiji I in II
If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNFα blocker is appropriate for you.
Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNFα za vas primerno.
Do not use this medicine after the expiry date which is stated on the label / blister / carton after EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatli poleg oznake “EXP”.
If you receive Hefiya while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Če prejemate zdravilo Hefiya med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
• Using a circular motion, clean the injection site with an alcohol wipe.
• S krožnim gibom obrišite mesto injiciranja z alkoholnim zložencem.
The highest dose level evaluated has been multiple intravenous doses of 10 mg / kg, which is approximately 15 times the recommended dose.
Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/kg, kar je približno 15-kraten priporočen odmerek.
Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
Izidi poročil bolnikov glede opravil, povezanih z vidom, so bili merjeni v obeh kliničnih študijah z uporabo vprašalnika NEI VFQ-25.
48.9a percent change in total fingernail NAPSI (%)
6,9 48,9a odstotek spremembe v celotnem indeksu NAPSI
• worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
• poslabšanje stanja, ki se imenuje dermatomiozitis (viden kot kožni izpuščaj, ki ga spremlja mišična šibkost).
• allergic reactions (including seasonal allergy);
• alergijske reakcije (vključno s sezonskimi alergijami);
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Neinfekcijski uveitis je vnetna bolezen, ki prizadene določene dele očesa.
Your doctor may decide to stop treatment.
Morda se bo odločil, da vaše zdravljenje prekine.
Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Z zdravjem povezano kakovost življenja in telesno funkcijo so ocenjevali s pomočjo vprašalnikov HAQ-S in SF-36.
Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by week 19.
Bolniki so bili kasneje deležni obveznega programa postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 19. tedna.
Approximately 40 % of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Pri približno 40 % bolnikih v študiji UC-II predhodno anti-TNF zdravljenje z infliksimabom ni bilo uspešno.
Patients who achieved PASI 75 and PGA clear or minimal were withdrawn from treatment for up to 36 weeks and monitored for loss of disease control (i.e. a worsening of PGA by at least 2 grades).
Bolniki, ki so dosegli PASI 75 in PGA čisto ali minimalno, so bili z zdravljenja odpuščeni in spremljani do 36 tednov glede izgube nadzora nad boleznijo (tj. poslabšanje PGA za najmanj 2 stopnji).
Improvement in quality of life was measured up to week 156 (36 months) and improvement was maintained through that time.
Do 156. tedna (36. meseca) se je ocenjevalo izboljšanje kvalitete življenja, ki se je v tem času tudi ohranilo.