natgillin/translations-raw huggingface dataset:
In the fourth study, which included 498 patients who had an inadequate response to TNF blockers, patients receiving RoActemra with methotrexate were around 9 times more likely to respond than those receiving placebo with methotrexate.
V četrti študiji pri 498 bolnikih, ki se niso zadostno odzvali na zaviralce tumorje nekrotizirajočega faktorja, so se bolniki, ki so prejemali zdravilo RoActemra z metotreksatom, približno devetkrat pogosteje odzvali na zdravljenje kot bolniki, ki so prejemali placebo z metotreksatom.
In this study 85% (64 out of 75) patients treated with RoActemra responded to treatment and no longer had fever after 3 months, compared with 24% (9 out of 37) patients receiving placebo.
V tej študiji se je 85 % (64 od 75) bolnikov, zdravljenih z zdravilom RoActemra, odzvalo na zdravljenje in po treh mesecih niso imeli več povišane telesne temperature v primerjavi s 24 % (9 od 37) bolnikov, ki so prejemali placebo.
In severe rheumatoid arthritis not previously treated with methotrexate, RoActemra given by infusion was investigated in one main study involving 1,162 patients.
Pri hudem revmatoidnem artritisu, ki še ni bil zdravljen z metotreksatom, so zdravilo RoActemra, dano z infundiranjem, raziskovali v eni glavni študiji, v katero je bilo vključenih 1 162 bolnikov.
RoActemra is available as a solution to be injected under the skin and as a concentrate for making a solution for infusion (drip) into a vein.
Zdravilo RoActemra je na voljo v obliki raztopine za injiciranje pod kožo in koncentrata za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
• adults with severe rheumatoid arthritis that is getting worse in patients who have not been previously treated with a medicine called methotrexate;
• hudega, slabšajočega se revmatoidnega artritisa pri odraslih bolnikih, ki se predhodno niso zdravili z metotreksatom;
RoActemra given by injection under the skin was investigated in two studies involving 1,918 patients with moderate to severe rheumatoid arthritis where previous treatment with DMARD had not worked well.
Zdravilo RoActemra, ki se injicira pod kožo, so raziskovali tudi v dveh študijah, pri katerih je sodelovalo 1 918 bolnikov z zmernim ali hudim revmatoidnim artritisom, pri katerih predhodno zdravljenje z zdravilom is skupine DMARD ni bilo učinkovito.
How RoActemra is given, its dose and how often it is given depends on the condition it is used to treat.
Način dajanja, odmerek in pogostost dajanja zdravila RoActemra so odvisni od bolezni, za katero se zdravilo uporablja.
In three of these studies, RoActemra was compared with placebo, as an add-on to failing treatment with conventional rheumatoid arthritis medicines in a total of over 3,000 patients.
V treh od teh študij so zdravilo RoActemra primerjali s placebom pri več kot 3 000 bolnikih kot dodatek k neuspešnemu zdravljenju z običajnimi zdravili za zdravljenje revmatoidnega artritisa.
One of the studies, which involved 1,196 patients, also showed that the combination of RoActemra and methotrexate slowed down the damage to the joints and improved physical function after up to 2 years, when compared with the combination of placebo and methotrexate.
Ena študija pri 1 196 bolnikih je dokazala, da je kombinacija zdravila RoActemra in metotreksata po največ dveh letih v primerjavi s kombinacijo placeba in metotreksata upočasnila tudi poškodbe sklepov in izboljšala funkcijsko zmogljivost.
Results showed that patients adding RoActemra were around 4 times more likely to respond to treatment than those adding placebo.
Rezultati kažejo, da so se bolniki, ki so dodatno prejemali zdravilo RoActemra, štirikrat pogosteje odzvali na zdravljenje kot bolniki, ki so dodatno prejemali placebo.
Giant cell arteritis
Velikocelični arteritis
Out of 51 patients who had CRS after being given the CAR-T cell medicine tisagenlecleucel, 39 responded to treatment with RoActemra (76.5%), while 8 out 15 patients (53.3%) who had CRS after being given axicabtagene ciloleucel responded.
Od 51 bolnikov, ki so po prejemu CAR-T celične terapije z učinkovino tisagenlecleucel zboleli za sindromom CRS, se jih je na zdravljenje z zdravilom RoActemra odzvalo 39 (76,5 %), medtem ko se jih je v skupini bolnikov, ki je zbolela za sindromom CRS po prejemu terapije z učinkovino aksicabtagen ciloleucel, odzvalo 8 od 15 bolnikov (53,3 %).
In juvenile idiopathic polyarthritis, RoActemra given by infusion was compared with placebo in one main study involving 166 children from 2 years of age who could not take methotrexate or it did not work well enough.
Pri juvenilnem idiopatskem poliartritisu so zdravilo RoActemra, ki je bilo dajano z infundiranjem, primerjali s placebom v eni glavni študiji, v kateri je sodelovalo 166 otrok, starih dve leti ali več, ki niso mogli jemati metotreksata ali pri katerih zdravljenje z njim ni bilo dovolj učinkovito.
• children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough.
• juvenilnega idiopatskega poliartritisa pri otrocih, starejših od dveh let, pri katerih predhodno zdravljenje z metotreksatom ni bilo dovolj uspešno.
Another study involving 51 children from 1 year of age showed that RoActemra given by injection under the skin had a similar distribution in the body and effect on the disease to that previously seen with RoActemra given by infusion.
Druga študija z 51 otroki, starejšimi od enega leta, je pokazala, da zdravilo RoActemra, dano z injiciranjem v podkožje, dosega podobno porazdelitev po telesu in učinek na bolezen kot zdravilo RoActemra, dano z infundiranjem.
How does RoActemra work?
Kako zdravilo RoActemra deluje?
After 6 months of treatment, 45% of patients taking RoActemra in combination with methotrexate (130 out of 290) and 39% of patients taking RoActemra on its own (113 out of 292) achieved remission (did not show symptoms of the disease), compared with 15% of those taking placebo plus methotrexate (43 out of 287).
Po šestmesečnem zdravljenju se je pri 45 % (130 od 290) bolnikov, ki so jemali zdravilo RoActemra v kombinaciji z metotreksatom, in 39 % (113 od 292) bolnikov, ki so jemali samo zdravilo RoActemra, pojavila remisija v primerjavi s 15 % (43 od 287) pri bolnikih, ki so jemali placebo z metotreksatom.
How is RoActemra used?
Kako se zdravilo RoActemra uporablja?
In systemic juvenile idiopathic arthritis, RoActemra given by infusion was compared with placebo in one main study involving 112 children in whom treatment with NSAID and corticosteroids did not work well enough.
Zdravilo RoActemra, ki je bilo dajano z infundiranjem, so pri sistemskem juvenilnem idiopatskem artritisu primerjali s placebom v eni glavni študiji, ki je vključevala 112 otrok, pri katerih zdravljenje z nesteroidnimi protivnetnimi zdravili (NSAID) in kortikosteroidi ni bilo dovolj učinkovito.
After 4 to 6 months of treatment, 26% of patients on RoActemra (21 out of 82) had a flare-up of symptoms during treatment, compared with 48% of patients taking placebo (39 out of 81).
Po štirih do šestih mesecih zdravljenja so se simptomi ponovno pojavili pri 26 % (21 od 82) bolnikov, ki so jemali zdravilo RoActemra, v primerjavi z 48 % (39 od 81) bolnikov, ki so jemali placebo.
RoActemra, on its own or in combination with methotrexate, was compared with placebo (a dummy treatment) plus methotrexate.
Zdravilo RoActemra, ki so ga bolniki prejemali samostojno ali v kombinaciji z metotreksatom, so primerjali s placebom (zdravilom brez učinkovine) ob sočasnem jemanju metotreksata.
In the first study, RoActemra was more effective than placebo in treating rheumatoid arthritis: after 6 months of treatment with RoActemra, 61% of patients responded to treatment compared with 32% on placebo.
V prvi študiji je bilo zdravilo RoActemra učinkovitejše od placeba pri zdravljenju revmatoidnega artritisa: po šestmesečnem zdravljenju se je nanj odzvalo
RoActemra contains the active substance tocilizumab.
Zdravilo RoActemra vsebuje učinkovino tocilizumab.
• children from 1 year of age with active systemic juvenile idiopathic arthritis in whom other treatments (with anti-inflammatory medicines called NSAIDs and corticosteroids) have not worked well enough;
• aktivnega sistemskega juvenilnega idiopatskega artritisa pri otrocih, starejših od enega leta, pri katerih predhodno zdravljenje z nesteroidnimi protivnetnimi zdravili (NSAIDs) ali sistemskimi kortikosteroidi ni bilo dovolj uspešno;
For the full list of side effects of RoActemra, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila RoActemra, glejte navodilo za uporabo.
In giant cell arteritis, RoActemra given by injection under the skin was found more effective than placebo in one main study involving 251 adults.
Pri velikoceličnem arteritisu so v eni glavni študiji pri 251 odraslih ugotovili, da je zdravilo RoActemra, ki se daje z injiciranjem pod kožo, bolj učinkovito od placeba.
RoActemra given by infusion was considered to be effective at treating severe CRS based on a review of data from 66 patients who experienced this condition after they were given CAR-T cell medicines to treat a blood cancer.
Na podlagi pregleda podatkov o 66 bolnikih, pri katerih se je po prejemu CAR-T celične terapije za zdravljenje krvnega raka pojavila huda oblika sindroma CRS, je bilo ugotovljeno, da je zdravilo RoActemra, dano v obliki infuzije, učinkovito pri zdravljenju tega sindroma.
For the treatment of moderate to severe rheumatoid arthritis where other medicines were unsuccessful, RoActemra given by infusion was studied in five main studies involving a total of over 4,000 adults.
Zdravilo RoActemra, ki se daje z infundiranjem, so za zdravljenje zmernega do hudega revmatoidnega artritisa, pri katerem druga zdravila niso bila uspešna, raziskovali v petih glavnih študijah, ki so skupaj vključevale več kot 4 000 odraslih.
This summary was last updated in 12/2012.
Povzetek je bil nazadnje posodobljen 12/2012.
A second application is not recommended.
Drugi nanos se ne priporoča.
The European Commission granted a marketing authorisation valid throughout the European Union for NexoBrid on 18 December 2012.
Evropska komisija je dovoljenje za promet z zdravilom NexoBrid, veljavno po vsej Evropski uniji, odobrila dne 18. decembra 2012.
Other information about NexoBrid
Druge informacije o zdravilu NexoBrid
It is available as a powder and gel, which are mixed together to make a gel (2 g/22 g or 5 g/55 g).
Na voljo je kot prašek in gel, ki se ju zmeša, da nastane gel (2 g/22 g ali 5 g/55 g).
In patients receiving NexoBrid, in around 15% (16 out of 106) of the wounds the eschar needed to be removed by surgery and around 18% (19 out of 106) required a skin graft, compared with around 63% (55 out of 88) and around 34% (30 out of 88) respectively in patients receiving standard debridement treatment.
Pri bolnikih, ki so prejemali zdravilo NexoBrid, je bilo treba pri približno 15 % (16 od 106) ran eshare odstraniti s kirurškim posegom in pri približno 18 % (19 od 106) ran izvesti presaditev kože v primerjavi s približno 63 % (55 od 88) in 34 % (30 od 88) ran pri bolnikih, pri katerih so rane oskrbeli s standardnim čiščenjem.
What measures are being taken to ensure the safe use of NexoBrid?
Kateri ukrepi se izvajajo za zagotovitev varne uporabe zdravila NexoBrid?
The effects of NexoBrid were first tested in experimental models before being studied in humans.
Učinki zdravila NexoBrid so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
It should only be used in specialised burns centres, and should not be applied to more than 15% of the patient's total body surface area.
Uporablja se samo v specializiranem centru za opekline, nanese pa se lahko na največ 15 % celotne površine telesa bolnika.
This is a summary of the European public assessment report (EPAR) for NexoBrid.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo NexoBrid.
What benefit has NexoBrid shown during the studies?
Kakšne koristi je zdravilo NexoBrid izkazalo med študijami?
NexoBrid should be used within 15 minutes after mixing and should be left in contact with the skin for four hours.
Zdravilo NexoBrid je treba uporabiti v 15 minutah po mešanju in ga v stiku s kožo pustiti štiri ure.
The company will also carry out a long-term study in adults and children comparing NexoBrid with standard debridement treatment to investigate the outcome of patients including cosmetic considerations.
Družba bo prav tako izvedla dolgoročno študijo na odraslih in otrocih za primerjavo zdravila NexoBrid s standardnim čiščenjem, s katero bo proučila rezultate bolnikov, vključno s kozmetičnim vidikom.
The summary of the opinion of the Committee for Orphan Medicinal Products for NexoBrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Povzetek mnenja Odbora za zdravila sirote za zdravilo NexoBrid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
For more information about treatment with NexoBrid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom NexoBrid preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
NexoBrid concentrate of proteolytic enzymes enriched in bromelain
NexoBrid koncentrat proteolitičnih encimov, obogatenih z bromelainom
Since some of the side effects seen, including delay in complete wound healing, may have been related to wound care procedures, the Committee decided that NexoBrid should only be used in specialised burns centres by healthcare professionals who have been trained to use it.
Ker so bili nekateri zabeleženi neželeni učinki, vključno z zakasnitvijo popolne zacelitve ran, morda povezani s postopki oskrbe rane, je Odbor odločil, da lahko zdravilo NexoBrid uporabljajo samo ustrezno usposobljeni zdravstveni delavci v specializiranih centrih za opekline.
The Committee considered that NexoBrid was shown to be an effective debridement treatment with an acceptable safety profile which complements available surgical techniques.
Odbor je ugotovil, da se je zdravilo NexoBrid izkazalo kot učinkovito za čiščenje in ima sprejemljiv varnostni profil, ki dopolnjuje razpoložljive kirurške tehnike.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NexoBrid.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo NexoBrid, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What is the risk associated with NexoBrid?
Kakšna tveganja so povezana z zdravilom NexoBrid?
The most commonly reported side effects with NexoBrid are local pain, and pyrexia (fever) or hyperthermia (high body temperature).
Najpogosteje opisana neželena učinka zdravila NexoBrid sta bila lokalna bolečina in povišana telesna temperatura (pireksija) ali hipertermija (visoka telesna temperatura).
Why has NexoBrid been approved?
Zakaj je bilo zdravilo NexoBrid odobreno?
The full EPAR for NexoBrid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo NexoBrid je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
NexoBrid was studied in one main study involving 156 patients, who were hospitalised with deep partial thickness or full thickness burn wounds.
Zdravilo NexoBrid so proučevali v eni glavni študiji, v katero je bilo vključenih 156 bolnikov, ki so bili hospitalizirani zaradi globokih dermalnih in subdermalnih opeklinskih ran.
NexoBrid is a medicine that contains the active substance ‘concentrate of proteolytic enzymes enriched in bromelain'.
NexoBrid je zdravilo, ki vsebuje zdravilno učinkovino „koncentrat proteolitičnih encimov, obogatenih z bromelainom“.
Because the number of patients with deep partial thickness and full thickness thermal burn wounds is low, the disease is considered ‘rare', and NexoBrid was designated an ‘orphan medicine' (a medicine used in rare diseases) on 30 July 2002.
Ker je bolnikov z globokimi dermalnimi in subdermalnimi termičnimi opeklinskimi ranami malo, velja ta bolezen za redko, zato je bilo zdravilo NexoBrid 30. julija 2002 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
In addition, it was found that NexoBrid removed eschar from wounds faster than standard treatments.
Ugotovili so tudi, da je zdravilo NexoBrid eshare z ran odstranilo hitreje kot standardna zdravljenja.
NexoBrid must not be used in people who are hypersensitive (allergic) to the active substance, pineapples, papain (an enzyme found in papaya fruit) or any of the other ingredients.
Zdravila NexoBrid ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) zdravilno učinkovino, ananas, papain (encim v papaji) ali katero koli drugo sestavino zdravila.
Deep partial thickness burns (sometimes called ‘second degree' burns) extend into a deep region of an inner layer of the skin called the dermis, while full thickness burns (sometimes called ‘third degree' burns) extend even deeper, through the whole dermis.
Globoke dermalne opekline (imenovane tudi opekline druge stopnje) se raztezajo v globoki predel notranje plasti kože, imenovan dermis, subdermalne opekline (imenovane tudi opekline tretje stopnje), pa segajo še globlje skozi celoten dermis.
The results were also considered for burn wounds of all thicknesses, including full thickness wounds.
Rezultate so prav tako upoštevali za opeklinske rane vseh globin, tudi za subdermalne rane.
The CHMP decided that NexoBrid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Zaključil je, da so koristi zdravila NexoBrid večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
For the full list of all side effects reported with NexoBrid, see the package leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila NexoBrid, glejte navodilo za uporabo.
For a burn wound area of 250 cm2, NexoBrid 5 g/50 g gel is used.
Za predel opeklinske rane površine 100 cm2 se uporabi zdravilo NexoBrid 2 g/20 g gel, za predel opeklinske rane površine 250 cm2 pa zdravilo NexoBrid 5 g/50 g gel.
The main measure of effectiveness was the proportion of deep partial thickness wounds that needed surgery to remove further skin tissue or that required a skin graft from another area of the patient's body.
Glavno merilo učinkovitosti je bil odstotek globokih dermalnih ran, pri katerih je bilo treba s kirurškim posegom odstraniti dodatno kožno tkivo ali izvesti presaditev kože z drugega predela bolnikovega telesa.
Removing the eschar helps to allow the living skin tissue to be treated and to heal.
Odstranitev eshar pripomore k zdravljenju in celjenju živega tkiva.
NexoBrid was also seen to be an effective debridement treatment for burn wounds of all thicknesses, including full thickness wounds.
Zdravilo NexoBrid se je pokazalo tudi kot učinkovito za čiščenje opeklinskih ran vseh globin, tudi dermalnih ran.
The active substance in NexoBrid is a mixture of enzymes extracted from the stem of the pineapple plant.
Zdravilna učinkovina v zdravilu NexoBrid je mešanica encimov iz stebla rastline ananasa.
This mixture of enzymes acts as a debriding agent, a substance used to remove dead tissue from areas of the skin such as burn wounds, by dissolving the burn wound eschar.
Mešanica encimov deluje kot čistilna snov, ki se uporablja za odstranitev mrtvega tkiva s predelov kože, kot so opeklinske rane, ker raztopi eshare z opeklinske rane.
The CHMP concluded that NexoBrid effectively removes eschar from deep partial thickness and full thickness wounds and reduces the need for surgery to remove further skin tissue in deep partial thickness wounds.
CHMP je zaključil, da zdravilo NexoBrid iz globokih dermalnih in subdermalnih ran učinkovito odstrani eshare ter zmanjša potrebo po nadaljnji kirurški odstranitvi kožnega tkiva globokih dermalnih ran.
The study showed that NexoBrid was more effective than standard of care treatment (surgical and non-surgical) at reducing the proportion of the deep partial thickness burn wounds that needed surgery to remove skin tissue or required a skin graft.
Študija je pokazala, da je bilo zdravilo NexoBrid učinkovitejše od standardnega zdravljenja (kirurškega in nekirurškega) pri zmanjšanju deleža globokih dermalnih opeklinskih ran, pri katerih je bilo treba s kirurškim posegom odstraniti kožno tkivo ali izvesti presaditev kože.
The company that markets NexoBrid must ensure that healthcare professionals in specialised burns centres who are expected to use NexoBrid receive appropriate training and an educational pack including a step-by-step guide to NexoBrid treatment, covering important safety considerations before and after using NexoBrid.
Družba, ki trži zdravilo NexoBrid, mora zagotoviti ustrezno usposabljanje in izobraževalno gradivo, vključno z navodili po korakih za zdravljenje z zdravilom NexoBrid, ki zajema pomembne varnostne vidike pred uporabo zdravila NexoBrid in po njem, za zdravstvene delavce v specializiranih centrih za opekline, ki bodo najverjetneje uporabljali zdravilo NexoBrid.
The CHMP noted the importance of prompt skin grafting of areas of full thickness and deep burn directly after debridement with NexoBrid, in line with the standard of care in European burns centres.
Opozoril je na pomen hitre presaditve kože na predelih s subdermalnimi in globokimi opeklinami neposredno po čiščenju z zdravilom NexoBrid v skladu s standardno nego v evropskih centrih za opekline.
NexoBrid is used in adults to remove eschar (dead tissue which is dried-out, thick, leathery and black) from deep partial thickness and full thickness burns of the skin caused by heat or fire.
Zdravilo NexoBrid se uporablja za odstranitev eshar (posušenega, debelega, usnju podobnega črnega mrtvega tkiva) pri odraslih z globokimi dermalnimi in subdermalnimi opeklinami zaradi vročine ali ognja.
How has NexoBrid been studied?
Kako je bilo zdravilo NexoBrid raziskano?
What is NexoBrid used for?
Za kaj se zdravilo NexoBrid uporablja?
What is NexoBrid?
Kaj je zdravilo NexoBrid?
The patients received either NexoBrid or standard debridement treatment (surgical or non-surgical treatments to remove the eschar) before receiving further treatment if required, such as surgery or a skin graft.
Bolniki so pred nadaljnjim zdravljenjem (če je bilo potrebno), na primer kirurškim posegom ali presaditvijo kože, prejemali zdravilo NexoBrid ali standardno čiščenje (kirurško ali nekirurško odstranjevanje eshar).
How does NexoBrid work?
Kako zdravilo NexoBrid deluje?
How is NexoBrid used?
Kako se zdravilo NexoBrid uporablja?
NexoBrid is applied to the area of burnt skin after the wound has been appropriately prepared.
Po ustrezni pripravi predela opeklinske rane se nanjo nanese zdravilo NexoBrid.
The maximum number of broachings should be limited to 20.
Največje število predrtij je omejeno na 20.
Waste materials should be disposed of in accordance with local requirements.
Odpadne snovi je treba odstraniti v skladu z lokalnimi predpisi.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 07-07-2009
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 07-07-2009
For lactating animals see section 4.11.
Za živali v obdobju laktacije glejte poglavje 4.11.
Injection site swelling may be painful.
Oteklina na mestu injiciranja je lahko boleča.
When treating groups of animals, use a draw-off needle to avoid excessive broaching of the stopper.
Med zdravljenjem skupin živali uporabite odvzemno iglo, da preprečite čezmerno predrtje gumijastega zamaška.
Melovem alone will not provide adequate pain relief during the dehorning procedure.
Samo zdravilo Melovem ne zagotavlja ustreznega lajšanja bolečine med postopkom odstranjevanja rogov.