natgillin/translations-raw huggingface dataset:
Combined remission at Week 24 (% patients) Combined remission at Week 52 (% patients)
Kombinirana remisija v 24. tednu (% bolnikov) Kombinirana remisija v 52. tednu (% bolnikov)
Because the final check takes place just before Alofisel is sent to the hospital, the results of this last check are not known when it is given to you.
Zadnji nadzor se izvaja tik preden zdravilo Alofisel pošljejo v bolnišnico, zato v trenutku, ko vam dajo zdravilo, rezultati tega zadnjega preverjanja niso znani.
• Guide for surgeons and other health professionals describing the method of administration
• Vodnik za kirurge in druge zdravstvene delavce, ki opisuje način uporabe
Before scheduling Alofisel administration, the surgeon must ensure that no abscesses are present.
Pred načrtovanjem uporabe zdravila Alofisel mora kirurg zagotoviti, da ni prisotnih abscesov.
• Relevant information on the risk of medication errors and the potential for transmission of infectious agents and details on how to minimise these, including reception, storage and administration instructions (i.e. fistula conditioning, preparation and injection).
• Ustrezne informacije o tveganju za napake pri zdravljenju in nevarnosti prenašanja povzročiteljev okužb ter podrobna navodila za njihovo zmanjšanje, vključno z navodili za prevzem, shranjevanje in dajanje (tj. pripravo fistule ter pripravo in injiciranje zdravila).
Therefore, no dose adjustment is required in elderly patients.
Zato prilagoditev odmerka pri starejših bolnikih ni potrebna.
After perianal and intrarectal injection of human eASC in athymic rats, cells were present in the rectum and jejunum at the site of injection for at least 14 days and were undetectable after 3 months.
Po perianalnem in intrarektalnem injiciranju človeških celic eASC atimičnim podganam so bile celice prisotne v rektumu in jejunumu na mestu injiciranja vsaj 14 dni, po 3 mesecih pa jih ni bilo mogoče zaznati.
See the end of Section 4 for how to report side effects.
Glejte na koncu poglavja 4, kako poročati o neželenih učinkih.
This leaflet was last revised in <MM/YYYY>
Navodilo je bilo nazadnje revidirano dne MM/LLLL
• proctalgia (pain in the rectum or anus).
• proktalgija (bolečina v rektumu ali anusu).
Alofisel is used when the fistulas have not responded sufficiently well to previous treatment.
Zdravilo Alofisel se uporablja, kadar se fistule ne odzivajo dobro na predhodno zdravljenje.
The product is intended for local injection.
To zdravilo je namenjeno lokalnemu injiciranju.
The vials are placed inside a cardboard box.
Viale so pakirane v kartonsko škatlo.
Immediately prior to the administration of Alofisel, the fistula tracts should be conditioned as follows: a) If setons are in place, they must be removed.
Neposredno pred uporabo zdravila Alofisel je treba trakte fistule pripraviti na naslednji način: a) Odstraniti je treba setone, če so vstavljeni.
b) Identify the location of the internal openings.
b) Identificirajte mesto notranjih odprtin.
The efficacy or safety of repeat administration of Alofisel has not been established.
Učinkovitost in varnost večkratne uporabe zdravila Alofisel ni bila dokazana .
Patients should be followed up for potential signs of infection after administration.
Po uporabi je treba bolnike spremljati glede morebitnih znakov okužbe.
Animal studies are not available with respect to reproductive toxicity (see section 5.3).
Študije škodljivih učinkov na sposobnost razmnoževanja pri živalih niso na voljo (glejte poglavje 5.3).
The nature and intended clinical use of darvadstrocel are such that conventional studies of pharmacokinetics (absorption, distribution, metabolism and elimination) are not applicable.
Narava in predvidena klinična uporaba darvadstrocela sta takšni, da običajne študije farmakokinetike (absorpcija, porazdelitev, presnova in izločanje) smiselno niso potrebne.
• massage softly for 20 to 30 seconds the area where the fistula opens on to the skin near your anus.
• 20 do 30 sekund nežno masiral območje, kjer se fistula odpira v kožo v bližini anusa.
* Including abscess drainage, seton placement/removal, curettage, suture of internal openings and medical treatments
* Vključuje drenažo abscesa, vstavitev/odstranjevanje setona, kiretažo, šivanje notranjih odprtin in zdravljenje z zdravili.
Each vial should be used immediately after re-suspension to prevent the cells from re-sedimenting.
Vsako vialo je treba uporabiti takoj po vnovičnem suspendiranju, da se prepreči vnovična sedimentacija celic.
Before treatment with Alofisel, you will be given an anaesthetic.
Pred zdravljenjem z zdravilom Alofisel vam bodo dali anestetik.
Hypersensitivity to the product, bovine serum or any of the excipients listed in section 6.1.
Preobčutljivost na zdravilo, goveji serum ali katero koli pomožno snov, navedeno v poglavju 6.1.
A total of 212 patients were randomised, and 205 patients received a local injection of either Alofisel 120 million cells or placebo in a 1:1 design.
Randomizirali so skupno 212 bolnikov, 205 bolnikov pa je prejelo lokalno injekcijo zdravila Alofisel 120 milijonov celic ali placebo v skupinah, razdeljenih v razmerju 1 : 1.
For injection in the fistula tract tissue in a surgical environment under anaesthesia (general or regional (see section 4.4)) as described below.
Za injiciranje v tkivo traktov fistule v kirurškem okolju pod anestezijo (splošno ali regionalno (glejte poglavje 4.4)), kot je opisano v nadaljevanju.
The effect of ex vivo expansion on the genetic stability of cells has been assessed in vitro without any indication of carcinogenic potential.
Učinek razmnoževanja ex vivo na genetsko stabilnost celic so ocenili in vitro, kjer niso ugotovili nobenih znakov kancerogenega potenciala.
Alofisel is a living cell therapy and, therefore, the final product cannot be sterilised.
Zdravilo Alofisel je terapija, ki vsebuje žive celice, zato končnega izdelka ni mogoče sterilizirati.
It is recommended that at least 2 to 3 weeks before the administration day, preparatory surgery is performed comprising exploration (under anaesthesia) of fistula anatomy (number of existing fistulas and openings), topography (extent and relationship with the sphincters and other pelvic muscles), potential associated complications (such as abscesses) and whether local mucosal disease is mild or inactive.
Priporoča se, da se vsaj 2 do 3 tedne pred dnem prve uporabe zdravila izvede pripravljalna operacija, ki zajema proučitev (pod anestezijo) anatomije fistule (število obstoječih fistul in odprtin), topografije (obseg ter povezava s sfinktri in drugimi medeničnimi mišicami), morebitnih povezanih zapletov (npr. abscesov) in tega, ali je lokalna bolezen sluznice blaga ali neaktivna.
As this medicine will be used during surgery, the hospital staff is responsible for the correct storage of the medicine before and during its use, as well as for its correct disposal.
To zdravilo bo uporabljeno med kirurškim posegom, zato je za pravilno shranjevanje zdravila pred uporabo in med njo ter njegovo pravilno odstranjevanje odgovorno osebje v bolnišnici.
If after the procedure you feel ill or have fever, please inform your physician as soon as you can.
Če boste po postopku zboleli ali imeli povišano telesno temperaturo, čim prej obvestite zdravnika.
The key secondary endpoints were defined as clinical remission (clinical closure of all treated fistula) and response (clinical closure of at least 50% of all treated fistulas) at Week 24.
Ključna sekundarna opazovana dogodka sta bila opredeljena kot klinična remisija (klinično zaprtje vseh zdravljenih fistul) in odziv (klinično zaprtje vsaj 50% vseh zdravljenih fistul) v 24. tednu.
Alofisel is indicated only for injection in the fistula tract tissue as described in section 4.2.
Zdravilo Alofisel je indicirano samo za injiciranje v tkivo traktov fistule, kot je opisano v poglavju 4.2.
Suspension for injection 1 dose consists of 4 vials of 6 mL (in total 24 mL)
suspenzija za injiciranje 1 odmerek sestavljajo 4 viale po 6 ml (skupno 24 ml)
Perianal fistulas are described as complex if they have multiple channels and openings, if they penetrate deep inside your body or if they are associated with other complications such as collections of pus (infected liquid also called abscesses).
Perianalne fistule se opisujejo kot zapletene, če vsebujejo več kanalov in odprtin, če segajo globoko v telo, ali če so povezane z drugimi zapleti, kot so ognojki (okužena tekočina, imenovana tudi absces).
No case of overdose has been reported.
Poročil o primerih prevelikega odmerjanja ni.
The following listing of adverse reactions is based on the clinical trial experience and is displayed by system organ class.
Naslednji seznam neželenih učinkov temelji na izkušnjah iz kliničnih preskušanj, razvrščen pa je po organskih sistemih.
Patients had draining complex perianal fistulas with an inadequate response to at least one of the following treatments: antibiotics, immunosuppressants or anti-TNFs.
Bolniki so imeli drenirajoče zapletene perianalne fistule in neustrezni odziv na vsaj eno izmed naslednjih zdravljenj: antibiotiki, zdravila za zaviranje imunske odzivnosti ali zaviralci TNF.
There are no data from the use of darvadstrocel in pregnant women.
Podatkov o uporabi darvadstrocela pri nosečnicah ni.
Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells (see section 4.2).
Lokalna anestezija ni priporočljiva, ker učinek lokalnih anestetikov na injicirane celice ni znan (glejte poglavje 4.2).
As Alofisel is a living stem cell therapy it cannot be sterilised, and therefore could contain potentially infected biological material although the risk is considered to be low and controlled in the manufacturing.
Zdravilo Alofisel je terapija z živimi matičnimi celicami, zato ga ni mogoče sterilizirati, torej lahko vsebuje potencialno okužen biološki material, čeprav se domneva, da je to tveganje majhno in nadzorovano pri izdelavi.
Darvadstrocel has no or negligible influence on the ability to drive and use machines.
Darvadstrocel nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
- If there are two or three external openings, inject the content of the remaining two vials equally between the associated tracts.
- Če obstajajo dve ali tri zunanje odprtine, enakomerno razporedite vsebino preostalih dveh vial med njihove trakte.
Concomitant use of stable doses of immunosuppressants (18% of patients) or anti-TNFs (33%) or both (28%) was allowed during the study.
Med študijo je bila dovoljena sočasna uporaba stabilnih odmerkov zdravil za zaviranje imunske odzivnosti (18% bolnikov) ali zaviralcev TNF (33%) ali obeh vrst zdravil (28%).
Also contains: Dulbecco's Modified Eagle´s Medium (DMEM) and Human albumin.
Vsebuje tudi: Eaglov medij, modificiran po Dulbeccu (DMEM) in humani albumin.
Perianal fistulas are abnormal channels that connect parts of the lower bowel (rectum and anus) and the skin near the anus, so that one or more openings appear near the anus.
Perianalne fistule so nenormalni kanali, ki povezujejo dele spodnjega dela črevesa (rektuma in anusa) in kože ob anusu, tako da se ob anusu pojavi ena ali več odprtin.
For this, injection of a sodium chloride 9 mg/mL (0.9%) solution through the external openings until it gets out through the internal openings is recommended.
Za to se priporoča injiciranje 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) skozi zunanje odprtine, dokler ne priteče skozi notranje odprtine.
This was a randomised, double blind, parallel group, placebo-controlled, multicentre clinical trial to assess efficacy and safety of Alofisel for the treatment of complex perianal fistulas in Crohn's disease patients.
To je bilo randomizirano, dvojno slepo, vzporedno, multicentrično klinično preskušanje, nadzorovano s placebom, za oceno učinkovitosti in varnosti zdravila Alofisel pri zdravljenju zapletenih perianalnih fistul pri bolnikih s Crohnovo boleznijo.
For further information on the use of Alofisel see section 4.2.
Za dodatne informacije o uporabi zdravila Alofisel glejte poglavje 4.2.
This immunoregulatory activity reduces inflammation, which may allow the tissues around the fistula tract to heal.
Ta imunoregulacijska aktivnost zmanjšuje vnetje, kar omogoča celjenje tkiv okoli trakta fistule.
The European Medicines Agency has deferred the obligation to submit the results of studies with Alofisel in one or more subsets of the paediatric population in the treatment of anal fistula (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Alofisel za eno ali več podskupin pediatrične populacije pri zdravljenju analne fistule (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
What Alofisel is and what it is used for 2.
Kaj je zdravilo Alofisel in za kaj ga uporabljamo 2.
There are two excipients used for storage of the cells: one is a liquid called Dulbecco's Modified Eagle´sMedium containing nutrients for the cells (amino acids, vitamins, salts and carbohydrates), and the other is human albumin, which is a natural protein found in the human body.
Za shranjevanje celic se uporabljata dve pomožni snovi: ena je tekočina, imenovana Eaglov medij,modificiranpoDulbeccu,kivsebujehranilnesnovizacelice(aminokisline,vitamine, soli in ogljikove hidrate), druga pa je humani albumin, ki je naravna beljakovina v človeškem telesu.
You may have had an initial consultation with the Surgeon 2 to 3 weeks prior to Alofisel administration.
Morda ste imeli 2 do 3 tri tedne pred prejemom zdravila Alofisel začetni posvet s kirurgom.
At Week 12, 23/63 (36%) showed anti-donor antibody production.
V 12. tednu so pri 23/63 (36%) zaznali nastajanje protiteles proti darovalcu.
c) Remove the cap from the vial, gently turn the vial upside down, and gently aspirate the whole content using a syringe with a conventional needle no thinner than 22G (see section 4.4).
c) Odstranite pokrovček z viale, jo počasi obrnite navzdol in nežno aspirirajte celotno vsebino z brizgo z običajno iglo, ki ne sme biti tanjša od 22G (glejte poglavje 4.4).
The procedure for injection along the walls of the fistula tracts should be performed based on prior knowledge of the anatomy and topology of the fistula tracts, as determined during the fistulas characterisation.
Postopek injiciranja vzdolž sten traktov fistule je treba izvesti na podlagi obstoječega poznavanja anatomije in topologije traktov fistule, ki sta ugotovljeni tekom določanja značilnosti fistul.
• Guide in form of a video for surgeons and other health professionals involved in the preparation and administration of Alofisel.
• Vodnik v obliki videoposnetka za kirurge in druge zdravstvene delavce, ki sodelujejo pri pripravi in dajanju zdravila Alofisel.
• Guide for pharmacists with instructions on the appropriate reception and storage of Alofisel.
• Vodnik za farmacevte z navodili za ustrezen prevzem in shranjevanje zdravila Alofisel.
Darvadstrocel is not recommended during pregnancy and in women of childbearing potential not using contraception.
Uporaba darvadstrocela ni priporočena pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
In case of an abscess, incision and drainage are needed, and setons should be placed, if appropriate, in accordance with routine surgical procedures.
Če obstaja absces, je treba izvesti incizijo ali drenažo in, če je primerno, namestiti setone, skladno z rutinskim kirurškim postopkom.
Driving and using machines Alofisel is not likely to affect your ability to drive or use tools or machines.
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Alofisel vplivalo na vašo sposobnost vožnje ali uporabljanja orodij ali strojev.
In order to follow-up on the efficacy of Alofisel, the MAH should submit the results of a Phase III randomised double-blind, placebo-controlled study Cx601-0303 investigating a single administration of Cx601 for the treatment of complex perianal fistulas in Crohn's disease patients.
Imetnik dovoljenja za promet z zdravilom mora z namenom spremljanja učinkovitosti zdravila Alofisel predložiti rezultate randomizirane, dvojno slepe študije 3. faze, Cx601-0303, nadzorovane s placebom, v kateri se proučuje enkratno dajanje zdravila Cx601 za zdravljenje zapletenih perianalnih fistul pri bolnikih s Crohnovo boleznijo.
Inflammatory cytokines, in particular IFN-γ released by activated immune cells (i.e., lymphocytes), activate eASC.
Vnetni citokini, zlasti IFN-γ, ki jih sproščajo aktivirane imunske celice (tj. limfociti), aktivirajo celice eASC.
Alofisel group (Alofisel+standard of care*) N= 103
Skupina, ki je prejemala zdravilo Alofisel (Alofisel + standardna oskrba*) N = 103
Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which Alofisel is indicated.
Zdravilo Alofisel sme dajati samo zdravnik specialist z izkušnjami pri diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Alofisel indicirano.
Prior to the launch of Alofisel in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom mora pred začetkom trženja zdravila Alofisel v posamezni državi članici s pristojnim nacionalnim organom uskladiti vsebino in obliko izobraževalnega gradiva, vključno s sredstvi komuniciranja, načini širjenja in vsemi drugimi vidiki programa.
Some side effects of Alofisel treatment are related to the process of cleaning your fistulas.
Nekateri neželeni učinki zdravljenja z zdravilom Alofisel so povezani s postopkom čiščenja fistul.
• inject Alofisel.
• injiciral zdravilo Alofisel.
Keep the product within the outer carton and inside the shipping container at all times until its administration, to maintain the required temperature.
Zdravilo do uporabe ves čas shranjujte v zunanji škatli in v transportnem vsebniku, da ohranite potrebno temperaturo.
Darvadstrocel contains expanded adipose stem cells (eASC), which exhibit immunomodulatory and anti-inflammatory effects at inflammation sites.
Darvadstrocel vsebuje razmnožene adipozne matične celice (eASC), ki kažejo imunomodulacijske in protivnetne učinke na mestih vnetja.
What you need to know before you are given Alofisel 3.
Kaj morate vedeti, preden vam bodo dali zdravilo Alofisel 3.
Dulbecco's Modified Eagle´s Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Eaglov medij, modificiran po Dulbeccu (DMEM) (ki vsebuje aminokisline, vitamine, soli in ogljikove hidrate).
Injection Two of the vials should be used for the internal openings and the remaining two for injection along the walls of the fistula tracts (via external openings).
Injiciranje Dve viali uporabite za notranje odprtine, preostali dve viali pa za injiciranje vzdolž sten traktov fistule (prek zunanjih odprtin).
Softly massage the area around the external openings for 20-30 seconds and cover the external openings with a sterile bandage.
20-30 sekund nežno masirajte območje okrog zunanjih odprtin in prekrijte zunanje odprtine s sterilno obvezo.
Pharmacodynamic effect
Farmakodinamični učinek
In a limited number of patients followed up to Week 104, clinical remission at Week 104 was 56% in the Alofisel group and 40% in the control group.
Pri omejenem številu bolnikov, ki so jih spremljali do 104. tedna, je bil odstotek klinične remisije v 104. tednu v skupini, ki je prejemala zdravilo Alofisel 56%, v kontrolni skupini pa 40%.
Thinner gauge needles can cause cell disruption during injection, and may compromise cell viability and therefore may affect efficacy of treatment.
Tanjše igle lahko povzročijo raztrganje celic med injiciranjem in lahko ogrozijo viabilnost celic ter posledično vplivajo na učinkovitost zdravljenja.
The most common treatment-emergent adverse events were anal abscess (Alofisel: 19.4% patients; control group: 13.7% patients), proctalgia (Alofisel: 14.6% patients; control group: 11.8% patients) and anal fistula (Alofisel: 10.7% patients; control group: 7.8% patients).
Najpogostejši neželeni dogodki, ki so se pojavili med zdravljenjem, so bili analni abscesi (Alofisel: 19,4% bolnikov; kontrolna skupina: 13,7% bolnikov), proktalgija (Alofisel: 14,6% bolnikov; kontrolna skupina: 11,8% bolnikov) in analna fistula (Alofisel: 10,7% bolnikov; kontrolna skupina: 7,8% bolnikov).
Store between 15 ºC and 25 ºC.
Shranjujte pri temperaturi od 15 ºC do 25 ºC.
Ensure cells are not injected into the lumen of the fistula tracts to avoid leakage of cells.
Paziti morate, da celic ne injicirate v svetlino traktov fistule, da preprečite odtekanje celic.
Alofisel is a medicine used for the treatment of complex perianal fistulas in adult patients with Crohn´s disease (a disease causing inflammation of the gut) when the other symptoms of the disease are controlled or have a mild intensity.
Alofisel je zdravilo, ki se uporablja za zdravljenje zapletenih perianalnih fistul pri odraslih bolnikih s Crohnovo boleznijo (boleznijo, ki povzroča vnetje črevesa), kadar so drugi simptomi bolezni nadzorovani ali blagi.
The primary endpoint was the combined remission at Week 24 after study treatment, defined as clinical closure of all treated fistulas (absence of draining despite gentle finger compression) and absence of collection (> 2 cm) confirmed by blinded central MRI.
Primarni opazovani dogodek je bila kombinirana remisija v 24. tednu po zdravljenju v kliničnem preskušanju, opredeljena kot klinično zaprtje vseh zdravljenih fistul (odsotnost dreniranja kljub nežnem pritisku s prstom) in odsotnost skupkov (> 2 cm), potrjena z zaslepljenim centralnim slikanjem z MR.
• Instructions how to handle medication errors and transmission of infectious agents
• Navodila za obvladovanje napak pri zdravljenju in prenašanja povzročiteljev okužb.
Alofisel is indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn's disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.
Zdravilo Alofisel je indicirano za zdravljenje zapletenih perianalnih fistul pri odraslih bolnikih z neaktivno/blago aktivno luminalno Crohnovo boleznijo, kadar se fistule neustrezno odzivajo na vsaj eno konvencionalno ali biološko terapijo.
Conditioning reactions Conditioning of fistulas has been associated with proctalgia and procedural pain (see section 4.8).
Reakcije na pripravo Priprava fistul je povezana s proktalgijo in bolečino pri postopku (glejte poglavje 4.8).
Keep the medicine inside the cardboard box.
Zdravilo shranjujte v kartonski škatli.
Reproductive and developmental toxicity studies have not been performed for darvadstrocel because preclinical biodistribution studies indicated no migration and integration of eASC into reproductive organs following administration of eASC via different routes.
Študij vpliva na sposobnost razmnoževanja in razvoja z darvadstrocelom niso izvedli, ker predklinične študije biološke porazdelitve niso kazale migracije in integracije celic eASC v reproduktivne organe po uporabi celic eASC po različnih poteh.
In the inflamed area, there is infiltration of activated lymphocytes and local release of inflammatory cytokines.
V vnetem območju prihaja do infiltracije aktiviranih limfocitov in lokalnega sproščanja vnetnih citokinov.
Biodistribution studies in preclinical models were conducted with the objective of evaluating the persistence of eASC at the site of injection and their potential migration into other tissues or organ systems.
Izvedli so študije biološke porazdelitve v predkliničnih modelih za oceno ohranitve celic eASC na mestu injiciranja in njihove morebitne migracije v druga tkiva in organske sisteme.
A single dose of Alofisel consists of 120 million cells supplied in 4 vials.
En odmerek zdravila Alofisel vsebuje 120 milijonov celic, dobavljenih v 4 vialah.
The suspension of cells may have settled in the bottom of the vial forming a sediment.
Suspenzija celic se lahko usede na dno viale in ustvari usedlino.
The following information is related to the day when Alofisel is administered.
Naslednje informacije se nanašajo na dan, ko boste prejeli zdravilo Alofisel.