FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: 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.
English: You may have had an initial consultation with the Surgeon 2 to 3 weeks prior to Alofisel administration.
Slovenian: Morda ste imeli 2 do 3 tri tedne pred prejemom zdravila Alofisel začetni posvet s kirurgom.
English: At Week 12, 23/63 (36%) showed anti-donor antibody production.
Slovenian: V 12. tednu so pri 23/63 (36%) zaznali nastajanje protiteles proti darovalcu.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: • Guide in form of a video for surgeons and other health professionals involved in the preparation and administration of Alofisel.
Slovenian: • Vodnik v obliki videoposnetka za kirurge in druge zdravstvene delavce, ki sodelujejo pri pripravi in dajanju zdravila Alofisel.
English: • Guide for pharmacists with instructions on the appropriate reception and storage of Alofisel.
Slovenian: • Vodnik za farmacevte z navodili za ustrezen prevzem in shranjevanje zdravila Alofisel.
English: Darvadstrocel is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Uporaba darvadstrocela ni priporočena pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: In case of an abscess, incision and drainage are needed, and setons should be placed, if appropriate, in accordance with routine surgical procedures.
Slovenian: Če obstaja absces, je treba izvesti incizijo ali drenažo in, če je primerno, namestiti setone, skladno z rutinskim kirurškim postopkom.
English: Driving and using machines Alofisel is not likely to affect your ability to drive or use tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi zdravilo Alofisel vplivalo na vašo sposobnost vožnje ali uporabljanja orodij ali strojev.
English: 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.
Slovenian: 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.
English: Inflammatory cytokines, in particular IFN-γ released by activated immune cells (i.e., lymphocytes), activate eASC.
Slovenian: Vnetni citokini, zlasti IFN-γ, ki jih sproščajo aktivirane imunske celice (tj. limfociti), aktivirajo celice eASC.
English: Alofisel group (Alofisel+standard of care*) N= 103
Slovenian: Skupina, ki je prejemala zdravilo Alofisel (Alofisel + standardna oskrba*) N = 103
English: Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which Alofisel is indicated.
Slovenian: Zdravilo Alofisel sme dajati samo zdravnik specialist z izkušnjami pri diagnosticiranju in zdravljenju bolezni, za katere je zdravilo Alofisel indicirano.
English: 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.
Slovenian: 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.
English: Some side effects of Alofisel treatment are related to the process of cleaning your fistulas.
Slovenian: Nekateri neželeni učinki zdravljenja z zdravilom Alofisel so povezani s postopkom čiščenja fistul.
English: • inject Alofisel.
Slovenian: • injiciral zdravilo Alofisel.
English: Keep the product within the outer carton and inside the shipping container at all times until its administration, to maintain the required temperature.
Slovenian: Zdravilo do uporabe ves čas shranjujte v zunanji škatli in v transportnem vsebniku, da ohranite potrebno temperaturo.
English: Darvadstrocel contains expanded adipose stem cells (eASC), which exhibit immunomodulatory and anti-inflammatory effects at inflammation sites.
Slovenian: Darvadstrocel vsebuje razmnožene adipozne matične celice (eASC), ki kažejo imunomodulacijske in protivnetne učinke na mestih vnetja.
English: What you need to know before you are given Alofisel 3.
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Alofisel 3.
English: Dulbecco's Modified Eagle´s Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Slovenian: Eaglov medij, modificiran po Dulbeccu (DMEM) (ki vsebuje aminokisline, vitamine, soli in ogljikove hidrate).
English: 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).
Slovenian: Injiciranje Dve viali uporabite za notranje odprtine, preostali dve viali pa za injiciranje vzdolž sten traktov fistule (prek zunanjih odprtin).
English: Softly massage the area around the external openings for 20-30 seconds and cover the external openings with a sterile bandage.
Slovenian: 20-30 sekund nežno masirajte območje okrog zunanjih odprtin in prekrijte zunanje odprtine s sterilno obvezo.
English: Pharmacodynamic effect
Slovenian: Farmakodinamični učinek
English: 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.
Slovenian: 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%.
English: Thinner gauge needles can cause cell disruption during injection, and may compromise cell viability and therefore may affect efficacy of treatment.
Slovenian: Tanjše igle lahko povzročijo raztrganje celic med injiciranjem in lahko ogrozijo viabilnost celic ter posledično vplivajo na učinkovitost zdravljenja.
English: 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).
Slovenian: 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).
English: Store between 15 ºC and 25 ºC.
Slovenian: Shranjujte pri temperaturi od 15 ºC do 25 ºC.
English: Ensure cells are not injected into the lumen of the fistula tracts to avoid leakage of cells.
Slovenian: Paziti morate, da celic ne injicirate v svetlino traktov fistule, da preprečite odtekanje celic.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: • Instructions how to handle medication errors and transmission of infectious agents
Slovenian: • Navodila za obvladovanje napak pri zdravljenju in prenašanja povzročiteljev okužb.
English: 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.
Slovenian: 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.
English: Conditioning reactions Conditioning of fistulas has been associated with proctalgia and procedural pain (see section 4.8).
Slovenian: Reakcije na pripravo Priprava fistul je povezana s proktalgijo in bolečino pri postopku (glejte poglavje 4.8).
English: Keep the medicine inside the cardboard box.
Slovenian: Zdravilo shranjujte v kartonski škatli.
English: 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.
Slovenian: 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.
English: In the inflamed area, there is infiltration of activated lymphocytes and local release of inflammatory cytokines.
Slovenian: V vnetem območju prihaja do infiltracije aktiviranih limfocitov in lokalnega sproščanja vnetnih citokinov.
English: 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.
Slovenian: 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.
English: A single dose of Alofisel consists of 120 million cells supplied in 4 vials.
Slovenian: En odmerek zdravila Alofisel vsebuje 120 milijonov celic, dobavljenih v 4 vialah.
English: The suspension of cells may have settled in the bottom of the vial forming a sediment.
Slovenian: Suspenzija celic se lahko usede na dno viale in ustvari usedlino.
English: The following information is related to the day when Alofisel is administered.
Slovenian: Naslednje informacije se nanašajo na dan, ko boste prejeli zdravilo Alofisel.
English: Alofisel will be used after adequate preparation of the fistula, see section 3.
Slovenian: Zdravilo Alofisel se uporablja po ustrezni pripravi fistule, glejte poglavje 3.
English: BATCH NUMBER, DONATION AND PRODUCT CODES
Slovenian: ŠTEVILKA SERIJE, ENOTNE OZNAKE DAROVANJA IN IZDELKOV
English: Treatment with Alofisel is not recommended during pregnancy or while breast-feeding.
Slovenian: Zdravljenje z zdravilom Alofisel med nosečnostjo ali dojenjem ni priporočljivo.
English: What Alofisel is and what it is used for
Slovenian: Kaj je zdravilo Alofisel in za kaj ga uporabljamo
English: What you need to know before you are given Alofisel
Slovenian: Kaj morate vedeti, preden vam bodo dali zdravilo Alofisel
English: Alofisel may contain traces of benzylpenicillin or streptomycin (antibiotics).
Slovenian: Zdravilo Alofisel lahko vsebuje sledi benzilpenicilina in streptomicina (antibiotikov).
English: The MAH shall ensure that in each Member State where Alofisel is marketed, all healthcare professionals who are expected to handle and administer Alofisel have access to the educational package for health professionals.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da v vsaki državi članici, v kateri bo tržil zdravilo Alofisel, vsi zdravstveni delavci, ki bodo predvidoma uporabljali in dajali zdravilo Alofisel, prejmejo naslednji izobraževalni paket oziroma imajo dostop do njega:
English: Therefore, no dose adjustment is required in hepatically or renally impaired patients.
Slovenian: Zato prilagoditev odmerka pri bolnikih z jetrno ali ledvično okvaro ni potrebna.
English: Anal abscess
Slovenian: Analni absces
English: Preparation a) The expiry time: date of Alofisel should be re-confirmed; vials should then be removed from the outer packaging.
Slovenian: Pri tem sledite naslednjima korakoma: Priprava a) Ponovno preverite datum in uro izteka roka uporabe zdravila Alofisel; viale nato odstranite iz zunanje ovojnine.
English: Alofisel may contain trace amounts of benzylpenicillin and streptomycin.
Slovenian: Zdravilo Alofisel lahko vsebuje sledi benzilpenicilina in streptomicina.
English: b) Injection along the walls of the fistula tracts: insert the needle through the external openings and, from within the fistulas lumen: - If there is a single external opening, inject separately the content of each of the remaining two vials superficially into the tissue walls along the length of the fistula tracts, making small deposits of the cell suspension.
Slovenian: b) Injiciranje vzdolž sten traktov fistule: vstavite iglo skozi zunanje odprtine in skozi notranjost svetline fistul: - Če obstaja ena zunanja odprtina, injicirajte posebej vsebino vsake izmed preostalih dveh vial v stene tkiva vzdolž dolžine traktov fistule, tako da ustvarite majhne depozite celične suspenzije.
English: Vigorous curettage of all fistula tracts is recommended, with special emphasis in the internal openings area, using a metallic curette.
Slovenian: Priporoča se močna kiretaža vseh traktov fistule s kovinsko kireto, s posebnim poudarkom na območju notranjih odprtin.
English: Alofisel must not be filtered, or administered using a needle thinner than 22G (see section 4.4).
Slovenian: Zdravila Alofisel ne smete filtrirati ali dajati z iglo, tanjšo od 22G (glejte poglavje 4.4).
English: As a precautionary measure, darvadstrocel is not recommended for administration during breast-feeding.
Slovenian: Kot previdnostni ukrep se uporaba darvadstrocela med dojenjem ne priporoča.
English: Data on the use of darvadstrocel in the elderly population are limited, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in elderly patients will differ from that observed in non-elderly patients.
Slovenian: Podatki o uporabi darvadstrocela pri starejši populaciji so omejeni, vendar glede na celično naravo darvadstrocela in lokalno pot uporabe ni pričakovati, da bi se profil koristi in tveganja darvadstrocela pri starejših bolnikih razlikoval od tistega, ki so ga opazili pri ostalih bolnikih.
English: eASC were not present in any of the tissues analysed after 3 months or 6 months.
Slovenian: Po 3 mesecih oz. 6 mesecih celice eASC niso bile prisotne v nobenem izmed analiziranih tkiv.
English: Then inject the content of the second vial in small deposits into the tissue around the second internal opening.
Slovenian: Nato injicirajte vsebino druge viale v majhnih depozitih še v tkivo okoli druge notranje odprtine.
English: Fax: +34 91 804 92 63 info@tigenix.com
Slovenian: Faks: +34 91 804 92 63 info@tigenix.com
English: c) Perform a vigorous curettage of all fistula tracts, with special emphasis in the internal openings areas, using a metallic curette.
Slovenian: c) Izvedite močno kiretažo vseh traktov fistule s kovinsko kireto, s posebnim poudarkom na območjih notranjih odprtin.
English: After the cells have been resuspended (by gentle manual tapping), Alofisel is a white to yellowish homogenous suspension.
Slovenian: Ko so celice znova suspendirane (z nežnim trkanjem z roko), je zdravilo Alofisel bela do rumenkasta homogena suspenzija.
English: When injected close to the perianal fistulas, Alofisel reduces their inflammation, increasing the likelihood of the fistulas healing.
Slovenian: Kadar se zdravilo Alofisel injicira v bližino perianalnih fistul, zmanjša vnetje in poveča verjetnost njihovega celjenja.
English: Anal fistulas typically present as fissures penetrating the intestinal lumen and perianal skin surface, and are characterised by local inflammation that is exacerbated by bacterial infections and faecal contamination.
Slovenian: Analne fistule se običajno kažejo v obliki fisur, ki prodirajo v svetlino črevesa in površino kože ob anusu, zanje pa je značilno lokalno vnetje, ki ga poslabšajo baterijske okužbe in kontaminacija z blatom.
English: Alofisel must not be administered using a needle thinner than 22G.
Slovenian: Zdravilo Alofisel se ne sme dajati z iglo, tanjšo od 22G.
English: Each vial contains 30 million cells in 6 mL of suspension.
Slovenian: Ena viala vsebuje 30 milijonov celic v 6 ml suspenzije.
English: After inserting the needle tip into each intended injection site, perform a slight aspiration to avoid intravascular administration.
Slovenian: Za tem, ko vbodete konico igle v želeno mesto injiciranja, izvedite rahlo aspiracijo, da preprečite neželeno intravaskularno vbrizgavanje.
English: During shipment, the cells may have settled in the bottom of the vials forming a sediment and will need to be resuspended.
Slovenian: Med dostavo se celice lahko usedejo na dno vial in ustvarijo usedlino, ki jo je treba znova suspendirati.
English: Alofisel must not be irradiated or otherwise sterilised.
Slovenian: Zdravila Alofisel ne smete obsevati ali drugače sterilizirati.
English: Alofisel is injected by a surgeon in the fistula tract tissue.
Slovenian: Zdravilo Alofisel kirurg injicira v tkivo traktov fistule.
English: Data on the use of darvadstrocel in patients with hepatic or renal impairment are not available, however, given the cell-based nature of darvadstrocel and its local administration route it is not expected that the benefit-risk profile of darvadstrocel in hepatically or renally impaired patients will differ from that observed in non-hepatically or non-renally impaired patients.
Slovenian: Podatki o uporabi darvadstrocela pri bolnikih z jetrno ali ledvično okvaro niso na voljo, vendar glede na celično naravo darvadstrocela in lokalno pot uporabe ni pričakovati, da bi se profil koristi in tveganj darvadstrocela pri bolnikih z jetrno ali ledvično okvaro razlikoval od tistega, ki so ga opazili pri ostalih bolnikih.
English: a) Injection around the internal openings of the fistulas tracts: insert the needle through the anus and proceed as follows: - If there is a single internal opening, inject the content of each of the two vials (one after the other) in small deposits into the tissue surrounding the single internal opening.
Slovenian: a) Injiciranje okrog notranjih odprtin traktov fistul: vstavite iglo skozi anus in nadaljujte, kot je opisano: - Če obstaja samo ena notranja odprtina, injicirajte vsebino obeh vial (eno za drugo) v tkivo okoli notranje odprtine v večih posameznih majhnih odmerkih.
English: Once activated, eASC impair proliferation of activated lymphocytes and reduce the release of pro-inflammatory cytokines.
Slovenian: Ko so celice eASC aktivirane, zavirajo proliferacijo aktiviranih limfocitov in zmanjšajo sproščanje provnetnih citokinov.
English: Alofisel is supplied on an individual patient basis.
Slovenian: Zdravilo Alofisel se dostavlja za vsakega bolnika posebej.
English: - If there are two internal openings, inject the content of the first of two vials in small deposits into the tissue around one internal opening.
Slovenian: - Če obstajata dve notranji odprtini, injicirajte vsebino ene viale v večih posameznih majhnih odmerkih v tkivo okoli prve notranje odprtine.
English: An individual dose of Alofisel comprises 4 glass vials each containing 6 millilitres of Alofisel contained within a cardboard box.
Slovenian: Posamezni odmerek zdravila Alofisel je sestavljen iz 4 steklenih vial, ki vsebujejo po 6 mililitrov zdravila Alofisel v kartonski škatli.
English: After gentle re-suspension, the product is a white to yellowish homogeneous suspension.
Slovenian: Po nežnem vnovičnem suspendiranju je zdravilo bela do rumenkasta homogena suspenzija.
English: In vitro interaction studies have shown that the cell viability and immunomodulatory function of Alofisel is not affected by the presence of clinically-relevant concentrations of conventional therapies for Crohn's disease (infliximab, methotrexate and azathioprine).
Slovenian: Študije medsebojnega delovanja in vitro so pokazale, da prisotnost klinično pomembnih koncentracij konvencionalnih zdravil za Crohnovo bolezen (infliksimaba, metotreksata in azatioprina) ne vpliva na viabilnost celic in imunomodulacijsko delovanje zdravila Alofisel.
English: Immediately before use, Alofisel must be re-suspended by gently tapping the bottom of the vial until a homogeneous suspension is obtained, avoiding bubble formation.
Slovenian: Neposredno pred uporabo morate zdravilo Alofisel znova suspendirati z nežnim trkanjem po dnu viale, dokler ne dobite homogene suspenzije.
English: The injection of any other substance through the fistula tracts, such as hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions is not allowed, as these agents compromise the viability of the cells to be injected (see section 4.4 and section 4.5).
Slovenian: Injiciranje katere koli druge snovi skozi trakte fistule, npr. vodikovega peroksida, metilenskega modrila, raztopin joda ali hipertoničnih raztopin glukoze ni dovoljeno, saj lahko te učinkovine ogrozijo viabilnost celic, ki bodo injicirane (glejte poglavje 4.4 ter poglavje 4.5).
English: If you have any further questions on the use of this medicine, ask your doctor or surgeon.
Slovenian: Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom ali kirurgom.
English: If you have any further questions, ask your doctor or surgeon.
Slovenian: Če imate dodatna vprašanja, se posvetujte z zdravnikom ali kirurgom.
English: Injuring, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih pogosti bolečina pri postopku*
English: The full content of the 4 vials must be administered for the treatment of up to two internal openings and up to three external openings.
Slovenian: Za zdravljenje največ dveh notranjih odprtin in največ treh zunanjih odprtin je treba uporabiti celotno vsebino 4 vial.