FrancophonIA/ELRC3.0 huggingface dataset:
English: The aim of the educational programme is to provide information on how to correctly administer the product in order to minimise the risk of medication errors and to increase awareness about the potential transmission of infectious agents.
Croatian: Svrha edukacijskog programa je pružanje informacija o tome kako pravilno primijeniti lijek u svrhu smanjenja rizika od medikacijskih pogrešaka i porast svijesti o potencijalnom prijenosu infektivnih čimbenika.
English: This medicine contains cells of human origin.
Croatian: Ovaj lijek sadrži stanice ljudskog podrijetla.
English: What Alofisel is and what it is used for 2.
Croatian: Što je Alofisel i za što se koristi 2.
English: Suspension for injection 1 dose consists of 4 vials of 6 mL (in total 24 mL)
Croatian: Suspenzija za injekciju 1 doza sadrži 4 bočice od 6 ml (ukupno 24 ml)
English: This should be considered in patients with known hypersensitivity to these classes of antibiotics.
Croatian: To je potrebno uzeti u obzir kod bolesnika s poznatom preosjetljivošću na ovu skupinu antibiotika.
English: Concomitant use of stable doses of immunosuppressants (18% of patients) or anti-TNFs (33%) or both (28%) was allowed during the study.
Croatian: Istodobna primjena stabilnih doza imunosupresiva (18% bolesnika) ili anti-TNF terapije (33%) ili oboje (28%) bila je dopuštena u ispitivanju.
English: 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.
Croatian: Naposredno prije primjene Alofisela, fistularne kanale potrebno je kondicionirati kao slijedi: a) Ako su postavljeni setoni, treba ih ukloniti.
English: 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.
Croatian: Budući da je Alofisel terapija živim matičnim stanicama, ne može se sterilizirati, i stoga može sadržavati potencijalno inficiran biološki materijal iako se smatra da je rizik nizak i kontroliran u proizvodnji.
English: Common side effects (may affect up to 1 to 10 patients):
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba):
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.
Croatian: Prije stavljanja lijeka Alofisel u promet u bilo kojoj državi članici EU, nositelj odobrenja za stavljanje lijeka u promet mora usuglasiti sadržaj i format edukacijskog programa, uključujući medije komunikacije, modalitete distribucije i sve druge aspekte programa, s nadležnim nacionalnim tijelima.
English: Combined remission at Week 24 (% patients) Combined remission at Week 52 (% patients)
Croatian: Kombinirana remisija u 24. tjednu (% bolesnika) Kombinirana remisija u 52. tjednu (% bolesnika)
English: The effect of ex vivo expansion on the genetic stability of cells has been assessed in vitro without any indication of carcinogenic potential.
Croatian: Utjecaj ex vivo ekspanzije na genetsku stabilnost stanica procijenjen je in vitro bez ikakve naznake karcinogenog potencijala.
English: In line with standards for the management of complex perianal fistulas, characterisation of the patient's fistulas is needed prior to treatment.
Croatian: U skladu sa standardima za zbrinjavanje kompleksnih perianalnih fistula, potrebna je karakterizacija fistula bolesnika prije početka liječenja.
English: Description of selected treatment-emergent adverse events (adverse events)
Croatian: Opis odabranih štetnih događaja koji su nastali tijekom liječenja (štetni događaji)
English: What you need to know before you are given Alofisel 3.
Croatian: Što morate znati prije nego počnete primati Alofisel 3.
English: • inject Alofisel.
Croatian: • injicirati Alofisel.
English: This means that with a dose of 120 million cells it is possible to treat up to three fistula tracts that open to the perianal area.
Croatian: To znači da je s dozom od 120 milijuna stanica moguće liječiti do tri fistularna kanala s otvorima u perianalnom području.
English: Also contains: Dulbecco's Modified Eagle´s Medium (DMEM) and Human albumin.
Croatian: Također sadrži: Dulbeccov modificirani Eagleov medij (DMEM) i ljudski albumin.
English: Some side effects of Alofisel treatment are related to the process of cleaning your fistulas.
Croatian: Neke nuspojave liječenja Alofiselom povezane su s postupkom čišćenja vaših fistula.
English: 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).
Croatian: Perianalne fistule opisane su kao kompleksne ako imaju višestruke kanale i otvore, ako prodiru duboko u vaše tijelo ili ako su povezane s ostalim komplikacijama kao što je nakupljanje gnoja (inficirana tekućina koja se još naziva i apsces).
English: Store between 15 ºC and 25 ºC.
Croatian: Čuvati na temperaturi između 15 ºC i 25 ºC.
English: There are no data from the use of darvadstrocel in pregnant women.
Croatian: Nema podataka o primjeni darvadstrocela kod trudnih žena.
English: • procedural pain (pain after fistula cleaning)
Croatian: • bol uzrokovana postupkom (bol nakon čišćenja fistule)
English: • Instructions how to handle medication errors and transmission of infectious agents
Croatian: • Upute o tome kako rješavati medikacijske pogreške i prijenos infektivnih čimbenika.
English: 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.
Croatian: Perianalne fistule su abnormalni kanali koji spajaju dijelove donjeg crijeva (rektum i anus) i kožu pored anusa, tako da se pojavljuje jedan ili više otvora pored anusa.
English: • Guide for surgeons and other health professionals describing the method of administration
Croatian: • Vodič za kirurge i ostale zdravstvene radnike koji opisuje način primjene.
English: 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.
Croatian: Ukupno je randomizirano 212 bolesnika, a 205 bolesnika primilo je lokalnu injekciju ili Alofisela sa 120 milijuna stanica ili placebo u omjeru 1:1.
English: • massage softly for 20 to 30 seconds the area where the fistula opens on to the skin near your anus.
Croatian: • masirati nježno 20 do 30 sekundi područje gdje se nalaze otvori fistula na koži u blizini anusa.
English: 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.
Croatian: Za to se preporučuje injicirati otopinu natrijeva klorida 9 mg/ml (0,9%) kroz vanjske otvore dok ne izađe kroz unutarnje otvore.
English: • proctalgia (pain in the rectum or anus).
Croatian: • proktalgija (bol u rektumu ili anusu).
English: In case of an abscess, incision and drainage are needed, and setons should be placed, if appropriate, in accordance with routine surgical procedures.
Croatian: U slučaju apscesa, potrebni su incizija i drenaža i ako je potrebno, treba staviti seton, u skladu s rutinskim kirurškim postupcima.
English: You may have had an initial consultation with the Surgeon 2 to 3 weeks prior to Alofisel administration.
Croatian: Uvodni posjet kirurgu treba se obaviti 2 do 3 tjedna prije primjene lijeka Alofisel.
English: The nature and intended clinical use of darvadstrocel are such that conventional studies of pharmacokinetics (absorption, distribution, metabolism and elimination) are not applicable.
Croatian: Priroda i namjeravana klinička primjena darvadstrocela je takva da konvencionalna ispitivanja farmakokinetike (apsorpcija, distribucija, biotransformacija i eliminacija) nisu primjenjiva.
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.
Croatian: Kod ograničenog broja bolesnika praćenih do 104. tjedna, klinička remisija u 104. tjednu iznosila je 56% u Alofisel skupini i 40% u kontrolnoj skupini.
English: Each vial should be used immediately after re-suspension to prevent the cells from re-sedimenting.
Croatian: Svaka bočica mora se upotrijebiti odmah nakon resuspenzije kako bi se spriječila ponovna sedimentacija stanica.
English: What Alofisel contains
Croatian: Što Alofisel sadrži
English: The following listing of adverse reactions is based on the clinical trial experience and is displayed by system organ class.
Croatian: Sljedeći popis nuspojava temelji se na iskustvima iz kliničkih ispitivanja i prikazan je prema klasifikaciji organskih sustava.
English: d) Replace the needle with a longer needle, also no thinner than 22G, in order to reach the intended sites of injection.
Croatian: d) Zamijenite iglu duljom iglom, također ne tanjom od 22G, kako bi dosegnuli mjesta u koja namjeravate injicirati.
English: Alofisel will be used after adequate preparation of the fistula, see section 3.
Croatian: Alofisel će se primijeniti nakon odgovarajuće pripreme fistule, vidjeti dio 3.
English: What you need to know before you are given Alofisel
Croatian: Što morate znati prije nego počnete primati Alofisel
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.
Croatian: Puni sadržaj 4 bočice mora se primijeniti za liječenje do dva unutarnja otvora i do tri vanjska otvora.
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.
Croatian: Postoje dvije pomoćne tvari koje se koriste za čuvanje stanica: jedna je tekućina zvana Dulbeccov modificirani Eagleov medij koja sadrži hranjive tvari za stanice (aminokiseline, vitamine, soli i ugljikohidrate), a druga je ljudski albumin, prirodni protein koji se nalazi u ljudskom tijelu.
English: - If there are two or three external openings, inject the content of the remaining two vials equally between the associated tracts.
Croatian: - Ako postoje dva ili tri vanjska otvora, injicirajte sadržaj preostale dvije bočice jednako između povezanih kanala.
English: Alofisel should only be administered by specialist physicians experienced in the diagnosis and treatment of conditions for which Alofisel is indicated.
Croatian: Alofisel smije primjenjivati samo liječnik specijalist iskusan u dijagnosticiranju i liječenju stanja za koja je Alofisel indiciran.
English: d) Suture closed the internal openings.
Croatian: d) Šavima zatvorite unutarnje otvore.
English: Of patients with DSA at Week 12, 7/23 (30%) had cleared DSA by Week 52.
Croatian: Među bolesnicima sa DSA u 12. tjednu, kod 7/23 (30%) DSA je nestao do 52. tjedna.
English: 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.
Croatian: Ključne sekundarne mjere ishoda definirane su kao klinička remisija (kliničko zatvaranje svih liječenih fistula) i odgovor (kliničko zatvaranje barem 50% svih liječenih fistula) u 24. tjednu.
English: For injection in the fistula tract tissue in a surgical environment under anaesthesia (general or regional (see section 4.4)) as described below.
Croatian: Za injekciju u tkivo fistularnog kanala u kirurškom okruženju pod anestezijom (općom ili regionalnom (vidjeti dio 4.4)) kao što je opisano u nastavku.
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.
Croatian: Provedena su ispitivanja biodistribucije u pretkliničkim modelima s ciljem procjene postojanosti eASC-a na mjestu primjene i njihove potencijalne migracije u druga tkiva ili organske sustave.
English: 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).
Croatian: Europska agencija za lijekove odgodila je obavezu podnošenja rezultata ispitivanja lijeka Alofisel u jednoj ili više podskupina pedijatrijske populacije u liječenju analne fistule (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europe.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: 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.
Croatian: Preporučuje se barem 2 do 3 tjedna prije planirane primjene provesti pripremni eksplorativni zahvat (u anesteziji) i utvrditi anatomiju fistula (broj postojećih fistula i otvora), topografiju (raširenost i odnos sa sfinkterima i ostalim zdjeličnim mišićima), potencijalno povezane komplikacije (primjerice apsces) te je li lokalna mukozna bolest blaga ili neaktivna.
English: What Alofisel is and what it is used for
Croatian: Što je Alofisel i za što se koristi
English: Alofisel may contain trace amounts of benzylpenicillin and streptomycin.
Croatian: Alofisel može sadržavati tragove benzilpenicilina i streptomicina.
English: Do not irradiate or otherwise sterilise.
Croatian: Ne zračiti niti bilo kako sterilizirati.
English: Dulbecco's Modified Eagle´s Medium (DMEM) (containing amino acids, vitamins, salts and carbohydrates).
Croatian: Dulbeccov modificirani Eagleov medij (DMEM) (sadrži aminokiseline, vitamine, soli i ugljikohidrate).
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.
Croatian: Studije reproduktivne i razvojne toksičnosti nisu se provodile s darvadstrocelom zato što su ispitivanja pretkliničke biodistribucije ukazala na nepostojanje migracije i integracije eASC-a u reproduktivne organe nakon primjene eASC-a različitim putevima.
English: Conditioning reactions Conditioning of fistulas has been associated with proctalgia and procedural pain (see section 4.8).
Croatian: Reakcije na kondicioniranje Kondicioniranje fistula povezano je s proktalgijom i boli uzrokovanom postupkom (vidjeti dio 4.8).
English: Alofisel is a living cell therapy and, therefore, the final product cannot be sterilised.
Croatian: Alofisel je terapija živim stanicama i stoga se gotovi lijek ne može sterilizirati.
English: When injected close to the perianal fistulas, Alofisel reduces their inflammation, increasing the likelihood of the fistulas healing.
Croatian: Kad se injicira pored perianalnih fistula, Alofisel smanjuje upalu fistula i povećava vjerojatnost izliječenja fistula.
English: Each vial contains 6 mL of eASC suspension and is closed with a rubber stopper and a flip-off seal.
Croatian: Svaka bočica sadrži 6 ml suspenzije eASC-a i zatvorena je gumenim čepom i flip-off zatvaračem.
English: Hypersensitivity to the product, bovine serum or any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na ovaj lijek, goveđi serum ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Darvadstrocel contains expanded adipose stem cells (eASC), which exhibit immunomodulatory and anti-inflammatory effects at inflammation sites.
Croatian: Darvadstrocel sadrži ekspandirane adipozne matične stanice (eASC), koje pokazuju imunomodulatorno i protuupalno djelovanje na mjestima upale.
English: Darvadstrocel has no or negligible influence on the ability to drive and use machines.
Croatian: Darvadstrocel ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Inflammatory cytokines, in particular IFN-γ released by activated immune cells (i.e., lymphocytes), activate eASC.
Croatian: Upalni citokini, naročito IFN-γ otpušten iz aktiviranih imunoloških stanica (tj. limfocita), aktiviraju eASC.
English: In the ADMIRE-CD study, 63/103 of the eASC-treated patient population were analysed for the presence of donor-specific antibodies (DSA) at baseline and Week 12.
Croatian: U ispitivanju ADMIRE-CD, u 63/103 bolesnika liječenih eASC-om ispitano je prisustvo donor specifičnih antitijela (engl. donor-specific antibodies, DSA) na početku liječenja i u 12. tjednu.
English: Softly massage the area around the external openings for 20-30 seconds and cover the external openings with a sterile bandage.
Croatian: Nježno masirajte područja oko vanjskih otvora 20-30 sekundi i pokrijte vanjske otvore sterilnim zavojem.
English: During shipment, the cells may have settled in the bottom of the vials forming a sediment and will need to be resuspended.
Croatian: Tijekom isporuke, stanice su se možda slegnule na dnu bočice formirajući talog i treba ih resuspendirati.
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).
Croatian: Injekcija Dvije bočice moraju se iskoristiti za unutarnje otvore, a preostale dvije za injekcije uzduž stijenki fistularnih kanala (kroz vanjske otvore).
English: Darvadstrocel is not recommended during pregnancy and in women of childbearing potential not using contraception.
Croatian: Ne preporučuje se koristiti darvadstrocel tijekom trudnoće niti u žena reproduktivne dobi koje ne koriste kontracepciju.
English: Ensure cells are not injected into the lumen of the fistula tracts to avoid leakage of cells.
Croatian: Osigurajte da stanice ne injicirate u lumen fistularnih kanala kako bi izbjegli curenje stanica.
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.
Croatian: Alofisel je lijek koji se upotrebljava za liječenje kompleksnih perianalnih fistula u odraslih bolesnika s Crohnovom bolešću (bolest koja uzrokuje upalu crijeva), kad su ostali simptomi bolesti pod kontrolom ili su blagog intenziteta.
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.
Croatian: Postupak injiciranja duž stijenki fistularnih kanala treba provesti temeljem prethodnog poznavanja anatomije i topologije fistularnih kanala, kako je definirano prilikom karakterizacije fistula.
English: 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.
Croatian: To je bilo randomizirano, dvostruko slijepo, placebom kontrolirano multicentrično kliničko ispitivanje u paralelnim skupinama radi procjene djelotvornosti i sigurnosti lijeka Alofisel za liječenje kompleksnih perianalnih fistula u bolesnika s Crohnovom bolešću.
English: The active ingredient of Alofisel is darvadstrocel which consists of human stem cells obtained from the fat tissue of a healthy adult donor that are subsequently grown (expanded) in the laboratory and provided at a concentration of 5 million cells per millilitre in vials which each contain 6 millilitres, i.e. 30 million cells per vial.
Croatian: Djelatni sastojak Alofisela je darvadstrocel koji sadrži ljudske matične stanice uzete iz masnog tkiva zdravog odraslog donora koje se zatim uzgajaju (ekspandiraju) u laboratoriju i dostupne su u koncentraciji od 5 milijuna stanica po mililitru u bočicama od kojih svaka sadrži 6 mililitara, tj. 30 milijuna stanica po bočici.
English: Treatment with Alofisel is not recommended during pregnancy or while breast-feeding.
Croatian: Liječenje Alofiselom se ne preporučuje u trudnoći ili tijekom dojenja.
English: This immunoregulatory activity reduces inflammation, which may allow the tissues around the fistula tract to heal.
Croatian: Ova imunoregulirajuća aktivnost smanjuje upalu, što omogućuje ozdravljenje tkiva oko fistularnog kanala.
English: There were no patients in Alofisel group with events of proctalgia of severe intensity and 3.9% patients with 4 events in the control group.
Croatian: U Alofisel skupini nijedan bolesnik nije razvio proktalgiju jakog intenziteta, dok je 3,9% bolesnika razvilo 4 događaja u kontrolnoj skupini.
English: Half of the dose will be injected into the tissue around the inner openings of the fistulas, and half of the dose in the tissue walls along the fistulas.
Croatian: Pola doze injicirat će se u tkivo oko unutarnjih otvora fistula, a druga polovica doze u stijenke tkiva duž fistula.
English: • Guide in form of a video for surgeons and other health professionals involved in the preparation and administration of Alofisel.
Croatian: • Video vodič za kirurge i ostale zdravstvene radnike uključene u pripremu i primjenu Alofisela.
English: Alofisel should be used only after conditioning of the fistulas (see section 4.2).
Croatian: Alofisel se može primijeniti samo nakon kondicioniranja fistula (vidjeti dio 4.2).
English: The following information is related to the day when Alofisel is administered.
Croatian: Sljedeće informacije odnose se na sam dan primjene lijeka Alofisel.
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.
Croatian: Analne fistule obično su fisure koje ulaze u intestinalni lumen i perianalnu površinu kože i karakterizira ih lokalna upala koje se pogoršava bakterijskom infekcijom i fekalnom kontaminacijom.
English: As a precautionary measure, darvadstrocel is not recommended for administration during breast-feeding.
Croatian: Kao mjera predostrožnosti, darvadstrocel se ne preporučuje za primjenu tijekom dojenja.
English: Before scheduling Alofisel administration, the surgeon must ensure that no abscesses are present.
Croatian: Prije zakazivanja termina primjene lijeka Alofisel kirurg mora osigurati da nema apscesa.
English: • Guide for pharmacists with instructions on the appropriate reception and storage of Alofisel.
Croatian: • Vodič za ljekarnike s uputama o odgovarajućem prihvatu isporuke i pohrani Alofisela.
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.
Croatian: Alofisel je indiciran za liječenje kompleksnih perianalnih fistula u odraslih bolesnika s neaktivnom ili blago aktivnom luminalnom Crohnovom bolešću, kad fistule nisu adekvatno reagirale na barem jednu konvencionalnu ili biološku terapiju.