FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: U svrhu praćenja djelotvornosti lijeka Alofisel, nositelj odobrenja za stavljanje lijeka u promet mora podnijeti rezultate randomiziranog, dvostruko slijepog, placebom kontroliranog ispitivanja faze III Cx601-0303 u kojem se ispitivala jedna primjena Cx601 za liječenje kompleksnih perianalnih fistula u bolesnika s Chronovom bolešću.
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).
Croatian: c) Uklonite čep bočice, nježno okrenite bočicu naopako i lagano uvucite cijeli sadržaj u štrcaljku konvencionalnom iglom, ne tanjom od 22G (vidjeti dio 4.4).
English: Thinner gauge needles can cause cell disruption during injection, and may compromise cell viability and therefore may affect efficacy of treatment.
Croatian: Tanja igla može uzrokovati oštećenje stanica prilikom injiciranja i može kompromitirati vijabilnost stanica i stoga utjecati na djelotvornost liječenja.
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.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet mora osigurati da u svakoj zemlji članici EU gdje se Alofisel nalazi na tržištu, svi zdravstveni radnici od kojih se očekuje rukovanje i primjena lijeka Alofisel dobiju edukacijski paket za zdravstvene radnike.
English: After inserting the needle tip into each intended injection site, perform a slight aspiration to avoid intravascular administration.
Croatian: Nakon uvođenja vrha igle u svako namjeravano mjesto primjene, lagano aspirirajte kako bi izbjegli intravaskularnu primjenu.
English: Perianal fistulas can cause pain, irritation and discharge of pus through the openings to the skin.
Croatian: Perianalne fistule uzrokuju bol, nadraženost i ispuštanje gnoja kroz otvore na koži.
English: Once activated, eASC impair proliferation of activated lymphocytes and reduce the release of pro-inflammatory cytokines.
Croatian: Jednom aktivirane, eASC slabe proliferaciju aktiviranih limfocita i smanjuju otpuštanje pro-upalnih citokina.
English: Patients had draining complex perianal fistulas with an inadequate response to at least one of the following treatments: antibiotics, immunosuppressants or anti-TNFs.
Croatian: Bolesnici su morali imati drenirajuće kompleksne perianalne fistule s neodgovarajućim odgovorom na najmanje jedno o sljedećih liječenja: antibiotici,
English: Alofisel is supplied on an individual patient basis.
Croatian: Alofisel se isporučuje posebno za svakog pojedinog bolesnika.
English: Alofisel must not be filtered, or administered using a needle thinner than 22G (see section 4.4).
Croatian: Alofisel se ne smije filtrirati, niti primijeniti kroz iglu tanju od 22G (vidjeti dio 4.4).
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.
Croatian: b) Injiciranje duž stijenki fistularnih kanala: uvedite iglu kroz vanjske otvore, te iz lumena fistula: - Ako postoji samo jedan vanjski otvor, injicirajte odvojeno sadržaj svake od dvije preostale bočice površinski u stijenke tkiva duž fistularnih kanala i napravite male depozite suspenzije stanica.
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.
Croatian: Primarna mjera ishoda bila je kombinirana remisija u 24. tjednu nakon ispitivanog liječenja, koja je definirana kao kliničko zatvaranje svih liječenih fistula (odsustvo drenažnog sadržaja usprkos blagom pritisku prstom) i odsustvo nakupljanja sadržaja (> 2 cm) što je potvrdio zaslijepljeni središnji centar za MR.
English: The proportion of patients with clinical remission at Week 52 was 59% in the Alofisel group and 41% in the control group (p = 0.012) and corresponding figures for response were 66% and 55% (p = 0.114).
Croatian: Udio bolesnika s kliničkom remisijom u 52. tjednu bio je 59% u Alofisel skupini i 41% u kontrolnoj skupini (p = 0,012), a odgovarajući postoci za odgovor bili su 66% i 55% (p = 0,114).
English: Keep the product within the outer carton and inside the shipping container at all times until its administration, to maintain the required temperature.
Croatian: Čuvati lijek u vanjskom pakiranju i unutar originalnog spremnika u kojem je isporučen cijelo vrijeme sve do njegove primjene, kako bi se održala željena temperatura.
English: Alofisel must not be irradiated or otherwise sterilised.
Croatian: Alofisel se ne smije zračiti niti bilo kako sterilizirati.
English: BATCH NUMBER, DONATION AND PRODUCT CODES
Croatian: BROJ SERIJE, OZNAKE DONACIJE I PROIZVODA
English: The vials are placed inside a cardboard box.
Croatian: Bočice su pakirane u kartonskoj kutiji.
English: Pharmacodynamic effect
Croatian: Farmakodinamički učinci
English: Results of the key secondary endpoints show that the proportion of patients with clinical remission at Week 24 was 55% in the Alofisel group and 42% in the control group (p = 0.052) and the corresponding figures for response were 69% and 55% (p = 0.039).
Croatian: Rezultati ključnih sekundarnih mjera ishoda pokazuju da je udio bolesnika s kliničkom remisijom u 24. tjednu bio 55% u Alofisel skupini i 42% u kontrolnoj skupini (p = 0,052) a odgovarajući postoci za odgovor bili su 69% i 55% (p = 0,039).
English: After gentle re-suspension, the product is a white to yellowish homogeneous suspension.
Croatian: Nakon nježne resuspenzije, lijek je bijela do žućkasta homogena suspenzija.
English: If you are allergic to Alofisel, bovine serum or to any of the ingredients of this medicine (listed in section6).
Croatian: Ne smijete primiti Alofisel: ako ste alergični na Alofisel, goveđi serum ili neki sastojak ovog lijeka (naveden u dijelu 6).
English: After the cells have been resuspended (by gentle manual tapping), Alofisel is a white to yellowish homogenous suspension.
Croatian: Nakon što se stanice resuspendiraju (blagim kucanjem prstima), Alofisel postaje bijela do žućkasta homogena suspenzija.
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.
Croatian: Neposredno prije primjene Alofisel se mora resuspendirati nježnim kuckanjem po dnu bočice do postizanja homogene suspenzije, uz izbjegavanje stvaranja mjehurića.
English: An individual dose of Alofisel comprises 4 glass vials each containing 6 millilitres of Alofisel contained within a cardboard box.
Croatian: Pojedinačna doza Alofisela sadrži 4 staklene bočice, od kojih svaka sadrži 6 mililitara Alofisela, koje su pakirane u kartonske kutije.
English: Proctalgia*
Croatian: Proktalgija*
English: Then inject the content of the second vial in small deposits into the tissue around the second internal opening.
Croatian: Zatim injicirajte sadržaj druge bočice u malim depozitima u tkivo oko drugog unutarnjeg otvora.
English: • stitch up the inner openings of the fistulas.
Croatian: • zašiti unutarnje otvore fistula,
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.
Croatian: a) Injiciranje oko unutarnjih otvora fistularnih kanala: uvedite iglu kroz anus i postupite kako slijedi: - Ako postoji samo jedan unutarnji otvor, injicirajte sadržaj obje bočice (jednu za drugom) u malim depozitima u tkivo koje okružuje jedan unutarnji otvor.
English: Procedural pain*
Croatian: Bol uzrokovana postupkom*
English: No association between DSA results and safety or efficacy up to Week 52 was seen in the subset tested.
Croatian: U ispitanoj podgrupi nije postojala povezanost između DSA statusa i sigurnosti i djelotvornosti do 52. tjedna.
English: Alofisel is supplied as one treatment dose contained in 4 Type I glass vials.
Croatian: Alofisel je dostupan kao doza za jedno liječenje u 4 staklene bočice tipa I.
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.
Croatian: Podaci o primjeni darvadstrocela u starijoj populaciji su ograničeni, međutim, s obzirom na staničnu prirodu darvadstrocela i lokalni put primjene, ne očekuje se da će se profil koristi i rizika darvadstrocela kod starijih bolesnika razlikovati od onog uočenog kod bolesnika koji nisu starije dobi.
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.
Croatian: - Ako postoje dva unutarnja otvora, injicirajte sadržaj prve od dvije bočice u malim depozitima u tkivo koje okružuje jedan unutarnji otvor.
English: • clean the fistulas with salt water and remove any scar tissue.
Croatian: • očistiti fistule fiziološkom otopinom i ukloniti tkivo s ožiljcima,
English: For further information on the use of Alofisel see section 4.2.
Croatian: Za dalje informacije o primjeni lijeka Alofisel vidjeti dio 4.2.
English: Alofisel is injected by a surgeon in the fistula tract tissue.
Croatian: Alofisel injicira kirurg u tkivo fistularnog kanala.
English: If you have any further questions, ask your doctor or surgeon.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku ili kirurgu.
English: Darvadstrocel is an expanded human allogeneic mesenchymal adult stem cells extracted from adipose tissue (expanded adipose stem cells - eASC).
Croatian: Darvadstrocel su ekspandirane ljudske alogene mezenhimalne matične stanice odraslih ljudi ekstrahirane iz adipoznog tkiva (ekspandirane adipozne matične stanice - eASC).
English: c) Perform a vigorous curettage of all fistula tracts, with special emphasis in the internal openings areas, using a metallic curette.
Croatian: c) Metalnom kiretom napravite snažnu kiretažu svih fistularnih kanala, s posebnim naglaskom na zone unutarnjih otvora.
English: In the inflamed area, there is infiltration of activated lymphocytes and local release of inflammatory cytokines.
Croatian: Na upaljenom području infiltriraju se aktivirani limfociti i lokalno se otpuštaju upalni citokini.
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).
Croatian: Injiciranje bilo kakve druge tvari kroz fistularne kanale kao što je vodikov peroksid, metilensko modrilo, otopine joda ili hipertonične otopine glukoze nije dozvoljeno, jer ti agensi kompromitiraju vijabilnost stanica koje će se injicirati (vidjeti dio 4.4 i dio 4.5).
English: A single dose of Alofisel consists of 120 million cells supplied in 4 vials.
Croatian: Jedna doza lijeka Alofisel sadrži 120 milijuna stanica koje dolaze u 4 bočice.
English: At Week 12, 23/63 (36%) showed anti-donor antibody production.
Croatian: U 12. tjednu rezultati su u 23/63 (36%) ispitanika pokazali nastanak DSA.
English: How to store Alofisel
Croatian: Kako čuvati Alofisel
English: Final Report to EMA: 2Q/3Q 2022
Croatian: Konačni izvještaj za EMA-u: 2./3. kvartal 2022.
English: The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) (see section 4.2 and section 4.5) through the fistula tracts is not allowed before, during, or after the injection of Alofisel as these may compromise the viability of the cells and, therefore, may affect the effectiveness of the treatment.
Croatian: Injiciranje bilo koje druge tvari osim otopine natrijevog klorida 9 mg/ml (0,9%) (npr. vodikovog peroksida, metilenskog modrila, otopine joda ili hipertonične otopine glukoze) (vidjeti dio 4.2 i dio 4.5) kroz fistularne kanale nije dozvoljena prije, za vrijeme ili poslije injiciranja Alofisela jer to može kompromitirati vijabilnost stanica i stoga može utjecati na učinkovitost liječenja.
English: Each vial contains 30 million cells in 6 mL of suspension.
Croatian: Svaka bočica sadrži 30 milijuna stanica u 6 ml suspenzije.
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).
Croatian: In vitro ispitivanja interakcija pokazala su da klinički relevantne koncentracije konvencionalnih terapija za Crohnovu bolest (infliksimab, metotreksat i azatioprin) ne utječu na vijabilnost stanica i imunomodulatornu funkciju Alofisela.
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).
Croatian: Najčešće nuspojave povezane s primjenom lijeka su analni apsces (Alofisel: 19,4% bolesnika; kontrolna skupina: 13,7% bolesnika), proktalgija (Alofisel: 14,6% bolesnika; kontrolna skupina:
English: b) Re-suspend the cells by gently tapping the bottom of the vials until a homogeneous suspension is obtained, avoiding bubble formation.
Croatian: b) Resuspendirajte stanice laganim kuckanjem po dnu bočice dok ne postignete homogenu suspenziju, ali izbjegavajte stvaranje mjehurića.
English: 2.2 Qualitative and quantitative composition Each vial contains a suspension of 30 million cells (eASC) in 6 mL solution, corresponding to a concentration of 5 million cells/mL.
Croatian: Svaka bočica sadrži suspenziju 30 milijuna stanica (eASC) u 6 ml otopine, što odgovara koncentraciji od 5 milijuna stanica/ml.
English: Each vial contains 6 mL of a suspension of 30 million of darvadstrocel.
Croatian: Svaka bočica sadrži 6 ml suspenzije 30 milijuna darvadstrocela.
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.
Croatian: Podaci o primjeni darvadstrocela kod bolesnika s oštećenjem jetre ili bubrega nisu dostupni, međutim, s obzirom na staničnu prirodu darvadstrocela i lokalni put primjene, ne očekuje se da će se profil koristi i rizika darvadstrocela kod osoba s oštećenjem jetre ili bubrega razlikovati od onog uočenog kod bolesnika koji nemaju oštećenje jetre ili bubrega.
English: Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells (see section 4.2).
Croatian: Radi nepoznatog utjecaja lokalnih anestetika na injicirane stanice, lokalna anestezija se ne preporučuje (vidjeti dio 4.2).
English: The suspension of cells may have settled in the bottom of the vial forming a sediment.
Croatian: Suspenzija stanica možda se slegnula na dnu bočice i formirala talog.
English: Therefore, no dose adjustment is required in hepatically or renally impaired patients.
Croatian: Stoga nije potrebna prilagodba doze kod bolesnika s oštećenjem jetre ili bubrega.
English: • anal fistula
Croatian: • analna fistula
English: GLASS VIAL
Croatian: STAKLENA BOČICA
English: If you have any further questions on the use of this medicine, ask your doctor or surgeon.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili kirurgu.
English: Alofisel 5 million cells/mL suspension for injection
Croatian: Alofisel 5 milijuna stanica/ml suspenzija za injekciju
English: Alofisel 5 million cells/mL suspension for injection Darvadstrocel
Croatian: ALOFISEL 5 milijuna stanica/ml suspenzija za injekciju darvadstrocel
English: Up to Week 52, 20 (19.4%) and 14 (13.7%) patients developed 21 and 19 anal abscess adverse events in the Alofisel and control groups, respectively, of which 4 and 5 adverse events in respective groups (3.9% patients in both groups) were of severe intensity.
Croatian: Do 52. tjedna, 20 (19,4%), odnosno 14 (13,7%) bolesnika razvilo je 21, odnosno 19 analnih apscesa kao nuspojavu u Alofisel skupini, odnosno u kontrolnoj skupini, od čega je 4 odnosno 5 nuspojava (3,9% bolesnika o obje skupine) bilo jakog intenziteta.
English: The active ingredient of Alofisel is darvadstrocel which consists of stem cells which are taken from the fat tissue of a healthy adult donor (so-called allogenic stem cells) and then grown in a laboratory.
Croatian: Djelatni sastojak Alofisela je darvadstrocel koji se sastoji od matičnih stanica uzetih iz masnog tkiva zdravogodraslogdonora(tzv.alogenematičnestanice),kojesezatimuzgajajuulaboratoriju.
English: Adverse reactions System Organ Class
Croatian: Tablica 1. Nuspojave Klasifikacija organskih sustava Učestalost
English: Up to Week 104, 5 (4.9%) and one (< 1.0%) patients developed 5 and 1 anal fistula serious adverse events in the Alofisel and control groups, respectively.
Croatian: Do 104. tjedna, 5 (4,9%), odnosno jedan (< 1,0%) bolesnik razvili su 5, odnosno 1 nuspojavu analne fistule u Alofisel, odnosno kontrolnoj skupini.
English: ALOFISEL 5 million cells/mL suspension for injection Darvadstrocel
Croatian: Alofisel 5 milijuna stanica/ml, suspenzija za injekciju darvadstrocel
English: Up to Week 52, 15 (14.6%) and 12 (11.8%) patients developed 20 and 17 proctalgia adverse events in the Alofisel and control groups, respectively, none of these events being serious in any group up to Week 104.
Croatian: Do 52. tjedna, 15 (14,6%), odnosno 12 (11,8%) bolesnika razvilo je 20, odnosno 17 nuspojava proktalgije u Alofisel skupini i kontrolnoj skupini, a nijedan od tih događaja nije bio ozbiljan ni u jednoj skupini do 104. tjedna.
English: Preparation a) The expiry time: date of Alofisel should be re-confirmed; vials should then be removed from the outer packaging.
Croatian: Nakon kondicioniranja fistularnih kanala, Alofisel treba primijeniti prema sljedeća dva koraka: Priprema a) Rok valjanosti: morate potvrditi datum valjanosti lijeka Alofisel; bočice se tada vade iz vanjskog pakiranja.
English: How Alofisel is given
Croatian: Kako se primjenjuje Alofisel
English: Driving and using machines Alofisel is not likely to affect your ability to drive or use tools or machines.
Croatian: Nije vjerojatno da će Alofisel utjecati na upravljanje vozilima ili strojevima.
English: Alofisel is indicated only for injection in the fistula tract tissue as described in section 4.2.
Croatian: Alofisel je indiciran samo za injiciranje u tkivo fistularnog kanala kao što je opisano u dijelu 4.2. Alofisel se ne smije davati kroz iglu tanju od 22G.
English: In Alofisel group, the number of patients who had combined remission at Week 24 and subsequently developed anal abscess/anal fistula by Week 52 was 2.9% (3/103), whereas the number of patients without combined remission at Week 24 who subsequently developed anal abscess/anal fistula by Week 52 was 9.7% (10/103).
Croatian: Alofisel skupini, 2,9% (3/103) bolesnika imalo je kombiniranu remisiju u 24. tjednu i naknadno razvilo analni apsces/analnu fistulu do 52. tjedna, dok je 9,7% (10/103) bolesnika bez kombinirane remisije u 24. tjednu naknadno razvilo analni apsces/analnu fistulu do 52. tjedna.
English: Up to Week 52, 11 (10.7%) and 8 (7.8%) patients developed 12 and 8 anal fistula adverse events in the Alofisel and control groups, respectively, none of these being of severe intensity.
Croatian: Do 52. tjedna, 11 (10,7%), odnosno 8 (7,8%) bolesnika razvilo je 12, odnosno 8 nuspojava analnih fistula Alofisel skupini, odnosno kontrolnoj skupini, ali nijedna nije bila jakog intenziteta.
English: In control group, the number of patients who had combined remission at Week 24 who developed anal abscess/anal fistula by Week 52 was 4.9% (5/102), whereas the number of patients without combined remission at Week 24 who developed anal abscess/anal fistula by Week 52 was 2.9% (3/102).
Croatian: U kontrolnoj skupini, 4,9% (5/102) bolesnika koji su imali kombiniranu remisiju u 24. tjednu razvili su analni apsces/analnu fistulu do 52. tjedna, dok je 2,9% (3/102) bolesnika bez kombinirane remisije u 24. tjednu naknadno razvilo analni apsces/analnu fistulu do 52. tjedna.
English: • anal abscess
Croatian: • analni apsces
English: Vigorous curettage of all fistula tracts is recommended, with special emphasis in the internal openings area, using a metallic curette.
Croatian: Preporučuje se metalnom kiretom snažno kiretirati sve fistularne kanala, a posebice područja unutarnjeg otvora.
English: Up to Week 104, 15 (14.6%) and 8 (7.8%) patients developed 15 and 9 serious adverse events of anal abscess in the Alofisel and control groups, respectively.
Croatian: Do 104. tjedna, 15 (14,6%), odnosno 8 (7,8%) bolesnika razvilo je 15, odnosno 9 događaja ozbiljnih nuspojava analnog apscesa u Alofisel skupini, odnosno kontrolnoj skupini.
English: P value
Croatian: vrijednost
English: e) Repeat steps (b), (c) and (d) for each of the vials in turn after the cells from one vial have been injected.
Croatian: Na primjer, potrebna je igla za spinalnu anesteziju duljine oko 90 mm. e) Ponovite korake (b), (c) i (d) za svaku bočicu nakon što su injicirane stanice iz prethodne bočice.
English: OTHER
Croatian: OSTALO
English: Hepatic or renal impairment
Croatian: Oštećenje jetre ili bubrega
English: Keep the product within the outer carton.
Croatian: Čuvati lijek u vanjskom pakiranju.
English: The injection of any substance other than sodium chloride 9 mg/mL (0.9%) (e.g. hydrogen peroxide, methylene blue, iodine solutions or hypertonic glucose solutions) (see section 4.2 and section 4.4) through the fistula tracts and use of local anaesthesia is not recommended due to the unknown effect on the injected cells (see section 4.4).
Croatian: Injiciranje bilo koje druge tvari osim otopine natrijevog klorida 9 mg/ml (0,9%) (npr. vodikovog peroksida, metilenskog modrila, otopine joda ili hipertonične otopine glukoze) (vidjeti dio 4.2 i dio
English: Proctalgia
Croatian: Nuspojave
English: Anal abscess
Croatian: Analni apsces
English: What Alofisel looks like and contents of the pack Alofisel is a suspension for injection.
Croatian: Alofisel je suspenzija za injekciju.
English: If you get any side effects, talk to your surgeon or doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti kirurga ili liječnika.
English: See the end of Section 4 for how to report side effects.
Croatian: Za postupak prijavljivanja nuspojava, pogledajte dio 4.
English: Takeda Pharma Ges.m.b.H.
Croatian: Takeda Pharma sp. z o.o tel.
English: Takeda Pharma sp. z o.o tel. + 48 22 608 13 00
Croatian: Slovenská republika Takeda Pharmaceuticals Slovakia s.r.o. Tel: +421 (2) 20 602 600
English: Adverse Reactions
Croatian: Upozorenjaimjereopreza
English: Anal fistula
Croatian: Analna fistula
English: Date of first authorisation: 26 July 2018
Croatian: Datum prvog odobrenja: 26. srpnja 2018.
English: It is not possible to advise on a minimum effective/safe dose in this population.
Croatian: Nije moguće dati savjet o minimalnoj učinkovitoj/sigurnoj dozi u ove populacije.