FrancophonIA/ELRC3.0 huggingface dataset:
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.
Danish: a) Injektion omkring fistelkanalernes interne åbninger: Indfør kanylen gennem endetarmsåbningen og fortsæt som følger: - Hvis der er en enkelt intern åbning, injiceres indholdet af hvert af de to hætteglas (først et og så det andet) i små depoter i vævet omkring denne ene interne åbning.
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).
Danish: I Alofisel-gruppen var antallet af patienter med kombineret remission ved uge 24, som efterfølgende udviklede anale abscesser/anale fistler ved uge 52, 2,9 % (3/103), hvorimod antallet af patienter uden kombineret remission ved uge 24, som efterfølgende udviklede anale abscesser/anale fistler ved uge 52, var 9,7 % (10/103).
English: Local anaesthesia is not recommended due to the unknown effect of local anaesthetics on the injected cells (see section 4.2).
Danish: Lokalanæstesi frarådes på grund af den ukendte effekt af lokalanæstesi på de injicerede stamceller (se pkt.
English: Anal abscess
Danish: Anal absces
English: How Alofisel is given
Danish: Sådan gives Alofisel
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).
Danish: I kontrolgruppen var antallet af patienter med kombineret remission ved uge 24, som udviklede anale abscesser/anale fistler ved uge 52, 4,9 % (5/102), hvorimod antallet af patienter uden kombineret remission ved uge 24, som udviklede anale abscesser/anale fistler ved uge 52 var 2,9 % (3/102).
English: Thinner gauge needles can cause cell disruption during injection, and may compromise cell viability and therefore may affect efficacy of treatment.
Danish: Kanyler med en tyndere kaliber kan forårsage fraktionering af stamcellerne under injektion og kan kompromittere deres levedygtighed og derved påvirke behandlingens effekt.
English: Driving and using machines Alofisel is not likely to affect your ability to drive or use tools or machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at Alofisel vil påvirke din evne til at føre motorkøretøj eller betjene maskiner.
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.
Danish: Det aktive indholdsstof i Alofisel er darvadstrocel, som består af humane stamceller udtaget fra fedtvæv hos en rask voksen donor, der derefter opdyrkes (ekspanderes) på laboratoriet til en koncentration på 5 millioner stamceller per milliliter.
English: For injection in the fistula tract tissue in a surgical environment under anaesthesia (general or regional (see section 4.4)) as described below.
Danish: Til injektion ved operation under anæstesi (universel eller lokal (se pkt.
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.
Danish: Alofisel er et lægemiddel, der anvendes til behandling af komplekse perianale fistler hos voksne patienter med Crohns sygdom (en sygdom der forårsager kronisk betændelse i tarmen).
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.
Danish: Der foreligger ingen data vedrørende brug af darvadstrocel hos patienter med nedsat lever- eller nyrefunktion Da darvadstrocel består af stamceller og det er en lokal administrationsvej forventes det ikke, at benefit/risk-forholdet for darvadstrocel hos patienter med nedsat lever- eller nyrefunktion vil afvige fra det, som er set hos patienter med normal lever- eller nyrefunktion.
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.
Danish: Op til uge 52 udviklede hhv. 20 (19,4 %) og 14 (13,7 ) patienter 21 og 19 uønskede hændelser med anale abscesser i Alofisel- og kontrolgrupperne, hvoraf 4 og 5 af de uønskede hændelser i de respektive grupper (3,9 % af patienter i begge grupper) var af svær intensitet.
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.
Danish: Den kan derfor indeholde potentielt inficeret biologisk materiale, omend risikoen betragtes som meget lav og materialet kontrolleres under fremstilling.
English: Each vial contains 30 million cells in 6 mL of suspension.
Danish: Hvert hætteglas indeholder 30 millioner stamceller i en 6 ml suspension.
English: Conditioning reactions Conditioning of fistulas has been associated with proctalgia and procedural pain (see section 4.8).
Danish: Forbehandling af fistler har været forbundet med proktalgi og smerter relateret til dette indgreb (se pkt.
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).
Danish: Andelen af patienter med klinisk remission ved uge 52 var 59 % i Alofisel-gruppen og 41 % i kontrolgruppen (p = 0,012).
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.
Danish: Dette blev defineret som klinisk lukning af alle behandlede fistler (ingen udsivning, trods let trykken med fingrene) og ingen ansamling (> 2 cm) bekræftet ved blindet central magnetisk resonans-skanning (MR).
English: Final Report to EMA: 2Q/3Q 2022
Danish: Endelig rapport til EMA: 2. kvartal/3.
English: This leaflet was last revised in <MM/YYYY>
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
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.
Danish: Umiddelbart før brug skal Alofisel resuspenseres ved at banke forsigtigt på bunden af hætteglasset til suspensionen er homogen.
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).
Danish: Resultater af de vigtigste sekundære effektmål viser, at andelen af patienter med klinisk remission ved uge 24 var 55 % i Alofisel-gruppen og 42 % i kontrolgruppen (p = 0,052).
English: • massage softly for 20 to 30 seconds the area where the fistula opens on to the skin near your anus.
Danish: • Forsigtigt massere området, hvor fistlerne udmunder i huden nær endetarmsåbningen, i 20 til
English: See the end of Section 4 for how to report side effects.
Danish: 4, hvordan du indberetter bivirkninger.
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).
Danish: Der må ikke injiceres andre typer opløsning gennem fistelkanalerne, såsom hydrogenperoxid, methylenblåt, jodopløsning eller hypertonisk glukoseopløsning, da disse kompromitterer levedygtigheden af stamcellerne, som skal injiceres (se pkt.
English: Adult stem cells are a special type of cells found in many adult tissues, whose primary role is the repair of the tissue in which they are found.
Danish: Det aktive indholdsstof i Alofisel er darvadstrocel, som består af stamceller, der er taget fra fedtvævet hosenraskvoksendonor(såkaldteallogenestamceller)ogderefteropdyrketietlaboratorium.De benyttede stamceller er en særlig type celler, der findes i mange væv hos voksne, hvis primære rolle er at reparere det væv, de findes i.
English: Each vial contains 6 mL of a suspension of 30 million of darvadstrocel.
Danish: Hvert hætteglas indeholder 6 ml opløsning med 30 millioner celler af darvadstrocel.
English: ALOFISEL 5 million cells/mL suspension for injection Darvadstrocel
Danish: Alofisel 5 millioner celler/ml injektionsvæske, suspension Darvadstrocel
English: Alofisel 5 million cells/mL suspension for injection Darvadstrocel
Danish: ALOFISEL 5 millioner celler/ml injektionsvæske, suspension Darvadstrocel
English: Alofisel 5 million cells/mL suspension for injection
Danish: Alofisel 5 millioner celler/ml injektionsvæske, suspension
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.
Danish: Anale fistler ses typisk som fissurer, der penetrerer tarmlumen og overfladen af den perianale hud.
English: Preparation a) The expiry time: date of Alofisel should be re-confirmed; vials should then be removed from the outer packaging.
Danish: Efter forbehandling af fistelkanalerne administreres Alofisel i disse to trin: Forberedelse a) Udløbsdato for Alofisel skal genbekræftes.
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.
Danish: Op til uge 104 udviklede hhv. 5 (4,9 %) og en (< 1,0 %) patient(er) 5 og 1 alvorlig(e) uønskede hændelser med anal fistel i Alofisel- og kontrolgruppen.
English: The suspension of cells may have settled in the bottom of the vial forming a sediment.
Danish: Suspensionen af stamceller vil muligvis have sat sig som bundfald i hætteglasset.
English: Alofisel is injected by a surgeon in the fistula tract tissue.
Danish: Alofisel indgives af en kirurg ved injektion meget nær ved eller ind i dine fistler.
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.
Danish: Op til uge 104 udviklede hhv. 15 (14,6 %) og 8 (7,8 %) patienter 15 og 9 alvorlige uønskede hændelser med anale abscesser i Alofisel- og kontrolgruppen.
English: After the cells have been resuspended (by gentle manual tapping), Alofisel is a white to yellowish homogenous suspension.
Danish: Resuspension af stamcellerne sker ved at banke let på hætteglasset, og derefter vil Alofisel fremstå som en hvid til gullig ensartet suspension.
English: Before scheduling Alofisel administration, the surgeon must ensure that no abscesses are present.
Danish: Kirugen skal sikre sig, at der ikke er nogen abscesser før administration af Alofisel planlægges.
English: Keep the medicine inside the cardboard box.
Danish: Opbevar lægemidlet i original emballage.
English: Alofisel should be used only after conditioning of the fistulas (see section 4.2).
Danish: Alofisel benyttes kun efter forbehandling af fistlerne, se pkt.
English: • proctalgia (pain in the rectum or anus).
Danish: • Smerter i endetarmen eller ved endetarmsåbningen (proktalgi)
English: What Alofisel looks like and contents of the pack Alofisel is a suspension for injection.
Danish: Alofisel er en suspension til injektion.
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.
Danish: Op til uge 52 udviklede hhv. 11 (10,7 %) og 8 (7,8 %) patienter 12 og 8 uønskede hændelser med anal fistel i Alofisel- og kontrolgrupperne.
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).
Danish: Injektion af alle andre stoffer end natriumklorid 9 mg/ml (0,9 %) (f.eks. hydrogenperoxid, methylenblåt, jod- eller hypertoniske glukoseopløsninger) (se pkt.
English: If you have any further questions, ask your doctor or surgeon.
Danish: Spørg lægen, eller kirurgen, hvis der er mere, du vil vide.
English: Fax: +34 91 804 92 63 info@tigenix.com
Danish: Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Spanien tlf. +34 91 804 92 64 fax +34 91 804 92 63 info@tigenix.com
English: Gastrointestinal disorders
Danish: Reaktioner på forbehandling af fistler
English: OUTER CARTON
Danish: YDRE EMBALLAGE - Karton
English: GLASS VIAL
Danish: Mave-tarm-kanalen
English: Proctalgia
Danish: Proktalgi
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.
Danish: Op til uge 52 udviklede hhv. 15 (14,6 %) og 12 (11,8 %) patienter 20 og 17 uønskede hændelser med proktalgi i Alofisel- og kontrolgruppen.
English: • anal fistula
Danish: • Fistel ved endetarmen (anal fistel)
English: What Alofisel is and what it is used for 2.
Danish: Virkning og anvendelse 2.
English: If you are allergic to Alofisel, bovine serum or to any of the ingredients of this medicine (listed in section6).
Danish: HvisduerallergiskoverforAlofisel,serumafbovinoprindelseelleretafdeøvrige indholdsstofferilægemidlet(angivetipkt.6).
English: The trials included 2,690 patients with the age of 18 years to 65 years.
Danish: Forsøgene omfattede 2.690 patienter i alderen 18 år til 65 år.
English: Environmental risk assessment (ERA)
Danish: Miljørisikovurdering (ERA)
English: It is not possible to advise on a minimum effective/safe dose in this population.
Danish: Det er ikke muligt at give råd vedrørende en effektiv/sikker minimumsdosis i denne population.
English: The safety and effectiveness in these patients were not evaluated.
Danish: Sikkerheden og virkningen hos disse patienter er ikke undersøgt.
English: The CGI-S was also assessed in trials 3 and 5 as secondary endpoint.
Danish: CGI-S blev også vurderet i forsøg 3 og 5 som sekundært endepunkt.
English: Remember to take the medicine pack with you so that it is clear what you have taken.
Danish: Husk at tage lægemiddelpakningen med, så det fremgår tydeligt, hvad du har taget.
English: Results for the (key) secondary outcome parameter and additional endpoints were supportive of the primary endpoint.
Danish: Resultater af det (vigtigste) sekundære resultatparameter og yderligere endepunkter understøttede det primære endepunkt.
English: The smaller number of female than male subjects enrolled in the study does not allow to draw definitive conclusions.
Danish: Det lavere antal kvinder end mænd, der var inkluderet i forsøget, gør det ikke muligt at drage endelige konklusioner.
English: • medicines having an effect on the central nervous system.
Danish: • lægemidler, der påvirker centralnervesystemet.
English: A risk to the new-borns/infants cannot be excluded.
Danish: En risiko for nyfødte/spædbørn kan ikke udelukkes.
English: Close medical supervision and monitoring should continue until the patient recovers.
Danish: Nøje medicinsk overvågning og monitorering bør fortsættes, indtil forsøgspersonen er kommet sig.
English: • withdrawal symptoms in new-born babies if the mother has taken this medicine during pregnancy.
Danish: • abstinenssymptomer hos nyfødte babyer, hvis moderen har taget dette lægemiddel under graviditeten,
English: Do not over-exercise and drink plenty of water.
Danish: Undgå fysisk overanstrengelse, og drik masser af vand.
English: People with this condition may also feel depressed, guilty, anxious or tense.
Danish: Personer med denne lidelse kan også føle sig deprimerede, skyldige, angste eller anspændte.
English: If you forget to take a dose, take it as soon as you remember it.
Danish: Hvis du glemmer at tage en dosis, skal du tage den, så snart du kommer i tanke om det.
English: Compulsive behaviours may result in harm to the patient and others if not recognised.
Danish: Kompulsiv adfærd kan medføre skade på patienten og andre, hvis adfærden ikke anerkendes.
English: Clinical monitoring of weight and lipid profile is recommended at baseline and during treatment.
Danish: Klinisk monitorering af vægt og lipidprofil anbefales ved baseline og under behandlingen.
English: Effects on QT
Danish: Effekt på QT
English: Confidence interval Treatment statistically significantly superior to placebo a
Danish: Konfidensinterval Behandling statistisk signifikant superiør i forhold til placebo a
English: This may for example be the case if other medicines lowered your white blood cells in the past.
Danish: Det kan f.eks. være tilfældet, hvis andre lægemidler tidligere har reduceret antallet af hvide blodlegemer i dit blod.
English: During treatment you may experience these serious side effects that require urgent medical attention.
Danish: Under behandlingen kan du opleve disse alvorlige bivirkninger, som kræver øjeblikkelig lægebehandling.
English: This medicine must not be taken by children and adolescents under 18 years of age.
Danish: Dette lægemiddel må ikke gives til børn og unge under 18 år.
English: At the beginning of treatment the lipid profile should be assessed.
Danish: I begyndelsen af behandlingen bør lipidprofilen vurderes.
English: • ever experienced or start to experience restlessness and inability to sit still.
Danish: • nogensinde har oplevet eller begynder at opleve rastløshed og manglende evne til at sidde stille.
English: This medicine may cause significant weight gain which may affect your health.
Danish: Dette lægemiddel kan medføre en betydelig vægtøgning, som kan påvirke dit helbred.
English: Adjusted dose
Danish: Justeret dosis
English: There are no or limited amount of data from the use of brexpiprazole in pregnant women.
Danish: Der er ingen eller kun begrænsede data fra anvendelse af brexpiprazol til gravide kvinder.
English: Suicidal thoughts and behaviours are more likely at the beginning of the treatment.
Danish: Selvmordstanker og selvmordsadfærd er mere sandsynlige i starten af behandlingen
English: These symptoms may occur early during treatment.
Danish: Disse symptomer kan optræde tidligt i behandlingen.
English: This medicinal product may pose a risk to the environment (see section 5.3).
Danish: Dette lægemiddel kan udgøre en risiko for miljøet (se pkt.
English: These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Danish: Disse symptomer kan midlertidigt forværres eller endog opstå efter afslutningen af behandlingen.
English: • dementia (loss of memory and other mental abilities) especially if you are elderly.
Danish: • har demens (hukommelsestab og tab af andre mentale evner), især hvis du er ældre
English: • have or had a low number of white blood cells in your blood and get a fever or any other sign of infection.
Danish: • har eller har haft et lavt antal hvide blodlegemer i blodet og får feber eller andre tegn på infektion.
English: Your medicine will usually be given to you in increasing doses as follows:
Danish: Du vil normalt få lægemidlet i stigende doser som følger:
English: • or had low or high blood pressure.
Danish: • har for lavt eller for højt blodtryk
English: It should be considered that plasma concentration of brexpiprazole will decline gradually and will be completely washed out in 1 to 2 weeks.
Danish: Der bør tages højde for, at plasmakoncentrationen af brexpiprazol vil falde gradvis og være fuldstændigt elimineret efter 1 til 2 uger.
English: • if you are allergic to brexpiprazole or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for brexpiprazol eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6).
English: Thus, DM-3411 is considered not to contribute to the therapeutic effects of brexpiprazole.
Danish: DM-3411 anses derfor ikke for at bidrage til brexpiprazols terapeutiske virkninger.
English: Your doctor will therefore check your weight and your fats in the blood regularly.
Danish: Lægen vil derfor tjekke din vægt og fedtstofferne i dit blod regelmæssigt.
English: However, if it is almost time for your next dose, skip the missed dose and continue as usual.
Danish: Hvis det næsten er tid til din næste dosis, skal du dog springe den glemte dosis over og fortsætte som normalt.
English: On day 8 the dose was increased to 4 mg for some of the treatment arms.
Danish: Dag 8 blev dosis øget til 4 mg i nogle af behandlingsgrupperne.
English: 2500 Valby Denmark
Danish: 2500 Valby Danmark
English: Do not drive or use any tools or machines until you know that this medicine does not affect you in a negative way.
Danish: Lad være med at føre motorkøretøj eller betjene maskiner, før du er sikker på, at lægemidlet ikke påvirker dig på en negativ måde.
English: Your doctor will stop the treatment immediately if the white blood cells in your blood are too low.
Danish: Lægen vil stoppe behandlingen øjeblikkeligt, hvis antallet af hvide blodlegemer er for lavt.
English: The primary statistical analysis was performed using an MMRM model with MAR (Missing At Random) imputation.
Danish: Den primære statistiske analyse blev foretaget ved brug af en MMRM-model med MAR (Missing At Random)-imputering.
English: Results of a sensitivity analysis using placebo based multiple imputation (PMI) were consistent with the primary analysis.
Danish: Resultaterne af en sensitivitetsanalyse ved brug af placebo-baseret multipel imputering (PMI) var konsistente med den primære analyse.
English: • akathisia (an uncomfortable feeling of inner restlessness and a compelling need to move constantly),
Danish: • akatisi (en ubehagelig følelse af indre rastløshed og en ubændig trang til at bevæge dig konstant)
English: It is not recommended to take RXULTI during your pregnancy.
Danish: Det anbefales ikke at tage RXULTI under graviditet.
English: • or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: • eller din familie/omsorgsperson bemærker, at du er ved at udvikle trang til at opføre dig på måder, der er usædvanlige for dig, og du ikke kan modstå trangen eller fristelsen til at udføre visse aktiviteter, der kan skade dig selv eller andre.
English: During long term treatment the plasma glucose levels should be monitored regularly for worsening of glucose control.
Danish: Ved længerevarende behandling bør plasmaglukoseniveauet overvåges regelmæssigt for forværret glukosekontrol.
English: Administer a quarter of the recommended dose
Danish: Administrér en fjerdedel af den anbefalede dosis
English: RXULTI can help to keep the symptoms under control and to prevent relapse as you continue treatment.
Danish: RXULTI kan hjælpe med at holde symptomerne under kontrol og forebygge tilbagefald, efterhånden som du fortsætter behandlingen.