FrancophonIA/ELRC3.0 huggingface dataset:
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).
Maltese: Il-proporzjon ta' pazjenti b'remissjoni klinika fil-Ġimgħa 52 kien ta' 59% fil-grupp ta' Alofisel u 41% fil-grupp ta' kontroll (p = 0.012) u ċ-ċifri korrispondenti għar-rispons kienu 66% u 55% (p = 0.114).
English: The nature and intended clinical use of darvadstrocel are such that conventional studies of pharmacokinetics (absorption, distribution, metabolism and elimination) are not applicable.
Maltese: In-natura u l-użu kliniku intenzjonat ta' darvadstrocel huma tali li studji konvenzjonali ta' farmakokinetiċi, (assorbiment, distribuzzjoni, metaboliżmu, u eliminazzjoni) mhumiex applikabbli.
English: Combined remission at Week 24 (% patients) Combined remission at Week 52 (% patients)
Maltese: Remissjoni kombinata filĠimgħa 24 (% ta' pazjenti) Remissjoni kombinata filĠimgħa 52 (% ta' pazjenti)
English: Each vial contains 6 mL of a suspension of 30 million of darvadstrocel.
Maltese: Kull kunjett fih 6 mL ta' suspensjoni bi 30 miljun ta' darvadstrocel.
English: • proctalgia (pain in the rectum or anus).
Maltese: • proctalgia (uġigħ fir-rektum jew fl-anus).
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).
Maltese: Studji ta' interazzjoni in vitro wrew li l-vijabilità taċ-ċelloli u l-funzjoni immunomodulatorja ta' Alofisel mhix affettwata mill-preżenza ta' konċentrazzjonijiet klinikament rilevanti ta' terapiji konvenzjonali għall-marda ta' Crohn (infliximab, methotrexate u azathioprine).
English: Alofisel is injected by a surgeon in the fistula tract tissue.
Maltese: Alofisel jiġi injettat minn kirurgu fit-tessut tal-passaġġ tal-fistula.
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.
Maltese: F'numru limitat ta' pazjenti segwiti sal-Ġimgħa 104, ir-remissjoni klinika fil-Ġimgħa 104 kienet 56% fil-grupp ta' Alofisel u 40% fil-grupp ta' kontroll.
English: The efficacy of Alofisel was assessed in the ADMIRE-CD study.
Maltese: L-effikaċja ta' Alofisel ġiet ivvalutata fl-istudju ADMIRE-CD.
English: Pharmacotherapeutic group: {not yet assigned}, ATC code: {not yet assigned}.
Maltese: {mhux assenjat}, kodiċi ATC:
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.
Maltese: Sabiex tiġi segwita l-effikaċja ta' Alofisel, il-MAH għandu jippreżenta r-riżultati ta' studjurandomised, double-blind, ikkontrollat bi plaċebo tal-Fażi III ta' Cx601-0303 li jinvestiga amministrazzjoni waħda ta' Cx601 għall-kura ta' fistuli perianali kumplessi f'pazjenti bil-marda ta' Crohn.
English: • Guide in form of a video for surgeons and other health professionals involved in the preparation and administration of Alofisel.
Maltese: • Gwida fil-forma ta' vidjo għall-kirurgi u għal professjonisti oħrajn fil-kura tas-saħħa involuti fil-preparazzjoni u fl-amministrazzjoni ta' Alofisel.
English: • Guide for health professionals providing information on potential for microbial information and advice on steps to follow in case a positive culture is identified.
Maltese: • Gwida għall-professjonisti fil-kura tas-saħħa li tipprovdi informazzjoni dwar il-potenzjal għal informazzjoni dwar il-mikrobi u pariri dwar x'passi jridu jiġu segwiti f'każ li tkun ġiet identifikata kultura pożittiva.
English: The frequency of adverse reactions is defined using the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from available data).
Maltese: (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000); mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
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.
Maltese: Ma kien hemm l-ebda pazjent fil-grupp ta' Alofisel b'avvenimenti tal- proctalgia ta' intensità severa u 3.9% tal-pazjenti b'4 avvenimenti fil-grupp ta' kontroll.
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).
Maltese: Ir-riżultati tal-punti ta' tmiem sekondarji ewlenin juru li l-proporzjon tal-pazjenti b'remissjoni klinika fil-Ġimgħa 24 kien 55% fil-grupp ta' Alofisel u 42% fil-grupp ta' kontroll (p = 0.052) u ċ-ċifri korrispondenti għar-rispons kienu 69% u 55% (p = 0.039).
English: The safety and efficacy of darvadstrocel in children and adolescents aged 0 to 17 years have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' darvadstrocel fit-tfal u adolexxenti minn età ta' 0 sa 17-il sena ma ġewx determinati s'issa.
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).
Maltese: Fil-Grupp ta' Alofisel, in-numru ta' pazjenti li kellhom remissjoni kombinata fil-Ġimgħa 24 u sussegwentement żviluppaw axxessi anali/fistula anali sal-Ġimgħa 52 kien 2.9% (3/103), filwaqt li n-numru ta' pazjenti mingħajr remissjoni kombinata fil-Ġimgħa 24 li sussegwentement żviluppaw axxessi anali/fistula anali sal-Ġimgħa 52 kien 9.7% (10/103).
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.
Maltese: Sal-Ġimgħa 104, 15 (14.6%) u 8 (7.8%) pazjenti żviluppaw 15 u 9 avvenimenti avversi tal-axxessi anali fil-gruppi ta' Alofisel u ta' kontroll rispettivament.
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.
Maltese: Kull kunjett fiħ suspensjoni ta' 30 miljun ċellola (eASC) f'soluzzjoni ta' 6 ml, li tikkorrispondi għal konċentrazzjoni ta' 5 miljun ċellola/mL
English: Do not store above 25 °C or below 15 °C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25 °C jew inqas minn 15 °C.
English: Hypersensitivity to the product, bovine serum or any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għall-prodott, serum bovin jew kwalunkwe sustanza mhux attiva elenkata f'sezzjoni 6.1.
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.
Maltese: Sal-Ġimgħa 104, 5 (4.9%) pazjenti u pazjent wieħed (< 1.0%) żviluppaw 5 avvenimenti avversi u avveniment avvers wieħed rispettivament fil-gruppi ta' Alofisel u ta' kontroll rispettivament.
English: Pharmacodynamic effect
Maltese: Effett farmakodinamiku
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).
Maltese: L-injezzjoni ta' kwalunkwe sustanza barra s-sodium chloride 9 mg/mL (0.9%) (eż. hydrogen peroxide, methylene blue, soluzzjonijiet tal-jodju, soluzzjonijiet tal-hypertonic glucose) (ara Sezzjoni 4.2 u Sezzjoni 4.4) minn ġol-passaġġi tal-fistula u l-użu ta'l-anestesija lokali mhumiex rakkomandati minħabba l-effett mhux magħruf tal-anestesiji lokali fuq iċ-ċelloli injettati (ara sezzjoni 4.4).
English: Darvadstrocel contains expanded adipose stem cells (eASC), which exhibit immunomodulatory and anti-inflammatory effects at inflammation sites.
Maltese: Darbadstrocel fih ċelloli staminali adipużi mkabbra (eASC), li jesibixxu effetti immunomodulatorji u anti-infjammatorji f'siti ta' infjammazzjoni.
English: Concomitant use of stable doses of immunosuppressants (18% of patients) or anti-TNFs (33%) or both (28%) was allowed during the study.
Maltese: L-użu konkomitanti ta' dożi stabbli ta' immunosuppressanti (18% tal-pazjenti) jew ta' anti-TNFs (33%) jew tat-tnejn (28%) ġie permess matul l-istudju.
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.
Maltese: Hemm żewġ eċċipjenti użati għall-ħażna taċ-ċelloli: wieħed hu likwidu msejjaħ Dulbecco's Modified Eagle´s Medium li fih nutrijenti għaċ-ċelloli (li fih amino acids, vitamini, imluħa u karboidrati), u l-ieħor hu albumina umana, li hu proteina naturali li tinstab fil-ġisem tal-bniedem.
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.
Maltese: L-injezzjoni ta' kwalunkwe sustanza barra s-sodium chloride 9 mg/mL (0.9%) (eż. hydrogen peroxide, methylene blue, soluzzjonijiet tal-jodju, soluzzjonijiet tal-hypertonic glucose) (ara Sezzjoni 4.2 u Sezzjoni 4.5), minn ġol-passaġġi tal-fistula qabel, matul u wara l-injezzjoni ta' Alofisel mhuwiex permess billi dawn jistgħu jikkompromettu l-vijabilità taċ-ċelloli u, għalhekk, jistgħu jaffettwaw l-effikaċja tal-kura.
English: The following listing of adverse reactions is based on the clinical trial experience and is displayed by system organ class.
Maltese: Il-lista li ġejja ta' reazzjonijiet avversi hi bbażata fuq l-esperjenza tal-prova klinika u hi murija skont il-klassifika tas-sistema tal-organi.
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).
Maltese: Fil-grupp ta' kontroll, in-numru ta' pazjenti li kellhom remissjoni kombinata fil-Ġimgħa 24 li żviluppaw axxessi anali/fistula anali sal-Ġimgħa 52 kien 4.9% (5/102), filwaqt li n-numru ta' pazjenti mingħajr remissjoni kombinata fil-Ġimgħa 24 li żviluppaw axxessi anali/fistula anali sal-Ġimgħa 52 kien 2.9% (3/102)
English: Each vial contains 30 million cells in 6 mL of suspension.
Maltese: Kull kunjett fih 30 miljun ċellola f'suspensjoni ta' 6 mL.
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.
Maltese: Sal-Ġimgħa 52, 20 (19.4%) u 14 (13.7%)-il pazjent żviluppaw 21 u 19-il avveniment avvers tal-axxessi anali fil-grupp ta' Alofisel u fil-grupp ta' kontroll rispettivament, li minnhom 4 u 5 avvenimenti avversi fil-gruppi rispettivi (3.9% tal-pazjenti fiż-żewġ gruppi) kienu ta' intensità severa.
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.
Maltese: Il-punti ta' tmiem sekondarji ewlenin ġew definiti bħala remissjoni klinika (għeluq kliniku tal-fistuli kkurati kollha) u rispons (għeluq kliniku ta' mill-inqas 50% tal-fistuli kkurati kollha) fil-Ġimgħa 24.
English: Of patients with DSA at Week 12, 7/23 (30%) had cleared DSA by Week 52.
Maltese: Mill-pazjenti b'DSA fil-Ġimgħa 12, 7/23 (30%) minnhom kienu ħelsu mid-DSA sal-Ġimgħa 52.
English: Alofisel must not be filtered, or administered using a needle thinner than 22G (see section 4.4).
Maltese: Alofisel ma jridx jiġi ffiltrat, jew mgħoti bl-użu ta' labra rqaq minn 22G (ara Sezzjoni 4.4).
English: Lack of de novo DSA generation was observed between Week 12 and Week 52.
Maltese: In-nuqqas ta' ġenerazzjoni DSA de novo ġie nnutat bejn il-Ġimgħa 12 u l-Ġimgħa 52.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Maltese: 2.2 Għamla kwalitattiva u kwantitattiva
English: • Guide for surgeons and other health professionals describing the method of administration
Maltese: • Gwida għall-kirurgi u għal professjonisti oħra fil-kura tas-saħħa li tiddeskrivi l-metodu ta'amministrazzjoni.
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.
Maltese: b) Injezzjoni tul il-ħajt tal-passaġġi tal-fistula: daħħal il-labra ġol-fetħiet esterni u minn ġewwa l-lumen tal-fistuli: - Jekk hemm fetħa esterna waħda, injetta separatament il-kontenut ta' kull wieħed mill-kunjetti li jibqa' b'mod superfiċjali fil-ħajt tat-tessut tul il-kanali tal-fistula, billi tagħmel depożiti żgħar tas-suspensjoni ċellulari.
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).
Maltese: L-injezzjoni ta' sustanza oħra minn ġol-passaġġi tal-fistula, bħal pereżempju hydrogen peroxide, methylene blue, soluzzjonijiet tal-jodju, soluzzjonijiet tal-hypertonic glucose mhumiex permessi, billi dawn l-aġenti jikkompromettu l-vijabilità taċ-ċelloli li jridu jiġu injettati (ara Sezzjoni 4.4. u Sezzjoni 4.5).
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.
Maltese: Sal-Ġimgħa 52, 15 (14.6%) u 12(11.8%)-il pazjent żviluppaw 20 u 17-il avveniment avvers talproctalgia fil-gruppi ta' Alofisel u ta' kontroll rispettivament, bl-ebda minn dawn l-avvenimenti ma jkunu serji fi kwalunkwe grupp sal-Ġimgħa 104.
English: Inflammatory cytokines, in particular IFN-γ released by activated immune cells (i.e., lymphocytes), activate eASC.
Maltese: Iċ-ċitokini infjammatorji, b'mod partikolari IFN-y rilaxxata minn ċelloli immuni attivati (jiġifieri, limfoċiti), jattivaw l-eASC.
English: e) Repeat steps (b), (c) and (d) for each of the vials in turn after the cells from one vial have been injected.
Maltese: e) Irrepeti l-passi (b), (ċ) u (d) għal kull kunjett wara xulxin wara li jkunu ġew injettati ċ-ċelloli minn kunjett wieħed.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europe.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropeja għall-Mediċini http://www.ema.europa.eu/ema/.
English: A single dose of Alofisel consists of 120 million cells supplied in 4 vials.
Maltese: Doża waħda ta' Alofisel tikkonsisti f'120 miljun ċellola forniti f'4 kunjetti.
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.
Maltese: Huwa rakkomandat li mill-inqas ġimgħatejn sa 3 ġimgħat qabel il-jum tal-amministrazzjoni, titwettaq operazzjoni ta' preparazzjoni li tkun tinkludi esplorazzjoni (taħt anestesija) tal-anatomija tal-fistula (in-numru ta' fistuli u fetħiet eżistenti), tat-topografija (il-firxa u r-relazzjoni mal-isfinteriċi u ma' muskoli pelviċi oħrajn), u tal-potenzjal ta' kumplikazzjonijiet assoċjati (bħal pereżempju axxessi) u jekk il-marda mukosali lokali hi ħafifa jew inattiva.
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.
Maltese: Għal dan, hija rakkomandata injezzjoni ta' soluzzjoni ta' 9 mg/mL (0.9%) sodium chloride minn ġol-fetħiet esterni sakemm toħroġ minn ġol-fetħiet interni.
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.
Maltese: Alofisel hu indikat għat-trattament ta' fistuli perianali kumplessi f'pazjenti adulti li għandhom il-marda ta' Crohn luminali mhux attiva/attiva b'mod ħafif, meta l-fistuli jkunu wrew rispons inadegwat għal tal-inqas terapija konvenzjonali jew bijoloġika waħda.
English: Patients should be followed up for potential signs of infection after administration.
Maltese: Il-pazjenti għandhom jiġu segwiti għal sinjali potenzjali ta' infezzjoni wara l-amministrazzjoni.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza miftehmin, dettaljati fl-RMP ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti mifthiem tal-RMP.
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.
Maltese: Il-punt tat-tmiem primarju kien ir-remissjoni kombinata fil-Ġimgħa 24 wara t-trattament tal-istudju, definit bħala għeluq kliniku tal-fistuli ttrattati kollha (nuqqas ta' likwidi minkejja kompressjoni bil-mod bis-swaba') u nuqqas ta' ġbir (> 2 ċm) ikkonfermati b'MRI ċentrali mgħammda.
English: In the inflamed area, there is infiltration of activated lymphocytes and local release of inflammatory cytokines.
Maltese: Fiż-żona infjammata, hemm infiltrazzjoni ta' limfoċiti attivati u rilaxx lokali ta' ċitokini infjammatorji.
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.
Maltese: Qabel it-tnedija ta' Alofisel f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) irid jaqbel dwar il-kontenut u l-format tal-programm edukattiv, li jinkludi mezzi tal-komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Conditioning reactions Conditioning of fistulas has been associated with proctalgia and procedural pain (see section 4.8).
Maltese: Il-kundizzjonament tal-fistuli ġie assoċjat ma' proctalgiaproktalġja u ma' wġigħ proċedurali (ara s-sezzjoni 4.8).
English: Once you have been anaesthetised (general or regional anaesthesia), your surgeon will:
Maltese: Ladarba tkun anestetizzat (anesteżija ġenerali jew reġjonali), il-kirurgu tiegħek:
English: * Including abscess drainage, seton placement/removal, curettage, suture of internal openings and medical treatments
Maltese: * Jinkludi tneħħija ta' likwidi tal-axxessi, tqegħid/tneħħija ta' seton, curettage, sutura tal-fetħiet interni u trattamenti mediċi.
English: Softly massage the area around the external openings for 20-30 seconds and cover the external openings with a sterile bandage.
Maltese: Immassaġġja ġentilment iż-żona madwar il-fetħiet esterni għal 20-30 sekonda u għatti l-fetħiet esterni b'faxxa sterili.
English: BATCH NUMBER, DONATION AND PRODUCT CODES
Maltese: NUMRU TAL-LOTT, DONAZZJONI U KOWD TAL-PRODOTT
English: • Relevant information on the risk of medication errors and the potential for transmission of infectious agents and details on how to minimise these, including reception, storage and administration instructions (i.e. fistula conditioning, preparation and injection).
Maltese: • Informazzjoni relevanti dwar ir-riskju ta' żbalji fil-medikazzjoni u l-potenzjal għat-trażmissjoni ta' aġenti infettivi u dettalji dwar kif dawn jiġu minimizzati, inkluż istruzzjonijiet dwar kif għandu jiġi riċevut, dwar il-ħażna u dwar l-amministrazzjoni (jiġifieri, l-kundizzjonament tal-fistula, il-preparazzjoni u l-injezzjoni).
English: When injected close to the perianal fistulas, Alofisel reduces their inflammation, increasing the likelihood of the fistulas healing.
Maltese: Meta jkun injettat viċin tal-fistuli perianali, Alofisel inaqqas l-infjammazzjoni tagħhom, u jżid il-probabbiltà ta' fejqan tal-fistuli.
English: Common side effects (may affect up to 1 to 10 patients):
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa pazjent 1 minn kull 10):
English: • procedural pain (pain after fistula cleaning)
Maltese: • axxess (likwidu infettat) anali
English: Alofisel is a living cell therapy and, therefore, the final product cannot be sterilised.
Maltese: Alofisel hu terapija b'ċellola ħajja, għalhekk, il-prodott finali ma jistax jiġi sterilizzat.
English: For example a needle for spinal anaesthesia measuring around 90 mm in length is required.
Maltese: Pereżempju, hi meħtieġa labra ta' madwar 90 mm tul għall-anestesija fis-sinsla.
English: Patients had draining complex perianal fistulas with an inadequate response to at least one of the following treatments: antibiotics, immunosuppressants or anti-TNFs.
Maltese: Il-pazjenti kellhom fistuli perianali kumplessi li jkunu qed jitbattlu mil-likwidi, b'rispons inadegwat għal tal-inqas wieħed mit-trattamenti li ġejjin: antibijotiċi, immunosuppressivi jew anti-TNFs.
English: Each vial contains 6 mL of eASC suspension and is closed with a rubber stopper and a flip-off seal.
Maltese: Kull kunjett fih 6 mL ta' suspensjoni ta' eASC u hu magħluq b'tapp tal-lastiku u b'siġill flip-off.
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.
Maltese: Data dwar l-użu ta' darvadstrocel fil-popolazzjoni anzjana hi limitata, madankollu, minħabba n-natura bbażata fuq iċ-ċelloli ta' darvadstrocel u r-rotta ta' amministrazzjoni lokali tiegħu, mhux mistenni li l-profil ta' bejn il-benefiċċju u r-riskju ta' darvadstrocel f'pazjenti anzjani jkun differenti minn dak osservat f'pazjenti mhux anzjani.
English: Alofisel must not be administered using a needle thinner than 22G.
Maltese: Alofisel m'għandux jingħata bl-użu ta' labra irqaq minn 22G.
English: An individual dose of Alofisel comprises 4 glass vials each containing 6 millilitres of Alofisel contained within a cardboard box.
Maltese: Doża waħda ta' Alofisel hija magħmula minn 4 kunjetti tal-ħġieġ b'kull wieħed fih 6 millilitri ta' Alofisel li jkunu ġo kaxxa tal-kartun.