FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Sebivo can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Sebivo jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 04-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'04-2012.
English: It is available as tablets (600 mg) and as an oral solution (20 mg/ml).
Maltese: Huwa disponibbli bħala kapsuli (600 mg) u bħala soluzzjoni orali (20 mg/ml).
English: Sebivo is a medicine that contains the active substance telbivudine.
Maltese: Sebivo huwa mediċina li fiha s-sustanza attiva telbivudina.
English: The most common side effects with Sebivo (seen in between 1 and 10 patients in 100) are dizziness, headache, cough, increased levels of some enzymes in the blood (amylase, lipase, creatine phosphokinase and alanine aminotransferase), diarrhoea, nausea (feeling sick), abdominal pain (stomach ache), skin rash and fatigue (tiredness).
Maltese: L-aktar effetti sekondarji komuni b'Sebivo (dehru f'bejn 1 u 10 pazjenti minn kull 100) huma sturdament, uġigħ ta' ras, sogħla, livelli aktar għoljin ta' xi enzimi (amylase, lipase, creatine phosphokinase, alanine aminotransferase), dijarea, dardir (tħossok marid), uġigħ addominali (talistonku), raxx tal-ġilda u għeja kbira.
English: The active substance in Sebivo, telbivudine, is an antiviral medicine that belongs to the class ‘nucleoside analogues'.
Maltese: Is-sustanza attiva f'Sebivo, it-telbivudina, hija mediċina antivirali tal-klassi tal-‘analogi nukleosidiċi'.
English: In the HBeAg-negative patients, Sebivo was as effective as lamivudine (75% and 77% responding, respectively).
Maltese: F'pazjenti b'HBeAg negattiv, Sebivo kien effettiv bħal lamivudine (75 u 77% jirrispondu rispettivament).
English: This is a summary of the European public assessment report (EPAR) for Sebivo.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Sebivo.
English: Why has Sebivo been approved?
Maltese: Għaliex ġie approvat Sebivo?
English: Sebivo tablets were compared with lamivudine (another medicine used in chronic hepatitis B) in a twoyear study involving 1,367 patients.
Maltese: Pilloli ta' Sebivo fl-epatite B kronika ġew imqabbla ma' lamivudine (mediċina oħra użata fl-epatite B kronika) fi studju ta' sentejn li kien jinvolvi 1,367 pazjenti.
English: What is Sebivo?
Maltese: X'inhu Sebivo?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sebivo on 24 April 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Sebivo valida fl-Unjoni Ewropea kollha fis-24 ta' April 2007.
English: After one year of treatment, Sebivo was more effective than lamivudine in the HBeAg-positive patients, with 75% responding to Sebivo and 67% to lamivudine.
Maltese: Wara sena ta' kura, Sebivo kien aktar effettiv minn lamividine f'pazjenti pożittivi b'HBeAg, b'75% jirrispondu għal Sebivo u 67% għal lamivudine.
English: What is the risk associated with Sebivo?
Maltese: X'inhu r-riskju assoċjat ma' Sebivo?
English: The results were also calculated separately between ‘HBeAg-positive' patients (infected with the common hepatitis B virus) and ‘HBeAg-negative' patients (infected with a virus that has mutated, leading to a form of chronic hepatitis B that is more difficult to treat).
Maltese: Ir-riżultati kienu kkalkulati wkoll separatament bejn il-pazjenti ‘HBeAg pożittivi' (dawk infettati bil-virus komuni ta' l-epatite B) u l-pazjenti ‘HBeAg negattivi' (dawk infettati b'virus li nbidel, li wassal għal forma ta' epatite B kronika li hija aktar diffiċli biex tiġi kkurata).
English: Sebivo must not be used in combination with pegylated or standard interferon alfa (other medicines used in the treatment of hepatitis).
Maltese: Sebivo ma għandux jintuża flimkien ma' pegilat jew interferon alfa standard (mediċini oħrajn użati għall-kura tal-epatite).
English: Treatment with Sebivo should be started by a doctor who has experience in the management of chronic hepatitis B. The recommended dose of Sebivo is 600 mg (one tablet) once a day.
Maltese: Id-doża tal-bidu rakkomandata ta' Sebivo hija ta' 600 mg (pillola waħda) darba kuljum.
English: Sebivo is used to treat adults with chronic (long-term) hepatitis B, a disease of the liver caused by infection with the hepatitis B virus.
Maltese: Sebivo jintuża fit-trattament ta' pazjenti adulti bl-epatite B kronika (fuq tul ta' żmien) (marda tal-fwied ikkawżata minn vajrus tal-epatite B).
English: How has Sebivo been studied?
Maltese: Kif ġie studjat Sebivo?
English: It is used in patients who have compensated liver disease (when the liver is damaged but is still able to work normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised liver enzymes in the blood or signs of damage when liver tissue is examined under a microscope).
Maltese: Jintuża f'pazjenti li jkollhom mard tal-fwied kompensat (meta lfwied ikollu l-ħsara iżda jibqa' jaħdem normali), li juru wkoll sinjali li l-vajrus ikun għadu qed jimmultiplika, u li jkollhom sinjali ta' ħsara fil-fwied (livelli għoljin ħafna ta' enzimi għoljin tal-fwied fiddemm jew sinjali ta' ħsara meta t-tessut tal-fwied jiġi eżaminat taħt il-mikroskopju).
English: A change of treatment should be considered if viral DNA is found.
Maltese: Għandha tiġi kkunsidrata bidla fil-kura jekk ma jinstabx DNA virali.
English: A response was defined as low levels of viral DNA in the blood, together with either the levels of a liver enzyme called alanine aminotransferase (ALT) returning to normal or the marker for the hepatitis B virus disappearing from the blood.
Maltese: Ġie definit firspons bħala livelli baxxi ta' DNA virali fid-demm, flimkiem ma' jew il-livelli ta' enzimi tal-fwied imsejħa alanine aminotransferase (ALT) li jiġu lura għan-normal jew il-market tal-vajrus tal-epatite B li jisparixxi mid-demm.
English: Because creatine phosphokinase is an enzyme that is raised when muscles are damaged, doctors need to monitor all muscle-related side effects closely.
Maltese: Minħabba li creatine phosphokinase hija enzima li togħla meta jkun hemm ħsara fil-muskoli, it-tobba jridu jimmonitorjaw l-effetti sekondarji kollha li huma relatati mal-muskoli.
English: Patients with kidney problems should be closely monitored.
Maltese: Pazjenti bi problem tal-kliewi għandhom jiġu mmonitorjati sikwit.
English: Telbivudine interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Maltese: Ittelbivudina tinterferixxi mal-azzjoni ta' enzima virali msejħa DNA polimerażi, li għandha x'taqsam malformazzjoni ta' DNA virali.
English: The CHMP decided that Sebivo's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Sebivo huma akbar mir-riskji tiegħu u rrikkomanda li jingħata awtorizzazzjoni biex jitpoġġa fuq is-suq.
English: Number
Maltese: Numbru
English: Packaging
Maltese: Ipakkjar
English: Content Package size Withdrawal period
Maltese: Daqs tal-pakett Perjodu ta'tiżmim
English: Route of administration
Maltese: Metodu ta'amministrazz joni
English: […] Paediatric population
Maltese: […] Popolazzjoni pedjatrika
English: Adverse reactions known to be associated with anticholinergic therapy, such as oxybutynin, are anorexia, vomiting, reflux oesophagitis, decreased sweating, heat stroke, decreased lacrimation, mydriasis, tachycardia, arrhythmia, disorientation, poor ability to concentrate, fatigue, nightmares, restlessness, convulsion, intraocular hypertension and induction of glaucoma, confusion, anxiety, paranoia, hallucination, photosensitivity, erectile dysfunction.
Maltese: Reazzjonijiet avversi magħrufa li huma assoċjati mat-terapija antikolinerġika, bħal oxybutynin, huma anoressja, rimettar, esofaġite ta' rifluss, nuqqas ta' għaraq, kolp ta' sħana, nuqqas tad-dmugħ, midrijasi, takikardija, arritmija, diżorjentazzjoni, kapaċità batuta biex tikkonċentra, għejja, inkubi, irrekwitezza, konvulżjoni, pressjoni għolja intraokulari u induzzjoni ta' glawkoma, konfużjoni, ansjetà, paranojja, alluċinazzjoni, fotosensittività, disfunzjoni erettili.
English: KENTERA (oxybutynin) - Psychiatric disorders (EPITT no
Maltese: KENTERA (oxybutynin) - Disturbi psikjatriċi (EPITT nru
English: Anxiety, confusion, nervousness, agitation, insomnia
Maltese: Ansjetà, konfużjoni, nervożiżmu, aġitazzjoni, insomnija
English: Frequencies are defined as: 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).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (>1/100 sa <1/10), mhux komuni (>1/1,000 sa <1/100), rari (>1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Adopted at the 11-14 January 2016 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-11-14 ta' Ottubru 2016
English: […] Tabulated list of adverse reactions
Maltese: […] Lista f'tabella tar-reazzjonijiet avversi
English: Memory impairment#, amnesia#, lethargy#, disturbance in attention#
Maltese: Indeboliment tal-memorja#, amnesija#, letarġija#, disturbi fl-attenzjoni#
English: Rare side effects: - panic reaction - mental confusion - hallucinations - disorientation - memory impairment - loss of memory - abnormal tiredness
Maltese: Effetti sekondarji rari: - reazzjoni ta' paniku - konfużjoni mentali - alluċinazzjonijiet - diżorjentament - indeboliment tal-memorja - telf ta' memorja - għejja mhux normali - konċentrazzjoni batuta
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: # post-marketing adverse reactions from post-marketing reports only (not seen in clinical trials), with the frequency category estimated from clinical trial safety data, and reported in association with oxybutynin topical use (anticholinergic class effects).
Maltese: # reazzjonijiet avversi ta' wara t-tqegħid fis-suq minn rapporti ta' wara t-tqegħid fis-suq biss (li ma dehrux fil-provi kliniċi), bil-kategorija ta' frekwenza stmata mid-data ta' sikurezza tal-prova klinika, u rrapportati flimkien ma' użu topiku ta' oxybutynin (effetti tal-klassi antikolinerġika).
English: Adverse reactions from phase 3 and 4 clinical studies are listed below by system organ class and frequency grouping.
Maltese: Reazzjonijiet avversi minn studji kliniċi ta' fażi 3 u 4 huma elenkati hawn taħt skont is-sistema talklassifika tal-organi u l-grupp ta' frekwenza.
English: Currently available data are described in section 4.8 but no recommendation on a posology can be made.
Maltese: Data disponibbli bħalissa hi deskritta f'sezzjoni 4.8, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar il-pożoloġija.
English: Applicable to all formulations: Kentera 3.9 mg / 24 hours transdermal patch, Kentera 90.7 mg/g gel in sachet and Kentera 90.7 mg/g gel in a metering pump
Maltese: Kentera 3.9 mg / roqgħa transdermali għal 24 siegħa, Kentera 90.7 mg/g ġell f'qartas u Kentera 90.7 mg/g ġell f'pompa tal-kejl
English: Panic reaction#, delirium#, hallucinations#, disorientation#
Maltese: Reazzjoni ta' paniku#, delirju#, alluċinazzjonijiet#, diżorjentazzjoni#
English: […] Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics.
Maltese: […] Kentera għandu jintuża b'kawtela f'pazjenti anzjani, li jistgħu jkunu aktar sensittivi għall-effetti ta' antikolinerġiċi li jaġixxu ċentralment u juru differenzi fil-farmakokinetiċi.
English: Kentera is not recommended for use in the paediatric population.
Maltese: Kentera mhux rakkomandat għall-użu fil-popolazzjoni pedjatrika.
English: Psychiatric and CNS anticholinergic events like sleep disorders (e.g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients.
Maltese: Episodji psikjatriċi u CNS antikolinerġiċi bħal disturbi fl-irqad (eż. insomnija) u disturbi konjittivi ġew assoċjati mal-użu ta' oxybutynin, speċjalment f'pazjenti anzjani.
English: Applicable to Kentera 3.9 mg / 24 hours transdermal patch only
Maltese: Applikabbli għal Kentera 3.9 mg / roqgħa transdermali għal 24 siegħa biss
English: 90.7 mg/g gel in sachet and Kentera 90.7 mg/g gel in a metering pump 4.2 Posology and method of administration […] Elderly population
Maltese: 24 siegħa, Kentera 90.7 mg/g ġell f'qartas u Kentera 90.7 mg/g ġell f'pompa tal-kejl 4.2.
English: Children may be more sensitive to the effects of the product, particularly the CNS and psychiatric adverse reactions.
Maltese: It-tfal jistgħu jkunu aktar sensittivi għall-effetti tal-prodott, b'mod partikolari s-CNS u reazzjonijiet avversi psikjatriċi.
English: Caution should be exercised when oxybutynin is administrated concomitantly with other anticholinergic medicines (see also section 4.5).
Maltese: Għandha tintuża kawtela meta oxybutynin jingħata flimkien ma' mediċini antikolinerġiċi oħra (ara wkoll sezzjoni 4.5).
English: Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics (see section 4.4).
Maltese: Kentera għandu jintuża b'kawtela f'pazjenti anzjani, li jistgħu jkunu aktar sensittivi għall-effetti ta' antikolinerġiċi li jaġixxu ċentralment u juru differenzi fil-farmakokinetiċi (ara sezzjoni 4.4).
English: The safety and efficacy of Kentera in the paediatric population has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Kentera fil-popolazzjoni pedjatrika ma ġewx determinati s'issa.
English: Other psychiatric events implying an anticholinergic mechanism have been reported during postmarketing use (see section 4.8).
Maltese: Avvenimenti psikjatriċi oħrajn li jimplikaw mekkaniżmu antikolinerġiku ġew irrapportati waqt l-użu wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: - anxiety - confusion - nervousness - agitation - difficulty in sleeping
Maltese: - ansjetà - konfużjoni - nervi - aġitazzjoni - diffikultajiet biex torqod
English: There is no dose adjustment necessary in this population.
Maltese: It-test attwali li għandu jitħassar huwa maqtugħ.
English: Campoverde di Aprilia (LT) ITALY
Maltese: Campoverde di Aprilia (LT) L-ITALJA
English: Tuberculosis
Maltese: Tuberkolożi
English: Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Maltese: Infezzjonijiet attivi klinikament importanti (eż. tuberkulożi attiva, ara sezzjoni 4.4).
English: • if you have tuberculosis (TB).
Maltese: • jekk għandek tuberkulożi (TB).
English: RZB = risankizumab UST = ustekinumab PBO = placebo p<0.001 at each time point
Maltese: RZB = risankizumab UST = ustekinumab PBO = plaċebo p<0.001 f'kull punt ta' żmien
English: There is limited information in subjects aged ≥65 years.
Maltese: Hemm informazzjoni limitata f'individwi ta' età ≥65 sena.
English: IMMVENT enrolled 605 subjects (301 randomised to risankizumab and 304 to adalimumab).
Maltese: IMMVENT irreġistra 605 individwi (301 randomizzati għal risankizumab u 304 għal adalimumab).
English: Concomitant immunosuppressive therapy or phototherapy
Maltese: Terapija immunosoppressiva konkomitanti jew fototerapija
English: • Repeat Steps 2 through 6 with the second syringe
Maltese: • Irrepeti Passi 2 sa 6 bit-tieni siringa
English: Excipients: disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 and water for injections.
Maltese: Eċċipjenti: disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 u ilma għallinjezzjonijiet.
English: Date of first authorisation: 26 April 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 26 ta' April 2019
English: 148, Pontina Km 52 snc
Maltese: AbbVie S.r.l. 148, Pontina Km 52 snc
English: Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, onychomycosis Includes: headache, tension headache, sinus headache Includes: fatigue, asthenia Includes: injection site bruising, erythema, haematoma, haemorrhage, irritation, pain, pruritus, reaction, swelling
Maltese: Tinkludi: infezzjoni fl-apparat respiratorju (virali, batterjali jew mhux speċifikata), sinusite (inkluż akuta), rinite, nażofarinġite, farinġite (inkluż virali), tonsillite Tinkludi: tinea pedis, tinea cruris, ħżieża tal-ġisem, tinea versicolor, tinea manuum, onikomikożi Tinkludi: uġigħ ta' ras, uġigħ ta' ras minħabba tensjoni, uġigħ ta' ras minħabba sinus Tinkludi: għeja, astenija Tinkludi: tbenġil fis-sit tal-injezzjoni, eritema, ematoma, emorraġija, irritazzjoni, uġigħ, pruritu, reazzjoni, nefħa
English: DLQI 0 or 1
Maltese: DLQI 0 jew 1
English: ULTIMMA-1 and ULTIMMA-2 enrolled 997 subjects (598 randomised to risankizumab 150 mg, 199 to ustekinumab 45 mg or 90 mg [according to baseline weight], and 200 to placebo).
Maltese: ULTIMMA-1 u ULTIMMA-2 irreġistraw 997 individwu (598 randomizzati għal risankizumab 150 mg, 199 għal ustekinumab 45 mg jew 90 mg [skont il-piż fil-linja bażi], u 200 għall-plaċebo).
English: The same information is also available at the following URL: www.skyrizi.eu
Maltese: L-istess informazzjoni hija disponibbli wkoll fil-URL li ġej: www.skyrizi.eu
English: STEP 8
Maltese: PASS 8
English: Skyrizi 75 mg injection risankizumab SC
Maltese: Skyrizi 75 mg injezzjoni risankizumab SC
English: This is normal
Maltese: Dan huwa normali
English: ULTIMMA-1 and ULTIMMA-2
Maltese: ULTIMMA-1 u ULTIMMA-2
English: Ltd Τηλ: +357 22 34 74 40
Maltese: Lifepharma (Z.A.M.) Ltd Τηλ: +357 22 34 74 40
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC18
Maltese: Immunosoppressanti, inibituri ta' interleukin, Kodiċi ATC:
English: Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system organ class and are based on 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); and very rare (< 1/10,000).
Maltese: Ir-reazzjonijiet avversi għal risankizumab mill-istudji kliniċi (Tabella 1) huma elenkati skont issistema tal-klassifika tal-organi MedDRA u huma bbażati fuq il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); u rari ħafna (< 1/10,000).
English: 2D barcode carrying the unique identifier included.
Maltese: barcode 2D li jkollu l-identifikatur uniku inklu.
English: The efficacy and safety of risankizumab was assessed in 2,109 subjects with moderate to severe plaque psoriasis in four multicentre, randomised, double-blind studies (ULTIMMA-1, ULTIMMA-2, IMMHANCE, and IMMVENT).
Maltese: L-effikaċja u s-sigurtà ta' risankizumab ġiet ivvalutata f'2,109 individwi bi psorjażi bil-qoxra moderata sa severa f'erba' studji multiċentriċi, randomizzati, double-blind (ULTIMMA-1, ULTIMMA-2, IMMHANCE, u IMMVENT).
English: • PASI 90 continued to receive adalimumab
Maltese: • PASI 90 komplew jirċievu adalimumab
English: See leaflet for further information
Maltese: Sorsi oħra ta᾽ informazzjoni
English: • <PASI 50 were switched to risankizumab
Maltese: • <PASI 50 nqalbu għal risankizumab
English: - The active substance is risankizumab.
Maltese: - Is-sustanza attiva hi risankizumab.
English: Baseline sPGA score was severe in 19.3% of subjects and moderate in 80.7% of subjects.
Maltese: Punteġġ sPGA fil-linja bażi kien sever fi 19.3 % tal-individwi u moderat fi 80.7% tal-individwi.
English: STEP 1
Maltese: PASS 1
English: For subjects treated with risankizumab at the recommended clinical dose for up to 52 weeks in psoriasis clinical trials, treatment-emergent anti-drug antibodies and neutralising antibodies were detected in 24% (263/1,079) and 14% (150/1,079) of evaluated subjects, respectively.
Maltese: Għal individwi kkurati b'risankizumab bid-doża klinika rakkomandata sa 52 ġimgħa fil-provi kliniċi tal-psorjażi, ġew identifikati antikorpi kontra l-mediċina li dehru mill-kura u antikorpi newtralizzanti f'24 % (263/1,079) u f'14 % (150/1,079) tal-individwi evalwati, rispettivament.
English: The exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate) and midazolam (CYP3A substrate) following risankizumab treatment were comparable to their exposures prior to risankizumab treatment, indicating no clinically meaningful drug interactions through these enzymes.
Maltese: L-esponiment tal-kaffeina (substrat ta' CYP1A2), warfarin (substrat ta' CYP2C9), omeprazole (substrat ta' CYP2C19), metoprolol (substrat ta' CYP2D6) u midazolam (substrat ta' CYP3A) wara kura b'risankizumab kien komparabbli għall-esponiment tagħhom qabel kura b'risankizumab, li ma jindika l-ebda interazzjoni mediċinali klinikament sinifikanti minn dawn lenzimi.
English: Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Str. 65
Maltese: Boehringer Ingelheim Pharma GmbH & Co.
English: STEP 5
Maltese: PASS 5
English: IMMHANCE Risankizumab Placebo Risankizumab Placebo Risankizumab Placebo
Maltese: IMMHANCE Risankizumab Plaċebo Risankizumab Plaċebo Risankizumab Plaċebo
English: IMMHANCE enrolled 507 subjects (407 randomised to risankizumab 150 mg and 100 to placebo).
Maltese: IMMHANCE rreġistra 507 individwi (407 randomizzati għal risankizumab 150 mg u 100 għallplaċebo).
English: • fungal skin infection
Maltese: • infezzjoni tal-ġilda fungali
English: Skyrizi contains sorbitol and sodium This medicine contains 68 mg sorbitol per 150 mg dose.
Maltese: Skyrizi fih sorbitol u sodium Din il-mediċina fiha 68 mg sorbitol għal kull doża ta' 150 mg.
English: Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody selective to the interleukin (IL)-23 protein produced in Chinese Hamster Ovary cells using recombinant DNA technology.
Maltese: Risankizumab huwa antikorp monoklonali ta' immunoglobina umanizzata G1 (IgG1) selettiv għallproteina interleukin (IL)-23 prodotta f'ċelluli tal-Ovarju tal-Ħamster Ċiniż permezz ta' teknoloġija ta' DNA rikombinanti.
English: The safety and efficacy of risankizumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Maltese: Is-sigurtà u l-effikaċja ta' risankizumab flimkien mal-immunosoppressanti, inkluż bijoloġiċi jew fototerapija ma ġewx evalwati.
English: - The other ingredients are disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate
Maltese: - Is-sustanzi mhux attivi l-oħra huma disodium succinate hexahydrate, succinic acid, sorbitol,
English: As with all therapeutic proteins, there is the potential for immunogenicity with risankizumab.
Maltese: Bħal kull proteina terapewtika, hemm potenzjal għall-immunoġeniċità b'risankizumab.
English: Across all studies, 30.9% of subjects were naïve to any systemic therapy (including non-biologic and biologic), 38.1% had received prior phototherapy or photochemotherapy, 48.3% had received prior non-biologic systemic therapy, 42.1% had received prior biologic therapy, and 23.7% had received at least one anti-TNF alpha agent for the treatment of psoriasis.
Maltese: Fl-istudji kollha, 30.9 % tal-individwi ma rċivew ebda terapija sistemika (inkluż mhux bijoloġika jew bijoloġika), 38.1 % kienu rċivew fototerapija jew fotokemoterapija preċedenti, 48.3 % kienu rċivew terapija sistemika mhux-bijoloġika preċedenti, 42.1 % kienu rċivew terapija bijoloġika preċedenti, u 23.7 % kienu rċivew tal-inqas aġent wieħed alfa kontra TNF għall-kura tal-psorjażi.
English: At week 16, risankizumab was superior to placebo on the co-primary endpoints of sPGA of clear or almost clear (83.5% risankizumab vs 7.0% placebo) and PASI 90 (73.2% risankizumab vs 2.0% placebo).
Maltese: F'ġimgħa 16, risankizumab kienu superjuri għall-plaċebo fuq l-end-points koprimarji ta' sPGA ta' xejn jew kważi xejn (83.5% risankizumab vs 7.0% plaċebo) u PASI 90 (73.2% risankizumab vs 2.0% plaċebo).