FrancophonIA/ELRC3.0 huggingface dataset:
English: Symtuza contains four active substances which work in different ways against HIV:
Maltese: Symtuza fih erba' sustanzi attivi li jaħdmu b'modi differenti kontra l-HIV:
English: How does Symtuza work?
Maltese: Kif jintuża Symtuza?
English: • Tenofovir alafenamide is a ‘prodrug' of tenofovir, meaning that it is converted into the active substance tenofovir in the body.
Maltese: • It-tenofovir alafenamid hija “promediċina” tat-tenofovir, li jfisser li tiġi kkonvertita fis-sustanza attiva tenofovir fil-ġisem.
English: In addition, one main study compared Symtuza with another antiviral medicine containing darunavir, cobicistat, emtricitabine and tenofovir disoproxil in 153 adult patients with HIV who had not been previously treated.
Maltese: Barra minn hekk, studju ewlieni wieħed qabbel Symtuza ma' mediċina antivirali oħra li fiha ddarunavir, il-kobiċistat, l-emtriċitabina u t-tenofovir disoproksil f'153 pazjent adult bl-HIV li ma ġewx ikkurati preċedentement.
English: As for all medicines, data on the use of Symtuza are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Symtuza hija ssorveljata kontinwament.
English: By blocking protease, Symtuza reduces the amount of HIV-1 in the blood and keeps it at a low level.
Maltese: Billi jimblokka protease, Symtuza jnaqqas l-ammont ta' HIV-1 fid-demm u jżommu f'livell baxx.
English: • Emtricitabine is also a reverse transcriptase inhibitor and it works in the same way as tenofovir.
Maltese: • L-emtriċitabina hija inibitur tat-transkriptażi inversa u dan jaħdem bl-istess mod bħat-tenofovir.
English: Tenofovir is a reverse transcriptase inhibitor, which means that it blocks the activity of the enzyme, reverse transcriptase, that the virus needs to reproduce itself.
Maltese: It-tenofovir hija inibitur tat-transkriptażi inversa, li jfisser li dan jimblokka l-attività tal-enzima, it-transkriptażi inversa, li l-virus jeħtieġ biex jirriproduċi lilu nnifsu.
English: Because the individual active substances of Symtuza have previously been shown to be effective and are authorised for use in the treatment of HIV infection, studies were mainly carried out to show that Symtuza produced similar levels of active substances in the blood as the active substances given separately.
Maltese: Minħabba li s-sustanzi attivi individwali ta' Symtuza preċedentement intwerew li huma effettivi u huma awtorizzati għall-użu fil-kura ta' infezzjoni tal-HIV, l-istudji saru prinċipalment biex juru li Symtuza jipproduċi livelli simili ta' sustanzi attivi fid-demm bħas-sustanzi attivi mogħtija separatament.
English: How is Symtuza used?
Maltese: Symtuza?
English: For the full list of side effects reported with Symtuza, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Symtuza, ara lfuljett ta' tagħrif.
English: Symtuza does not cure HIV-1 infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Symtuza ma jikkurax l-infezzjoni tal-HIV-1 jew l-AIDS, iżda jista' jittardja l-ħsara li ssir lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: Symtuza was also as effective as a similar combination medicine containing tenofovir disoproxil in place of tenofovir alafenamide.
Maltese: Symtuza kien effettiv ukoll daqs kombinazzjoni ta' mediċina simili li fiha t-tenofovir disoproksil minflok it-tenofovir alafenamid. Peress li t-tenofovir alafenamid hija effettiva f'doża iktar baxxa mit-tenofovir disoproksil, Symtuza joffri l-possibbiltà ta' effetti sekondarji mnaqqsa.
English: Side effects reported with Symtuza are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Symtuza huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: • Cobicistat acts as a ‘booster' to increase the effects of darunavir, by slowing down the breakdown of darunavir and therefore prolonging its antiviral activity in the body.
Maltese: • Il-kobiċistat taġixxi bħala “booster” biex iżżid l-effetti tad-darunavir, billi ddewwem it-tkissir taddarunavir u b'hekk ittawwal l-attività antivirali tagħha fil-ġisem.
English: Further information on Coagadex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Factor X deficiency is rare and Coagadex was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 September 2007.
Maltese: Id-defiċjenza tal-fattur X hija rari u Coagadex kien ikklassifikat bħala ‘mediċina orfni' (mediċina użata f'mard rari) fl-14 ta' Settembru 2007.
English: Coagadex (human coagulation factor X)
Maltese: Coagadex (fattur X ta' koagulazzjoni tal-bniedem)
English: Coagadex has been investigated in one main study involving 16 patients with hereditary factor X deficiency aged 12 to 58 years.
Maltese: Coagadex ġie investigat fi studju ewlieni wieħed li jinvolvi 16-il pazjent b'defiċjenza ereditarja tal-fattur X fl-etajiet ta' 12-il sena sa 58 sena.
English: Other information about Coagadex
Maltese: Informazzjoni oħra dwar Coagadex
English: Coagadex received a marketing authorisation valid throughout the EU on 16 March 2016.
Maltese: Coagadex ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Marzu 2016.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation Coagadex contains the active substance human coagulation factor X.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: For the treatment of bleeding, 187 bleeding episodes were recorded and assessed, and treatment with Coagadex was rated as ‘excellent' or ‘good' for 98.4% of bleeding episodes.
Maltese: Għall-kura ta' fsada, ġew irreġistrati u vvalutati 187 episodju ta' fsada, u l-kura b'Coagadex ġiet ikklassifikata bħala ‘eċċellenti' jew ‘tajba' għal 98.4% tal-episodji ta' fsada.
English: In a study with 9 children aged less than 12 years (4 of whom were under4 years of age), a routine preventive treatment with Coagadex over 6 months was rated as excellent in reducing or preventing bleeding episodes.
Maltese: Fi studju b'9 itfal taħt it-12-il sena (4 minnhom taħt l-4 snin), kura preventiva ta' rutina b'Coagadex għal aktar minn 6 xhur ġiet ikklassifikata bħala eċċellenti fit-tnaqqis jew fil-prevenzjoni ta' episodji ta' fsada.
English: The side effects of Coagadex were considered manageable and of mild or moderate intensity.
Maltese: L-effetti sekondarji ta' Coagadex kienu kkunsidrati maniġevoli u ta' intensità ħafifa jew moderata.
English: Factor X deficiency is a bleeding disorder caused by lack of factor X, a protein needed for normal clotting of the blood.
Maltese: Id-defiċjenza tal-fattur X hija disturb ta' fsada kkawżat minn nuqqas tal-fattur X, proteina meħtieġa għal koagulazzjoni normali tad-demm.
English: Coagadex is a medicine used for the treatment and prevention of bleeding (including during and after an operation) in patients with hereditary factor X deficiency.
Maltese: Coagadex huwa mediċina użata għall-kura u l-prevenzjoni ta' fsada (inkluż waqt u wara operazzjoni) f'pazjenti b'defiċjenza ereditarja tal-fattur X.
English: The Agency considered the lack of specific therapies for factor X deficiency, and concluded that Coagadex was effective at treating and preventing bleeding in patients with the condition.
Maltese: L-Aġenzija kkunsidrat in-nuqqas ta' terapiji speċifiċi għaddefiċjenza tal-fattur X, u kkonkludiet li Coagadex kien effettiv fil-kura u fil-prevenzjoni ta' fsada f'pazjenti bil-kondizzjoni.
English: How does Coagadex work?
Maltese: Coagadex?
English: As for all medicines, data on the use of Coagadex are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Coagadex hija ssorveljata kontinwament.
English: In total, 10 bleeds were reported in the study, of which 4 were treated with Coagadex.
Maltese: B'kollox, ġew irrappurtati 10 fsadiet, li minnhom 4 ġew ikkurati b'Coagadex.
English: The most common side effects with Coagadex (which may affect up to 1 in 10 people) are pain or redness at the injection site, fatigue (tiredness), and back pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Coagadex (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma uġigħ jew ħmura fis-sit tal-injezzjoni, għejja, u uġigħ fid-dahar.
English: For the full list of side effects and restrictions with Coagadex, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Coagadex, ara l-fuljett ta' tagħrif.
English: Patients with hereditary factor X deficiency lack factor X, a protein needed to form the blood clot that stops wounds from bleeding.
Maltese: Pazjenti b'defiċjenza ereditarja tal-fattur X għandhom nuqqas tal-fattur X, proteina meħtieġa sabiex tifforma emboli tad-demm li jipprevjenu l-fsada tal-ġrieħi.
English: These reactions have not been reported during clinical studies with Coagadex.
Maltese: Dawn ir-reazzjonijiet ma ġewx irrappurtati waqt studji kliniċi b'Coagadex.
English: The active substance in Coagadex is human factor X isolated from the plasma of blood donors.
Maltese: Is-sustanza attiva f'Coagadex hija l-fattur X tal-bniedem iżolat mill-plażma tad-donaturi tad-demm.
English: What are the risks associated with Coagadex?
Maltese: X'inhuma r-riskji assoċjati ma' Coagadex?
English: The main measure of effectiveness was based on the doctor's and patient's assessment of how well the treatment worked in preventing and treating bleeding episodes.
Maltese: Għal tliet kirurġiji waqt listudju, Coagadex ġie kklassifikat bħala eċċellenti fil-prevenzjoni ta' episodji ta' fsada.
English: Hypersensitivity (allergic) reactions can occur rarely in patients treated for bleeding disorders (in up to 1 patient in 1,000) and can be severe in some cases.
Maltese: Reazzjonijiet ipersensittivi (allerġiċi) jistgħu jseħħu rarament f'pazjenti kkurati għal disturbi ta' fsada (sa pazjent 1 minn 1000) u f'xi każijiet jistgħu jkunu severi.
English: Patients received Coagadex either to treat any spontaneous bleeding during the treatment period or to prevent bleeding during surgery.
Maltese: Il-pazjenti rċevew Coagadex għall-kura ta' kwalunkwe fsada spontanja waqt il-perjodu ta' kura jew għall-prevenzjoni ta' fsada waqt il-kirurġija.
English: However, given the extreme rarity of the condition, the safety database is small and rare events are not expected to be captured during the clinical studies.
Maltese: Madankollu, minħabba r-rarità kbira tal-kondizzjoni, il-bażi tad-data tas-sigurtà hija żgħira u mhumiex mistennija li jinqabdu avvenimenti rari waqt l-istudji kliniċi.
English: Coagadex can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in the treatment of rare bleeding disorders.
Maltese: Coagadex jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda taħt superviżjoni ta' tabib esperjenzat fil-kura ta' disturbi ta' fsada rari.
English: EU Number
Maltese: Numru ta' l-EU Isem inventat
English: It is available as light green oval tablets (30, 60 or 90 mg).
Maltese: Huwa disponibbli f'pilloli ovali aħdar ċar (30, 60 u 90 mg).
English: This summary was last updated in 06-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 06-2008.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PARAREG EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) PARAREG Sommarju ta' l-EPAR għall-pubbliku
English: • to treat secondary hyperparathyroidism.
Maltese: • biex jittratta iperparatirojdiżmu sekondarju.
English: Parareg was compared with placebo (a dummy treatment).
Maltese: Parareg tqabbel ma' plaċebo (trattament finta).
English: Parareg is a medicine containing the active substance cinacalcet.
Maltese: Parareg huwa mediċina li fiha s-sustanza attiva cinacalcet.
English: The active substance in Parareg, cinacalcet, is a calcimimetic agent.
Maltese: Is-sustanza attiva f'Parareg, cinacalcet, hija aġent kalċimimetiku.
English: Parareg produced a decrease in blood calcium of more than 1 mg/dl in 62% of the cancer patients (18 out of 29) and in 88% of the patients with primary hyperparathyroidism(15 out of 17).
Maltese: Parareg irriżulta fi tnaqqis tal-kalċju fid-demm ta' aktar minn 1 mg/dl fi 62% tal-pazjenti bil-kanċer (18 minn 29) u 88% tal-pazjenti b'iperparatirojdiżmu primarju (15 minn 17).
English: Parareg is used in adults and elderly patients:
Maltese: Parareg jintuża f'pazjenti adulti u anzjani:
English: The marketing authorisation holder is Dompé Biotec S.p.A.
Maltese: Id-detentur ta' l-awtorizzazzjoni għat-tqegħid fis-suq huwa Dompé Biotec S.p.A.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni relatata mar-rakkomandazzjonijiet ta' CHMP, aqra dDiskussjoni Xjentifika (ukoll parti mill-EPAR).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Parareg's benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Parareg huma akbar mir-riskji għat-trattament ta' iperparatirojdiżmu sekondarju f'pazjenti b'mard renali avvanzat li huma għaddejjin minn terapija ta' dijaliżi ta' manutenzjoni, u għat-tnaqqis ta' iperkalċemija f'pazjenti b'karċinoma tal-paratirojde jew iperparatirojdiżmu primarju li għalihom paratirojdektomija tkun indikata skond il-livelli tal-kalċju fis-serum iżda li dan il-proċess ma jkunx klinikament xieraq għalihom jew ikun kontraindikat.
English: In dialysis patients with serious kidney disease, about 40% of the patients taking Parareg had PTH levels below 250 micrograms/l at the end of the study, compared with about 6% of those taking placebo.
Maltese: Fil-pazjenti b'mardiet serji tal-kliewi li kienu fuq dijaliżi, madwar 40% tal-pazjenti li kienu qed jieħdu Parareg kellhom livelli tal-PTH inqas minn 250 mikrogrammi/l fi tmiem l-istudju, meta tqabblu ma' madwar 6 % ta' dawk li kienu qegħdin jieħdu plaċebo.
English: In secondary hyperparathyroidism, the recommended starting dose for adults is 30 mg once a day.
Maltese: Fl-iperparatirojdiżmu sekondarju, id-doża tal-bidu rakkomandata għall-adulti hi ta' 30 mg darba kuljum.
English: Parareg has been studied in three main studies involving 1,136 dialysis patients with serious kidney disease.
Maltese: Parareg ġie studjat fi tliet studji ewlenin li fihom ħadu sehem 1,136 pazjent b'mard serju tal-kliewi li kienu fuq dijaliżi.
English: Why has Parareg been approved?
Maltese: Għaliex ġie approvat Parareg?
English: It can be used as part of treatment including phosphate binders or vitamin D sterols.
Maltese: Jista' jintuża bħala parti mit-trattament li jinkludi binders tal-fosfat (phosphate binders) jew l-isterols tal-vitamina D.
English: Parareg brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.
Maltese: Parareg wera tnaqqis ta' madwar 42% fil-livelli tal-PTH meta mqabbel ma' żieda ta' 8% f'pazjenti li ħadu plaċebo.
English: How has Parareg been studied?
Maltese: Kif ġie studjat Parareg?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Parareg on 22 October 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Parareg fit-22 ta' Ottubru 2004.
English: Parareg has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
Maltese: Parareg ġie studjat ukoll fi studju li kien jinvolvi 46 pazjent b'iperkalċemija, li 29 minnhom kellhom karċinoma tal-paratirojde u 17 kellhom iperparatirojdiżmu primarju li ma setgħux ikollhom il-glandoli tal-paratirojde mneħħija jew li kirurġija għat-tneħħija ta' dawn il-glandoli ma kenitx effettiva.
English: What is Parareg?
Maltese: Kif jaħdem Parareg?
English: In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Parareg for adults is 30 mg twice a day.
Maltese: F'pazjenti bil-karċinoma tal-paratirojde jew iperparatirojdiżmu primarju, id-doża inizjali rakkomandata ta' Parareg għall-adulti hi ta' 30 mg darbtejn kuljum.
English: The most common side effects with Parareg in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Parareg f'iperparatirojdiżmu sekondarju (li dehru f'aktar minn pazjent 1 minn 10) huma nawżea (dardir) u remettar.
English: • to reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands), or in patients with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that removal of the parathyroid glands is not appropriate.
Maltese: • biex inaqqas l-iperkalċemija (livelli għoljin tal-kalċju fid-demm) f'pazjenti li jkollhom karċinoma tal-paratirojde (kanċer tal-glandoli tal-paratirojde), jew f'pazjenti b'iperparatirojdiżmu primarju li ma jkunux jistgħu jneħħu l-glandoli tal-paratirojde jew meta ttabib ikun ta' l-opinjoni li t-tneħħija ta' dawn il-glandoli mhuwiex xieraq.
English: By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands.
Maltese: Iż-żieda minn cinacalcet fis-sensittività ta' dawn ir-riċetturi twassal għat-tnaqqis fil-produzzjoni ta' PTH mill-glandoli tal-paratirojd.
English: Other information about Parareg:
Maltese: Tagħrif ieħor dwar Parareg:
English: A further three studies compared the effectiveness of Parareg and placebo in a total of 136 patients with primary hyperparathyroidism over up to a year.
Maltese: Tliet studji oħra qabblu l-effikaċja ta' Parareg u plaċebo f'total ta' 136 pazjent b'iperparatirojdiżmu primarju għal sena.
English: For the full list of all side effects reported with Parareg, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji irrappurtati f' Parareg, ara l-Fuljett ta' Tagħrif.
English: What is the risk associated with Parareg?
Maltese: X'inhu r-riskju assoċjat ma' Parareg?
English: In patients with parathyroid carcinoma or primary hyperparathyroidism, the side effects are similar to those seen in patients with long-standing kidney disease - the most frequent side effects are nausea and vomiting.
Maltese: Fil-pazjenti b'kanċer tal-paratirojde jew iperparatirojdiżmu primarju, l-effetti sekondarji kienu simili għal dawk ta' pazjenti li kienu ilhom ibatu bil-mard tal-kliewi - l-iktar effetti sekondarji komuni kienu n-nawżea u r-remettar.
English: The dose of Parareg should be increased every two to four weeks up to 90 mg three or four times a day as necessary to reduce blood calcium to normal levels.
Maltese: Id-doża ta' Parareg għandha tiġi miżjuda bejn kull ġimagħtejn u erba' ġimgħat sa 90 mg tlieta jew erba' darbiet kuljum kif meħtieġ biex jonqsu l-livelli tal-kalċju fid-demm għal-livelli normali.
English: The dose is adjusted every two to four weeks, according the patient's PTH levels, up to a maximum of 180 mg once a day.
Maltese: Id-doża tiġi aġġustata bejn kull ġimagħtejn u kull erba' ġimgħat, skond il-livelli ta' PTH talpazjent, sa massimu ta' 180 mg darba kuljum.
English: How is Parareg used?
Maltese: Għal xiex jintuża Parareg?
English: The full EPAR for Parareg is available here.
Maltese: Kif jintuża Parareg?
English: PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Parareg.
Maltese: Il-livelli tal-PTH għandhom jiġu ċċekkjati ta' l-inqas 12il siegħa wara d-doża u bejn ġimgħa u erba' ġimgħat wara kull aġġustament tad-doża ta' Parareg.
English: • The active substance is apremilast.
Maltese: • Is-sustanza attiva hi apremilast.
English: Response Rate +/- SE (%)
Maltese: Rata ta' rispons +/- SE (%)
English: Date of latest renewal: 23 August 2019
Maltese: Data tal-aħħar tiġdid: 23 ta' Awwissu 2019
English: Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg
Maltese: Jum 6 u wara AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg
English: UNIQUE IDENTIFIER - 2D BARCODE 2 D barcode carrying the unique identifier included
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D barcode 2D li jkollu l-identifikatur uniku inkluż
English: croscarmellose sodium and magnesium stearate.
Maltese: croscarmellose sodium u magnesium stearate.
English: • rifampicin - an antibiotic used for tuberculosis
Maltese: • rifampicin - antibijotiku li jintuża kontra t-tuberkulożi
English: • Swallow the tablets whole, preferably with water.
Maltese: • Ibla' l-pilloli sħaħ, preferibbilment mal-ilma.
English: System Organ Class Frequency
Maltese: Sistema tal-Klassifika tal-Organi
English: Day 8 - Day 14
Maltese: Jum 8 - Jum 14
English: • The film-coating contains poly(vinyl alcohol), titanium dioxide (E171), macrogol (3350), talc, iron oxide red (E172).
Maltese: • Il-kisja tar-rita fiha poly(vinyl alcohol), titanium dioxide (E171), - macrogol (3350), talc, iron oxide red (E172).
English: Summary of adverse reactions in psoriatic arthritis (PsA) and/or psoriasis (PSOR)
Maltese: Sommarju ta' reazzjonijiet avversi f'artrite psorjatika (PsA) u/jew psorjasi (PSOR)
English: Clinical response at week 16 in studies ESTEEM 1 and ESTEEM 2 (FAS a, LOCFb) ESTEEM 1
Maltese: Rispons kliniku f'ġimgħa 16 fi studji ESTEEM 1 u ESTEEM 2 (FAS a LOCFb)
English: QR code to be included www.otezla-eu-pil.com
Maltese: Għandu jiġi inkluż il-kodiċi QR www.otezla-eu-pil.com
English: Table 1: Dose titration schedule
Maltese: Tabella 1: Skeda tat-titrazzjoni tad-doża
English: Otezla contains the active substance ‘apremilast'.
Maltese: Otezla fih is-sustanza attiva ‘apremilast'.
English: INFORMATION IN BRAILLE Otezla 10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Otezla 10 mg
English: • The other ingredients in the tablet core are cellulose microcrystalline, lactose monohydrate,
Maltese: • Is-sustanzi l-oħra fil-qalba tal-pillola huma cellulose microcrystalline, lactose monohydrate,
English: Oxidative metabolism of apremilast is primarily mediated by CYP3A4, with minor contributions from CYP1A2 and CYP2A6.
Maltese: Il-metaboliżmu ossidattiv ta' apremilast jiġi medjat primarjament minn CYP3A4, b'kontribuzzjonijiet minuri minn CYP1A2 u CYP2A6.
English: Patients with each subtype of PsA were enrolled in the 3 studies, including symmetric polyarthritis (62.0%), asymmetric oligoarthritis (26.9%), distal interphalangeal (DIP) joint arthritis (6.2%), arthritis mutilans (2.7%), and predominant spondylitis (2.1%).
Maltese: Pazjenti b'kull sottotip ta' PsA ġew irreġistrati fit-3 studji, li kienu jinkludu poliartrite simetrika (62.0%), oligoartrite asimetrika (26.9%), artrite tal-ġogi interfalanġeali distali (DIP (6.2%), artrite mutilans (2.7%), u spondilite predominanti (2.1%).
English: Placebo 30 mg twice daily APR*
Maltese: Plaċebo 30 mg darbtejn kuljum APR*
English: The major circulating inactive metabolite is the glucuronide conjugate of O-demethylated apremilast (M12).
Maltese: Il-metabolit inattiv maġġuri li jiċċirkola hu l-konjugat ta' glucuronide ta' O-demethylated apremilast (M12).
English: 10 mg (pink)
Maltese: 10 mg (roża)
English: Celgene Europe B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Maltese: Celgene Europe B.V. Winthontlaan 6 N 3526 KV Utrecht In-Netherlands