FrancophonIA/ELRC3.0 huggingface dataset:
English: Rheumocam is an anti-inflammatory medicine used in cattle, pigs, horses, dogs and cats.
Maltese: Rheumocam huwa mediċina antiinfjammatorja li tintuża fil-frat, il-majjali, iż-żwiemel, il-klieb u lqtates.
English: How does Rheumocam work?
Maltese: Kif jintuża Rheumocam?
English: What are the benefits and risks of Rheumocam?
Maltese: Kif jaħdem Rheumocam?
English: In horses, Rheumocam is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Maltese: Fiż-żwiemel, Rheumocam jintuża għat-taffija tal-uġigħ assoċjat mal-kolika (uġigħ addominali) u għattaffija tal-infjammazzjoni u tal-uġigħ f'disturbi muskoluskeletali akuti u kroniċi (disturbi li jaffettwaw ilmuskoli u l-għadam).
English: This summary was last updated in: 04-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 04-2013.
English: It is available in three pack sizes; 20 ml, 50 ml and 150 ml and supplied with appropriate dosing devices.
Maltese: Hija tiġi f'pakketti fi tliet daqsijiet; 20 ml, 50 ml u 150 ml u tiġi b'tagħmir xieraq għad-dożaġġ.
English: The dogs also received other medicines during the study as required, such as anti-inflammatory drugs (including NSAIDs), antimicrobials, parasiticides, vaccines, dietary supplements, vitamins, hormones and cardiovascular drugs.
Maltese: Il-klieb irċevew mediċini oħra waqt l-istudju kif meħtieġ, bħal mediċini anti-infjammatorji (li jinkludu NSAIDS), mediċini kontra l-mikrobi, mediċini li joqtlu l-parassiti, vaċċini, supplimenti tad-dieta, vitamini, ormoni u mediċini kardjovaskulari.
English: The active substance in Slentrol, dirlotapide, works in the gut by blocking a protein (the microsomal triglyceride transfer protein).
Maltese: Is-sustanza attiva fi Slentrol, dirlotapide, taħdem fl-imsaren billi timblokka proteina (il-proteina li tittrasferixxi t-trigliċeridi mikrosomali).
English: Specific interactions were not investigated.
Maltese: Interazzjonijiet speċifiċi ma ġewx mistħarrġa.
English: Other information about Slentrol:
Maltese: Tagħrif ieħor dwar Slentrol:
English: What is Slentrol?
Maltese: X'inhu Slentrol?
English: Some dogs (less than 10%) experienced repeated vomiting (i.e. more than once every 20 days on average).
Maltese: Xi klieb (inqas minn 10%) kellhom rimettar ripetut (jiġifieri fuq medja ta' aktar minn darba kull 20 jum).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Slentrol on 13.04.2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni tal-kummerċ valida fl-Unjoni Ewropea kollha, għal Slentrol f'13.04.2007.
English: For a full list of all side-effects reported with Slentrol, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrapportati bi Slentrol, ara l-Fuljett ta' Tagħrif.
English: The weight lowering effect was up to 20 % after 6 months of therapy in the initial weight loss phase of treatment.
Maltese: L-effett ta' tnaqqis fil-piż kien sa 60% wara 6 xhur ta' terapija fil-fażi inizjali ta' trattament għat-telf fil-piż.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Slentrol excede the risks for the management of overweight and obesity in adult dogs and recommended that Slentrol be given a marketing authorisation.
Maltese: Il-Kumitat dwar il-Prodotti Mediċinali għal Użu Veterinarju (CVMP) ikkonkluda li s-siwi ta' Slentrol jisboq ir-riskji fil-ġestjoni ta' piż żejjed u ħxuna żejda fi klieb adulti u rrakomanda li Slentrol jingħata l-awtorizzazzjoni tal-kummerċ.
English: This protein is normally involved in the absorption of fats from the diet. By blocking the protein Slentrol decreases the absorption of fats from the gut and this change in fat absorption has an appetite suppressant effect.
Maltese: Meta jimblokka l-proteina Slentrol inaqqas l-assorbiment tax-xaħmijiet millimsaren u din il-bidla fl-assorbiment tax-xaħmijiet għandha l-effett li tnaqqis l-aptit.
English: How has Slentrol been studied?
Maltese: Kif kien studjat Slentrol?
English: What is the risk associated with Slentrol?
Maltese: X'inhu r-riskju assoċjat ma' Slentrol?
English: Slentrol is an oral solution, colourless to pale yellow in colour.
Maltese: Slentrol huwa soluzzjoni orali, mingħajr kulur li tagħti fl-isfar ċar.
English: Slentrol at the recommended dose of 5 mg/ml and using the recommended treatment schedule reduced body weight in obese dogs when compared to the control group.
Maltese: Slentrol fid-doża rakkomandata ta' 5 mg/ml u meta ngħata skond l-iskeda rakkomandata naqqas il-piż tal-ġisem fi klieb ħoxnin ħafna meta mqabbel mal-grupp li ntuża bħala kontroll.
English: Certain medications, e.g. drugs that lower serum cholesterol or other serum lipids, or drugs that affect appetite and/or body weight, e.g. long-acting glucorticoids, were not permitted for use during the study.
Maltese: Ċertu mediċini, eż. mediċini li jbaxxu l-livell ta' kolesterol fis-serum jew il-lipidi fis-serum, jew mediċini li jaffettwaw l-aptit u/jew il-piż korporali, eż. glukortikojdi li jaħdmu fuq perijodu ta' żmien twil ma tħallewx jintużaw waqt l-istudju.
English: Rebound weight gain was seen after treatment was completed.
Maltese: Ilpiż reġa' deher li żdied wara li ntemm it-trattament.
English: What benefit has Slentrol shown during the studies?
Maltese: Għaliex ġie approvat Slentrol?
English: Slentrol contains the active substance dirlotapide which helps to reduce weight in dogs.
Maltese: Slentrol fih is-sustanza attiva dirlotapide li tgħin tnaqqas il-piż fil-klieb.
English: Vomiting, sometimes accompanied by signs of lethargy, diarrhoea or softened faeces may occur during treatment.
Maltese: Rimettar, minn daqqiet akkumpanjat b'sinjali ta' letarġija, dijarrea jew ippurgar maħlul jistgħu jseħħu waqt it-trattament.
English: It is available as capsules (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).
Maltese: Jiġi bħala kapsuli (5 mg; 20 mg; 100 mg; 140 mg; 180 mg; 250 mg).
English: The full EPAR for Temozolomide Accord can be found 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: Temozolomide Accord is a ‘generic medicine'.
Maltese: Temozolomide Accord huwa ‘mediċina ġenerika'.
English: Temozolomide Accord temozolomide
Maltese: Temozolomide Accord temozolomid
English: The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Hospira on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Temozolomide Hospira fil-15 ta' Marzu 2010.
English: This is a summary of the European Public Assessment Report (EPAR) for Temozolomide Accord.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Temozolomide Accord.
English: The dose of Temozolomide Accord depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Maltese: Id-doża ta' Temozolomide Accord tiddependi mill-erja tas-superfiċje tal-ġisem'(ikkalkolata skont it-tul u l-piż tal-pazjent) u tvarja minn 75 sa 200 mg għal kull metru kwadru, darba kuljum.
English: • adults and children three years of age and over with malignant glioma such as glioblastoma multiforme or anaplastic astrocytoma, when the tumour has returned or got worse after standard treatment.
Maltese: • adulti u tfal minn tliet snin 'il fuq li jbatu minn glijoma malinna bħall-glijoblastoma multiforme jew astroċitoma anaplastika, meta t-tumur tagħhom jerġa' jitfaċċa jew jiggrava wara l-kura standard.
English: 1 Previously known as Temozolomide Hospira.
Maltese: 1 Magħruf qabel bħala Temozolomide Hospira.
English: The CHMP concluded that, in accordance with EU requirements, Temozolomide Accord has been shown to have comparable quality and to be bioequivalent to Temodal.
Maltese: Is-CHMP ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Temozolomide Accord wera li għandu kwalità komparabbli u li huwa bijoekwivalenti għal Temodal.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubblku
English: Because Temozolomide Accord is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Maltese: Peress li Temozolomide Accord huwa mediċina ġenerika, l-istudji fuq in-nies ġew limitati għal testijiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Temodal.
English: Temozolomide Accord is used to treat malignant glioma (brain tumours) in the following groups of patients:
Maltese: Temozolomide Accord jintuża għall-kura ta' glijoma malinna (tumuri fil-moħħ) fil-gruppi ta' dawn ilpazjenti li ġejjin:
English: The active substance in Temozolomide Accord, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Maltese: Is-sustanza attiva f'Temozolomide Accord, it-temozolomid, tappartjeni għal grupp ta' mediċini kontra lkanċer li jissejħu aġenti alkilanti.
English: Temozolomide Accord is a cancer medicine that contains the active substance temozolomide.
Maltese: Temozolomide Accord huwa mediċina kontra l-kanċer li fiha s-sustanza attiva temozolomid.
English: This means that Temozolomide Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Maltese: Dan ifisser li Temozolomide Accord huwa simili għall‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Temodal.
English: What are the benefit and risk of Temozolomide Accord?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Temozolomide Accord?
English: What is Temozolomide Accord?
Maltese: X'inhu Temozolomide Accord?
English: Because Temozolomide Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Temozolomide Accord huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Other information about Temozolomide Accord:
Maltese: Infromazzjoni oħra dwar Temozolomide Accord:
English: Why has Temozolomide Accord been approved?
Maltese: Għaliex ġie approvat Temozolomide Accord?
English: In the body, temozolomide is converted to another compound called MTIC.
Maltese: Fil-ġisem it-temozolomid tinbidel f'kompost imsejjaħ MTIC.
English: Primary Endpoint
Maltese: Endpoint Primarju
English: * p<0.05, ** p<0.01, *** p<0.001; versus placebo
Maltese: * p<0.05, ** p<0.01, *** p<0.001; versus plaċebo
English: Oral herpes
Maltese: Herpes orali
English: ** p values versus etanercept: p=0.0250
Maltese: ** valuri p kontra etanercept: p=0.0250
English: DAS28-CRP Week 16
Maltese: DAS28-CRP Ġimgħa 16
English: 9/l (CTCAE grade 4) were reported.
Maltese: 9/l (grad 4 ta' CTCAE).
English: Clinically important, active infection, e.g. active tuberculosis (see section 4.4).
Maltese: Infezzjoni attiva ta' importanza klinika, eż. tuberkulożi attiva (ara sezzjoni 4.4).
English: Uncommon Oral candidiasis Tinea pedis
Maltese: Mhux komuni Kandidjażi orali Tinea pedis
English: Uncommon Urticaria Rare
Maltese: Mhux komuni Urtikarja Rari
English: Psoriasis study 2 (FIXTURE) evaluated 1,306 patients.
Maltese: Studju 2 dwar Psorjasi (FIXTURE) evalwa 1,306 pazjenti.
English: ASAS 40 response, % hsCRP, (post-BSL/BSL ratio)
Maltese: Rispons tal-ASAS 20, % Rispons tal-ASAS 40, % hsCRP, (proporzjon post-BSL/BSL)
English: Table 6 Change in modified Total Sharp Score in psoriatic arthritis
Maltese: Tabella 6 Bidla fil-Punteġġ Sharp totali modifikat f'artrite psorjatika
English: Concomitant immunosuppressive therapy
Maltese: Terapija immunosoppressiva konkomitanti
English: Outcome (p-value versus placebo)
Maltese: Riżultat (valur p versus plaċebo)
English: Neutropenia <1.0-0.5x10
Maltese: Newtropenija ta' <1.0-0.5x10
English: The primary endpoint was ASAS 20 at week 16.
Maltese: L-endpoint primarju kien ASAS 20 f'ġimgħa 16.
English: • if you have tuberculosis.
Maltese: • jekk tbati minn tuberkulożi.
English: Placebo (n = 74)
Maltese: Plaċebo (n = 74)
English: Placebo n=296
Maltese: Plaċebo n=296
English: Placebo n=179
Maltese: Plaċebo n=179
English: Psoriasis study 1 (ERASURE) evaluated 738 patients.
Maltese: Studju 1 dwar Psorjasi (ERASURE) evalwa 738 pazjent.
English: Do not use Cosentyx:
Maltese: Tużax Cosentyx:
English: Psoriasis study 5 (SCULPTURE) evaluated 966 patients.
Maltese: Studju 5 dwar Psorjasi (SCULPTURE) evalwa 966 pazjent.
English: SensoReady pen
Maltese: Pinna SensoReady
English: methionine, polysorbate 80 and water for injections.
Maltese: methionine, polysorbate 80 u ilma għall-injezzjonijiet.
English: Number of patients with ≥3% BSA psoriasis skin involvement at baseline
Maltese: Numru ta' pazjenti b'≥3% BSA involviment ta' psorjasi fil-ġilda fillinja bażi
English: (nasopharyngitis, rhinitis)
Maltese: (dermatite esfoljattiva)
English: Placebo (n=245)
Maltese: Plaċebo (n=245)
English: Week 52 Placebo 150 mg 300 mg 150 mg 300 mg 150 mg 300 mg
Maltese: Ġimgħa 52 Plaċebo 150 mg 300 mg 150 mg 300 mg 150 mg 300 mg
English: • infection of the external ear (otitis externa)
Maltese: • infezzjoni tal-parti ta' barra tal-widna (otitis externa)
English: Table 3 Summary of clinical response on psoriasis study 2 (FIXTURE)
Maltese: Tabella 3 Sommarju tar-reazzjoni klinika fl-istudju 2 dwar psorjasi (FIXTURE)
English: BASDAI 50, %
Maltese: Reazzjoni PASI 50
English: • It is preferable to avoid the use of Cosentyx in pregnancy.
Maltese: • Huwa preferibbli li jiġi evitat l-użu ta' Cosentyx fit-tqala.
English: ACR20 response n (%)
Maltese: ACR20 rispons n (%)
English: Placebo 150 mg
Maltese: Plaċebo 150 mg
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC10
Maltese: Immunosoppressivi, inibituri ta' interleukin, Kodiċi ATC:
English: Cosentyx is used in adults with active ankylosing spondylitis.
Maltese: Cosentyx jintuża f'adulti fi spondilite ankilotika attiva.
English: Date of first authorisation: 15 January 2015 Date of latest renewal: 03 September 2019
Maltese: Data tal-aħħar tiġdid: 03 Settembru 2019
English: Cosentyx SensoReady pen 150 mg
Maltese: Il-pinna Cosentyx SensoReady 150 mg
English: For all studies, the primary endpoint was American College of Rheumatology (ACR) 20 response.
Maltese: Għall-istudji kollha, l-endpoint primarju kien ir-rispons 20 tal-American College of Rheumatology (ACR).
English: • oral thrush (oral candidiasis)
Maltese: • traxx orali (kandidjażi orali)
English: Rare cases of neutropenia <0.5x10
Maltese: Ġew irrapportati każijiet rari ta' newtropenija <0.5x10
English: Week 52 Placebo 150 mg 300 mg Etanercept 150 mg 300 mg Etanercept 150 mg 300 mg Etanercept
Maltese: Ġimgħa 52 Plaċebo 150 mg 300 mg Etanercept 150 mg 300 mg Etanercept 150 mg 300 mg Etanercept
English: Other medicines and Cosentyx
Maltese: Mediċini oħra u Cosentyx
English: IGA mod 2011 “clear” or “almost clear” response n (%) * The IGA mod 2011 is a 5-category scale including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe”, indicating the physician's overall assessment of the psoriasis severity focusing on induration, erythema and scaling.
Maltese: 2011 “ċara” jew “kważi ċara” n (%) * IGA mod 2011 hu skala ta' 5 kategoriji li tinkludu “0 = ċara”, “1 = kważi ċara”, “2 - ħafifa”, “3 = moderata” jew “4 = gravi”, li tindika l-evalwazzjoni sħiħa tat-tabib dwar il-gravità tal-psorjasi billi tiffoka fuq l-indurazzjoni, l-eritema u l-qxur.
English: Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in clinical studies without dose-limiting toxicity.
Maltese: Dożi sa 30 mg/kg (madwar 2000 sa 3000 mg) ingħataw fil-vina waqt studji kliniċi mingħajr tossiċità li tillimita d-doża.
English: Statistically significant difference in ACR 20 versus placebo was reached at week 3.
Maltese: Fit-3 ġimgħa ntlaħqet differenza statistikament sinjifikanti f'ACR 20 versus plaċebo.
English: PsA study 1 (FUTURE 1) evaluated 606 patients, of whom 60.7% had concomitant MTX.
Maltese: L-istudju 1 tal-PsA (FUTURE 1) evalwa 606 pazjenti, li minnhom 60.7% kellhom MTX konkomitanti.
English: Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Maltese: Cosentyx hu indikat għat-trattament ta' psorjasi tal-plakka minn moderata sa gravi fl-adulti li huma kandidati għal terapija sistemika.
English: The safety and efficacy of secukinumab were assessed in four randomised, double-blind, placebo-controlled phase III studies in patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy [ERASURE, FIXTURE, FEATURE, JUNCTURE].
Maltese: III, randomised, double-blind, ikkontrollati bil-plaċebo f'pazjenti bi psorjasi tal-plakka moderata sa gravi li kienu kandidati għal fototerapija jew terapija sistemika [ERASURE, FIXTURE, FEATURE, JUNCTURE].
English: PASI 75 response n (%) 2 (3.3%) 43
Maltese: Reazzjoni PASI 75 n (%) 2 (3.3%) 43
English: The bioavailability of secukinumab in PsA patients was 85% on the basis of the population pharmacokinetic model.
Maltese: Il-bijodisponibbiltà ta' secukinumab f'pazjenti b'PsA kienet ta' 85% abbażi tal-mudell farmakokinetiku tal-popolazzjoni.
English: - The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate,
Maltese: - Is-sustanzi l-oħra huma trehalose dihydrate, histidine, histidine hydrochloride monohydrate,
English: Cosentyx 150 mg injection secukinumab
Maltese: Cosentyx 150 mg injezzjoni secukinumab
English: Cosentyx is indicated for the treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.
Maltese: Cosentyx hu indikat għat-trattament ta' spondilite ankilotika attiva f'adulti li rrispondew b'mod inadegwat għat-terapija konvenzjonali.
English: Patients with each subtype of PsA were enrolled in these studies, including polyarticular arthritis with no evidence of rheumatoid nodules, spondylitis with peripheral arthritis, asymmetric peripheral arthritis, distal interphalangeal involvement and arthritis mutilans.
Maltese: F'dawn l-istudji ġew irreġistrati pazjenti b'kull sottotip ta' PsA, inklużi artrite poliartikulari mingħajr evidenza ta' noduli rewmatiċi, spondilite b'artrite periferali, artrite periferali asimmetrika, involviment interfalanġali distali u artrite mutilans.
English: Week 24 data are presented in Table 6.
Maltese: Id-dejta tal-24 ġimgħa hija ppreżentata fit-Tabella 6.
English: Possible serious infection - the signs may include:
Maltese: Infezzjoni serja possibbli - is-sinjali jistgħu jinkludu:
English: Secukinumab is a recombinant fully human monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells.
Maltese: Secukinumab huwa antikorp monoklonali uman rikombinat għal kollox prodott f'ċelluli tal-Ovarju tal-Ħamster Ċiniż (CHO - Chinese Hamster Ovary).
English: PASI 75 response n (%)
Maltese: PASI 75 rispons n (%)
English: Secukinumab was administered concomitantly with methotrexate (MTX), sulfasalazine and/or corticosteroids in arthritis studies (including in patients with psoriatic arthritis and ankylosing spondylitis).
Maltese: Secukinumab ingħata flimkien ma' methotrexate (MTX), sulfasalazine u/jew kortikosterojdi fi studji dwar l-artrite (inkluż f'pazjenti b'artrite psorjatika u spondilite ankilotika).
English: Cosentyx contains the active substance secukinumab.
Maltese: Cosentyx fih is-sustanza attiva secukinumab.
English: The efficacy and safety of secukinumab 150 mg and 300 mg were evaluated versus either placebo or etanercept.
Maltese: L-effikaċja u s-sigurtà ta' secukinumab 150 mg u 300 mg kienu evalwati kontra plaċebo jew etanercept.
English: Serious infections occurred in 0.14% of patients treated with secukinumab and in 0.3% of patients treated with placebo (see section 4.4).
Maltese: Kien hemm infezzjonijiet serji f'0.14% tal-pazjenti ttrattati b'secukinumab u f'0.3% tal-pazjenti ttrattati bi plaċebo (ara sezzjoni 4.4).
English: • cold sores (oral herpes)
Maltese: • ponot tad-deni (herpes orali)
English: Ankylosing spondylitis
Maltese: Spondilite ankilotika
English: • athlete's foot (tinea pedis)
Maltese: • fungu li jattakka s-sieq (tinea pedis)
English: PASI 50 response n (%) 3 (5.1%) 51
Maltese: n (%) 3 (5.1%) 51
English: 9/l (CTCAE grade 3) was reported in 18 out of 3,430 (0.5%) patients on secukinumab, with no dose dependence and no temporal relationship to infections in 15 out of 18 cases.
Maltese: 9/l (CTCAE grad 3) kienet irrappurtata fi 18 minn 3,430 (0.5%) pazjent fuq secukinumab, bl-ebda dipendenza fuq id-doża u l-ebda relazzjoni temporali għal infezzjonijiet fi 15 minn 18 il-każ.
English: Secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month †In patients with dactylitis at baseline (n=27, 32, 46, respectively for PsA study 2 and n=124, 80, 82, respectively for PsA study 3) ‡In patients with enthesitis at baseline (n=65, 64, 56, respectively for PsA study 2 and n=192, 141, 140, respectively for PsA study 3)
Maltese: Secukinumab 150 mg jew 300 mg s.c. fil-ġimgħat 0, 1, 2, 3, u 4 segwiti bl-istess doża kull xahar †F'pazjenti b'dattilite fil-linja bażi (n=27, 32, 46, rispettivament għall-istudju 2 tal-PsA u n=124, 80, 82, rispettivament għall-istudju 3 tal-PsA) ‡F'pazjenti b'entesite fil-linja bażi (n=65, 64, 56, rispettivament għall-istudju 2 tal-PsA u n=192, 141, 140, rispettivament għall-istudju 3 tal-PsA)
English: In addition, the corresponding frequency category for each adverse drug reaction is 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); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Maltese: Barra minn hekk, il-kategorija ta' frekwenza korrispondenti għal kull reazzjoni avversa tal-mediċina tissejjes 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); rari ħafna (<1/10,000); u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: The frequency of neutropenia in psoriatic arthritis and ankylosing spondylitis is similar to psoriasis.
Maltese: Il-frekwenza ta' newtropenija f'artrite psorjatika u spondilite ankilotika hija simili għal psorjasi.
English: Total score
Maltese: Punteġġ totali
English: For Psoriatic Arthritis study 1 (PsA study 1) and Psoriatic Arthritis study 2 (PsA study 2), the primary endpoint was at week 24.
Maltese: Għall-istudju 1 dwar l-Artrite Psorjatika (Studju 1 tal-PsA) u studju 2 dwar l-Artrite Psorjatika (studju 2 tal-PsA), l-endpoint primarju kien fl-24 ġimgħa.
English: Secukinumab 300 mg was superior to placebo at week 12 as assessed by significant improvement from baseline in both the PSSI 90 response (52.9% versus 2.0%) and IGA mod 2011 0 or 1 scalp only response (56.9% versus 5.9%).
Maltese: Secukinumab 300 mg kien superjuri għall-plaċebo fit-12-il ġimgħa hekk kif evalwat permezz ta' titjib qawwi millinja bażi kemm skont ir-rispons ta' PSSI 90 (52.9% kontra 2.0%) u IGA mod 2011 0 jew ir-rispons tal-qurriegħa biss (56.9% kontra 5.9%).
English: PASI 50 response n (%) 5 (8.2%) 48
Maltese: n (%) 5 (8.2%) 48
English: PsA study 3 (FUTURE 5) evaluated 996 patients, of whom 50.1% had concomitant MTX.
Maltese: L-istudju 3 tal-PsA (FUTURE 5) evalwa 996 pazjent, li minnhom 50.1% kellhom MTX konkomitanti.
English: IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.
Maltese: IL-17A hu ċitokin li jseħħ b'mod naturali u li hu involut f'reazzjonijiet infjammatorji u immuni normali.
English: Larger differences in response rates, favouring 300 mg over 150 mg, were observed in anti-TNFα-IR patients (n=36) compared to anti-TNFα-naïve patients (n=114).
Maltese: Dehru differenzi akbar fir-rati ta' rispons, li jiffavorixxu t-300 mg għallkuntrarju tal-150 mg, f'pazjenti b'anti-TNFα-IR (n=36) imqabbel ma' pazjenti b'anti-TNFα-naïve (n=114).