FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery.
Maltese: Kien hemm rapporti li NSAIDs għall-għajnejn jistgħu jikkawżaw żieda fil-fsada tat-tessuti tal-għajnejn (inkluż ifemiji) meta jintużaw f'konġunzjoni ma' kirurġija okulari.
English: Amfenac inhibits the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.
Maltese: Amfenac jinibixxi l-azzjoni ta' prostaglandin H synthase (cyclooxygenase), enżima meħtieġa għall-produzzjoni ta' prostaglandin.
English: After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug.
Maltese: Infezzjoni akuta tal-għajnejn tista' tiġi mgħottija bl-użu topiku ta' prodotti mediċinali antiinfjammatorji.
English: PHARMACEUTICAL PARTICULARS
Maltese: PPROPRJETAJIET FARMAKOLOĠIĊI
English: Animal studies have shown excretion of nepafenac in the milk of rats.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-flixkun u l-kartuna wara EXP.
English: Nasonex medicinal products are registered in the following EU Members States: Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and United Kingdom and also in Iceland and Norway.
Maltese: Prodotti mediċinali Nasonex huma rreġistrati fl-Istati Membri tal-UE li ġejjin: l-Awstrija, il-Belġju, ilBulgarija, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Finlandja, Franza, il-Ġermanja, il-Greċja, lUngerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja, l-Isvezja u r-Renju Unit kif ukoll flIslanda u Norveġja.
English: Mometasone furoate is devoid of androgenic, antiandrogenic, estrogenic or antiestrogenic activity.
Maltese: Mometasone furoate m'għandux attività androġenika, antiandroġenika, estorġenika jew antiestroġenika.
English: Summary of product characteristics (SmPC)
Maltese: Sommarju tal-karatteristiċi tal-prodott (SmPC - Summary of Product Characteristics)
English: Nasonex Nasal Spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate; in an aqueous medium containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate
Maltese: Nasonex Sprej Nażali 50 mcg huwa sprej b'doża mkejla b'pompa manwali li fih sospensjoni likwida ta' mometasone furoate monoidrat ekwivalenti għal 0.05% w/w mometasone furoate; f'mezz milwiem li fih il-gliċerina, ċelluloża mikrokristallina u carboxymethylcellulose sodium, sodju ċitrat, aċidu ċitriku, sodium citrate, citric acid, benzalkonium chloride, u polisorbat 80.
English: Section 4.5- Interaction with other medicinal products and other forms of interaction
Maltese: Sezzjoni 4.5- Interazzjonijiet ma' prodotti mediċinali oħra u forom oħra ta' interazzjonijiet
English: Seasonal allergic rhinitis
Maltese: Rinite allerġika staġjonali
English: A cross reference to section 4.4 for use with systemic corticosteroids is made.
Maltese: Saret kontroreferenza għal sezzjoni 4.4 għall-użu b'kortikosterojdi sistemiċi.
English: Package Leaflet (PL)
Maltese: Fuljett ta' tagħrif (PL - Package Leaflet)
English: Two 4-month randomized, placebo-controlled, double-blind, parallel-group multicentre, efficacy and safety treatment trials and a no-treatment, observational, follow-up study have been discussed in support of the indication for the treatment of nasal polyposis, where two doses of mometasone furoate compared with placebo (200 µg QD and BID) were investigated in a total of 664 subjects, of which 441 were treated with mometasone furoate.
Maltese: Żewġ provi ta' kura ta' sigurtà u effikaċja ta' 4 xhur randomizzati, ikkontrollati bi plaċebo, doubleblind, multiċentru bi gruppi paralleli, provi ta' kura tal-effikaċja u s-sigurtà u studju follow-up ta' osservazzjoni, bla kura ġew studjati b'appoġġ tal-indikazzjoni għall-kura ta' polipożi nażali, fejn żewġ dożi ta' mometasone furoate mqabbla ma' plaċebo (200 µg QD u BID) ġew investigati f'total ta' 664 individwu, li minnhom 441 ġew ikkurati b'mometasone furoate.
English: The active ingredient of Nasonex, mometasone furoate monohydrate is a synthetic, 17-heterocyclic corticosteroid with anti-inflammatory activity.
Maltese: L-ingredjent attiv ta' Nasonex, mometasone furoate monoidrat hija kortikosterojde 17-eteroċikliku, sintetiku b'attività anti-infjammatorja.
English: The mean scores for physician evaluations of total nasal symptoms showed greater reductions for mometasone furoate at all visits (ranging from 36 to 62%) compared to placebo (22% to 48%).
Maltese: Il-punteġġi medji għall-evalwazzjonijiet tat-tobba ta' sintomi nasali totali wrew tnaqqis akbar għal mometasone furoate fil-visti kollha (ivarjaw bejn 36 u 62%) meta mqabbla mal-plaċebo (22% sa
English: Nasonex is a nasal preparation for topical use and contains benzalkonium chloride.
Maltese: Nasonex huwa preparazzjoni nażali għal użu topiku u fih klorur benżalkonju.
English: Treatment of acute sinusitis
Maltese: Kura ta' sinusite akuta
English: On the basis of 19 Phase II and III studies completed using mometasone furoate in adolescents and adults, a total dose 200 µg once daily was chosen as the standard clinical adolescent/adult dosage, allowing dose titration up to a maximum daily total dose of 400 mg.
Maltese: II u III li tlestew bl-użu ta' mometasone furoate f'adolexxenti u adulti, doża totali ta' 200 µg darba kuljum intgħażlet bħala d-dożaġġ kliniku standard għalladolexxenti/adulti, li tippermetti żieda sa massimu ta' doża totali ta' kuljum ta' 400 µg.
English: The overall response in terms of improvement from baseline was shown to be similar between the 3- to 5-year-old and 6- to 11-year-old subgroups.
Maltese: Ir-rispons globali fir-rigward ta' titjib mil-linja bażi wera li hu simili bejn is-sottogruppi ta' età minn 3 sa 5 snin u ta' 6 sa 11-il sena.
English: Prophylaxis of seasonal allergic rhinitis
Maltese: Profilassi ta' rinite allerġika staġjonali
English: Perennial rhinitis
Maltese: Rinite perennjali
English: The results obtained for the user testing in variation UK/H/0196/001/II/032 submitted as a commitment to a renewal in the (MRP) and approved in January 2009, were considered acceptable by the CHMP.
Maltese: Ir-riżultati miksuba għall-provi mill-utenti fil-varjazzjoni UK/H/0196/001/II/032 sottomessi bħala impenn għal tiġdid fl-(MRP) u approvati f'Jannar 2009, ġew ikkunsidrati aċċettabbli mis-CHMP.
English: Nasonex medicinal products are currently not registered in Cyprus.
Maltese: Prodotti mediċinali Nasonex attwalment mhumiex irreġistrati f'Ċipru.
English: The information proposed by the MAH in this section of the SmPC was listed under the headings absorption, distribution, biotransformation and elimination, and was considered to be acceptable by the CHMP, with the recommended amendments.
Maltese: L-informazzjoni proposta mill-MAH f'din is-sezzjoni tal-SmPC ġiet elenkata taħt l-intestaturi assorbiment, distribuzzjoni, biotrasformazzjoni u eliminazzjoni, u ġiet ikkunsidrata aċċettabbli misCHMP, bl-emendi rakkomandati.
English: The MAH has chosen not to include the indication for the prevention of nasal polyp relapse after functional endoscopic sinus surgery (FESS) in the proposed harmonized SmPC, which is approved only in Sweden.
Maltese: L-MAH għażel li ma jinkludix l-indikazzjoni għall-prevenzjoni ta' rikaduta ta' polipi nażali wara kirurġija endoskopika funzjonali tas-sinus (FESS - functional endoscopic sinus surgery) fl-SmPC armonizzat propost, ħaġa li hija approvata biss fl-Isvezja.
English: Thus there is support for efficacy in the age group 3-5 years, and no difference in efficacy is to be expected in a 3 year old as compared to a 6 year old from a pharmacological perspective.
Maltese: Għalhekk hemm appoġġ għall-effikaċja fil-grupp taletajiet 3-5 snin, u ebda differenza fl-effikaċja mhija mistennija f'tifel/tifla ta' 3 snin meta mqabbla ma' tifel/tifla ta' 6 snin minn perspettiva farmakoloġika.
English: The adverse events were presented independently of the indication and presenting all data (pooled) in a single tabulated format.
Maltese: Lavvenimenti avversi ġew ippreżentati indipendentament mill-indikazzjoni u d-dejta kollha (kollettiva) ġiet ippreżentata f'forma tabulata waħda.
English: A section on the systemic effects of corticosteroids including as well as reports of increased intraocular pressure following the use of intranasal corticosteroids has also been mentioned.
Maltese: Sezzjoni fuq l-effetti sistemiċi ta' kortikosterojdi li tinkludi wkoll rapporti ta' pressjoni intraokulari miżjuda wara użu ta' kortikosterojdi intranażali ssemmiet ukoll.
English: Subsequently, a study Q97-921 specifically in subjects with perennial non-allergic rhinitis (PNAR) was completed indicating a positive outcome, and resulting in an indication for PNAR being granted in May 2000 in Sweden.
Maltese: Sussegwentement, l-istudju Q97-921 speċifikament f'suġġetti b'rinite perennjali mhux allerġika (PNAR - Perennial Non-Allergic Rhinitis) tlesta u indika riżultat pożittiv, u rriżulta fl-għoti tal-indikazzjoni għal PNAR f'Mejju 2000 fl-Isvezja.
English: Information on the paediatric program and the study results (efficacy and safety) has been provided by the MAH.
Maltese: Informazzjoni fuq il-programm pedjatriku u r-riżultati tal-istudji (effikaċja u sigurtà) ġiet ipprovduta mill-MAH.
English: Based on the 9 studies in the original perennial rhinitis program, the perennial rhinitis indication was approved for MRP countries in 1997, and by the other concerned Member States between 1997 and 1998.
Maltese: Abbażi tad-9 studji fil-programm oriġinali tar-rinite perennjali, l-indikazzjoni ta' rinite perennjali ġiet approvata għall-pajjiżi MRP fl-1997, u mill-Istati Membri kkonċernati oħrajn bejn l-1997 u l1998.
English: It was authorised according to the national procedure in 16 European countries and according to the mutual recognition procedure (MRP) in 13 Member States, with the United Kingdom (UK) acting as reference Member State (RMS).
Maltese: Ġie awtorizzat skont il-proċedura nazzjonali f'16-il pajjiż Ewropew u skont il-proċedura ta' rikonoxximent reċiproku (MRP - Mutual Recognition Procedure) fi 13-il Stat Membru, bir-Renju Unit (UK) bħala l-Istat Membru ta' riferiment (RMS - Reference Member State).
English: As the amount of benzalkonium chloride - 0.02 mg per actuation is above the threshold of 10 micrograms /delivered dose, a statement that Nasonex contains benzalkonium chloride, which may cause nasal irritation is included in the PL, in accordance with the Guideline on Excipients in the label and PL (2003).
Maltese: Billi l-ammont ta' klorur benżalkonju - 0.02 mg għal kull attwazzjoni huwa ogħla mil-limitu ta' 10 mikrogrammi / doża mwassla, fil-PL hemm inkluż stqarrija li tgħid li Nasonex fih klorur benżalkonju, li jista' jikkawża irritazzjoni nażali, b'mod konformi mal-Linja Gwida dwar Eċċipjenti fit-tikketta u l-PL
English: The safety and efficacy of Nasonex Nasal Spray has not been established in:
Maltese: Is-sigurtà u l-effikaċja ta' Nasonex Sprej Nażali ma ġewx stabbiliti fi:
English: It is stated that overdose is unlikely to require any therapy other than observation since the systemic bioavailability of mometasone furoate is <1%.
Maltese: Huwa ddikjarat li doża eċċessiva x'aktarx m'għandha bżonn ebda terapija ħlief osservazzjoni billi lbiodisponibbilità sistemika ta' mometasone furoate hija <1%.
English: Of the 6 studies, 4 were pooled, and the patient diary results showed a reduction from baseline of 33% compared to 15% in placebo-treated patients in the first 2 weeks of treatment with mometasone furoate.
Maltese: Minn dawn is-6 studji, 4 kienu kollettivi, u r-riżultati tad-djarji tal-pazjenti wrew tnaqqis ta' 33% mil-linja bażi meta mqabbla mal-15% f'pazjenti kkurati bi plaċebo fl-ewwel ġimagħtejn ta' kura b'mometasone furoate.
English: This section of the proposed SmPC contains information on the mechanism of action of mometasone furoate, and its pharmacodynamic effects in patients with seasonal allergic rhinitis.
Maltese: Din is-sezzjoni tal-SmPC propost fiha informazzjoni dwar il-mekkaniżmu ta' azzjoni ta' mometasone furoate, u l-effetti farmakodinamiċi f'pazjenti b'rinite allerġika staġjonali.
English: The initial dose for rhinitis and nasal polyps is 100 µg once daily in each nostril (total daily dose of 200 µg).
Maltese: Id-doża inizjali għal rinite u polipi nażali hija 100 µg darba kuljum f'kull minfes (doża totali ta' kuljum ta' 200 µg).
English: Mometasone furoate is not recommended for use in case of nasal septum perforation (the reported instances of nasal septum perforation information is mentioned in section 4.8).
Maltese: Mometasone furoate mhuwiex rakkomandat għall-użu f'kas ta' perforazzjoni tas-septum talimnieħer (il-każijiet irrappurtati ta' perforazzjoni tas-septum tal-imnieħer huma msemmijin f'sezzjoni 4.8).
English: - children and adolescents under 18 years of age have not been established in nasal polyposis.
Maltese: - tfal u adolexxenti taħt it-18-il sena ma ġewx determinati f'polipożi nażali.
English: Mention is made of the immunosuppressive effects of corticosteroids and the risk of exposure of patients to certain infections (e.g., chickenpox, measles), and of the importance of obtaining medical advice if such exposure occurs.
Maltese: Issemmew l-effetti immunosupressivi ta' kortikosterojdi u r-riskju ta' espożizzjoni tal-pazjenti għal ċertu infezzjonijiet (eż. ġidri r-riħ, ħosba), u l-importanza tal-kisba ta' pariri mediċi jekk isseħħ espożizzjoni simili.
English: Nasal polyposis
Maltese: Anness II
English: The European Medicines Agency has waived the obligation to submit the results of studies with Nasonex Nasal Spray and associated names in all subsets of the paediatric population in seasonal and perennial allergic rhinitis (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini neħħiet l-obbligu li jiġu sottomessi r-riżultati ta' studji b'Nasonex Sprej Nażali u ismijiet assoċjati fis-sottogruppi kollha tal-popolazzjoni pedjatrika f'rinite allerġika staġjonali jew perennjali (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Six studies were conducted to demonstrate the efficacy of mometasone furoate in 2544 patients with seasonal allergic rhinitis randomised to treatment with mometasone furoate, placebo or active control.
Maltese: Twettqu sitt studji biex juru l-effikaċja ta' mometasone furoate f'2544 pazjenti b'rinite allerġika staġjonali randomizzati għal kura b'mometasone furoate, plaċebo jew kontroll attiv.
English: - children under 3 years of age in seasonal allergic rhinitis and perennial allergic rhinitis
Maltese: - tfal taħt it-3 snin f'rinite allerġika staġjonali u f'rinite allerġika perennjali
English: Mometasone furoate is contraindicated in the presence of untreated localised infection such as herpes simplex, involving the nasal mucosa, and also in patients who have experienced recent nasal surgery or trauma until healing has occurred because of the inhibitory effect of corticosteroids on wound healing.
Maltese: Mometasone furoate huwa kontraindikat fil-preżenza ta' infezzjoni lokalizzata mhux ikkurata bħal herpes simplex, li tinvolvi l-mukoża nażali, kif ukoll f'pazjenti li kellhom esperjenza ta' kirurġija nażali riċenti jew trawma sakemm din tfieq minħabba l-effett inibitorju ta' kortikosterojdi fuq ilfejqan ta' ġrieħi.
English: Known hypersensitivity to the active substance, mometasone furoate, or to any of the excipients has been proposed as per the current Guideline on the Summary of Product Characteristics.
Maltese: Sensittività eċċessiva magħrufa għas-sustanza attiva, mometasone furoate, jew għal kwalunkwe eċċipjent ġiet proposta skont il-Linji
English: Section 4.8 was restructured as suggested by the CHMP to increase readability and to comply with the QRD template and SmPC guideline.
Maltese: Sezzjoni 4.8 ġiet ristrutturata kif irrakkomandat mis-CHMP biex tinqara aktar faċilment u sabiex tkun konformi mal-linji gwida tal-mudell ta' reviżjoni tal-kwalità tad-dokument (QRD) u l-SmPC.
English: These studies support the proposed indication for the symptomatic treatment of rhinitis (seasonal allergic and perennial) in adults.
Maltese: Dawn l-istudji jappoġġjaw l-indikazzjoni proposta għall-kura sintomatika ta' rinite (allerġika staġjonali u perennjali) f'adulti.
English: The onset of action of mometasone furoate in patients with allergic symptoms is rapid, and hence the observed effect after prophylactic treatment (as defined in the studies) could be related to a treatment effect as covered by the general rhinitis indication.
Maltese: Il-bidu tal-azzjoni ta' mometasone furoate f'pazjenti b'sintomi ta' allerġija huwa rapidu, u għalhekk l-effett osservat wara kura profilattika (kif definit fl-istudji) jista' jkun relatat ma' effett talkura kif inhu kopert mill-indikazzjoni ġenerali ta' rinite.
English: • The committee reviewed the data submitted by the MAH from the existing clinical and nonclinical studies and post-marketing experience with Nasonex and associated names as reported by the MAH justifying the proposed harmonisation of the product information.
Maltese: • Il-kumitat irreveda d-dejta ppreżentata mill-MAH mill-istudji kliniċi u mhux kliniċi eżistenti u mill-esperjenza ta' wara t-tqegħid fis-suq b'Nasonex u ismijiet assoċjati kif irrappurtat mill-MAH li tiġġustifika l-armonizzazzjoni proposta tal-informazzjoni tal-prodott.
English: Two randomised multicentre clinical studies from the MRP dossier have been referred to, where mometasone furoate was administered to patients with a history of seasonal allergic rhinitis.
Maltese: Saret referenza għal żewġ studji kliniċi randomizati b'ċentri multipli mid-dossier tal-MRP, fejn mometasone furoate ngħata lil pazjenti bi storja ta' rinite allerġika staġjonali.
English: • The committee agreed with the harmonised summary of product characteristic, labelling and package leaflet proposed and discussed by the marketing authorisation holder.
Maltese: • Il-kumitat qabel mas-sommarju tal-karatteristiċi tal-prodott armonizzat, tikkettar u fuljett ta' tagħrif proposti u diskussi mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq.
English: Two studies investigating sinusitis and also the results and analysis of an additional study (A2-3852) conducted to assess the clinical relevance of the observed effect size of the treatment showed that the clinical relevance of the data generated in these studies with respect to the indication proposed had not been established.
Maltese: Żewġ studji li investigaw is-sinusite kif ukoll ir-riżultati u l-analiżi ta' studju addizzjonali (A2-3852) li saru biex tiġi evalwata r-relevanza klinika tad-daqs tal-effett osservat urew li r-relevanza klinika tad-dejta li ġiet iġġenerata f'dawn l-istudji fir-rigward tal-indikazzjoni proposta ma ġietx stabbilita.
English: The section on ‘Fertility' was amended to include only the relevant conclusions from non-clinical toxicity studies in accordance with current Guideline on the summary of product characteristics.
Maltese: Is-sezzjoni dwar il-‘Fertilità' ġiet emendata biex tinkludi konklużjonijiet relevanti biss minn studji mhux kliniċi ta' tossiċità konformi mal-Linji Gwida attwali fuq is-sommarju tal-karatteristiċi talprodott.
English: Treatment of symptoms of rhinitis
Maltese: Kura tas-sintomi ta' rinite
English: Instead, text was introduced in Section 4.2 of the SmPC to clarify that treatment may need to be initiated a few days before the expected onset of the allergy season in patients with a history of moderate to severe symptoms of seasonal allergic rhinitis.
Maltese: Minflok, ġie introdott test f'Sezzjoni 4.2 talSmPC biex jikjarifika li l-kura jista' jkollha bżonn tinbeda ftit jiem qabel il-bidu mistenni tal-istaġun tal-allerġiji f'pazjenti bi storja ta' sintomi moderati sa severi ta' rinite allerġika staġjonali.
English: Further information on Xeljanz 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: Xeljanz received a marketing authorisation valid throughout the EU on 22 March 2017.
Maltese: Xeljanz irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fit-22 ta' Marzu 2017.
English: Xeljanz contains the active substance tofacitinib.
Maltese: Xeljanz fih is-sustanza attiva tofaċitinib.
English: Other information about Xeljanz
Maltese: Informazzjoni oħra dwar Xeljanz
English: The first study compared Xeljanz with adalimumab (an injected medicine for psoriatic arthritis) and placebo in 422 patients.
Maltese: L-ewwel studju qabbel Xeljanz ma' adalimumab (mediċina injettata għal artrite psorjatika) u plaċebo f'422 pazjent.
English: The most common serious side effects seen with Xeljanz are serious infections such as pneumonia (infection of the lungs), cellulitis (infection of the deep skin tissue), herpes zoster (shingles), urinary tract infection, diverticulitis (infection affecting the intestines) and appendicitis (infection of the appendix) as well as opportunistic infections that can occur in patients with weakened immune systems.
Maltese: L-effetti sekondarji serji l-aktar komuni b'Xeljanz huma infezzjonijiet serji bħal pulmonite (infezzjoni tal-pulmun), ċellulite (infezzjoni tat-tessut fil-fond tal-ġilda), herpes zoster (ħruq ta' Sant'Antnin), infezzjoni fl-apparat tal-awrina, divertikulite (infezzjoni li taffettwa l-imsaren) u appendiċite (infezzjoni tal-appendiċi) kif ukoll infezzjonijiet opportunistiċi li jistgħu jseħħu f'pazjenti b'sistemi immuni mdgħajfa.
English: The active substance in Xeljanz, tofacitinib, works by blocking the action of enzymes known as Janus kinases.
Maltese: Is-sustanza attiva f'Xeljanz, jiġifieri it-tofaċitinib, taħdem billi timblokka l-azzjoni ta' enzimi msejħa Janus kinases.
English: In the first study in 614 patients with ulcerative colitis, 18% of patients treated with Xeljanz 10 mg twice a day had mild or no symptoms after 8 weeks of treatment compared with 8% of patients who received placebo.
Maltese: Fl-ewwel studju f'614-il pazjent b'kolite ulċerattiva, 18 % tal-pazjenti kkurati b'Xeljanz 10 mg darbtejn kuljum kellhom sintomi ħfief jew l-ebda sintomu wara 8 ġimgħat ta' kura meta mqabbel ma' 8 % talpazjenti li rċevew il-plaċebo.
English: Xeljanz must not be used in patients with active tuberculosis, serious infections or any opportunistic infection.
Maltese: Xeljanz ma għandux jintuża f'pazjenti b'tuberkulożi attiva, b'infezzjonijiet serji jew bi kwalunkwe infezzjoni opportunistika.
English: In a third study with 593 patients, 34% of patients treated with Xeljanz 5 mg twice a day had mild or no symptoms after a year of treatment compared with 11% of patients receiving placebo.
Maltese: Fit-tielet studju b'593 pazjent, 34 % tal-pazjenti kkurati b'Xeljanz 5 mg darbtejn kuljum kellhom sintomi ħfief jew l-ebda sintomu wara sena ta' kura meta mqabbel ma' 11 % tal-pazjenti li rċevew ilplaċebo.
English: What are the risks associated with Xeljanz?
Maltese: X'inhuma r-riskji assoċjati ma' Xeljanz?
English: Similarly, in the second study Xeljanz was more effective than placebo at improving symptoms (50% of Xeljanz-treated patients versus 24% of those given placebo) and ability to perform everyday activities.
Maltese: Bl-istess mod, fit-tieni studju Xeljanz kien aktar effettiv mill-plaċebo biex itejjeb is-sintomi (50 % tal-pazjenti kkurati b'Xeljanz kontra 24 % ta' dawk li ngħataw il-plaċebo) u l-ħila li jagħmlu attivitajiet ta' kuljum.
English: Several studies have shown that Xeljanz is effective at treating rheumatoid arthritis, psoriatic arthritis and ulcerative colitis in patients who had previously tried other treatments.
Maltese: Diversi studji wrew li Xeljanz huwa effettiv fil-kura ta' artrite rewmatika, artrite psorjatika u kolite ulċerattiva f'pazjenti li preċedentement kienu pprovaw kuri oħra.