FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients receiving sirolimus, nifedipine or itraconazole in combination with micafungin should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see section 4.4).
Maltese: Pazjenti li jirċievu sirolimus, nifedipine jew itraconazole flimkien ma' micafungin għandhom jiġu mmonitorjati għal tossiċità minn sirolimus, nifedipine jew itraconazole u d-doża ta' sirolimus, nifedipine jew itraconazole għandha titnaqqas jekk ikun meħtieġ (ara sezzjoni 4.4)..
English: Consequently, the occurrence of these adverse responses may be expected in human clinical use of micafungin.
Maltese: Konsegwentement, risponsi avversi bħal dawn huma mistennija li jseħħu waqt l-użu kliniku b'micafungin.
English: One abortion occurred in rabbits at 32 mg/kg/day.
Maltese: Abort wieħed seħħ fil-fniek meta ngħata 32 mg/kg/kuljum.
English: EUCAST breakpoints
Maltese: Biocodex UAB
English: Astellas Pharma B.V.
Maltese: Astellas Pharma B.V. Branch Tél/Tel:
English: Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall.
Maltese: Micafungin jinibixxi b'mod mhux kompetittiv is-sintesi ta' 1,3-β-D-glucan, komponent essenzjali tar riti ċellulari fungali. 1,3-β-D-glucan m'huwiex preżenti fiċ-ċelloli mammiferi.
English: Hepatobiliary disorders blood alkaline phosphatase increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased (including hyperbilirubinaemia), liver function test abnormal hepatic failure (see section 4.4), gammaglutamyltransferase increased, jaundice, cholestasis, hepatomegaly, hepatitis hepatocellular damage including fatal cases (see section 4.4)
Maltese: - Għandu indeboliment sever fil-funzjoni tal-fwied - Għandhu mard kroniku tal-fwied magħruf li jirrapreżenta kondizzjonijiet preneoplastiċi (eż. fibrożi avvanzata tal-fwied, ċirrosi, epatite virali, mard tal-fwied fi trabi tat-twelid jew difetti konġenitali)
English: Mycamine is effective in treating systemic infections (those that have penetrated within the body).
Maltese: Mycamine huwa effettiv biex jittratta infezzjonijiet sistemiċi (dawk li jkunu ppenetraw il-ġisem).
English: FAH recorded after treatment for 13 weeks or longer persisted after a 13-week withdrawal period and developed into hepatocellular tumours following a treatment free period which covered the life span of rats.
Maltese: L-FAH reġistrati wara t-trattament għal 13-il ġimgħa jew aktar ippersistew għal perijodu ta' 13-il ġimgħa wara l-waqfien u żviluppaw f'tumuri epatoċellulari wara perijodu li fih ma sar l-ebda trattament li kopriet ħajjet il-firien.
English: Astellas Pharma Ltd. Tel: +44 (0) 203 3798700
Maltese: Astellas Pharma d.o.o. Tel: +389 (0) 14011400
English: Astellas d.o.o.
Maltese: Vistor hf.
English: Prescriber checklist
Maltese: KUNDIZZJONIJIET OĦRA U REKWIŻITI
English: Cases of serious hepatic dysfunction occurred uncommonly (see section 4.4).
Maltese: nekroliżi epidermali tossika (ara sezzjoni 4.4)
English: Nervous system disorders headache somnolence, tremor, dizziness, dysgeusia
Maltese: Disturbi fis-sistema nervuża uġigħ ta' ras ngħas, rogħda,
English: General disorders and administration site conditions pyrexia, rigors injection site thrombosis, infusion site inflammation, injection site pain, peripheral oedema
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropeja dwar ilMediċini http://www.ema.europa.eu/.
English: Patients receiving sirolimus, nifedipine or itraconazole in combination with micafungin should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary (see section 4.5).
Maltese: Pazjenti li qed jirċievu sirolimus, nifedipine jew itraconazole flimkien ma' micafungin għandhom jiġu mmonitorjati għat-tossiċità ta' sirolimus, nifedipine jew itraconazole u d-dożaġġ ta' sirolimus, nifedipine jew itraconazole għandu jitnaqqas jekk ikun meħtieġ (ara sezzjoni 4.5).
English: Unopened vials
Maltese: Disturbi vaskulari
English: The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Maltese: Il-perijodu ta' dożaġġ ta' micafungin f'dawn l-istudji fuq il-firien (6 xhur) jaqbeż il-perijodu ta' dożi ta' micafungin fil-pazjenti (ara sezzjoni 5.1).
English: The MAH should agree the final content, format and distribution modalities of the Prescriber checklist with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Maltese: L-MAH għandu jaqbel l-aħħar kontenut, format u l-modalitajiet ta 'distribuzzjoni tal-lista ta' dawk li jippreskrivu mal-Awtorità Kompetenti Nazzjonali f'kull Stat Membru u jiżgura li l-materjali fihom lelementi ewlenin kif deskritti hawn taħt.
English: After reconstitution each ml contains 10 mg micafungin (as sodium).
Maltese: Wara r-rikostituzzjoni kull ml fih 10 mg micafungin (bħala sodium).
English: Special populations
Maltese: Pazjenti Adulti
English: 31 May 2016 EMA/270540/2016
Maltese: EMA/270540/2016
English: Further information on the HMPC assessment of knotgrass herb medicines, including details of the Committee's conclusions can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Documents') fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC also considered studies in laboratory tests which support anti-inflammatory and antibacterial effects of knotgrass herb medicines.
Maltese: L-HMPC ikkunsidra studji f'testijiet tal-laboratorju li jappoġġjaw l-effetti antinfjammatorji u antibatterjali talmediċini li fihom il-ħaxixa tal-Lewża tar-Raba'.
English: Although a possible effect in decreasing gingivitis was observed, information on how the study was conducted is incomplete, so firm conclusions could not be drawn.
Maltese: Għalkemm effett possibbli kien osservat fit-tnaqqis tal-ġinġivite, l-informazzjoni dwar kif twettaq l-istudju mhijiex kompluta, għaldaqstant ma setgħux isiru konklużjonijiet sodi.
English: Knotgrass herb is the common name for the flowering aerial parts of the plant Polygonum aviculare L. The HMPC conclusions only cover knotgrass herb preparations which are obtained by drying and comminuting (reducing into tiny pieces) the flowering aerial parts.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom il-ħaxixa tal-Lewża tar-Raba', inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Iddokumenti kollha' (All Documents') fis-sit elettroniku tal-Aġenzija:
English: Herbal medicines containing these knotgrass herb preparations are usually available as herbal material that is used to make herbal teas to be drunk or added to water to produce a liquid (decoction) to be applied to the lining of the mouth.
Maltese: Mediċini tal-ħxejjex li fihom dawn il-preparazzjonijiet tal-ħaxixa tal-Lewża tar-Raba' normalment ikunu disponibbli bħala materjal tal-ħxejjex li huwa użat sabiex isiru t-tejiet tal-ħxejjex biex jinxtorbu jew jiġu miżjuda mal-ilma sabiex jiġi prodott likwidu (dekozzjoni) li għandu jiġi applikat mal-kisja tal-ħalq.
English: Knotgrass herb medicines should only be used in adults and adolescents over the age of 12 years.
Maltese: Il-mediċini li fihom il-ħaxixa tal-Lewża tar-Raba' għandhom jintużaw biss f'adulti u adolexxenti li għandhom iktar minn 12-il sena.
English: The HMPC concluded, that on the basis of its long-standing use, these knotgrass herb preparations can be used for the relief of symptoms of common cold, for treating symptoms of minor mouth or throat inflammation and for minor problems affecting the urinary tract (structures that carry urine) to increase the production of urine in order to achieve flushing of the urinary tract.
Maltese: L-HMPC ikkonkluda li, abbażi tal-użu fit-tul tagħhom, dawn il-preparazzjonijiet li fihom il-ħaxixa talLewża tar-Raba' jistgħu jintużaw għas-serħan ta' sintomi tar-riħ komuni, għall-kura tas-sintomi ta' infjammazzjoni ħafifa tal-ħalq jew tal-griżmejn u għal problemi minuri li jaffettwaw il-passaġġ urinarju (strutturi li jġorru l-awrina) biex tiżdied il-produzzjoni tal-awrina, sabiex jitlaħlaħ il-passaġġ urinarju.
English: In its assessment, the HMPC considered a clinical study in men with gingivitis (inflammation of the gum).
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra studju kliniku fl-irġiel bil-ġinġivite (infjammazzjoni talħanek).
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing knotgrass herb.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Knotgrass herb preparations may also be found in combination with other herbal substances in some herbal medicines.
Maltese: Fiż-żmien tal-valutazzjoni tal-HMPC, ma kien ġie rrappurtat ebda effett sekondarju b'dawn il-mediċini.
English: The HMPC conclusions on the use of these knotgrass herb medicines for common colds, minor mouth or throat inflammation and minor problems affecting the urinary tract are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' dawn il-mediċini li fihom il-ħaxixa tal-Lewża tar-Raba' għallirjiħat komuni, għall-infjammazzjoni ħafifa tal-ħalq jew tal-griżmejn u għal problemi minuri li jaffettwaw il-passaġġ urinarju huma bbażati fuq l-‘użu tradizzjonali' tagħhom.
English: Neupro rotigotine
Maltese: Neupro rotigotina
English: The full EPAR for Neupro can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Neupro jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 03-2013.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'03-2013.
English: The decrease seen with Neupro was similar to that seen with pramipexole (2.8 h).
Maltese: It-tnaqqis innotat b'Neupro kien simili ta' dak li ntwera bi pramipexole (2.8 h).
English: This is a summary of the European public assessment report (EPAR) for Neupro.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Neupro.
English: In advanced Parkinson's disease, patients using Neupro had a greater decrease in their ‘off' time than those taking placebo (a decrease of 2.1 to 2.7 h with Neupro compared with 0.9 h with placebo).
Maltese: Fil-marda ta' Parkinson fl-istadju avvanzat, il-pazjenti ttrattati b'Neupro esperjenzaw tnaqqis akbar filperjodu li tqiesu bħala 'off' minn dawk ittrattati bil-plaċebo (tnaqqis ta' 2.1 sa 2.7 siegħa b'Neupro meta mqabbel ma' 0.9 sigħat bil-plaċebo).
English: • moderate to severe restless legs syndrome, a disorder where the patient has uncontrollable urges to move the limbs to stop uncomfortable, painful or odd sensations in the body, usually at night.
Maltese: • sindromu minn moderat sa gravi tar-riġlejn irrekwieti (restless legs syndrome), disturb li bih ilpazjent ikollu impulsi bla rażan biex iċaqlaq riġlejh ħalli jwaqqaf sensazzjonijiet skomdi jew li jweġġgħu jew strambi fil-ġisem, normalment bil-lejl.
English: In early-stage disease, 48 to 52% of the patients using Neupro had an improvement in symptoms, compared with 19 to 30% of those using placebo.
Maltese: Fl-istadju bikri talmarda, bejn 48% u 52% tal-pazjenti li użaw Neupro kellhom titjib fis-sintomi, apparagun mad-19% sa 30% ta' dawk li ngħataw il-plaċebo.
English: In Parkinson's disease, Neupro has been compared with placebo (a dummy treatment) in four studies involving 830 patients with early-stage disease and 842 patients with advanced disease.
Maltese: Fil-marda ta' Parkinson, Neupro tqabbel ma' plaċebo (trattament finta) f'erba' studji li fihom ħadu sehem 830 pazjent bil-marda fi stadju bikri u 842 pazjent bil-marda fi stadju avvanzat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neupro on 15 February 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Neupro valida fl-Unjoni Ewropea kollha fil-15 ta' Frar 2006.
English: The most common side effects with Neupro in patients with Parkinson's disease (seen in more than 1 patient in 10) are somnolence (sleepiness), dizziness, headache, nausea (feeling sick), vomiting, and application site reactions such as redness, itching and irritation of the skin.
Maltese: L-effetti sekondarji l-aktar komuni b'Neupro fil-pazjenti bil-marda ta' Parkinson (li dehru f'aktar minn pazjent 1 minn 10) huma ħedla, sturdament, uġigħ ta' ras, nawżja (dardir) remettar, u reazzjonijiet filpost fejn titqiegħed ir-roqgħa, bħal irritazzjoni u ħruq fil-ġilda.
English: Why has Neupro been approved?
Maltese: Għaliex ġie approvat Neupro?
English: What is Neupro?
Maltese: X'inhu Neupro?
English: The active substance in Neupro, rotigotine, is a dopamine agonist, which means that it imitates the action of dopamine.
Maltese: Is-sustanza attiva f'Neupro, rotigotina, hija agonista tad-dopamina li jfisser li timita l-azzjoni taddopamina.
English: What is the risk associated with Neupro?
Maltese: X'inhu r-riskju assoċjat ma' Neupro?
English: Neupro was less effective than ropinirole: an improvement was seen in 70% of the patients receiving ropinirole.
Maltese: Neupro irriżulta anqas effikaċi mir-ropinirol: ġie nnotat titjib f'70% tal-pazjenti li ngħataw ropinirol.
English: Neupro is a range of transdermal patches (patches that deliver a medicine across the skin).
Maltese: Neupro huwa firxa ta' stikks transdermiċi (dan ifisser li l-mediċina tingħata minn ġol-ġilda).
English: In restless legs syndrome, patients using doses of Neupro between 1 and 3 mg/24 h had a greater improvement than those using placebo in the two studies, as measured on both symptom scales.
Maltese: Fis-sindromu tar-riġlejn bla mistrieħ, il-pazjenti ttrattati b'dożaġġi ta' Neupro ta' bejn 1 u 3 mg/24 siegħa esperjenzaw titjib akbar minn dawk ittrattati bil-plaċebo fiż-żewġ studi, hekk kif imkejjel fiż-żewġ skali tas-sintomi.
English: Two of these studies also compared Neupro with other dopamine agonists (ropinirole in early-stage disease and pramipexole in advanced disease).
Maltese: Dawn iż-żewġ studji qabblu wkoll Neupro ma' agonisti tad-dopamina oħrajn (ropinirolo għall-istadju bikri u pramipexolo fl-istadju avvanzat).
English: Neupro is used to treat the symptoms of the following diseases in adults:
Maltese: Neupro jintuża fit-trattament tas-sintomi ta' dan il-mard li ġej fl-adulti:
English: In the smaller studies completed later, the effectiveness of Neupro was found to be comparable with ropinirole.
Maltese: Fl-istudji ż-żgħar li saru wara, l-effikaċja ta' Neupro instabet li kienet komparabbli mar-ropinirol.
English: Dopamine is a messenger substance in the parts of the brain that control movement and co-ordination.
Maltese: Id-dopamina hija sustanza messaġġiera li taħdem fil-partijiet tal-moħħ li jikkontrollaw ilmoviment u l-koordinazzjoni.
English: In moderate to severe restless legs syndrome, Neupro has been compared with placebo in two main studies involving a total of 963 patients.
Maltese: Fis-sindromu tar-riġlejn irrekwieti Neupro tqabbel ma' plaċebo f'żewġ studji ewlenin li fihom ħadu sehem total ta' 963 pazjent.
English: The patch is applied to dry, clean, healthy skin on the abdomen (tummy), thigh, hip, side, shoulder or upper arm.
Maltese: Ir-roqgħa titqiegħed fuq ġilda xotta, nadifa u f'saħħitha fuq l-addome (iż-żaqq), il-koxxa, il-ġenbejn, il-ġenb, l-ispalla jew filparti ta' fuq tad-driegħ.
English: The CHMP decided that Neupro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Neupro huma akbar mir-riskji tiegħu u għaldaqstant irrikkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: A special pack with patches of four different strengths is available to help when starting treatment for early-stage Parkinson's disease.
Maltese: Biex jinbeda t-trattament tal-marda ta' Parkinson fi stadju bikri huwa disponibbli pakkett speċjali li fih irqajja' b'erba' dożaġġi differenti.
English: Neupro is used on its own in early-stage disease, or in combination with levodopa (another medicine used in Parkinson's disease) at any stage of the disease, including the later stages when levodopa starts becoming less effective;
Maltese: Neupro jintuża waħdu fl-istadju bikri, jew flimkien mal-levodopa (mediċina oħra użata għall-marda ta' Parkinson) fl-istadji kollha tal-marda, anke fl-aħħar stadji meta llevodopa tibda titlef l-effikaċja tagħha;
English: Neupro was more effective than placebo in treating Parkinson's disease.
Maltese: Neupro rriżulta aktar effikaċi mill-plaċebo fit-trattament tal-marda ta' Parkinson.
English: The full EPAR for Zoledronic acid Teva Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ ta' Zoledronic acid Teva Pharma jinstab fis-sit web tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zoledronic acid Teva Pharma is a ‘generic medicine'.
Maltese: Zoledronic acid Teva Pharma huwa ‘mediċina ġenerika'.
English: Zoledronic acid Teva Pharma is given as an infusion lasting at least 15 minutes.
Maltese: Zoledronic acid Teva Pharma jingħata bħala infużjoni li ddum 15-il minuta.
English: Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Zoledronic acid Teva Pharma can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion.
Maltese: L-użu ta' paraċetamol jew ibuprofen (mediċini antiinfjamamtorji) eżatt wara Zoledronic acid Teva Pharma jista' jnaqqas is-sintomi bħad-deni, l-uġigħ fil-muskoli, sintomi simili għal dawk tal-influwenza, uġigħ fil-ġogi u wġigħ ta' ras fit-tlitt ijiem ta' wara l-infużjoni.
English: Zoledronic acid Teva Pharma is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid (5 mg).
Maltese: Zoledronic acid Teva Pharma huwa soluzzjoni għal infużjoni (dripp) fil-vina li fiha s-sustanza attiva aċidu żoledroniku (5 mg).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva Pharma on 16 August 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zoledronic acid Teva Pharma fis-16 ta' Awwissu 2012.
English: The active substance in Zoledronic acid Teva Pharma, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Zoledronic acid Teva Pharma, l-aċidu żoledroniku, hija bisfosfonat.
English: This is a summary of the European public assessment report (EPAR) for Zoledronic acid Teva Pharma.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zoledronic acid Teva Pharma.
English: Other information about Zoledronic acid Teva Pharma
Maltese: Informazzjoni oħra dwar Zoledronic acid Teva Pharma
English: A risk management plan has been developed to ensure that Zoledronic acid Teva Pharma is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Zoledronic acid Teva Pharma jintuża bl-aktar mod sigur possibbli.
English: This means that Zoledronic acid Teva Pharma is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aclasta.
Maltese: Dan ifisser li Zoledronic acid Teva Pharma huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) bl-isem Aclasta.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva Pharma has been shown to be comparable to Aclasta.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Zoledronic acid Teva Pharma wera li jista' jitqabbel ma' Aclasta.
English: What is Zoledronic acid Teva Pharma?
Maltese: X'inhu Zoledronic acid Teva Pharma?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva Pharma, including the appropriate precautions to be followed by healthcare professionals and patients.
Maltese: tagħrif ġiet inkluża informazzjoni rigward is-sigurtà ta' Zoledronic acid Teva Pharma, inklużi lprekawzjonijiet xierqa li għandhom ikunu segwiti mill-professjonisti tal-kura tas-saħħa u l-pazjenti.
English: Because Zoledronic acid Teva Pharma is a generic, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Zoledronic acid Teva Pharma huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu huma meqjusa l-istess bħal dawk tal-mediċina ta' referenza.
English: Zoledronic acid Teva Pharma is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men.
Maltese: Zoledronic acid Teva Pharma jintuża biex tiġi kkurata l-osteoporożi (marda li tagħmel l-għadam fraġli) fin-nisa li għaddew mill-menopawża u fl-irġiel.
English: What are the benefits and risks of Zoledronic acid Teva Pharma?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Zoledronic acid Teva Pharma?
English: Therefore, the CHMP's view was that, as for Aclasta, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Aclasta, il-benefiċċji huma akbar mir-riskji identifikati.
English: Maintenance (OCTAVE Sustain)
Maltese: Manteniment (OCTAVE Sostenn)
English: Active control (ADA)
Maltese: Kontroll attiv (ADA)
English: macrogol, and triacetin (E1518).
Maltese: macrogol, u triacetin (E1518).
English: *Spontaneous reporting data
Maltese: *Data minn rapportar spontanju
English: Date of first authorisation: 22 March 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 22 Marzu 2017
English: SD = Standard Deviation b
Maltese: SD=Devjazzjoni Standard b
English: Nominal p≤0.05;
Maltese: p≤0.05 nominali;
English: Rare ≥1/10,000 to
Maltese: Rari ≥1/10,000 sa
English: Nominal p<0.001;
Maltese: p<0.001 nominali;
English: - The active substance is tofacitinib.
Maltese: - Is-sustanza attiva hi tofacitinib.
English: Placebo + DMARD(s)
Maltese: Plaċebo + DMARD(s)
English: FD&C Blue #2/Indigo Carmine Aluminum Lake (E132) (10 mg strength only) FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133) (10 mg strength only)
Maltese: FD&C Blue #2/Indigo Carmine Aluminum Lake (E132) (qawwa ta' 10 mg biss) FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133) (qawwa ta' 10 mg biss)
English: 4.1 Therapeutic indication
Maltese: 4.1 Indikazzjoni terapewtika
English: Durability of clinical responses
Maltese: Durabilità tar-risponsi kliniċi
English: Abbreviations: TNFi=tumour necrosis factor inhibitor; UC=ulcerative colitis.
Maltese: TNFi=inibitur tal-fattur tan-nekrożi tat-tumur; UC=kolite ulċerattiva.
English: • Japanese or Korean patients.
Maltese: • pazjenti Ġappuniżi jew Koreani.
English: (see section 4.2).
Maltese: 3 (ara sezzjoni 4.2).
English: Tablet core sorbitol (E420) hydroxyethyl cellulose copovidone magnesium stearate
Maltese: Qalba tal-pillola sorbitol (E420) hydroxyethyl cellulose copovidone magnesium stearate
English: However, this difference is not considered to be clinically relevant.
Maltese: Madankollu, din id-differenza ma kinitx meqjusa klinikament rilevanti.
English: p<0.0001, tofacitinib versus placebo + MTX, LS = least squares, N = number of patients, QOW = every other week, NA = not applicable, HAQ-DI = Health Assessment Questionnaire Disability Index
Maltese: p<0.0001, tofacitinib kontra plaċebo + MTX, LS = least squares, N = numru ta' pazjenti, QOW = kull ġimagħtejn, NA = mhux applikabbli, HAQ-DI = Health Assessment Questionnaire Disability Index
English: Tablet core microcrystalline cellulose lactose monohydrate croscarmellose sodium magnesium stearate
Maltese: Qalba tal-pillola microcrystalline cellulose lactose monohydrate croscarmellose sodium magnesium stearate
English: Dyslipidaemia Hyperlipidaemia Dehydration
Maltese: Dislipidemija Iperlipidemija Deidrazzjoni