FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains duloxetine hydrochloride equivalent to 30 mg duloxetine.
Maltese: Kull kapsula fiha duloxetine hydrochloride ekwivalenti għal 30 mg duloxetine
English: • suffer from bipolar disorder;
Maltese: • tbati minn mard bipolari;
English: However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Maltese: Il-maġġoranza tar-reazzjonijiet avversi komuni, iżda, kienu ħfief jew moderati, ġeneralment bdew kmieni fit-terapija, u ħafna minnhom kellhom tendenza li jonqsu anki waqt it-tkomplija tat-terapija.
English: Very rare side effects (may affect up to 1 in 10,000 people): • inflammation of the blood vessels in the skin (cutaneous vasculitis).
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000):
English: Anaphylactic reaction Hyper-sensitivity
Maltese: Reazzjoni anafilattika Mard ta' sensitività eċċessiva
English: Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis and jaundice have been reported with duloxetine (see section 4.8).
Maltese: B'duloxetine ġew irrappurtati każi ta' ħsara fil-fwied, fosthom żidiet b'mod serju ta' enzimi tal-fwied (>10 darbiet il-limitu ta' fuq tan-normal), epatite u suffejra (ara sezzjoni 4.8).
English: Menopausal symptoms
Maltese: Riġidità talmuskoli
English: Co-administration of duloxetine with aluminium- and magnesium-containing antacids or duloxetine with famotidine had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.
Maltese: It-teħid ta' duloxetine flimkien ma' mediċini kontra l-aċtu fl-istonku li fihom aluminium u magnesium jew ma' famotidine ma kellhiex effett sinifikanti fuq ir-rata jew il-miżura ta' assorbiment ta' duloxetine wara li ngħatat doża orali ta' 40 mg.
English: Muscle tightness Muscle twitching
Maltese: .8 Effetti mhux mixtieqa
English: Adverse reactions may be more common during concomitant use of Duloxetine Zentiva and herbal preparations containing St. John's wort (Hypericum perforatum).
Maltese: • qiegħed/qiegħda tieħu St.John's Wort, kura bbażata fuq il-ħxejjex (Hypericum perforatum);
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal thoughts prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicidal behaviour, and should receive careful monitoring during treatment.
Maltese: Jekk ifeġġu sintomi intollerabbli wara tnaqqis fid-doża jew wara sospensjoni tal-kura, jista' jiġi kkunsidrat li terġa' tinbeda id-doża preċedenti ordnata.
English: Capsule shell
Maltese: Kapsula gastro-reżistenti, iebsa.
English: Duloxetine demonstrated statistically significant superiority over placebo in five out of five studies including four randomised, double-blind, placebo-controlled acute studies and a relapse prevention study in adult patients with generalised anxiety disorder.
Maltese: Duloxetine wera superjorità statistikament sinifikanti fuq plaċebo f'kull wieħed minn ħames studji li jinkludu erba' studji magħmula f'sitwazzjonijiet akuti, ikontrollati bi plaċebo, double-blind u randomised u studju ta' prevenzjoni ta' rikaduta f'pazjenti adulti b'disturb ta' ansjetà ġeneralizzata.
English: 160 00 Praha 6 - Vokovice Czech Republic
Maltese: Evropská 846/176a 160 00 Praha 6 - Vokovice Czech Republic
English: Actavis Group PTC ehf Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Maltese: Actavis Group PTC ehf Reykjavikurvegur 76-78 220
English: Farmaceutici Caber S.P.A. Viale Citta' D'Europa, 681 Rome
Maltese: Viale Citta' D'Europa, 681 Rome
English: Sanofi-Aventis Magyarország Kereskedelmi és Szolgáltató Kft. Tó u. 1-5
Maltese: Sanofi-Aventis Magyarország Kereskedelmi és Szolgáltató
English: Sanofi Aventis France 1-13, boulevard Romain Rolland 75014 Paris
Maltese: France 1-13, boulevard Romain Rolland 75014
English: Via Domenico Scarlatti, 31 20124 Milan
Maltese: Via Domenico Scarlatti, 31 20124
English: 67100 L'Aquila
Maltese: Via Campo di Pile S.N.C. 67100 L'Aquila
English: Les Trois Moulins Parc de Sophia Antipolis 06600 Antibes France
Maltese: Laboratoires Genevrier S.A. 280, rue de Goa Z.I. Les Trois Moulins Parc de Sophia Antipolis 06600 Antibes France
English: SPA - Societa' Prodotti Antibiotici S.P.A.
Maltese: SPA - Societa' Prodotti Antibiotici S.P.A. Via Biella, 8
English: Acarpia Servicos Farmaceuticos Lda Rua dos Murcas, 88
Maltese: Rua dos Murcas, 88
English: MYOPLEGE 4 mg, gélule
Maltese: MYOPLEGE 4 mg, gélule 4mg
English: Laboratorio Farmaceutico C.T.
Maltese: Laboratorio Farmaceutico C.T. S.R.L.
English: Zentiva Italia S.R.L.
Maltese: Italia S.R.L.
English: Valle Slimbene (Pavia) I-27010 Italy
Maltese: Valle Slimbene (Pavia)
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, Id-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq fl
English: Sanofi-Aventis AEBE Syngrou Av. 348
Maltese: AEBE Syngrou Av.
English: TIOCOLCHICOSIDE ZENTIVA 4mg
Maltese: TIOCOLCHICOSIDE ZENTIVA
English: Breakable tablet
Maltese: Germed Pharma
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: (44-20) 74 18 84 00 Faks (44-20) 74 18 84 16 Email: mail@emea.europa.eu http://www.emea.europa.eu
English: The active substance in Removab, catumaxomab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Removab, catumaxomab, hija antikorp monoklonali.
English: Other information about Removab:
Maltese: Informazzjoni oħra dwar Removab:
English: This summary was last updated in 03-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2009.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REMOVAB EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) REMOVAB Sommarju tal-EPAR għall-pubbliku
English: It contains the active substance catumaxomab.
Maltese: Fih is-sustanza attiva catumaxomab.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Removab to Fresenius Biotech GmbH on 20 April 2009.
Maltese: Ewropea, għal Removab lill-Fresenius Biotech GmbH fi 20 ta' April 2009.
English: The overall treatment period should not be longer than 20 days.
Maltese: Il-perjodu globali tat-trattament ma għandux ikun itwal minn 20 jum.
English: Around 90% of patients treated with Removab have side effects.
Maltese: Madwar 90% tal-pazjenti kkurati b'Removab għandhom effetti sekondarji.
English: It is usually given as four infusions in increasing doses from 10 to 150 micrograms over 11 days.
Maltese: Normalment jingħata bħala erba' infużjonijiet f'dożi li jiżdiedu minn 10 sa 150
English: The most common side effects with Removab (seen in more than 1 patient in 10) are lymphopenia (low level of lymphocytes, a type of white blood cell), abdominal (tummy) pain, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), fatigue (tiredness), chills and pain.
Maltese: L-effetti sekondarji l-aktar komuni b'Removab (li dehru f'aktar minn pazjent wieħed minn kull 10) huma limfopenija (livell baxx ta' limfositi, tip ta' ċellola bajda), uġigħ addominali (fiż-żaqq), nawseja (dardir), rimettar, dijarea, pireksja (deni), għeja kbira, tertir ta' bard u uġigħ.
English: Removab must be given as an intraperitoneal (into the peritoneal cavity) infusion using a pump system.
Maltese: Removab għandu jingħata bħala infużjoni intraperitoneali (ġol-kavità tal-peritonew) permezz ta' sistema ta' pompa.
English: Removab is used to treat malignant ascites, fluid accumulation in the peritoneal cavity (abdominal space) that is caused by a cancer.
Maltese: Removab jintuża għat-trattament ta' axxite malinna (malignant ascites), l-akkumulazzjoni ta' fluwidu fil-kavità tal-peritoneali (spazju addominali) ikkawżata minn kanċer.
English: Why has Removab been approved?
Maltese: Għaliex ġie approvat Removab?
English: What is Removab?
Maltese: X'inhu Removab?
English: How has Removab been studied?
Maltese: Kif ġie studjat Removab?
English: Removab was studied in one main study involving 258 patients with malignant ascites caused by an EpCAM-positive cancer and for which standard therapy was not available or was no longer feasible.
Maltese: Removab ġie studjat fi studju ewlieni li kien jinvolvi 258 pazjent b'axxite malinna kkawżata minn kanċer EpCAM-pożittiv għal u fejn it-terapija standard ma kinitx disponibbli jew ma kinitx aktar possibbli.
English: This compared with 11 days for patients who were treated with drainage alone.
Maltese: Dan tqabbel ma' 11-il jum għal pazjenti li rċevew it-trattament ta' drenaġġ biss.
English: On average, patients who received Removab lived for 46 days without the need for further drainage.
Maltese: B'mod ġenerali, il-pazjenti li rċevew Removab għexu għal 46 jum mingħajr il-ħtieġa ta' aktar drenaġġ.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Removab's benefits are greater than its risks for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinoma where standard therapy is not available or no longer feasible.
Maltese: Removab huma ikbar mir-riskji tiegħu għat-trattament intraperitoneali tal-axxite malinna f'pazjenti b'karċinoma pożittiva għal EpCAM fejn it-terapja standard ma tkunx disponibbli jew ma tkunx aktar possibbli.
English: Removab is a concentrate that is made up into a solution for infusion (a drip).
Maltese: Removab huwa konċentrat li jinħadem f'soluzzjoni għall-infużjoni (dripp).
English: Removab should not be used in people who may be hypersensitive (allergic) to catumaxomab, to any of the other ingredients, or to murine (rat or mouse) proteins.
Maltese: Removab m'għandux jintuża f'nies li huma ipersensittivi (allerġiċi) għal catumaxomab, għal kwalunkwe sustanza oħra, jew għal proteini murine (li ġejjin mill-ġrieden jew mill-firien).
English: What is the risk associated with Removab?
Maltese: X'inhu r-riskju assoċjat ma' Removab?
English: How does Removab work?
Maltese: Liema benefiċċju wera Removab waqt l-istudji mwettqa?
English: Patients who have severe problems with their liver, or moderate or severe kidney problems should only be given Removab treatment after careful consideration of the medicine's benefits and risks.
Maltese: Il-pazjenti li għandhom problemi severi fil-fwied, jew problemi moderati jew severi fil-kliewi għandhom jingħataw it-trattament b'Removab biss wara eżami b'attenzjoni tal-benefiċċji u r-riskji tal-mediċina.
English: Removab can only be used in patients with EpCAM-positive carcinomas.
Maltese: Removab jista' jintuża biss għal pazjenti li għandhom karċinomi EpCAM-pożittivi.
English: Catumaxomab has been designed to attach to two antigens: EpCAM, which is found in high levels on some types of cancer cells and CD3, which is found on T-cells.
Maltese: EpCAM, li jinsab f'livelli għoljin fuq xi tipi ta' ċelloli tal-kanċer u CD3, li jinsab fuq ċelloli T. Iċ-ċelloli T huma parti mis-sistema immuni (id-difiżi naturali tal-ġisem), u huma involuti fil-koordinazzjoni tal-qerda taċ-ċelloli infettati u anormali.
English: Catumaxomab also attaches to a third substance called the Fc-gamma receptor, which also helps the body's immune system to target the cancer cells.
Maltese: Catumaxomab jeħel ukoll ma' sustanza oħra msejħa r-riċettur Fcgamma, li jgħin ukoll lis-sistema immuni tal-ġisem biex timmira ċ-ċelluli tal-kanċer.
English: In patients with cancer, ascites forms because cancer cells develop on the peritoneum, the membrane around the peritoneal cavity, where they block the natural drainage of fluid from the abdomen.
Maltese: F'pazjenti bil-kanċer, l-axxite tifforma għax iċ-ċelloli tal-kanċer jiżviluppaw fuq il-peritonew, ilmembrana ta' madwar il-kavità tal-peritonew, fejn jikkawżaw imblokk għad-drenaġġ naturali tal fluwidi mill-addome.
English: Removab is not recommended for use in patients below the age of 18 years because of a lack of information on safety and effectiveness in this age group.
Maltese: Removab mhuwiex rakkomandat għall-użu f'pazjenti iżgħar minn 18-il sena minħabba nuqqas ta' tagħrif dwar is-sigurtà u l-effikaċja f'dan il grupp ta' età.
English: EU/1/19/1400/001 Rhokiinsa
Maltese: EU/1/19/1400/001 Rhokiinsa µg/ml
English: Eye drops, solution Ocular use bottle (LDPE)
Maltese: Użu okulari flixkun (LDPE)
English: 2.5 ml
Maltese: 2.5 ml flixkun 1
English: MA (EU) Number
Maltese: Numru tal-MA (tal-UE)
English: IU/1200 IU solvent: 10 ml
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Prof. Pieter de Graeff (the Netherlands)
Maltese: Pieter de Graeff (L-Olanda)
English: EMA/106818/2010 Rev. 1 EMEA/H/A-29/1247
Maltese: EMEA/H/A-29/1247
English: What is Clopidogrel Orion?
Maltese: X'inhu Clopidogrel Orion?
English: Clopidogrel Orion is a generic medicine based on a ‘reference medicine', Plavix, which is authorised in the EU.
Maltese: Clopidogrel Orion hija mediċina ġenerika bbażata fuq il-‘mediċina ta' referenza', Plavix, li hija awtorizzata fl-UE.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Clopidogrel Orion outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden.
Maltese: IlKumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li l-benefiċċji ta' Clopidogrel Orion huma akbar mir-riskji, u li l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata filĠermanja u fl-Istati Membri tal-UE li ġejjin: ir-Repubblika Ċeka, id-Danimarka, il-Finlandja, il-Latvja, ilLitwanja, in-Norveġja, is-Slovakkja u l-Iżvezja.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden).
Maltese: fi Stati Membri oħrajn (l-‘Istati Membri kkonċernati', f'dan il-każ ir-Repubblika Ċeka, id-Danimarka, ilFinlandja, il-Latvja, il-Litwanja, in-Norveġja, is-Slovakkja u l-Iżvezja).
English: Teva Pharma B.V. submitted Clopidogrel Orion to Germany for a decentralised procedure.
Maltese: Orion Pharma B.V. issottomattiet Clopidogrel Orion lill-Ġermanja għal proċedura diċentralizzata.
English: Clopidogrel Orion is a medicine that contains the active substance clopidogrel.
Maltese: Clopidogrel Orion huwa prodott mediċinali li fih is-sustanza attiva clopidogrel.
English: 2 June 2010
Maltese: 2 ta' Ġunju 2010
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Clopidogrel Orion and associated names.
Maltese: L-Aġenzija Ewropea tal-Mediċini lestiet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost Stati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Clopidogrel Orion u l-ismijiet assoċjati.
English: Clopidogrel base is less stable than the salt form, and BHA is included in the medicine to stabilise it..
Maltese: Clopidogrel base huwa inqas stabbli mill-forma tal-melħ, u BHA ġie inkluż fil-mediċina biex jistabilizzaha.
English: As the Member States were not able to reach an agreement, the German medicines regulatory agency referred the matter to the CHMP for arbitration on 29 October 2009.
Maltese: Minħabba li l-Istati Membri ma setgħux jilħqu ftehim, l-aġenzija regolatorja tal-mediċini Ġermaniża irriferiet il-kwistjoni lis-CHMP għal arbitraġġ fid-29 ta' Ottubru 2009.
English: Date of first authorisation: 18 May 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Mejju 2018
English: EU/1/18/1280/001 EU/1/18/1280/002 EU/1/18/1280/003 EU/1/18/1280/004 EU/1/18/1280/005
Maltese: EU/1/18/1280/001 EU/1/18/1280/002 EU/1/18/1280/003 EU/1/18/1280/004
English: Study 11*
Maltese: Studju 11*
English: (pleurisy)
Maltese: (ċellulite)
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies
Maltese: Antikorpi antinukleari (ANA)/ antikorpi kontra double stranded DNA (dsDNA)
English: Maintenance (n = 99)
Maltese: (n = 99)
English: 10 6336 Langkampfen AUSTRIA
Maltese: 10 6336 Langkampfen L-Awstrija
English: Depression, insomnia.
Maltese: Komuni: Depressjoni, insomnja.
English: EU/1/18/1280/001 1 vial 100 mg EU/1/18/1280/002 2 vials 100 mg EU/1/18/1280/003 3 vials 100 mg EU/1/18/1280/004 4 vials 100 mg EU/1/18/1280/005 5 vials 100 mg
Maltese: EU/1/18/1280/001 1 kunjett 1 ta' 100 mg EU/1/18/1280/002 2 kunjetti ta' 100 mg EU/1/18/1280/003 3 kunjetti ta' 100 mg EU/1/18/1280/004 4 kunjetti ta' 100 mg EU/1/18/1280/005 5 kunjetti ta' 100 mg
English: Tachycardia, palpitation.
Maltese: Komuni: Takikardija, palpitazzjoni.
English: Excipients: Disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
Maltese: Disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
English: Study 13
Maltese: Studju 13
English: Limit of Normal (ULN) have been observed (see Table 2).
Maltese: Żidiet tal-ALT ≥ 5 darbiet il-Limitu ta' Fuq tan-Normal (ULN) ġew osservati (ara Tabella 2).
English: Reduction in CDAI ≥ 25% and ≥ 70 points.
Maltese: Tnaqqis Mingħajr Sterojdi a Tnaqqis fis-CDAI ≥ 25% u ≥ 70 punt.
English: d p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Maltese: d p = 0.030 u < 0.001 għall-gruppi ta' kura b'3 mg/kg u 6 mg/kg rispettivament vs. plaċebo +
English: Allergic respiratory symptom.
Maltese: Komuni: Sintomu respiratorju allerġiku.
English: Store at 2°C - 8°C.
Maltese: Aħżen f'temperatura ta' 2 °C - 8 °C.
English: Study 5 (week-14 responders)
Maltese: Studju 5 (Persuni li rrispondew sa ġimgħa 14)
English: • The other ingredients are disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
Maltese: • Is-sustanzi l-oħra huma disodium succinate hexahydrate, succinic acid, sucrose, polysorbate 80.
English: At single doses of 3, 5, or 10 mg/kg, the median Cmax values were 77, 118, and 277 micrograms/ml, respectively.
Maltese: F'dożi waħidhom ta' 3, 5, jew 10 mg/kg, il-valuri Cmax medjani kienu 77, 118 u 277 mikrogrammi/ml rispettivament.
English: Study 10
Maltese: Studju 10
English: Viral infection (e.g. influenza, herpes virus infection).
Maltese: Infezzjoni virali (eż. influwenza, infezzjonijiet bil-virus tal erpes)
English: Based on an observational study from Northern Europe, an increased risk (OR, 95% CI; p-value) for C-section section (1.50, 1.14-1.96; p = 0.0032), preterm birth (1.48, 1.05-2.09; p = 0.024), small for gestational age (2.79, 1.54-5.04; p = 0.0007), and low birth weight (2.03, 1.41-2.94; p = 0.0002) was observed in women exposed during pregnancy to infliximab (with or without immunomodulators/corticosteroids, 270 pregnancies) as compared to women exposed to immunomodulators and/or corticosteroids only (6,460 pregnancies).
Maltese: Abbażi ta' studju ta' osservazzjoni mill-Ewropa tat-Tramuntana, ġew osservati żieda fir-riskju (OR, CI ta' 95%; valur p) ta' ċesarja (1.50, 1.14-1.96; p=0.0032), twelid qabel iż-żmien (1.48, 1.05-2.09; p=0.024), tarbija żgħira għall-età tat-tqala (2.79, 1.54-5.04; p=0.0007), u piż tat-twelid baxx (2.03, 1.41-2.94; p=0.0002) f'nisa esposti għal infliximab matul it-tqala (flimkien ma' immunomodulaturi/kortikosterojdi jew mingħajrhom, 270 tqala) meta mqabbla ma' nisa esposti għal immunomodulaturi u/jew kortikosterojdi biss (6,460 tqala).
English: Zessly contains Sodium
Maltese: Zessly fih sodium
English: infliximab Maintenance (5 mg/kg) (n = 96)
Maltese: Manteniment b'Infliximab (5 mg/kg) (n = 96)
English: Fistula Response (%) a Complete fistula response (%) b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Maltese: Rispons fistula komplet (%) b a Tnaqqis ta' ≥ 50% mill-linja bażi fin-numru ta' fistuli li kienu qed inixxu fuq perjodu ta'
English: Week 50
Maltese: PASI 75.
English: Zessly contains the active substance infliximab.
Maltese: Zessly fih is-sustanza attiva infliximab.
English: Study 3 was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
Maltese: double-blind, bi 3 partijiet tal-istudji, ta' grupp parallel.
English: Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000
Maltese: Fil-klassijiet tassistema tal-organi, ir-reazzjonijiet avversi huma elenkati taħt it-titli tal-frekwenza bl-użu tal-kategoriji li ġejjin: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1000 sa < 1/100); rari
English: Zessly is available in packs containing 1, 2, 3, 4, or 5 vials.
Maltese: Zessly huwa disponibbli f'pakketti li fihom 1, 2, 3, 4 jew 5 kunjetti.
English: Clinical Responsea Clinical Remission
Maltese: Rispons Klinikua Tnaqqis Kliniku
English: infliximab Maintenance 5 mg/kg (n = 113) (p value)
Maltese: Manteniment b'Infliximab 5 mg/kg (n = 113) (Valur p)
English: Table 9 Effects on ACR and PASI in patients with active psoriatic arthritis, data from study 10 and study 11
Maltese: Tabella 9 Effetti fuq l-ACR u PASI f'pazjenti b'artrite psorjatika attiva, data minn studju 10 u studju 11
English: N ≥ 90% improvement
Maltese: N Titjib ta' ≥ 90%
English: The following adverse reactions were reported more commonly in paediatric Crohn's disease patients (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leukopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
Maltese: Crohn (ara sezzjoni 5.1) milli f'pazjenti adulti bil-marda ta' Crohn: anemija (10.7%), demm fl-ippurgar (9.7%), lewkopenja (8.7%), fwawar (8.7%), infezzjonijiet virali (7.8%), newtropenija
English: Other medicines and Zessly
Maltese: Mediċini oħra u Zessly
English: There is limited safety experience of infliximab treatment in patients who have undergone surgical procedures, including arthroplasty.
Maltese: Hemm esperjenza limitata dwar is-sigurtà tal-kura b'infliximab f'pazjenti li kellhom proċeduri kirurġiċi, inkluż arthroplasty.
English: Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30, and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Maltese: Minn 22 individwu li kellhom fistuli fil-linja bażi, 63.6% (14/22), 59.1% (13/22) u 68.2% (15/22) kellhom rispons sħiħ tal fistula f'ġimgħa 10, 30 u 54, rispettivament, fil-gruppi ta' manteniment kombinati tal-ġimgħat q8 u ġimgħat q12.
English: infliximab Maintenance 10 mg/kg (n = 112) (p value)
Maltese: Manteniment b'Infliximab 10 mg/kg (n = 112) (Valur p)
English: Study 13 evaluated the efficacy of infliximab induction and maintenance therapy in 378 patients with plaque psoriasis.
Maltese: Studju 13 evalwa l-effikaċja tat-terapija ta' induzzjoni b'infliximab u terapija ta' manteniment f'378 pazjent bi psorjasi tal-plakka.
English: • Zessly will be given to you by your doctor or nurse.
Maltese: • Zessly ser jiġi mogħti lilek mit-tabib tiegħek jew infermier.
English: b Based on patients with PASI ≥ 2.5 at baseline for study 10, and patients with ≥ 3% BSA
Maltese: b Bażata fuq pazjenti li kellhom PASI > 2.5 fil-linja bażi għal studju 10, u pazjenti b'> 3% BSA
English: Juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis
Maltese: Artrite idjopatika ġuvenili, artrite psorijatika u ankylosing spondylitis