FrancophonIA/ELRC3.0 huggingface dataset:
English: haematuria, incontinence, micturition urgency, renal colic, renal pain
Maltese: Kalkulu flawrina, inkontinenza ta' l-awrina, ematurja, inkontinenza, urġenza biex turina, kolika talkliewi, uġigħ filkliewi
English: Topamax and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally] topiramate
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) pilloli ta' 100 mg miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] topiramate
English: Treatment of children over 6 years of age should begin at 0.5 to 1 mg/kg nightly for the first week.
Maltese: Kura ta' tfal li għandhom età ta' iktar minn 6 snin għandha tibda b'0.5 sa 1 mg/kg kull lejl għall-ewwel ġimgħa.
English: In patients with impaired renal function (CLCR ≤ 60 mL/min) topiramate should be administered with caution as the plasma and renal clearance of topiramate are decreased.
Maltese: F'pazjenti b'indeboliment fil-funzjoni tal-kliewi (CLCR ≤ 60 mL/min) topiramate għandu jingħata b'kawtela minħabba li t-tneħħija ta' topiramate mill-plażma u mill-kliewi tonqos.
English: A suitable warning to the effect that the possibility of decreased contraceptive efficacy and increased breakthrough bleeding should be considered in patients taking combination oral contraceptive products with Topamax has been included and is supported by the CHMP.
Maltese: Il-possibiltà ta' tnaqqis fl-effikaċja kontraċettiva u żieda fil-fsada f'nofs iċ-ċiklu għandha tkun ikkunsidrata f'pazjenti li jieħdu prodotti kontraċettivi orali kkombinati flimkien ma' Topamax.
English: In paediatric clinical trials, topiramate was gradually withdrawn over a 2-8 week period.
Maltese: Fi provi kliniċi fit-tfal, topiramate twaqqaf bil-mod il-mod fuq perjodu ta' bejn ġimgħatejn u 8 ġimgħat.
English: AED Coadministered AED Concentration Topamax Concentration
Maltese: Jekk tinsa tieħu Topamax
English: Topamax belongs to a group of medicines called “antiepileptic medicines.” It is used:
Maltese: Topamax jagħmel parti minn grupp ta' mediċini msejħa “mediċini kontra l-epilessija”.
English: Topiramate did not affect metformin tmax.
Maltese: Topiramate m'affettwax it- tmax ta' metformin.
English: Topiramate showed a reduction of PTGC seizures rate in the American/CR study, and when both studies were combined.
Maltese: Topiramate wera tnaqqis fir-rata ta' attakki PGTC fl-istudju Amerikan/Kosta Rika, u meta ż-żewġ studji ngħaqdu flimkien.
English: • Severe skin reaction, including Stevens-Johnson syndrome, a life threatening skin condition in which the upper layer of the skin separates from the lower, and erythma multiforme, a condition of raised red spots that can blister
Maltese: • Reazzjoni qawwija fil-ġilda, inkluż is-sindrome ta' Stevens-Johnson, kundizzjoni fil-ġilda li tista' tkun ta' periklu għall-ħajja fejn il-parti ta'fuq tal-ġilda tinfired minn dik tal-parti ta' taħt, u erythema multiforme, kundizzjoni ta' marki tondi mqabbżin li jitgħu jsiru nfafet
English: Topamax and associated names (see Annex I) 50 mg film-coated tablets [See Annex I - To be completed nationally] topiramate
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) pilloli ta' 50 mg miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] topiramate
English: • Swollen glands in the neck armpit or groin
Maltese: • għandek problemi fl-għajnejn, speċjalment glawkoma
English: Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination.
Maltese: Riżultati kliniċi tal-laboratorju indikaw tnaqqis fil-potassium tas-serum wara li ngħata topiramate jew HCTZ, li kien akbar meta HCTZ u topiramate ingħataw flimkien.
English: This is seen to be supportive of the proposed indication of topimarate as adjunctive therapy for partial onset seizures with or without secondarily generalised seizures in the paediatric population.
Maltese: Dan jitqies bħala appoġġ għall-indikazzjoni proposta ta' topimarate bħala terapija aġġuntiva għall-attakki parzjali talbidu bi jew mingħajr attakki ġeneralizzati sekondarji fil-popolazzjoni pedjatrika.
English: Concomitant multiple-dose administration of topiramate, 100 to 400 mg twice a day, with phenytoin or carbamazepine shows dose proportional increases in plasma concentrations of topiramate.
Maltese: L-għoti ta' ħafna dożi konkomitanti ta' 100 mg sa 400 mg topiramate darbtejn kuljum ma' phenytoin jew carbamazepine juri żidiet fil-konċentrazzjonijiet ta' topiramate fil-plasma fi proporzjon mad-doża.
English: Strength
Maltese: Depressjoni
English: SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF
Maltese: Intreazzjonijiet ma' prodotti mediċinali oħra
English: A low capacity binding site for topiramate in/on erythrocytes that is saturable above plasma concentrations of 4 µg/ml has been observed.
Maltese: Kien osservat sit ta' kapaċita baxxa fl-eritroċiti jew fuqhom ma' fejn jeħel topiramate li jilħaq il-limiti ta' saturazzjoni f'konċentrazzjonijiet tal-plasma 'l fuq minn 4 µg/ml.
English: Janssen-Cilag S.A. - ES
Maltese: Janssen-Cilag AS - NO
English: There were no relevant effects on long bone (tibia) growth or bone (femur) mineral density, preweaning and reproductive development, neurological development (including assessments on memory and learning), mating and fertility or hysterotomy parameters.
Maltese: Ma kien hemm l-ebda effetti rilevanti fuq kif kibret l-għadma t-twila (tibia) jew id-densità minerali tal-għadma (femur), żvilupp qabel il-fatma u riproduttiv, żvilupp newroloġiku (inkluż stimi fuq il-memorja u t-tagħlim), tgħammir u fertilità jew fuq parametri ta' inċiżjoni fl-utru.
English: In clinical studies, there was no consistent relationship between plasma concentrations and efficacy or adverse events.
Maltese: Fi studji kliniċi, ma kien hemm l-ebda relazzjoni konsistenti bejn konċentrazzjonijiet fil-plasma u effikaċja jew każijiet avversi.
English: Topamax and associated names (see Annex I) 15 mg hard capsules
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 15 mg
English: • Involuntary movement of the eyes
Maltese: • Moviment involontarju tal-għajnejn
English: • Eye problems including dry eyes, light sensitivity, involuntary twitching, tearing and decreased vision
Maltese: • Problemi fl-għajnejn inkluż għajnejn xotti, sensittività għad-dawl, moviment involontarju għall għarrieda, joħroġ id-dmugħ u tnaqqis fil-vista
English: EXP:
Maltese: Huwa jintuża:
English: INFORMATION IN BRAILLE Not applicable.
Maltese: INFORMAZZJONI BIL-BRAILLE
English: In addition, a statement on the interaction of topiramate with St John's Wort was also included in the Product Information.
Maltese: Barra minn hekk, dikjarazzjoni dwar l-interazzjoni ta' topiramate ma' St John's Wort ġiet inkluża wkoll fl-Informazzjoni dwar il-Prodott.
English: • Never store any medicine and food mixture for use at a later time.
Maltese: • Qatt taħżen xi taħlita ta' ikel u mediċina biex tintuża aktar tard.
English: 20 October 2015 EMA/490629/2015
Maltese: EMA/490629/2015
English: Herbal medicines containing matricaria flower preparations are available as herbal teas to be drunk or their steam inhaled; as infusions to be applied onto the skin or lining of the mouth; as liquid forms to be taken by mouth, used for steam inhalation, for rinsing the mouth or applied on the skin, or used as bath additives; and as semi-solid forms (such as ointments) to be applied onto the skin.
Maltese: Il-mediċini erbali li fihom il-preparazzjonijiet tal-fjuri tal-kamumella huma disponibbli bħala tejiet erbali li għandhom jinxtorbu jew li l-fwar tagħhom jinġibed man-nifs; bħala infużjonijiet li għandhom jiġu applikati fuq il-ġilda jew ir-rita tal-ħalq; forom likwidi li għandhom jittieħdu mill-ħalq, użati għallinalazzjoni tal-fwar, għat-tlaħliħ tal-ħalq jew applikati fuq il-ġilda, jew użati bħala addittivi fil-banju; u bħala forom semi-solidi (bħal ingwenti) li għandhom jiġu applikati fuq il-ġilda.
English: • treating the symptoms of minor gastro-intestinal (stomach and gut) complaints such as bloating and minor spasms;
Maltese: • il-kura ta' sintomi ta' ilmenti gastro-intestinali (stonku u msaren) minuri bħal nefħa u spażmi żgħar;
English: Matricaria flower medicines are usually for use in adults and adolescents (above 12 years of age).
Maltese: Il-mediċini li fihom il-fjura tal-kamumella ġeneralment jintużaw biss f'adulti u adolexxenti (li għandhom iktar minn 12-il sena).
English: • relieving the symptoms of common cold;
Maltese: • is-solliev mis-sintomi ta' riħ komuni;
English: Matricaria flower is the common name for the flower heads of the plant Matricaria recutita L. (also known as chamomile).
Maltese: Fjura tal-kamumella huwa l-isem komuni għall-blanzuni tal-fjuri tal-pjanta Matricaria recutita L. (magħrufa wkoll bħala kamumella).
English: Other information about matricaria flower medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom il-fjura tal-kamumella
English: Their frequency has not been established.
Maltese: Il-frekwenza tagħhom ma ġietx stabbilita.
English: What are the risks associated with matricaria flower medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom il-fjura tal-kamumella?
English: For dry extracts the solvent is then evaporated to obtain the extract.
Maltese: Għal estratti nexfin, is-solvent imbagħad jiġi evaporat biex jinkiseb l-estratt.
English: Further information on the risks associated with matricaria flower medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini li fihom il-fjura tal-kamumella, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku tal-Aġenzija:
English: Matricaria flower medicines must not be used in patients allergic to matricaria flowers or other plants of the Asteraceae (Compositae) family.
Maltese: Il-fjura tal-kamumella ma għandhiex tintuża f'pazjenti li huma allerġiċi għall-fjuri tal-kamumella jew pjanti oħrajn tal-familja Asteraceae (Compositae).
English: • as add-on treatment of irritation of the skin and areas around the anus and genitals, once serious conditions have been excluded by a doctor;
Maltese: • bħala kura addizzjonali għall-irritazzjoni tal-ġilda u l-partijiet madwar l-anus u l-ġenitali, ladarba jiġu esklużi kundizzjonijiet serji minn tabib;
English: Matricaria flower
Maltese: Fjura tal-kamumella
English: Further information on the HMPC assessment of matricaria flower 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: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: • treating minor inflammation of the skin (sunburn) and superficial wounds and small boils
Maltese: • il-kura ta' infjammazzjoni minuri tal-ġilda (ħruq mix-xemx) u feriti superfiċjali u tismit ta' partijiet żgħar (furunkli).
English: • treating minor ulcers (open sores) and inflammations of the mouth and throat;
Maltese: • il-kura ta' ulċeri minuri (feriti miftuħin) u l-infjammazzjonijiet tal-ħalq u l-griżmejn;
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of matricaria flower.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-fjura tal-kamumella.
English: Allergic reactions, sometimes severe, have been reported following contact of liquid chamomile preparations with internal moist surfaces such as the lining of the mouth.
Maltese: Reazzjonijiet allerġiċi, xi drabi severi, ġew irrapportati wara li l-preparazzjonijiet ta' kamumella likwida jiġu f'kuntatt mal-uċuh ta' umdu interni bħar-rita tal-ħalq.
English: What are the HMPC conclusions on its medicinal uses?
Maltese: X'inhuma l-konklużjonijiet tal-HMPC dwar l-użu mediċinali tagħha?
English: Extracts are prepared using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol).
Maltese: L-estratti jitħejjew permezz ta' teknika biex jiġu estratti l-komposti mill-materjal tal-pjanta billi jiddewbu f'solvent (bħall-etanol).
English: EMEA/H/C/000549
Maltese: EMA/H/C/000549
English: Each injection lasts 15 minutes.
Maltese: Kull injezzjoni ddum 15-il minuta.
English: Other information about Pedea
Maltese: Informazzjoni oħra dwar Pedea
English: This is a summary of the European public assessment report (EPAR) for Pedea.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pedea.
English: The most common side effects seen in babies receiving the medicine (seen in more than 1 baby in 10) are thrombocytopenia (low blood platelet counts), neutropenia (low levels of neutrophils, a type of white blood cell), bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely), increased blood creatinine levels (a marker of kidney function) and decreased blood sodium levels.
Maltese: L-iktar effetti sekondarji komuni li dehru fit-trabi li ngħataw il-mediċina(li dehru f'iktar minn tarbija 1 minn kull 10) huma tromboċitopenja (livell baxx ta' platelets tad-demm), newtropenija (tnaqqis tallivelli ta' newtrofili, tip ta' ċellola bajda tad-demm), displażija bronkopulmonari (tessut anormali filpulmun, li ġeneralment jinstab fit-trabi li jkunu twieldu qabel iż-żmien), żieda fil-livelli ta' kreatinina (sinjal ta' problemi fil-kliewi) u tnaqqis fil-livelli tas-sodju fid-demm.
English: Pedea is a solution for injection that contains the active substance ibuprofen.
Maltese: Pedea huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva ibuprofen.
English: In the study looking at the treatment of patent ductus arteriosus, the approved dose of Pedea led to a closure rate of 75% in babies born 11 to 13 weeks premature (six out of eight) and 33% in babies born 14 to 16 weeks premature (two out of six).
Maltese: Fl-istudju li ffoka fuq id-ductus arteriosus bil-preve ntiva, id-doża approvata ta' Pedea wasslet għal rata ta' għeluq ta' 75% fit-trabi mwielda bejn 11 u 13-il ġimgħa qabel (sitta minn tmienja) u 33% fit-trabi li twieldu bejn 14 u 16-il ġimgħa qabel (tnejn minn sitta).
English: What is the risk associated with Pedea?
Maltese: X'inhu r-riskju assoċjat ma' Pedea?
English: The active substance in Pedea, ibuprofen, has been used since the 1960s as a painkiller and an anti inflammatory medicine.
Maltese: Is-sustanza attiva f'Pedea, l-ibuprofen, ilha tintuża sa mis-sittinijiet biex ittaffi l-uġigħ u bħala mediċina antiinfjammatorja.
English: However, the study had to be stopped early because of side effects (kidney and lung problems).
Maltese: Madankollu, l-istudju kellu jitwaqqaf kmieni minħabba tal-effetti sekondarji (problemi filfwied u fil-pulmun).
English: The full EPAR for Pedea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Send a question via our website www.ema.europa.eu/contact© L-Aġenzija Ewropea għall-Mediċini, 2015.
English: Pedea is given as three injections into a vein at 24-hour intervals.
Maltese: Pedea jingħata bħala tliet injezzjonijiet fil-vina b'intervalli ta' 24 siegħa.
English: Why has Pedea been approved?
Maltese: Għaliex ġie approvat Pedea?
English: Because ibuprofen has been in use for a long time, the company presented information from the published literature.
Maltese: Minħabba li ibuprofen ilu jintuża għal ħafna żmien, il-kumpanija ppreżentat informazzjoni minn dokumentazzjoni ppubblikata.
English: The European Commission granted a marketing authorisation valid throughout the European Union to Orphan Europe SARL on 29 July 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fuq is-suq valida madwar l-Unjoni Ewropea għal Pedea lil Orphan Europe SARL fid-29 ta' Lulju 2004.
English: What is Pedea?
Maltese: X'inhu Pedea?
English: Pedea should not be used before there is proof that the baby has patent ductus arteriosus.
Maltese: Pedea ma għandux jintuża qabel ikun hemm evidenza li t-tarbija għandha d-ductus arteriosus bilpreventiva.
English: As prostaglandins are also involved in keeping the ductus arteriosus open after birth, Pedea is thought to work by reducing the levels of prostaglandins, allowing this blood vessel to close.
Maltese: Peress li l-prostaglandini huma involuti fiż-żamma tad-ductus arteriosus miftuħ wara ttwelid, Pedea huwa maħsub li jaħdem billi jnaqqas il-livelli ta' prostaglandini, u jippermetti li din il-vina tingħalaq.
English: In study looking at the use of Pedea before there was proof that the babies had patent ductus arteriosus, Pedea seemed to be more effective than placebo at preventing surgery.
Maltese: Fl-istudju li ffoka fuq l-użu ta' Pedea qabel ma kien hemm evidenza li t-trabi kienu jbatu minn ductus arteriosus bil-preventiva, Pedea deher li kien iktar effettiv mill-plaċebo fl-intervent kirurġiku ta' prevenzjoni.
English: A further study compared the effects of Pedea and placebo (a dummy treatment) in 131 newborns who were treated before there was proof that they had patent ductus arteriosus.
Maltese: Studju ieħor qabbel l-effetti ta' Pedea u plaċebo (kura finta) f'131 tarbija tat-twelid li kienu diġà ġew ikkurati qabel ma kien hemm evidenza li kienu qed isofru minn ductus arteriosus bil-preventiva.
English: It works by reducing the level of chemical messengers called prostaglandins within cells.
Maltese: Ir-riproduzzjoni hija awtorizzata kemm-il darba jissemma' s-sors oriġinali.
English: Pedea must not be used in babies who have a life-threatening infection, bleeding, blood clotting problems or significant kidney problems.
Maltese: Pedea ma għandux jintuża fi trabi li għandhom infezzjoni serja, fsada, problemi ta' tagħqid tad-demm jew problemi fil-kliewi.
English: For the full list of restrictions see the see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet ara l-fuljett ta' tagħrif.
English: For the full list of all side effects reported with Pedea, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrapportati ma' Pedea, ara l-fuljett ta' tagħrif.
English: How has Pedea been studied?
Maltese: Kif ġie studjat Pedea?
English: Patent ductus arteriosus is a condition where the ductus arteriosus (the blood vessel that allows blood to bypass the baby's lungs before birth) fails to close after birth.
Maltese: Ductus arteriosus bil-preventiva hija kondizzjoni fejn id-ductus arteriosus (il-vina li tippermetti d-demm sabiex jevita milli jgħaddi minn ġol-pulmuni tattarbija qabel it-twelid) ma tagħlaqx wara t-twelid.
English: Pedea is used to treat ‘patent ductus arteriosus' in newborn premature babies who were born six or more weeks too early (less than 34 weeks gestational age).
Maltese: Pedea jintuża fil-kura tal-‘ductus arteriosus bil-preventiva' fit-trabi tat-twelid prematur li twieldu sitt ġimgħat jew qabel (inqas minn 34 ġimgħa tqala).
English: If the condition is unchanged after the second course of therapy, surgery may be necessary.
Maltese: Jekk il-kondizzjoni tibqa' ma tinbidilx wara t-tieni kors ta' terapija, jista' jkun neċessarju intervent kirurġiku.
English: It must also not be used in babies with congenital heart disease where an open ductus arteriosus is needed for the blood to flow, or in babies with necrotising enterocolitis (a severe bacterial infection causing death of tissue in the gut).
Maltese: Pedea ma għandux jintuża lanqas fi trabi b' mard konġenitu fil-qalb fejn ductus arteriosus miftuħa hija meħtieġa sabiex id-demm jgħaddi, jew fi trabi b'enterokolite nekrotizzanti (infezzjoni batterjali serja li tikkawża rqajja' ta' tessut mejjet fl-intestin).
English: This causes heart and lung problems in the baby.
Maltese: Dan joħloq problemi fil-qalb u fil-pulmun tat-tarbija.
English: For more information about treatment with Pedea, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.This summary was last updated in 11-2015.
Maltese: Dan issommarju ġie aġġornat l-aħħar f' 11-2015.
English: The main measure of effectiveness was the number of babies whose ductus arteriosus closed without the need for surgery.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' trabi li ductus arteriosus tagħhom ingħalqet waħdeha mingħajr il-bżonn ta' intervent kirurġiku.
English: The CHMP decided that Pedea's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Pedea huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Treatment with Pedea should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist (a doctor specialising in newborn babies).
Maltese: Il-kura b'Pedea għandha ssir biss fit-taqsima tal-kura intensiva għat-trabi tat-twelid taħt issuperviżjoni ta' neonatologu espert (tabib speċjalizzat fit-trabi li jkunu għadhom kif twieldu).
English: If the ductus arteriosus has not closed by 48 hours after the final injection, or if it re-opens, a second course of three doses of Pedea may be given.
Maltese: Jekk idductus arteriosus ma tagħlaqx wara 48 siegħa mill-injezzjoni finali, jew jekk terġa' tinfetaħ, kors ieħor ta' tliet dożi ta' Pedea jista' jerġa' jingħata.
English: The full EPAR for Kevzara 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: This compared with 33% of the patients receiving placebo.
Maltese: Dan tqabbel ma' 33 % tal-pazjenti li rċevew il-plaċebo.
English: Kevzara contains the active substance sarilumab.
Maltese: Kevzara fih is-sustanza attiva sarilumab.
English: Other information about Kevzara
Maltese: Informazzjoni oħra dwar Kevzara
English: Why is Kevzara approved?
Maltese: Għaliex ġie approvat Kevzara?
English: A third study involving 369 patients compared Kevzara with adalimumab (another monoclonal antibody for the treatment of rheumatoid arthritis).
Maltese: It-tielet studju li involva 369 pazjent qabbel Kevzara ma' adalimumab (antikorp monoklonali ieħor għall-kura tal-artrite rewmatojde).
English: Kevzara is available as a solution for injection in pre-filled pens and pre-filled syringes (150 mg and 200 mg).
Maltese: Kevzara jiġi bħala soluzzjoni għall-injezzjoni f'pinen u f'siringi mimlija għal-lest (150 mg u 200 mg).
English: Patients treated with Kevzara had greater improvement in the function of their joints, compared with patients treated with adalimumab (based on a standard rating score called DAS28-ESR).
Maltese: Il-pazjenti kkurati b'Kevzara kellhom titjib akbar fil-funzjoni tal-ġogi tagħhom, meta mqabbla ma' pazjenti kkurati b'adalimumab (abbażi ta' punteġġ ta' klassifikazzjoni standard imsejjaħ DAS28-ESR).
English: 58% of patients given Kevzara 150 mg and 66% of patients given Kevzara 200 mg had a reduction in symptoms of 20% or more, based on a standard rating score (ACR 20).
Maltese: L-ewwel studju involva madwar 1,200 pazjent li l-kundizzjoni tagħhom ma rrispondietx b'mod adegwat għall-kura b'methotrexate; il-pazjenti rċevew Kevzara flimkien ma' methotrexate jew plaċebo flimkien ma' methotrexate. 58 % tal-pazjenti li ngħataw Kevzara 150 mg u 66 % tal-pazjenti li ngħataw Kevzara 200 mg raw tnaqqis fis-sintomi ta' 20 % jew aktar, abbażi ta' punteġġ ta' klassifikazzjoni standard (ACR 20).