FrancophonIA/ELRC3.0 huggingface dataset:
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N=472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95% CI=0.51-0.81, p=0.0002).
Maltese: L-istudju laħaq il-punt primarju tiegħu u wera titjib statistikament sinifikanti fil-PFS fil-fergħa ta' pemetrexed meta mqabbel mal-fergħa tal-plaċebo (N=472, popolazzjoni eżaminata b'mod indipendenti; medjan ta' 3.9 ta' xahar u 2.6 ta' xahar rispettivament) (hazard ratio = 0.64, 95% CI = 0.51-0.81, p = 0.0002).
English: When using Pemetrexed Krka in combination with cisplatin:
Maltese: Meta tuża Pemetrexed Krka flimkien ma' cisplatin:
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Krka 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 500 mg pemetrexed (bħala pemexetred disodium hemipentahydrate).
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Reconstitute 100 mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 100 mg b'4.2 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Krka 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 100 mg pemetrexed (bħala pemexetred disodium hemipentahydrate).
English: Pemetrexed Krka in combination with cisplatin The recommended dose of Pemetrexed Krka is 500 mg/m2 of body surface area (BSA) administered as an intravenous infusion over 10-minutes on the first day of each 21-day cycle.
Maltese: Pemetrexed Krka flimkien ma' cisplatin Id-doża rakkomandata ta' Pemetrexed Krka hu ta' 500 mg/m2 tal-erja tas-superfiċje tal-ġisem (BSA) mogħtija bħala infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: Stomatitis/Pharyngitis Diarrhoea without colostomy
Maltese: Dijarrea Rimettar Stomatite/ Farinġite Tqallih Anoressija
English: Anticipated complications of overdose include bone marrow suppression as manifested by neutropenia, thrombocytopenia, and anaemia.
Maltese: Komplikazzjonijiet mistennija ta' doża eċċessiva jinkludu: soppressjoni tal-mudullun kif jixhdu n-newtropenja, t-tromboċitopenja, u l-anemija.
English: After reconstitution, each vial contains 25 mg/ml pemetrexed.
Maltese: Wara r-rikostituzzjoni, kull kunjett fih 25 mg/ml pemetrexed.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni u d-dilwazzjoni tal-prodott mediċinali, ara sezzjoni 6.3.
English: Clinically relevant CTC toxicities that were reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' > 1% u < 5% (komuni) tal-pazjenti li ntgħażlu bl-addoċċ biex jirċievu pemetrexed jinkludu: infezzjoni mingħajr newtropenja newtropenja bid-deni, reazzjoni allerġika/sensittivita aċċessiva, żieda fil-krejatinina, newropatija motorja, newropatija sensittiva, eritema multiforme u wġigħ addominali.
English: Nadir ANC < 500/mm 3 and nadir platelets
Maltese: L-għadd l-iktar baxx ta' ANC < 500 /mm 3 u lgħadd l-iktar baxx ta' plejtlits  50,000 /mm
English: Progression-free survival (months)
Maltese: SurvivalTime (months)
English: Common Vomiting Mucositis/Stomatitis
Maltese: Rimettar Mukosite/Stomatite 6.8
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5% of 265 patients randomly assigned to receive single-agent pemetrexed with folic acid and vitamin B12 supplementation, and 276 patients randomly assigned to receive single-agent docetaxel.
Maltese: It-tabella hawn taħt tati l-frekwenza u s-severità ta' l-effetti mhux mixtieqa li ġew irrapportati f'>5% tal-265 pazjent li ntgħażlu b'mod arbitrarju biex jirċievu pemetrexed waħdu b'supplimentazzjoni ta' folic acid u vitamina
English: ***According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2
Maltese: *** Skont is-CTC (v2.0; NCI 1998) tal-Istitut Nazzjonali tal-Kanċer, it-tibdil fit-togħma u l-alopeċja għandhom jiġu rrapportati biss bħala Grad 1 jew 2.
English: This is equivalent to 2.7% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan hu ekwivalenti għal 2.7% tat-teħid djetetiku ta' kuljum ta' sodju għal adult.
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Maltese: Tossiċitajiet klinikament rilevanti li ġew irrapportati f' ≥ 1% u ≤ 5% (komuni) tal-pazjenti li ntgħażlu bl-addoċċ biex jirċievu cisplatin u pemetrexed jinkludu: żieda fl-AST, żieda fl-ALT, infezzjoni, newtropenja bid-deni, insuffiċjenza renali, deni, diżidratazzjoni, konġuntivite u tnaqqis fit-tneħħija ta' krejatinina.
English: Common Pruritus Alopecia
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: How to store Pemetrexed Krka
Maltese: X'fih Pemetrexed Krka
English: EMPHACIS, a multi-centre, randomised, single-blind Phase 3 study of pemetrexed plus cisplatin versus cisplatin in chemonaive patients with malignant pleural mesothelioma, has shown that patients treated with pemetrexed and cisplatin had a clinically meaningful 2.8-month median survival advantage over patients receiving cisplatin alone.
Maltese: EMPHACIS, studju multiċentrali ta' Fażi 3, single-blind,, randomised, b'pemetrexed flimkien ma' cisplatin kontra cisplatin, f'pazjenti b'mesoteljoma plewrali malinna u li ma kienu ħadu ebda kimoterapija oħra,wera li pazjenti kkurati b'pemetrexed u cisplatin kellhom medjan ta' vantaġġ ta'
English: • Median
Maltese: Medjan
English: • 95% CI for median
Maltese: 95 % CI għal medjan
English: After reconstitution, the solution contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjoni, kull kunjett ikun fih 25 mg/ml pemetrexed.
English: Common Dyspepsia/heartburn
Maltese: Dispepsja/qrusa tal-istonku
English: Very common (may affect more than 1 in 10 people) - Low white blood cells - Low haemoglobin level (anaemia) - Low platelet count - Diarrhoea - Vomiting - Pain, redness, swelling or sores in your mouth - Nausea - Loss of appetite - Fatigue (tiredness) - Skin rash - Hair loss - Constipation - Loss of sensation - Kidney: abnormal blood tests
Maltese: Komuni ħafna (jistgħu jaffettwaw iżjed minn 1 minn kull 10 persuni) - Ammont baxx ta' ċelluli bojod tad-demm - Livell baxx ta' emoglobina (anemija) - Għadd baxx ta' plejtlits - Dijarrea - Rimettar - Uġigħ, ħmura, nefħa u ġrieħi f'ħalqek - Dardir - Nuqqas ta' aptit - Għeja (ħedla) - Raxx fil-ġilda - Twaqqigħ ta' xagħar - Stitikezza - Telf ta' sensazzjoni - Kliewi: testijiet tad-demm anormali
English: • Response rate (%) (95% CI)
Maltese: Respons (n: eliġibbli għar-respons) Persentaġġ ta' respons (%) (95 % CI) Marda stabbli(%)
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma
Maltese: Analiżi ta' sottogrupp saret fuq pazjenti li rċevew folic acid u l-vitamina
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Maltese: Il-volum xieraq tas-soluzzjoni rikostitwita ta' pemetrexed irid jerġa' jiġi dilwit sa 100ml b' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, u jingħata bħala infużjoni fil-vini għal 10 minuti.
English: PARAMOUNT: Kaplan-Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Maltese: Dijagrammi Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u Sopravivenza Totali (OS) għat-tkomplija ta' manteniment b'pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous (kkwantifikat permezz ta' għażla b'mod arbitrarju)
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (N=481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI=0.56-0.88, p=0.002).
Maltese: Il-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn listoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous (N=481) kien ta' 15.5 xhur għall-fergħa ta' pemetrexed u ta' 10.3 xhur għall-fergħa tal-plaċebo (hazard ratio = 0.70, 95% CI = 0.56-0.88, p=0.002).
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Pemetrexed Krka 500 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Pemetrexed Krka 100 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Krka 500 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni pemetrexed
English: Pemetrexed Krka is available in transparent glass vials containing either 100 mg or 500 mg pemetrexed.
Maltese: Pemetrexed Krka huwa disponibbli f'kunjetti tal-ħġieġ trasparenti li fihom 100 mg jew 500 mg pemetrexed.
English: Adenocarcinoma
Maltese: Il-vitamina
English: Rare cases of bullous conditions have been reported including Stevens-Johnson syndrome and Toxic epidermal necrolysis which in some cases were fatal.
Maltese: Ġew irrapportati każijiet rari ta' kundizzjonijiet tat-tip bullożi li jinkludu s-sindromu ta' StevensJohnson u Toxic epidermal necrolysis li f'xi każijiet kienu fatali.
English: Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Kull kunjett fih 500 mg pemetrexed (bħala pemetrexed disodium hemipentahydrate).
English: Concomitant administration of nephrotoxic drugs (e.g., aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed.
Maltese: Jekk jingħataw mediċini nefrotossiċi (eż., aminoglikosidi, dijuretiċi li jaħdmu fuq il-liwja tubulari, komposti tal-platinu, cyclosporin) flistess żmien, dawn jistgħu jwasslu għal dewmien fit-tneħħija ta' pemetrexed.
English: Cisplatin (N=222)
Maltese: (N=222)
English: In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min), the concomitant administration of pemetrexed with NSAIDs (e.g., ibuprofen) or acetylsalicylic acid at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Maltese: F'pazjenti li jkollhom insuffiċjenza renali ħafifa għal moderata (tneħħija tal-krejatinina bejn 45 u 79 ml/min) l-għoti ta' pemetrexed fl-istess żmien ma' NSAIDs (eż., ibuprofen) jew acetylsalicylic acid f'dożi għoljin għandu jkun evitat minn jumejn qabel, dakinhar u sa jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.4).
English: Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Maltese: Il-pazjenti kollha kienu ddijanjostikati li kellhom NSCLC fi Stadju IIIB je IV u li diġà kienu rċevew kemoterapija bbażata fuq il-platinum.
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI=0.56-0.88, p=0.002).
Maltese: Meta tinkludi l-fażi tal-induzzjoni l-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous kien ta' 18.6 xhur għall-fergħa ta' pemetrexed u ta' 13.6 xhur għall-fergħa tal-plaċebo (hazard ratio =0.71, 95% CI=0.56-0.88, p=0.002).
English: Reconstitute each 500 mg vial with 20 ml of 9 mg/ml (0.9%) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Maltese: Irrikostitwixxi kull kunjett ta' 500 mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9 mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: There are limited data in patients with malignant pleural mesothelioma treated with pemetrexed alone.
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFETTIV TALPRODOTT MEDIĊINALI
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Krka is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Maltese: F'pazjenti kkurati għall-kanċer tal-pulmun mhux b'ċelluli żgħar wara kimoterapija preċedenti, id-doża rakkomandata ta' Pemetrexed Krka hi ta' 500 mg/m2 BSA mogħtija b'infużjoni minn ġol-vina fuq perijodu ta' 10 minuti fl-ewwel ġurnata ta' kull ċiklu ta' 21 ġurnata.
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Krka powder with 9 mg/ml (0.9%) sodium chloride solution for injection before it is given to you.
Maltese: Qabel ma' jingħatalek, it-trab ta' Pemetrexed Krka jiġi mħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/ml(0.9 %) sodium chloride, mill-ispiżjar ta' l-isptar, infermier jew tabib.
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium-free”.
Maltese: Pemetrexed Krka 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Dan il-prodott mediċinali fih inqas minn mmol 1 ta' sodium (23 mg) f'kull kunjett, jiġifieri tista' tgħid li huwa ‘hieles mis-sodium'.
English: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased”
Maltese: *Irreferi għal verżjoni 2 tas-CTC tal-Istitut Nazzjonali tal-Kanċer għal kull grad ta' tossiċità ħlief għat-terminu “tnaqqis fit-tneħħija tal-kreatinina”
English: Loxicom (meloxicam)
Maltese: Loxicom (melossikam)
English: Other information about Loxicom
Maltese: Informazzjoni oħra dwar Loxicom
English: In cattle, Loxicom is used together with appropriate antibiotic therapy, to reduce clinical signs of acute respiratory infection (infection of the lungs and airways).
Maltese: Fl-ifrat, Loxicom jintuża flimkien ma' terapija antibijotika adatta, biex inaqqas is-sintomi kliniċi talinfezzjoni respiratorja akuta (infjammazzjoni fil-pulmun u fil-passaġġi tal-arja).
English: Loxicom contains the active substance meloxicam and is a ‘generic medicine'.
Maltese: Loxicom fih is-sustanza attiva melossikam u huwa mediċina ġenerika.
English: Loxicom contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: Loxicom fih il-melossikam, li tagħmel parti minn klassi ta' mediċini msejħa mediċini antiinfjammatorji mhux sterojdi (NSAIDs).
English: Loxicom received a marketing authorisation valid throughout the EU on 10 February 2009.
Maltese: Loxicom ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-10 ta' Frar 2009.
English: For the 20 mg/ml solution for injection the meat withdrawal period is five days, and for the 50 mg/ml oral paste it is three days.
Maltese: Għas-soluzzjoni għall-injezzjoni ta' 20 mg/ml il-perjodu ta' tiżmim għal-laħam huwa ħamest ijiem, u għall-krema tal-ħalq ta' 50 mg/ml il-perjodu huwa tlett ijiem.
English: In pigs, Loxicom is used to reduce lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move that are not caused by an infection) and to support together with appropriate antibiotic therapy the treatment of diseases that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome).
Maltese: Fil-ħnieżer, Loxicom, jintuża biex inaqqas iz-zappip u l-infjammazzjoni f'disturbi lokomotorji mhux infettivi (mard li jaffettwa l-ħila taċ-ċaqliq li mhuwiex ikkawżat minn infezzjoni) u biex jappoġġa flimkien ma' terapija bl-antibijotiċi adatti l-kura ta' mard li jiżviluppa wara t-tifrigħ (twelid) bħassettiċemija pwerperali u t-tossjemija (sindromu tal-mastite-metrite-agalassija).
English: Loxicom is available as an oral (taken by mouth) suspension, oral paste, chewable tablets and a solution for injection.
Maltese: Loxicom huwa disponibbli bħala sospensjoni orali (meħud mill-ħalq), krema tal-ħalq, pilloli tal-magħad u soluzzjoni għall-injezzjoni.
English: Further information on Loxicom can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/loxicom.
Maltese: ema.europa.eu/medicines/veterinary/EPAR/loxicom Informazzjoni dwar il-mediċina ta' referenza tinstab ukoll fis-sit elettroniku tal-Aġenzija.
English: Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Metacam, and do not need to be repeated for Loxicom.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi awtorizzati bil-mediċina ta' referenza, Metacam, u ma għandhomx għalfejn jiġu ripetuti għal Loxicom.
English: In cats, Loxicom is used to reduce pain and inflammation after ovariohysterectomy (spaying operation), orthopaedic and minor soft tissue surgery.
Maltese: Fil-qtates, Loxicom jintuża biex inaqqas l-uġigħ u l-infjammazzjoni wara li tkun saritilhom ovarjoisterektomija (operazzjoni li tneħħi l-ovarji u l-utru), kirurġija ortopediku u kirurġija fuq it-tessut artab.
English: How has Loxicom been studied?
Maltese: Kif ġie studjat Loxicom?
English: Because Loxicom is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Loxicom huwa mediċina ġenerika u bijoekwivalenti għall-mediċini ta' referenza, il-benefiċċji u r-riskji tiegħu huma meqjusa li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: Why is Loxicom authorised in the EU?
Maltese: Għalfejn Loxicom huwa awtorizzat fl-UE?
English: Dogs
Maltese: Frat
English: The precautions are the same as for the reference medicine since Loxicom is a generic medicine.
Maltese: Il-prekawzjonijiet huma bħal dawk tal-mediċina ta' referenza minħabba li Loxicom huwa mediċina ġenerika.
English: In dogs, Loxicom is used to reduce pain and inflammation following orthopaedic (e.g. fracture operation) and soft tissue surgery.
Maltese: Fil-klieb, Loxicom jintuża biex inaqqas l-uġigħ u l-infjammazzjoni wara li tkun saritilhom kirurġija ortopedika (eż. operazzjoni fuq ksur) u kirurġija fuq it-tessut artab.
English: This means that Loxicom contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Metacam.
Maltese: Dan ifisser li Loxicom fih l-istess sustanza attiva u jaħdem bl-istess mod bħal “mediċina ta' referenza” diġà awtorizzata fl-Unjoni Europea (UE) msejħa Metacam.
English: In horses, Loxicom is used to reduce pain associated with colic (abdominal pain) and to lessen inflammation and relieve pain in acute and chronic musculo-skeletal disorders (disorders affecting the muscles and bones).
Maltese: Fiż-żwiemel, Loxicom jintuża biex inaqqas l-uġigħ assoċjat mal-kolika (uġigħ addominali) u għat-taffija tal-infjammazzjoni u tal-uġigħ f'disturbi muskoluskeletali (disturbi li jaffettwaw il-muskoli u l-għadam).
English: As prostaglandins trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Maltese: Peress li l-prostaglandini jiskattaw l-infjamazzjoni, l-uġigħ, it-tnixxija (fluwidu li joħroġ mill-vażi waqt infjamazzjoni) u d-deni, il-melossikam tnaqqas dawn issinjali tal-marda.
English: What are the benefits and risks of Loxicom?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Loxicom?
English: Loxicom is an anti-inflammatory medicine used in cattle, pigs, horses, dogs and cats.
Maltese: Loxicom huwa mediċina antiinfjammatorja li tintuża fil-frat, il-ħnieżer, iż-żwiemel, il-klieb u l-qtates.
English: It can be used to relieve pain following dehorning in calves and to support the treatment of acute mastitis (inflammation of the udder), in combination with antibiotics.
Maltese: Jista' jintuża għat-taffija tal-uġigħ wara t-tneħħija tal-qrejjen fl-għoġġiela u bħala terapija ta' appoġġ fil-kura ta' mastite akuta (infjammazzjoni tad-driegħ), flimkien mal-antibijotiċi.
English: How does Loxicom work?
Maltese: Kif jintuża Loxicom?
English: h-4197-AA-en
Maltese: Il-pakkett li jmiss malprodott
English: Further information on Zykadia 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: Zykadia contains the active substance ceritinib.
Maltese: Zykadia fih is-sustanza attiva ceritinib.
English: In the second study, the overall response rate was 41% (57 of 140 patients) and the average length of response was 10.6 months.
Maltese: Fit-tieni studju, ir-rata ta' rispons globali kienet ta' 41 % (57 minn 140 pazjent) u t-tul medju tar-rispons kien ta' 10.6 xhur.
English: Zykadia received a conditional marketing authorisation valid throughout the EU on 06 May 2015.
Maltese: Zykadia rċieva awtorizzazzjoni kondizzjonali għat-tqegħid fis-suq valida fl-UE fis-6 ta' Mejju 2015.
English: This was switched to full marketing authorisation on 26 July 2017.
Maltese: Din inqalbet għal awtorizzazzjoni għat-tqegħid fis-suq sħiħa fis-26 ta' Lulju 2017.
English: The most common side effects with Zykadia (which may affect 1 or more people in 10) are diarrhoea, nausea (feeling sick), vomiting, tiredness, abnormal liver tests, abdominal (belly) pain, decreased appetite, weight loss, constipation, rash, increases in the level of a waste product called creatinine in the blood (a possible sign of kidney problems), oesophageal disorder (problems affecting the food pipe) and anaemia (low levels of red blood cells).
Maltese: L-effetti sekondarji l-aktar komuni b'Zykadia (li jistgħu jaffettwaw 1 jew aktar minn kull 10) huma dijarea, nawsja (tħossok ma tiflaħx), rimettar, għeja, testijiet tal-fwied anormali, uġigħ addominali (ta' żaqq), tnaqqis fl-aptit, tnaqqis fil-piż, stitikezza, raxx, żidiet fil-livell ta' prodott żejjed imsejjaħ kreatinina fid-demm (sinjal possibbli ta' problemi fil-kliewi), disturb fl-esofagu (problemi li jaffettwaw il-pajp tal-ikel) u anemija (livelli baxxi ta' ċelloli ħomor tad-demm).
English: Other information about Zykadia
Maltese: Informazzjoni oħra dwar Zykadia
English: In the third study in 231 patients, Zykadia was compared with standard chemotherapy (medicines to treat cancer).
Maltese: Fit-tielet studju f'231 pazjent, Zykadia tqabbel ma' kimoterapija standard (mediċini għall-kura talkanċer).
English: The most common severe reactions (which may affect 1 or more people in 20) are abnormal liver tests, tiredness, diarrhoea, nausea, vomiting and hyperglycaemia (high blood sugar).
Maltese: Ir-reazzjonijiet severi l-aktar komuni (li jistgħu jaffettwaw 1 jew aktar minn kull 20) huma testijiet tal-fwied anormali, għeja, dijarea, nawsja, rimettar u ipergliċemija (livell għoli ta' zokkor fid-demm).