FrancophonIA/ELRC3.0 huggingface dataset:
English: In rare cases, application site reactions such as transitory scratching, erythema (redness of skin), alopecia (loss of hair) or dermatitis (inflammation of the skin) at the application site may occur.
Maltese: F'każijiet rari ħafna, jista' jkun hemm ħakk li jgħaddi, eritema (ħmura tal-ġilda), alopexja (telf ta' pil) jew dermatite (imfjammazzjoni tal-ġilda) fiż-żona tal-applikazzjoni.
English: This is not a sign of intoxication and disappears within some minutes without treatment.
Maltese: Dan mhuwiex sinjal ta' avvelenament u jisparixxi fi ftit minuti mingħajr il-bżonn ta' kura.
English: The safety of the product has not been established in cats younger than 8 weeks of age.
Maltese: Is-sigurtà tal-prodott ma ġietx stabbilita fi qtates età iżgħar minn 8 ġimgħat.
English: Dosage schedule:
Maltese: Skeda tad-dożaġġ:
English: PACKAGE LEAFLET Activyl spot-on solution for dogs
Maltese: FIL-PAKKETT Activyl soluzzjoni spot-on għal klieb
English: Pharmacotherapeutic group: Ectoparasiticides for topical use, incl.
Maltese: Ektoparassitiċida għall-użu topikali, inkl. insettiċidi: indoxacarb Kodiċi ATC veterinarja:
English: EU/02/10/118/003 EU/02/10/118/004 EU/02/10/118/005 EU/02/10/118/006 EU/02/10/118/007 EU/02/10/118/008 EU/02/10/118/009 EU/02/10/118/010 EU/02/10/118/015 EU/02/10/118/016 EU/02/10/118/017 EU/02/10/118/018 EU/02/10/118/019
Maltese: EU/02/10/118/015 EU/02/10/118/016 EU/02/10/118/017 EU/02/10/118/018 EU/02/10/118/019
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinstab fuq il-websajt tal-Aġenzija Ewropea għall-Mediċini (EMA) (http://www.ema.europa.eu/).
English: Activyl for very small dogs (1.5 - 6.5 kg) Activyl for small dogs (6.6 - 10 kg) Activyl for medium dogs (10.1 - 20 kg) Activyl for large dogs (20.1 - 40 kg) Activyl for extra large dogs (40.1 - 60 kg)
Maltese: Activyl għal klieb żgħar ħafna (1.5 - 6.5 kg) Activyl għal klieb żgħar (6.6 - 10 kg) Activyl għal klieb medji (10.1 - 20 kg) Activyl għal klieb kbar (20.1 - 40 kg) Activyl għal klieb kbar ħafna (40.1 - 60 kg)
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance or hair clumping at the application site.
Maltese: L-applikazzjoni tal-prodott mediċinali veterinarju tista' tagħti dehra żejtnija temporanja u lokalizzata u l-pil isir iwaħħal fiż-żona tal-applikazzjoni.
English: In rare cases, neurological signs (e.g. incoordination, tremor, ataxia, convulsions, mydriasis and impaired vision) have been observed.
Maltese: F'każijiet rari, ġew osservati sinjali newroloġiċi (eż. sko-ordinazzjoni, rogħda, atassja, eċċessjonijiet, midrijasi u vista mfixkla).
English: The major route of excretion is in faeces.
Maltese: Tista' titfaċċa lega niexfa ta' trab abjad.
English: Activyl 100 mg spot-on solution for very small dogs Activyl 150 mg spot-on solution for small dogs Activyl 300 mg spot-on solution for medium dogs Activyl 600 mg spot-on solution for large dogs Activyl 900 mg spot-on solution for extra large dogs indoxacarb
Maltese: Activyl 100 mg soluzzjoni spot-on għal klieb żgħar ħafna Activyl 150 mg soluzzjoni spot-on għal klieb żgħar Activyl 300 mg soluzzjoni spot-on għal klieb medji Activyl 600 mg soluzzjoni spot-on għal klieb kbar Activyl 900 mg soluzzjoni spot-on għal klieb kbar ħafna
English: Activyl 100 mg spot-on for small cats Activyl 200 mg spot-on for large cats indoxacarb
Maltese: Activyl 100 mg spot-on għal qtates żgħar Activyl 200 mg spot-on għal qtates kbar indoxacarb
English: In the mid-gut of susceptible insect species, the insect's enzymes remove the carbomethoxy group from parent indoxacarb, and convert it into its biologically active form.
Maltese: Fil-musrana tan-nofs ta' speċji ta' insetti li huma suxxettibbli, l-enżimi tal-insett ineħħu l-carbomethoxy group mill-indoxacarb ewlieni u jibdluh filforma bijoloġikalment attiva.
English: VIRBAC BELGIUM NV,
Maltese: VIRBAC Danmark A/S,
English: Dogs 1.5 - 6.5 kg Dogs 6.6 - 10 kg Dogs 10.1 - 20 kg Dogs 20.1 - 40 kg Dogs 40.1 - 60 kg
Maltese: Piż tal-kelb (kg) Daqs tal-pipetta li għandha tintuża 1.5 - 6.5 Activyl għal klieb żgħar ħafna 6.6 - 10 Activyl għal klieb żgħar 10.1 - 20 Activyl għal klieb medji 20.1 - 40
English: The bioactivated metabolite acts as a voltage-dependent sodium channel antagonist in insects, by blocking the sodium channels that regulate the flow of sodium ions in the insect's nervous system.
Maltese: Il-metabolit bijoattiv jaħdem bħala antagonist fl-insetti tal-kanali tassodju li huma dipendenti fuq il-vultaġġ billi jimblokka il-kanali li jirregolaw il-moviment tal-ijoni tassodju fis-sistema nervuża tal-insett.
English: Cats ≤ 4 kg
Maltese: SPEĊI GĦAL XIEX HUWA INDIKAT IL-PRODOTT Qtates ≤ 4 kg
English: Special precautions for use in animals: Ensure that the dosage (pipette) corresponds to the weight of the treated cat (see section 8).
Maltese: Assigura li d-dożaġġ (pipetta) jikkorrispondi għall-piż tal-qattus ittrattat (ara sezzjoni 8).
English: Do not apply an excessive amount of solution at any one spot in order to prevent run-off.
Maltese: Reazzjonijiet lokali u/jew sistemiċi ġew osservati f'xi nies wara l-espożizzjoni.
English: Activyl 100 mg spot-on for very small dogs Activyl 150 mg spot-on for small dogs Activyl 300 mg spot-on for medium dogs Activyl 600 mg spot-on for large dogs Activyl 900 mg spot-on for extra large dogs indoxacarb
Maltese: Activyl 100 mg soluzzjoni spot-on għal klieb żgħar ħafna Activyl 150 mg soluzzjoni spot-on għal klieb żgħar Activyl 300 mg soluzzjoni spot-on għal klieb medji Activyl 600 mg soluzzjoni spot-on għal klieb kbar Activyl 900 mg soluzzjoni spot-on għal klieb kbar ħafna indoxacarb
English: Further information on Tamiflu can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/tamiflu.
Maltese: Aktar informazzjoni dwar Tamiflu tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/tamiflu.
English: Prevention of flu
Maltese: Prevenzjoni tal-influwenza
English: The medicine contains the active substance oseltamivir.
Maltese: Il-mediċina fiha s-sustanza attiva oseltamivir.
English: Tamiflu is available as capsules (30 mg, 45 mg, and 75 mg) and as a powder that is made up into a liquid to be drunk (6 mg/ml and 12 mg/ml).
Maltese: Tamiflu jiġi bħala kapsuli (30 mg, 45 mg, u 75 mg) u bħala trab li jsir f'likwidu biex jinxtorob (6 mg/ml u 12 mg/ml)
English: Other information about Tamiflu
Maltese: Informazzjoni oħra dwar Tamiflu
English: Tamiflu reduced the duration of the illness compared with placebo (a dummy treatment) in several studies (involving 2,413 patients aged 13 years or over, 741 elderly patients aged 65 years or over and 1,033 children aged between 1 and 12 years).
Maltese: Tamiflu naqqas it-tul tal-marda meta mqabbel mal-plaċebo (kura finta) f'diversi studji (li kienu jinvolvu 2,413-il pazjent ta' 13-il sena jew iktar, 741 pazjent anzjan ta' 65 sena jew iktar u 1,033 tifel u tifla ta' bejn sena u 12-il sena).
English: Tamiflu reduced the incidence of flu in people who had come into contact with the disease when one of their family members contracted flu (962 cases) or during an epidemic (1,562 people aged between 16 and 65 years, and 548 elderly people in nursing homes).
Maltese: Tamiflu naqqas l-inċidenza tal-influwenza f'nies li kienu ġew f'kuntatt mal-marda meta wieħed millmembri tal-familja tagħhom kien ħa l-influwenza (962 każ) jew matul pandemija (1,562 persuna ta' bejn 16-il sena u 65 sena, u 548 persuna anzjana fi djar tal-kura).
English: The studies measured the number of cases of flu proven by laboratory tests.
Maltese: L-istudji kejlu n-numru ta' każijiet ta' influwenza li rriżultaw bi prova minn testijiet fil-laboratorju.
English: Tamiflu received a marketing authorisation valid throughout the EU on 20 June 2002.
Maltese: Tamiflu ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fl-20 ta' Ġunju 2002.
English: Effectiveness was measured by recording symptoms (feeling feverish, muscle pain, headache, sore throat, cough, overall discomfort and runny nose).
Maltese: L-effikaċja tkejlet billi ġew irreġistrati s-sintomi (tħossok bid-deni, uġigħ filmuskoli, uġigħ ta' ras, griżmejn infjammati, sogħla, skumdità ġenerali u flissjoni).
English: Tamiflu is an antiviral medicine used to treat or prevent influenza (flu).
Maltese: Tamiflu huwa mediċina antivirali li tintuża għall-kura jew għall-prevenzjoni tal-influwenza (flu).
English: Tamiflu can also be used as preventative treatment in exceptional cases, for instance when the seasonal flu vaccine may not provide sufficient protection and when there is a pandemic (a global epidemic of flu).
Maltese: Tamiflu jista' jintuża wkoll bħala kura preventiva f'każijiet ta' eċċezzjoni, pereżempju meta l-vaċċin tal-influwenza staġjonali jista' ma jipprovdix protezzjoni suffiċjenti u meta tfaqqa' pandemija (pandemija globali tal-influwenza).
English: In families with one patient who had flu, 7% of the family members in the household developed flu when receiving Tamiflu, compared with 20% of those receiving no preventative treatment.
Maltese: Fil-familji b'pazjent wieħed li kellu l-influwenza, 7 % tal-membri tal-familja fl-unità domestika żviluppaw l-influwenza meta kienu qed jirċievu Tamiflu, meta mqabbla ma' 20 % ta' dawk li ma kienu qed jirċievu l-ebda kura preventiva.
English: What are the risks associated with Tamiflu?
Maltese: X'inhuma r-riskji assoċjati ma' Tamiflu?
English: The active substance in Tamiflu, oseltamivir, acts on the flu virus, blocking some of the enzymes on its surface known as neuramidases.
Maltese: Is-sustanza attiva f'Tamiflu, l-oseltamivir, taġixxi fuq il-virus tal-influwenza, billi timblokka xi wħud mill-enzimi fuq il-wiċċ tiegħu magħrufa bħala newramidażi.
English: The usual dose for adults and children weighing more than 40 kg is 75 mg given once a day for at least 10 days after contact with an infected person.
Maltese: Id-doża tas-soltu għall-adulti u għat-tfal li jiżnu iktar minn 40 kg hija ta' 75 mg li tingħata darba kuljum għal mill-inqas għaxart ijiem wara kuntatt ma' persuna infettata.
English: Side effects are generally mild or moderate in severity.
Maltese: L-effetti sekondarji huma normalment ħfief jew moderati fil-gravità tagħhom.
English: Oseltamivir works on the neuramidases of both influenza A (the most common type) and influenza B viruses.
Maltese: L-oseltamivir taħdem fuq in-newramidażi kemm tal-virus tal-influwenza A (ittip l-aktar komuni) kif ukoll il-virus tal-influwenza B.
English: As for all medicines, data on the use of Tamiflu are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Tamiflu hija ssorveljata kontinwament.
English: For the full list of side effects and restrictions with Tamiflu, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Tamiflu, ara l-fuljett ta' tagħrif.
English: • to treat flu, it can be used in adults and children (including full-term newborns) who have the symptoms of flu, when the flu virus is circulating in the community;
Maltese: • għall-kura tal-influwenza, jista' jintuża f'adulti u fit-tfal (inklużi trabi tat-twelid wara terminu sħiħ) li jkollhom is-sintomi tal-influwenza, meta l-virus tal-influwenza jkun qed jiċċirkola fil-komunità;
English: In the study carried out during an epidemic, 1% of the people taking Tamiflu developed flu after contact, compared with 5% of those taking placebo.
Maltese: Fl-istudju li twettaq matul pandemija, 1 % tan-nies li kienu qed jieħdu Tamiflu żviluppaw l-influwenza wara kuntatt, meta mqabbla ma' 5 % ta' dawk li kienu qed jieħdu l-plaċebo.
English: The usual dose for adults and children weighing more than 40 kg is 75 mg given twice a day for 5 days.
Maltese: Id-doża tas-soltu għall-adulti u għat-tfal li jiżnu iktar minn 40 kg hija ta' 75 mg li tingħata darbtejn kuljum għal ħamest ijiem.
English: In adults, the duration of the illness was reduced from an average of 5.2 days for patients taking placebo, to 4.2 days for patients taking Tamiflu.
Maltese: Fl-adulti, it-tul talmarda tnaqqas minn medja ta' 5.2 ijiem għall-pazjenti li kienu qed jieħdu l-plaċebo, għal 4.2 ijiem għall-pazjenti li kienu qed jieħdu Tamiflu.
English: Why is Tamiflu authorised in the EU?
Maltese: Għaliex Tamiflu huwa awtorizzat fl-UE?
English: The most common side effects with Tamiflu (seen in more than 1 patient in 10) in adults and adolescents are headache and nausea (feeling sick).
Maltese: L-effetti sekondarji l-aktar komuni b'Tamiflu (li dehru f'aktar minn pazjent 1 minn 10) fl-adulti u fladoloxxenti huma wġigħ ta' ras u nawżja (dardir).
English: The average reduction in the duration of the illness in children aged 1 to 6 years was 1.5 days.
Maltese: It-tnaqqis medju fit-tul tal-marda fit-tfal ta' bejn sena u sitt snin kien ta' 1.5 ijiem.
English: • to prevent flu, it can be used in adults and children over 1 year of age who have been in contact with someone who has flu and flu is circulating in the community.
Maltese: • għall-prevenzjoni tal-influwenza, jista' jintuża f'adulti u fit-tfal li jkollhom aktar minn sena li kellhom kuntatt ma' xi ħadd li jkollu l-influwenza u l-influwenza tkun qed tiċċirkola fil-komunità.
English: It can also reduce the incidence of flu in patients who had come into contact with the disease or during a pandemic.
Maltese: Jista' jnaqqas ukoll l-inċidenza tal-influwenza f'pazjenti li jkunu ġew f'kuntatt mal-marda jew matul pandemija.
English: In the prevention of flu, Tamiflu must be started within two days of contact with someone who has flu.
Maltese: Matul pandemija tal-influwenza, Tamiflu jista' jintuża wkoll biex jipprevjeni l-influwenza fi trabi taħt issena.
English: What measures are being taken to ensure the safe and effective use of Tamiflu?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Tamiflu?
English: A study also looked at using Tamiflu in a family setting (277 families) for both the treatment of the person with flu, and the treatment or prevention of flu in those in contact with the person.
Maltese: Studju ħares ukoll lejn l-użu ta' Tamiflu fi sfond ta' familja (277 familja) kemm għall-kura tal-persuna bl-influwenza, kif ukoll għall-kura jew għall-prevenzjoni tal-influwenza f'dawk li jkunu f'kuntatt mal-persuna.
English: How does Tamiflu work?
Maltese: Kif jintuża Tamiflu?
English: When used for treatment of flu, Tamiflu reduces the duration of illness in adults and children.
Maltese: Meta jintuża għall-kura tal-influwenza, Tamiflu jnaqqas it-tul tal-marda fl-adulti u fit-tfal.
English: In children the most common side effects (seen in more than 1 patient in 10) are vomiting, cough and nasal congestion (a blocked nose).
Maltese: Fit-tfal l-effetti sekondarji l-aktar komuni (li dehru f'aktar minn pazjent 1 minn 10) huma remettar, sogħla u konġestjoni fl-imnieħer (imnieħer imblukkat).
English: In the treatment of flu, Tamiflu must be started within two days of the onset of symptoms.
Maltese: Fil-kura tal-influwenza, Tamiflu għandu jinbeda fi żmien jumejn mill-bidu tas-sintomi.
English: Side effects reported with Tamiflu are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Tamiflu huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: EMA/CHMP/249688/2019 EMEA/H/C/004447
Maltese: EMA/191978/2019 EMEA/H/C/004447
English: Further information on Aimovig can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/aimovig.
Maltese: ema.europa.eu/medicines/human/EPAR/aimovig.
English: Aimovig (erenumab) EMA/CHMP/249688/2019
Maltese: Aimovig (erenumab) EMA/191978/2019
English: Other information about Aimovig
Maltese: Informazzjoni oħra dwar Aimovig
English: Some patients may benefit from a dose of 140 mg every 4 weeks, given as either a single injection of 140 mg or two injections of 70 mg.
Maltese: Xi pazjenti jistgħu jibbenefikaw minn doża ta' 140 mg kull 4 ġimgħat, mogħtija jew bħala injezzjoni waħda ta' 140 mg jew bħala żewġ injezzjonijiet ta' 70 mg.
English: Aimovig received a marketing authorisation valid throughout the EU on 26 July 2018.
Maltese: Aimovig irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fis-26 ta' Lulju 2018.
English: The active substance in Aimovig, erenumab, is a monoclonal antibody (a type of protein) designed to attach to a receptor (target) for CGRP on body's cells.
Maltese: Is-sustanza attiva f'Aimovig, erenumab, hija antikorp monoklonali (tip ta' proteina) imfassla biex teħel ma' riċettur (mira) għas-CGRP fuq iċ-ċelloli tal-ġisem.
English: In a second study of 955 patients who had migraines 8 days a month on average, those treated with Aimovig had on average 3 to 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo.
Maltese: F'tieni studju ta' 955 pazjent li bħala medja kellhom emigranji 8 ijiem fix-xahar, dawk ikkurati b'Aimovig kellhom, bħala medja, 3 sa 4 ijiem inqas b'emigranji kull xahar meta mqabbla ma' madwar jumejn inqas għall-pazjenti fuq plaċebo.
English: In a study of 667 patients who had migraines 18 days a month on average, those treated with Aimovig had 7 fewer days with migraines per month, compared with 4 fewer days for patients on placebo.
Maltese: Fi studju ta' 667 pazjent li bħala medja kellhom emigranji 18-il jum fix-xahar, dawk ikkurati b'Aimovig kellhom 7 ijiem inqas b'emigranji kull xahar, meta mqabbla ma' 4 ijiem inqas għall-pazjenti fuq plaċebo.
English: The recommended dose is 70 mg every 4 weeks as a single injection.
Maltese: Id-doża rakkomandata hija 70 mg kull 4 ġimgħat bħala injezzjoni waħda.
English: What are the risks associated with Aimovig?
Maltese: X'inhuma r-riskji assoċjati ma' Aimovig?
English: Aimovig is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Maltese: Aimovig huwa mediċina użata biex tipprevjeni l-emigranja f'adulti li jkollhom emigranji ta' mill-anqas 4 ijiem fix-xahar.
English: The most common side effects with Aimovig (which may affect up to 1 in 10 people) are reactions at the site of injection, constipation, muscle spasms and itching.
Maltese: L-effetti sekondarji l-aktar komuni b'Aimovig (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni, stitikezza, spażmi fil-muskoli u ħakk.
English: A chemical messenger called CGRP has been shown to be involved in the development of migraine.
Maltese: Messaġġier kimiku msejjaħ CGRP intwera li huwa involut fl-iżvilupp tal-emigranja.
English: As for all medicines, data on the use of Aimovig are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Aimovig hija ssorveljata kontinwament.
English: Only patients with migraines at least 4 days a month were included in the studies as patients with less frequent migraines are not usually eligible for preventative treatment.
Maltese: Pazjenti b'emigranji ta' mill-anqas 4 ijiem f'xahar biss kienu inklużi fl-istudji billi pazjenti b'emigranji anqas frekwenti mhumiex normalment eliġibbli għal kura preventiva.
English: Most of the side effects are mild or moderate in severity.
Maltese: Il-biċċa l-kbira tal-effetti sekondarji huma ħfief sa moderati fis-severità.
English: For the full list of side effects and restrictions of Aimovig, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Aimovig, ara l-fuljett ta' tagħrif.
English: Side effects reported with Aimovig are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Aimovig huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Aimovig is effective at reducing the number of days patients suffer migraines.
Maltese: Aimovig huwa effettiv fit-tnaqqis tan-numru ta' jiem li l-pazjenti jbatu minn emigranji.
English: The European Medicines Agency therefore decided that Aimovig's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Għaldaqstant, l-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Aimovig huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: If any of the above apply to you (or you are not sure) talk to your doctor or nurse before you are given Polivy.
Maltese: Dan ifisser li għad trid tingħata aktar evidenza dwar dan il-prodott mediċinali.
English: Irreferi għall-Irlanda
Maltese: Malta Irreferi għall-Irlanda
English: Grade 2-3
Maltese: Grad 2-3
English: Human Immunodeficiency Virus (HIV)
Maltese: Virus tal-Immunodefiċjenza Umana (HIV - Human Immunodeficiency Virus)
English: MMAE does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Maltese: MMAE ma tinibixxix lil CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, jew CYP2D6.
English: Active severe infections (see section 4.4).
Maltese: Infezzjonijiet severi attivi (ara sezzjoni 4.4).
English: In vitro, MMAE is moderately bound (71%-77%) to human plasma proteins.
Maltese: In vitro, MMAE tintrabat b'mod moderat (71%-77%) mal-proteini tal-plażma talbniedem.
English: Lonzastrasse CH-3930 Visp Switzerland
Maltese: Lonzastrasse CH-3930 Visp L-Iżvizzera
English: Pharmacotherapeutic group: antineoplastic agents; other antineoplastic agents; monoclonal antibodies ATC code: L01XC37
Maltese: Kategorija farmakoterapewtika: sustanzi antineoplastiċi; sustanzi antineoplastiċi oħra; antikorpi monoklonali, Kodiċi ATC: L01XC37
English: Peripheral neuropathy (PN)
Maltese: Newropatija periferali (PN - peripheral neuropathy)
English: LIST OF EXCIPIENTS succinic acid, sodium hydroxide, sucrose, polysorbate 20.
Maltese: TA' EĊĊIPJENTI succinic acid, sodium hydroxide, sucrose, polysorbate 20.
English: Among 173 patients treated with Polivy in Study GO29365, 95 (55%) were ≥65 years of age.
Maltese: Fost 173 pazjent ittrattati b'Polivy fl-Istudju GO29365, 95 (55%) kellhom età ta' ≥65 sena.
English: IRC: Independent Review Committee; INV: Investigator; HR: Hazard Ratio; CI: Confidence Interval, NE: Not evaluable; CMH Cochran-Mantel-Haenszel *Per modified Lugano 2014 criteria: Bone marrow confirmation of PET-CT CR required.
Maltese: HR: Hazard Ratio (Proporzjon ta' Periklu); CI: Confidence Interval (Intervall ta' Kunfidenza), NE: Not evaluable (Ma jistax jiġi evalwat); CMH: CochranMantel-Haenszel *Skont il-kriterji mmodifikati ta' Lugano 2014:
English: Sodium hydroxide (for pH-adjustment) Sucrose
Maltese: Sodium hydroxide (għall-aġġustament tal-pH) Sucrose
English: Polivy contains a cytotoxic component.
Maltese: Polivy fih komponent ċitotossiku.
English: Polivy contains sodium
Maltese: Polivy fih sodium
English: Each cycle lasts 21 days.
Maltese: Kull ċiklu jdum 21 jum.
English: Discontinue Polivy.
Maltese: Waqqaf Polivy.
English: Delayed IRRs as late as 24 hours after receiving Polivy have occurred.
Maltese: Seħħew IRRs li ħarġu tard sa 24 siegħa wara li l-pazjent irċieva Polivy.
English: The median PFS in the Polivy+BR arm was 7.6 months (95% CI: 6.0, 17.0) vs 2.0 months (95% CI: 1.5, 3.7) in the control arm.
Maltese: Polivy+BR kienet ta' 7.6 xhur (CI ta' 95%: 6.0, 17.0) kontra 2.0 xhur (CI ta' 95%: 1.5, 3.7) fil-grupp ta' kontroll.
English: Dose modification1
Maltese: Modifika fid-doża1
English: See section 4 for more information about side effects.
Maltese: Ara s-sezzjoni 4 għal aktar informazzjoni dwar l-effetti sekondarji.
English: See section “Polivy contains sodium”.
Maltese: Ara s-sezzjoni “Polivy fih sodium”.
English: Polivy can cause IRRs , including severe cases.
Maltese: Polivy jista' jwassal għal IRRs, inklużi każijiet severi.