FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment was continued with a vitamin K antagonist dose-adjusted to maintain the PT/INR values within the therapeutic range of 2.0 to 3.0.
Maltese: It-trattament tkompla b'doża aġġustata ta' antagonist tal-vitamina K biex il-valuri ta' PT/INR jinżammu fil-firxa terapewtika ta' 2.0 sa 3.0.
English: Zerit stavudine
Maltese: Zerit stavudina
English: The full EPAR for Zerit 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: It is available as capsules containing 15, 20, 30 and 40 mg stavudine.
Maltese: Jiġi bħala kapsuli li fihom 15, 20, 30 u 40 mg stavudina.
English: Zerit is an antiviral medicine containing the active substance stavudine.
Maltese: Zerit huwa mediċina antivirali li fiha s-sustanza attiva stavudina.
English: Adults weighing less than 60 kg and children weighing over 30 kg take a dose of 30 mg, and adults over 60 kg take 40 mg. Children over the age of 14 days receive 1 mg per kilogram body weight, unless they weigh more than 30 kg.
Maltese: Adulti li jiżnu anqas minn 60 kg u tfal li jiżnu aktar minn 30 kg jieħdu doża ta' 30 mg, u adulti ta' aktar minn 60 kg jieħdu 40 mg.
English: The most common side effects when taking Zerit (seen in between 1 and 10 patients in 100) are peripheral neuropathy (damage to the nerves in the extremities causing tingling, numbness and pain in the hands and feet), diarrhoea, nausea, abdominal (stomach) pain, dyspepsia (heartburn), tiredness, lipoatrophy (a loss of fat in some areas of the body which can cause disfigurement), dizziness, insomnia (difficulty sleeping), abnormal thinking or dreams, somnolence (sleepiness), headache, depression, rash, pruritus (itching) and hyperlactataemia (elevated lactic acid levels in the blood).
Maltese: L-effetti sekondarji l-aktar komuni meta jittieħed Zerit (li dehru f'bejn pazjent 1 u 10 minn kull 100) huma newropatija periferika (ħsara lin-nervituri fl-estremitajiet li jikkaġunaw textix, tirżiħ u wġigħ flidejn u s-saqajn), dijarea, nawżja, uġigħ addominali (ta' żaqq), dispepsja (ħruq ta' stonku), għeja, lipodistrofija (telf ta' xaħam f'xi partijiet tal-ġisem), lipoatropija (telf ta' xaħam f'xi partijiet tal-ġisem li jista' jikkawża sfigurament), sturdament, insomnja (diffikultà fl-irqad), ħsibijiet anormali jew ħolm, somnolenza (ngħas eċċessiv), uġigħ ta' ras, depressjoni, raxx, prurite (ħakk) u iperlaktatimja (livelli għolja ta' aċidu lattiku fid-demm).
English: The active substance in Zerit, stavudine, is a nucleoside reverse transcriptase inhibitor (NRTI).
Maltese: Is-sustanza attiva f'Zerit, l-istavudina, hija inibitur nukleosidiku tat-transkrittażi inversa (NRTI).
English: Other information about Zerit
Maltese: Informazzjoni oħra dwar Zerit
English: This is a summary of the European public assessment report (EPAR) for Zerit.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zerit.
English: What is Zerit?
Maltese: Zerit?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zerit on 8 May 1996.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zerit fit-8 ta' Mejju 1996.
English: Three side effects are possibly related to the medicine's toxic effect on mitochondria (the energyproducing components within cells): lipoatrophy, lactic acidosis (a build-up of lactic acid in the body) and peripheral neuropathy.
Maltese: Tliet effetti sekondarji huma possibbilment relatati mal-effett tossiku tal-mediċina fuq mitokondrija (ilkomponenti li jipproduċu l-eneġija fiċ-ċelloli): il-lipoatropija, l-aċidożi lattika (jittrabba aċidu lattiku filġisem) u n-newropatija periferika.
English: The main measures of effectiveness were the levels of HIV in the blood (viral load) and the number of CD4 T cells in the blood (CD4 cell count) after 48 weeks of treatment.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-livelli ta' HIV fid-demm (tagħbija virali) u n-numru ta' ċelloli CD4 T fiddemm (għadd taċ-ċelloli CD4) wara 48 ġimgħa ta' kura.
English: Zerit is used in combination with other antiviral medicines to treat adults and children who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Zerit jintuża flimkien ma' mediċini antivirali oħrajn fil-kura ta' adulti u tfal li jkunu infettati bil-virus talimmunodefiċjenza umana (HIV), il-virus li jikkawża s-sindromu tal-immunodefiċjenza akkwiżita (AIDS).
English: When taken in combination with lamivudine and efavirenz, around 70% of the patients taking Zerit had viral loads below 400 copies/ml after 48 weeks.
Maltese: Meta meħud flimkien ma' lamivudine u efavirenz, madwar 70% tal-pazjenti li kienu qed jieħdu Zerit kellhom tagħbijiet virali taħt 400 kopja/ml wara 48 ġimgħa.
English: Babies less than 13 days old should be given 0.5 mg/kg body weight.
Maltese: Trabi iżgħar minn 13-il jum għandhom jingħataw 0.5 mg/kg ta' piż tal-ġisem.
English: For the full list of side effects and restrictions with Zerit, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet kollha b'Zerit, ara l-fuljett ta' tagħrif.
English: Two further studies assessed the effectiveness of Zerit, taken in combination with lamivudine and efavirenz (other antiviral medicines) in 467 treatment-naïve patients (who had not taken treatment for HIV infection before).
Maltese: Żewġ studji addizzjonali vvalutaw l-effikaċja ta' Zerit, meħud flimkien ma' lamivudine u efavirenz (mediċini antivirali oħrajn) f'467 pazjent li ma kinux ħadu l-kura għal infezzjoni tal-HIV qabel.
English: CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.
Maltese: Iċ-ċelloli T CD4 huma ċelloli tad-demm bojod li huma importanti fil-ġlieda kontra infezzjonijiet, imma li jinqatlu bl-HIV.
English: How does Zerit work?
Maltese: X'benefiċċju wera Zerit matul l-istudji?
English: The first study compared the effects of Zerit taken alone with those of zidovudine (another antiviral medicine) in 822 HIV-infected patients who had been taking zidovudine for at least six months.
Maltese: L-ewwel studju qabbel l-effetti ta' Zerit meħud waħdu ma' dawk ta' zidovudine (mediċina antivirali oħra) fi 822 pazjent infettati bl-HIV li kienu ilhom jieħdu zidovudine għal mill-anqas sitt xhur.
English: Zerit must not be used in people who are taking another HIV medicine called didanosine, which can also have toxic effects on mitochondria.
Maltese: Zerit m'għandux jintuża f'nies li jkunu qed jieħdu mediċina oħra kontra l-HIV imsejħa didanosine, li jista' jkollha effetti tossiċi wkoll fuq mitokondrija.
English: The studies showed that Zerit could reduce the rates of disease progression in HIV-infected patients.
Maltese: L-istudji wrew li Zerit jista' jnaqqas ir-rati ta' progressjoni tal-mard f'pazjenti infettati bl-HIV.
English: The patients' CD4 cell counts also rose from around 280 cells/mm3 before treatment by an average of around 185 cells/mm3.
Maltese: L-għadd taċ-ċelloli CD4 tal-pazjenti tela' wkoll minn madwar 280 ċellola/mm3 qabel kura b'medja ta' madwar 185 ċellola/mm3.
English: Zerit is also available as a powder to make up into an oral solution.
Maltese: Zerit jiġi wkoll bħala trab li jitħallat f'soluzzjoni orali.
English: Since its authorisation, post-marketing reports and published literature regarding the side effects of Zerit have led the CHMP to update the prescribing information for Zerit, recommending that it should be used for as short a time as possible and only when other antiviral medicines cannot be used.
Maltese: Minn meta ġie awtorizzat, rapporti ta' wara t-tqegħid fis-suq u letteratura ppubblikata rigward l-effetti sekondarji ta' Zerit wasslu biex is-CHMP jaġġorna linformazzjoni dwar il-preskrizzjoni għal Zerit, bir-rakkomandazzjoni li għandu jintuża għal żmien laktar qasir possibbli u biss meta ma jkunux jistgħu jintużaw mediċini antivirali oħrajn.
English: Why has Zerit been approved?
Maltese: Għaliex ġie approvat Zerit?
English: It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Maltese: Din timblokka l-attività tat-transkrittażi inversa, enzima prodotta mill-HIV li tħallih jinfetta ċ-ċelloli filġisem u jirriproduċi aktar virusis.
English: The second study compared two doses of Zerit in over 13,000 patients who did not respond to, or could not take, other types of antiviral medicine.
Maltese: It-tieni studju qabbel żewġ dożi ta' Zerit f'aktar minn 13,000 pazjent li ma rrispondewx għal, jew ma setgħux jieħdu, tipi oħrajn ta' mediċina antivirali.
English: What is the risk associated with Zerit?
Maltese: X'inhu r-riskju assoċjat ma' Zerit?
English: How is Zerit used?
Maltese: Kif jaħdem Zerit?
English: Zerit does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Zerit ma jikkurax infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati mal-AIDS.
English: Slovenia).
Maltese: u s-Slovenja).
English: Levonorgestrel (a progestogen) and ethinylestradiol (an oestrogen) are both hormones and Seasonique is what is known as a ‘combined hormonal contraceptive'.
Maltese: Levonorgestrel (proġestoġenu) u ethinylestradiol (estroġenu) it-tnejn huma ormoni u Seasonique huwa dak li huwa magħruf bħala ‘kontraċettiv ormonali kombinat'.
English: Seasonique is an oral contraceptive for women.
Maltese: Seasonique huwa kontraċettiv orali għan-nisa.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance France) assesses a medicine with a view to granting a marketing authorisation that will be valid in that country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and
Maltese: Din hi proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan il-każ Franza) jevalwa mediċina bil-għan li tingħata awtorizzazzjoni għattqegħid fis-suq li tkun valida kemm f'dak il-pajjiż kif ukoll fi Stati Membri oħrajn (l-‘Istati Membri konċernati', f'dan il-każ l-Awstrija, il-Belġju, il-Ġermanja, l-Italja, il-Polonja, ir-Rumanija, is-Slovakkja
English: What is Seasonique?
Maltese: X'inhu Seasonique?
English: For 84 days the woman takes the tablets containing levonorgestrel and ethinylestradiol and then for the remaining 7 days she takes tablets containing only ethinylestradiol.
Maltese: Għal 84 ġurnata il-mara tieħu l-pilloli li fihom levonorgestrel u ethinylestradiol imbagħad għas-7 ijiem li jifdal hija tieħu pilloli li fihom ethinylestradiol biss.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Seasonique outweigh its risks and that marketing authorisation should be granted in France and in the following EU Member States: Austria, Belgium, Germany, Italy, Poland, Romania, Slovakia and Slovenia.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Seasonique jisbqu r-riskji tiegħu u li l-awtorizzazzjoni għat-tqegħid fis-suq għandha tingħata fi Franza u fl-Istati Membri li ġejjin: l-Awstrija, il-Belġju, il-Ġermanja, l-Italja, il-Polonja, irRumanija, is-Slovakkja u s-Slovenja.
English: Teva Pharma submitted an application to the French medicines agency (ANSM) for Seasonique to be authorised in a decentralised procedure.
Maltese: Teva Pharma sottomettiet applikazzjoni għall-aġenzija Franċiża għall-mediċini (ANSM) għal Seasonique biex jiġi awtorizzat fi proċedura deċentralizzata.
English: Why was Seasonique reviewed?
Maltese: Għaliex ġie rivedut Seasonique?
English: On 26 June 2014, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the oral contraceptive Seasonique.
Maltese: Fis-26 ta' Ġunju 2014, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) fir-rigward tal-awtorizzazzjoni tal-kontraċettiv orali Seasonique.
English: Because the treatment cycle of 91 days is longer than that of most other combined contraceptives (which is normally 28 days), Seasonique is known as an extended cycle oral contraceptive.
Maltese: Minħabba li ċ-ċiklu tal-kura ta' 91 ġurnata huwa itwal minn dak tal-maġġoranza ta' kontraċettivi kkombinati oħrajn (li normalment huwa ta' 28 ġurnata), Seasonique huwa magħruf bħala kontraċettiv orali ta' ċiklu estiż.
English: After evaluating data from studies and post-marketing data from outside the EU, the CHMP was of the view that there was adequate evidence that Seasonique is an effective contraceptive.
Maltese: Wara li evalwa d-dejta minn studji u dejta ta' wara t-tqegħid fis-suq minn barra l-UE, is-CHMP kien talopinjoni li kien hemm evidenza adegwata li Seasonique huwa kontraċettiv effettiv.
English: It is available as blister packs containing 91 tablets to be taken once a day in the order shown on the pack.
Maltese: Huwa disponibbli bħala pakketti bil-folji li fihom 19-il pillola li jittieħdu darba kuljum fl-ordni murija fuq il-pakkett.
English: The grounds for the referral related to concerns raised by the German medicines agency about the effectiveness of Seasonique in preventing pregnancy and the irregular bleeding experienced by women taking the contraceptive.
Maltese: Ir-raġunijiet għar-referenza rrelataw ma' tħassib imqajjem mill-aġenzija Ġermaniża għall-mediċini dwar l-effikaċja ta' Seasonique fil-prevenzjoni ta' tqala u l-fsada irregolari esperjenzata minn nisa li jkunu qed jieħdu l-kontraċettiv.
English: Combined hormonal contraceptives work by stopping the release of eggs from the ovaries and by causing changes in the cervix and the lining of the womb that make it harder for a sperm to reach an egg and for a fertilised egg to implant in the womb.
Maltese: Kontraċettivi ormonali kombinati jaħdmu billi jwaqqfu r-rilaxx tal-bajd mill-ovarji u billi jikkawżaw bidliet fl-għonq tal-utru u fir-rita tal-ġuf li jagħmluha iktar diffiċli biex sperma tilħaq il-bajda u biex bajda fertilizzata timpjanta ruħa fil-ġuf.
English: ribavirin
Maltese: ribavirina
English: The full EPAR for Ribavirin Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Rivabirin Teva Pharma B.V. jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ribavirin Teva Pharma B.V. available as tablets (200 and 400 mg).
Maltese: Rivabirin Teva Pharma B.V. jiġi bħala pilloli (200 u 400 mg).
English: The active substance in Ribavirin Teva Pharma B.V., ribavirin, is an antiviral belonging to the class ‘nucleoside analogues'.
Maltese: Is-sustanza attiva f'Rivabirin Teva Pharma B.V., ribavirin, hija antivirali li jappartjeni għall-klassi ta' ‘analogi ta' nukleoside'.
English: Ribavirin Teva Pharma B.V. can also be used in adults (aged 18 years and older) whose disease has come back after previous treatment.
Maltese: Rivabirin Teva Pharma B.V. jista' jintuża wkoll f'adulti (minn 18-il sena 'l fuq) li lmarda tagħhom reġgħet ħarġet wara kura preċedenti.
English: Ribavirin Teva Pharma B.V. must never be used on its own but only together with interferon alfa 2b (another medicine used in hepatitis).
Maltese: Rivabirin Teva Pharma B.V. qatt ma għandu jintuża waħdu iżda biss ma' interferon alfa 2b (mediċina oħra użata fl-epatite).
English: Ribavirin Teva Pharma B.V. is a ‘generic medicine'.
Maltese: Rivabirin Teva Pharma B.V. huwa ‘mediċina ġenerika'.
English: This is a summary of the European public assessment report (EPAR) for Ribavirin Teva Pharma B.V.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rivabirin Teva Pharma B.V.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Rebetol and do not need to be repeated for Ribavirin Teva Pharma B.V.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Rebetol , u ma għandhomx għalfejn jiġu ripetuti għal Rivabirin Teva Pharma B.V.
English: The European Commission granted a marketing authorisation valid throughout the EU for Ribavirin Teva Pharma B.V. on 1 July 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Rivabirin Teva Pharma B.V. fl-1 ta' Lulju 2009.
English: Because Ribavirin Teva Pharma B.V. 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: Billi Rivabirin Teva Pharma B.V. huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji jitqiesu li huma l-istess bħal dawk tal-mediċina ta' referenza.
English: What are the benefits and risks of Ribavirin Teva Pharma B.V.?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Rivabirin Teva Pharma B.V.?
English: Ribavirin Teva Pharma B.V. is a medicine used to treat long-term hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in patients aged three years and older.
Maltese: Rivabirin Teva Pharma B.V. jintuża fil-kura tal-epatite Ċ kronika fit-tul (marda tal-fwied dovuta għal infezzjoni bil-virus tal-epatite C) f'pazjenti li għandhom minn tliet snin ‘il fuq.
English: Ribavirin Teva Pharma B.V. is used in patients who have not been treated before for all types of hepatitis C except for genotype 1, as long as the liver is still working normally and hepatitis C virus can be found in the blood.
Maltese: Rivabirin Teva Pharma B.V. huwa maħsub li jinterferixxi mal-produzzjoni jew mal-azzjoni ta' DNA u RNA virali, li huma meħtieġa sabiex il-virusis jissopravvivu u jimmultiplikaw.
English: The company also carried out studies that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija wettqet ukoll studji li wrew li hija 'bijoekwivalenti' għall-mediċina ta' referenza.
English: This means that Ribavirin Teva Pharma B.V. contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Rebetol.
Maltese: Dan ifisser li Rivabirin Teva Pharma B.V. fih listess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) msejħa Rebetol.
English: The Committee recommended that Ribavirin Teva Pharma B.V. be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Rivabirin Teva Pharma B.V. jkun approvat għall-użu fl-UE.
English: How is Ribavirin Teva Pharma B.V. used?
Maltese: Kif jintuża Rivabirin Teva Pharma B.V.?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Ribavirin Teva Pharma B.V. has been shown to have comparable quality and to be bioequivalent to Rebetol.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Rivabirin Teva Pharma B.V. għandu kwalità komparabbli u huwa bijoekwivalenti għal Rebetol.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ribavirin Teva Pharma B.V. have been included in the summary of product characteristics and the package leaflet.
Maltese: Ir-rakkomandazzjonijiet u l-prekawzjonijiet li għandhom jiġu segwiti mill-professjonisti fil-qasam talkura tas-saħħa u mill-pazjenti għall-użu sigur u effettiv ta' Rivabirin Teva Pharma B.V. ġew inklużi fissommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif.
English: Why is Ribavirin Teva Pharma B.V. approved?
Maltese: Għaliex ġie approvat Rivabirin Teva Pharma B.V.?
English: Intravenous use vial (glass)
Maltese: Numru tal- ta' l-EMA Isem (ivvintat)
English: Avda de la Industria, 30
Maltese: Avda de la Industria, 30 Alcobendas
English: Alcobendas 28108 Madrid Spain
Maltese: 28108 Madrid Spanja
English: System Organ Class (MedDRA)
Maltese: Sistema ta' Klassifika talOrgani (MedDRA)
English: County Cork Ireland
Maltese: County Cork L-Irlanda
English: Lilly France Fegersheim 2 rue du Colonel Lilly 67640 Fegersheim France
Maltese: Lilly France Fegersheim 2 rue du Colonel Lilly 67640 Fegersheim Franza
English: (12.5%), thrombocytopenia (4.2%), diarrhoea (2.3%) and stomatitis (2.3%).
Maltese: (12.5%), tromboċitopenija (4.2%), dijarea (2.3%) u stomatite (2.3%).
English: Hypertensiona,e
Maltese: Ipertensjonia,e
English: 18.3-123 μg/ml), respectively.
Maltese: 3-123 μg/ml), rispettivament.
English: Palmar-plantar erthyrodysaesthesia syndromeg
Maltese: Sindromu ta' palmar-plantar erthyrodysaesthesiag
English: Terminology Criteria for Adverse Events [NCI
Maltese: Criteria for Adverse Events])
English: Proteinuriaa,f
Maltese: Proteinurja a,f
English: 13.3 months).
Maltese: 13.3 xhur).
English: 1,200 mg/m2 over 46-48 hours a 5-FU = 5-fluorouracil.
Maltese: 46-48 siegħa a 5-FU = 5-fluorouracil.
English: Placebo N=95
Maltese: Plaċebo N=95
English: <1.5 x upper limit of normal value (ULN)
Maltese: <1.5 x il-limitu ta' fuq tal-valur normali (ULN - upper limit of normal)
English: Stomatitis/Mucositis 2
Maltese: Stomatite/Mukosite 2
English: Colorectal cancer
Maltese: Kanċer kolorektali
English: Gastrointestinal haemorrhage eventsa,f Gastrointestinal perforationa
Maltese: Avvenimenti emorraġiċi gastrointestinalia,f Perforazzjoni gastrointestinalia
English: Cyramza contains sodium
Maltese: Cyramza fih sodium
English: - The active substance is ramucirumab.
Maltese: - Is-sustanza attiva hi ramucirumab.
English: Histidine monohydrochloride Sodium chloride Glycine (E640) Polysorbate 80 (E433) Water for injections
Maltese: Histidine monohydrochloride Sodium chloride Glycine (E640) Polysorbate 80 (E433) Ilma għall-injezzjonijiet
English: Excipients: histidine, histidine monohydrochloride, sodium chloride, glycine, polysorbate 80, water for injections.
Maltese: Eċċipjenti: histidine, histidine monohydrochloride, sodium chloride, glycine, polysorbate 80, ilma għall-injezzjonijiet.
English: It is given with other medicines called ‘FOLFIRI chemotherapy', including ‘5-fluorouracil', ‘folinic acid', and ‘irinotecan'.
Maltese: Huwa jingħata ma' mediċini oħra msejħa ‘kimoterapija FOLFIRI', li jinkludu ‘5-fluorouracil', ‘folinic acid', u ‘irinotecan'.
English: Date of first authorisation: 19 December 2014 Date of latest renewal: 26 September 2019
Maltese: Data tal-aħħar tiġdid: 26 Settembru 2019
English: The median relative dose intensity of Cyramza was 98.6% and of placebo was 99.6%.
Maltese: Il-medjan tal-intensità relattiva tad-doża ta' Cyramza kien 98.6% u dak tal-plaċebo kien 99.6%.
English: NCI CTCAE grade
Maltese: Grad NCI CTCAE
English: Median (95% CI) Hazard ratio (95% CI) Stratified log-rank p-value
Maltese: Medjan (95% CI) Hazard ratio (95% CI) Stratified log-rank p-value
English: The following convention has been used for classification of frequency:
Maltese: Il-konvenzjoni li ġejja ntużat għall-klassifikazzjoni tal-frekwenza:
English: EU/1/14/957/002 - 2 vials of 10 ml.
Maltese: EU/1/14/957/002 - 2 kunjetti ta' 10 ml.
English: Objective Response Rate (CR + PR)
Maltese: Rata ta' rispons oġġettiva (CR + PR)
English: Placebo plus paclitaxel N=335
Maltese: Plaċebo u paclitaxel N=335
English: REACH-2 efficacy results are shown in Table 12 and Figure 8.
Maltese: Ir-riżultati ta' effikaċja ta' REACH-2 huma murija f'Tabella 12 u Figura 8.
English: Hepatocellular carcinoma (HCC)
Maltese: Karċinoma epatoċellulari (HCC-Hepatocellular carcinoma)
English: Cyramza may increase the risk of problems with wound healing.
Maltese: Cyramza jista' jżid ir-riskju ta' problemi bil-fejqan ta' feriti.
English: Abdominal paina,e Diarrhoea
Maltese: Uġigħ addominalia,e Dijarea
English: Stratified log-rank p-value
Maltese: Valur p log-rank stratifikat