FrancophonIA/ELRC3.0 huggingface dataset:
English: • There is no alternative manufacturing site registered in the marketing authorisation of Ammonaps;
Maltese: • Ma hemm ebda sit ta' manifattura alternattiv rreġistrat fl-awtorizzazzjoni għat-tqegħid fis-suq ta' Ammonaps;
English: As a consequence, the CHMP recommends that the marketing authorisation for Dutasteride Actavis (and associated names) should be varied to remove Pharmaceutical International Inc. as manufacturing site from their marketing authorisations.
Maltese: Bħala konsegwenza, is-CHMP jirrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq għal Dutasteride Actavis (u ismijiet assoċjati) għandha tkun varjata biex tneħħi lil Pharmaceutical International Inc. bħala sit ta' manifattura mill-awtorizzazzjonijiet ta' manifattura tagħhom.
English: Based on the nature of the disease and the fact that therapeutic alternatives are not available in all Member States, the CHMP considers the product Ammonaps to be critical.
Maltese: Abbażi tan-natura talmarda u l-fatt li alternattivi terapewtiċi mhux disponibbli fl-Istati Membri kollha, is-CHMP kkonsidra lprodott Ammonaps bħala kritiku.
English: This summary was last updated in April 2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'April 2016.
English: The full EPAR for Clomicalm can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Clomicalm clomipramine hydrochloride
Maltese: Clomicalm klomipramina idrokloridrat
English: It works by increasing the levels of certain neurotransmitters, serotonin and noradrenaline, in the central nervous system.
Maltese: Taħdem billi żżid il-livelli ta' ċerti newrotrażmettituri, is-serotonin u n-noradrenalina, fis-sistema ċentrali nervuża.
English: It contains the active substance clomipramine hydrochloride.
Maltese: Dan fih is-sustanza attiva klomipramina idrokloridrat.
English: This is a summary of the European public assessment report (EPAR) for Clomicalm.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Clomicalm.
English: The European Commission granted a marketing authorisation valid throughout the EU for Clomicalm on 1 April 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Clomicalm fl-1 ta' April 1998.
English: Clomicalm is available as tablets (5, 20 and 80 mg) and can only be obtained with a prescription.
Maltese: Clomicalm jiġi f'pilloli ta' (5, 20 u 80 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Why is Clomicalm approved?
Maltese: Għaliex ġie approvat Clomicalm?
English: Clomicalm must not be used in dogs with a known hypersensitivity to clomipramine and related medicines (known as tricyclic antidepressants).
Maltese: Clomicalm ma għandux jintuża fi klieb b'ipersensittività magħrufa għal klomipramina u mediċini relatati (magħrufa bħala antidepressanti triċikliċi).
English: Clomipramine is an antidepressant.
Maltese: Il-klomipramina hija antidipressant.
English: Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (lack of energy) or an elevation in liver enzymes which is reversible when treatment is stopped.
Maltese: Clomicalm jista' rarament jikkawża remettar, tibdil fl-aptit, letarġija (nuqqas ta' enerġija) jew kwalunkwe żieda fl-enzimi tal-fwied li huma reversibbli ladarba l-kura titwaqqaf.
English: What are the risks associated with Clomicalm?
Maltese: X'inhuma r-riskji assoċjati ma' Clomicalm?
English: to be effective in reducing behavioural problems in dogs associated with separation anxiety and was more effective than behavioural therapy alone on the basis of a broad spectrum of behavioural signs of anxiety including signs of high attachment to the owner.
Maltese: Studji fuq il-post li saru fl-Istati Uniti u fl-Ewropa wrew li meta Clomicalm jintuża ma' terapija tal-imġiba, biex ikun effettiv fit-tnaqqis ta' problemi ta' mġiba fi klieb assoċjati ma' anzjetà ta' separazzjoni u kien iktar effettiv mit-terapija ta' mġiba waħedha abbażi ta' spettru wiesa' ta' sinjali ta' mġiba ta' anzjetà fosthom sinjali ta' rabta kbira mas-sid.
English: The tablets are given twice a day with or without food and usually 2 - 3 months is sufficient to control the condition although some dogs may need longer treatment.
Maltese: Il-pilloli jingħataw darbtejn kuljum mal-ikel jew le u ġeneralment bejn 2 - 3 xhur huwa biżżejjed biex jikkontrolla l-kondizzjoni minkejja li xi klieb jistgħu jeħtieġu kura itwal.
English: If a child accidentally swallows the medicine, this could cause serious reactions.
Maltese: Jekk tifel aċċidentalment jibla' l-mediċina, dan jista' jikkawża reazzjonijiet serji.
English: Such problems may include destruction of property and inappropriate defaecation and urination in the home. Clomicalm should only be given in combination with behavioural therapy.
Maltese: Tali problemi jistgħu jinkludu t-tkissir tal-proprjetà u jgħaddu l-awrina jew jippurgaw mhux kif suppost fid-dar. Clomicalm għandu jingħata biss flimkien mat-terapija tal-imġiba.
English: A neurotransmitter is a substance that relays signals from a nerve cell to another cell.
Maltese: Newrotrasmettitur huwa sustanza li jibgħat sinjali minn ċellola tan-nervituri għal ċellola oħra.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Clomicalm's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija kkonkluda li l-benefiċċji ta' Clomicalm huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Clomicalm is a veterinary medicine used as an aid in the treatment of dogs with behavioural problems when separated from their owners, their home or other dogs.
Maltese: Clomicalm huwa mediċina veterinarja użata bħala għajnuna fil-kura tal-klieb bi problemi fl-imġiba meta jiġu sseparati minn sidhom, id-dar fejn jgħixu jew minn klieb oħra.
English: Since low levels of these neurotransmitters can be linked to depression and anxiety, increasing them can help the dogs feel calmer so improving the behavioural signs in dogs with separation related problems.
Maltese: Peress li livelli baxxi ta' dawn in-newrotrażmettituri jistgħu jkunu marbuta mad-dipressjoni u l-anzjetà, iż-żieda tagħhom tista' jgħin lill-klieb biex iħossuhom aktar kalmi u għaldaqstant itejbu s-sinjali ta' mġiba bi problemi relatati ma' separazzjoni .
English: For practical information about using Clomicalm, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Maltese: Ġew irrapportati effetti fuq il-fwied speċjalment fi klieb li kienu diġà jbatu minn problemi bil-fwied.
English: (Invented) name Strength Pharmaceutical form
Maltese: Għamla farmaċewtika
English: ATCvet code: QI08AA
Maltese: Kodici ATC veterinarja QI08AA
English: La Selva, 135 17170 Amer SPAIN
Maltese: La Selva, 135 17170 Amer SPANJA
English: HIPRA BENELUX NV Tel: (+32) 9 324 21 58
Maltese: Luxembourg HIPRA BENELUX NV Tel: (+32) 9 324 21 58
English: Duration of immunity: 9 months demonstrated by challenge
Maltese: Tul tal-immunità: 9 xhur murija bi sfida
English: Onset of immunity: 1 week Duration of immunity: 9 months demonstrated by challenge
Maltese: Ġimgħa Tul tal-immunità: 9 xhur murija bi sfida
English: EU/2/16/199/001 (5 ml) EU/2/16/199/002 (20 ml) EU/2/16/199/003 (0.5 ml)
Maltese: EU/2/16/199/002 (20 ml)
English: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: -very common (more than 1 in 10 animals treated displaying adverse reaction (s)) -common (more than 1 but less than 10 animals in 100 animals treated) -uncommon (more than 1 but less than 10 animals in 1,000 animals treated) -rare (more than 1 but less than 10 animals in 10,000 animals treated) -very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: Il-frekwenza ta' effetti mhux mixtieqa hija definita skont din il-konvenzjoni: - komuni ħafna (aktar minn wieħed f'10 annimali li juru effett(i) mhux mixtieq(a)) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal, inklużi rapporti iżolati).
English: The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
Maltese: It-tilqima tipprovdi biss protezzjoni kontra RHDV2; protezzjoni inkroċjata kontra RHDV klassiku ma ntwerietx.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Maltese: L-addittivi (inkluż l-aġġuvanti) elenkati f'sezzjoni 6.1 tas-Sommarju tal-Karatteristiċi tal-Prodott huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan ilprodott mediċinali veterinarju.
English: Date of first authorisation: 22 September 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI / TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizazzjoni: 22.09.2016
English: Thiomersal: ………………..0.05 mg Whitish emulsion.
Maltese: Thiomersal: ………………0.05 mg
English: Laboratory studies in pregnant doe rabbits in the last third of gestation have not produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Maltese: Studji fil-laboratorji fuq fniek nisa fl-aħħar terz tal-ġestazzjoni ma produċew ebda evidenza ta' effetti teratoġeniċi, fetetotossiċi u maternotossiċi.
English: Mineral oil: ………………..104.125 mg
Maltese: Żejt minerali: ………………104.125 mg Aġġuvant:
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 ….
Maltese: Mard emorraġiku tal-fniek virus tat-tip 2 (RHDV2) mhux attivat, razzaV-1037:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali veterinarju tinstab fuq il-websajt tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Maltese: Għal immunizzazzjoni attiva ta' fniek minn 30 jum biex tnaqqas il-mortalità kkawżata minn mard emorraġiku tal-fniek virus tat-tip 2 (RHDV2).
English: Onset of immunity: 1 week.
Maltese: Bidu tal-immunità:
English: Very common: a transient temperature increase slightly above 40 ºC might occur between two or three days following vaccination.
Maltese: Komuni ħafna: tista' seħħ żieda temporanja fit-temperatura ta' ftit iżjed minn 40ºC bejn jumejn jew tlett ijiem wara t-tilqima.
English: ERAVAC emulsion for injection for rabbits.
Maltese: VETERINARJU ERAVAC emulsjoni għal injezzjoni għal fniek.
English: Inactivated RHDV2, strain V-1037: ……… ≥70% cELISA40*
Maltese: RHDV2 inattivat, razza V-1037: ≥70% cELISA40* * ≥70 % tal-fniek imlaqqma għandhom jagħtu titri tal-antikopri cELISA ugwali għal jew ogħla minn
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 dwar ilMediċini http://www.ema.europa.eu/.
English: Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strainV-1037……≥70% cELISA40*
Maltese: Mard emorraġiku tal-fniek virus tat-tip 2 (RHDV2) mhux attivat, razzaV-1037……≥70% cELISA40* (*) ≥70 % tal-fniek imlaqqma għandhom jagħtu titri tal-antikopri cELISA ugwali għal jew ogħla minn
English: Pregnancy
Maltese: TAMMINISTRA
English: ERAVAC Emulsion for injection for rabbits
Maltese: VETERINARJU ERAVAC emulsjoni għal injezzjoni għall-fniek
English: This slight temperature increase resolves spontaneously without treatment by day 5 post-vaccination.
Maltese: Din iż-żieda ħafifa fit-temperatura tirriżolvi ruħha b'mod spontajnu mingħajr kura sa jum 5 minn wara t-tilqima.
English: Very common: nodules or swelling (< 2 cm) can be observed in the injection site, which may last 24 hours.
Maltese: Komuni ħafna: noduli jew nefħa (<2 cm) jistgħu jiġu osservati fil-post tat-tilqima, li jistgħu jdumu 24 siegħa.
English: Cardboard box of 10 glass vial of 1 dose (0.5 ml) Cardboard box of 1 glass vial of 10 doses (5 ml).
Maltese: Kaxxa tal-kartun b'10 kunjetti tal-ħġieġ ta' doża 1 (0.5 ml).
English: Rabbits.
Maltese: U LUŻU
English: Avda.
Maltese: Amer
English: Thiomersal…………0.05 mg For the full list of excipients, see section 6.1.
Maltese: Għal-lista sħiħa tal-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: 5 April 2016 EMA/154066/2016
Maltese: EMA/154066/2016
English: Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian essential oil medicines.
Maltese: Pazjenti bi ġrieħi miftuħin, problemi tal-ġilda, deni għoli, infezzjonijiet severi u problemi severi tal-qalb u taċ-ċirkolazzjoni ma għandhomx jieħdu banjijiet sħaħ b'mediċini biż-żejt volatili tal-Valerjana.
English: Side effects have been reported with valerian essential oil medicines.
Maltese: Ġew irrapportati effetti sekondarji bil-mediċini li fihom iż-żejt volatili tal-Valerjana.
English: Valerian essential oil medicines should be used only in adults and adolescents over the age of 12 years.
Maltese: Mediċini li fihom iż-żejt volatili tal-Valerjana għandhom jintużaw biss f'adulti u adolexxenti li għandhom 'il fuq minn 12-il sena.
English: Other information about valerian essential oil medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom iż-żejt volatili tal-Valerjana
English: Further information on the HMPC assessment of valerian essential oil 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: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom iż-żejt volatili tal-Valerjana, inklużi d-dettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' fil-websajt talAġenzija:
English: This means that, although there is insufficient evidence from clinical studies, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini tal-ħxejjex hija plawżibbli u hemm evidenza li ilhom jintużaw b'mod sigur b'dan il-mod millinqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: What is valerian essential oil?
Maltese: X'inhu ż-żejt volatili tal-Valerjana?
English: Valerian essential oil is the common name for the essential oil extracted from the underground parts of the plant Valeriana officinalis L.
Maltese: Iż-żejt volatili tal-Valerjana huwa l-isem komuni għaż-żejt miksub mill-partijiet ta' taħt l-art tal-pjanta Valeriana officinalis L.
English: Further information on the risks associated with these valerian essential oil 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 ma' dawn il-mediċini li fihom iż-żejt volatili tal-Valerjana, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fil-websajt tal-Aġenzija:
English: How are valerian essential oil medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini li fihom iż-żejt volatili tal-Valerjana?
English: The HMPC conclusions on the use of these valerian essential oil medicines for the relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' dawn il-mediċini li fihom iż-żejt volatili tal-Valerjana għasserħan ta' sintomi ħfief ta' stress mentali u sabiex jgħinu fl-irqad huma bbażati fuq l-"użu tradizzjonali" tagħhom.
English: Any applications for the licensing of medicines containing valerian essential oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom iż-żejt volatili tal-Valerjana għandha titressaq lill-awtoritajiet nazzjonali responsabbli għall-prodotti mediċinali, li ser jivvalutaw lapplikazzjoni għall-mediċina tal-ħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: Herbal medicines containing valerian essential oil are usually available in liquid forms to be taken by mouth or used as bath additives.
Maltese: Il-mediċini tal-ħxejjex li fihom iż-żejt volatili tal-Valerjana normalment huma disponibbli f'forom likwidi sabiex jittieħdu mill-ħalq jew bħala addittiv fil-banju.
English: Valerian essential oil is obtained by directing steam through the underground parts of the plant.
Maltese: Iż-żejt volatili tal-Valerjana huwa miksub billi fwar jiġi dirett minn ġol-partijiet ta' taħt l-art tal-pjanta.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing valerian essential oil.
Maltese: Il-konklużjonijiet tal-HMPC jiġu kkunsidrati mill-Istati Membri tal-UE waqt l-evalwazzjoni tal-applikazzjonijiet għal-liċenzjar ta' mediċini tal-ħxejjex li fihom iż-żejt volatili tal-Valerjana.
English: United Kingdom Medimpex UK LTD 127 Shirland road,
Maltese: Il-Lussemburgu Medimpex UK LTD 127 Shirland Road,
English: 28 x 1 tablets (calendar pack)
Maltese: Daqs tal-pakkett folja (OPA/al/PVC/al) 28 x 1 pillola (pakkett ta' kalendarju)
English: Onivyde (irinotecan)
Maltese: Onivyde (irinotekan)
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu311933.
Maltese: Aktar informazzjoni dwar id-denominazzjoni orfni tista' tinstab hawn: ema.europa.eu/medicines/human/orphan-designations/eu311933.
English: Further information on Onivyde can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Onivyde.
Maltese: ema.europa.eu/medicines/human/EPAR/Onivyde.
English: Onivyde received a marketing authorisation valid throughout the EU on 14 October 2016.
Maltese: Onivyde rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fl-14 ta' Ottubru 2016.
English: Other information about Onivyde
Maltese: Informazzjoni oħra dwar Onivyde
English: The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors'.
Maltese: Is-sustanza attiva f'Onivyde, l-irinotekan, hija mediċina kontra l-kanċer li tappartjeni għall-grupp tal‘inibituri tat-topojsomerażi'.
English: Pancreatic cancer is rare, and Onivyde was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 December 2011.
Maltese: Il-kanċer tal-frixa huwa rari, u Onivyde ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fid-9 ta' Diċembru 2011.
English: The recommended dose is 70 mg per square metre of body surface given every 2 weeks together with 5-fluorouracil and leucovorin.
Maltese: Id-doża rakkomandata hija 70 mg għal kull metru kwadru tas-superfiċje tal-ġisem mogħtija kull ġimagħtejn flimkien ma' 5-fluorouracil u leucovorin.
English: Onivyde is used together with 5-fluorouracil and leucovorin (two other cancer medicines) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.
Maltese: Onivyde jintuża flimkien ma' 5-fluorouracil u leucovorin (żewġ mediċini oħra kontra l-kanċer) f'adulti li l-kanċer tagħhom iggrava minkejja l-kura li fiha l-mediċina kontra l-kanċer gemcitabine.
English: The most common side effects with Onivyde (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth) and fever.
Maltese: L-effetti sekondarji l-aktar komuni b'Onivyde (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma dijarea, nawżja (tħossok ma tiflaħx), rimettar, telf ta' aptit, newtropenija (livelli baxxi ta' newtrofili, tip ta' ċellola bajda tad-demm), għeja, debbulizza, anemija (għadd baxx ta' ċelloli ħomor tad-demm) stomatite (infjammazzjoni tar-rita tal-ħalq) u deni.
English: The Agency considered that the increase in survival seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.
Maltese: L-Aġenzija ikkunsidrat li ż-żieda fis-sopravivenza li dehret meta Onivyde ntuża flimkien ma' 5-fluorouracil u leucovorin kienet sinifikanti f'pazjenti li qabel kienu kkurati b'adenokarċinoma metastatika tal-frixa, li għalihom huma disponibbli għażliet ta' kura limitati; il-profil tas-sigurtà ta' Onivyde huwa f'konformità ma' dak tal-irinotekan standard, u l-effetti sekondarji maniġġabbli.
English: The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients' lives: patients taking the three medicines together lived for around 6.1 months, compared with 4.2 months for patients taking 5-fluorouracil plus leucovorin, and 4.9 months for patients taking Onivyde alone.
Maltese: L-istudju wera li ż-żieda ta' Onivyde mar-reġim ta' 5-fluorouracil flimkien ma' leucovorin tawlet il-ħajja tal-pazjenti: pazjenti li kienu qed jieħdu t-tliet mediċini flimkien għexu għal madwar 6.1 xhur, meta mqabbla mal-4.2 xhur għal pazjenti li kienu qed jieħdu 5-fluorouracil u leucovorin, u 4.9 xhur għal pazjenti li kienu qed jieħdu Onivyde waħdu.
English: The most common serious side effects (which may affect more than 1 in 50 people) included diarrhoea, nausea and vomiting, neutropenia and fever, infections of blood or lungs (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low levels of blood platelets).
Maltese: L-effetti sekondarji serji l-aktar komuni (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 50) kienu jinkludu dijarea, nawżja u rimettar, newtropenija u deni, infezzjonijiet tad-demm jew tal-pulmun (sepsi, pulmonite) xokk, deidrazzjoni, insuffiċjenza tal-kliewi u tromboċitopenija (livelli baxxi ta' pjastrini tad-demm).
English: What are the risks associated with Onivyde?
Maltese: X'inhuma r-riskji assoċjati ma' Onivyde?