FrancophonIA/ELRC3.0 huggingface dataset:
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 kunjetti 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: Patients in both study arms were fully supplemented with folic acid and vitamin B12.
Maltese: Il-pazjenti fiż-żewġ fergħat tal-istudju ġew mogħtija lfolic acid u l-vitamina B12.
English: Nausea
Maltese: Dijarrea
English: Neuropathy-Sensory
Maltese: Il-Monitoraġġ
English: For patients with NSCLC other than predominantly squamous cell histology (n= 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio= 0.47 (95% CI= 0.37-0.60, p= 0.00001).
Maltese: Għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ-ċelluli huma liżjed tat-tip squamous (n= 430, popolazzjoni analizzata indipendentement), il-medjan tal-PFS kien ta' 4.4 xhur għall-fergħa ta' pemetrexed u ta' 1.8 xhur għall-fergħa tal-plaċebo, hazard ratio = 0.47, 95 % CI = 0.37-0.60,p= 00001.
English: Constipation Common Dyspepsia
Maltese: Dijarrea mingħajr kolostomija
English: Time to treatment failure (months)
Maltese: OS Time (Months)
English: After reconstitution (see section 6.6), each vial contains 25 mg/ml of pemetrexed.
Maltese: Wara r-rikostituzzjoni (ara sezzjoni 6.6), kull kunjett fih 25 mg/ml ta' pemetrexed Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with lavender flip-off seal containing 100 mg of pemetrexed.
Maltese: Pemetrexed Accord 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Pemetrexed Accord 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni.
English: Pemetrexed Accord 500 mg powder for concentrate for solution for infusion Type I glass vial with a grey bromobutyl rubber stopper with royal blue flip-off seal containing 500 mg of pemetrexed.
Maltese: Pemetrexed Accord 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kunjett tal-ħġieġ ta' Tip I b'tapp tal-lasktu bromobutyl griż b'siġill li jista' jinqala' ta' kulur blu jgħajjat li fih 500 mg ta' pemetrexed.
English: a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001).
Maltese: ITT = intenzjoni li tikkura; N = daqs talpopolazzjoni kollha a Statistikament sinifikanti biex ma tkunx inferjuri, bl-intervall ta' kunfidenza għal HR kollu kemm hu ħafna taħt il-marġni ta' 1.17645 li turi li m'hemmx inferjorità (p <.001).
English: Pemetrexed Accord 1000 mg powder for concentrate for solution for infusion pemetrexed
Maltese: Pemetrexed Accord 1000 mg trab għal konċentrat għal soluzzjoni għall-infużjoni pemetrexed
English: A hospital pharmacist, nurse or doctor will have mixed the Pemetrexed Accord 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 Accord jiġi mħallat ma' soluzzjoni għall-injezzjoni ta' 9 mg/ml(0.9 %) sodium chloride, mill-ispiżjar ta' lisptar, infermier jew tabib.
English: Reconstitute 1000-mg vials with 40 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 kunjetti ta' 1000 mg b'40 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: Reconstitute each 100 mg vial with 4.2 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 kunjetti 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: 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 listoloġija 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: Common Pain
Maltese: Komuni ħafna
English: Common Vomiting Mucositis/ stomatitis
Maltese: Rimettar Mukosite/stomatite 6.8
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 l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous (n= 481) kien ta' 15.5 xhur għall-fergħa ta' Pemetrexed Accord u ta' 10.3 xhur għall-fergħa tal-plaċebo (hazard ratio = 0.70, 95% CI = 0.56-0.88, p=0.002).
English: Nadir platelets < 50,000 /mm3 with bleedinga, regardless of nadir ANC
Maltese: L-għadd l-iktar baxx ta' plejtlits < 50,000 /mm3 bi fsadaa, hu x'inhu l-għadd l-iktar baxx ta' ANC
English: Edema
Maltese: Rimettar
English: Large cell (N=153)
Maltese: Popolazzjoni ITT (N = 1725)
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Accord has finished.
Maltese: Cisplatin ukoll jingħata b'infużjoni f'waħda mill-vini tiegħek, u jingħata madwar 30 minuta wara li tkun spiċċat l-infużjoni ta' Pemetrexed Accord.
English: Reconstitute 500-mg vials with 20 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' 500mg b'20 ml ta' soluzzjoni għall-injezzjoni ta' 9mg/ml (0.9%) sodium chloride, mingħajr preservattiv, li jirriżulta f'soluzzjoni li jkollha 25 mg/ml pemetrexed.
English: When using Pemetrexed Accord in combination with cisplatin:
Maltese: Meta tuża Pemetrexed Accord flimkien ma' cisplatin:
English: Pemetrexed Accord is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Maltese: Pemetrexed Accord tingħata flimkien ma' cisplatin, mediċina oħra kontra l-kanċer, bħala kura għal mesoteljoma plewrali malinna, tip ta' kanċer li jaffettwa r-rita tal-pulmun, lil pazjenti li jkunu għadhom ma ngħatawx kimoterapija.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed Accord 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Maltese: Pemetrexed Accord 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni Kull kunjett fih 100 mg ta' pemetrexed (bħala pemexetred disodium hemipentahydrate).
English: Side effects with Pemetrexed Accord may include:
Maltese: Effetti sekondarji ta' Pemetrexed Accord jistgħu jinkludu:
English: Of the 939 patients treated with pemetrexed plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Maltese: Mid-939 pazjent li bdew il-kura b'pemetrexed flimkien ma' cisplatin, 539 pazjent ġew magħżula b'mod arbitrarju biex jieħdu kura ta' manteniment b'pemetrexed jew plaċebo.
English: This suggests that pemetrexed may impair male fertility.
Maltese: Irriskju jikber f'persuni li jkunu diġà immunosoppressi minħabba l-marda li jkollhom.
English: Chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at 25°C.
Maltese: L-istabbilità kimika u fiżika ta' waqt l-użu, tas-soluzzjonijiet rikostitwiti u ta' infużjoni ta' pemetrexed ġiet ippruvata għal 24 siegħa f'temperatura ta' 25°C.
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95 % CI = 0.47-0.74).
Maltese: Għal dawk il-pazjenti magħżula b'mod arbitrarju, kif mkejjel mill-bidu tal-kura primarja inizjali ta' pemetrexed flimkien ma' cisplatin, il-medjan talPFS evalwat mill-investigatur kien ta' 6.9 xhur għall-fergħa ta' pemetrexed u ta' 5.6 ta' xahar għallfergħa tal-plaċebo (hazard ratio = 0.59, 95% CI = 0.
English: IV use
Maltese: Għeja
English: Constipation
Maltese: Adenokarċinoma
English: Pemetrexed Accord in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Maltese: Pemetrexed Accord hija mediċina li tintuża fil-kura tal-kanċer.
English: Women of childbearing potential must use effective contraception during treatment with pemetrexed (see section 4.6).
Maltese: It-treddigħ għandu jieqaf waqt it-terapija b'pemetrexed (ara sezzjoni 4.3).
English: Stomatitis/ Pharyngitis Nausea
Maltese: Żieda filkrejatinina
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: * Irreferi għal verżjoni 2 tas-CTC ta' l-Istitut Nazzjonali tal-Kanċer għal kull grad ta' tossiċità. ** Skont is-CTC (v 2.0; NCI 1998) ta' l-Istitut Nazzjonali tal-Kanċer, l-alopeċja għandha tiġi rrapportata biss bħala Grad 1 jew 2.
English: Pemetrexed Accord 100 mg powder for concentrate for solution for infusion pemetrexed
Maltese: TAL-PRODOTT MEDIĊINALI Pemetrexed Accord 100 mg trab għal konċentrat għal soluzzjoni għall-infużjoni pemetrexed
English: Strength Pharmaceutical Form Route of Administration Packaging
Maltese: Qawwa Għamla farmaċewtika
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom defences) how to defend itself against a disease.
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: It contains live Escherichia coli (E.coli) bacteria of a strain (O8:K87) that does not produce toxins that cause disease.
Maltese: Fiha batterja Escherichia coli (E.coli) ħajja tar-razza (O8:K87) li ma tipproduċix tossini li jikkawżaw mard.
English: In each study 350 pigs were vaccinated with Coliprotec F4 and 350 pigs remained unvaccinated.
Maltese: F'kull studju tlaqqmu 350 majjal b'Coliprotec F4 u 350 majjal baqgħu mhux imlaqqmin.
English: Coliprotec F4 is given to pigs from 18 days of age to reduce the incidence of moderate to severe post-weaning E. coli diarrhoea.
Maltese: Coliprotec F4 jingħata lill-majjali mill-età ta' 18-il jum biex titnaqqas l-inċidenza ta' dijarea b'E. coli wara t-treddigħ moderata sa severa.
English: The vaccine starts to be effective 7 days after vaccination and protection lasts for 21 days after vaccination.
Maltese: It-tilqima tibda ssir effettiva 7 ijiem wara t-tilqim u l-protezzjoni ddum għal 21 jum wara t-tilqima.
English: Other information about Coliprotec F4:
Maltese: Informazzjoni oħra dwar Coliprotec F4:
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni abbażi tmar-rakkomandazzjonijiet tas-CVMP, aqra d-diskussjoni xjentifika (parti wkoll mill-EPAR).
English: Coliprotec F4 is a vaccine that is available as a lyophilisate (a freeze-dried pellet) which is made up into an oral suspension with water.
Maltese: Coliprotec F4 huwa tilqima li tiġi bħala lijofilizzat (pellit mnixxfa bil-friża) li hija magħmula f'sospensjoni orali bl-ilma.
English: Coliprotec F4 is a vaccine.
Maltese: Coliprotec F4 huwa tilqima.
English: The types of E.coli associated with post-weaning diarrhoea often produce a protein called F4 on their outer coat that allows them to attach to the cells of the gut.
Maltese: It-tipi ta' E.coli assoċjati ma' dijarea wara t-treddigħ ħafna drabi jipproduċu proteina msejħa F4 fuq il-kisja ta' barra li tippermettilhom li jeħlu maċ-ċelloli tal-imsaren.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Coliprotec F4 on 16 March 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Coliprotec F4 f'16/03/2015.
English: This will help protect the pigs against E. coli infection and disease.
Maltese: Dan ser jgħin jipproteġi l-majjali kontra infezzjoni u mard tal-E. coli.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Maltese: Il-bilanċ talbenefiċċu-riskju jista' jinstab fil-modulu tad-diskussjoni xjentifika ta' dan l-EPAR.
English: The CVMP concluded that the benefits of Coliprotec F4 exceed the risks for the approved indication and recommended that Coliprotec F4 be given a marketing authorisation.
Maltese: Is-CVMP ikkonkluda li l-benefiċċji ta' Coliprotec F4 huma akbar mir-riskji tiegħu għall-indikazzjoni approvata u rrakkomanda li Coliprotec F4 jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is Coliprotec F4?
Maltese: X'inhu Coliprotec F4?
English: This is a summary of the European public assessment report.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' vValutazzjoni.
English: The purpose of these studies was to establish how long it took for pigs to be fully protected and the length of time protection lasts against E. coli.
Maltese: L-iskop ta' dawn l-istudji kien biex jiġi stabbilit kemm il-majjali jdumu sakemm jiġu protetti kompletament u ttul ta' żmien li ddum il-protezzjoni kontra E. coli.
English: The effectiveness of Coliprotec F4 was investigated in two field studies involving pigs where the farms had a history of post-weaning diarrhoea.
Maltese: L-effikaċja ta' F4 ġiet investigata f'żewġ studji fuq il-post li involvew majjali fejn l-irziezet kellhom storja ta' dijarea wara t-treddigħ.
English: Although E.coli is naturally found in the gut, some strains (known as enterotoxigenic strains) produce a toxin that causes diarrhoea, and can result in dehydration, weight loss and occasionally death of the animal.
Maltese: Għalkemm E.coli jinstab b'mod naturali fl-imsaren, xi razez (magħrufin bħala razez enterotossiġeniċi) jipproduċu tossina li tikkawża dijarea, u tista' tirriżulta f'deidrazzjoni, tnaqqis fil-piż u xi drabi mewt tal-annimal.
English: What is the risk associated with Coliprotec F4?
Maltese: X'riskji huma assoċjati ma' Coliprotec F4?
English: Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the vaccine.
Maltese: Meta tiġi mmaniġġata t-tilqima għandu jintlibes tagħmir personali protettiv li jikkonsisti minn ingwanti protettivi li jintremew wara l-użu u nuċċalijiet ta' sigurtà.
English: Why has Coliprotec F4 been approved?
Maltese: Għaliex ġie approvat Coliprotec F4?
English: How has Coliprotec F4 been studied?
Maltese: Kif ġie studjat Coliprotec F4?
English: EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR)
English: 10 (2 x 5 ) prefilled pens (multipack)
Maltese: 10 (2 x 5) pinen mimlijin għal-lest (pakkett multiplu)
English: 1 cartridge
Maltese: Qawwa
English: Follow-up assessment after the referral under Article 35 of Directive 2001/82/EC (EMEA/V/A/089)
Maltese: Valutazzjoni ta' segwitu wara r-referenza skont l-Artikolu 35 tadDirettiva 2001/82/KE (EMEA/V/A/089)
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Marzu 2018 EMA/184512/2018
English: What is enrofloxacin?
Maltese: X'inhu enrofloxacin?
English: It works against a broad spectrum of Gram-negative and Gram-positive bacteria as well as Mycoplasma spp.
Maltese: Huwa jaħdem kontra spettru wiesa' ta' batterji Gram-negattivi u Gram-pożittivi kif ukoll Mycoplasma spp.
English: Enrofloxacin is an antibiotic belonging to class ‘fluoroquinolones'.
Maltese: Enrofloxacin huwa antibijotiku li jagħmel parti mill-klassi “fluworokinoloni”.
English: Following review of the relevant information submitted in 2013 (during the initial phase of the referral procedure) and the additional data provided by the marketing authorisation holders as a follow-up of the Commission Implementing Decision (C(2014) 1484), in February 2018 the CVMP concluded that the outstanding concern over optimisation of the dosage regimen for the treatment of Escherichia coli infections was not resolved.
Maltese: Wara l-analiżi tal-informazzjoni rilevanti sottomessa fl-2013 (matul il-fażi inizjali tal-proċedura ta' referenza) u d-data addizzjonali pprovduta mid-detenturi tal-awtorizzazzjoni għat-tqegħid fuq is-suq bħala segwitu tad-Deċiżjoni ta' Implimentazzjoni tal-Kummissjoni (C(2014) 1484), fi Frar 2018, isCVMP ikkonkluda li t-tħassib pendenti dwar l-ottimizzazzjoni tar-reġim tad-dożaġġ għat-trattament talinfezzjonijiet ta' Escherichia coli ma ġiex riżolt.
English: The CVMP reviewed the available pre-clinical (laboratory) and clinical data (in chickens and turkeys) on enrofloxacin.
Maltese: Is-CVMP eżamina d-data preklinika (fil-laboratorju) u klinika (fit-tiġieġ u fid-dundjani) disponibbli dwar enrofloxacin.
English: Enrofloxacin is for veterinary use only.
Maltese: Enrofloxacin huwa għall-użu veterinarju biss.
English: These included data from companies and from the published literature.
Maltese: Din kienet tinkludi data minn kumpaniji u mil-letteratura ppubblikata.
English: What are the conclusions of the CVMP after the follow-up assessment?
Maltese: X'inhuma l-konklużjonijiet tas-CVMP wara l-valutazzjoni ta' segwitu?
English: On 14 February 2018, the European Medicines Agency updated its recommendations for enrofloxacincontaining medicines administered via drinking water to chickens and turkeys.
Maltese: Fl-14 ta' Frar 2018, l-Aġenzija Ewropea għall-Mediċini aġġornat ir-rakkomandazzjonijiet tagħha għal mediċini li fihom enrofloxacin, mogħtija permezz tal-ilma tax-xorb lit-tiġieġ u lid-dundjani.
English: The CVMP considered that the currently-approved dosage may accelerate development of bacterial resistance to enrofloxacin, which would limit its use as treatment of last resort for colibacillosis in poultry.
Maltese: Dak iż-żmien, id-detenturi tal-awtorizzazzjoni għat-tqegħid fuq is-suq kienu mitluba jipprovdu aktar data li tiġġustifika d-dożaġġ ta' enrofloxacin użat fil-pollam.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that these products should no longer be used in chickens and turkeys to treat Escherichia coli infections and that the product information for the products should be amended accordingly.
Maltese: Il-Kumitat tal-Aġenzija għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li dawn il-prodotti ma għandhomx jintużaw aktar fit-tiġieġ u d-dundjani sabiex jiġu ttrattati l-infezzjonijiet ta' Escherichia coli u li l-informazzjoni dwar il-prodott għall-prodotti għandha tiġi emendata kif xieraq.
English: Why were enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys reviewed?
Maltese: Għaliex mediċini veterinarji li fihom enrofloxacin kienu jingħataw permezz ta' ilma tax-xorb lit-tiġieġ u lid-dundjani eżaminati?
English: The marketing authorisation holders were advised to contact the National Competent Authorities of the Member States in order to discuss the next steps for the implementation of CVMP's recommended changes to the product information.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fuq is-suq ingħataw il-parir li jikkuntattjaw lill-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri sabiex jiddiskutu l-passi li jmiss għall-implimentazzjoni talbidliet rakkomandati tas-CVMP tal-informazzjoni dwar il-prodott.
English: In November 2013, the CVMP made recommendations for these products to ensure that they are used appropriately in chickens and turkeys, and to lower the risk of bacteria developing resistance to enrofloxacin.
Maltese: F'Novembru 2013, is-CVMP għamel rakkomandazzjonijiet għal dawn il-prodotti sabiex jiżgura li jintużaw b'mod xieraq fit-tiġieġ u d-dundjani, sabiex jitbaxxa r-riskju li l-batterji jiżviluppaw reżistenza għal enrofloxacin.
English: Therefore, the CVMP concluded that enrofloxacin should no longer be used for treatment of Escherichia coli infections in chickens and turkeys and recommended that the product information of the concerned products be amended accordingly.
Maltese: Għalhekk, is-CVMP ikkonkluda li enrofloxacin ma għandux jintuża aktar għat-trattament talinfezzjonijiet ta' Escherichia coli fit-tiġieġ u fid-dundjani u rrakkomanda li l-informazzjoni dwar ilprodott tal-prodotti kkonċernati tiġi emendata kif xieraq.
English: Questions and answers on use of enrofloxacin-containing veterinary medicines administered via drinking water to chickens and turkeys
Maltese: Mistoqsijiet u tweġibiet dwar l-użu ta' mediċini veterinarji li fihom enrofloxacin, mogħtija permezz tal-ilma tax-xorb lit-tiġieġ u lid-dundjani
English: Alternative options are available.
Maltese: Jeżistu għażliet alternattivi.
English: According to the ICH E14-Guideline (“The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs”, 2005) drugs “that prolong the mean QT/QTc interval by > 20 ms have a substantially increase likelihood of being proarrhythmic …”.
Maltese: Skond il-Linja gwida ICH E14 (“L-evalwazzjoni klinika tat-titwil ta' l-intervall QT/QTc u l-potenzjal pro-arritmiku tal-mediċini mhux anti-arritmiċi”, 2005), il-mediċini “li jtawlu l-intervall QT/QTc medju b' > 20 ms għandhom probabbiltà sostanzjali akbar li jkunu pro-arritmiċi …”.
English: The multiple rising dose trial was randomised, double-blind and placebo controlled within dose groups.
Maltese: Il-prova ta' doża inkrimentali multipla kienet randomizzata, double-blind u kkontrollata bil-plaċebo fi gruppi ta' dożi.
English: • The Committee considered the procedure under Article 107 of Directive 2001/83/EC, as amended, for medicinal products containing clobutinol
Maltese: • Il-Kumitat ikkunsidra l-proċedura skond l-Artikolu 107 tad-Direttiva 2001/83/KE, kif emendat, għal prodotti mediċinali li fihom clobutinol
English: The observed maximum mean increase of QTc interval at one specific time point was 32 ms for the 240 mg daily dose, 43 ms for the 480 mg daily dose and 54 ms for the 720 mg daily dose.
Maltese: Iż-żieda massima medja osservata ta' l-intervall QTc f'punt tal-ħin wieħed speċifiku kienet ta' 32 ms għad-doża ta' 240 mg kuljum, 43 ms għad-doża ta' 480 mg kuljum u 54 ms għad-doża ta' 720 mg kuljum.
English: Boehringer Ingelheim performed both in vitro and in vivo electrophysiological studies in order to further characterise the torsadogenic potential of clobutinol.
Maltese: Boehringer Ingelheim wettqet studji elettrofiżjoloġiċi kemm in vitro u anki in vivo bil-għan li tikkaratterizza aktar il-potenzjal torsadoġeniku ta' clobutinol.
English: Further to a publication (Bellocq et al., 2004) of a case of a young boy with a congenital long QTSyndrome who developed syncopes and Torsades de Pointes after intake of clobutinol, the German Competent Authority requested Boehringer Ingelheim to perform a preclinical investigational program and - at a later date - a clinical study to evaluate the risk of QT prolongation.
Maltese: B'referenza għall-pubblikazzjoni (Bellocq et al., 2004) ta' każ ta' tifel żgħir b'Sindrome ta' QT twil konġenitali li żviluppa sinkopi u Torsades de Pointes wara li ħa clobutinol, l-Awtorità Kompetenti Ġermaniża tablet lil Boehringer Ingelheim biex twettaq programm investigattiv ta' qabel l-użu kliniku - aktar tard - studju kliniku biex tevalwa r-riskju ta' titwil tal-QT.