FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH confirmed that the statistical analyses aiming to establish the correlation between reduction of lung lesions and reduction of clinical signs were performed using the results of all relevant studies (i.e., 12 challenge studies, 6 for each serotype).
Maltese: L-MAH ikkonferma li l-analiżijiet statistiċi li għandhom l-għan li jistabbilixxu l-korrelazzjoni bejn ittnaqqis tal-leżjonijiet fil-pulmun u t-tnaqqis tas-sinjali kliniċi twettqu permezz tar-riżultati tal-istudji rilevanti kollha (jiġifieri, 12-il studju ta' sfida, 6 għal kull serotip).
English: Strain NT3 belongs to the serotype 1, expressing ApxI whereas strains SzII, PO, U3 and B4 belong to the serotype 2, expressing ApxIII.
Maltese: Ir-razza NT3 tappartjeni għall-serotip 1, tesprimi ApxI billi razez SzII, PO, U3 u B4 jappartjenu għasserotip 2, jesprimu ApxIII.
English: Although acknowledging the justifications provided by the MAH concerning the complexity of the topic and the technical difficulties encountered, a major question arose as to whether a parameter shown to be significant in one relevant study is sufficient to erase the non-significance of the same parameters in a “non-significant” study.
Maltese: Għalkemm ġew rikonoxxuti lġustifikazzjonijiet ipprovduti mill-MAH li jikkonċernaw il-kumplessità tas-suġġett u d-diffikultajiet tekniċi li wieħed jiltaqa' magħhom, tqajmu dubji kbar dwar jekk parametru li ntwera li huwa sinifikanti fi studji rilevanti wieħed huwiex biżżejjed biex iħassar in-nuqqas ta' sinifikat tal-istess parametri fi studju "mhux sinifikanti".
English: Ireland Ceva Santé Animale 10, av. de La
Maltese: L-Irlanda Ceva Santé Animale 10, av. de La
English: Coglapix is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Maltese: Coglapix huwa maħsub għall-immunizzazzjoni attiva tal-ħnieżer kontra plewropnewmonja kkawżata mis-serotipi 1 u 2 ta' A. pleuropneumoniae.
English: During the MRP the MAH reduced the initial indication from four clinical parameters (clinical signs, losses, lung lesions and infection associated with the disease) to only two i.e. reduction of clinical signs and lung lesions (both of which are included in the European Pharmacopoeia (Ph.
Maltese: Matul l-MRP, il-MAH naqqas l-indikazzjonijiet inizjali minn erba' parametri kliniċi (sinjali kliniċi, telf, leżjonijiet fil-pulmun u infezzjoni assoċjata mal-marda) għal tnejn biss jiġifieri tnaqqis tas-sinjali kliniċi u tal-leżjonijiet fil-pulmun (li t-tnejn huma inklużi fil-Farmakopea Ewropea (Ph. Eur.) Monografija 04/2013:1360, Vaċċini kontra l-Atinobaċillożi tal-Porċini (inattivati)).
English: In particular, Italy considered that (i) the correlation between the reduction of lung lesions and the reduction of clinical signs has not been adequately demonstrated; (ii) the benefit of the vaccine under practical conditions of use (i.e. reduction of lung lesions and clinical signs resulting in reduced weight losses in vaccinated animals) has not been demonstrated and (iii) inconsistent results were obtained from duration of immunity studies.
Maltese: B'mod partikolari, l-Italja kkunsidrat li (i) il-korrelazzjoni bejn it-tnaqqis tal-leżjonijiet fil-pulmun u t-tnaqqis tas-sinjali kliniċi ma ntwerietx b'mod adegwat; (ii) il-benefiċċji talvaċċin f'kundizzjonijiet prattiċi ta' użu (jiġifieri t-tnaqqis tal-leżjonijiet fil-pulmun u s-sinjali kliniċi li jirriżultaw f'tnaqqis fit-telf ta' piż f'annimali mlaqqmin) ma ntwerietx u (iii) inkisbu riżultati inkonsistenti matul l-istudji tal-immunità.
English: The vaccine contains five, formaldehyde-inactivated strains of Actinobacillus pleuropneumoniae.
Maltese: Il-vaċċin fih ħames razez inattivati minn formaldehyde ta' Actinobacillus pleuropneumoniae.
English: Latvia
Maltese: IlFinlandja
English: These issues remained unresolved and therefore a referral under Article 33(1) of Directive 2001/82/EC to the Coordination group for Mutual recognition and Decentralised procedures (veterinary) (CMD(v)) was started.
Maltese: Dawn il-kwistjonijiet baqgħu mhux solvuti u għalhekk inbdiet referenza skont l-Artikolu 33(1) tad-Direttiva 2001/82/KE lill-Grupp ta' Koordinazzjoni għar-Rikonoxximent Reċiproku u l-Proċeduri Deċentralizzati (veterinarju) (CMD(v)).
English: Iceland Ceva Santé Animale 10, av. de La
Maltese: L-Islanda Ceva Santé Animale 10, av. de La
English: Based on the assessment of the overall efficacy of Coglapix vaccine, duration of immunity was established for both serotypes (1 and 2) up to 16 weeks after vaccination according to the results of relevant challenge studies carried out at 16 and 24 weeks.
Maltese: Abbażi tal-valutazzjoni tal-effikaċja globali tal-vaċċin ta' Coglapix, it-tul ta' żmien tal-immunità kien stabbilit għaż-żewġ serotipi (1 u 2) sa 16-il ġimgħa wara l-vaċċinazzjoni skont ir-riżultati tal-istudji ta' sfida rilevanti mwettqin wara 16 u 24 ġimgħa.
English: In conclusion, the CVMP agreed that the MAH has provided satisfactory evidence that Coglapix is manufactured and tested to an acceptable quality standard regarding the batch potency test and consequently the appearance of clinical signs are correlated with the presence of lung lesions.
Maltese: Bħala konklużjoni, is-CVMP qabel li l-MAH ipprovda evidenza sodisfaċenti li Coglapix huwa mmanifatturat u ttestjat bi standard aċċettabbli ta' kwalità fir-rigward tat-test tal-potenza tal-lott u għaldaqstant id-dehra ta' sinjali kliniċi hija korrelata mal-preżenza ta' leżjonijiet fil-pulmun.
English: Since the issues raised by Italy remained unresolved, the Member States concerned failed to reach agreement regarding the efficacy of Coglapix and consequently the matter was referred to the CVMP on 24 October 2014 under Article 33(4) of Directive 2001/82/EC.
Maltese: Peress li l-kwistjonijiet imqajmin millItalja baqgħu ma ssolvewx, l-Istati Membri kkonċernati naqsu milli jilħqu ftehim fir-rigward tal-effikaċja ta' Coglapix u għaldaqstant il-kwistjoni kienet riferuta lis-CVMP fl-24 ta' Ottubru 2014 skont lArtikolu 33(4) tad-Direttiva 2001/82/KE.
English: The marketing authorisation holder (MAH), Ceva-Phylaxia Veterinary Biologicals Co. Ltd., submitted an application for mutual recognition of the marketing authorisation granted by Hungary in accordance with Article 32 of Directive 2001/82/EC.
Maltese: Ltd., ippreżenta applikazzjoni għar-rikonoxximent reċiproku tal-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mill-Ungerija skont l-Artikolu 32 tad-Direttiva 2001/82/KE.
English: Duration of immunity is 16 weeks following second vaccination.
Maltese: It-tul ta' żmien tal-immunità huwa 16il ġimgħa wara t-tieni vaċċinazzjoni.
English: The strains belong to the serotype 1 or serotype 2 groups.
Maltese: Ir-razez jappartjenu għall-gruppi tas-serotip 1 jew tas-serotip 2.
English: In these studies vaccinated animals showed lower incidence of the typical clinical signs (dyspnoea, coughing and vomiting) and lung lesions of porcine pleuropneumonia associated with infection by the microorganism when compared with controls.
Maltese: F'dawn l-istudji, l-annimali mlaqqmin urew inċidenza aktar baxxa tas-sinjali kliniċi tipiċi (qtugħ ta' nifs, sogħla u rimettar) u leżjonijiet fil-pulmun ta' plewropnewmonja tal-porċini assoċjati ma' infezzjoni mill-mikroorganiżmu meta mqabblin mal-kontrolli.
English: To complement the answer, the batch release protocols for two batches were provided revealing consistent germ-count-based target formulation.
Maltese: Biex tikkumplimenta t-tweġiba, kienu pprovduti protokolli ta' rilaxx tal-lottijiet għaż-żewġ lottijiet li jiżvelaw formulazzjoni fil-mira konsistenti bbażata fuq l-għadd ta' mikrobi.
English: Libourne
Maltese: IsSlovenja
English: The vaccine contains inactivated Actinobacillus pleuropneumoniae bacteria.
Maltese: Il-vaċċin fih batterja Pleuropneumoniae Actinobacillus inattivata.
English: Overall summary of the scientific evaluation of Coglapix suspension for injection for pigs (see Annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' Coglapix sospensjoni għal injezzjoni għall-ħnieżer (ara l-Anness I)
English: Package leaflet:
Maltese: Kategorija farmakoterapewtika:
English: For the active immunisation of pigs as an aid to control pleuropneumonia caused by Actinobacillus pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Maltese: Għat-tilqim attiv ta' majjali bħala għajnuna għall-kontroll plewropnewmonja kkawżati minn Pleuropneumoniae Actinobacillus serotipi 1 u 2, billi tnaqqas is-sinjali kliniċi u leżjonijiet fil-pulmun assoċjata mal-marda.
English: Lithuania Ceva Santé Animale 10, av. de La
Maltese: Il-Litwanja Ceva Santé Animale 10, av. de La
English: The MAH submitted data from 12 laboratory studies and 3 field studies to support the efficacy claim.
Maltese: L-MAH issottometta d-dejta minn 12-il studju kliniku u 3 studji fuq il-post biex jappoġġja l-pretensjoni ta' effikaċja.
English: The CVMP was asked to consider the available data supporting the efficacy of Coglapix and conclude whether the veterinary medicinal product may present a potential serious risk to the animal health.
Maltese: Is-CVMP intalab jikkunsidra d-data disponibbli li tappoġġja l-effikaċja ta' Coglapix u jikkonkludi jekk ilprodott mediċinali veterinarju jistax jippreżenta riskju serju potenzjali għas-saħħa tal-annimali.
English: The MAH conducted 2 studies to evaluate the onset of immunity and 4 studies to evaluate the duration of immunity, using appropriate challenge strains for both A. pleuropneumoniae serotypes (1 and 2) included in the vaccine.
Maltese: L-MAH wettaq 2 studji biex jevalwa l-bidu tal-immunità u 4 studji biex jevalwa t-tul ta' żmien tal-immunità, permezz ta' razez ta' sfida xierqa għaż-żewġ serotipi (1 u 2) ta' A. pleuropneumoniae inklużi fil-vaċċin.
English: Vaccination of pigs reduces the clinical signs and lung lesions associated with the disease, thus reducing the need for antimicrobial treatment and increasing the range of available prophylactic treatment possibilities against pneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Maltese: Il-vaċċinazzjoni tal-ħnieżer tnaqqas is-sinjali kliniċi u lleżjonijiet fil-pulmun assoċjati mal-marda, u għalhekk tnaqqas il-ħtieġa għal kura antimikrobjali u żżid il-firxa ta' possibbiltajiet ta' kura profilattika disponibbli kontra pnewmonja kkawżata mis-serotipi 1 u 2 ta' A. pleuropneumoniae.
English: The MAH confirmed that a meta-analysis of all the results obtained from the different studies has been provided.
Maltese: Il-MAH ikkonferma li meta-analiżi tar-riżultati kollha miksubin minn studji differenti ġiet ipprovduta.
English: The vaccine is supplied in multidose containers as a suspension for injection containing an aluminium hydroxide-based adjuvant.
Maltese: Il-vaċċin jiġi f'kontenituri b'ħafna dożi bħala sospensjoni għal injezzjoni li fiha aġġuvant tal-aluminju bbażat fuq hydroxide.
English: Product name Strength
Maltese: Isem talProdott
English: Vaccinated pigs develop active immunity against disease caused by serotype 1 or 2 of Actinobacillus pleuropneumoniae.
Maltese: Il-vaċċin huwa maħsub għall-immunizzazzjoni attiva tal-ħnieżer kontra plewropnewmonja kkawżata mis-serotipi 1 u 2 ta' A. pleuropneumoniae, sabiex jitnaqqsu ssinjali kliniċi u l-leżjonijiet fil-pulmun assoċjati mal-marda.
English: The concern related to the overall efficacy of the vaccine have been assessed and it is concluded that Coglapix is expected to be efficacious in immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Maltese: It-tħassib relatat mal-effikaċja globali tal-vaċċin ġie vvalutat u huwa konkluż li Coglapix huwa mistenni li jkun effikaċi fl-immunizzazzjoni tal-ħnieżer bħala għajnuna biex tiġi kkontrollata plewropnewmonja kkawżata mis-serotipi 1 u 2 ta' A. pleuropneumoniae, billi jitnaqqsu s-sinjali kliniċi u l-leżjonijiet filpulmun assoċjati mal-marda.
English: However, the MAH clarified that the efficacy in the field has only been partially demonstrated and that lack of relevant information could be reflected in the Summary of Product Characteristics.
Maltese: Madankollu, il-MAH iċċara li l-effikaċja fil-qasam intweriet biss b'mod parzjali u n-nuqqas ta' informazzjoni rilevanti tista' tiġi riflessa fis-Sommarju tal-Karatteristiċi tal-Prodott.
English: Coglapix is intended for active immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, and reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory studies.
Maltese: Coglapix huwa maħsub għall-immunizzazzjoni attiva tal-ħnieżer bħala għajnuna biex jikkontrolla plewropnewmonja kkawżata mis-serotipi 1 u 2 ta' A. pleuropneumoniae, u ntwera tnaqqis fis-sinjali kliniċi u fil-leżjonijiet fil-pulmun assoċjati mal-marda fl-istudji kliniċi.
English: The variability of the results observed in the efficacy studies was suggested to be correlated with the quality of the vaccine batches administered in the trials, with sub-potent batches formulated with insufficient antigen content.
Maltese: Il-varjabbiltà tar-riżultati osservati flistudji tal-effikaċja kienet issuġġerita li hija korrelata mal-kwalità tal-lottijiet tal-vaċċini mogħtija filprovi, bil-lottijiet sotto-potenti fformulati b'kontenut insuffiċjenti ta' antiġenu.
English: The MAH also provided clarification in relation to some discrepant data emerging from a comparative analysis of the batch protocols of the two vaccines.
Maltese: Il-MAH ipprovda wkoll kjarifika fir-rigward ta' xi data diskrepanti li toħroġ minn analiżi komparattiva tal-protokolli tal-lott tażżewġ vaċċini.
English: Finland Ceva Santé Animale 10, av. de La
Maltese: L-Estonja Ceva Santé Animale 10, av. de La
English: Special attention was given to the use of a combined analysis using a limited number of animals for sample size and the use of global clinical scores as measure of the primary efficacy parameter.
Maltese: Ingħatat attenzjoni speċjali għall-użu ta' analiżi kkombinata permezz ta' numru limitat ta' annimali għad-daqs tal-kampjun u l-użu ta' punteġġi kliniċi bħala kejl tal-parametru primarju tal-effikaċja.
English: The full EPAR for Pemetrexed Hospira UK Limited 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: Pemetrexed Hospira UK Limited contains the active substance pemetrexed.
Maltese: Pemetrexed Hospira UK Limited fih is-sustanza attiva pemetrexed.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Maltese: Fil-ġisem, il-pemetrexed tinbidel f'forma attiva li timblokka l-attività tal-enzimi li huma involuti fil-produzzjoni ta' "nukleotidi" (blokki li fuqhom jinbnew id-DNA u l-RNA, il-materjal ġenetiku taċ-ċelloli).
English: Pemetrexed Hospira UK Limited is a cancer medicine used to treat two types of lung cancer:
Maltese: Pemetrexed Hospira UK Limited huwa mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers tal-pulmun:
English: Other information about Pemetrexed Hospira UK Limited
Maltese: Informazzjoni oħra dwar Pemetrexed Hospira UK Limited
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Hospira UK Limited.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi approvati bil-mediċina ta' referenza, Alimta, u ma għandhomx għalfejn jiġu ripetuti għal Pemetrexed Hospira UK Limited.
English: Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Billi Pemetrexed Hospira UK Limited huwa mediċina ġenerika, il-benefiċċju u r-riskji tiegħu jitqiesu listess bħal dawk tal-mediċina ta' referenza.
English: The active substance in Pemetrexed Hospira UK Limited is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Pemetrexed Hospira UK Limited hija mediċina ċitotossika (mediċina li toqtol iċċelloli li jkunu qegħdin jinqasmu, bħaċ-ċelloli tal-kanċer), li tagħmel parti mill-grupp tal"antimetaboliti".
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Maltese: Il-konverżjoni tal-pemetrexed għall-forma attiva tagħha ssir iktar malajr fiċ-ċelloli tal-kanċer milli f'ċelloli normali, u dan iwassal għal livelli ogħla tal-forma attiva tal-mediċina u l-azzjoni ddum iktar fiċ-ċelloli tal-kanċer.
English: When Pemetrexed Hospira UK Limited is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Maltese: Meta Pemetrexed Hospira UK Limited jingħata ma' ċisplatin, mediċina "antiemetika" (biex tipprevjeni rremettar) u fluwidi (biex jipprevjenu d-deidratazzjoni) għandhom jingħataw ukoll qabel jew wara ddoża ta' ċisplatin.
English: Pemetrexed Hospira UK Limited is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Pemetrexed Hospira UK Limited jiġi bħala trab li jsir soluzzjoni għal infużjoni (dripp) ġol-vina.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira UK Limited.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pemetrexed Hospira UK Limited.
English: There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Hospira UK Limited is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn għal studji ta' "bijoekwivalenza" biex jinvestigaw jekk Pemetrexed Hospira UK Limited jiġix assorbit similarment bħall-mediċina ta' referenza biex jipproduċi l-istess livell ta' sustanza attiva fid-demm.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Hospira UK Limited.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, Pemetrexed Hospira UK Limited wera li huwa komparabbli ma' Alimta.
English: Pemetrexed Hospira UK Limited pemetrexed
Maltese: Kif jintuża Pemetrexed Hospira UK Limited?
English: Why is Pemetrexed Hospira UK Limited approved?
Maltese: Għaliex ġie approvat Pemetrexed Hospira UK Limited ?
English: How has Pemetrexed Hospira UK Limited been studied?
Maltese: Kif ġie studjat Pemetrexed Hospira UK Limited?
English: Further information on Zerbaxa can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zerbaxa.
Maltese: Aktar informazzjoni dwar Zerbaxa tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/zerbaxa.
English: Other information about Zerbaxa
Maltese: Informazzjoni oħra dwar Zerbaxa
English: Zerbaxa received a marketing authorisation valid throughout the EU on 18 September 2015.
Maltese: Zerbaxa rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-18 ta' Settembru 2015.
English: Both medicines cured 94% of patients (353 out of 375 given Zerbaxa and 375 out of 399 given meropenem).
Maltese: Iż-żewġ mediċini fejqu 94 % tal-pazjenti (353 minn 375 li ngħataw Zerbaxa u 375 minn 399 li ngħataw meropenem).
English: Zerbaxa is an antibiotic used to treat adults with:
Maltese: Zerbaxa huwa mediċina li tintuża biex tikkura adulti bi:
English: Zerbaxa successfully treated the infection in about 85% of the cases where it was given (288 of 340), compared with 75% (266 of 353) of those given another antibiotic called levofloxacin.
Maltese: Zerbaxa fejjaq l-infezzjoni b'suċċess f'madwar 85 % tal-każijiet fejn ingħata (288 minn 340), meta mqabbel ma' 75 % (266 minn 353), ta' dawk li ngħataw antibijotiku ieħor imsejjaħ levofloksaċina.
English: Zerbaxa was compared with another antibiotic, meropenem.
Maltese: Zerbaxa tqabbel ma' antibijotiku ieħor, meropenem.
English: • complicated (difficult to treat) infections of tissues and organs within the belly (intra-abdominal infections);
Maltese: • infezzjonijiet ikkumplikati (diffiċli biex jiġu kkurati) tat-tessuti u tal-organi fiż-żaqq (infezzjonijiet intra-addominali);
English: The second study involved 993 patients with complicated intra-abdominal infections.
Maltese: It-tieni studju kien jinvolvi 993 pazjent b'infezzjonijiet intra-addominali kkumplikati.
English: As for all medicines, data on the use of Zerbaxa are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Zerbaxa hija ssorveljata kontinwament.
English: It found Zerbaxa to be at least as effective as meropenem: the infection had resolved in 54% of patients (197 out of 362) after 7 to 14 days of treatment with Zerbaxa compared with 53% of patients (194 out of 362) on meropenem.
Maltese: Dan sab li Zerbaxa kien tal-inqas effettiv daqs meropenem: l-infezzjoni kienet irriżolviet f'54 % tal-pazjenti (197 minn 362) wara sebat ijiem sa 14-il jum ta' kura b'Zerbaxa meta mqabbel ma' 53 % tal-pazjenti (194 minn 362) fuq meropenem.
English: What are the risks associated with Zerbaxa?
Maltese: X'inhuma r-riskji assoċjati ma' Zerbaxa?
English: The active substances in Zerbaxa, ceftolozane and tazobactam, work in different ways.
Maltese: Iż-żewġ sustanzi attivi f'Zerbaxa, iċ-ċeftolożan u l-tażobaktam, jaħdmu b'modi differenti.
English: The Agency considered that Zerbaxa was effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included.
Maltese: L-Aġenzija kkunsidrat li Zerbaxa kien effettiv fil-kura ta' infezzjonijiet fil-pazjenti studjati, iżda rrikonoxxiet li numru limitat biss ta' pazjenti b'infezzjonijiet ikkumplikati tal-passaġġ urinarju kien ġie inkluż.
English: Zerbaxa contains the active substances ceftolozane and tazobactam.
Maltese: Zerbaxa fih is-sustanzi attivi ċeftolożan u tażobaktam.
English: • hospital-acquired pneumonia (an infection of the lungs that is caught in the hospital), including ventilator-associated pneumonia (pneumonia in patients using a ventilator, a machine that helps a patient to breathe).
Maltese: • pulmonite li tittieħed mill-isptar (infezzjoni tal-pulmuni li tittieħed fl-isptar), inkluż pulmonite assoċjata mal-ventilaturi (pulmonite f'pazjenti li jużaw ventilatur, magna li tgħin lil pazjent jieħu nnifs).
English: The most common side effects with Zerbaxa (which may affect up to 1 in 10 people) are nausea (feeling sick), headache, constipation, diarrhoea and fever.
Maltese: L-effetti sekondarji l-aktar komuni b'Zerbaxa (li jistgħu jaffettwaw sa persuna 1 minn 10) huma nawżja (tħossok ma tiflaħx), uġigħ ta' ras, stitikezza, dijarea u deni.
English: • serious kidney infection (acute pyelonephritis);
Maltese: • infezzjoni tal-kliewi serja (pjelonepefrite akuta);
English: The third study involved 726 patients who were using a ventilator and who had either hospitalacquired pneumonia or ventilator-associated pneumonia.
Maltese: It-tielet studju kien jinvolvi 726 pazjent li kienu qed jużaw ventilatur u li kellhom pulmonite li tittieħed mill-isptar jew pulmonite assoċjata ma' ventilaturi.
English: The Agency also noted that tazobactam is not active against some classes of beta-lactamase that can cause problems of resistance.
Maltese: L-Aġenzija nnotat wkoll li t-tażobaktam mhijiex attiva kontra xi klassijiet ta' betalattamażi li jistgħu jikkawżaw problemi ta' reżistenza.
English: What measures are being taken to ensure the safe and effective use of Zerbaxa?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Zerbaxa?