FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR for Reyataz 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 (100 mg, 150 mg, 200 mg and 300 mg) and oral powder (50 mg).
Maltese: Jiġi bħala kapsuli (100 mg, 150 mg, 200 mg u 300 mg) u fi trab orali (50 mg).
English: Other information about Reyataz:
Maltese: Informazzjoni oħra dwar Reyataz:
English: This document is a summary of the European Public Assessment Report (EPAR) for Reyataz.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Reyataz.
English: The active substance in Reyataz, atazanavir, is a protease inhibitor.
Maltese: Is-sustanza attiva f'Reyataz, l-atażanavir, hija inibitur tal-proteażi.
English: Reyataz is an antiviral medicine that contains the active substance atazanavir.
Maltese: Reyataz huwa mediċina antivirali li fiha s-sustanza attiva atażanavir.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Reyataz on 2 March 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Reyataz valida fl-Unjoni Ewropea kollha fit-2 ta' Marzu 2004.
English: In adults, the most common side effects with Reyataz (seen in between 1 and 10 patients in 100) are headache, ocular icterus (yellowing of the eyes), vomiting, diarrhoea, abdominal pain (stomach ache), nausea (feeling sick), dyspepsia (heartburn), rash, fatigue (tiredness) and jaundice (yellowing of the skin and eyes because of liver problems).
Maltese: Fl-adulti, l-effetti sekondarji l-aktar komuni rrapportati b'Reyataz (li dehru f'bejn pazjent wieħed u 10 pazjenti minn kull 100) kienu wġigħ ta' ras, itteru okulari (sfura fl-għajnejn), remettar, dijarrea, uġigħ addominali (uġigħ fl-istonku), nawżja (dardir), dispepsija (ħruq fl-istonku), raxx, għeja u suffejra (sfurija fil-ġilda u fl-għajnejn assoċjata ma' problemi fil-fwied).
English: Reyataz is used together with low-dose ritonavir and other antiviral medicines to treat adults and children aged 3 months and over and weighing at least 5 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Reyataz jintuża flimkien ma' doża baxxa ta' ritonavir u ma' mediċini antivirali oħra fil-kura ta' adulti u tfal minn 3 xhur 'il fuq u li jiżnu mill-inqas 5 kg li jkunu infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu ta' immunodefiċjenza akkwiżita(AIDS).
English: In studies, side effects were similar in younger patients.
Maltese: Fl-istudji l-effetti sekondarji kienu simili f'pazjenti iżgħar.
English: For adults (aged 18 years or over), the recommended dose is 300 mg once a day.
Maltese: Għall-adulti (minn 18-il sena 'l fuq), id-doża rakkomandata hija 300 mg darba kuljum.
English: Reyataz oral powder with ritonavir has been assessed in two main studies involving 155 children aged from 3 months up to 11 years.
Maltese: It-trab orali ta' Reyataz mar-ritonavir kien ivvalutat f'żewġ studji ewlenin li kienu jinvolvu 155 tifel u tifla minn 3 xhur sa 11-il sena.
English: In the patients aged between 6 and 18 years, 81% of those who had not taken HIV treatment in the past (13 out of 16) and 24% of those who had taken it in the past (6 out of 25) had viral loads below 50 copies/ml after 48 weeks.
Maltese: F'pazjenti li kellhom bejn sitt snin u 18-il sena, 81% ta' dawk li ma ngħatawx kura qabel kontra l-HIV (13 minn 16) u 24% minn dawk li kienu ngħataw kura fl-imgħoddi (6 minn 25) kellhom tagħbijiet virali taħt il-50 kopja/ml wara 48 ġimgħa.
English: A small dose of another medicine, ritonavir, is normally given at the same time as a ‘booster'.
Maltese: Doża żgħira ta' mediċina oħra, ritonavir, normalment tingħata fl-istess ħin bħala 'buster'.
English: The CHMP considered that Reyataz's effectiveness had been shown in patients aged at least 3 months and weighing at least 5 kg.
Maltese: Is-CHMP ikkunsidra li l-effikaċja ta' Reyataz intweriet f'pazjenti ta' mill-inqas 3 xhur u li jiżnu mill-inqas 5 kg.
English: In the study in patients who already had undetectable viral loads with ritonavir-boosted Reyataz capsules, these were maintained in 68 of 87 patients (78%) who continued treatment with a higher dose of Reyataz without ritonavir, and in 64 of 85 (75%) who continued with the boosted combination.
Maltese: Fl-istudju f'pazjenti li kien diġà kellhom tagħbijiet virali li ma jistgħux jiġu osservati bil-kapsuli ta' Reyataz imsaħħaħ bir-ritonavir, dawn baqgħu fi 68 minn 87 pazjent (78%) li baqgħu jieħdu l-kura b'doża ogħla ta' Reyataz mingħajr ritonavir, u f'64 minn 85 (75%) li komplew jieħdu l-kombinazzjoni msaħħa.
English: In all of the studies, the patients also took two nucleoside or nucleotide reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine).
Maltese: Fl-istudji kollha, il-pazjenti ngħataw ukoll żewġ inibituri nukleosidiċi jew nukleotidiċi tat-transkrittażi inversa (NRTIs, tip ta' mediċina antivirali).
English: At the start of the study, the patients' viral loads were around 88,100 copies/ml, but after 48 weeks, 78% of the patients taking Reyataz (343 out of 440) had viral loads below 50 copies/ml, compared with 76% of those taking lopinavir (338 out of 443).
Maltese: Fil-bidu tal-istudju, it-tagħbijiet virali tal-pazjenti kienu madwar 88,100 kopja/ml, iżda wara 48 ġimgħa, 78% tal-pazjenti li kienu ngħataw kura b'Reyataz (343 minn 440) kellhom tagħbijiet virali taħt il-50 kopja/ml, meta mqabbla ma' 76% ta' dawk li kienu ngħataw il-lopinavir (338 minn 443).
English: In the third study, patients taking ritonavir-boosted Reyataz capsules had similar falls in viral load after 24 and 48 weeks as those taking ritonavir-boosted lopinavir: they had fallen by around 99% after 48 weeks.
Maltese: Fit-tielet studju, il-pazjenti li ngħataw kura bilkapsuli ta' Reyataz imsaħħaħ bir-ritonavir kellhom tnaqqis simili fit-tagħbija virali wara 24 u 48 ġimgħa bħal dawk li ngħataw il-lopinavir imsaħħaħ bir-ritonavir: dawn kellhom tnaqqis b'madwar 99% wara 48 ġimgħa.
English: A further main study involved 172 patients who had achieved undetectable viral load (below 50 copies/ml) after treatment with Reyataz capsules and ritonavir.
Maltese: Studju ewlieni ieħor involva 172 pazjent li kellhom tagħbija virali li ma setgħetx tiġi osservata (taħt 50 kopja/ml) wara l-kura bil-kapsuli ta' Reyataz u bir-ritonavir.
English: One study compared ritonavir-boosted Reyataz with ritonavir-boosted lopinavir (another antiviral medicine) in 883 patients who had not taken treatment for HIV infection before.
Maltese: Studju minnhom qabbel Reyataz imsaħħaħ bir-ritonavir imsaħħaħ ma' lopinavir (mediċina antivirali oħra) imsaħħaħ bir-ritonavir fi 883 pazjent li qabel qatt ma ngħataw kura għall-infezzjoni tal-HIV.
English: What is Reyataz?
Maltese: X'inhu Reyataz?
English: In addition, Reyataz must not be given to patients taking rifampicin (used to treat tuberculosis), sildenafil (when this medicine is used to treat pulmonary arterial hypertension), St John's wort (a herbal medicine used to treat depression) or medicines that are broken down in the body in the same way as Reyataz and are harmful at high levels in the blood.
Maltese: Barra minn hekk, Reyataz m'għandux jingħata lil pazjenti li jkunu qed jieħdu r-rifampiċina (tintuża għall-kura tattuberkolożi), is-sildenafil (meta din il-mediċina tintuża fil-kura ta' pressjoni għolja fl-arterji talpulmun), il-fexfiex tal-irdum (St John' s wort - mediċina tal-ħaxix użata fil-kura tad-dipressjoni) jew mediċini li jiġu metabolizzati fil-ġisem bl-istess mod bħal Reyataz u li jikkaġunaw ħsara meta l-livelli tagħhom fid-demm ikunu għoljin.
English: The other three studies involved a total of 743 patients who had taken treatment for HIV infection before: the first two compared Reyataz, taken with saquinavir (another antiviral medicine) but without ritonavir, with ritonavir-boosted saquinavir or ritonavir-boosted lopinavir.
Maltese: It-tliet studji l-oħra involvew total ta' 743 pazjent li qabel kienu ħadu kura għall-infezzjoni tal-HIV: l-ewwel tnejn qabblu Reyataz meta jittieħed ma' saquinavir (mediċina antivirali oħra) iżda mingħajr ritonavir, mas-saquinavir imsaħħaħ bir-ritonavir jew ma' lopinavir imsaħħaħ bir-ritonavir.
English: Reyataz, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Reyataz, meta jittieħed flimkien ma' mediċini antivirali oħra, inaqqas lammont tal-HIV fid-demm u jżommu f'livell baxx.
English: Why has Reyataz been approved?
Maltese: Għaliex ġie approvat Reyataz?
English: What is the risk associated with Reyataz?
Maltese: X'inhu r-riskju assoċjat ma' Reyataz?
English: How does Reyataz work?
Maltese: Kif jaħdem Reyataz?
English: Treatment with Reyataz should be started by a doctor who has experience in the treatment of HIV infection.
Maltese: Aktar minn nofs dawn il-pazjenti kienu diġà ngħataw kura kontra l-HIV fil-passat.
English: For the full list of all side effects reported with Reyataz, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rappurtati b'Reyataz, ara l-fuljett ta' tagħrif.
English: The medicine is not expected to work in patients in whom many medicines in the same class as Reyataz (protease inhibitors) do not work.
Maltese: Mhuwiex mistenni li l-mediċina taħdem fuq pazjenti li fuqhom ma jkunux jaħdmu ħafna mediċini fl-istess klassi ta' Reyataz (inibituri tal-proteażi).
English: Reyataz capsules boosted with ritonavir have also been studied in 41 patients aged between 6 and 18 years.
Maltese: Il-kapsuli ta' Reyatez imsaħħa bir-ritonavir ġew studjati wkoll fuq 41 pazjent ta' bejn sitt snin u 18-il sena.
English: The final study compared Reyataz plus either ritonavir or saquinavir with ritonavir-boosted lopinavir in 358 patients.
Maltese: L-istudju finali qabbel Reyataz meħud flimkien jew mar-ritonavir jew mas-saquinavir flimkien mal-lopinavir imsaħħaħ birritonavir fi 358 pazjent.
English: Reyataz is normally given with ritonavir to boost its action but doctors can consider stopping ritonavir in adults in some specific situations.
Maltese: Normalment Reyataz jingħata ma' ritonavir biex tissaħħaħ l-azzjoni tiegħu iżda f'sitwazzjonijiet speċifiċi, i-tobba jistgħu jikkunsidraw li jwaqqfu ritonavir fl-adulti.
English: Module 3
Maltese: Modulu 3
English: Septicaemia, bacteraemia
Maltese: Settiċimja, batterimja
English: Several member states used outdated wording of the Systemic Organ Classes (SOC) and the ADRs were in some cases listed with different frequencies.
Maltese: Diversi Stati Membri użaw formulazzjoni antika tas-Sistema ta' Klassifikazzjoni tal-Organi (SOC) u lADRs f'xi każi kienu elenkati bi frekwenzi differenti.
English: The MAH listed the following interactions: non-depolarizing muscle relaxants, oral anticoagulants, methotrexate, probenecid, aminoglycosides, and vancomycin and provided an overview of the divergences between the nationally approved wordings for Section 4.5.
Maltese: Il-MAH elenka l-interazzjonijiet li ġejjin: rilassanti tal-muskoli li mhumiex depolarizzanti, antikoagulanti orali, metotrexato, probeneċid, aminoglikoside, u vankomċina, u pprovda ħarsa ġenerali tad-differenzi bejn il-formulazzjonijiet approvati mill-pajjiżi differenti għas-Sezzjoni 4.5.
English: Urinary tract infections
Maltese: Infezzjonijiet tal-Apparat Urinarju
English: “Complicated urinary tract infections (including pyelonephritis)”
Maltese: “Infezzjonijiet ikkumplikati fl-apparat urinarju (fosthom il-pjalonefrite)”
English: “Children 2 to 12 years of age - Complicated intra-abdominal infections
Maltese: “Tfal minn 2 sa 12-il sena - Infezzjonijiet ikkumplikati ġewwa l-addome
English: The MAH proposed a list of harmonised indications based upon current guidelines (the EC guideline on SPC, September 2009 and CPMP/EWP/558/95 rev 1 - Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections, 2004) and on the MAH core data sheet (CDS).
Maltese: Il-MAH ippropona lista ta' indikazzjonijiet terapewtiċi bbażati fuq linji gwida kurrenti (il-linja gwida talKE dwar is-SPC, Settembru 2009 u l-CPMP/EWP/558/95 rev 1 - Nota għall-Gwida dwar il-Valutazzjoni ta' Prodotti Mediċinali Indikati għat-Trattament tal-Infezzjonijiet Batteriċi, 2004) u fuq l-iskeda teknika essenzjali (core data sheet, CDS) tal-MAH.
English: The CHMP adopted the following harmonised indication:
Maltese: Il-CHMP adotta din l-indikazzjoni armonizzata:
English: The MAH proposed a harmonised wording, in line with its Core Data Sheet.
Maltese: Il-MAH ippropona formulazzjoni armonizzata, bi qbil mal-Core Data Sheet tiegħu.
English: Following a number of clarifications, the MAH proposal was accepted and the CHMP adopted a harmonised Module 3.
Maltese: Wara numru ta' kjarifiki, ilproposta tal-MAH ġiet aċċettata u l-CHMP adotta Modulu 3 armonizzat.
English: The CHMP agreed with the MAH proposals and adopted harmonised wordings for Section 6.1 - List of excipients, Section 6.2 Incompatibilities, Section 6.3 Shelf life, Section 6.4 - Special precautions for storage, Section 6.5 - Nature and contents of container and Section 6.6 - Special precautions for disposal and other handling.
Maltese: Il-CHMP qabel mal-proposti tal-MAH u adotta formulazzjoni armonizzata għas-Sezzjoni 6.1 - Lista ta' sustanzi mhux attivi, Sezzjoni 6.2 Inkompatibilitajiet, Sezzjoni 6.3 Żmien kemm idum tajjeb il-prodott mediċinali, Sezzjoni 6.4 - Prekawzjonijiet speċjali għall-ħażna, Sezzjoni 6.5 - In-natura tal-kontenitur u tal-kontenut tiegħu u Sezzjoni 6.6 - Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġar ieħor.
English: The MAH proposed a harmonised Section 4.5 in line with its Core Data Sheet.
Maltese: Il-MAH ippropona Sezzjoni 4.5 armonizzata bi qbil mal-Core Data Sheet tiegħu.
English: The CHMP required a complete re-write of the section, written strictly in accordance with current guideline (NfG on evaluation of medicinal products indicated for treatment of bacterial infections CPMP/EWP/558/95 rev 1) and without excessive listings of species.
Maltese: IlCHMP talab li ssir formulazzjoni kompleta tas-sezzjoni mill-ġdid, li għandha tinkiteb strettament skont il-linja gwida preżenti (NfG dwar il-valutazzjoni ta' prodotti mediċinali indikati għat-trattament ta' infezzjonijiet batteriċi CPMP/EWP/558/95 rev 1) u mingħajr listi eċċessivi ta' speċijiet.
English: The CHMP agreed on a dosage of 4 g piperacillin/0.5 g tazobactam given every 6 to 8 hours.
Maltese: Il-CHMP qabel fuq dożaġġ ta' 4 g piperaċillina/0.5 g tażobaktam mogħtija kull 6 sa 8 sigħat.
English: The CHMP also implemented a tabular presentation of the doses.
Maltese: Il-CHMP implimenta wkoll preżentazzjoni tabulari tad-dożi.
English: The MAH agreed and the CHMP adopted a harmonised wording for Section 5.3.
Maltese: Il-MAH qabel u l-CHMP adotta formulazzjoni armonizzata għas-Sezzjoni 5.3.
English: Regarding children aged 2-12 years with normal renal function, the CHMP agreed to a dosage of 80/10 mg/kg every 6 hours for neutropenic children and 100/12.5 mg/kg every 8 hours for complicated intra-abdominal infections.
Maltese: Fir-rigward tat-tfal minn sentejn sa tnax-il sena b'funzjoni normali tal-kliewi, il-CHMP qabel ma' dożaġġ ta' 80/10 mg/kg kull 6 sigħat għal tfal newtropeniċi u 100/12.5 mg/kg kull 8 sigħat għal infezzjonijiet ikkumplikati ġewwa l-addome.
English: “Complicated skin and soft tissue infections (including diabetic foot infections)”
Maltese: “Infezzjonijiet ikkumplikati fil-ġilda u fit-tessuti rotob (inklużi infezzjonijiet fis-saqajn ikkaġunati middijabete)”
English: The MAH noted and provided an overview of the differences between the currently approved wording of Section 4.9 and proposed a harmonised wording in line with its Core Data Sheet.
Maltese: Il-MAH innota u pprovda ħarsa ġenerali tad-differenzi bejn it-testi tas-Sezzjoni 4.9 li huma approvati bħalissa u ppropona li t-testi jkunu armonizzati b'mod konformi mal-Core Data Sheet tiegħu.
English: The MAH noted no major differences in the nationally approved SPCs for Section 4.8.
Maltese: Il-MAH ma nnotax differenzi importanti fis-SPCs approvati mill-pajjiżi differenti għas-Sezzjoni 4.8.
English: The CHMP provided general comments on Section 4.1, noting that the Note for Guidance states that an indication may be granted if the clinical data support a favourable benefit-risk ratio and reflect the range of type and severity of infections that are commonly encountered.
Maltese: Il-CHMP ipprovda kummenti ġenerali dwar Sezzjoni 4.1, fejn irrimarka li n-Nota għall-Gwida ssostni li indikazzjoni tista' tingħata jekk id-dejta klinika tappoġġa proporzjon favorevoli fir-relazzjoni bejn il-benefiċċji u r-riskji u jekk din tirrifletti l-firxa u s-severità talinfezzjonijiet li jinstabu b'mod komuni.
English: The CHMP assessed the submitted data but considered that the terms “respiratory tract infection” (RTI) and “lower respiratory tract infections” (LRTI) are non-specific and that their precise meaning is open to interpretation and therefore separated the discussion into community acquired pneumonia (CAP) and hospital acquired pneumonia (HAP), including ventilator acquired pneumonia (VAP).
Maltese: Infezzjonijiet fil-Parti ta' Isfel tal-Apparat Respiratorju Il-CHMP ivvaluta d-dejta ppreżentata iżda qies li t-termini “infezzjoni tal-apparat respiratorju” (RTI) u “infezzjonijiet fil-parti ta' isfel tal-apparat respiratorju (LRTI) mhumiex speċifiċi u li t-tifsira preċiża tagħhom hija miftuħa għall-interpretazzjoni u għalhekk issepara d-diskussjoni f'pulmonite akkwiżita mill-komunità (CAP) u pulmonite akkwiżita mill-isptar (HAP), li tinkludi l-pulmonite akkwiżita millventilatur (VAP).
English: The combination of piperacillin and tazobactam in a ratio of 8:1 is effective in the treatment of moderate to severe polymicrobial infections including intra-abdominal, skin and soft-tissue and is approved and marketed for the treatment of a number of infections caused by gram-positive and gram-negative aerobic and anaerobic organisms.
Maltese: It-taħlita ta' piperaċillina u tażobaktam fi proporzjon ta' 8:1 hija effikaċi fit-trattament ta' infezzjonijiet polimikrobiċi minn moderati għal severi fosthom fladdome, fil-ġilda u fit-tessuti rotob, u hija approvata u kummerċjalizzata għat-trattament ta' għadd ta' infezzjonijiet ikkawżati minn organiżmi aerobiċi u anerobiċi gram-pożittivi u gram-negattivi.
English: The CHMP adopted a revised harmonised wording for Section 4.7.
Maltese: Il-CHMP adotta formulazzjoni armonizzata riveduta għas-Sezzjoni 4.7.
English: “Severe pneumonia including hospital-acquired and ventilator-associated pneumonia”
Maltese: “Pulmonite severa li tinkludi pulmonite akkwiżita mill-isptar u pulmonite assoċjata mal-ventilatur”
English: Information on hypersensitivity to the active substances or any of the other ingredients and class specific hypersensitivity to β-lactams and β-lactamase inhibitors was included and the MAH proposed a harmonised wording in line with its current Core Data Sheet.
Maltese: Ġiet inkluża informazzjoni dwar is-sensittività eċċessiva għas-sustanzi attivi jew għal xi sustanzi oħra u s-sensittività eċċessiva speċifika tal-klassi tal-betalattamiċi u għall-inibituri tal-betalattamasi, u l-MAH ippropona formulazzjoni armonizzata li taqbel mal-Core Data Sheet preżenti tiegħu.
English: The MAH provided an overview of the divergences in the nationally approved wordings and proposed a harmonised wording for this section, updated in accordance with the current MedDRA terminology.
Maltese: Il-MAH ipprovda ħarsa ġenerali tad-diverġenzi filformulazzjonijiet approvati mill-pajjiżi differenti u ppropona formulazzjoni armonizzata għal din issezzjoni, aġġornata skont it-terminoloġija kurrenti tal-MedDRA.
English: The MAH proposed a wording in line with its Core Data Sheet and provided supporting data.
Maltese: Il-MAH ippropona formulazzjoni li taqbel malCore Data Sheet tiegħu u pprovda dejta ta' sostenn.
English: Only EUCAST MIC breakpoints and only species relevant for the approved indication were listed.
Maltese: Kienu elenkati biss breakpoints tal-MIC ddefiniti mill-EUCAST u speċijiet biss li huma rilevanti għall-indikazzjoni approvata.
English: The CHMP agreed with the available information on the interaction studies and adopted a harmonised wording for Section 4.5.
Maltese: Il-CHMP qabel mal-informazzjoni disponibbli dwar l-istudji tal-interazzjoni u adotta formulazzjoni armonizzata għas-Sezzjoni 4.5.
English: Skin and Soft Tissue Infections
Maltese: Infezzjonijiet tal-Ġilda u tat-Tessuti Rotob
English: The CHMP assessed the data submitted but noted that the comparative studies were all performed at the initial US-approved regimen of 3.375 g every 6 hours.
Maltese: Il-CHMP ivvaluta d-dejta ppreżentata iżda nnota li l-istudji komparattivi kollha saru bir-reġim inizjali approvat mill-US ta' 3.375 g kull 6 sigħat.
English: The total evidence suggests that 4.5 g administered either 8 hourly, or preferably 6 hourly, provides satisfactory efficacy in the treatment of patients with HAP and VAP.
Maltese: L-evidenza totali turi li doża ta' 4.5 g mogħtija kull 8 sigħat jew prefebbilment kull 6 sigħat, tipprovdi effikaċja sodisfaċenti fit-trattament ta' pazjenti li jkollhom il-HAP jew il-VAP.
English: As clinical data in children are very sparse and will mainly have to be derived by extrapolation from the adult population, the acceptance of indications in this population will be influenced by the indications accepted for the adult population.
Maltese: Billi d-dejta klinika fit-tfal hija limitata ħafna u ġeneralment trid tiġi derivata permezz ta' estrapolazzjoni mill-popolazzjoni adulta, l-aċċettazzjoni ta' indikazzjonijiet f'din il-popolazzjoni se tkun influwenzata mill-indikazzjonijiet aċċettati għall-popolazzjoni adulta.
English: Its clinical role has been strengthened by the addition of an irreversible β-lactamase-inhibitor (tazobactam), which protects piperacillin against enzymatic degradation from β-lactamase-producing bacteria and therefore expanding the antimicrobial spectrum.
Maltese: Ir-rwol kliniku tiegħu issaħħaħ biż-żieda ta' inibitur irriversibbli ta' betalattamasi (tażobaktam), li jipproteġi l-piperaċillina kontra d-degradazzjoni enzimatika minn batterji li jipproduċu betalattamasi, u għalhekk twessa' l-ispettru antimikrobiku.
English: Piperacillin sodium is a semi-synthetic ureidopenicillin with broad spectrum anti-bacterial activity, used for the treatment of infections caused by Pseudomonas aeruginosa, and other susceptible bacteria.
Maltese: Il-piperaċillina sodika hija ureidopeniċillina semisintetika b'attività antibatterika ta' spettru wiesa', li jintuża għat-trattament ta' infezzjonijiet ikkawżati minn Pseudomonas aeruginosa, u batterji oħra suxxettibbli.
English: The CHMP considered Tazocin to be a very valuable agent due to its broad antibacterial activity including many Gram-positive and Gram-negative pathogens, anaerobes as well as several multi-drug resistant organisms common in nosocomial infections.
Maltese: Il-CHMP ikkunsidra li Tazocin huwa sustanza siewja ħafna minħabba l-attività antimikrobika wiesgħa tagħha li tinkludi bosta patoġeni Gram-pożittivi u Gram-negattivi, anerobji kif ukoll diversi organiżmi reżistenti għal bosta mediċini, li huma komuni fl-infezzjonijiet li jittieħdu mill-isptarijiet.
English: For each of the three drug substance manufacturers (the two separate manufacturer for piperacillin and the tazobactam manufacturer), the MAH presented and discussed general information, the manufacture, the control of drug substance, the reference standard or materials, the container closure system and the stability.
Maltese: Għal kull wieħed mit-tliet manifatturi ta' sustanzi tal-mediċina (iż-żewġ manifatturi separati għall-piperaċillina u l-manifattur tat-tażobaktam), il-MAH ippreżenta u ddiskuta informazzjoni ġenerali, il-manifattura, il-kontroll tas-sustanza tal-mediċina, l-istandard ta' referenza jew il-materjali, is-sistema tal-għeluq tal-kontenitur u l-istabilità.