FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP therefore considered that Tazocin is not appropriate for the routine treatment of uncomplicated urinary tract infections.
Slovenian: CHMP je zato menil, da je zdravilo Tazocin neprimerno za rutinsko zdravljenje nezapletenih okužb sečil.
English: “Complicated urinary tract infections (including pyelonephritis)”
Slovenian: „Zapletene okužbe sečil (vključno s pielonefritisom)“
English: Only EUCAST MIC breakpoints and only species relevant for the approved indication were listed.
Slovenian: Navedene so bile le mejne vrednosti MIK standarda EUCAST in bakterijske vrste, pomembne za odobreno indikacijo.
English: Gastrointestinal, Biliary and Abdominal Infections The CHMP assessed the submitted data and noted that all involved member states included the indication intra-abdominal infections, although the exact wording differed.
Slovenian: Okužbe prebavil, žolčnika in žolčevodov ter trebuha CHMP je ovrednotil predložene podatke in ugotovil, da so vse države članice vključile indikacijo intraabdominalnih okužb, čeprav se natančno besedilo razlikuje.
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.
Slovenian: Natrijev piperacilinat je polsintetični ureidopenicilin s širokim spektrom protibakterijske aktivnosti, ki se uporablja za zdravljenje okužb s Pseudomonas aeruginosa in drugimi občutljivimi bakterijami.
English: A harmonised wording was adopted for Section 5.2.
Slovenian: Sprejeto je bilo usklajeno besedilo poglavja 5.2.
English: Lower Respiratory Tract Infections
Slovenian: Okužbe spodnjih dihal
English: The CHMP included only the preclinical information relevant to prescribers and also the current state of knowledge about the reproductive toxicity of the product, in line with the text approved for recent EU procedures for generics of piperacillin-tazobactam and including a summary of published data about the reproductive toxicity testing of piperacillin and tazobactam.
Slovenian: CHMP je vključil le predklinične podatke, ki so pomembni za zdravnike, ki zdravilo predpisujejo, in trenutno znanje o vplivu na sposobnost razmnoževanja v skladu z besedilom, ki je bilo odobreno v nedavnih postopkih EU za generične oblike piperacilina - tazobaktama, ter povzetek objavljenih podatkov o preskusih o vplivu piperacilina in tazobaktama na sposobnost razmnoževanja.
English: Based on the numerous clinical studies, the pharmacokinetic properties of Tazocin and its antibacterial spectrum, the efficacy of the drug is established in this indication, but the CHMP also noted that uncomplicated UTI is a very common infection and according to international guidance documents, there are several recommended treatment options, generally not including Tazocin.
Slovenian: Farmakokinetične lastnosti zdravila Tazocin, njegov protibakterijski spekter in učinkovitost zdravila za to indikacijo so določili na podlagi številnih kliničnih študij, vendar je CHMP ugotovil tudi, da so nezapletene okužbe sečil zelo pogosta okužba in da na podlagi mednarodnih smernic obstaja več priporočenih možnosti za zdravljenje, ki običajno ne vključujejo zdravila Tazocin.
English: Section 6 - PHARMACEUTICAL PARTICULARS
Slovenian: Poglavje 6 - Farmacevtski podatki
English: The Marketing Authorisation Holder (MAH) took the opportunity to harmonise Module 3 and submitted an updated Quality Overall Summary (QOS).
Slovenian: Imetnik dovoljenja za promet z zdravilom je ob tej priložnosti uskladil modul 3 in predložil posodobljen skupni povzetek kakovosti.
English: Gynaecological Infections including postpartum endometritis and pelvic inflammatory disease The CHMP noted the submitted data but considered inadequate to support the broad indication claimed or any qualified version of this indication.
Slovenian: Ginekološke okužbe, vključno s postpartalnim endometritisom in medeničnim vnetjem CHMP je obravnaval predložene podatke, vendar je menil, da niso zadostni za podporo tej široki indikaciji ali vsem kvalificiranim različicam te indikacije.
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.
Slovenian: Skupni dokazi kažejo, da je 4,5 g zdravila, uporabljenega vsakih 8 ur ali prednostno vsakih 6 ur, zadostno učinkovitih za zdravljenje bolnikov z bolnišnično pridobljeno pljučnico in z ventilatorji povezano pljučnico.
English: The CHMP noted the data submitted and acknowledged that several studies have demonstrated the safety and efficacy of Tazocin in the management of patients with septicaemia and that broadspectrum agents such as piperacillin-tazobactam are widely used in clinical practice in these situations.
Slovenian: CHMP je upošteval predložene podatke in potrdil, da so v več študijah dokazali varnost in učinkovitost zdravila Tazocin pri zdravljenju bolnikov s septikemijo in da se širokospektralna zdravila, kot je piperacilin - tazobaktam, v teh primerih v klinični praksi splošno uporabljajo.
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.
Slovenian: CHMP je zahteval popolno predelavo poglavja, napisanega strogo v skladu s trenutno smernico (Navodila o vrednotenju zdravil, indiciranih za zdravljenje bakterijskih okužb CPMP/EWP/558/95 izd.
English: However, the single study supporting the initial European application for Tazocin for the indication bone- and joint infections was an open-labelled non-comparative study and no additional data from any comparative study was provided.
Slovenian: Vendar je bila edina študija, ki podpira prvotno evropsko vlogo za zdravilo Tazocin za indikacijo okužb kosti in sklepov, nezaslepljena neprimerjalna študija.
English: Results from three single-dose, open label studies to characterize the tissue penetration of piperacillin-tazobactam were provided but these data alone could not justify the indication claimed.
Slovenian: Predloženi so bili rezultati treh nezaslepljenih študij z enim odmerkom za ugotavljanje prodiranja piperacilina - tazobaktama v tkiva, vendar ti podatki sami ne morejo utemeljiti predlagane indikacije.
English: Regarding CAP, the CHMP noted that the non-comparative studies submitted in the context of the initial MAA were performed involving patients with respiratory tract infections including lower respiratory tract infections and acute exacerbation of chronic bronchitis (AECB).
Slovenian: CHMP je v zvezi z izvenbolnišnično pridobljeno pljučnico ugotovil, da so bile neprimerjalne študije, predložene v okviru začetne pridobitve dovoljenja za promet, opravljene pri bolnikih z okužbami dihal, vključno z okužbami spodnjih dihal in akutnim poslabšanjem kroničnega bronhitisa.
English: In conclusion, the CHMP adopted the following harmonised indications:
Slovenian: CHMP je sprejel naslednje usklajene indikacije:
English: The CHMP considered that the justifications provided by the MAH for the proposed wording were acceptable and adopted a harmonised wording for Section 4.8.
Slovenian: CHMP je menil, da so utemeljitve imetnika dovoljenja za promet z zdravilom za predlagano besedilo sprejemljive in sprejel usklajeno besedilo poglavja 4.8.
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.
Slovenian: Njegovo klinično vlogo je okrepil dodatek ireverzibilnega zaviralca laktamaz beta (tazobaktam), ki ščiti piperacilin pred encimsko razgradnjo zaradi bakterij, ki tvorijo laktamaze beta.
English: The CHMP considered that the studies suggests that Tazocin is efficacious in the treatment of cSSTI and was of the opinion that the safety and efficacy of Tazocin in the treatment of skin and soft tissue infections is well justified by numerous clinical studies, treatment guidelines from scientific societies and experience from clinical practice.
Slovenian: CHMP je menil, da študije kažejo, da je zdravilo Tazocin učinkovito za zdravljenje zapletenih okužb kože in mehkih tkiv, ter da je varnost in učinkovitost zdravila Tazocin za zdravljenje okužb kože in mehkih tkiv dobro utemeljena s številnimi kliničnimi študijami, terapevtskimi smernicami strokovnih društev in izkušnjami iz klinične prakse.
English: The MAH only provided in vitro data in support of this section and identified the pathogens against which clinical efficacy has been demonstrated in clinical trials.
Slovenian: Imetnik dovoljenja za promet z zdravilom je v podporo temu poglavju predložil le in vitro podatke ter naštel bolezenske povzročitelje, proti katerim je v kliničnih preskušanjih dokazana klinična učinkovitost.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil pregled razlik nacionalno odobrenih besedil ter predlog usklajenega besedila tega poglavja, posodobljen v skladu s trenutnim izrazoslovjem MedDRA.
English: With regards to the method of administration, the CHMP recommended intravenous infusion over 30 minutes based on the relationship between efficacy and the time during which the free (unbound) drug concentration in blood exceeds the MIC of the organism (T > MIC).
Slovenian: CHMP je v zvezi z načinom uporabe na podlagi razmerja med učinkovitostjo in časom, v katerem koncentracije prostega (nevezanega) zdravila v krvi presežejo povzročiteljevo vrednost MIK (T > MIK), priporočil intravensko infundiranje v trajanju 30 minut.
English: It was noted that piperacillin-tazobactam had similar efficacy as the comparator used in the studies and that all cases of “bacteraemia” were in patients with one or more of the other indications.
Slovenian: Ugotovljeno je bilo, da je piperacilin - tazobaktam podobno učinkovit kot primerjano zdravilo, uporabljeno v študijah, in da je bila v vseh primerih „bakteriemiji“ pridružena še vsaj ena indikacija.
English: The MAH revised the table of commonly susceptible species.
Slovenian: Imetnik dovoljenja za promet z zdravilom je popravil preglednico pogosto občutljivih vrst.
English: The CHMP assessed the submitted data and noted that most member states list urinary tract infections (UTIs) as an indication and that in some SPCs the indication is limited to complicated UTIs.
Slovenian: CHMP je ovrednotil predložene podatke in ugotovil, da so v večini držav članic okužbe sečil navedene kot indikacija ter da so indikacije v določenih povzetkih glavnih značilnosti zdravila omejene na zapletene okužbe sečil.
English: Tazocin may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection”
Slovenian: Zdravilo Tazocin se lahko uporabi za zdravljenje nevtropeničnih otrok s povišano telesno temperaturo s sumom bakterijske okužbe.“
English: The CHMP considered that AECB could not be accepted due to the lack of a superiority study.
Slovenian: CHMP je menil, da akutnega poslabšanja kroničnega bronhitisa ni mogoče sprejeti, ker ni študije o superiornosti.
English: The MAH proposed a harmonised Section 4.5 in line with its Core Data Sheet.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal usklajeno poglavje 4.5, ki je v skladu s podatkovnim listom s temeljnimi podatki.
English: “Tazocin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection”
Slovenian: „Zdravilo Tazocin se lahko uporabi za zdravljenje nevtropeničnih bolnikov s povišano telesno temperaturo s sumom bakterijske okužbe“
English: In conclusion, in line with the position of the CHMP drafting group, taking into account the extensive clinical experience and despite the limited data, The CHMP considered that Tazocin covers most organisms responsible for causing severe CAP, HAP and VAP.
Slovenian: CHMP je v skladu s stališčem svoje skupine za osnutke, ob upoštevanju obširnih kliničnih izkušenj in kljub omejenim podatkom menil, da zdravilo Tazocin pokriva večino organizmov, ki povzročajo hudo izvenbolnišnično pridobljeno pljučnico, bolnišnično pridobljeno pljučnico in z ventilatorji povezano pljučnico.
English: Bone and Joint Infections
Slovenian: Okužbe kosti in sklepov
English: There is vast clinical experience in treating neutropenic adults as well as children > 2 years with fever suspected to be due to bacterial infections, often in combination with an aminoglycoside and the safety of piperacillin-tazobactam is well documented in immunocompetent patients.
Slovenian: Obstajajo obsežne klinične izkušnje z zdravljenjem nevtropeničnih odraslih bolnikov ter otrok starejših od 2 let s povišano telesno temperaturo in sumom bakterijske okužbe, pogosto v kombinaciji z aminoglikozidom.
English: Therefore, the CHMP considered the evidence sufficient to support the use of Tazocin in the treatment of HAP and VAP.
Slovenian: CHMP je zato menil, da so ti dokazi zadostni za podporo uporabi zdravila Tazocin za zdravljenje bolnišnično pridobljene pljučnice in z ventilatorji povezane pljučnice.
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).
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal seznam usklajenih indikacij na podlagi trenutnih smernic (Smernice ES o povzetku glavnih značilnosti zdravila, september 2009 in dokumentu CPMP/EWP/558/95 izd.
English: The MAH noted no major differences in the nationally approved SPCs for Section 4.8.
Slovenian: Imetnik dovoljenja za promet z zdravilom ni ugotovil poglavitnih razlik med nacionalno odobrenimi povzetki glavnih značilnosti zdravila v poglavju 4.8.
English: Instead, the more restricted indication in complicated UTI and pyelonephritis was proposed, in line with other recently harmonised products as well as in compliance with clinical practice.
Slovenian: Namesto tega je bila v skladu z nedavno usklajenimi zdravili in s klinično prakso pri zapletenih okužbah sečil in pielonefritisu predlagana bolj omejena indikacija.
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.
Slovenian: Imetnik dovoljenja za promet z zdravilom je ugotovil razlike med nacionalno odobrenimi besedili poglavja 4.9 in predložil njihov pregled ter predlog usklajenega besedila v skladu s svojim podatkovnim listom s temeljnimi podatki.
English: • the scope of the referral was the harmonisation of the summary of products characteristics,
Slovenian: • namen napotitve je bila uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
English: • the summary of products characteristic, labelling and package leaflet proposed by the marketing authorisation holders have been assessed based on the documentation submitted and the scientific discussion within the Committee the CHMP has recommended the amendment of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Tazocin and associated names (see Annex I).
Slovenian: • povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, so bili ovrednoteni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora.
English: Following discussions with the CHMP drafting group and based on the total available data, the CHMP decided to reword the indication and adopted the following indication:
Slovenian: Po razpravah s skupino za osnutke in na podlagi vseh razpoložljivih podatkov se je CHMP odločil spremeniti besedilo indikacije in sprejel naslednjo indikacijo:
English: The MAH proposed a wording in line with its Core Data Sheet and provided supporting data.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal besedilo v skladu s svojim podatkovnim listom in predložil podporne podatke.
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.
Slovenian: Kombinacija piperacilina in tazobaktama v razmerju 8:1 je učinkovita za zdravljenje zmernih do hudih polimikrobnih okužb, vključno z okužbami trebušne votline, kože in mehkih tkivih.
English: The CHMP also implemented a tabular presentation of the doses.
Slovenian: Uvedel je tudi prikaz odmerkov v preglednici.
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.
Slovenian: Menil je, da je zdravilo Tazocin zaradi svoje široke protibakterijske aktivnosti, ki pokriva številne grampozitivne in gramnegativne bolezenske povzročitelje, anaerobe ter različne večkratno odporne organizme, ki pogosto povzročajo bolnišnične okužbe, zelo dragoceno sredstvo.
English: Section 4.2 Posology and method of administration
Slovenian: Poglavje 4.2 - Odmerjanje in način uporabe
English: Following discussions with the CHMP drafting group and based on the total available data, the CHMP decided to restrict the indication and adopted the following indication:
Slovenian: CHMP se je po razpravah s skupino za osnutke in na podlagi vseh razpoložljivih podatkov odločil omejiti indikacijo in sprejel naslednjo indikacijo:
English: The MAH agreed and the CHMP adopted a harmonised wording for Section 5.3.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je strinjal in CHMP je sprejel usklajeno besedilo za poglavje 5.3.
English: The MAH stated that all required information is present in all countries, but the statements differ in the depth of elaborations.
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel, da so v vseh državah prisotne vse potrebne informacije, vendar se izjave razlikujejo v izčrpnosti.
English: The MAH proposal was in line with its Core Data Sheet.
Slovenian: Predlog imetnika dovoljenja za promet z zdravilom je bil v skladu s podatkovnim listom s temeljnimi podatki.
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.
Slovenian: Podatki o preobčutljivosti za zdravilni učinkovini ali kateri koli drugi sestavini zdravila ter o skupinsko specifični preobčutljivosti za laktame beta in zaviralce laktamaz beta so bili vključeni.
English: The MAH proposed a harmonised wording, in line with its Core Data Sheet.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predlagal usklajeno besedilo v skladu s trenutnim podatkovnim listom s temeljnimi podatki.
English: The CHMP adopted a revised harmonised wording for Section 4.7.
Slovenian: CHMP je sprejel popravljeno usklajeno besedilo poglavja 4.7.
English: The MAH stated that although the required information is present in all member states, the statements differ in the depth of elaborations.
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel, da so vse potrebne informacije prisotne v vseh državah članicah, vendar se izjave razlikujejo v izčrpnosti.
English: The CHMP agreed to the revised proposal and adopted a harmonised wording for Section 5.1.
Slovenian: CHMP se je s popravljenih predlogom strinjal in sprejel usklajeno besedilo za poglavje
English: Regarding HAP, the CHMP noted the presented comparative studies which included patients with HAP only, HAP including VAP or VAP only.
Slovenian: CHMP je v zvezi z bolnišnično pridobljeno pljučnico obravnaval predložene primerjalne študije, ki so vključevale bolnike samo z bolnišnično pridobljeno pljučnico, bolnike z bolnišnično pridobljeno pljučnico, vključno z ventilatorji povezano pljučnico, ali bolnike samo z ventilatorji povezano pljučnico.
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).
Slovenian: CHMP je ovrednotil predložene podatke in menil, da sta izraza „okužba dihal“ in „okužba spodnjih dihal“ nespecifična in da je njun natančen pomen odvisen od interpretacije.
English: The CHMP adopted a harmonised wording for Section 4.6.
Slovenian: CHMP je sprejel usklajeno besedilo poglavja 4.6.
English: In conclusion, the CHMP adopted a harmonised wording for Section 4.9.
Slovenian: CHMP je sprejel usklajeno besedilo za poglavje 4.9.
English: The CHMP adopted a harmonised wording for Section 4.3.
Slovenian: CHMP je sprejel usklajeno besedilo poglavja 4.3.
English: The CHMP adopted a harmonised wording for Section 4.4.
Slovenian: CHMP je sprejel usklajeno besedilo poglavja 4.4.
English: In conclusion, the CHMP adopted a harmonised wording for Section 4.2.
Slovenian: CHMP je sprejel usklajeno besedilo za poglavje 4.2.
English: The MAH presented a proposed wording in line with its Core Data Sheet.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predstavil predlog v skladu s podatkovnim listom s temeljnimi podatki.
English: The CHMP concluded that the MAH provided satisfactory evidence demonstrating the efficacy of
Slovenian: CHMP je menil, da je imetnik dovoljenja za promet z zdravilom predložil zadostne dokaze o učinkovitosti zdravila Tazocin za zdravljenje okužbe spodnjih dihal.
English: c Based on laboratory assessments.
Slovenian: c Na podlagi laboratorijskih ocen.
English: Such reactions may be allergic.
Slovenian: Takšne reakcije so lahko alergijske.
English: Availability of resuscitation equipment must be ensured.
Slovenian: Zagotoviti je treba razpoložljivost opreme za oživljanje.
English: The causes of these deaths and their relationship to treatment were not always known.
Slovenian: Vzroki za te smrti in njihova povezanost z zdravljenjem niso bili vedno znani.
English: This corresponds to a half-life of approximately 14 days.
Slovenian: To ustreza razpolovnemu času, ki znaša približno 14 dni.
English: Eleven of the 12 patients had an unwitnessed death.
Slovenian: Pri enajstih od 12 bolnikov je prišlo do smrti brez prič.
English: a MedDRA preferred term (Version 16).
Slovenian: a Priporočeni izraz po MedDRA (različica 16).
English: Portrazza should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Slovenian: Zdravila Portrazza se ne sme dajati bolnikom, mlajšim od 18 let, saj ni podatkov o njegovem delovanju v tej starostni skupini.
English: The predicted time to reach steady state was approximately 70 days.
Slovenian: Predvideni čas za doseganje stanja dinamičnega ravnovesja je bil približno 70 dni.
English: • Monitor patient for worsening of condition.
Slovenian: • Bolnika spremljajte glede poslabšanja stanja.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 February 2016
Slovenian: Datum prve odobritve: 15. februar 2016
English: Portrazza may increase this risk.
Slovenian: Zdravilo Portrazza lahko to tveganje poveča.
English: The onset of events occurred mainly during the first cycle of treatment.
Slovenian: Ti dogodki so se pojavili v glavnem v času prvega cikla zdravljenja.