natgillin/translations-raw huggingface dataset:
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. 
CHMP je predložil splošne opombe o poglavju 4.1 in ugotovil, da navodilo za smernico določa, da se lahko indikacija odobri, če klinični podatki potrjujejo ugodno razmerje med koristmi in tveganji ter odražajo razpon običajnih vrst okužb in njihovo resnost.
The CHMP adopted the following harmonised indication: 
CHMP je sprejel naslednjo usklajeno indikacijo:
Following a number of clarifications, the MAH proposal was accepted and the CHMP adopted a harmonised Module 3. 
Po številnih pojasnilih je bil predlog imetnika dovoljenja za promet z zdravilom sprejet in CHMP je sprejel usklajen modul 3.
In view of the submitted data and the clinical experience of the safety and efficacy of piperacillin-tazobactam in neutropenic and nonneutropenic children, the CHMP considered the inclusion of the paediatric indications in neutropenic children to be justified. 
Z vidika predloženih podatkov in kliničnih izkušenj z varnostjo in učinkovitostjo piperacilinatazobaktama pri nevtropeničnih in nenevtropeničnih otrocih je CHMP menil, da je vključitev pediatrične indikacije za nevtropenične otroke utemeljena.
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. 
Imetnik dovoljenja za promet z zdravilom je navedel naslednje interakcije: nedepolarizirajoči mišični relaksansi, peroralni antikoagulanti, metotreksat, probenecid, aminoglikozidi in vankomicin ter predložil pregled razlik med nacionalno odobrenimi besedili poglavja 4.5.
The CHMP noted the submitted data and that the indication bone and joint infections were approved in about half the EU member states. 
CHMP je obravnaval predložene podatke in ugotovil, da je indikacija okužb kosti in sklepov odobrena v približno polovici držav članic EU.
Section 4.4 - Special Warnings and Precaution for Use 
Poglavje 4.4 - Posebna opozorila in previdnostni ukrepi
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. 
Za vsakega od treh izdelovalcev zdravilnih učinkovin (dva izdelovalca piperacilina in izdelovalec tazobaktama) je imetnik dovoljenja za promet z zdravilom predstavil in obravnaval splošne podatke, izdelavo, nadzor nad zdravilno učinkovino, referenčne standarde ali materiale, sistem zapiranja vsebnikov ter stabilnost.
The CHMP agreed with the MAH proposal but enforced some additions, in particular by inserting a caution regarding use in patients without severe hypersensitivity reaction to non-penicillin β-lactams but who may have had non-severe reactions and by supplementing the warning on pseudomembranous colitis. 
CHMP se je strinjal s predlogom imetnika dovoljenja za promet z zdravilom, vendar je uveljavil določena dopolnila, zlasti z vstavitvijo previdnostnega ukrepa pri bolnikih brez hude preobčutljivostne reakcije na nepenicilinske laktame beta, ki so morda imeli blago reakcijo, in z dopolnitvijo opozorila o psevdomembranskem kolitisu.
Several member states used outdated wording of the Systemic Organ Classes (SOC) and the ADRs were in some cases listed with different frequencies. 
V več državah so uporabljali zastarele izraze organskih sistemov (SOC), neželeni učinki pa so bili v določenih primerih navedeni z različnimi pogostnostmi.
The CHMP considered the justification provided by the MAH to be acceptable but included a mention of studies showing developmental toxicity in animals. 
CHMP je menil, da je utemeljitev imetnika dovoljenja za promet z zdravilom sprejemljiva, vendar je dodal omembo študij, ki kažejo razvojno toksičnost pri živalih.
The MAH provided a ‘CMC-Divergence Overview' document describing the changes performed to all the existing national dossiers. 
Imetnik dovoljenja za promet z zdravilom je predložil dokument „Pregled razlik CMC“, v katerem so opisane spremembe v vseh obstoječih nacionalnih dokumentacijah.
Section 5.3 - Preclinical safety data 
Poglavje 5.3 -Predklinični podatki o varnosti
“Severe pneumonia including hospital-acquired and ventilator-associated pneumonia” 
„Huda pljučnica, vključno z bolnišnično pridobljeno pljučnico in z ventilatorji povezano pljučnico“
The CHMP noted the submitted data and considered that the data from adults was considered relevant and that the pharmacokinetic information can be used to extrapolate efficacy to the paediatric population. 
CHMP je obravnaval predložene podatke ter menil, da so podatki o odraslih ustrezni in da se lahko učinkovitost s pomočjo farmakokinetičnih podatkov ekstrapolira na pediatrično populacijo.
The CHMP considered the MAH justification to be acceptable but added a sentence on discontinuation of treatment in case of overdose and the absence of an antidote. 
CHMP je menil, da je utemeljitev imetnika dovoljenja za promet z zdravilom sprejemljiva, vendar je dodal stavek o prekinitvi zdravljenja v primeru prevelikega odmerjanja in odsotnosti antidota.
For the drug product, the MAH presented and discussed the description and composition of the drug product, the pharmaceutical development, the manufacture, control of excipients, the control of drug products, the reference standard, the container closure system and the stability. 
V zvezi z zdravilom je imetnik dovoljenja za promet z zdravilom predstavil in obravnaval opis in sestavo zdravila, farmacevtski razvoj, izdelavo, nadzor nad pomožnimi snovmi, nadzor nad zdravilom, referenčni standard, sistem zapiranja vsebnikov ter stabilnost.
Although pharmacokinetic data suggest that piperacillin and tazobactam concentrations in both bone and synovial tissue are sufficient to treat the majority of infections caused by susceptible organisms, the available clinical documentation is considered too limited and insufficient to justify an indication in treatment of bone and joint infections. 
Čeprav farmakokinetični podatki kažejo, da sta koncentraciji piperacilina in tazobaktama v kosteh in sinovijskem tkivu zadostni za zdravljenje večine okužb z občutljivimi organizmi, je razpoložljiva klinična dokumentacija preveč omejena in nezadostna za utemeljitev indikacije zdravljenja okužb kosti in sklepov.
All member states use the same minimum inhibitory concentration (MIC) based on UK-breakpoints but due to national approvals and different approval times there were minor divergences in the presentation of the data and also the summary/listing of susceptible organism differed slightly. 
V vseh državah članicah so predstavljene minimalne inhibitorne koncentracije (MIK), ki temeljijo na mejnih vrednostih iz Združenega kraljestva, vendar obstajajo majhne razlike v predstavitvi podatkov ter povzetku/seznamu občutljivih organizmov zaradi nacionalnih odobritev in različnih časov odobritve.
The CHMP agreed with the available information on the interaction studies and adopted a harmonised wording for Section 4.5. 
CHMP se je strinjal z razpoložljivimi podatki o študijah interakcij ter sprejel usklajeno besedilo poglavja 4.5.
The section 4.8 is in all countries consistent with the MAH Core Data Sheet. 
Poglavje 4.8 je bilo v vseh državah v skladu z imetnikovim podatkovnim listom s temeljnimi podatki.
The CHMP also agreed that no dose adjustment is necessary in patients with hepatic impairment. 
CHMP se je prav tako strinjal, da pri bolnikih z okvaro jeter odmerka ni treba prilagajati.
However, taking into account the view of the CHMP drafting group and despite the very limited data for this indication and acknowledging the difficulties of conducting retrospective analysis, the CHMP was of the opinion that piperacillin-tazobactam has broad-spectrum antibacterial activity and is therefore a suitable option for the treatment of bacteraemia. 
Vendar je CHMP ob upoštevanju stališča skupine za osnutke in kljub zelo omejenim podatkom za to indikacijo ter ob priznavanju težav pri izvedbi retrospektivnih analiz menil, da ima piperacilin - tazobaktam širok spekter protimikrobne aktivnosti in je zato primerna možnost za zdravljenje bakteriemije.
Tazobactam is a penicillanic acid sulfone derivative with β-lactamase inhibitory properties similar to those of sulbactam although it is regarded as more potent. 
Tazobaktam je sulfonski derivat penicilanske kisline z lastnostjo zaviranja laktamaz beta, ki so podobne sulbaktamu, vendar velja za močnejšega.
The CHMP therefore considered that Tazocin is not appropriate for the routine treatment of uncomplicated urinary tract infections. 
CHMP je zato menil, da je zdravilo Tazocin neprimerno za rutinsko zdravljenje nezapletenih okužb sečil.
“Complicated urinary tract infections (including pyelonephritis)” 
„Zapletene okužbe sečil (vključno s pielonefritisom)“
Only EUCAST MIC breakpoints and only species relevant for the approved indication were listed. 
Navedene so bile le mejne vrednosti MIK standarda EUCAST in bakterijske vrste, pomembne za odobreno indikacijo.
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. 
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.
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. 
Natrijev piperacilinat je polsintetični ureidopenicilin s širokim spektrom protibakterijske aktivnosti, ki se uporablja za zdravljenje okužb s Pseudomonas aeruginosa in drugimi občutljivimi bakterijami.
A harmonised wording was adopted for Section 5.2. 
Sprejeto je bilo usklajeno besedilo poglavja 5.2.
Lower Respiratory Tract Infections 
Okužbe spodnjih dihal
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. 
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.
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. 
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.
Section 6 - PHARMACEUTICAL PARTICULARS 
Poglavje 6 - Farmacevtski podatki
The Marketing Authorisation Holder (MAH) took the opportunity to harmonise Module 3 and submitted an updated Quality Overall Summary (QOS). 
Imetnik dovoljenja za promet z zdravilom je ob tej priložnosti uskladil modul 3 in predložil posodobljen skupni povzetek kakovosti.
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. 
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.
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. 
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.
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. 
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.
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. 
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.
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. 
Vendar je bila edina študija, ki podpira prvotno evropsko vlogo za zdravilo Tazocin za indikacijo okužb kosti in sklepov, nezaslepljena neprimerjalna študija.
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. 
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.
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). 
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.
In conclusion, the CHMP adopted the following harmonised indications: 
CHMP je sprejel naslednje usklajene indikacije:
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. 
CHMP je menil, da so utemeljitve imetnika dovoljenja za promet z zdravilom za predlagano besedilo sprejemljive in sprejel usklajeno besedilo poglavja 4.8.
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. 
Njegovo klinično vlogo je okrepil dodatek ireverzibilnega zaviralca laktamaz beta (tazobaktam), ki ščiti piperacilin pred encimsko razgradnjo zaradi bakterij, ki tvorijo laktamaze beta.
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. 
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.
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. 
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.
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. 
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.
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). 
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.
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. 
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.
The MAH revised the table of commonly susceptible species. 
Imetnik dovoljenja za promet z zdravilom je popravil preglednico pogosto občutljivih vrst.
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. 
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.
Tazocin may be used in the management of neutropenic children with fever suspected to be due to a bacterial infection” 
Zdravilo Tazocin se lahko uporabi za zdravljenje nevtropeničnih otrok s povišano telesno temperaturo s sumom bakterijske okužbe.“
The CHMP considered that AECB could not be accepted due to the lack of a superiority study. 
CHMP je menil, da akutnega poslabšanja kroničnega bronhitisa ni mogoče sprejeti, ker ni študije o superiornosti.
The MAH proposed a harmonised Section 4.5 in line with its Core Data Sheet. 
Imetnik dovoljenja za promet z zdravilom je predlagal usklajeno poglavje 4.5, ki je v skladu s podatkovnim listom s temeljnimi podatki.
“Tazocin may be used in the management of neutropenic patients with fever suspected to be due to a bacterial infection” 
„Zdravilo Tazocin se lahko uporabi za zdravljenje nevtropeničnih bolnikov s povišano telesno temperaturo s sumom bakterijske okužbe“
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. 
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.
Bone and Joint Infections 
Okužbe kosti in sklepov
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. 
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.
Therefore, the CHMP considered the evidence sufficient to support the use of Tazocin in the treatment of HAP and VAP. 
CHMP je zato menil, da so ti dokazi zadostni za podporo uporabi zdravila Tazocin za zdravljenje bolnišnično pridobljene pljučnice in z ventilatorji povezane pljučnice.
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). 
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.
The MAH noted no major differences in the nationally approved SPCs for Section 4.8. 
Imetnik dovoljenja za promet z zdravilom ni ugotovil poglavitnih razlik med nacionalno odobrenimi povzetki glavnih značilnosti zdravila v poglavju 4.8.
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. 
Namesto tega je bila v skladu z nedavno usklajenimi zdravili in s klinično prakso pri zapletenih okužbah sečil in pielonefritisu predlagana bolj omejena indikacija.
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. 
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.
• the scope of the referral was the harmonisation of the summary of products characteristics, 
• namen napotitve je bila uskladitev povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo;
• 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). 
• 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.
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: 
Po razpravah s skupino za osnutke in na podlagi vseh razpoložljivih podatkov se je CHMP odločil spremeniti besedilo indikacije in sprejel naslednjo indikacijo: