natgillin/translations-raw huggingface dataset:
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.
V eni študiji so pri 883 bolnikih, ki predhodno še niso bili zdravljeni zaradi okužbe z virusom HIV, z ritonavirjem okrepljeno zdravilo Reyataz primerjali z lopinavirjem (drugim protivirusnim zdravilom), okrepljenim z ritonavirjem.
The CHMP considered that Reyataz's effectiveness had been shown in patients aged at least 3 months and weighing at least 5 kg.
Odbor za zdravila za uporabo v humani medicini (CHMP) je menil, da je bila učinkovitost zdravila Reyataz dokazana pri bolnikih, starih najmanj tri mesece in s telesno maso najmanj pet kg. Zaključil je, da so koristi zdravila Reyataz večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Neonates and children
Novorojenčki in otroci
A statement on the emergence of resistant organisms was inserted.
Dodana je bila izjava o pojavu odpornih organizmov.
“Children 2 to 12 years of age - Complicated intra-abdominal infections
„Otroci, stari od 2 do 12 let - Zapletene intraabdominalne okužbe
Septicaemia, bacteraemia
Septikemija, bakteriemija
After the initial assessment, a number of lists of outstanding issues were discussed.
Po prvotnem vrednotenju je odbor razpravljal o številnih nerešenih vprašanjih.
Overall summary of the scientific evaluation of Tazocin and associated names (see Annex I)
Splošni povzetek znanstvenega vrednotenja zdravila Tazocin in povezanih imen (glejte Prilogo I)
Indications have to be infection (site) specific.
Indikacije morajo biti specifične za (mesto) okužbe.
For all indications, differences in clinical practices and national treatment recommendations are addressed by the sentence “Consideration should be given to official guidance on the appropriate use of antibiotics.”
Pri vseh indikacijah so razlike v kliničnih praksah in nacionalnih priporočilih za zdravljenje obravnavane s stavkom „Upoštevati je treba uradne smernice o ustrezni rabi antibiotikov“.
Regarding adult and adolescent patients (> 12 years of age), the dosage depends on the severity, location of the infection and the indication.
Pri odraslih bolnikih in mladostnikih (>12 let starosti) je odmerjanje odvisno od resnosti okužbe, mesta okužbe in indikacije.
Infections in Neutropenic Patients
Okužbe pri nevtropeničnih bolnikih
Module 2 (QOS) was also updated in line with Module 3.
V skladu z modulom 3 je bil posodobljen tudi Modul 2 (QOS).
“Complicated intra-abdominal infections”
„Zapletene intraabdominalne okužbe“
Where an agent may be used in certain patient subpopulations (e.g. immunocompromised patients), it is still required that indications should be as specific as possible based on the available data.
Če naj se zdravilo uporabi za določene podskupine bolnikov (npr. imunsko kompromitirane bolnike), morajo biti indikacije kolikor je mogoče specifične glede na razpoložljive podatke.
The pooled analysis included patients with positive blood cultures however none of the studies had prospectively defined these patients and therefore it is very likely that most of these patients would not satisfy the criteria for sepsis.
V združeni analizi so bili vključeni bolniki s pozitivnimi hemokulturami, vendar v nobeni študiji niso prospektivno opredeliti teh bolnikov, zato je zelo verjetno, da večina teh bolnikov ne bi ustrezala merilom za sepso.
However, the wording proposed by the MAH was not in line with the common European terminology or with the wording used in several recently finalised procedures for generics.
Vendar besedilo, ki ga je predlagal imetnik dovoljenja za promet z zdravilom ni bilo v skladu s skupno evropsko terminologijo ali besedilom v več nedavno končanih postopkih za generična zdravila.
The MAH stated that the contents of the section ‘4.6 Pregnancy and lactation' were the same in all countries although the wording used was slightly different.
Imetnik dovoljenja za promet z zdravilom je navedel, da je bila vsebina poglavja „4.6 Nosečnost in dojenje“ enaka v vseh državah, čeprav je bilo besedilo nekoliko različno.
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.
Pri otrocih, starih od 2 do 12 let, z normalnim delovanjem ledvic se je strinjal z odmerjanjem 80/10 mg/kg vsakih 6 ur za nevtropenične otroke in 100/12,5 mg/kg vsakih 8 ur za zapletene intraabdominalne okužbe.
The CHMP noted the data submitted.
CHMP je upošteval predložene podatke.
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.
CHMP je ovrednotil predložene podatke in ugotovil, da so bile vse primerjalne študije opravljene z odmerkom 3,375 g vsakih 6 ur, ki je bil prvotno odobren v ZDA.
A CHMP drafting group was convened on two occasions.
Skupina za osnutke CHMP se je sešla na dveh sejah.
As already stated, piperacillintazobactam should be preserved for situations where a broad-spectrum agent really is required, i.e. not for the treatment of non-severe infections.
Kot je bilo že omenjeno, je treba piperacilin - tazobaktam ohraniti za primere, ko je širokospektralno zdravilo zares potrebno, tj. ne za zdravljenje blažjih okužb.
The CHMP therefore deleted the indication.
Zato je CHMP indikacijo izbrisal.
Infections caused by bacteria with higher MIC values will require more frequent dosing, while more sensitive bacteria may be adequately treated with less frequent dosing.
Okužbe, ki jih povzročijo bakterije z višjimi vrednostmi MIK, zahtevajo pogostejše odmerjanje, občutljivejše bakterije pa se lahko zadostno zdravijo z manj pogostim odmerjanjem.
Specific indications are discussed below by site of infection.
Razprava o specifičnih indikacijah je v nadaljevanju razdeljena po mestih okužbe.
The CHMP revised the wording of the indication to reflect the study population in the pivotal study and current practice and brought it in line with the indication in adults.
CHMP je spremenil besedilo indikacije, da odraža proučevano populacijo v ključni študiji in trenutno prakso, ter jo uskladil z indikacijo pri odraslih.
The CHMP noted that the supporting evidence is mainly derived from studies in febrile neutropenia and that only about a quarter of patients across different trials had “bacteraemia”.
CHMP je ugotovil, da podporni dokazi v glavnem izvirajo iz študij febrilne nevtropenije in da je v raznih preskušanjih le približno četrtina bolnikov imela „bakteriemijo“.
Tazocin was included in the list of products for Summary of Product Characteristics (SPC) harmonisation, due to the divergent national decisions taken by Member States concerning the authorisation of the product.
Zdravilo Tazocin je bilo vključeno na seznam za usklajevanje povzetkov glavnih značilnosti zdravila zaradi različnih nacionalnih odločitev držav članic glede odobritve zdravila.
"Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above".
„Zdravljenje bolnikov z bakteriemijo, ki se pojavi v povezavi s katero koli od zgoraj navedenih okužb ali ob sumu povezave z njimi“.
The CHMP agreed on a statement that the usual duration of treatment for most indications is in the range of 5-14 days but that the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.
CHMP se je strinjal z izjavo, da je običajno trajanje zdravljenja večine indikacij v razponu od 5 do 14 dni, vendar mora biti pri trajanju zdravljenja vodilo resnost okužbe, povzročitelj(i) in bolnikovo klinično in bakteriološko napredovanje.
Similarly, the clinical and pharmacokinetic data from comparative studies in adults and children, as well as wide clinical experience in children aged > 2 years, support the safety and efficacy in the treatment of intra-abdominal infections in paediatric patients.
Podobno, klinični in farmakokinetični podatki iz primerjalnih študij pri odraslih in otrocih ter obsežne klinične izkušnje pri otrocih, starejših od 2 let, podpirajo varnost in učinkovitost pri zdravljenju intraabdominalnih okužb pri pediatričnih bolnikih.
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.
Ker je kliničnih podatkov o otrocih zelo malo in se večinoma ekstrapolirajo iz populacije odraslih bolnikov, bodo na sprejem indikacij v tej populaciji vplivale indikacije, sprejete za populacijo odraslih bolnikov.
The CHMP revised the MAH proposal to bring it in line with the current guidelines and considered that the available evidence sufficiently supports the use of Tazocin 4.5 g every 8 hours for this indication.
CHMP je popravil predlog imetnika dovoljenja za promet z zdravilom in ga uskladil s trenutnimi smernicami ter menil, da so razpoložljivi podatki zadostni za podporo uporabi zdravila Tazocin 4,5 g vsakih 8 ur za to indikacijo.
These studies used a number of different regimens of Tazocin and a variety of comparators, each administered with or without an aminoglycoside in different studies.
V teh študijah so uporabili številne različne režime zdravljenja z zdravilom Tazocin in različna primerjalna zdravila, pri čemer so v različnih študijah vsakega uporabili zdravilo z aminoglikozidom ali brez njega.
This is why the drug should not be used in less severe infections, where more appropriate alternatives are available and instead be used in severely ill patients for cases of CAP that require hospitalisation.
Zdravila se zato ne sme uporabljati za blažje okužbe, za katere so na voljo primernejša alternativna zdravila, ampak samo za hudo bolne bolnike v primerih izvenbolnišnično pridobljene pljučnice, za katere je potrebna hospitalizacija.
“Complicated skin and soft tissue infections (including diabetic foot infections)”
„Zapletene okužbe kože in mehkih tkiv (vključno z okužbami diabetičnega stopala)“
The CHMP agreed on a dosage of 4 g piperacillin/0.5 g tazobactam given every 6 to 8 hours.
CHMP se je strinjal glede odmerjanja 4 g piperacilina/0,5 g tazobaktama, ki se dajeta vsakih 6 do 8 ur.
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.
CHMP se je strinjal s predlogi imetnika dovoljenja za promet z zdravilom in sprejel usklajeno besedilo poglavja 6.1 - Seznam pomožnih snovi, poglavja 6.2 - Inkompatibilnosti, poglavja 6.3 - Rok uporabnosti, poglavja 6.4 - Posebna navodila za shranjevanje, poglavja 6.5 - Vrsta ovojnine in vsebina ter poglavja 6.6 - Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom.
The CHMP decided to remove the triple combination (intramuscular administration with lidocaine) from the scope of the procedure, in line with the notification.
CHMP se je v skladu z obvestilom odločil umakniti trojno kombinacijo (intramuskularna uporabo z lidokainom) iz obsega postopka.
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.