natgillin/translations-raw huggingface dataset:
Having reviewed all available data, and taking into account the current clinical practice and current clinical guideline recommendations, the CHMP considered that vancomycin is an important therapeutic option in the following indications: 
Po pregledu vseh razpoložljivih podatkov in ob upoštevanju trenutne klinične prakse ter priporočil v trenutnih kliničnih smernicah je odbor CHMP menil, da je vankomicin pomembna terapevtska možnost pri naslednjih indikacijah:
Vancomycin is a glycopeptide antibiotic authorised around six decades ago. 
Vankomicin je glikopeptidni antibiotik, za katerega je bilo izdano dovoljenje za promet pred približno šestimi desetletji.
- powder for solution for injection or infusion (500 mg and 1000 mg) used by intravenous administration. 
- praška za raztopino za injiciranje ali infundiranje (500 mg in 1000 mg) za intravensko dajanje.
The active substance is obtained mainly by fermentation. 
Zdravilna učinkovina je pridobljena zlasti s fermentacijo.
CHMP agreed that these risks can be minimised by appropriate warnings and recommendations in the product information. 
Odbor se je strinjal, da je ta tveganja mogoče zmanjšati z ustreznimi opozorili in priporočili v informacijah o zdravilu.
Vancomycin hydrochloride is defined as the hydrochloride salt of a mixture of related glycopeptides for which the characteristics are defined in the European Pharmacopeia 1058 monograph (currently under revision). 
Vankomicinijev klorid je opredeljen kot klorovodikova sol zmesi sorodnih glikopeptidov, katerih značilnosti so opredeljene v monografiji 1058 Evropske farmakopeje (trenutno v pregledu).
Among other issues, the CHMP discussed the need for updating the wording of the product information. 
Med drugim je odbor CHMP obravnaval tudi potrebo po posodobitvi besedila informacij o zdravilu.
Moreover, existing data (including comparative) on the use of a continuous vs. an intermittent infusion are not conclusive. 
Poleg tega obstoječi podatki (vključno s primerjalnimi podatki) o primerjavi uporabe neprekinjenega in intermitentnega infundiranja niso prepričljivi.
Its effect is mainly bactericidal and it is exerted mainly by the inhibition of the cell wall peptidoglycan synthesis. 
Njegov učinek je predvsem baktericidni in se v glavnem kaže kot zaviranje sinteze peptidoglikana v celični steni.
Trough-only monitoring may be not sufficient to guide vancomycin dosing in all cases, because peak levels (Cmax) are primarily influenced by the volume of distribution. 
Spremljanje zgolj vrednosti Ctrough morda ne zadostuje za določanje odmerjanja vankomicina v vseh primerih, ker na najvišje koncentracije (Cmax) v prvi vrsti vpliva volumen porazdelitve.
It is also noted that staphylococcal enterocolitis is a rare entity and that its diagnosis is controversial. 
Prav tako je treba opozoriti, da je stafilokokni enterokolitis redka bolezen in da je njegova diagnoza sporna.
The Annex 3 of the CHMP guideline on setting specifications for related impurities in antibiotics would apply to new active substances and for new sources of existing active substances. 
Priloga 3 smernic odbora CHMP o določitvi specifikacij za sorodne nečistoče v antibiotikih bi veljala za nove zdravilne učinkovine in nove vire obstoječih zdravilnih učinkovin.
The potential usefulness of model-based methods in the prediction of individual dose requirements to reach an adequate AUC is also addressed. 
Obravnavana je tudi potencialna uporabnost metod na osnovi modelov za napovedovanje potreb po odmerkih za posameznega bolnika, da se doseže ustrezna vrednost AUC.
Vancomycin treatment is recommended in severe or recurrent cases. 
Zdravljenje z vankomicinom je priporočljivo v primerih hude ali ponavljajoče se okužbe.
In these cases, continuous infusions were used due to a failure of response to treatment or to a persistence of subtherapeutic vancomycin levels despite optimizing dosing and frequency during intermittent vancomycin administration. 
V teh primerih so neprekinjeno infundiranje uporabili zaradi neodzivanja na zdravljenje ali perzistence subterapevtskih ravni vankomicina kljub optimizaciji odmerjanja in pogostnosti pri intermitentnem dajanju vankomicina.
Therefore, in light of the above the Spanish Medicines Agency (AEMPS) considered in the interest of the Union to refer the matter to the CHMP and request that its gives its opinion under Article 31 of Directive 2001/83/EC on the benefit-risk of vancomycin-containing products and on the need for regulatory measures to be taken. 
Glede na zgoraj navedeno je španska agencija za zdravila (AEMPS) menila, da je v interesu Unije napotitev zadeve na odbor CHMP, in odbor zaprosila za mnenje v skladu s členom 31 Direktive 2001/83/ES o razmerju med koristmi in tveganji pri zdravilih, ki vsebujejo vankomicin, in o potrebnih regulativnih ukrepih.
Furthermore, the CHMP noted that updated clinical guidelines for staphylococcal enterocolitis (diagnosis or treatment) do not mention this use of vancomycin. 
Poleg tega je odbor CHMP ugotovil, da posodobljene klinične smernice za stafilokokni enterokolitis (diagnozo ali zdravljenje) ne omenjajo takšne uporabe vankomicina.
In addition, significant differences between the product information of vancomycin-containing medicines across the EU Member States were identified in particular in the indications, posology and method of administration, but also in other sections of the product information. 
Poleg tega so bile med državami članicami EU ugotovljene bistvene razlike v informacijah o zdravilu za zdravila, ki vsebujejo vankomicin, zlasti glede indikacij, odmerjanja in načina uporabe ter v drugih poglavjih informacij o zdravilu.
The CHMP noted that no update of the EUCAST breakpoints is warranted at this time. 
Odbor je ugotovil, da trenutno ni treba posodobiti mejnih vrednosti EUCAST.
Finally, revisions were made to sections 5.1 and 5.2 to reflect current pharmacokinetic and pharmacodynamic data, and to sections 1 and 2 to reflect the amount of active substance in the finished product (based on the potency expressed in IU), and the dose and strength of vancomycin containing products (to be expressed in milligrams). 
Na koncu sta bili popravljeni poglavji 5.1 in 5.2, da odražata trenutne farmakokinetične in farmakodinamične podatke, ter poglavji 1 in 2, da odražata količino zdravilne učinkovine v končnem zdravilu (na podlagi potence, izražene v mednarodnih enotah - i.e.) ter odmerek in jakost zdravil, ki vsebujejo vankomicin (izraženo v miligramih).
Therefore, the CHMP discussed different alternative approaches to estimate the vancomycin exposure. 
Zato je odbor CHMP razpravljal o različnih alternativnih pristopih za oceno izpostavljenosti vankomicinu.
For this specific group, the PDCO recommended one possible dosing regimen based on post-menstrual age (similar to the recommended dosing regimen by the British National Formulary (BNF) for children), but overall CHMP agreed that no universal recommendations on the dosage regimen in neonates could be made and that for establishing the dosing regimen in this population, the advice of a physician experienced in the management of neonates should be sought. 
Za to posebno skupino je odbor PDCO priporočil možno shemo odmerjanja, ki temelji na pomenstrualni starosti (podobno priporočeni shemi odmerjanja publikacije British National Formulary (BNF) za otroke), vendar se je odbor CHMP na splošno strinjal, da ni mogoče določiti univerzalnih priporočil za odmerjanje pri novorojenčkih in da se je treba pri določitvi sheme odmerjanja pri tej populaciji posvetovati z zdravnikom, ki ima izkušnje z obravnavanjem novorojenčkov.
• With regards to the “treatment of staphylococcal enterocolitis”, the CHMP concluded that the MAHs did not provide data establishing the efficacy and safety of oral vancomycin in this indication. 
• V zvezi z „zdravljenjem stafilokoknega enterokolitisa“ je odbor CHMP zaključil, da imetniki dovoljenj za promet niso predložili podatkov, ki dokazujejo učinkovitost in varnost peroralnega vankomicina pri tej indikaciji.
- and capsules, for oral administration. 
- in kapsul za peroralno uporabo.
Vancomycin spectrum includes a wide range of pathogens including Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium, Streptococus pneumoniae, Listeria monocytogenes and Clostridium difficile. 
Spekter delovanja vankomicina obsega številne bolezenske povzročitelje, vključno s Staphylococcus aureus, Enterococcus faecalis, Enterococcus faecium, Streptococcus pneumoniae, Listeria monocytogenes in Clostridium difficile.
10 Bauer MP. et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): treatment guidance document for Clostridium difficile infection (CDI). 
10 Bauer MP. et al., Evropsko združenje za klinično mikrobiologijo in infekcijske bolezni (ESCMID): dokument s smernicami za zdravljenje okužbe s Clostridium difficile (CDI).
In view of the importance of ensuring the availability of efficacious antibiotics for the EU patients, in the interest of public health and in order to contribute to tackling the threat posed by the spread of antimicrobial resistance, a critical review of the benefit-risk of vancomycin containing products in the approved indications, including the relevant posology, was considered needed. 
Zaradi pomembnosti zagotavljanja razpoložljivosti učinkovitih antibiotikov za bolnike v EU, interesa varovanja javnega zdravja in zagotavljanja prispevka k obravnavanju grožnje zaradi širjenja protimikrobne odpornosti, je bil potreben kritičen pregled razmerja med koristmi in tveganji pri zdravilih, ki vsebujejo vankomicin, za odobrene indikacije, vključno z ustreznim odmerjanjem.
• the CHMP considered the available data to be sufficient to support revisions of the indication for both oral use and parenteral use, as well as the posology in adults and paediatrics populations, in line with clinical experience and current therapeutic guidelines, 
• odbor CHMP je menil, da razpoložljivi podatki zadostno podpirajo revizijo indikacije za peroralno in parenteralno uporabo, kot tudi odmerjanje pri odraslih in pediatrični populaciji, v skladu s kliničnimi izkušnjami in trenutnimi terapevtskimi smernicami;
The wording on therapeutic drug monitoring in section 4.2 of the SmPC has been amended accordingly by the CHMP. 
Besedilo o terapevtskem spremljanju zdravila v poglavju 4.2 povzetka glavnih značilnosti zdravila je odbor CHMP ustrezno spremenil.
The antibacterial activity of vancomycin is confined to Gram-positive microorganisms. 
Vankomicin deluje protibakterijsko samo proti grampozitivnim mikroorganizmom.
• the existing product information including the indications, dosage recommendations and pharmacokinetic and pharmacodynamic information for vancomycin-containing products in the EU need to be revised in accordance with the latest available information, 
• obstoječe informacije o zdravilu, vključno z indikacijami, priporočili za odmerjanje ter farmakokinetičnimi in farmakodinamičnimi podatki za zdravila, ki vsebujejo vankomicin v EU, je treba popraviti v skladu z najnovejšimi razpoložljivimi informacijami;
For certain medicinal vancomycin-containing products, the intraperitoneal route and oral route of administration are authorised, 
Določena zdravila, ki vsebujejo vankomicin, je dovoljeno dajati po intraperitonealni in peroralni poti;
• Concerning the “decontamination of the GI tract in immune-compromised patients when combined with an aminoglycoside”, the CHMP reviewed the available data submitted throughout this procedure. 
• Glede „dekontaminacije prebavil pri bolnikih z oslabljenim imunskim sistemom v kombinaciji z aminoglikozidom“ je odbor CHMP pregledal razpoložljive podatke, predložene v postopku.
Currently, there is no evidence that medical prophylaxis for CDI is efficacious and therefore there is not recommended prophylactic antibiotics. 
dokazov, da je medicinska profilaksa za okužbe s Clostridium difficile učinkovita in zato ni priporočljivih profilaktičnih antibiotikov.
In addition, in line with the outcome of the MSWG consultation, the CHMP concluded that Bayesian methods could be clinically useful for more accurate dose predictions as a complementary part of routine therapeutic drug monitoring (TDM), especially for the patient groups with altered pharmacokinetic (PK) profile (i.e. children, haemodynamically unstable patients, intensive care), and acknowledged that this is already in clinical use. 
Poleg tega je odbor CHMP v skladu z izidom posvetovanj z delovno skupino MSWG zaključil, da bi Bayesove metode lahko bile klinično uporabne za bolj natančne napovedi odmerka kot dopolnilo rutinskemu terapevtskemu spremljanju zdravila, zlasti za skupine bolnikov s spremenjenim farmakokinetičnim (PK) profilom (tj. otroke, hemodinamsko nestabilne bolnike, bolnike na intenzivni negi), in priznava, da se že uporabljajo v klinični praksi.
In the case of mild CDI clearly induced by the use of antibiotics, it is acceptable to discontinue the inducing antibiotic and observe the clinical response. 
V primeru blage oblike okužbe s Clostridium difficile, ki jo je nedvomno sprožila uporaba antibiotikov, je sprejemljiva prekinitev uporabe antibiotikov, ki so sprožili okužbo, in opazovanje kliničnega odziva.
The CHMP also reviewed the dosage regimen for vancomycin for the various approved indications and patient subpopulations. 
Odbor CHMP je pregledal tudi shemo odmerjanja vankomicina pri različnih odobrenih indikacijah in podskupinah bolnikov.
The CHMP noted that the European Society of Clinical Microbiology and Infection (ESCMID) issued a treatment guidance document9,10 for Clostridium difficile infection in 2009 that is currently being updated. 
Odbor CHMP je ugotovil, da je Evropsko združenje za klinično mikrobiologijo in infekcijske bolezni (ESCMID) leta 2009 izdalo smernice za zdravljenje9,10 okužb s Clostridium difficile, ki jih trenutno posodabljajo.
However, to ensure that the established therapeutic dose in terms of IU (potency) is maintained, and as indicated in the Question and Answer on expression/declaration of potency in quantitative and qualitative composition for vancomycin products (EMA/CHMP/QWP/667469/2015), the amount (mg) of active substance in the drug product should be adjusted to achieve the declared product strength in terms of IU. 
Da pa bi zagotovili, da se vzdržuje uveljavljen terapevtski odmerek, izražen v mednarodnih enotah (potenca), in zagotovi skladnost z vprašanji in odgovori glede izražanja/navajanja jakosti pri kvalitativni in kvantitativni sestavi za zdravila, ki vsebujejo vankomicin (EMA/CHMP/QWP/667469/2015), mora biti količina (mg) zdravilne učinkovine v zdravilu prilagojena tako, da doseže navedeno jakost zdravila v smislu števila mednarodnih enot.
However, continuous vancomycin infusions have a few disadvantages such as that there may be compatibility issues with other IV medications or solutions that are given concurrently; practical problems associated with reduced line availability when infusions are given over a 24-h period; increased risk of infusing a bolus dose of vancomycin when the intravenous solution is changed or when another medication is infused into the same intravenous tubing which is filled with vancomycin 24 h/day etc. 
Vendar ima neprekinjeno infundiranje vankomicina nekaj slabosti, kot so nekompatibilnost z drugimi intravenoznimi zdravili ali raztopinami, ki se dajejo sočasno; praktične težave, povezane z zmanjšano razpoložljivostjo cevk, če se infuzije dajejo v 24-urnem obdobju; povečano tveganje za infundiranje bolusnega odmerka vankomicina pri menjavi intravenske raztopine ali kadar se drugo zdravilo infundira v intravensko cevko, ki je napolnjena z vankomicinom 24 ur/dan itd.
• the CHMP considered that the pharmacokinetic and pharmacodynamic data in the product information need to be updated, 
• odbor CHMP je menil, da je treba posodobiti farmakokinetične in farmakodinamične podatke v informacijah o zdravilu;
The SmPC has been amended accordingly, including the dosing regimen in children based on post-menstrual age as a possible way of dosing vancomycin in this population. 
Povzetek glavnih značilnosti zdravila je bil ustrezno spremenjen, vključno s shemo odmerjanja pri otrocih, ki temelji na pomenstrualni starosti kot možnem načinu odmerjanja vankomicina pri tej populaciji.
A statement in the section 4.2 had been included accordingly by the CHMP. 
Odbor CHMP je dodal ustrezno navedbo v poglavje 4.2.
The CHMP acknowledged that the current therapeutic guidelines stress the importance of therapeutic drug monitoring and the use of the trough vancomycin concentration as a surrogate for the target AUC. 
Odbor CHMP priznava, da trenutne terapevtske smernice poudarjajo pomen terapevtskega spremljanja zdravila in uporabo koncentracije vankomicina pred naslednjim odmerkom (Ctrough) kot nadomestka za ciljno vrednost AUC.
The Committee, as a consequence, recommends the variation to the terms of the marketing authorisations for vancomycin-containing products. 
Odbor posledično priporoča spremembo pogojev dovoljenja za promet z zdravili, ki vsebujejo vankomicin.
The CHMP reviewed also the optimal way of expressing the strength and dose of vancomycincontaining products. 
Odbor CHMP je pregledal tudi optimalen način izražanja jakosti in odmerka zdravil, ki vsebujejo vankomicin.
• Treatment of peritoneal dialysis-associated peritonitis. 
• Zdravljenje peritonitisa, povezanega s peritonealno dializo.
In addition, the CHMP reviewed the available evidence submitted within the referral procedure including several references to published literature and a meta-analysis of a total of 64 studies (32 for initial treatment and negative culture, 28 reporting treatment for Gram-positive and 24 reporting treatment for Gram-negative) and 21 randomized clinical trials (14 for initial treatment and negative culture, 8 reporting treatment for Gram-positive and 8 reporting treatment for Gram-negative), confirming the efficacy of vancomycin for the treatment of peritonitis in peritoneal dialysis. 
Poleg tega je odbor CHMP pregledal razpoložljive dokaze, predložene v postopku napotitve, vključno z več sklici na objavljeno literaturo in metaanalizo skupno 64 študij (32 o začetnem zdravljenju in negativni kulturi, 28 o zdravljenju okužb z grampozitivnimi povzročitelji in 24 o zdravljenju okužb z gramnegativnimi povzročitelji) ter 21 randomiziranih kliničnih preskušanj (14 o začetnem zdravljenju in negativni kulturi, 8 o zdravljenju okužb z grampozitivnimi povzročitelji in 8 o zdravljenju okužb z gramnegativnimi povzročitelji), ki je potrdila učinkovitost vankomicina za zdravljenje peritonitisa pri peritonealni dializi.
The CHMP also reviewed the limits for related substances and impurities in the active substance and in the finished products and it was concluded that the limits for related components and impurities in the drug substance and in the final drug products already authorised are qualified. 
Odbor je pregledal tudi mejne vrednosti za sorodne snovi innečistoče v zdravilni učinkovini in končnem zdravilu ter zaključil, da so omejitve za sorodne sestavine in nečistoče v zdravilni učinkovini in končnih zdravilih, ki so že odobrena, ustrezne.
The most commonly used dosage regimen (1 g every 12 hours) was considered adequate by the CHMP from a pharmacokinetic and pharmacodynamic perspective for the majority of patients with normal renal function and based on the usual susceptibility of staphylococci (minimum inhibitory concentration (MIC) ≤1 mg/L). 
Odbor CHMP je najpogosteje uporabljeno shemo odmerjanja (1 g na vsakih 12 ur) štel za ustrezno z vidika farmakokinetike in farmakodinamike za večino bolnikov z normalno ledvično funkcijo in osnovano na običajni občutljivosti stafilokokov (minimalna inhibitorna koncentracija (MIK) ≤ 1 mg/l).
Current guidelines from the European Society of Clinical Microbiology and Infectious Diseases (ESCMID1,2) and Infectious Diseases Society of America (IDSA3) also support its role in the treatment of MRSA infections. 
Tudi trenutne smernice Evropskega združenja za klinično mikrobiologijo in nalezljive bolezni (ESCMID1,2) in Ameriškega združenja za nalezljive bolezni (IDSA3) podpirajo vlogo vankomicina pri zdravljenju okužb z MRSA.
However, having reviewed the data presented by the MAHs, the CHMP also considered the existing limitations of monitoring Ctrough in certain situations. 
Vendar je odbor CHMP po pregledu podatkov, ki so jih predstavili imetniki dovoljenja za promet z zdravilom, obravnaval tudi obstoječe omejitve za spremljanje vrednosti Ctrough v določenih okoliščinah.
• the CHMP considered that the risks of nephrotoxicity, ototoxicity, infusion related adverse reactions and hypersensitivity reactions observed with vancomycin for intravenous use can be minimised by appropriate warnings and recommendations in the product information, 
• odbor CHMP je menil, da je tveganje nefrotoksičnosti, ototoksičnosti, z infuzijo povezanih neželenih reakcij in preobčutljivostnih reakcij, ki so bile ugotovljene pri intravenski uporabi zdravil, ki vsebujejo vankomicin, mogoče zmanjšati z ustreznimi opozorili in priporočili v informacijah o zdravilu;
The CHMP noted that the measurement of trough serum concentrations at steady state is an accepted surrogate to check if effective vancomycin exposure has been achieved. 
Odbor CHMP je izpostavil, da je merjenje serumske koncentracije pred naslednjim odmerkom v stanju dinamičnega ravnovesja sprejemljiv nadomestek za preverjanje, ali je bila dosežena učinkovita izpostavljenost vankomicinu.
The CHMP also reviewed the dose recommendation in paediatric population. 
Pregledal je tudi priporočila za odmerjanje pri pediatrični populaciji.
The CHMP also acknowledged that some already approved vancomycin containing medicines already include some dosing recommendations for both term and preterm neonates11. 
Odbor CHMP priznava, da nekatera odobrena zdravila, ki vsebujejo vankomicin, že vključujejo nekatera priporočila za odmerjanje pri donošenih in nedonošenih novorojenčkih11.
The CHMP noted that the current guidelines for the treatment of acute bacterial meningitis from several learned societies (ESCMID4, IDSA5 guideline and UK joint specialist societies guidelines6, European Federation Neurological Societies (EFNS)) recommend vancomycin for both empirical treatment and etiological treatment of MRSA (alone) and penicillin-resistant Streptococcus pneumoniae (PRSP) in combination with other antibacterials in adults and children. 
Odbor CHMP je ugotovil, da trenutne smernice za zdravljenje akutnega bakterijskega meningitisa številnih strokovnih združenj (ESCMID4, IDSA5, skupne smernice združenj specialistov v Združenem kraljestvu6 in Evropske zveze nevroloških društev (EFNS) priporočajo vankomicin za empirično in etiološko zdravljenje okužb z MRSA (v monoterapiji) in okužb s proti penicilinu odporno bakterijo Streptococcus pneumoniae (PRSP) v kombinaciji z drugimi antibiotiki pri odraslih in otrocih.
However, increases in the rates of heteroresistance and tolerance to vancomycin, combined with its pharmacodynamic (i.e. slow bactericidal activity, variable tissue penetration) and clinical (clinical failures reported in patients with invasive infections produced by Staphylococcus aureus with a MIC above 1 mcg/mL) shortcomings have questioned the current role of vancomycin for the treatment of these infections. 
Vendar zvišane stopnje heterorezistence in toleranca na vankomicin v kombinaciji s farmakodinamičnimi (tj. počasna baktericidna aktivnost, različna penetracija tkiv) in kliničnimi (poročila o klinična neodzivnost pri bolnikih z invazivnimi okužbami zaradi Staphylococcus aureus z MIK nad 1 µg/ml) pomanjkljivostmi postavljajo pod vprašaj obstoječo vlogo vankomicina pri zdravljenju teh okužb.
The Committee, as a consequence, concluded that the benefit-risk balance of the vancomycin containing products included in the scope of this procedure remains positive under normal conditions of use, taking into account the agreed changes to the product information. 
Odbor je posledično zaključil, da razmerje med koristmi in tveganji za zdravila, ki vsebujejo vankomicin in so bila zajeta v tem postopku, ostaja pozitivno pri normalnih pogojih uporabe, ob upoštevanju dogovorjenih sprememb v informacijah o zdravilu.