natgillin/translations-raw huggingface dataset:
Moxifloxacin demonstrated efficacy against S. pneumoniae and pathogens associated with atypical pneumonia and the Applicant also discussed data obtained by the competence network CAPNETZ. 
Moksifloksacin je izkazal učinkovitost proti S. pneumoniae in patogenom, povezanim z netipično pljučnico, predlagatelj pa je prav tako razpravljal o podatkih, pridobljenih v pristojni mreži CAPNETZ.
The Applicant presented the results from the two studies, concluding that the bacteriological responses to moxifloxacin were supportive of the clinical responses and that the bacteriological eradication rates for moxifloxacin indicated good consistency between the two studies. 
Predlagatelj je predstavil rezultate dveh študij, v katerih je zaključil, da bakteriološki odzivi na moksifloksacin podpirajo klinične odzive in da stopnje bakteriološkega uničenja pri moksifloksacinu kažejo na zadovoljivo skladnost med tema dvema študijama.
The CHMP did not agree with the Applicant's conclusions, although the boxed warning was considered appropriate. 
CHMP se ni strinjal s predlagateljevimi zaključki, čeprav se je opozorilni okvir upošteval kot primeren.
The toxicological experiments did not indicate that the liver was a prominent target organ for moxifloxacin and no specific risk factors for severe hepatic events were identified. 
Toksikološki poskusi niso pokazali, da bi bila jetra pomemben ciljni organ za moksifloksacin, specifičnih dejavnikov tveganja za hude jetrne dogodke pa niso ugotovili.
Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea. 
Zdravila, ki zavirajo peristaltiko, so pri bolnikih, ki imajo hudo drisko, kontraindicirana.
These effects occurred after the administration of high doses of moxifloxacin or after prolonged treatment. 
Te učinke so opazili šele po zdravljenju z velikimi odmerki moksifloksacina ali po podaljšanem zdravljenju.
The frequency of possible side effects listed below is defined using the following convention: 
Pogostnost spodaj navedenih možnih neželenih učinkov je navedena kot sledi: Zelo pogosti:
Octegra will always be given to you by a doctor or healthcare professional. 
KAKO UPORABLJATI ZDRAVILO OCTEGRA Zdravilo Octegra vam bo vedno dal zdravnik ali zdravstveno osebje.
Female patients and elderly patients may be more sensitive to the effects of QTc-prolonging medications such as moxifloxacin and therefore special caution is required. 
Bolnice in starejši bolniki so lahko bolj občutljivi za zdravila, ki podaljšajo interval QTc kot je npr. moksifloksacin, zato je pri uporabi potrebna posebna previdnost.
In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started (see section 5.1). 
V primeru domnevne ali potrjene okužbe z MRSA, je treba začeti z ustreznim učinkovitim protimikrobnim zdravljenjem (glejte poglavje 5.1).
The Applicant discussed the many factors that affect the QT interval and stated that while prolongation of the QTc interval is commonly used as a surrogate marker for the risk of developing ventricular arrhythmias such as Torsade de Pointes (TdP), there is no consensus on the degree of QT prolongation that is considered clinically significant. 
Predlagatelj je razpravljal o mnogih dejavnikih, ki vplivajo na interval QT in izjavil, da čeprav se podaljšanje intervala QTc pogosto uporablja kot nadomestni označevalec za tveganje nastanka ventrikularne aritmije, kot je Torsade de Pointes (TdP), o stopnji podaljšanja QT, za katerega se domneva, da je klinično pomemben, ni soglasja.
If medically indicated the solution for infusion can be administered via a T-tube, together with compatible infusion solutions (see section 6.6). 
Če je indicirano, se raztopino za infundiranje lahko daje s pomočjo T-cevke, skupaj s kompatibilnimi raztopinami za infundiranje (glejte poglavje 6.6)
If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. 
Pri potrjeni ali domnevni AAD ali AAC, je treba zdravljenje s protimikrobnimi zdravili, vključno z moksifloksacinom, prekiniti in takoj začeti z ustreznim zdravljenjem.
The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/min. 
Dejanski povprečni skupni očistek iz telesa po odmerku 400 mg je 179 do 246 ml/min.
Infused at a constant flow rate over 60 minutes. 
Neprekinjeno infundiranje naj traja 60 minut.
The data indicates that moxifloxacin carries a risk of severe hepatotoxicity at least 2-fold greater than comparators and the CHMP considers that the consistency of these risk estimates is a strong signal of an increased risk of hepatotoxicity, supporting non-first line use in the proposed indications. 
Podatki kažejo, da ima moksifloksacin vsaj dvakrat večje tveganje za resno hepatotoksičnost kot primerjalna zdravila, CHMP pa je mnenja, da je doslednost teh ocen tveganja jasen znak povečanega tveganja za hepatotoksičnost kar za predlagane indikacije podpira uvrstitev zdravila med zdravila, ki niso prvega izbora.
Do not use Octegra - If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients (see section 6. 
Ne uporabljajte zdravila Octegra - če ste alergični (preobčutljivi) na zdravilno učinkovino moksifloksacin, druge kinolone ali katerokoli sestavino (glejte poglavje 6.
EXP Use immediately after first opening and/or dilution. 
EXP Zdravilo je treba uporabiti takoj po prvem odprtju in/ali redčenju.
The CHMP does not concur with the argument that the benefit-risk is different for patients in need of initial IV treatment as it can be argued that these patients are actually at greater risk of experiencing ADRs. 
CHMP se ne strinja s trditvijo, da je razmerje med koristmi in tveganji pri bolnikih, ki potrebujejo začetno intravenozno zdravljenje, drugačno, saj lahko trdimo, da imajo ti bolniki pravzaprav višje tveganje za nastanek neželenih učinkov.
The following symptoms have been observed more frequently in patients treated intravenously: Common: 
V nadaljevanju so našteti znaki, ki so se pri bolnikih, ki so se zdravili intravensko, pojavili pogosteje: Pogosti:
Patients should be advised to see how they react to moxifloxacin before driving or operating machinery. 
Bolnikom je treba svetovati, da preden začnejo voziti ali upravljati s stroji, ocenijo svoj odziv na moksifloksacin.
The Applicant concluded that there are no differences between moxifloxacin and the comparator when comparing the total numbers and frequencies of reports on possible drug-related hepatic disorders. 
Predlagatelj je zaključil, da med moksifloksacinom in primerjalnimi zdravili, kar zadeva primerjavo skupnega števila in pogostosti poročil o možnih, z zdravili povezanih okvarah jeter, ni razlik.
In several cases, the lower 95% CI around the treatment differences in individual studies were borderline with instances of notable numerical inferiority for moxifloxacin versus comparators. 
V nekaj primerih je nižji 95 % interval zaupanja za razlike v zdravljenju v posameznih študijah mejil na primere znatne številčne manjvrednosti za moksifloksacin v primerjavi s primerjalnimi zdravili.
Pharmacodynamic studies of fluoroquinolones in animal infection models and in human trials indicate that the primary determinant of efficacy is the AUC24/MIC ratio. 
Farmakodinamične študije s fluorokinoloni na okuženih živalih in preskušanja pri ljudeh so pokazala, da je razmerje AUC24/MIK primarni pokazatelj učinkovitosti.
However, there was a suggestion that moxifloxacin may not be as effective against anaerobes, which might correlate with erratic in-vitro activity against anaerobic species. 
Kljub temu so domnevali, da moksifloksacin morda ni tako učinkovit proti anaerobom, kar bi se lahko skladalo z neenakomerno in vitro aktivnostjo proti anaerobnim vrstam.
The Applicant also claimed growing evidence that moxifloxacin has the best PK/PD profile to avoid the selection of resistance amongst the respiratory fluoroquinolones currently available in Europe. 
Predlagatelj se je prav tako skliceval na vse močnejše dokaze, da ima moksifloksacin najboljši profil farmakokinetike/farmakodinamike, zaradi česar se lahko izogne izbiri odpornosti med dihalnimi fluorokinoloni, ki so trenutno na voljo v Evropi.
In addition, the post-marketing data show that significant and serious ADRs associated with QTc prolongation do occur. 
Poleg tega podatki po začetku trženja kažejo, da se pojavljajo pomembni in resni neželeni učinki zdravila, povezani s podaljšanjem QTc.
#ESBL-producing strains are commonly also resistant to fluoroquinolones. 
#ESBL-pozitivni sevi so navadno tudi odporni proti fluorokinolonom.
Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5). 
Moksifloksacina se ne sme uporabljati sočasno z drugimi zdravili, ki podaljšujejo interval QT (glejte tudi poglavje 4.5).
The wording to be implemented was agreed by the CHMP and communicated to the Applicant. 
Besedilo, ki naj bi bilo vstavljeno, je potrdil CHMP, nato pa je bilo posredovano predlagatelju.
The combination of glibenclamide and moxifloxacin could theoretically result in a mild and transient hyperglycaemia. 
Kombinacija glibenklamida in moksifloksacina bi teoretično lahko povzročila blago in prehodno hiperglikemijo.
Distinct alteration of the electrical activity of the heart (ECG) in patients with decreased blood potassium 
izrazite spremembe v električni aktivnosti srca (EKG) pri bolnikih, ki imajo zmanjšano koncentracijo kalija v krvi
Prothrombin level increased / INR decreased 
zvečane vrednosti protrombina/ znižane vrednosti INR
Moraxella (Branhamella) catarrhalis 
Moraxella (Branhamella) catarrhalis anaerobni mikroorganizmi
Polyolefine bags with polypropylene port sealed in aluminium foil overwrap. 
Poliolefinske vreče s polipropilensko zaporko zapečateno v ovitku iz aluminijaste folije.
The CHMP considered that the effects of moxifloxacin on QTc indicate a correlation between plasma concentration and QTc. 
CHMP je menil, da učinki moksifloksacina na QTc kažejo na povezavo med koncentracijo v plazmi in QTc.
Moxifloxacin inhibits bacterial type II topoisomerases (DNA gyrase and topoisomerase IV) that are required for bacterial DNA replication, transcription and repair. 
Moksifloksacin zavira bakterijska tipa topoizomeraz II (girazo DNK in topoizomerazo IV), ki sta potrebni pri podvajanju, prepisovanju in obnavljanju bakterijske DNK.
The fact that moxifloxacin undergoes considerable metabolism led to concerns regarding its hepatotoxic potential. 
Dejstvo, da se moksifloksacin znatno presnavlja, je vodilo v zadržke glede njegovega hepatotoksičnega potenciala.
- If you are currently taking oral anti-coagulants (e.g. warfarin), it may be necessary for your doctor to monitor your blood clotting times. 
Če jemljete peroralne antikoagulante (npr. varfarin), so potrebne laboratorijske kontrole strjevanja krvi pri vašem zdravniku.
Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively. 
Sočasno jemanje aktivnega oglja in peroralnega ali intravenskega odmerka moksifloksacina (400 mg) zmanjša sistemsko uporabnost zdravila za več kot 80 % oz. 20 %.
In some cases your doctor may start your treatment with Octegra solution for infusion and then continue your treatment with Octegra tablets. 
V nekaterih primerih lahko zdravnik začne zdraviti z raztopino za infundiranje Octegra in nadaljuje zdravljenje s tabletami Octegra.
Post-marketing data show that patients have been given moxifloxacin despite the contraindications and warnings in the SPC, therefore strengthening these precautions in the SPC is unlikely to achieve a major shift in behaviour. 
Podatki po začetku trženja kažejo, da so bolniki prejemali moksifloksacin kljub kontraindikacijam in opozorilom v povzetku glavnih značilnosti zdravila, zato poudarjanje teh previdnostnih ukrepov v povzetku glavnih značilnosti zdravila najverjetneje ne bo doseglo velike spremembe v vedenju.
- Infections of the skin and soft tissue 
- okužbe kože in mehkih tkiv
In conclusion, the CHMP is of the opinion that the efficacy of moxifloxacin in the two indications claimed is not over-impressive. 
CHMP je naposled menil, da učinkovitost moksifloksacina za ti dve indikaciji ni pretirano prepričljiva.
Octegra is used in adults for treating the following bacterial infections: - Infection of the lungs (pneumonia) acquired outside the hospital - Infections of the skin and soft tissue 
Zdravilo Octegra se pri odraslih uporablja za zdravljenje naslednjih bakterijskih okužb: pljučnice (pnevmonije), pridobljene izven bolnišnice, okužbe kože in mehkih tkiv.
Emotional instability, depression (in very rare cases leading to self-harm), hallucination 
čustvena labilnost, depresija (v zelo redkih primerih samoogrožajoče vedenje), halucinacije
Maximum concentrations of 5.4 mg/kg and 20.7 mg/l (geometric mean) were reached in bronchial mucosa and epithelial lining fluid, respectively, 2.2 h after an oral dose. 
Največja koncentracija 5,4 mg/kg oziroma 20,7 mg/l (geometrijska sredina) sta doseženi v sluznici bronhijev oziroma v epitelijski tekočini, 2,2 uri po peroralnem odmerku.
Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular reabsorption of the drug from the kidneys. 
Ledvični očistek je približno 24 do 53 ml/min, kar kaže na delno tubulno reabsorpcijo zdravila v ledvicah.
Ear Rare: 
Uho Redki:
No specific countermeasures after accidental overdose are recommended. 
Posebnih protiukrepov pri nenamerno prevelikem odmerjanju ni.
PHARMACEUTICAL FORM Solution for infusion Clear, yellow solution 
FARMACEVTSKA OBLIKA raztopina za infundiranje bistra, rumena raztopina
This applied to the overall incidence rates during IV/oral therapy and during initial IV therapy. 
To se je nanašalo na stopnjo splošne pojavnosti med intravenoznim/peroralnim zdravljenjem in med začetnim intravenoznim zdravljenjem.
Octegra is for intravenous use. 
Zdravilo Octegra je za intravensko uporabo.
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA 
DODATEK II ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA POZITIVNO MNENJE IN DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODIL ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA
As renal function decreases, concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/min/1.73 m2). 
Z oslabitvijo ledvične funkcije se koncentracije presnovka M2 (glukoronid) zvečajo do 2,5-krat (očistek kreatinina < 30 ml/min/1,73 m2).
Important information about some of the ingredients of Octegra This medicinal product contains 787mg (approximately 34mmol) sodium per dose. 
Pomembne informacije o nekaterih sestavinah zdravila Octegra To zdravilo vsebuje 787 mg (približno 34 mmolov) natrija na odmerek.
After intravenous administration findings indicative of systemic toxicity were most pronounced when moxifloxacin was given by bolus injection (45 mg/kg) but they were not observed when moxifloxacin (40 mg/kg) was given as slow infusion over 50 minutes. 
Ugotovitve, ki nakazujejo sistemsko toksičnost po intravenski uporabi, so bile najbolj izrazite, ko so moksifloksacin dali kot velik enkraten odmerek (45 mg/kg), niso pa jih opazili, če so moksifloksacin (40 mg/kg) počasi infundirali (infundiranje je trajalo 50 minut).
PK/PD predictions of the relative likelihood of levofloxacin and moxifloxacin selecting for resistance are scientifically plausible but not fully validated clinically. 
Napovedi farmakokinetike/farmakodinamike o relativni verjetnosti izbire levofloksacina in moksifloksacina za odpornost so znanstveno mogoče, vendar ne popolnoma klinično potrjene.
In vitro studies with human cytochrome P450 enzymes support these findings. 
Študije in vitro s humanim encimskim sistemom citokrom P 450 so potrdile te ugotovitve.
In conventional repeated dose studies moxifloxacin revealed haematological and hepatic toxicity in rodents and non-rodents. 
V običajnih študijah s ponovljenimi odmerki je moksifloksacin pokazal hematološko toksičnost in hepatotoksičnost pri glodalcih in ne-glodalcih.
Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin. 
To je pomembno upoštevati pri bolnikih, pri katerih se huda driska pojavi med uporabo moksifloksacina ali po njej.
Octegra contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones. 
Octegra vsebuje zdravilno učinkovino moksifloksacin, ki spada v skupino antibiotikov, imenovano fluorokinoloni.
- Treatment with moxifloxacin should be stopped if signs or symptoms that may be associated with cardiac arrhythmia occur during treatment, with or without ECG findings. 
Zdravljenje z moksifloksacinom je treba prekiniti, če se med zdravljenjem pojavijo znaki in simptomi, ki so lahko povezani s srčno aritmijo, z ali brez EKG sprememb.
Using Octegra with food and drink The effect of Octegra is not influenced by food including dairy products. 
Uporaba zdravila Octegra skupaj s hrano in pijačo Hrana (vključno z mlečnimi izdelki) ne vpliva na učinke zdravila Octegra.
Taking into account these considerations, the CHMP did not support the Applicant's assertion that the difference in benefit-risk relationship between oral and intravenous uses justifies an unqualified indication for the use of IV moxifloxacin to treat CAP. 
CHMP ob upoštevanju navedenega ni podprl predlagateljeve trditve, da razlika med peroralno in intravenozno uporabo v razmerju med koristmi in tveganji upravičuje neuvrščeno indikacijo za uporabo intravenoznega moksifloksacina pri zdravljenju izvenbolnišnično pridobljene pljučnice.
Potential co-morbidities do not change the fact that IV administration carried an excess risk over comparators, including in the study in elderly. 
Možna soobolevnost ne spremeni dejstva, da je imela intravenozna uporaba, v primerjavi s primerjalnimi zdravili, presežek tveganja, tudi v študiji na ostarelih.
Octegra is a clear, yellow solution for infusion. 
Zdravilo Octegra je bistra, rumena raztopina za infundiranje.
- Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration. 
Poročali so o preobčutljivostnih in alergijskih reakcijah fluorokinolonov (tudi moksifloksacina) po prvi uporabi.
The Applicant concluded that moxifloxacin has enhanced activity against penicillin/macrolide-susceptible and -resistant strains of S. pneumoniae, is active against pathogens associated with atypical pneumonia and is consistently effective in hospitalised patients requiring initial IV therapy. 
Predlagatelj je zaključil, da ima moksifloksacin okrepljeno aktivnost na seve S. pneumoniae, dovzetne in odporne na penicilin/makrolid, da učinkuje na patogene, povezane z netipično pljučnico in da je dosledno učinkovit pri hospitaliziranih bolnikih, ki potrebujejo začetno intravenozno zdravljenje.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 
Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
- If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4. 
Če se pojavijo spremembe na koži ali mehurčki in/ali luščenje kože in/ali spremembe na sluznici (glejte poglavje 4.
The 250 ml bottle is available in packs of 1 and 5 bottles. 
Steklenice po 250 ml so na voljo v pakiranjih, ki vsebujejo 1 ali 5 steklenic.
Regarding the risk of hepatic ADRs associated with IV/PO moxifloxacin, the greater background morbidity/clinical monitoring may partly explain the increased rates but it remains plausible that it is linked to the greater bioavailability of the IV formulation. 
Glede tveganja za neželene učinke na jetra, povezane z intravenoznim/peroralnim zdravljenjem z moksifloksacinom, lahko večja osnovna obolevnost/klinično nadziranje delno razloži porast, ostaja pa verjetno, da je povezan z večjo biološko razpoložljivostjo intravenozne formulacije.
In vitro, moxifloxacin revealed cardiac electrophysiological properties that can cause prolongation of the QT interval, even though at high concentrations. 
In vitro je moksifloksacin pokazal vpliv na elektrofiziologijo srca, kar lahko povzroči podaljšanje intervala QT, čeprav pri velikih koncentracijah.
The Applicant considered that moxifloxacin IV had demonstrated non-inferiority or superiority in six controlled studies involving over 1,100 moxifloxacin-treated patients. 
Učinkovitost pri zdravljenju izvenbolnišnično pridobljene pljučnice Predlagatelj je menil, da je intravenozni moksifloksacin izkazal neinferiornost ali večjo učinkovitost v šestih nadzorovanih študijah, ki so vključevale več kot 1 100 bolnikov, zdravljenih z moksifloksacinom.
Active ingredient: Moxifloxacin 
Zdravilna učinkovina: moksifloksacin
Intravenous moxifloxacin was not associated with an increased incidence of events that would be considered surrogates for a QTc-related arrhythmia. 
Intravenozni moksifloksacin ni bil povezan s povečano pojavnostjo dogodkov, ki bi lahko bili nadomestki za aritmijo, povezano s QTc.
You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking Octegra. 
Med uporabo zdravila Octegra se morate izogibati daljšemu izpostavljanju sončni svetlobi ali močni sončni svetlobi in ne smete uporabljati solarija ali drugih UV svetilk.
The clinical development plan for cSSSI consisted of two controlled studies which were the basis for the approval. 
V načrtu kliničnega razvoja zapletenih okužb kože in mehkih tkiv sta bili vključeni dve nadzorovani študiji, ki sta bili podlaga za odobritev.
The Applicant then discussed the cumulative review of spontaneous ADR reports on “QT/QTc prolongation” and “Torsade de Pointes” for IV only or IV/PO sequential treatment. 
Nato je predlagatelj razpravljal o kumulativnem pregledu poročil o spontanih neželenih učinkih, tj. „podaljšanju QT/QTc“ in „Torsade de Pointes“ pri samo intravenoznem ali intravenoznem/peroralnem zaporednem zdravljenju.
In in vivo tests, no evidence of genotoxicity was found despite the fact that very high moxifloxacin doses were used. 
V in vivo testih genotoksičnosti kljub uporabi zelo velikih odmerkov moksifloksacina niso ugotovili.
The Applicant considers that the proposed SPC now contains adequate warning regarding the patient groups at risk and potential precautionary measures to be noted before administering IV moxifloxacin. 
Predlagatelj je menil, da predlagani povzetek glavnih značilnosti zdravila zdaj vsebuje zadostna opozorila glede tveganih skupin bolnikov in glede možnih previdnostnih ukrepov, ki jih je treba upoštevati pred uporabo intravenoznega moksifloksacina.
The magnitude of QT prolongation may increase with increasing plasma concentrations due to rapid intravenous infusion. 
Interval QT se lahko podaljša z zvečanjem plazemskih koncentracij zaradi hitrega intravenskega infundiranja.
Animal studies have shown reproductive toxicity (see section 5.3). 
Študije na živalih so pokazale, da moksifloksacin vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
If you stop using Octegra 
Če ste prenehali uporabljati zdravilo Octegra
As necessary, expert advice should be sought where the local prevalence of resistance is such that utility of the agent in at least some types of infections is questionable. 
Kjer je lokalna prevalenca odpornosti tolikšna, da je koristnost uporabe učinkovine pri vsaj nekaterih vrstah okužb dvomljiva, se je nujno potrebno posvetovati s strokovnjakom.