FrancophonIA/ELRC3.0 huggingface dataset:
English: - 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.
Slovenian: Če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, obvestite svojega zdravnika ali farmacevta.
English: - If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4.
Slovenian: Če se pojavijo spremembe na koži ali mehurčki in/ali luščenje kože in/ali spremembe na sluznici (glejte poglavje 4.
English: The 250 ml bottle is available in packs of 1 and 5 bottles.
Slovenian: Steklenice po 250 ml so na voljo v pakiranjih, ki vsebujejo 1 ali 5 steklenic.
English: 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.
Slovenian: 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.
English: In vitro, moxifloxacin revealed cardiac electrophysiological properties that can cause prolongation of the QT interval, even though at high concentrations.
Slovenian: In vitro je moksifloksacin pokazal vpliv na elektrofiziologijo srca, kar lahko povzroči podaljšanje intervala QT, čeprav pri velikih koncentracijah.
English: The Applicant considered that moxifloxacin IV had demonstrated non-inferiority or superiority in six controlled studies involving over 1,100 moxifloxacin-treated patients.
Slovenian: 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.
English: Active ingredient: Moxifloxacin
Slovenian: Zdravilna učinkovina: moksifloksacin
English: Intravenous moxifloxacin was not associated with an increased incidence of events that would be considered surrogates for a QTc-related arrhythmia.
Slovenian: Intravenozni moksifloksacin ni bil povezan s povečano pojavnostjo dogodkov, ki bi lahko bili nadomestki za aritmijo, povezano s QTc.
English: You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking Octegra.
Slovenian: Med uporabo zdravila Octegra se morate izogibati daljšemu izpostavljanju sončni svetlobi ali močni sončni svetlobi in ne smete uporabljati solarija ali drugih UV svetilk.
English: The clinical development plan for cSSSI consisted of two controlled studies which were the basis for the approval.
Slovenian: V načrtu kliničnega razvoja zapletenih okužb kože in mehkih tkiv sta bili vključeni dve nadzorovani študiji, ki sta bili podlaga za odobritev.
English: 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.
Slovenian: 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.
English: In in vivo tests, no evidence of genotoxicity was found despite the fact that very high moxifloxacin doses were used.
Slovenian: V in vivo testih genotoksičnosti kljub uporabi zelo velikih odmerkov moksifloksacina niso ugotovili.
English: 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.
Slovenian: 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.
English: The magnitude of QT prolongation may increase with increasing plasma concentrations due to rapid intravenous infusion.
Slovenian: Interval QT se lahko podaljša z zvečanjem plazemskih koncentracij zaradi hitrega intravenskega infundiranja.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale, da moksifloksacin vpliva na sposobnost razmnoževanja (glejte poglavje 5.3).
English: If you stop using Octegra
Slovenian: Če ste prenehali uporabljati zdravilo Octegra
English: 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.
Slovenian: Kjer je lokalna prevalenca odpornosti tolikšna, da je koristnost uporabe učinkovine pri vsaj nekaterih vrstah okužb dvomljiva, se je nujno potrebno posvetovati s strokovnjakom.
English: While the efficacy data are sufficient to support an indication for use in CAP they suggest that moxifloxacin may not be as good as some alternative regimens.
Slovenian: Medtem ko so podatki o učinkovitosti zadostni za podporo indikacije za uporabo pri izvenbolnišnično pridobljeni pljučnici, pa nakazujejo, da moksifloksacin morda ni tako dober kot nekateri alternativni režimi zdravljenja.
English: culture test by suppression of mycobacterial growth causing false negative results.
Slovenian: Zdravljenje z moksifloksacinom lahko ovira preizkus rasti kulture Mycobacterium spp., tako da zavre rast mikobakterije, kar povzroča lažno negativne rezultate.
English: Sodium content: 34 mmol/250 ml
Slovenian: Vsebnost natrija: 34 mmol/250 ml
English: If you are on a controlled-salt diet, please inform your doctor immediately.
Slovenian: Če ste na dieti z nadzorovanim vnosom natrija, o tem takoj obvestite svojega zdravnika.
English: In addition, the Applicant was requested to commit to amend the SPC for the moxifloxacin tablets, in order to bring it in line with the IV formulation, and make it clear that the tablets may be used for cSSSI and CAP of any severity only when IV therapy has already resulted in substantial improvement in the patient's condition, such that a switch to oral treatment is considered appropriate.
Slovenian: Poleg tega se je od predlagatelja zahtevalo, naj se zaveže k spremembi povzetka glavnih značilnosti zdravila za tablete moksifloksacin, da bo v skladu z intravenozno formulacijo, in naj jasno opredeli, da se lahko tablete uporabljajo pri zapletenih okužbah kože in mehkih tkiv in izvenbolnišnično pridobljeni pljučnici katere koli stopnje le, ko je intravenozno zdravljenje že pokazalo bistveno izboljšanje stanja bolnika, tako da je prehod na peroralno zdravljenje primeren.
English: and monkeys (p.o.) did not show evidence of teratogenicity or impairment of fertility following administration of moxifloxacin.
Slovenian: in opicah (p.o.) niso pokazale teratogenih učinkov ali vpliva na sposobnost razmnoževanja po uporabi moksifloksacina.
English: After intravenous administration of moxifloxacin to dogs (30 mg/kg infused over 15, 30 or 60 minutes) the degree of QT prolongation was clearly depending on the infusion rate, i.e. the shorter the infusion time the more pronounced the prolongation of the QT interval.
Slovenian: Če so psom moksifloksacin dajali intravensko (30 mg/kg, z infundiranjem, ki je trajalo 15, 30 ali 60 minut), je bila stopnja podaljšanja intervala QT očitno odvisna od hitrosti infundiranja, t.j.
English: Like all medicines, Octegra can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo Octegra neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines besides Octegra, including medicines obtained without a prescription.
Slovenian: Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
English: An early evaluation of the effects of moxifloxacin on QTc showed a correlation between plasma concentration and QTc in healthy subjects and increases in QTc were significantly higher in healthy elderly subjects post-moxifloxacin versus placebo.
Slovenian: Zgodnje ovrednotenje učinkov moksifloksacina na QTc je pokazalo povezavo med koncentracijo v plazmi in QTc pri zdravih osebah, porast QTc pa je bil znatno višji pri zdravih starejših osebah po uporabi moksifloksacina kot pri tistih po uporabi placeba.
English: Do not use if you notice any visible particulate matter or if the solution is cloudy.
Slovenian: Ne uporabljajte zdravila, če opazite vidne delce, ali če je raztopina motna.
English: However, in light of the ADR and cardiac safety data submitted by the Applicant, there were differences between the two treatment groups with respect to the incidence of clinical AEs that could be considered surrogates for QTc prolongation, as higher incidences of ventricular tachycardia and cardiac arrest were seen in the moxifloxacin group.
Slovenian: Kljub temu pa so bile glede na neželene učinke in podatke o varnosti srca, ki jih je predložil predlagatelj, z ozirom na pojavnost kliničnih neželenih dogodkov, med obema zdravljenima skupinama razlike, ki bi lahko bile nadomestek za podaljšanje QTc, saj je bila v skupini, ki je prejemala moksifloksacin, opažena višja pojavnost ventrikularne tahikardije in zastoja srca.
English: Octegra works by killing bacteria that cause infections if they are caused by bacteria that are susceptible to moxifloxacin.
Slovenian: Zdravilo Octegra uničuje bakterije, ki povzročajo okužbe in so občutljive za moksifloksacin.
English: In clinical Phase I and in vitro studies no metabolic pharmacokinetic interactions with other drugs undergoing Phase I biotransformation involving cytochrome P450 enzymes were observed.
Slovenian: V kliničnih študijah I. faze in v študijah in vitro niso opazili presnovnih farmakokinetičnih interakcij z drugimi zdravili, ki se biotransformirajo v I. fazi z encimskim sistemom citokrom P 450.
English: Regarding section 5.2 of the SPC, the Applicant agreed to remove the CLSI disk diffusion and MIC breakpoint criteria for aerobic bacteria but retained the CLSI recommendations for anaerobes in the SPC, as there are no MIC breakpoints established by EUCAST making the CLSI standard the only reference available to guide physicians.
Slovenian: Glede poglavja 5.2 povzetka glavnih značilnosti zdravila se predlagatelj strinja o odstranitvi CLSI disk difuzije in kriterijev prelomne točke najnižje inhibicijske koncentracije za aerobne bakterije, ohranil pa je priporočila Inštituta za klinične in laboratorijske standarde (CLSI) za anaerobe v povzetku glavnih značilnosti zdravila, saj Evropski odbor za testiranje občutljivosti za protibakterijske učinkovine (EUCAST) ni postavil nikakršnih prelomnih točk najnižje inhibicijske koncentracije in so zato standardi CLSI edina referenca, ki je na voljo za usmerjanje zdravnikov.
English: Following a 400 mg intravenous infusion recovery of unchanged drug from urine was approximately 22% and from faeces approximately 26%.
Slovenian: Po intravenskemu infundiranju 400 mg se je s sečem izločilo približno 22 % nespremenjene učinkovine, z blatom pa približno 26 %.
English: In addition, the lower 95% CI in the primary analyses exceeded or bordered on -10%, which adds to the opinion that IV/PO moxifloxacin is not an optimal overall treatment for cSSSI.
Slovenian: Poleg tega je nižji 95 % interval zaupanja v primarnih analizah presegel ali mejil na 10 %, kar dodatno podkrepi mnenje, da intravenozno / peroralno zdravljenje z moksifloksacinom ne predstavlja optimalnega celovitega zdravljenja zapletenih okužb kože in mehkih tkiv.
English: In studies conducted in diabetic volunteers, concomitant administration of oral moxifloxacin with glibenclamide resulted in a decrease of approximately 21% in the peak plasma concentrations of glibenclamide.
Slovenian: V študijah, v katerih so sodelovali prostovoljci s sladkorno boleznijo, ki so sočasno peroralno dobivali moksifloksacin in glibenklamid, so ugotovili, da se je največja koncentracija glibenklamida v plazmi zmanjšala za približno 21 %.
English: Uncommon: Distinct alteration of the electrical activity of the heart (ECG), palpitations, irregular and fast heart beat, severe cardiac rhythm abnormalities, angina pectoris, flushing
Slovenian: izrazite spremembe v električni aktivnosti srca (EKG), palpitacije, nereden in hiter srčni utrip, hude nepravilnosti srčnega ritma, angina pektoris, rdečica obraza
English: The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.
Slovenian: Lahko je koristno, če se med absorpcijo zdravila dovolj zgodaj uporabi aktivno oglje, saj se v primerih, ko bolnik prekomerni odmerek zaužije peroralno, preprečimo prekomerno povečanje sistemske izpostavljenosti moksifloksacinu.
English: The following side effects have been observed during treatment with Octegra.
Slovenian: V nadaljevanju so našteti neželeni učinki, ki so jih opazili med zdravljenjem z zdravilom Octegra.
English: The CHMP noted the Applicant response but considered that the data indicated that moxifloxacin is probably not quite as good as comparative therapy.
Slovenian: CHMP je upošteval odgovor predlagatelja, a je menil, da podatki kažejo, da moksifloksacin najverjetneje ni tako dober kot primerjalno zdravljenje.
English: There is no advantage to be expected from moxifloxacin over approved fluoroquinolones in the indications claimed except over ciprofloxacin in CAP (due to the inherently low activity of ciprofloxacin against S. pneumoniae).
Slovenian: Prednost moksifloksacina pred odobrenimi fluorokinoloni za dane indikacije se ne pričakuje, razen za ciprofloksacin pri izvenbolnišnično pridobljeni pljučnici (zaradi po naravi manjšega delovanja ciprofloksacina na S. pneumoniae).
English: The Applicant again presented data for the pooled CAP studies, stating that adverse events and drug reactions were slightly less common in patients treated with moxifloxacin.
Slovenian: Predlagatelj je znova predložil podatke za zbrane študije izvenbolnišnično pridobljene pljučnice in navedel, da so bili neželeni dogodki in neželeni učinki zdravila nekoliko manj pogosti pri bolnikih, zdravljenih z moksifloksacinom.
English: Moxifloxacin is distributed to extravascular spaces rapidly.
Slovenian: Moksifloksacin se po ekstravaskularnem prostoru hitro razporedi.
English: If you feel you are suffering from a side effect, especially 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 immediately to get advice before taking the next dose.
Slovenian: Če se je pri vas pojavil neželeni učinek, posebno če katerikoli neželeni učinek postane resen ali če opazite katerikoli neželeni učinek, ki ni omenjen v tem navodilu, o tem takoj obvestite svojega zdravnika ali farmacevta in se pred uporabo naslednjega odmerka z njim posvetujte.
English: Alterations of the skin and mucous membranes (painful blisters in the mouth/nose or at the penis/vagina), potentially life-threatening (Stevens-Johnson-Syndrome, toxic epidermal necrolysis)
Slovenian: Zelo redki: spremembe na koži in sluznici (boleči mehurčki v ustih/nosu ali na penisu/v nožnici), ki so lahko smrtno nevarne (Stevens-Johnsonov sindrom, toksična epidermalna nekroliza)
English: The data collected during the first two CAP studies shows that patients were more likely to have a notable increase in QTc on intravenous moxifloxacin.
Slovenian: Podatki, zbrani v prvih dveh študijah izvenbolnišnično pridobljene pljučnice, kažejo, da je večja verjetnost, da bodo imeli bolniki znatno povečan QTc pri intravenoznem zdravljenju z moksifloksacinom.
English: The submitted ECG data and the analysis of outlying QTc values demonstrated a consistent excess risk of moxifloxacin in the studies with ECG data.
Slovenian: Predloženi podatki EKG in analiza izstopajočih vrednosti QTc dokazujejo skladen presežek tveganja pri moksifloksacinu iz študij s presežkom iz podatkov EKG.
English: However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness, see section 4.8) or acute and short lasting loss of consciousness (syncope, see section 4.8).
Slovenian: Vendar lahko fluorokinoloni (tudi moksifloksacin) zmanjšajo bolnikovo sposobnost za vožnjo ali upravljanja strojev zaradi vpliva na osrednji živčni sistem (npr. omotica, glejte poglavje 4.8) ali nenadne kratkotrajne nezavesti (sinkopa, glejte poglavje 4.8).
English: - Special care is need if you are taking other medicines that can lower your blood potassium levels or cause a slow heart rate because these can also increase the risk of serious heart rhythm disturbances while taking Octegra.
Slovenian: Posebna pozornost je potrebna, če jemljete druga zdravila, ki lahko zmanjšajo vrednosti kalija ali upočasnijo srčni utrip, ker to lahko poveča tveganje za pojav hudih motenj srčnega ritma med jemanjem zdravila Octegra.
English: Due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals and reversible joint injuries described in children receiving some fluoroquinolones, moxifloxacin must not be used in pregnant women (see section 4.3).
Slovenian: Zaradi z eksperimenti dokazanega tveganja, da moksifloksacin povzroča okvare hrustanca nosilnih sklepov nerazvitih živali in reverzibilne poškodbe sklepov, o katerih so poročali pri otrocih, ki so prejemali nekatere fluorokinolone, se moksifloksacina ne sme uporabljati pri nosečnicah (glejte poglavje 4.3).
English: What Octegra is and what it is used for Before you use Octegra How to use Octegra Possible side effects How to store Octegra Further information
Slovenian: Kaj je zdravilo Octegra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Octegra Kako uporabljati zdravilo Octegra Možni neželeni učinki
English: Moxifloxacin hydrochloride is a synthetic antibacterial agent of the fluoroquinolone class.
Slovenian: Moksifloksacinijev klorid je sintetična protibakterijska učinkovina razreda fluorokinolonov.
English: Use immediately after first opening and/or dilution.
Slovenian: Zdravilo je treba uporabiti takoj po prvem odprtju in/ali redčenju.
English: The safety profile of oral moxifloxacin also applies to intravenous moxifloxacin and there are particular concerns regarding hepatotoxicity and adverse reactions resulting from the effects of moxifloxacin on cardiac conduction.
Slovenian: Profil varnosti peroralne uporabe moksifloksacina prav tako velja za intravenozno uporabo moksifloksacina, glede hepatotoksičnosti in neželenih učinkov zaradi učinkov moksifloksacina na prevodnost srca pa predstavlja določene zadržke.
English: If the blood supply to your heart muscle is impaired, consult your doctor before you are given Octegra because this can increase the risk of heart rhythm disturbances.
Slovenian: Če je oskrba vašega srca s krvjo motena, se posvetujte s svojim zdravnikom preden vzamete zdravilo Octegra, ker to lahko poveča tveganje za pojav motenj srčnega ritma.
English: The CHMP noted that while the pre-defined non-inferiority margins had been met, the data indicates that IV moxifloxacin was not quite as good as the best available regimens.
Slovenian: CHMP je izpostavil, da čeprav so bile predhodno določene meje neinferiornosti dosežene, podatki kažejo, da intravenozni moksifloksacin ni bil tako učinkovit kot najboljši razpoložljivi režimi zdravljenja.
English: After a single 400 mg intravenous 1 hour infusion peak plasma concentrations of approximately 4.1 mg/l were observed at the end of the infusion corresponding to a mean increase of approximately 26% relative to those seen after oral administration (3.1 mg/l).
Slovenian: Po enkratni enourni infuziji 400 mg so največje koncentracije v plazmi (približno 4,1 mg/l ) opazili na koncu infundiranja, kar je v povprečju predstavljalo približno 26 % zvečanje glede na koncentracije, ki so jih opazili po peroralni uporabi (3,1 mg/l).
English: Considering these results a metabolic interaction via cytochrome P450 enzymes is unlikely.
Slovenian: Glede na te rezultate so presnovne interakcije z encimskim sistemom citokrom P 450 malo verjetne.
English: Consult your doctor if you wish to stop the treatment with Octegra solution for infusion or Octegra tablets before the end of the course of treatment.
Slovenian: Posvetujte se s svojim zdravnikom, če želite prenehati uporabljati raztopino za infundiranje Octegra ali tablete Octegra pred zaključkom zdravljenja, posebno s poznejšim jemanjem tablet.
English: What Octegra looks like and contents of the pack
Slovenian: Izgled zdravila Octegra in vsebina pakiranja
English: Before using Octegra for the first time - Octegra can temporarily change your heart's ECG, which can very rarely lead to life-threatening disturbances of the heart rhythm.
Slovenian: Zdravilo Octegra lahko začasno vpliva na vaš EKG srca, ki lahko v zelo redko privede do življensko ogrožujoče motnje srčnega ritma.
English: Unspecific abnormal heart rhythms, irregular heart beat (Torsade de Pointes), stopping of heart beat (see section 2.
Slovenian: Zelo redki: neznačilne motnje srčnega ritma, nereden srčni utrip (Torsade de Pointes), srčni zastoj (glejte poglavje 2.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA za intravensko uporabo
English: - Moxifloxacin solution for infusion is for intravenous administration only.
Slovenian: Moksifloksacin raztopina za infundiranje je samo za intravensko uporabo.
English: - Clinical efficacy of moxifloxacin in the treatment of severe burn infections, fasciitis, major abscesses and diabetic foot infections with osteomyelitis has not been established.
Slovenian: Klinična učinkovitost moksifloksacina pri zdravljenju hudih okužb opeklin, fasciitisa, obsežnejših abscesov in okužb diabetične noge z osteomielitisom ni dokazana.
English: Excipient: 250 ml of solution for infusion contains 34 mmol sodium.
Slovenian: Pomožne snovi: 250 ml raztopine za infundiranje vsebuje 34 mmol natrija .
English: After intra-arterial injection inflammatory changes involving the peri-arterial soft tissue were observed suggesting that intra-arterial administration of moxifloxacin should be avoided.
Slovenian: Po intraarterijski injekciji so opazili vnetne spremembe na periarterialnem mehkem tkivu, zato se je treba intraarterialni uporabi moksifloksacina izogibati.
English: Moxifloxacin IV for CAP was approved through MRP in two subsequent waves, in 2002 and 2004.
Slovenian: V postopku medsebojnega priznavanja je bil intravenozni miksofloksacin za izvenbolnišnično pridobljeno pljučnico odobren v dveh zaporednih obdobjih, leta 2002 in 2004.
English: Moxifloxacin is contraindicated in children and growing adolescents.
Slovenian: Uporaba moksifloksacina je kontraindicirana pri otrocih in mladostnikih v obdobju rasti.
English: Rare ≥ 1/10,000 to
Slovenian: redki > 1/10.000 do <
English: - Octegra should be given intravenously (in the vein) only, and should not be administered into an artery.
Slovenian: Zdravilo se daje samo intravensko (v veno) in ne v arterijo.
English: - There is limited experience on use of sequential intravenous/oral Octegra for the treatment of infection of the lungs (pneumonia) acquired outside the hospital.
Slovenian: Izkušnje z uporabo zdravila Octegra (sekvenčno intravensko/peroralno) pri zdravljenju pljučnice (pnevmonije), pridobljene izven bolnišnice, so omejene.