FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor or other healthcare professional will give you this medicine into one of your veins through an infusion (a drip) lasting one hour.
Slovenian: To zdravilo vam bo dal zdravnik ali drug zdravstveni delavec v eno izmed ven z infuzijo (kapalno), ki bo trajala eno uro.
English: One of these 60 patients had bacteraemia at baseline.
Slovenian: Eden od 60 bolnikov je imel v izhodišču bakteriemijo.
English: Variations in colour within this range do not affect the potency of the product.
Slovenian: Razlike v barvi v tem okviru ne vplivajo na učinkovitost zdravila.
English: The dose of medicine given to you depends on whether or not you have kidney problems.
Slovenian: Odmerek zdravila, ki ga boste prejeli, je odvisen od tega, ali imate kakšne težave z ledvicami ali ne.
English: Treatment with Zerbaxa sometimes causes production of antibodies that react with your red blood cells.
Slovenian: Zdravljenje z zdravilom Zerbaxa včasih povzroči nastanek protiteles, ki reagirajo z rdečimi krvnimi celicami.
English: These include: - Probenecid (a medicine for gout).
Slovenian: Med takšnimi je: - probenecid (zdravilo za protin).
English: Non-susceptible micro-organisms
Slovenian: Neobčutljivi mikroorganizmi
English: Treatment with Zerbaxa normally lasts between 4 and 14 days, depending on the severity and location of the infection and on how your body responds to the treatment.
Slovenian: Zdravljenje z zdravilom Zerbaxa po navadi traja od 4 do 14 dni, odvisno od tega, kako huda je okužba, kje v telesu je in kako se telo odzove na zdravljenje.
English: However, active substances that inhibit OAT1 or OAT3 (e.g., probenecid) may increase tazobactam plasma concentrations.
Slovenian: Vendar pa lahko zdravilne učinkovine, ki zavrejo OAT1 ali OAT3 (npr. probenecid), povečajo koncentracijo tazobaktama v plazmi.
English: Zerbaxa should only be used during pregnancy if the expected benefit outweighs the possible risks to the pregnant woman and foetus.
Slovenian: Zdravilo Zerbaxa se sme med nosečnostjo uporabiti le, če pričakovane prednosti odtehtajo možna tveganja za nosečnico in plod.
English: AmpC enzymes (produced by Enterobacterales)
Slovenian: encimov AmpC (ki jih tvorijo Enterobacterales)
English: Zerbaxa is indicated for the treatment of the following infections in adults (see section 5.1):
Slovenian: Zdravilo Zerbaxa je indicirano za zdravljenje naslednjih okužb (glejte poglavje 5.1) pri odraslih:
English: If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, se posvetujte z zdravnikom ali farmacevtom, preden prejmete to zdravilo.
English: Zerbaxa is a medicine used to treat a range of bacterial infections.
Slovenian: Zdravilo Zerbaxa je zdravilo, ki se uporablja za zdravljenje različnih bakterijskih okužb.
English: Environmental Risk Assessment (ERA)
Slovenian: Ocena tveganja za okolje
English: These types of infection may range in severity from mild to life-threatening.
Slovenian: Resnost takšnih okužb je lahko od blage do življenjsko nevarne.
English: In such circumstances, the discontinuation of therapy with ceftolozane/tazobactam and the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered.
Slovenian: V takšnih primerih je treba razmisliti o prenehanju zdravljenja s ceftolozanom/tazobaktamom in o uporabi podpornih ukrepov skupaj s specifičnim zdravljenjem okužbe s Clostridioides difficile.
English: Environmental risk assessment studies have shown that one of the active ingredients, ceftolozane, may pose a risk to surface water organisms (see section 6.6).
Slovenian: Študije ocene tveganja za okolje so pokazale, da lahko ena od učinkovin, ceftolozan, predstavlja tveganje za organizme površinskih voda (glejte poglavje 6.6).
English: Tell your doctor straight away if you get these symptoms as you may need urgent medical treatment: - Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems.
Slovenian: Nemudoma obvestite zdravnika, če se pojavijo naslednji simptomi, saj boste morda potrebovali nujno zdravljenje: - nenadno otekanje ustnic, obraza, žrela ali jezika, hud izpuščaj in težave s požiranjem ali dihanjem.
English: Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia
Slovenian: Serokonverzija direktnega antiglobulinskega testa (Coombsov test) in možno tveganje za hemolitično anemijo
English: Do not take Zerbaxa - if you are allergic to ceftolozane, tazobactam or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Zerbaxa - če ste alergični na ceftolozan, tazobaktam ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If a severe allergic reaction occurs during treatment with ceftolozane/tazobactam, the medicinal product should be discontinued and appropriate measures taken.
Slovenian: Če se med zdravljenjem s ceftolozanom/tazobaktamom pojavi huda alergijska reakcija, je treba zdravljenje s tem zdravilom prekiniti in ustrezno ukrepati.
English: Frequency categories are derived according to the following conventions: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) (see Table 3).
Slovenian: Kategorije pogostnosti so opredeljene po naslednjem dogovoru: pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) (glejte preglednico 3).
English: What you need to know before you take Zerbaxa
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Zerbaxa
English: 8-14 days
Slovenian: 8 do 14 dni
English: If you are told that you have an abnormal blood test (called Coombs test) tell your doctor that you are having or have recently had Zerbaxa.
Slovenian: Če vam je zdravnik povedal, da imate nenormalen izvid laboratorijskega krvnega testa (imenovan Coombsov test), zdravniku povejte, da se zdravite oziroma ste se pred kratkim zdravili z zdravilom Zerbaxa.
English: If you think you have not been given a dose of Zerbaxa, tell your doctor or other healthcare professional immediately.
Slovenian: Če menite, da niste prejeli odmerka zdravila Zerbaxa, to nemudoma povejte zdravniku ali drugemu zdravstvenemu delavcu.
English: Your doctor will advise if you should receive Zerbaxa during pregnancy.
Slovenian: Zdravnik vam bo povedal, ali lahko prejemate zdravilo Zerbaxa med nosečnostjo.
English: - if you are allergic to medicines known as “cephalosporins”.
Slovenian: - če ste alergični na zdravila, imenovana cefalosporini.
English: - if you have had a severe allergic reaction (e.g., severe skin peeling; swelling of the face, hands, feet, lips, tongue or throat; or difficulty swallowing or breathing) to certain other antibiotics (e.g., penicillins or carbapenems).
Slovenian: - če ste kdaj imeli hudo alergijsko reakcijo (npr. hudo luščenje kože, oteklost obraza, dlani, stopal, ustnic, jezika ali žrela, oziroma težave s požiranjem ali dihanjem) na določene druge antibiotike (npr. peniciline ali karbapeneme).
English: Frequency Infusion time
Slovenian: Pogostnost Čas infundiranja
English: Adverse reactions are classified according to MedDRA system organ class and frequency.
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih MedDRA in pogostnosti.
English: This can increase the time it takes for tazobactam to leave your body.
Slovenian: To zdravilo lahko podaljša čas, potreben, da se tazobaktam odstrani iz telesa.
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions are possible (see sections 4.3 and 4.8).
Slovenian: Možne so resne preobčutljivostne (anafilaktične) reakcije, občasno s smrtnim izidom (glejte poglavji 4.3 in 4.8).
English: 4-14 days
Slovenian: 4 do 14 dni
English: Other medicines and Zerbaxa
Slovenian: Druga zdravila in zdravilo Zerbaxa
English: Augmented renal clearance
Slovenian: Povečan ledvični očistek
English: Approximately 82% of all patients in the trial had APACHE II (Acute Physiology and Chronic Health Evaluation II) scores of < 10 and 2.3% had bacteraemia at baseline.
Slovenian: Pri približno 82 % vseh bolnikov v preskušanju je bila ocena APACHE II (Acute Physiology and Chronic Health Evaluation II) < 10, 2,3 % bolnikov je imelo bakteriemijo v izhodišču.
English: The use of ceftolozane/tazobactam may promote the overgrowth of non-susceptible micro-organisms.
Slovenian: Uporaba ceftolozana/tazobaktama lahko spodbudi razrast neobčutljivih mikroorganizmov.
English: In patients with moderate or severe renal impairment, and in patients with end stage renal disease on haemodialysis, the dose should be adjusted as listed in Table 2 (see sections 5.1 and 6.6).
Slovenian: Pri bolnikih z zmerno ali hudo okvaro ledvic in bolnikih s končno odpovedjo ledvic na hemodializi je odmerek treba prilagoditi, kot je prikazano v preglednici 2 (glejte poglavji 5.1 in 6.6).
English: Pharmacokinetic/pharmacodynamic relationships
Slovenian: Farmakokinetično/farmakodinamično razmerje
English: Your doctor may need to reduce the dose of Zerbaxa or decide how often Zerbaxa is given to you.
Slovenian: Zdravnik vam bo morda moral zmanjšati odmerek zdravila Zerbaxa, ali presoditi, kako pogosto boste prejemali zdravilo Zerbaxa.
English: Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
Slovenian: V predkliničnih študijah so učinke opazili samo pri izpostavljenostih, bistveno večjih od največje izpostavljenosti pri človeku, kar kaže na majhen pomen za klinično uporabo.
English: What Zerbaxa is and what it is used for
Slovenian: Kaj je zdravilo Zerbaxa in za kaj ga uporabljamo
English: For intravenous use after reconstitution and dilution.
Slovenian: Za intravensko uporabo po rekonstituciji in redčenju.
English: The time above a threshold concentration has been determined to be the parameter that best predicts the efficacy of tazobactam in in vitro and in vivo non-clinical models.
Slovenian: Čas nad mejno vrednostjo koncentracije se je izkazal kot parameter, ki najbolje napove učinkovitost tazobaktama v nekliničnih modelih in vitro in in vivo.
English: More than 80% of tazobactam was excreted as the parent compound with the remaining amount excreted as the tazobactam M1 metabolite.
Slovenian: Več kot 80 % tazobaktama se je izločilo v obliki matične spojine, preostala količina pa kot presnovek tazobaktama M1.
English: One of the active ingredients, ceftolozane, may have harmful effects if it reaches the aquatic environment.
Slovenian: Ena od učinkovin, ceftolozan, ima lahko škodljiv učinek, če pride v vodno okolje.
English: In the clinically evaluable (CE) patients, the clinical cure rates for ceftolozane/tazobactam were 95.9% in 293 patients aged less than 65 years and 87.8% in 82 patients aged 65 years or more.
Slovenian: Pri klinično ocenljivih bolnikih je bila stopnja klinične ozdravitve za ceftolozan/tazobaktam 95,9 % pri 293 bolnikih, starih manj kot 65 let, in 87,8 % pri bolnikih, starih 65 let ali več.
English: Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI54.
Slovenian: Farmakoterapevtska skupina: Zdravila za sistemsko zdravljenje bakterijskih infekcij, drugi cefalosporini in penemi, oznaka ATC: J01DI54
English: There is no experience with overdose of Zerbaxa.
Slovenian: Izkušenj s prevelikim odmerjanjem zdravila Zerbaxa ni.
English: 1, abdominal distension dyspepsia
Slovenian: 1, abdominalna distenzija
English: Mechanisms of bacterial resistance to ceftolozane/tazobactam include: i.
Slovenian: Mehanizem bakterijske odpornosti proti ceftolozanu/tazobaktamu vključuje: i.
English: In vitro data indicate that the following species are not susceptible to ceftolozane/tazobactam: Staphylococcus aureus
Slovenian: Podatki in vitro kažejo, da naslednje vrste niso občutljive na ceftolozan/tazobaktam: Staphylococcus aureus
English: The resultant concentration is approximately 132 mg/mL (88 mg/mL of ceftolozane and 44 mg/mL of tazobactam) per vial.
Slovenian: Dobljena koncentracija je približno 132 mg/ml (88 mg/ml ceftolozana in 44 mg/ml tazobaktama) na vialo.
English: If you stop taking Zerbaxa
Slovenian: Če ste prenehali prejemati zdravilo Zerbaxa
English: CrCL (mL/min)*
Slovenian: Ocenjeni očistek kreatinina (ml/min)*
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zerbaxa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prekinitvijo/prenehanjem zdravljenja z zdravilom Zerbaxa, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: This medicine contains 230 mg sodium (main component of cooking/table salt) in each vial.
Slovenian: Zdravilo vsebuje 230 mg natrija (ki je glavna sestavina kuhinjske/namizne soli) na vialo.
English: Ceftolozane is eliminated in the urine as unchanged parent substance and thus does not appear to be metabolised to any appreciable extent.
Slovenian: Ceftolozan se izloča v urin kot nespremenjena matična spojina, tako da ni videti, da bi se presnavljal v znatni meri.
English: Clinical efficacy data in patients with complicated lower urinary tract infection are limited.
Slovenian: Kliničnih podatkov o učinkovitosti pri bolnikih z zapletenimi okužbami spodnjih sečil je malo.
English: In the event of overdose, Zerbaxa should be discontinued and general supportive treatment given.
Slovenian: V primeru prevelikega odmerjanja je treba prekiniti uporabo zdravila Zerbaxa in bolniku nuditi splošno podporno zdravljenje.
English: Carcinogenicity studies with ceftolozane/tazobactam have not been conducted.
Slovenian: Študije kancerogenosti s ceftolozanom/tazobaktamom niso bile opravljene.
English: Gram-positive bacteria Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
Slovenian: Grampozitivne bakterije Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP.” The expiry date refers to the last day of that month.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in viali poleg oznake "EXP".
English: Type of infection
Slovenian: Vrsta okužbe
English: Ceftolozane exerts bactericidal activity through binding to important penicillin-binding proteins (PBPs), resulting in inhibition of bacterial cell-wall synthesis and subsequent cell death.
Slovenian: Ceftolozan deluje baktericidno z vezavo na pomembne beljakovine, ki vežejo penicilin (PBP - penicillin-binding proteins), ter s tem zavre sintezo bakterijske celične stene in posledično povzroči celično smrt.
English: 1, venous thrombosis
Slovenian: 1, venska tromboza
English: Zerbaxa may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Zerbaxa ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: Elderly (≥ 65 years of age) No dose adjustment is necessary for the elderly based on age alone (see section 5.2).
Slovenian: Starejši bolniki (starost ≥ 65 let) Prilagoditev odmerka pri starejših bolnikih zgolj zaradi starosti ni potrebna (glejte poglavje 5.2).
English: Alanine aminotransferase increased aspartate aminotransferase increased transaminases increased
Slovenian: Preiskave zvišana alanin-aminotransferaza zvišana aspartat-aminotransferaza zvišane transaminaze
English: Atrial fibrillation 1, tachycardia angina pectoris
Slovenian: Srčne bolezni atrijska fibrilacija 1, tahikardija angina pektoris
English: Zerbaxa solution for infusion is clear and colourless to slightly yellow.
Slovenian: Raztopina zdravila Zerbaxa za infundiranje je bistra in brezbarvna do rahlo rumena.
English: The binding of ceftolozane and tazobactam to human plasma proteins is low (approximately 16% to 21% and 30%, respectively).
Slovenian: Vezava ceftolozana in tazobaktama na plazemske beljakovine pri človeku je majhna (ceftolozan približno 16-21 %, tazobaktam približno 30 %).
English: What Zerbaxa is and what it is used for What you need to know before you take Zerbaxa How to take Zerbaxa
Slovenian: Kaj je zdravilo Zerbaxa in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Zerbaxa Kako uporabljati zdravilo Zerbaxa Možni neželeni učinki
English: Unopened vials: Store in a refrigerator (2°C - 8°C).
Slovenian: Neodprte viale: Shranjujte v hladilniku (2 °C - 8 °C).
English: It contains two active substances: - ceftolozane, an antibiotic that belongs to the group of “cephalosporins” and which can kill certain bacteria that can cause infection; - tazobactam, which blocks the action of certain enzymes called beta-lactamases.
Slovenian: Vsebuje dve zdravilni učinkovini: - ceftolozan, antibiotik iz skupine cefalosporinov, ki uničuje določene bakterije, ki lahko povzročajo okužbe, - tazobaktam, ki zavre delovanje določenih encimov, imenovanih betalaktamaze.
English: For tazobactam the PD index associated with efficacy was determined to be the percentage of the dose interval during which the plasma concentration of tazobactam exceeds a threshold value (%T > threshold).
Slovenian: Za tazobaktam je bil farmakodinamični indeks, povezan z učinkovitostjo, določen kot odstotek odmernega intervala, v katerem plazemska koncentracija tazobaktama preseže mejno vrednost (% t > mejna vrednost).
English: In patients with mild renal impairment (estimated creatinine clearance [CrCL] > 50 mL/min), no dose adjustment is necessary, see section 5.2.
Slovenian: Pri bolnikih z blago okvaro ledvic (ocenjeni očistek kreatinina > 50 ml/min) prilagoditev odmerka ni potrebna, glejte poglavje 5.2.
English: In vitro, tazobactam inhibited human OAT1 and OAT3 transporters with IC50 values of 118 and 147 mcg/mL, respectively.
Slovenian: In vitro je tazobaktam zavrl humana prenašalca OAT1 in OAT3 z IC50 118 µg/ml za prvega in 147 µg/ml za drugega.
English: Preparation of doses
Slovenian: Priprava odmerkov
English: However, if you have any concerns you should let your doctor, nurse or pharmacist know immediately.
Slovenian: Toda če vas kar koli skrbi, morate to takoj povedati zdravniku, medicinski sestri ali farmacevtu.
English: Patients who were immunocompromised, patients with severe neutropenia, and patients with end stage renal disease on haemodialysis were excluded from clinical trials.
Slovenian: Bolniki s pomanjkljivo imunostjo, bolniki s hudo nevtropenijo in bolniki s končno odpovedjo ledvic na hemodializi niso bili vključeni v klinična preskušanja.
English: Pack size of 10 vials.
Slovenian: Velikost pakiranja je 10 vial.
English: Patients with renal impairment at baseline should be monitored frequently for any changes in renal function during treatment and the dose of ceftolozane/tazobactam should be adjusted as necessary.
Slovenian: Bolnike z okvaro ledvic v izhodišču je treba med zdravljenjem redno spremljati glede sprememb v delovanju ledvic in jim po potrebi prilagoditi odmerek ceftolozana/tazobaktama.
English: In a trial in patients with complicated intra-abdominal infections, the most common diagnosis was appendiceal perforation or peri-appendiceal abscess (420/970 [43.3%] patients), of which 137/420 (32.6%) had diffuse peritonitis at baseline.
Slovenian: V preskušanju pri bolnikih z zapletenimi okužbami v trebušni votlini je bila najpogostejša diagnoza predrtje slepiča ali periapendikalni absces (pri 420/970 [43,3 %] bolnikov), pri kateri je imelo 137/420 (32,6 %) bolnikov difuzni peritonitis v izhodišču.
English: 1, diarrhoea
Slovenian: 1, diareja
English: Some medicines may interact with ceftolozane and tazobactam.
Slovenian: Nekatera zdravila lahko medsebojno delujejo s ceftolozanom in tazobaktamom.
English: Animal studies with tazobactam have shown reproductive toxicity (see section 5.3) without evidence of teratogenic effects.
Slovenian: Študije tazobaktama na živalih so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3) brez znakov teratogenosti.
English: The Cmax and AUC of ceftolozane/tazobactam increase in proportion to dose.
Slovenian: Cmax in AUC ceftolozana/tazobaktama se povečujeta sorazmerno odmerku.
English: Co-administration of ceftolozane/tazobactam with OAT1 and OAT3 substrate furosemide in a clinical study did not significantly increase furosemide plasma exposures (geometric mean ratios of 0.83 and 0.87 for Cmax and AUC, respectively).
Slovenian: Sočasna uporaba ceftolozana/tazobaktama s substratom OAT1 in OAT3 furosemidom v klinični študiji ni pomembno povečala izpostavljenosti furosemidu v plazmi (razmerje geometričnih sredin 0,83 za Cmax in 0,87 za AUC).
English: Free plasma ceftolozane concentrations were greater than 8 mcg/mL over 70% of an 8-hour period; free tazobactam concentrations were greater than 1 mcg/mL over 60% of an 8-hour period.
Slovenian: Koncentracija prostega ceftolozana v plazmi je bila nad 8 mcg/ml v 70 % 8-urnega obdobja; koncentracija prostega tazobaktama je bila nad 1 mcg/ml v 60 % 8-urnega obdobja.
English: Production of beta-lactamases that can hydrolyse ceftolozane and which are not inhibited by tazobactam (see below)
Slovenian: nastajanje betalaktamaz, ki lahko hidrolizirajo ceftolozan in ki jih tazobaktam ne zavira (glejte spodaj)
English: Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterial agents may also be hypersensitive to ceftolozane/tazobactam.
Slovenian: Bolniki, ki imajo v anamnezi preobčutljivost na cefalosporine, peniciline ali druge betalaktamske antibiotike, so lahko preobčutljivi tudi na ceftolozan/tazobaktam.
English: Powder for concentrate for solution for infusion 10 vials
Slovenian: prašek za koncentrat za raztopino za infundiranje 10 vial
English: This is equivalent to 13.3% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To ustreza 13,3 % največjega priporočenega dnevnega prehranskega vnosa natrija za odrasle.
English: Limitations of the clinical data
Slovenian: Pomanjkanje kliničnih podatkov
English: The infusion time is 1 hour for all doses of Zerbaxa.
Slovenian: Čas infundiranja za vse odmerke zdravila Zerbaxa je 1 ura.
English: This is equivalent to 11.5% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To ustreza 11,5 % največjega priporočenega dnevnega prehranskega vnosa natrija za odrasle.