FrancophonIA/ELRC3.0 huggingface dataset:
English: The eGFR was calculated using the MDRD4 equation.
Croatian: Za izračun eGFR korištena je jednadžba MDRD4.
English: The tablets are swallowed whole and can be taken with or without food or drink.
Croatian: Tablete treba progutati cijele i mogu se uzeti sa ili bez hrane ili pića.
English: • Streptococcus anginosus group (including S. anginosus, S. intermedius and S. constellatus)
Croatian: • Streptococcus anginosus skupina (uključuje S. anginosus, S. intermedius i S. constellatus)
English: Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Croatian: Granične vrijednosti minimalne inhibicijske koncentracije (MIK) koje je odredilo Europsko povjerenstvo za ispitivanje osjetljivosti na antimikrobne lijekove (European Committee on Antimicrobial Susceptibility Testing, EUCAST) su sljedeće:
English: If a rapid antibiotic effect is needed, the intravenous administration should be considered.
Croatian: Ako je potreban brzi učinak antibiotika, treba razmotriti intravensku primjenu.
English: The average binding of tedizolid to human plasma proteins is approximately 70-90%.
Croatian: Prosječno vezivanje tedizolida za proteine ljudske plazme je približno 70-90%.
English: This is when antibiotics cannot stop the growth of bacteria and treat your infection.
Croatian: To je kada antibiotici ne mogu zaustaviti rast bakterija i izliječiti Vašu infekciju.
English: What Sivextro is and what it is used for
Croatian: Što je Sivextro i za što se koristi
English: Other than tedizolid, which accounts for approximately 95% of the total radiocarbon AUC in plasma, there are no other significant circulating metabolites.
Croatian: Osim tedizolida, koji čini približno 95% AUC ukupnog radioaktivnog ugljika u plazmi, nema drugih značajnih cirkulirajućih metabolita.
English: It works by stopping the growth of certain bacteria which can cause serious infections.
Croatian: Svojim djelovanjem zaustavlja rast određenih bakterija koje mogu izazvati ozbiljne infekcije.
English: - are taking certain medicines to treat migraine known as “triptans”.
Croatian: - ako uzimate određene lijekove za liječenje migrene poznate kao „triptani“.
English: Bacteria can become resistant to treatment with antibiotics over time.
Croatian: Bakterije mogu postati otporne na liječenje antibioticima tijekom vremena.
English: It is available in packs containing 1 or 6 vials.
Croatian: Dostupan je u pakiranjima koja sadrže 1 ili 6 bočica.
English: No clinically relevant interactions are expected to occur with these transporters, with the exception of BCRP.
Croatian: Ne očekuju se klinički značajne interakcije s ovim prijenosnicima, osim BCRP-a.
English: • anaemia (low red blood cells)
Croatian: • anemija (niski broj crvenih krvnih stanica)
English: Patients who commence treatment on the parenteral formulation may be switched to the oral presentation when clinically indicated.
Croatian: Bolesnici koji započnu liječenje parenteralnom formulacijom mogu se prebaciti na peroralnu formulaciju kada je to klinički indicirano.
English: It is used to treat adults with infections of the skin and tissues below the skin.
Croatian: Koristi se za liječenje odraslih s infekcijama kože i tkiva ispod kože.
English: The absolute bioavailability of tedizolid is above 90%.
Croatian: Apsolutna bioraspoloživost tedizolida je iznad 90%.
English: Tell your doctor straight away if you suffer from any of the following while taking Sivextro:
Croatian: Odmah obavijestite svog liječnika ako imate bilo što od sljedećeg dok uzimate Sivextro:
English: The film-coated tablets can be taken with or without food.
Croatian: Filmom obložene tablete mogu se uzimati s hranom ili bez nje.
English: The clinical experience in patients ≥75 years is limited.
Croatian: ≥75 godina je ograničeno.
English: Sivextro may have a minor influence on the ability to drive and use machines as it may cause dizziness, fatigue or, uncommonly, somnolence (see section 4.8).
Croatian: Sivextro može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima jer može prouzročiti omaglicu, umor ili, manje često, somnolenciju (vidjeti dio 4.8).
English: Sivextro must not be mixed with other medicinal products.
Croatian: Sivextro se ne smije miješati s drugim lijekovima.
English: It must not be administered as an intravenous bolus.
Croatian: Ne smije se primjenjivati intravenskim bolusom.
English: Warnings and precautions Your doctor will have decided if Sivextro is suitable to treat your infection.
Croatian: Upozorenja i mjere opreza Vaš liječnik će odlučiti je li Sivextro prikladan za liječenje Vaše infekcije.
English: Non-susceptible microorganisms
Croatian: Neosjetljivi mikroorganizmi
English: Acute bacterial skin and skin structure infections
Croatian: Akutne bakterijske infekcije kože i kožnih struktura
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Croatian: Učestalosti su definirane kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: Tedizolid demonstrated linear pharmacokinetics with regard to dose and time.
Croatian: Tedizolid pokazuje linearnu farmakokinetiku s obzirom na dozu i vrijeme.
English: Tedizolid is eliminated in excreta, primarily as a non-circulating sulfate conjugate.
Croatian: Tedizolid se eliminira u ekskretima, primarno u obliku necirkulirajućeg sulfatnog konjugata.
English: • Poor control of diabetes
Croatian: • slaba kontrola šećerne bolesti
English: The potential for serotonergic interactions has not been studied in either patients or healthy volunteers (see section 5.2).
Croatian: Potencijal serotonergičkih interakcija nije ispitan u bolesnika niti u zdravih dobrovoljaca (vidjeti dio 5.2).
English: Only the pharmacokinetic profile of tedizolid is discussed in this section.
Croatian: U ovom dijelu se razmatra samo farmakokinetički profil tedizolida.
English: Elderly population (≥ 65 years)
Croatian: Starija populacija (≥65 godina)
English: It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.
Croatian: Dobivat ćete ga infuzijom (kapanjem) izravno u venu (intravenski) tijekom približno sat vremena.
English: Membrane transporters
Croatian: Membranski prijenosnici
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tedizolid phosphate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Mora se odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od terapije tedizolidfosfatom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Pharmacokinetic studies were conducted in healthy volunteers and population pharmacokinetic analyses were conducted in patients from Phase 3 studies.
Croatian: Farmakokinetička ispitivanja provedena su u zdravih dobrovoljaca, a populacijske farmakokinetičke analize provedene su u bolesnika iz ispitivanja faze 3.
English: The safety and efficacy of tedizolid phosphate in children and adolescents below 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost tedizolidfosfata u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: • methotrexate (used to treat cancer, rheumatoid arthritis or psoriasis)
Croatian: • metotreksat (koristi se za liječenje raka, reumatoidnog artritisa ili psorijaze)
English: Do not use this medicine if you notice any particles or the solution is cloudy.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite čestice ili je otopina zamućena.
English: Patients with neutropenia
Croatian: Bolesnici s neutropenijom
English: In the event of overdose, Sivextro should be discontinued and general supportive treatment given.
Croatian: U slučaju predoziranja treba prekinuti terapiju lijekom Sivextro i pružiti opće potporno liječenje.
English: Tedizolid phosphate film-coated tablets or powder for concentrate for solution for infusion may be used as initial therapy.
Croatian: Tedizolidfosfat filmom obložene tablete ili prašak za koncentrat za otopinu za infuziju mogu se koristiti za početnu terapiju.
English: The elimination half-life of tedizolid is approximately 12 hours and the intravenous clearance is 6-7 L/h.
Croatian: Poluvijek eliminacije tedizolida je približno 12 sati, a intravenski klirens je 6-7 l/h.
English: Organisms
Croatian: Organizmi
English: The AUC/MIC ratio to achieve bacteriostasis in neutropenic mice was at least 16 times that in immunocompetent animals (see section 4.4).
Croatian: Omjer AUC/MIK za postizanje bakteriostaze u miševa s neutropenijom bio je najmanje 16 puta veći od onog u imunokompetentnih životinja (vidjeti dio 4.4).
English: Antibacterial activity against other relevant pathogens
Croatian: Antibakterijska aktivnost protiv drugih relevantnih patogena
English: Avoid shaking or rapid movement as it may cause foaming.
Croatian: Izbjegavajte protresanje i brze pokrete jer mogu izazvati pjenjenje.
English: • Anxiety, irritability, shaking or trembling
Croatian: • tjeskoba, razdražljivost, tresenje ili drhtanje
English: Available in packs of 1 vial and 6 vials.
Croatian: Dostupno u pakiranjima od 1 bočice i 6 bočica.
English: This study used sensitive morphologic evaluation of perfusion-fixed peripheral and central nervous system tissue.
Croatian: To je ispitivanje koristilo osjetljivu morfološku procjenu tkiva perifernog i središnjeg živčanog sustava fiksiranog perfuzijom.
English: The combined storage time (from reconstitution to dilution to administration) must not exceed 24 hours when stored at either room temperature or in a refrigerator (2°C - 8°C).
Croatian: Ukupno vrijeme čuvanja (od rekonstitucije do razrjeđivanja i primjene) ne smije biti dulje od 24 sata ako se čuva pri sobnoj temperaturi ili u hladnjaku (2°C - 8°C).
English: • Abnormal sense of taste
Croatian: • poremećen osjet okusa
English: Any unused medicine or waste material, including materials used for reconstitution, dilution and administration, should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal, uključujući materijal korišten za rekonstituciju, razrjeđivanje i primjenu, potrebno je zbrinuti sukladno nacionalnim propisima.
English: Controlled clinical studies did not include patients with neutropenia (neutrophil counts <1,000 cells/mm
Croatian: Kontrolirana klinička ispitivanja nisu uključivala bolesnike s neutropenijom (broj neutrofila <1000 stanica/mm
English: • bleeding or bruising easily
Croatian: • krvarenje ili lako stvaranje modrica
English: Sivextro can interfere with the effects of these medicines.
Croatian: Sivextro može utjecati na djelovanje tih lijekova.
English: Sivextro must be administered by intravenous infusion over a 60-minute period.
Croatian: Sivextro se mora primjenjivati intravenskom infuzijom tijekom 60 minuta.
English: All patients should be advised to report symptoms of visual impairment, such as changes in visual acuity, changes in colour vision, blurred vision, or visual field defect.
Croatian: Sve bolesnike treba uputiti na prijavu simptoma pogoršanja vida, primjerice promjene oštrine vida, promjene u opažanju boja, zamagljen vid ili ispad vidnog polja.
English: Only limited data are available on the compatibility of Sivextro with other intravenous substances, therefore additives or other medicinal products should not be added to Sivextro single use vials or infused simultaneously.
Croatian: Dostupni su samo ograničeni podaci o kompatibilnosti lijeka Sivextro s drugim intravenskim tvarima, stoga se aditivi ili drugi lijekovi ne smiju dodavati jednokratnim bočicama lijeka Sivextro niti istovremeno primjenjivati infuzijom.
English: Your doctor will decide if you should be given Sivextro to treat your infection.
Croatian: Vaš liječnik će odlučiti smijete li dobivati Sivextro za liječenje infekcije.
English: Adverse reactions such as lactic acidosis, anaemia and neuropathy (optic and peripheral) may occur as a result of this inhibition.
Croatian: Nuspojave kao što su laktacidoza, anemija i neuropatija (optička i periferna) mogu se pojaviti kao posljedica te inhibicije.
English: Driving and using machines Do not drive or use machines if you feel dizzy or tired after taking this medicine.
Croatian: Nemojte upravljati vozilima niti raditi sa strojevima ako imate omaglicu i osjećate umor nakon uzimanja ovog lijeka.
English: Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials, ATC code: J01XX11
Croatian: Farmakoterapijska skupina: Pripravci za liječenje bakterijskih infekcija za sustavnu primjenu, ostali antimikrobici, ATK oznaka: J01XX11
English: C-labeled tedizolid phosphate under fasted conditions, the majority of elimination occurred via the liver with 81.5% of the radioactive dose recovered in faeces and 18% in urine, with most of the elimination (>85%) occurring within 96 hours.
Croatian: C) tedizolidfosfata natašte, veći dio se eliminirao putem jetre, s 81,5% radioaktivne doze pronađene u stolici i 18% u urinu, a veći dio eliminacije (>85%) odvio se unutar 96 sati.
English: Studies in mice and rats showed developmental effects (see section 5.3).
Croatian: Ispitivanja na miševima i štakorima pokazala su učinke na razvoj (vidjeti dio 5.3).
English: The resulting solution is a clear colourless or light-yellow solution and should be administered over approximately 1 hour.
Croatian: Dobivena otopina je prozirna, bezbojna ili svijetlo žuta otopina i treba se primjenjivati tijekom približno 1 sata.
English: If CDAD is suspected or confirmed, tedizolid phosphate and, if possible, other antibacterial agents not directed against C. difficile should be discontinued and adequate therapeutic measures should be initiated immediately.
Croatian: Ako se sumnja na CDAD ili se CDAD potvrdi, potrebno je odmah prekinuti primjenu tedizolidfosfata i, ako je moguće, drugih antibakterijskih lijekova koji nisu usmjereni protiv C. difficile te odmah poduzeti odgovarajuće terapijske mjere.
English: • Blurred vision, ‘floaters' (small shapes seen floating in the field of vision)
Croatian: • zamagljen vid, „leteće mušice“ u vidnom polju (mali oblici koji plutaju u vidnom polju)
English: It belongs to a group of medicines called “oxazolidinones.”
Croatian: Pripada skupini lijekova koji se nazivaju „oksazolidinoni“.
English: In cases where tedizolid phosphate was discontinued, the affected haematological parameters have returned back to pre-treatment levels.
Croatian: U slučajevima kada je primjena tedizolidfosfata prekinuta, zahvaćeni hematološki parametri vratili su se na razine prije liječenja.
English: Other medicines and Sivextro
Croatian: Drugi lijekovi i Sivextro
English: If not, the reconstituted and diluted solution should be stored at room temperature or in a refrigerator at 2°C to 8°C, and administered within 24 hours after reconstitution.
Croatian: U suprotnome, rekonstituiranu i razrijeđenu otopinu treba čuvati na sobnoj temperaturi ili u hladnjaku na temperaturi od 2°C do 8°C, te primijeniti unutar 24 sata nakon rekonstitucije.
English: The impact of gender on the pharmacokinetics of tedizolid phosphate was evaluated in healthy males and females in clinical studies and in a population pharmacokinetics analysis.
Croatian: Utjecaj spola na farmakokinetiku tedizolidfosfata procijenjen je u zdravih muškaraca i žena u kliničkim ispitivanjima i u populacijskoj farmakokinetičkoj analizi.
English: Do not use Lactated Ringer's Injection or Hartmann's Solution.
Croatian: Nemojte koristiti otopinu za injekciju Ringerovog laktata niti Hartmannovu otopinu.
English: No meaningful changes in blood pressure or heart rate with pseudoephedrine were observed in the healthy volunteers, and no clinically relevant increase in tyramine sensitivity was observed.
Croatian: Nisu opažene značajne promjene u krvnom tlaku ili srčanoj frekvenciji sa pseudoefedrinom u zdravih dobrovoljaca niti je bilo opaženo klinički značajno povećanje osjetljivosti na tiramin.
English: Intravenous use after reconstitution and dilution For single use only
Croatian: Za intravensku primjenu nakon rekonstitucije i razrjeđivanja Samo za jednokratnu primjenu
English: • any problems with your eyesight such as blurred vision, changes in colour vision, difficulty in seeing detail or if your field of vision becomes restricted.
Croatian: • bilo kakvi problemi s vidom, primjerice zamućen vid, promjene u opažanju boja, poteškoće u viđenju detalja, ili ako Vaše vidno polje postane suženo.
English: • a low white blood cell count
Croatian: • niski broj bijelih krvnih stanica
English: Grip strength decreased Transaminases increased White blood cell count decreased
Croatian: Pretrage smanjena snaga stiska povišene vrijednosti transaminaza smanjen broj bijelih krvnih stanica
English: Haemodialysis does not result in meaningful removal of tedizolid from systemic circulation.
Croatian: Hemodijaliza ne rezultira značajnim uklanjanjem tedizolida iz sistemske cirkulacije.
English: Sivextro is administered intravenously over approximately 1 hour.
Croatian: Sivextro se primjenjuje intravenski tijekom približno 1 sata.
English: When incubated with pooled human liver microsomes, tedizolid was stable suggesting that tedizolid is not a substrate for hepatic CYP450 enzymes.
Croatian: Kada je inkubiran sa sakupljenim mikrosomima ljudske jetre, tedizolid je bio stabilan, što ukazuje na to da tedizolid nije supstrat za jetrene enzime CYP450.
English: In such cases, prompt evaluation is recommended with referral to an ophthalmologist as necessary.
Croatian: U takvim se slučajevima preporučuje hitan pregled, uz upućivanje oftalmologu prema potrebi.
English: Serotonergic effects at doses of tedizolid phosphate up to 30-fold above the human equivalent dose did not differ from vehicle control in a mouse model that predicts brain serotonergic activity.
Croatian: Serotonergički učinci pri dozama tedizolidfosfata do 30 puta većima od ekvivalentne doze u ljudi nisu se razlikovali od kontrolnog vehikula u mišjem modelu koji predviđa serotonergičku aktivnost mozga.
English: Less than 3% of tedizolid phosphate administered dose is excreted as active tedizolid.
Croatian: Manje od 3% primijenjene doze tedizolidfosfata izlučuje se kao aktivni tedizolid.
English: Prescribing tedizolid phosphate in the absence of a proven or strongly suspected bacterial infection increases the risk of the development of drug-resistant bacteria.
Croatian: Propisivanje tedizolidfosfata kada nema dokaza ili snažne sumnje na bakterijsku infekciju povećava rizik od razvoja bakterija rezistentnih na lijek.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Sivextro in one or more subsets of the paediatric population in the treatment of acute bacterial skin and skin structure infections (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Sivextro u jednoj ili više podskupina pedijatrijske populacije u liječenju akutnih bakterijskih infekcija kože i kožnih struktura (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Justification for not including Braille accepted.
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: Appropriate supportive measures, antibiotic treatment of C. difficile, and surgical evaluation should be considered.
Croatian: Potrebno je razmotriti prikladne potporne mjere, antibiotsko liječenje C. difficile te kiruršku procjenu.
English: Film-coated tablet 6 x 1 film-coated tablets
Croatian: Filmom obložena tableta 6 x 1 filmom obložena tableta
English: Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.
Croatian: Liječenje antibakterijskim lijekovima mijenja normalnu floru debelog crijeva, što može dovesti do prekomjernog rasta bakterije C. difficile.
English: • amitriptyline, citalopram, clomipramine, dosulepin, doxepin, fluoxetine, fluvoxamine,
Croatian: • amitriptilin, citalopram, klomipramin, dosulepin, doksepin, fluoksetin, fluvoksamin, imipramin,
English: Tedizolid is primarily active against Gram-positive bacteria.
Croatian: Tedizolid je primarno aktivan protiv gram-pozitivnih bakterija.
English: If the same intravenous line is used for sequential infusion of several different medicinal products, the line should be flushed before and after infusion with 0.9% sodium chloride.
Croatian: Ako se koristi ista intravenska linija za sekvencijalnu infuziju nekoliko različitih lijekova, liniju je potrebno isprati prije i poslije infuzije s 0,9%-tnom otopinom natrijevog klorida.
English: Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to tedizolid in the absence of acquired mechanisms of resistance:
Croatian: Nije utvrđena klinička djelotvornost protiv sljedećih patogena iako ispitivanja in vitro upućuju da bi bili osjetljivi na tedizolid u odsutnosti stečenih mehanizama rezistencije:
English: Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
Croatian: Nužno je uzeti podrobnu anamnezu budući da ima izvješća o pojavi CDAD-a čak dva i više mjeseca nakon primjene antibakterijskih lijekova.
English: Animal studies with tedizolid phosphate do not indicate harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja provedena na životinjama s tedizolidfosfatom ne ukazuju na štetan učinak na plodnost (vidjeti dio 5.3).
English: The most commonly observed mutations in staphylococci and enterococci that result in oxazolidinone resistance are in one or more copies of the 23S rRNA genes (G2576U and T2500A).
Croatian: Najčešće opažene mutacije u stafilokoka i enterokoka koje rezultiraju rezistencijom na oksazolidinon su u jednoj ili više kopija gena za 23S rRNA (G2576U i T2500A).
English: You will be given one 200 mg infusion of Sivextro once a day for 6 days.
Croatian: Dobivat ćete jednu infuziju od 200 mg lijeka Sivextro jedanput na dan tijekom 6 dana.
English: The mechanism of action is different from that of non-oxazolidinone class antibacterial medicinal products; therefore, cross-resistance between tedizolid and other classes of antibacterial medicinal products is unlikely.
Croatian: Mehanizam djelovanja se razlikuje od mehanizma djelovanja antibakterijskih lijekova iz skupina različitih od oksazolidinona; stoga je malo vjerojatna križna rezistencija između tedizolida i drugih skupina antibakterijskih lijekova.
English: Antibacterial activity in combination with other antibacterial and antifungal agents
Croatian: Antibakterjiska aktivnost u kombinaciji s drugim antibakterijskim lijekovima i antimikoticima
English: The safety profile in this study was similar to the Phase 3 clinical trials; however, infusion site reactions (phlebitis) were reported more frequently (2.7%) in tedizolid phosphate treated subjects than in the linezolid control group (0%), particularly among Asian patients.
Croatian: Sigurnosni profil u ovom ispitivanju bio je sličan onome iz kliničkih ispitivanja faze 3, međutim, reakcije na mjestu infuzije (flebitis) bile su prijavljene s većom učestalošću (2,7%) u bolesnika liječenih tedizolidfosfatom u odnosu na kontrolnu skupinu bolesnika liječenih linezolidom (0%), posebice među bolesnicima azijskog podrijetla.
English: Tedizolid is a reversible, non-selective inhibitor of monoamine oxidase (MAO) in vitro (see section 4.5).
Croatian: Tedizolid je reverzibilan, neselektivan inhibitor monoaminoksidaze (MAO) in vitro (vidjeti dio 4.5).
English: Long-term carcinogenicity studies have not been conducted with tedizolid phosphate.
Croatian: Nisu provedena dugoročna ispitivanja kancerogenosti s tedizolidfosfatom.
English: Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Croatian: Sivextro je indiciran za liječenje akutnih bakterijskih infekcija kože i kožnih struktura u odraslih (vidjeti dijelove 4.4. i 5.1).
English: 6 vials
Croatian: 6 bočica