FrancophonIA/ELRC3.0 huggingface dataset:
English: Powder for concentrate for solution for infusion Multipack: 12 (12x1) vials
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje Skupno pakiranje: 12 (12 × 1) vial
English: 500 mL
Slovenian: 500 ml 500 ml
English: The reconstituted and diluted solution must be administered as an intravenous infusion only.
Slovenian: Rekonstituirana in razredčena raztopina se lahko da samo v obliki intravenske infuzije.
English: 10mL Type I glass vial with chlorobutyl rubber stopper and aluminium cap.
Slovenian: 10-ml viala iz stekla tipa I s klorbutilnim gumijastim zamaškom in aluminijastim pokrovčkom.
English: Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
Slovenian: V obratnem primeru, tj. ob prekinitvi, sta za upad indukcije CYP3A4 potrebna vsaj dva tedna.
English: In patients co-administered strong CYP3A4 inducers the recommended dose regimen is 1.5 mg/kg eravacycline every 12 hours for 4 to 14 days (see sections 4.4 and 4.5).
Slovenian: Pri bolnikih, ki sočasno jemljejo močne induktorje CYP3A4, priporočeni odmerek znaša 1,5 mg/kg eravaciklina vsakih 12 ur od 4 do 14 dni (glejte poglavji 4.4 in 4.5).
English: For patients weighing ≥ 40 kg - 49 kg:
Slovenian: Za bolnike, ki tehtajo ≥ 40-49 kg:
English: For patients weighing >100 kg:
Slovenian: Za bolnike, ki tehtajo > 100 kg:
English: What Xerava is used for
Slovenian: Za kaj se zdravilo Xerava uporablja
English: A drug-drug interaction in vivo cannot be excluded and co-administration of eravacycline and other medicinal products that inhibit these transporters (examples of OATP1B1/3 inhibitors; atazanavir, cyclosporine, lopinavir, and saquinavir) may increase the eravacycline plasma concentration.
Slovenian: Medsebojnega delovanja zdravil in vivo ni mogoče izključiti, sočasno dajanje eravaciklina z drugimi zdravili, ki zavirajo te transportne beljakovine (primeri zaviralcev OATP1B1/3: atazanavir, ciklosporin, lopinavir in sakvinavir), pa lahko poveča plazemsko koncentracijo eravaciklina.
English: Following dilution, Xerava is administered intravenously over approximately 1 hour.
Slovenian: Po redčenju je treba zdravilo Xerava dajati intravensko približno eno uro.
English: After further dilution 1 mL contains 0.3 mg eravacycline.
Slovenian: Po nadaljnjem redčenju 1 ml vsebuje 0,3 mg eravaciklina.
English: Talk to your doctor if you have liver problems or if you are overweight, particularly if you are also taking itraconazole (a medicine to treat fungal infections), ritonavir (a medicine used to treat viral infections) or clarithromycin (an antibiotic) as your doctor will monitor you for side effects.
Slovenian: Če imate težave z jetri ali ste pretežki, še posebej, če hkrati jemljete itrakonazol (zdravilo za zdravljenje glivičnih okužb), ritonavir (zdravilo za zdravljenje virusnih okužb) ali klaritromicin (antibiotik), se posvetujte z zdravnikom, saj bo ta spremljal neželene učinke pri vas.
English: Eravacycline is metabolised primarily by CYP3A4- and FMO-mediated oxidation of the pyrrolidine ring to TP-6208, and by chemical epimerisation at C-4 to TP-498.
Slovenian: Eravaciklin se v glavnem presnavlja z oksidacijo pirolidinskega obroča, ki jo posredujeta CYP3A4 in FMO, v TP-6208 in s kemično epimerizacijo na C-4 v TP-498.
English: Xerava is used to treat adults with a complicated infection in the abdomen.
Slovenian: Zdravilo Xerava se uporablja za zdravljenje odraslih z zapleteno okužbo v trebuhu.
English: Pancreatitis has been reported with eravacycline and other tetracycline class antibiotics, and has been severe in some cases (see section 4.8).
Slovenian: Pri eravaciklinu in drugih tetraciklinskih antibiotikih so poročali o pankreatitisu; v nekaterih primerih je bil resen (glejte poglavje 4.8).
English: Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines including rifampicin and clarithromycin (antibiotics), phenobarbital, carbamazepine and phenytoin (used to treat epilepsy), St. John's Wort (a herbal remedy used for treatment of depression and anxiety) itraconazole (a medicine to treat fungal infections), ritonavir, atazanavir, lopinavir and saquinavir (medicines used to treat viral infections), and cyclosporine (a medicine used to suppress the immune system).
Slovenian: Obvestite zdravnika ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, vključno z rifampicinom in klaritromicinom (antibiotikoma), fenobarbitalom, karbamazepinom in fenitoinom (ki se uporabljajo za zdravljenje epilepsije), šentjanževko (zeliščnim zdravilom za zdravljenje depresije in tesnobnosti), itrakonazolom (zdravilom za zdravljenje glivičnih okužb), ritonavirjem, atazanavirjem, lopinavirjem in sakvinavirjem (zdravili za zdravljenje virusnih okužb) in ciklosporinom (zdravilom za zaviranje imunskega sistema).
English: - The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
Slovenian: - Druge sestavine so manitol (E421), klorovodikova kislina (za prilagoditev pH) in natrijev hidroksid (za prilagoditev pH).
English: It is unknown whether eravacycline and its metabolites are excreted in human breast milk.
Slovenian: Ni znano, ali se eravaciklin in njegovi presnovki izločajo v materino mleko.
English: If you develop diarrhoea during or after your treatment, tell your doctor straight away.
Slovenian: Če imate med zdravljenjem ali po njem drisko, o tem takoj obvestite zdravnika.
English: In clinical trials, the most common adverse reactions in patients with cIAI treated with eravacycline (n=576) were nausea (3.0%), vomiting, infusion site phlebitis (each 1.9%), phlebitis (1.4%), infusion site thrombosis (0.9%), diarrhoea (0.7%), vessel puncture site erythema (0.5%), hyperhidrosis, thrombophlebitis, infusion site hypoaesthesia, and headache (each 0.3%), which were generally mild or moderate in severity.
Slovenian: V kliničnih preskušanjih so bili najpogostejši neželeni učinki pri bolnikih s kompliciranimi intraabdominalnimi okužbami, zdravljenih z eravaciklinom (n = 576), navzea (3,0 %), bruhanje, flebitis na mestu infuzije (vsak po 1,9 %), flebitis (1,4 %), tromboza na mestu infuzije (0,9 %), driska (0,7 %), eritem na mestu vboda v žilo (0,5 %), hiperhidroza, tromboflebitis, hipestezija na mestu infuzije in glavobol (vsak po 0,3 %); ti neželeni učinki so bili na splošno blagi ali zmerni.
English: Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see sections 4.4, 4.5 and 5.2).
Slovenian: Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna (glejte poglavja 4.4, 4.5 in 5.2).
English: The in vitro binding of eravacycline to human plasma proteins increases with increasing concentrations, with 79%, 86% and 90% (bound) at 0.1, 1 and10 µg/mL, respectively.
Slovenian: Vezava eravaciklina in vitro na beljakovine v človeški plazmi se povečuje skupaj s povečevanjem koncentracij, pri čemer so deleži (vezanega) pri 0,1, 1 oziroma 10 µg/ml znašali 79, 86 in 90 %.
English: Each vial should be reconstituted with 5 mL water for injections, and swirled gently until the powder has dissolved entirely.
Slovenian: Vsako vialo je treba rekonstituirati s 5 ml vode za injekcije in nežno obračati, dokler se prašek popolnoma ne raztopi.
English: Xerava should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 4.6).
Slovenian: Zdravilo Xerava se zaradi obarvanja zob ne sme uporabljati pri otrocih, mlajših od osem let (glejte poglavji 4.4 in 4.6).
English: Xerava is a pale yellow to dark yellow cake in a 10mL glass vial.
Slovenian: Zdravilo Xerava je skupek svetlo do temno rumene barve v 10-mililitrski stekleni viali.
English: Exposure may be increased in patients with severe hepatic impairment (Child-Pugh Class C).
Slovenian: Pri bolnikih s hudo okvaro jeter (razreda C po Child-Pughu) je izpostavljenost lahko povečana.
English: It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.
Slovenian: S kapalno infuzijo vam ga bodo približno eno uro dajali neposredno v veno (intravensko).
English: What Xerava is and what it is used for What Xerava is
Slovenian: Kaj je zdravilo Xerava in za kaj ga uporabljamo Kaj je zdravilo Xerava
English: Antibiotic class adverse reactions include pseudomembranous colitis, and overgrowth of nonsusceptible organisms, including fungi (see section 4.4).
Slovenian: Med neželene učinke skupine antibiotikov spadajo psevdomembranski kolitis in razraščanje neobčutljivih organizmov, vključno z glivami (glejte poglavje 4.4).
English: The recommended dose for adults is based on body weight and is 1 mg/kg every 12 hours.
Slovenian: Priporočeni odmerek za odrasle temelji na telesni masi, znaša pa 1 mg/kg vsakih 12 ur.
English: In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in AUC by gender were observed for eravacycline.
Slovenian: V populacijski farmakokinetični analizi eravaciklina niso opazili klinično pomembnih razlik v vrednosti AUC glede na spol.
English: Hypersensitivity to tetracycline class antibiotics.
Slovenian: Preobčutljivost za tetraciklinske antibiotike.
English: mannitol (E421), sodium hydroxide, hydrochloric acid
Slovenian: manitol (E421), natrijev hidroksid, klorovodikova kislina
English: Clinical trials have failed to demonstrate the efficacy of Xerava for the treatment of complicated urinary tract infections.
Slovenian: V kliničnih preskušanjih niso uspeli dokazati učinkovitosti zdravila Xerava za zdravljenje kompliciranih okužb sečil.
English: In vitro, eravacycline and its metabolites are not inhibitors or inducers of CYP enzymes or transport proteins (see section 5.2).
Slovenian: Možnost vpliva eravaciklina na farmakokinetiko drugih zdravil Eravaciklin in njegovi presnovki in vitro niso zaviralci ali induktorji encimov CYP ali transportnih beljakovin (glejte poglavje 5.2).
English: What Xerava looks like and contents of the pack
Slovenian: Izgled zdravila Xerava in vsebina pakiranja
English: Tetracycline class adverse reactions include photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased BUN, azotaemia, acidosis, and hyperphosphataemia.
Slovenian: Med neželene učinke tetraciklinskih antibiotikov spadajo preobčutljivost za svetlobo, stanje pseudotumor cerebri in antianabolno delovanje, ki vodi v povečano vrednost dušika sečnine v krvi (BUN), azotemijo, acidozo in hiperfosfatemijo.
English: As for other tetracycline class antibiotics, eravacycline may induce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses exposed in utero during the 2nd and 3rd trimester, due to accumulation in tissues with a high calcium turnover and formation of calcium chelate complexes (see sections 4.4 and 5.3).
Slovenian: Tako kot drugi tetraciklinski antibiotiki lahko eravaciklin zaradi kopičenja v tkivih z visokim obratom kalcija in nastajanja kompleksov kalcijevega kelata povzroči trajne okvare zob (obarvanje in okvare sklenine) ter zakasnitev zakostenevanja pri plodih, ki so zdravilu izpostavljeni in utero v drugem in tretjem trimesečju (glejte poglavji 4.4 in 5.3).
English: Eravacycline is a substrate for the transporters P-gp, OATP1B1 and OATP1B3 but not for BCRP.
Slovenian: Eravaciklin je substrat za transportne beljakovine P-gp, OATP1B1 in OATP1B3, ne pa za BCRP.
English: Xerava may affect your ability to drive or use machines safely.
Slovenian: Zdravilo Xerava lahko vpliva na sposobnost varnega upravljanja vozil in strojev.
English: Animal studies have shown excretion of eravacycline and its metabolites in breast milk (see section 5.3).
Slovenian: V študijah na živalih so dokazali izločanje eravaciklina in njegovih presnovkov v materino mleko (glejte poglavje 5.3).
English: The contents of the required number of vials should each be reconstituted with 5 mL water for injections, and swirled gently until the powder has dissolved entirely.
Slovenian: Vsebino vsake viale je treba rekonstituirati s 5 ml vode za injekcije in nežno obračati, dokler se prašek popolnoma ne raztopi.
English: • Inflammation of a vein causing pain and swelling (phlebitis)
Slovenian: • vnetje vene, ki povzroča bolečino in otekanje (flebitis);
English: These findings were reversible following a 70-day (10-week) recovery period, equivalent to a spermatogenic cycle in the rat.
Slovenian: Po obdobju okrevanja 70 dni (deset tednov), enakovrednega ciklu spermatogeneze pri podganah, so bili ti ugotovljeni izvidi reverzibilni.
English: Co-administration of a strong CYP3A4 inducer (such as phenobarbital, rifampicin, carbamazepine, phenytoin, St. John's Wort) is expected to reduce the effect of eravacycline (see sections 4.2 and 4.5).
Slovenian: Po pričakovanjih naj bi sočasno dajanje močnega induktorja CYP3A4 (kot so fenobarbital, rifampicin, karbamazepin, fenitoin in šentjanževka) zmanjšalo učinek eravaciklina (glejte poglavji 4.2 in 4.5).
English: Eravacycline and its metabolites are not inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 in vitro.
Slovenian: Eravaciklin in njegovi presnovki in vitro niso zaviralci CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4.
English: Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 72 hours at refrigerated conditions (2-8°C) .
Slovenian: Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 72 ur pri shranjevanju v hladilniku (2-8 °C) po redčenju v infuzijski vreči.
English: • Breathing difficulties
Slovenian: • oteženo dihanje;
English: Eravacycline, TP-498 and TP-6208 are not inducers of CYP1A2, CYP2B6 or CYP3A4.
Slovenian: Eravaciklin, TP-498 in TP-6208 niso induktorji CYP1A2, CYP2B6 ali CYP3A4.
English: Findings on the male reproductive organs were also observed in rats in the repeated dose toxicity studies for 14 days or 13 weeks at exposures more than 10- or 5-fold the clinical exposure based on AUC.
Slovenian: Pri podganah so v študijah toksičnosti pri ponovljenih odmerkih, ki so trajale 14 dni ali 13 tednov in pri katerih so bile izpostavljenosti večje od deset- ali petkratnika klinične izpostavljenosti na podlagi AUC, opazovali tudi spremembe v zvezi z reproduktivnimi organi pri samcih.
English: Eravacycline may be administered without regard to the timing of haemodialysis (see section 5.2).
Slovenian: Eravaciklin je mogoče uporabiti ne glede na čas hemodialize (glejte poglavje 5.2).
English: • Redness or swelling at the site of the injection
Slovenian: • pordelost ali otekanje na mestu vboda.
English: In vitro, eravacycline was shown to be a substrate for the transporters P-gp, OATP1B1 and OATP1B3.
Slovenian: V študijah in vitro so dokazali, da je eravaciklin substrat za transportne beljakovine P-gp, OATP1B1 in OATP1B3.
English: For patients weighing 50 kg - 100 kg:
Slovenian: Za bolnike, ki tehtajo 50-100 kg:
English: In fertility studies in male rats, eravacycline administered at about 5 times the clinical exposure (based on AUC), gave rise to a significantly reduced number of pregnancies.
Slovenian: V študijah plodnosti pri podganjih samcih se je zaradi eravaciklina, danega v odmerku, ki je bil enak približno petkratni klinični izpostavljenosti (na podlagi AUC), pomembno zmanjšalo število brejosti.
English: 6.6 Special precautions for disposal and other handling
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Splošni previdnostni ukrepi
English: Aseptic technique must be followed when preparing the infusion solution.
Slovenian: Pri pripravi raztopine za infundiranje je treba upoštevati aseptični postopek.
English: No dose adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.
Slovenian: Pri bolnikih z okvaro ledvic ali pri bolnikih, ki se zdravijo s hemodializo, prilagoditev odmerka ni potrebna.
English: Chemical and physical in-use stability after reconstitution in the vial has been demonstrated for 1 hour at 25°C.
Slovenian: Kemijska in fizikalna stabilnost med uporabo je bila dokazana za eno uro pri 25 °C po rekonstituciji v viali.
English: Xerava is given by an infusion (drip) directly into your vein.
Slovenian: Zdravilo Xerava se daje z infundiranjem (kapalno infuzijo) neposredno v veno.
English: Concomitant administration of the strong CYP3A inhibitor itraconazole altered the pharmacokinetics of eravacycline, increasing Cmax by approximately 5% and AUC0-24 by approximately 23%, and decreasing clearance.
Slovenian: Zaradi sočasnega dajanja močnega zaviralca CYP3A itrakonazola se je spremenila farmakokinetika eravaciklina, vrednost Cmax se je povečala za približno 5 %, vrednost AUC0-24 se je povečala za približno 23 %, očistek pa se je zmanjšal.
English: Seek urgent medical attention if you suspect you have an anaphylactic reaction, or develop any of the following symptoms, whilst receiving Xerava:
Slovenian: Poiščite nujno zdravniško pomoč, če sumite, da se je med prejemanjem zdravila Xerava pri vas pojavila anafilaktična reakcija, ali če se je pojavil kateri koli od teh simptomov:
English: Table 3 Example calculations for weights ranging from 40 kg to 200 kg
Slovenian: Preglednica 3 Primeri izračunov za telesne mase od 40 do 200 kg Telesna masa bolnika
English: Clostridium difficile-associated diarrhoea
Slovenian: Clostridium difficile.
English: The recommended dose regimen is 1 mg/kg eravacycline every 12 hours for 4 to 14 days.
Slovenian: Priporočeni režim odmerjanja je 1 mg/kg eravaciklina vsakih 12 ur od 4 do 14 dni.
English: Xerava is therefore not indicated for the treatment of complicated urinary tract infections.
Slovenian: Zato zdravilo Xerava ni indicirano za zdravljenje kompliciranih okužb sečil.
English: Concomitant administration of the strong CYP 3A4/3A5 inducer rifampicin altered the pharmacokinetics of eravacycline, decreasing exposure by approximately 32% and increasing clearance by approximately 54%.
Slovenian: Možnost vpliva drugih zdravil na farmakokinetiko eravaciklina Zaradi sočasnega dajanja močnega induktorja CYP 3A4/3A5 rifampicina se je spremenila farmakokinetika eravaciklina, za približno 32 % se je zmanjšala izpostavljenost, očistek pa se je povečal za približno 54 %.
English: Seek urgent medical attention if you suspect you have an anaphylactic reaction whilst receiving Xerava.
Slovenian: Poiščite nujno zdravniško pomoč, če sumite, da se je med prejemanjem zdravila Xerava pri vas pojavila anafilaktična reakcija.
English: Do not drive or use machines if you feel dizzy, light-headed or unsteady after receiving this medicine.
Slovenian: Če se vam po prejemu tega zdravila vrti ali se počutite omotični ali nestabilni, ne upravljajte vozil in strojev.
English: It is not known if Xerava passes into breast milk.
Slovenian: Ni še znano, ali se zdravilo Xerava izloča v materino mleko.
English: In repeated dose toxicity studies in rats, dogs and monkeys, lymphoid depletion/atrophy of lymph nodes, spleen and thymus, decreased erythrocytes, reticulocytes, leukocytes, and platelets (dog and monkey), in association with bone marrow hypocellularity, and adverse gastrointestinal effects (dog and monkey) were observed with eravacycline.
Slovenian: V študijah toksičnosti pri ponovljenih odmerkih, ki so jih za eravaciklin izvedli pri podganah, psih in opicah, so odkrili izginjanje limfatičnega tkiva/atrofijo bezgavk, vranice in timusa, zmanjšano število eritrocitov, retikulocitov, levkocitov in trombocitov (pri psih in opicah) v povezavi s hipocelularnim kostnim mozgom in neželene učinke na prebavila (pri psih in opicah).
English: Eravacycline may have a minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Eravaciklin ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: The recommended dose regimen of Xerava is 1 mg/kg every 12 hours for 4 to 14 days.
Slovenian: Priporočeni režim odmerjanja zdravila Xerava je 1 mg/kg vsakih 12 ur od 4 do 14 dni.
English: The geometric least square mean Cmax for eravacycline was increased by 8.8% for subjects with end stage renal disease (ESRD) versus healthy subjects with 90% CI -19.4, 45.2.
Slovenian: Geometrijsko povprečje najmanjših kvadratov Cmax za eravaciklin se je pri osebah s končno ledvično odpovedjo (end stage renal disease - ESRD) v primerjavi z zdravimi osebami povečalo za 8,8 % pri intervalu zaupanja 90 % -19,4, 45,2.
English: Infusion site reactions
Slovenian: Reakcije na mestu infuzije
English: The geometric least square mean AUC0-inf for eravacycline was decreased by 4.0% for subjects with ESRD versus healthy subjects with 90% CI -14.0, 12.3.
Slovenian: Geometrijsko povprečje najmanjših kvadratov AUC0-inf za eravaciklin se je pri osebah z ESRD v primerjavi z zdravimi osebami zmanjšalo za 4,0 % pri intervalu zaupanja 90 % -14,0, 12,3.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: MULTIPACK, CONTAINS BLUE BOX
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA: SKUPNO PAKIRANJE, Z MODRIM OKENCEM
English: Additional minor metabolites are formed by glucuronidation, oxidation and hydrolysis.
Slovenian: Z glukuronidacijo, oksidacijo in hidrolizo se tvorijo dodatni manjši presnovki.
English: Table 1 Example calculations for weights ranging from 40 kg to 200 kg
Slovenian: Preglednica 1 Primeri izračunov za telesne mase od 40 do 200 kg Telesna masa bolnika
English: Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics.
Slovenian: Pri drugih tetraciklinskih antibiotikih so poročali o anafilaktičnih (alergijskih) reakcijah.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj hiperhidroza
English: Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 12 hours at 25°C.
Slovenian: Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 12 ur pri 25 °C po redčenju v infuzijski vreči.
English: In embryo-foetal studies, no adverse effects were observed in rats at exposures comparable to clinical exposure or in rabbits at exposures 1.9-fold higher than the clinical exposure (based on AUC) in rats and rabbits respectively.
Slovenian: V študijah zarodkov/plodov pri podganah pri izpostavljenostih, ki so bile primerljive s klinično izpostavljenostjo, ali pri kuncih pri izpostavljenostih, ki so bile za 1,9-krat višje od klinične izpostavljenosti (na podlagi AUC), pri podganah oziroma kuncih niso opazili neželenih učinkov.
English: Tell your doctor or nurse if you have any of these side effects.
Slovenian: Obvestite zdravnika ali medicinsko sestro, če opazite katerega od teh neželenih učinkov.
English: How you will be given Xerava
Slovenian: Kako vam bodo dajali zdravilo Xerava
English: Serious and occasionally fatal hypersensitivity reactions are possible and have been reported with other tetracycline class antibiotics (see section 4.3).
Slovenian: Pri drugih tetraciklinskih antibiotikih so možne resne in občasno smrtne preobčutljivostne reakcije; o njih so tudi poročali (glejte poglavje 4.3).
English: The geometric mean AUC0-inf for eravacycline was increased by 22.9%, 37.9%, and 110.3% for subjects with mild, moderate, and severe hepatic impairment versus healthy subjects, respectively.
Slovenian: Geometrijska srednja vrednost AUC0-inf za eravaciklin se je pri osebah z blago, zmerno in hudo okvaro jeter v primerjavi z zdravimi osebami povečala za 22,9, 37,9 oziroma 110,3 %.
English: - The active substance is eravacycline.
Slovenian: - Učinkovina je eravaciklin.
English: What you need to know before you are given Xerava You must not receive Xerava:
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Xerava
English: Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following:
Slovenian: Preden prejmete zdravilo Xerava, se posvetujte z zdravnikom ali medicinsko sestro, če vas skrbi kar koli od naslednjega:
English: Eravacycline is not a substrate for the MepA pump in Staphylococcus aureus that has been described as a resistance mechanism for tigecycline.
Slovenian: Staphylococcus aureus, ki je bila opisana kot mehanizem odpornosti za tigeciklin.