natgillin/translations-raw huggingface dataset:
Table 3 Example calculations for weights ranging from 40 kg to 200 kg
Preglednica 3 Primeri izračunov za telesne mase od 40 do 200 kg Telesna masa bolnika
Clostridium difficile-associated diarrhoea
Clostridium difficile.
The recommended dose regimen is 1 mg/kg eravacycline every 12 hours for 4 to 14 days.
Priporočeni režim odmerjanja je 1 mg/kg eravaciklina vsakih 12 ur od 4 do 14 dni.
Xerava is therefore not indicated for the treatment of complicated urinary tract infections.
Zato zdravilo Xerava ni indicirano za zdravljenje kompliciranih okužb sečil.
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%.
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 %.
Seek urgent medical attention if you suspect you have an anaphylactic reaction whilst receiving Xerava.
Poiščite nujno zdravniško pomoč, če sumite, da se je med prejemanjem zdravila Xerava pri vas pojavila anafilaktična reakcija.
Do not drive or use machines if you feel dizzy, light-headed or unsteady after receiving this medicine.
Če se vam po prejemu tega zdravila vrti ali se počutite omotični ali nestabilni, ne upravljajte vozil in strojev.
It is not known if Xerava passes into breast milk.
Ni še znano, ali se zdravilo Xerava izloča v materino mleko.
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.
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).
Eravacycline may have a minor influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Eravaciklin ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
The recommended dose regimen of Xerava is 1 mg/kg every 12 hours for 4 to 14 days.
Priporočeni režim odmerjanja zdravila Xerava je 1 mg/kg vsakih 12 ur od 4 do 14 dni.
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.
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.
Infusion site reactions
Reakcije na mestu infuzije
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.
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.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: MULTIPACK, CONTAINS BLUE BOX
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA: SKUPNO PAKIRANJE, Z MODRIM OKENCEM
Additional minor metabolites are formed by glucuronidation, oxidation and hydrolysis.
Z glukuronidacijo, oksidacijo in hidrolizo se tvorijo dodatni manjši presnovki.
Table 1 Example calculations for weights ranging from 40 kg to 200 kg
Preglednica 1 Primeri izračunov za telesne mase od 40 do 200 kg Telesna masa bolnika
Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics.
Pri drugih tetraciklinskih antibiotikih so poročali o anafilaktičnih (alergijskih) reakcijah.
Skin and subcutaneous tissue disorders
Bolezni kože in podkožja izpuščaj hiperhidroza
Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 12 hours at 25°C.
Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 12 ur pri 25 °C po redčenju v infuzijski vreči.
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.
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.
Tell your doctor or nurse if you have any of these side effects.
Obvestite zdravnika ali medicinsko sestro, če opazite katerega od teh neželenih učinkov.
How you will be given Xerava
Kako vam bodo dajali zdravilo Xerava
Serious and occasionally fatal hypersensitivity reactions are possible and have been reported with other tetracycline class antibiotics (see section 4.3).
Pri drugih tetraciklinskih antibiotikih so možne resne in občasno smrtne preobčutljivostne reakcije; o njih so tudi poročali (glejte poglavje 4.3).
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.
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 %.
- The active substance is eravacycline.
- Učinkovina je eravaciklin.
What you need to know before you are given Xerava You must not receive Xerava:
Kaj morate vedeti, preden boste prejeli zdravilo Xerava
Talk to your doctor or nurse before you receive Xerava if you are concerned about any of the following:
Preden prejmete zdravilo Xerava, se posvetujte z zdravnikom ali medicinsko sestro, če vas skrbi kar koli od naslednjega:
Eravacycline is not a substrate for the MepA pump in Staphylococcus aureus that has been described as a resistance mechanism for tigecycline.
Staphylococcus aureus, ki je bila opisana kot mehanizem odpornosti za tigeciklin.
Bone discolouration (in the absence of histological findings), which was not fully reversible over recovery periods of up to 7-weeks, was observed in rats and monkeys after 13 weeks of dosing.
Pri podganah in opicah so po 13 tednih odmerjanja odkrili obarvanje kosti (brez histoloških sprememb); to v obdobju okrevanja do sedem tednov ni bilo popolnoma reverzibilno.
Efficacy has been demonstrated in clinical studies against the pathogens listed for cIAI that were susceptible to eravacycline in vitro:
V kliničnih študijah so dokazali učinkovitost proti patogenom, navedenim za komplicirane intraabdominalne okužbe, ki so bili občutljivi za eravaciklin in vitro:
Dizziness may occur following administration of eravacycline (see section 4.8).
Po dajanju eravaciklina se lahko pojavi omotica (glejte poglavje 4.8).
Unchanged eravacycline is the major medicinal product-related component in human plasma and human urine.
Glavni sestavni del v človeški plazmi in urinu, povezan z zdravilom, je nespremenjeni eravaciklin.
Elderly (≥ 65 years old) No dose adjustment is required in elderly patients (see section 5.2).
Pri starejših bolnikih prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
Eravacycline, TP-498 and TP-6208 are not inhibitors of BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 or MATE2-K transporters.
Eravaciklin, TP-498 in TP-6208 niso zaviralci prenašalcev BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 ali MATE2-K. Presnovka TP-498 in TP-6208 in vitro nista zaviralca P-gp.
Package leaflet: Information for the patient Xerava 50 mg powder for concentrate for solution for infusion eravacycline This medicine is subject to additional monitoring.
Navodilo za uporabo Xerava 50 mg prašek za koncentrat za raztopino za infundiranje eravaciklin Za to zdravilo se izvaja dodatno spremljanje varnosti.
No adverse effects on mating or fertility were observed in female rats.
Pri samicah podgan niso opazili neželenih učinkov na parjenje ali plodnost.
In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in the pharmacokinetics of eravacycline were observed with respect to age.
Starejši (≥ 65 let) V populacijski farmakokinetični analizi eravaciklina niso opazili klinično pomembnih razlik v farmakokinetiki eravaciklina glede na starost.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: 1 VIAL
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA: 1 VIALA
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INNER CARTON: MULTIPACK, CONTAINS NO BLUE BOX
NOTRANJA ŠKATLA: SKUPNO PAKIRANJE, BREZ MODREGA OKENCA
For single use only, any unused solution should be discarded.
Neuporabljeno raztopino je treba zavreči.
In the case of suspected overdose Xerava should be discontinued and the patient monitored for adverse reactions.
Če obstaja sum na prevelik odmerek, je treba dajanje zdravila Xerava prekiniti, pri bolniku pa spremljati neželene učinke.
Each vial contains 50 mg eravacycline.
Ena viala vsebuje 50 mg eravaciklina.
• Feeling lightheaded or faint
• omotičnost ali omedlevica;
100 mL
odmerka 60 mg
Mild to moderate infusion site reactions, including pain or discomfort, erythema and swelling or inflammation at the injection site as well as superficial thrombophlebitis and/or phlebitis have been reported in patients treated with eravacycline.
Pri bolnikih, ki so bili zdravljeni z eravaciklinom, so poročali o blagih do zmernih reakcijah na mestu infuzije, vključno z bolečino ali neugodjem, eritemom in otekanjem ali vnetjem na mestu vboda ter površinskim tromboflebitisom in/ali flebitisom.
The ready to use solution should be inspected visually for particulate matter prior to administration.
Pred dajanjem raztopine, pripravljene za uporabo, jo je treba vizualno pregledati, da ne vsebuje trdnih delcev.
However, patients receiving strong CYP3A inhibitors (for example ritonavir, itraconazole, clarithromycin) with a combination of factors that may increase the exposure, such as severe hepatic impairment and/or obesity should be monitored for adverse reactions (see sections 4.4 and 4.8).
Ni verjetno, da bi bila povečana izpostavljenost klinično pomembna, zato pri sočasnem dajanju eravaciklina skupaj z zaviralci CYP3A odmerka ni treba prilagoditi, vendar pa je treba pri bolnikih, ki prejemajo močne zaviralce CYP3A (na primer ritonavir, itrakonazol, klaritromicin) in pri katerih je prisotna kombinacija dejavnikov, ki lahko povečajo izpostavljenost, kot so huda okvara jeter in/ali debelost, spremljati neželene učinke (glejte poglavji 4.4 in 4.8).
Infusion-site erythema, pain/tenderness, phlebitis and thrombophlebitis were observed with intravenous eravacycline in clinical trials (see section 4.8).
V kliničnih preskušanjih so pri intravenskem dajanju eravaciklina na mestu infuzije opazili eritem, bolečino/občutljivost, flebitis in tromboflebitis (glejte poglavje 4.8).
After reconstitution each mL contains 10 mg eravacycline.
Po rekonstituciji 1 ml vsebuje 10 mg eravaciklina.
Xerava 50 mg powder for concentrate eravacycline
Xerava 50 mg prašek za koncentrat eravaciklin i.v.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with the use of nearly all antibiotics and may range in severity from mild to life-threatening.
Pri uporabi skoraj vseh antibiotikov so poročali o kolitisu, povezanem z antibiotiki, in psevdomembranskem kolitisu; ti dogodki so obsegali vse od blagih do smrtno nevarnih.
There is no target-based cross-resistance between eravacycline and other classes of antibiotics such as quinolones, penicillins, cephalosporins, and carbapenems.
Med eravaciklinom in drugimi skupinami antibiotikov, kot so kinoloni, penicilini, cefalosporini in karbapenemi, ni navzkrižne odpornosti na podlagi prijemališča.
Other side effects have been reported with other tetracycline antibiotics including minocycline and doxycycline.
Pri drugih tetraciklinskih antibiotikih, vključno z minociklinom in doksiciklinom, so poročali o drugih neželenih učinkih.
It belongs to a group of antibiotics called ‘tetracyclines' which work by stopping the growth of certain infectious bacteria.
Ti delujejo tako, da ustavijo rast določenih bakterij, ki povzročijo okužbo.
Intravenous administration of high doses of eravacycline has been associated with cutaneous responses (including hives, scratching, swelling, and/or skin erythema) in rat and dog studies.
V študijah pri podganah in psih so intravensko dajanje visokih odmerkov eravaciklina povezali s kožnimi odzivi (vključno s koprivnico, praskanjem, otekanjem in/ali kožnim eritemom).
Xerava must be reconstituted with water for injections and subsequently diluted using sodium chloride 9 mg/mL (0.9%) solution for injection.
Zdravilo Xerava je treba rekonstituirati z vodo za injekcije in nato razredčiti z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
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 sodium chloride 9 mg/ml (0.9%) solution for injection.
Če se za zaporedno infuzijo več različnih zdravil uporablja ista intravenska linija, jo je treba pred infuzijo in po njej splakniti z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
Tell your doctor or nurse if you notice any of these side effects during your treatment with Xerava.
Obvestite zdravnika ali medicinsko sestro, če med zdravljenjem z zdravilom Xerava opazite katerega koli od teh neželenih učinkov.
Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 250 mL infusion bag.
Izračunajte zahtevano količino rekonstituirane raztopine na podlagi telesne mase bolnika in jo injicirajte v 250mililitrsko infuzijsko vrečo.
The geometric mean Cmax for eravacycline was increased by 13.9%, 16.3%, and 19.7% for subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), and severe (Child-Pugh Class C) hepatic impairment versus healthy subjects, respectively.
Geometrijska srednja vrednost Cmax za eravaciklin se je pri osebah z blago (razreda A po ChildPughu), zmerno (razreda B po Child-Pughu) in hudo (razreda C po Child-Pughu) okvaro jeter v primerjavi z zdravimi osebami povečala za 13,9, 16,3 oziroma 19,7 %.
Eravacycline dosing
Odmerjanje eravaciklina
If the same intravenous line is used for sequential infusion of different medicinal products, the line should be flushed before and after infusion with sodium chloride 9 mg/ml (0.9%) solution for injection.
Če se za zaporedno infuzijo različnih zdravil uporablja ista intravenska linija, jo je treba pred infuzijo in po njej splakniti z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
Potential for drug-drug interactions
Možnost medsebojnega delovanja zdravil
The reconstituted solution will be withdrawn from the vial and added to an infusion bag of sodium chloride 9 mg/mL (0.9%) solution for injection in the hospital.
Rekonstituirana raztopina se v bolnišnici odvzame iz viale in doda v infuzijsko vrečo z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
Powder for concentrate for solution for infusion 1 vial.
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje 1 viala.
Susceptibility testing breakpoints
Mejne koncentracije testiranja občutljivosti
Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 500 mL infusion bag.
Izračunajte zahtevano količino rekonstituirane raztopine na podlagi telesne mase bolnika in jo injicirajte v 500mililitrsko infuzijsko vrečo.
Aspartate aminotransferase (AST) increased Alanine aminotransferase (ALT) increased Hyperbilirubinaemia
zvišana raven alanin-aminotransferaze
Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 100 mL infusion bag.
Izračunajte zahtevano količino rekonstituirane raztopine na podlagi telesne mase bolnika in jo injicirajte v 100mililitrsko infuzijsko vrečo.
Resistance to eravacycline has been observed in Enterococcus harbouring mutations in rpsJ.
Pri bakteriji Enterococcus, ki vsebuje mutacije gena rpsJ, so opazili odpornost proti eravaciklinu.
Eravacycline did affect mating and fertility in male rats at clinically relevant exposures (see section 5.3).
Podatkov o učinku eravaciklina na plodnost pri človeku ni. Eravaciklin je pri podganjih samcih pri klinično pomembnih izpostavljenostih vplival na parjenje in plodnost (glejte poglavje 5.3).
Renal clearance and biliary and direct intestinal excretion account for approximately 35% and 48% of total body clearance after administration of a single IV dose of 60 mg 14C-eravacycline, respectively.
C-eravaciklina znašajo približno 35 oziroma 48 % celotnega telesnega očistka.
Women of childbearing potential should avoid becoming pregnant while receiving eravacycline.
Med prejemanjem eravaciklina morajo ženske v rodni dobi preprečevati zanositev.
For administration, the reconstituted solution must be further diluted using sodium chloride 9 mg/ml (0.9%) solution for injection.
Za dajanje je treba rekonstituirano raztopino dodatno razredčiti z raztopino natrijevega klorida 9 mg/ml (0,9 %) za injiciranje.
In a population pharmacokinetic analysis it was shown that eravacycline disposition (clearance and volume) was dependent on body weight.
V populacijski farmakokinetični analizi so dokazali, da je dispozicija eravaciklina (očistek in količina) odvisna od telesne mase, vendar posledična razlika v izpostavljenosti eravaciklinu v smislu vrednosti AUC v proučevanem razponu telesne mase ni podlaga za prilagoditve odmerka.
• Tightness of the chest
• stiskanje v prsih;
Name and address of the manufacturer(s) responsible for batch release Patheon Italia S.p.A.
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij
Shaking or rapid movement should be avoided as it may cause foaming.
Viale ne tresite in je ne premikajte hitro, saj lahko sicer nastane pena.
Dizziness Headache
Okvara ledvic
How to store Xerava
Shranjevanje zdravila Xerava
The infusion solution should be inspected visually for particulate matter prior to administration.
Pred dajanjem raztopine za infundiranje jo je treba vizualno pregledati, da ne vsebuje trdnih delcev.
The solution should not be used if it appears to contain any particles or the solution is cloudy.
Če se zdi, da so v raztopini kakršni koli delci, ali če je raztopina motna, se ne sme uporabiti.
and in children under 8 years of age) as it may cause permanent discolouration of the teeth (yellowgrey-brown) (see sections 4.2 and 4.6).
Zdravila Xerava se ne sme uporabljati v obdobju razvoja zob (med drugim in tretjim trimesečjem nosečnosti ter pri otrocih, mlajših od osem let), saj lahko povzroči trajno obarvanje zob (rumeno-sivorjavo) (glejte poglavji 4.2 in 4.6).
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
6.1 Seznam pomožnih snovi manitol (E421) natrijev hidroksid (za prilagoditev pH) klorovodikova kislina (za prilagoditev pH)
Powder for concentrate for solution for infusion (powder for concentrate).
FARMACEVTSKA OBLIKA prašek za koncentrat za raztopino za infundiranje (prašek za koncentrat) Svetlo do temno rumen skupek.
• Nausea
• navzea
Your doctor may increase your dose (1.5 mg/kg every 12 hours) if you are taking other medicines including rifampicin, phenobarbital, carbamazepine, phenytoin, or St. John's Wort.
Če jemljete druga zdravila, vključno z rifampicinom, fenobarbitalom, karbamazepinom, fenitoinom ali šentjanževko, vam zdravnik lahko odmerek poveča (na 1,5 mg/kg vsakih 12 ur).
EU/1/18/1312/001 EU/1/18/1312/002
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z EU/1/18/1312/001
Xerava 50 mg powder for concentrate for solution for infusion
IME ZDRAVILA Xerava 50 mg prašek za koncentrat za raztopino za infundiranje
Xerava 50 mg powder for concentrate for solution for infusion eravacycline
IME ZDRAVILA Xerava 50 mg prašek za koncentrat za raztopino za infundiranje eravaciklin
• Diarrhoea
• glavobol;
There is approximately a 45% accumulation following intravenous dosing of 1 mg/kg every 12 hours.
Po intravenskem odmerjanju 1 mg/kg vsakih 12 ur kopičenje znaša približno
The eravacycline dose should be increased by approximately 50% (1.5 mg/kg IV q12h) when co-administered with rifampicin or other strong CYP3A inducers such as phenobarbital, carbamazepine, phenytoin and St. John's Wort (see sections 4.2 and 4.4).
Če se eravaciklin daje sočasno z rifampicinom ali drugimi močnimi induktorji CYP3A, kot so fenobarbital, karmabazepin, fenitoin in šentjanževka, je treba njegov odmerek povečati za približno 50 % (1,5 mg/kg i.v.
• Increased sweating
• povečano potenje;
Pancreatitis Diarrhoea
Bolezni prebavil navzea bruhanje pankreatitis driska
• Dizziness
• izpuščaj;
In vitro data indicate that the following pathogen is not susceptible to eravacycline: • Pseudomonas aeruginosa
Protibakterijska dejavnost proti drugim zadevnim patogenom Podatki in vitro kažejo, da naslednji patogen ni občutljiv za eravaciklin: