natgillin/translations-raw huggingface dataset:
Long term use of other tetracyclines during breast-feeding may result in significant absorption by the breast-fed infant and is not recommended because of the risk of dental discolouration and delay in ossification processes of the breast-fed infant.
Zaradi dolgotrajne uporabe drugih tetraciklinov med dojenjem lahko pri dojenem otroku pride do pomembne absorpcije, zato taka uporaba zaradi tveganja obarvanja zob in zakasnitve zakostenevanja pri dojenem otroku, ni priporočljiva.
The mechanism of action of eravacycline involves the disruption of bacterial protein synthesis by binding to the 30S ribosomal subunit thus preventing the incorporation of amino acid residues into elongating peptide chains.
Mehanizem delovanja eravaciklina vključuje prekinitev sinteze bakterijskih beljakovin, tako da se eravaciklin veže na ribosomalno podenoto 30S in s tem prepreči vgradnjo aminokislinskih ostankov v podaljšujoče se peptidne verige.
Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Pomembno: Pred predpisovanjem preberite povzetek glavnih značilnosti zdravila.
The European Medicines Agency has deferred the obligation to submit the results of studies with Xerava in one or more subsets of the paediatric population in cIAI (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Xerava za eno ali več podskupin pediatrične populacije pri zdravljenju kompliciranih intraabdominalnih okužb (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Tell your doctor or nurse if you notice any of the following at the site of infusion during or after your treatment: redness of the skin, rash, inflammation, or pain or tenderness.
Obvestite zdravnika ali medicinsko sestro, če na mestu infuzije med zdravljenjem ali po njem opazite kar koli od naslednjega: pordečitev kože, izpuščaj, vnetje, bolečina ali občutljivost.
The area under the plasma concentration-time curve (AUC) divided by the minimum inhibitory concentration (MIC) of eravacycline has been shown to be the best predictor of efficacy in vitro, utilising human steady state exposures in a chemostat and confirmed in vivo in animal models of infection.
Območje pod časovno krivuljo plazemske koncentracije (AUC), deljeno z minimalno inhibicijsko koncentracijo (MIC) eravaciklina, je dokazano najboljši kazalnik učinkovitosti in vitro, pri čemer so uporabljene izpostavljenosti v stanju dinamičnega ravnovesja pri človeku v kemostatu, učinkovitost pa je bila potrjena in vivo na živalskih modelih okužbe.
Eravacycline is administered via intravenous infusion, using an infusion time of approximately 1 hour to minimise the risk of infusion-site reactions.
Eravaciklin se daje v obliki intravenske infuzije, ki traja približno eno uro, da je tveganje reakcij na mestu infuzije čim manjše.
Eravacycline is excreted in both urine and faeces.
Eravaciklin se izloča v urinu in blatu.
From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately.
Z mikrobiološkega stališča je treba zdravilo porabiti takoj, razen če je način odpiranja/rekonstitucije/redčenja tak, da je tveganje mikrobne kontaminacije preprečeno.
In studies administering up to 3 mg/kg eravacycline to healthy volunteers it has been observed that doses higher than the recommended dose lead to a higher rate of nausea and vomiting.
V študijah, v katerih so zdravim prostovoljcem dajali do 3 mg/kg eravaciklina, so ugotovili, da se pri odmerkih, višjih od priporočenih, pogosteje pojavita navzea in bruhanje.
PK parameters arithmetic mean (%CV)
Farmakokinetični parametri aritmetična sredina (%KV)
It is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to treatment with eravacycline (see section 4.8).
To diagnozo je pomembno upoštevati pri bolnikih, pri katerih se med zdravljenjem z eravaciklinom ali po njem pojavi driska (glejte poglavje 4.8).
Symptoms to look out for include rash, swelling of the face, feeling lightheaded or faint, tightness of the chest, breathing difficulties, fast heartbeat, or losing consciousness (see also section 4).
Simptomi, na katere morate biti pozorni, so izpuščaj, otekanje obraza, omotica ali omedlevica, stiskanje v prsih, težave z dihanjem, hiter srčni utrip ali izguba zavesti (glejte tudi poglavje 4).
Reconstituted Xerava should be a clear, pale yellow to orange solution.
Rekonstituirano zdravilo Xerava mora biti bistra raztopina svetlo rumene do oranžne barve.
If you are given more Xerava than you should
Če ste prejeli večji odmerek zdravila Xerava, kot bi smeli
Xerava will be given to you in hospital by a doctor or nurse.
Zdravilo Xerava vam bo v bolnišnici dal zdravnik ali medicinska sestra.
Xerava is administered only by intravenous infusion over approximately 1 hour (see section 4.4).
Zdravilo Xerava se daje samo z intravensko infuzijo, ki traja približno eno uro (glejte poglavje 4.4).
Table 1 Tabulated list of adverse reactions to eravacycline in clinical trials
Preglednica 1 Preglednica z neželenimi učinki eravaciklina v kliničnih preskušanjih
Pack sizes: 1 vial and multipacks containing 12 (12 packs of 1) vials.
Velikosti pakiranja: 1 viala in skupna pakiranja, ki vsebujejo 12 vial (12 pakiranj s po 1 vialo).
TP-6208 and TP-498 are not considered to be pharmacologically active.
Velja, da TP-6208 in TP-498 nista farmakološko dejavna.
The dose should be calculated based on the patient's weight; 1 mg/kg body weight.
Odmerek je treba izračunati glede na telesno maso bolnika (1 mg/kg telesne mase).
• Inflammation and pain caused by blood clots at the injection site (thrombophlebitis)
• vnetje in bolečina, ki jo povzročajo krvni strdki na mestu vboda (tromboflebitis);
See example calculations in Table 1.
Glejte primere izračunov v preglednici 1.
• Inflammation of the pancreas which causes severe pain in the abdomen or back (pancreatitis)
• vnetje trebušne slinavke, ki povzroča hude bolečine v trebuhu ali hrbtu (pankreatitis);
Doses more than 2- or 4-fold higher than the clinical exposure (based on AUC) were associated with maternal toxicity (clinical observations and reduced body weight gain and food consumption), and reduced foetal body weights and delays in skeletal ossification in both species and abortion in the rabbit.
Odmerki, ki so bili za več kot dva- ali štirikrat večji od klinične izpostavljenosti (na podlagi AUC), so bili povezani s toksičnostjo pri materi (klinične ugotovitve ter zmanjšana telesna masa in uživanje hrane), z zmanjšanimi telesnimi masami plodov in zakasnitvami okostenitve skeleta pri obeh vrstah ter splavi pri kuncih.
Eravacycline is also not affected by aminoglycoside inactivating or modifying enzymes.
Na eravaciklin prav tako ne vplivajo encimi, ki deaktivirajo ali spreminjajo aminoglikozide.
Xerava is an antibiotic medicine that contains the active substance eravacycline.
Zdravilo Xerava je zdravilo z antibiotičnim delovanjem in vsebuje učinkovino eravaciklin.
In such circumstances, the discontinuation of eravacycline and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
V takih primerih je treba razmisliti o prekinitvi zdravljenja z eravaciklinom in uporabi podpornih ukrepov, skupaj z uporabo specifičnega zdravljenja za bakterijo
If pancreatitis is suspected, eravacycline should be discontinued.
Če obstaja sum na pankreatitis, je treba dajanje eravaciklina prekiniti.
Severe pain in the abdomen and back with fever may be signs of inflammation of the pancreas.
Huda bolečina v trebuhu in hrbtu s povišano telesno temperaturo je lahko znak vnetja trebušne slinavke.
Within the range of eravacycline multiple intravenous doses studied clinically, the pharmacokinetic parameters AUC and Cmax demonstrate linearity, but with increasing doses the increase in both AUC and Cmax are slightly less than dose-proportional.
V okviru klinično proučenih več intravenskih odmerkov eravaciklina se pri farmakokinetičnih parametrih AUC in Cmax kaže linearnost, s povečevanjem odmerkov pa je povečanje AUC in Cmax nekoliko manjše od sorazmernega z odmerkom.
If you miss a dose of Xerava
Če niste prejeli odmerka zdravila Xerava
Xerava will be given to you by a doctor or nurse.
Zdravilo Xerava vam bo dal zdravnik ali medicinska sestra.
Powder for concentrate for solution for infusion Multipack: 12 (12x1) vials
FARMACEVTSKA OBLIKA IN VSEBINA prašek za koncentrat za raztopino za infundiranje Skupno pakiranje: 12 (12 × 1) vial
The reconstituted and diluted solution must be administered as an intravenous infusion only.
Rekonstituirana in razredčena raztopina se lahko da samo v obliki intravenske infuzije.
10mL Type I glass vial with chlorobutyl rubber stopper and aluminium cap.
10-ml viala iz stekla tipa I s klorbutilnim gumijastim zamaškom in aluminijastim pokrovčkom.
Conversely, on discontinuation, CYP3A4 induction may take at least 2 weeks to decline.
V obratnem primeru, tj. ob prekinitvi, sta za upad indukcije CYP3A4 potrebna vsaj dva tedna.
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).
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).
For patients weighing ≥ 40 kg - 49 kg:
Za bolnike, ki tehtajo ≥ 40-49 kg:
For patients weighing >100 kg:
Za bolnike, ki tehtajo > 100 kg:
What Xerava is used for
Za kaj se zdravilo Xerava uporablja
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.
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.
Following dilution, Xerava is administered intravenously over approximately 1 hour.
Po redčenju je treba zdravilo Xerava dajati intravensko približno eno uro.
After further dilution 1 mL contains 0.3 mg eravacycline.
Po nadaljnjem redčenju 1 ml vsebuje 0,3 mg eravaciklina.
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.
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.
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.
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.
Xerava is used to treat adults with a complicated infection in the abdomen.
Zdravilo Xerava se uporablja za zdravljenje odraslih z zapleteno okužbo v trebuhu.
Pancreatitis has been reported with eravacycline and other tetracycline class antibiotics, and has been severe in some cases (see section 4.8).
Pri eravaciklinu in drugih tetraciklinskih antibiotikih so poročali o pankreatitisu; v nekaterih primerih je bil resen (glejte poglavje 4.8).
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).
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).
- The other ingredients are mannitol (E421), hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).
- Druge sestavine so manitol (E421), klorovodikova kislina (za prilagoditev pH) in natrijev hidroksid (za prilagoditev pH).
It is unknown whether eravacycline and its metabolites are excreted in human breast milk.
Ni znano, ali se eravaciklin in njegovi presnovki izločajo v materino mleko.
If you develop diarrhoea during or after your treatment, tell your doctor straight away.
Če imate med zdravljenjem ali po njem drisko, o tem takoj obvestite zdravnika.
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.
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.
Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see sections 4.4, 4.5 and 5.2).
Pri bolnikih z okvaro jeter prilagoditev odmerka ni potrebna (glejte poglavja 4.4, 4.5 in 5.2).
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.
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 %.
Each vial should be reconstituted with 5 mL water for injections, and swirled gently until the powder has dissolved entirely.
Vsako vialo je treba rekonstituirati s 5 ml vode za injekcije in nežno obračati, dokler se prašek popolnoma ne raztopi.
Xerava should not be used in children aged under 8 years because of teeth discolouration (see sections 4.4 and 4.6).
Zdravilo Xerava se zaradi obarvanja zob ne sme uporabljati pri otrocih, mlajših od osem let (glejte poglavji 4.4 in 4.6).
Xerava is a pale yellow to dark yellow cake in a 10mL glass vial.
Zdravilo Xerava je skupek svetlo do temno rumene barve v 10-mililitrski stekleni viali.
Exposure may be increased in patients with severe hepatic impairment (Child-Pugh Class C).
Pri bolnikih s hudo okvaro jeter (razreda C po Child-Pughu) je izpostavljenost lahko povečana.
It will be given to you through a drip directly into a vein (intravenously) over approximately 1 hour.
S kapalno infuzijo vam ga bodo približno eno uro dajali neposredno v veno (intravensko).
What Xerava is and what it is used for What Xerava is
Kaj je zdravilo Xerava in za kaj ga uporabljamo Kaj je zdravilo Xerava
Antibiotic class adverse reactions include pseudomembranous colitis, and overgrowth of nonsusceptible organisms, including fungi (see section 4.4).
Med neželene učinke skupine antibiotikov spadajo psevdomembranski kolitis in razraščanje neobčutljivih organizmov, vključno z glivami (glejte poglavje 4.4).
The recommended dose for adults is based on body weight and is 1 mg/kg every 12 hours.
Priporočeni odmerek za odrasle temelji na telesni masi, znaša pa 1 mg/kg vsakih 12 ur.
In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in AUC by gender were observed for eravacycline.
V populacijski farmakokinetični analizi eravaciklina niso opazili klinično pomembnih razlik v vrednosti AUC glede na spol.
Hypersensitivity to tetracycline class antibiotics.
Preobčutljivost za tetraciklinske antibiotike.
mannitol (E421), sodium hydroxide, hydrochloric acid
manitol (E421), natrijev hidroksid, klorovodikova kislina
Clinical trials have failed to demonstrate the efficacy of Xerava for the treatment of complicated urinary tract infections.
V kliničnih preskušanjih niso uspeli dokazati učinkovitosti zdravila Xerava za zdravljenje kompliciranih okužb sečil.
In vitro, eravacycline and its metabolites are not inhibitors or inducers of CYP enzymes or transport proteins (see section 5.2).
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).
What Xerava looks like and contents of the pack
Izgled zdravila Xerava in vsebina pakiranja
Tetracycline class adverse reactions include photosensitivity, pseudotumor cerebri, and anti-anabolic action which have led to increased BUN, azotaemia, acidosis, and hyperphosphataemia.
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.
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).
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).
Eravacycline is a substrate for the transporters P-gp, OATP1B1 and OATP1B3 but not for BCRP.
Eravaciklin je substrat za transportne beljakovine P-gp, OATP1B1 in OATP1B3, ne pa za BCRP.
Xerava may affect your ability to drive or use machines safely.
Zdravilo Xerava lahko vpliva na sposobnost varnega upravljanja vozil in strojev.
Animal studies have shown excretion of eravacycline and its metabolites in breast milk (see section 5.3).
V študijah na živalih so dokazali izločanje eravaciklina in njegovih presnovkov v materino mleko (glejte poglavje 5.3).
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.
Vsebino vsake viale je treba rekonstituirati s 5 ml vode za injekcije in nežno obračati, dokler se prašek popolnoma ne raztopi.
• Inflammation of a vein causing pain and swelling (phlebitis)
• vnetje vene, ki povzroča bolečino in otekanje (flebitis);
These findings were reversible following a 70-day (10-week) recovery period, equivalent to a spermatogenic cycle in the rat.
Po obdobju okrevanja 70 dni (deset tednov), enakovrednega ciklu spermatogeneze pri podganah, so bili ti ugotovljeni izvidi reverzibilni.
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).
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).
Eravacycline and its metabolites are not inhibitors of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 in vitro.
Eravaciklin in njegovi presnovki in vitro niso zaviralci CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4.
Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 72 hours at refrigerated conditions (2-8°C) .
Kemijska in fizikalna stabilnost med uporabo je bila dokazana za 72 ur pri shranjevanju v hladilniku (2-8 °C) po redčenju v infuzijski vreči.
• Breathing difficulties
• oteženo dihanje;
Eravacycline, TP-498 and TP-6208 are not inducers of CYP1A2, CYP2B6 or CYP3A4.
Eravaciklin, TP-498 in TP-6208 niso induktorji CYP1A2, CYP2B6 ali CYP3A4.
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.
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.
Eravacycline may be administered without regard to the timing of haemodialysis (see section 5.2).
Eravaciklin je mogoče uporabiti ne glede na čas hemodialize (glejte poglavje 5.2).
• Redness or swelling at the site of the injection
• pordelost ali otekanje na mestu vboda.
In vitro, eravacycline was shown to be a substrate for the transporters P-gp, OATP1B1 and OATP1B3.
V študijah in vitro so dokazali, da je eravaciklin substrat za transportne beljakovine P-gp, OATP1B1 in OATP1B3.
For patients weighing 50 kg - 100 kg:
Za bolnike, ki tehtajo 50-100 kg:
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.
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.
6.6 Special precautions for disposal and other handling
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Splošni previdnostni ukrepi
Aseptic technique must be followed when preparing the infusion solution.
Pri pripravi raztopine za infundiranje je treba upoštevati aseptični postopek.
No dose adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.
Pri bolnikih z okvaro ledvic ali pri bolnikih, ki se zdravijo s hemodializo, prilagoditev odmerka ni potrebna.
Chemical and physical in-use stability after reconstitution in the vial has been demonstrated for 1 hour at 25°C.
Kemijska in fizikalna stabilnost med uporabo je bila dokazana za eno uro pri 25 °C po rekonstituciji v viali.
Xerava is given by an infusion (drip) directly into your vein.
Zdravilo Xerava se daje z infundiranjem (kapalno infuzijo) neposredno v veno.
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.
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.
Seek urgent medical attention if you suspect you have an anaphylactic reaction, or develop any of the following symptoms, whilst receiving Xerava:
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: