FrancophonIA/ELRC3.0 huggingface dataset:
English: It is unknown whether eravacycline and its metabolites are excreted in human breast milk.
Croatian: Nije poznato izlučuju li se eravaciklin i njegovi metaboliti u majčino mlijeko u ljudi.
English: Eravacycline may have a minor influence on the ability to drive and use machines.
Croatian: Eravaciklin može malo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Each vial is for single use only.
Croatian: Bočica je namijenjena samo za jednu uporabu.
English: Following dilution, Xerava is administered intravenously over approximately 1 hour.
Croatian: Nakon razrjeđivanja Xerava se primjenjuje intravenski tijekom približno jednog sata.
English: The metabolites TP-498 and TP-6208 are not inhibitors of P-gp in vitro.
Croatian: Metaboliti TP-498 i TP-6208 nisu inhibitori P-glikoproteina in vitro.
English: 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.
Croatian: Bubrežni klirens i izlučivanje putem žuči i izravno putem crijeva čine približno 35 % odnosno 48 % ukupnog tjelesnog klirensa nakon primjene jedne intravenske doze od 60 mg
English: Hypersensitivity to tetracycline class antibiotics.
Croatian: Preosjetljivost na tetraciklinsku skupinu antibiotika.
English: Eravacycline may be administered without regard to the timing of haemodialysis (see section 5.2).
Croatian: Eravaciklin je moguće primijeniti bez obzira na vrijeme hemodijalize (vidjeti dio 5.2).
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Croatian: Nemojte uzimati nikakve lijekove protiv proljeva bez savjetovanja s liječnikom.
English: Eravacycline, TP-498 and TP-6208 are not inhibitors of BCRP, BSEP, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 or MATE2-K transporters.
Croatian: Eravaciklin, TP-498 i TP-6208 nisu inhibitori BCRP-a, BSEP-a, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 ili MATE2-K prijenosnika.
English: Strong CYP3A4 inducers
Croatian: Jaki induktori CYP3A4
English: Pancreatitis has been reported with eravacycline and other tetracycline class antibiotics, and has been severe in some cases (see section 4.8).
Croatian: Pankreatitis je prijavljen prilikom primjene eravaciklina i drugih antibiotika tetraciklinske skupine te je u nekim slučajevima bio težak (vidjeti dio 4.8).
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.
Croatian: Istodobna primjena jakog inhibitora CYP3A, itrakonazola, izmijenila je farmakokinetiku eravaciklina, povećavajući Cmax za približno 5 % te AUC0-24 za približno 23 %, a smanjujući klirens.
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).
Croatian: Očekuje se da će istodobna primjena jakog induktora CYP3A4 (kao što su fenobarbital, rifampicin, karbamazepin, fenitoin, gospina trava) smanjiti učinak eravaciklina (vidjeti dijelove 4.2 i 4.5).
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.
Croatian: Sadržaj potrebnog broja bočica treba svaki rekonstituirati s 5 ml vode za injekcije te pažljivo miješati dok se prašak potpuno ne otopi.
English: Uncommon side effects (may affect up to 1 in 100 people):
Croatian: Manje česte nuspojave (mogu se pojaviti u do 1 na 100 osoba)
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%.
Croatian: Istodobna primjena jakog induktora CYP 3A4/3A5, rifampicina, izmijenila je farmakokinetiku eravaciklina, smanjila izloženost za približno 32 % te povećala klirens za približno 54 %.
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.
Croatian: Geometrijska srednja vrijednost dobivena metodom najmanjih kvadrata AUC0-inf za eravaciklin smanjila se za 4,0 % za ispitanike s ESRD-om u usporedbi sa zdravim ispitanicima s 90 % CI -14,0; 12,3.
English: Infusion-site erythema, pain/tenderness, phlebitis and thrombophlebitis were observed with intravenous eravacycline in clinical trials (see section 4.8).
Croatian: Eritem na mjestu infuzije, bol/osjetljivost, flebitis i tromboflebitis opaženi su pri intravenskoj primjeni eravaciklina u kliničkim ispitivanjima (vidjeti dio 4.8).
English: Potential for eravacycline to affect the pharmacokinetics of other medicinal products
Croatian: Mogućnost eravaciklina da utječe na farmakokinetiku drugih lijekova
English: Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see sections 4.4, 4.5 and 5.2).
Croatian: U bolesnika s oštećenjem funkcije jetre nije potrebna prilagodba doze (vidjeti dijelove 4.4, 4.5 i 5.2).
English: Reconstituted Xerava should be a clear, pale yellow to orange solution.
Croatian: Rekonstituirani lijek Xerava treba biti prozirna, blijedožuta do narančasta otopina.
English: Pack sizes: 1 vial and multipacks containing 12 (12 packs of 1) vials.
Croatian: Veličina pakiranja: 1 bočica i višestruko pakiranje s 12 (12 pakiranja po 1) bočica.
English: Resistance to eravacycline has been observed in Enterococcus harbouring mutations in rpsJ.
Croatian: Rezistencija na eravaciklin opažena je u vrstama roda Enterococcus koje nakupljaju mutacije u genu rpsJ.
English: Clinical trials have failed to demonstrate the efficacy of Xerava for the treatment of complicated urinary tract infections.
Croatian: U kliničkim ispitivanjima nije dokazana djelotvornost lijeka Xerava za liječenje kompliciranih infekcija mokraćnog sustava.
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.
Croatian: Geometrijska srednja vrijednost AUC0-inf za eravaciklin povećala se za 22,9 %, 37,9 % odnosno 110,3 % za ispitanike s blagim, umjerenim odnosno teškim oštećenjem funkcije jetre u usporedbi sa zdravim ispitanicima.
English: The increased exposure is not likely to be clinically significant; thus, no dose adjustment is required when eravacycline is co-administered with CYP3A inhibitors.
Croatian: Stoga se ne zahtijeva prilagodba doze kad se eravaciklin primjenjuje istodobno s inhibitorima CYP3A.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane padajućim redoslijedom prema ozbiljnosti.
English: Eravacycline is a substrate for the transporters P-gp, OATP1B1 and OATP1B3 but not for BCRP.
Croatian: Eravaciklin je supstrat za prijenosnike P-glikoprotein, OATP1B1 i OATP1B3, ali ne za BCRP.
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.
Croatian: U embrio-fetalnim ispitivanjima nisu opažene nuspojave u štakora pri izloženostima usporedivima s kliničkim izloženostima ni u kunića pri izloženostima 1,9 puta većima od kliničke izloženosti (na temelju AUC-a).
English: In vitro, eravacycline was shown to be a substrate for the transporters P-gp, OATP1B1 and OATP1B3.
Croatian: In vitro se eravaciklin pokazao kao supstrat za prijenosnike P-glikoprotein, OATP1B1 i OATP1B3.
English: In clinical trials, treatment-related diarrhoea occurred in 0.7% of patients; all cases were mild in severity.
Croatian: U kliničkim ispitivanjima proljev povezan s liječenjem pojavio se u 0,7 % bolesnika.
English: 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.
Croatian: Geometrijska srednja vrijednost Cmax za eravaciklin povećala se za 13,9 %, 16,3 % odnosno 19,7 % za ispitanike s blagim (Child-Pugh razred A), umjerenim (Child-Pugh razred B) odnosno teškim (ChildPugh razred C) oštećenjem funkcije jetre u usporedbi sa zdravim ispitanicima.
English: 1.0 mg/kg IV every 12 hours (n=6) Day 1 2125 (15) Day 10 1825 (16)
Croatian: 1. dan 2125 (15) 10. dan 1825 (16)
English: Chemical and physical in-use stability after dilution in the infusion bag has been demonstrated for 12 hours at 25°C.
Croatian: Kemijska i fizikalna stabilnost u primjeni nakon razrjeđivanja u vrećicama za infuziju dokazana je nakon 12 sati na temperaturi od 25 °C.
English: Keep the vial in the carton in order to protect from light.
Croatian: Bočicu čuvati u kutiji radi zaštite od svjetlosti.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING INNER CARTON: MULTIPACK, CONTAINS NO BLUE BOX
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU UNUTARNJA KUTIJA: VIŠESTRUKO PAKIRANJE, NE SADRŽI PLAVI OKVIR
English: Eravacycline, TP-498 and TP-6208 are not inducers of CYP1A2, CYP2B6 or CYP3A4.
Croatian: Eravaciklin, TP-498 i TP-6208 nisu induktori CYP1A2, CYP2B6 ili CYP3A4.
English: Elderly (≥ 65 years old) No dose adjustment is required in elderly patients (see section 5.2).
Croatian: U starijih bolesnika nije potrebna prilagodba doze (vidjeti dio 5.2).
English: Adverse reactions are classified according to MedDRA system organ classification and frequency.
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava prema MedDRA-i i prema učestalosti.
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.
Croatian: Geometrijska srednja vrijednost dobivena metodom najmanjih kvadrata Cmax za eravaciklin povećala se za 8,8 % za ispitanike sa završnim stadijem bubrežne bolesti (engl. end stage renal disease, ESRD) u usporedbi sa zdravim ispitanicima s 90 % CI -19,4; 45,2.
English: 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).
Croatian: Dozu eravaciklina potrebno je povećati za približno 50 % (1,5 mg/kg, intravenski, svakih 12 sati) kad se primjenjuje istodobno s rifampicinom ili drugim jakim induktorom CYP3A kao što su fenobarbital, karbamazepin, fenitoin i gospina trava (vidjeti dijelove 4.2 i 4.4).
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.
Croatian: U ispitivanju toksičnosti ponovljenih doza eravaciklina u štakora, pasa i majmuna opaženi su: limfoidna deplecija/atrofija limfnih čvorova, slezene i timusa, snižen broj eritrocita, retikulocita, leukocita i trombocita (u pasa i majmuna) uz hipocelularnost koštane srži te gastrointestinalne nuspojave (u pasa i majmuna).
English: Efficacy has been demonstrated in clinical studies against the pathogens listed for cIAI that were susceptible to eravacycline in vitro:
Croatian: Djelotvornost je dokazana u kliničkim ispitivanjima protiv patogena navedenih za komplicirane intraabdominalne infekcije osjetljivih na eravaciklin in vitro:
English: The recommended dose regimen is 1 mg/kg eravacycline every 12 hours for 4 to 14 days.
Croatian: Preporučeni režim doziranja iznosi 1 mg/kg eravaciklina svakih 12 sati tijekom 4 do 14 dana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: MULTIPACK, CONTAINS BLUE BOX
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA: VIŠESTRUKO PAKIRANJE, SADRŽI PLAVI OKVIR
English: Pale yellow to dark yellow cake.
Croatian: Blijedožuti do tamnožuti kolačić.
English: Each vial should be reconstituted with 5 mL water for injections, and swirled gently until the powder has dissolved entirely.
Croatian: Bočicu treba rekonstituirati s 5 ml vode za injekcije te pažljivo miješati dok se prašak potpuno ne otopi.
English: Non-susceptible micro-organisms
Croatian: Otporni mikroorganizmi
English: Xerava may affect your ability to drive or use machines safely.
Croatian: Xerava može utjecati na sposobnost upravljanja vozilima i strojevima.
English: The solution should not be used if it appears to contain any particles or the solution is cloudy.
Croatian: Otopina se ne smije upotrebljavati ako se čini da sadrži bilo kakve čestice ili ako je zamućena.
English: In the case of suspected overdose Xerava should be discontinued and the patient monitored for adverse reactions.
Croatian: U slučaju sumnje na predoziranje potrebno je prekinuti liječenje lijekom Xerava i pratiti bolesnika radi otkrivanja eventualnih nuspojava.
English: The recommended dose regimen of Xerava is 1 mg/kg every 12 hours for 4 to 14 days.
Croatian: Preporučeni režim doziranja lijeka Xerava iznosi 1 mg/kg svakih 12 sati tijekom 4 do 14 dana.
English: Infusion site reactions
Croatian: Reakcije na mjestu infuzije
English: Xerava is therefore not indicated for the treatment of complicated urinary tract infections.
Croatian: Stoga lijek Xerava nije indiciran za liječenje kompliciranih infekcija mokraćnog sustava.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON: 1 VIAL
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA: 1 BOČICA
English: Table 1 Example calculations for weights ranging from 40 kg to 200 kg
Croatian: Tablica 1 Primjer izračuna za tjelesne težine od 40 kg do 200 kg Tjelesna težina bolesnika (kg)
English: Chemical and physical in-use stability after reconstitution in the vial has been demonstrated for 1 hour at 25°C.
Croatian: Kemijska i fizikalna stabilnost u primjeni nakon rekonstitucije u bočicama dokazana je nakon jednog sata na temperaturi od 25 °C.
English: Talk to your doctor or nurse if you are suffering from diarrhoea before being given Xerava.
Croatian: Obratite se svojem liječniku ili medicinskoj sestri ako patite od proljeva prije primanja lijeka Xerava.
English: How to store Xerava
Croatian: Kako čuvati lijek Xerava
English: Animal studies have shown excretion of eravacycline and its metabolites in breast milk (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su izlučivanje eravaciklina i njegovih metabolita u majčino mlijeko (vidjeti dio
English: In a population pharmacokinetic analysis of eravacycline, no clinically relevant differences in AUC by gender were observed for eravacycline.
Croatian: U populacijskoj farmakokinetičkoj analizi eravaciklina nisu opažene klinički značajne razlike između spolova s obzirom na AUC za eravaciklin
English: After reconstitution each mL contains 10 mg eravacycline.
Croatian: Nakon rekonstitucije 1 ml sadrži 10 mg eravaciklina.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Croatian: PODATCI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI
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 sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Ako se ista intravenska linija upotrebljava za sekvencijsku infuziju nekoliko različitih lijekova, liniju je potrebno isprati prije i nakon infuzije otopinom natrijeva klorida za injekcije od 9 mg/ml (0,9 %).
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: Predstavljena srednja vrijednost (raspon)
English: 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.
Croatian: Ako se ista intravenska linija upotrebljava za sekvencijsku infuziju različitih lijekova, liniju je potrebno isprati prije i nakon infuzije otopinom natrijeva klorida za injekcije od 9 mg/ml (0,9 %).
English: The adverse reactions identified with eravacycline are presented in Table 1.
Croatian: Nuspojave utvrđene kod primjene eravaciklina navedene su u Tablici
English: Xerava should not be used during pregnancy unless the clinical condition of the woman requires treatment with eravacycline.
Croatian: Osim ako kliničko stanje žene zahtijeva liječenje eravaciklinom, lijek Xerava ne smije se primjenjivati tijekom trudnoće.
English: Tell your doctor or nurse if you have any of these side effects.
Croatian: Obavijestite svojeg liječnika ili medicinsku sestru ako primijetite bilo koju od tih nuspojava.
English: Eravacycline is excreted in both urine and faeces.
Croatian: Eravaciklin se izlučuje mokraćom i stolicom.
English: How you will be given Xerava 4.
Croatian: Kako ćete primati lijek Xerava 4. Moguće nuspojave
English: Dizziness Headache
Croatian: • glavobolja
English: Xerava must be reconstituted with water for injections and subsequently diluted using sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: Xerava se mora rekonstituirati vodom za injekcije i kasnije razrijediti otopinom natrijeva klorida za injekcije od 9 mg/ml (0,9 %).
English: Justification for not including Braille accepted.
Croatian: 16. PODATCI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Croatian: Važno: Prije propisivanja pročitajte sažetak opisa svojstava lijeka.
English: Fertility
Croatian: Ferentino
English: Tell your doctor or nurse immediately if you are concerned that you may have been given too much Xerava.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako mislite da ste primili previše lijeka Xerava.
English: The ready to use solution should be inspected visually for particulate matter prior to administration.
Croatian: Prije primjene otopinu spremnu za uporabu treba vizualno pregledati da vidite sadrži li neke čestice.
English: Number of vials to reconstitute
Croatian: Broj bočica za rekonstituciju
English: Tell your doctor or nurse if you notice any of these during your treatment with Xerava.
Croatian: Obavijestite svojeg liječnika ili medicinsku sestru ako opazite bilo koju od tih nuspojava tijekom liječenja lijekom Xerava.
English: What you need to know before you are given Xerava You must not receive Xerava:
Croatian: Što morate znati prije nego počnete primati lijek Xerava
English: There is approximately a 45% accumulation following intravenous dosing of 1 mg/kg every 12 hours.
Croatian: Nakon intravenske primjene 1 mg/kg svakih 12 sati dolazi do akumulacije od približno 45 %.
English: 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.
Croatian: U ispitivanjima na štakorima i psima intravenska primjena visokih doza eravaciklina bila je povezana s kožnim reakcijama (uključujući koprivnjaču, svrbež, oticanje i /ili eritem na koži).
English: 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.
Croatian: U bolesnika liječenih eravaciklinom prijavljene su blage do umjerene reakcije na mjestu infuzije, uključujući bol ili nelagodu, eritem i oticanje ili upalu na mjestu injekcije te površinski tromboflebitis i/ili flebitis.
English: How you will be given Xerava
Croatian: Kako ćete primati lijek Xerava
English: Eravacycline dosing
Croatian: Doza eravaciklina
English: Xerava 50 mg powder for concentrate eravacycline
Croatian: Xerava 50 mg prašak za koncentrat eravaciklin i.v.
English: • Abnormal blood test results for liver
Croatian: • odstupanja u rezultatima testova jetrene funkcije.
English: Dizziness may occur following administration of eravacycline (see section 4.8).
Croatian: Nakon primjene eravaciklina može doći do omaglice (vidjeti dio 4.8).
English: Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.
Croatian: Odmah obavijestite liječnika ili medicinsku sestru ako mislite da ste propustili dozu lijeka Xerava.
English: Each vial contains 50 mg eravacycline.
Croatian: Jedna bočica sadrži 50 mg eravaciklina.
English: Powder for concentrate for solution for infusion 1 vial.
Croatian: Prašak za koncentrat za otopinu za infuziju 1 bočica.
English: • Tightness of the chest
Croatian: • stezanje u prsima
English: Thrombophlebitis a
Croatian: Krvožilni poremećaji tromboflebitisa flebitis b
English: The solution should not be used if particles are present or the solution is cloudy.
Croatian: Otopina se ne smije upotrebljavati ako su u njoj prisutne bilo kakve čestice ili ako je zamućena.
English: 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).
Croatian: Xerava se ne smije upotrebljavati tijekom razvoja zuba (tijekom 2. i 3. tromjesečja trudnoće te u djece mlađe od osam godina) jer može prouzročiti trajnu promjenu boje zuba (u žutu, sivu, smeđu) (vidjeti dijelove 4.2 i 4.6).
English: The solution should not be used if any particles are noticed or the solution is cloudy.
Croatian: Otopina se ne smije upotrebljavati ako su u njoj vidljive bilo kakve čestice ili ako je zamućena.
English: What Xerava is and what it is used for What Xerava is
Croatian: Što je Xerava i za što se koristi
English: Immune system disorders
Croatian: Poremećaji imunosnog sustava preosjetljivost
English: 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.
Croatian: Rekonstituirana otopina se povuče iz bočice i doda u vrećicu za infuziju koja sadržava otopinu natrijeva klorida za injekcije od 9 mg/ml (0,9 %).
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 500 mL infusion bag.
Croatian: Za bolesnike tjelesne težine > 100 kg: izračunajte potreban volumen rekonstituirane otopine na temelju tjelesne težine bolesnika i ubrizgajte u vrećicu za infuziju od 500 ml.
English: Calculate the required volume of the reconstituted solution based on the patient's weight and inject into a 250 mL infusion bag.
Croatian: Za bolesnike tjelesne težine od 50 kg do 100 kg: izračunajte potreban volumen rekonstituirane otopine na temelju tjelesne težine bolesnika i ubrizgajte u vrećicu za infuziju od 250 ml.
English: Package leaflet: Information for the patient Xerava 50 mg powder for concentrate for solution for infusion eravacycline This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za bolesnika Xerava 50 mg prašak za koncentrat za otopinu za infuziju eravaciklin
English: It is not known if Xerava passes into breast milk.
Croatian: Nije poznato izlučuje li se Xerava u mlijeko.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari manitol (E421) natrijev hidroksid (za prilagodbu pH vrijednosti) kloridna kiselina (za prilagodbu pH vrijednosti)
English: In vitro data indicate that the following pathogen is not susceptible to eravacycline: • Pseudomonas aeruginosa
Croatian: Podaci in vitro pokazuju da patogen naveden u nastavku nije osjetljiv na eravaciklin:
English: For administration, the reconstituted solution must be further diluted using sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Prije primjene rekonstituirana otopina mora se dodatno razrijediti s pomoću otopine natrijeva klorida za injekciju od 9 mg/ml (0,9 %).