FrancophonIA/ELRC3.0 huggingface dataset:
English: These can develop suddenly and can potentially be life-threatening.
Croatian: One se mogu iznenada pojaviti i biti potencijalno opasne po život.
English: Your doctor will decide how long you should be treated for.
Croatian: Vaš će liječnik odlučiti koliko ćete dugo primati lijek.
English: Resistant (R >)
Croatian: Rezistencija (R >)
English: If not, it may be stored at room temperature and used within 12 hours.
Croatian: U protivnom, može se čuvati na sobnoj temperaturi i upotrijebiti u roku od 12 sati.
English: • delay the natural formation of the bones of your unborn child.
Croatian: • odgoditi prirodno stvaranje kostiju Vašeg nerođenog djeteta.
English: Read all of this leaflet carefully before you receive this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži Vama važne podatke.
English: It is, therefore, unlikely that you will miss a dose.
Croatian: Stoga nije vjerojatno da ćete propustiti dozu lijeka.
English: Via Morolense, 5 03013 Ferentino (FR) Italy
Croatian: SX. Via Morolense, 5 03013 Ferentino (FR) Italija
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate zatrudnjeti, obratite se svojem liječniku za savjet prije primjene ovog lijeka.
English: Component of a multipack, can't be sold seperately.
Croatian: Dio višestrukog pakiranja, ne može se prodavati zasebno.
English: Xerava is not recommended for use during pregnancy as it can:
Croatian: Xerava se ne preporučuje za primjenu tijekom trudnoće jer može:
English: These findings were reversible or partially reversible during recovery periods of 3- to 7-weeks.
Croatian: Ti rezultati bili su reverzibilni ili djelomično reverzibilni tijekom razdoblja oporavka od tri do sedam tjedana.
English: This medicine should not be used in children and adolescents under the age of 18 years as it has not been studied enough in these populations.
Croatian: Ovaj se lijek ne smije upotrebljavati u djece i adolescenata mlađih od 18 godina jer u tih populacija nije dostatno ispitan.
English: • Losing consciousness
Croatian: • gubitak svijesti
English: A course of treatment usually lasts for 4 to 14 days.
Croatian: Ciklus liječenja obično traje 4 do 14 dana.
English: 100 mL 250 mL 250 mL 250 mL 500 mL 500 mL
Croatian: 100 ml 250 ml 250 ml 250 ml
English: In these cases, no recommendation on a posology can be made.
Croatian: U tim slučajevima nije moguće dati preporuke o doziranju.
English: Contents of the pack and other information What Xerava contains
Croatian: Sadržaj pakiranja i druge informacije Što Xerava sadrži
English: Eravacycline is not genotoxic.
Croatian: Eravaciklin nije genotoksičan.
English: The safety and efficacy of Xerava in children and adolescents less than 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Xerava u djece i adolescenata mlađih od 18 godina nisu utvrđene.
English: Do not drive or use machines if you feel dizzy, light-headed or unsteady after receiving this medicine.
Croatian: Nemojte voziti ni upravljati strojevima ako osjećate vrtoglavicu, omaglicu ili nesigurnost nakon primanja ovog lijeka.
English: • Allergic reaction
Croatian: • alergijske reakcije
English: Xerava must not be mixed with other medicinal products.
Croatian: Xerava se ne smije miješati s drugim lijekovima.
English: If you are given more Xerava than you should
Croatian: Ako ste primili više lijeka Xerava nego što ste trebali
English: It must not be administered as an intravenous bolus.
Croatian: Ne smije se primijeniti kao intravenski bolus.
English: Other medicines and Xerava
Croatian: Drugi lijekovi i Xerava
English: Dublin 2, D02 T380, Ireland
Croatian: Dublin 2, D02 T380, Irska
English: Interactions with medicinal products that are substrates for these enzymes or transporters are therefore unlikely.
Croatian: Stoga interakcije s lijekovima koji su supstrati za te enzime ili prijenosnike nisu vjerojatne.
English: Total volume to be diluted (mL)
Croatian: Ukupni volumen koji je potrebno razrijediti (ml)
English: If not used immediately, in-use storage times and conditions are the responsibility of the user.
Croatian: Ako se proizvod ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka u primjeni odgovornost su korisnika.
English: Aseptic technique must be followed when preparing the infusion solution.
Croatian: Potrebno je pridržavati se aseptične tehnike pri pripremi otopine za infuziju.
English: No data are available for patients weighing more than 137 kg.
Croatian: Nisu dostupni podaci za bolesnike teže od 137 kg.
English: • permanently stain your unborn child's teeth
Croatian: • prouzročiti trajne mrlje na zubima Vašeg nerođenog djeteta
English: What Xerava is and what it is used for 2.
Croatian: Što je Xerava i za što se koristi 2.
English: - if you are allergic to eravacycline or any of the other ingredients of this medicine (listed in section 6).
Croatian: − ako ste alergični na eravaciklin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Total Dose (mg)
Croatian: Ukupna doza (mg)
English: Other appropriate measures should be taken and alternative antimicrobial treatment should be considered in accordance with existing therapeutic guidelines.
Croatian: Potrebno je poduzeti druge prikladne mjere i razmotriti zamjensko antimikrobno liječenje u skladu s postojećim terapijskim smjernicama.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Croatian: Potrebno je razmotriti službene smjernice o prikladnoj primjeni antibakterijskih lijekova.
English: Exposure may be increased in patients with severe hepatic impairment (Child-Pugh Class C).
Croatian: Izloženost može biti povećana u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh razred C).
English: Although antibiotics including Xerava fight certain bacteria, other bacteria and fungi may continue to grow.
Croatian: Iako se antibiotici, uključujući lijek Xerava, bore protiv određenih bakterija, druge bakterije i gljivice mogu nastaviti rasti.
English: New infection
Croatian: Nove infekcije
English: Medicinal products that inhibit peristalsis should not be given.
Croatian: Pri tome se ne smiju davati lijekovi koji inhibiraju peristaltiku.
English: If superinfection occurs during therapy, it may require interruption of treatment.
Croatian: Ako tijekom terapije dođe do superinfekcije, možda će biti potrebno prekinuti liječenje.
English: Reconstituted and diluted solutions containing visible particles or that are cloudy in appearance should be discarded.
Croatian: Rekonstituirane i razrijeđene otopine koje sadržavaju vidljive čestice ili koje izgledaju zamućeno treba baciti.
English: 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.
Croatian: Diskoloracija kostiju (u odsutnosti histoloških nalaza), koja nije bila potpuno reverzibilna tijekom razdoblja oporavka u trajanju do sedam tjedana, opažena je u štakora i majmuna nakon 13 tjedana doziranja.
English: Xerava is given by an infusion (drip) directly into your vein.
Croatian: Xerava se daje infuzijom (dripom) izravno u venu.
English: Eravacycline is administered intravenously and therefore has 100% bioavailability.
Croatian: Eravaciklin se primjenjuje intravenski pa tako ima 100 %-tnu bioraspoloživost.
English: Other side effects may include:
Croatian: Ostale nuspojave uključuju:
English: It is, therefore, unlikely that you will be given too much.
Croatian: Stoga nije vjerojatno da ćete primiti previše lijeka.
English: These findings were reversible following a 70-day (10-week) recovery period, equivalent to a spermatogenic cycle in the rat.
Croatian: Ti su nalazi bili reverzibilni nakon razdoblja oporavka od 70 dana (10 tjedana), što je jednako ciklusu spermatogeneze u štakora.
English: It belongs to a group of antibiotics called ‘tetracyclines' which work by stopping the growth of certain infectious bacteria.
Croatian: Pripada skupini antibiotika koji se nazivaju „tetraciklini” koji djeluju blokiranjem rasta određenih zaraznih bakterija.
English: The exact dose needs to be calculated based on the specific patient weight.
Croatian: Točnu dozu potrebno je izračunati na temelju tjelesne težine pojedinog bolesnika.
English: The reconstituted and diluted solution must be administered as an intravenous infusion only.
Croatian: Rekonstituirana i razrijeđena otopina mora se primijeniti samo kao intravenska infuzija.
English: - if you are allergic to any tetracycline antibiotics (e.g., minocycline and doxycycline) because you may also be allergic to eravacycline.
Croatian: − ako ste alergični na bilo koji tetraciklinski antibiotik (npr. minociklin i doksiciklin) jer možete biti alergični i na eravaciklin
English: Shaking or rapid movement should be avoided as it may cause foaming.
Croatian: Treba izbjegavati mućkanje i brze pokrete jer može doći do pjenjenja.
English: Once the powder has been made into a solution and diluted ready for use, it should be given to you immediately.
Croatian: Nakon što se od praška napravi otopina i ona se razrijedi te je spremna za uporabu, treba se odmah primijeniti.
English: Medicines that induce CYP3A4 are expected to increase the rate and extent of metabolism of eravacycline.
Croatian: Očekuje se da će lijekovi koji induciraju CYP3A4 povećati brzinu i opseg metabolizma eravaciklina.
English: Your doctor will monitor you closely for any new infections or stop treatment with Xerava and give you another treatment if necessary.
Croatian: Vaš će Vas liječnik pratiti kako ne bi došlo do bilo kakvih novih infekcija ili će prekinuti liječenje lijekom Xerava i odrediti Vam drugo liječenje, ako bude potrebno.
English: The Cmax and AUC of eravacycline in healthy adults increase approximately in proportion to an increase in dose.
Croatian: Cmax i AUC eravaciklina u zdravih odraslih osoba povećavaju se približno proporcionalno povećanju doze.
English: Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines, ATC code: J01AA13.
Croatian: Farmakoterapijska skupina: antibakterijski lijekovi za sustavnu primjenu, tetraciklini, ATK oznaka: J01AA13.
English: See example calculations in Table 3.
Croatian: Vidjeti primjer izračuna u Tablici 3.
English: If you miss a dose of Xerava
Croatian: Ako propustite dozu lijeka Xerava
English: Clinical efficacy against specific pathogens
Croatian: Klinička djelotvornost protiv određenih patogena
English: Xerava must not be used in children below 8 years of age because it can cause permanent effects on their teeth such as discolouration.
Croatian: Xerava se ne smije upotrebljavati u djece mlađe od osam godina jer može prouzročiti trajne učinke na njihove zube kao što je promjena boje.
English: What Xerava looks like and contents of the pack
Croatian: Kako Xerava izgleda i sadržaj pakiranja
English: What you need to know before you are given Xerava 3.
Croatian: Što morate znati prije nego počnete primati lijek Xerava 3.
English: Additional minor metabolites are formed by glucuronidation, oxidation and hydrolysis.
Croatian: Dodatni manji metaboliti oblikuju se glukuronidacijom, oksidacijom i hidrolizom.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for eravacycline are:
Croatian: Granične vrijednosti minimalne inhibitorne koncentracije (MIK) koje je utvrdio Europski odbor za testiranje osjetljivosti na antimikrobne lijekove (EUCAST) za eravaciklin jesu:
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja provedena na životinjama pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: In a population pharmacokinetic analysis it was shown that eravacycline disposition (clearance and volume) was dependent on body weight.
Croatian: U populacijskoj farmakokinetičkoj analizi pokazalo se da dispozicija eravaciklina (klirens i volumen) ovisi o tjelesnoj težini.
English: Other tetracycline antibiotics
Croatian: Drugi tetraciklinski antibiotici
English: Xerava is administered only by intravenous infusion over approximately 1 hour (see section 4.4).
Croatian: Xerava se primjenjuje samo intravenskom infuzijom tijekom približno jednog sata (vidjeti dio 4.4).
English: 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.
Croatian: U ispitivanjima u kojima je primijenjeno do 3 mg/kg eravaciklina u zdravih dobrovoljaca opaženo je da doze više od preporučene doze dovode do više stope mučnine i povraćanja.
English: If you develop diarrhoea during or after your treatment, tell your doctor straight away.
Croatian: Ako proljev nastupi tijekom ili nakon liječenja, odmah obavijestite svojeg liječnika.
English: In case of serious reactions, eravacycline should be discontinued until a new intravenous access site is established.
Croatian: U slučaju ozbiljnih reakcija potrebno je prekinuti liječenje eravaciklinom dok se ne odredi novo mjesto intravenskog pristupa.
English: Powder for concentrate for solution for infusion Multipack: 12 (12x1) vials
Croatian: Prašak za koncentrat za otopinu za infuziju Višestruko pakiranje: 12 (12 x 1) bočica
English: See example calculations in Table 1.
Croatian: Vidjeti primjer izračuna u Tablici 1.
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor (see also section 4).
Croatian: Nemojte uzimati nikakve lijekove protiv proljeva bez savjetovanja s liječnikom (pogledajte također dio 4.).
English: Anaphylactic (allergic) reactions have been reported with other tetracycline antibiotics.
Croatian: Anafilaktičke (alergijske) reakcije prijavljene su s drugim tetraciklinskim antibioticima.
English: Potential for drug-drug interactions
Croatian: Potencijal za interakcije između lijekova
English: a Mean (range) represented b AUC of Day 1 = AUC 0-12 after the first dose and AUC for Day 10 = steady state AUC0- 12
Croatian: AUC 1. dana = AUC 0-12 nakon prve doze i AUC za 10.
English: In case of hypersensitivity reactions, treatment with eravacycline must be discontinued immediately and appropriate emergency measures must be initiated.
Croatian: U slučaju reakcije preosjetljivosti, liječenje eravaciklinom mora se smjesta prekinuti i započeti s prikladnim mjerama hitne medicinske pomoći.
English: 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.
Croatian: U takvim je okolnostima potrebno razmotriti prekid liječenja eravaciklinom i primjenu suportivnih mjera uz primjenu posebnog liječenja za Clostridium difficile.
English: The potential influence of severe obesity on eravacycline exposure has not been studied.
Croatian: Potencijalni utjecaj teške pretilosti na izloženost eravaciklinu nije ispitan.
English: uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Croatian: Kategorije učestalosti određuju se prema sljedećoj ljestvici: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Xerava should be made, taking into account the benefit of breast-feeding for the child, and the benefit of therapy for the woman.
Croatian: Mora se donijeti odluka o nastavku ili prestanku dojenja ili nastavku ili prekidu terapije lijekom Xerava, uzimajući u obzir korist dojenja za dijete i korist terapije za ženu.
English: • Feeling lightheaded or faint
Croatian: • osjećaj ošamućenosti ili slabosti
English: Table 1 Tabulated list of adverse reactions to eravacycline in clinical trials
Croatian: Tablica 1 Tablični popis nuspojava eravaciklina u kliničkim ispitivanjima
English: The dose should be calculated based on the patient's weight; 1 mg/kg body weight.
Croatian: Dozu je potrebno izračunati na temelju tjelesne težine bolesnika; 1 mg/kg tjelesne težine.
English: Unchanged eravacycline is the major medicinal product-related component in human plasma and human urine.
Croatian: Nepromijenjeni eravaciklin glavna je komponenta povezana s lijekom u plazmi i mokraći ljudi.
English: The mean (%CV) volume of distribution at steady-state in healthy normal volunteers following 1 mg/kg every 12h is approximately 321 L (6.35), which is greater than total body water.
Croatian: Srednja vrijednost (%CV) volumena distribucije u stanju dinamičke ravnoteže u zdravih, normalnih dobrovoljaca nakon 1 mg/kg svakih 12 sati približno iznosi 321 l (6,35), što je više od ukupne količine vode u organizmu.
English: The calculated volume of the reconstituted solution should be added to the infusion bag to a target concentration of 0.3 mg/mL, within a range of 0.2 to 0.6 mg/mL.
Croatian: Izračunati volumen rekonstituirane otopine potrebno je dodati u vrećicu za infuziju s ciljanom koncentracijom od 0,3 mg/ml, unutar raspona od 0,2 do 0,6 mg/ml.
English: Do not use this medicine after the expiry date which is stated on the vial label and carton after ‘EXP'.
Croatian: Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici na bočici i kutiji iza oznake „EXP”.
English: Severe pain in the abdomen and back with fever may be signs of inflammation of the pancreas.
Croatian: Snažna bol u trbuhu i leđima s vrućicom može biti znak upale gušterače.
English: 500 mL
Croatian: 500 ml 500 ml
English: This medicinal product may pose a risk to the environment (See section 5.3).
Croatian: Lijek može predstavljati rizik za okoliš (vidjeti dio 5.3).
English: For intravenous use after reconstitution and dilution.
Croatian: Intravenska primjena nakon rekonstitucije i razrjeđivanja.
English: The C-7 and C-9 substitutions in eravacycline are not present in any naturally occurring or semisynthetic tetracyclines and the substitution pattern imparts microbiological activities including retention of in vitro potency against Gram-positive and Gram-negative strains expressing tetracycline-specific resistance mechanism(s) (i.e., efflux mediated by tet(A), tet(B), and tet(K); ribosomal protection as encoded by tet(M) and tet(Q)).
Croatian: Supstitucije C-7 i C-9 u eravaciklinu nisu prisutne ni u jednom prirodnom ili polusintetičkom tetraciklinu, a obrazac supstitucije uzrokuje mikrobiološku aktivnost uključujući zadržavanje in vitro sposobnosti djelovanja protiv gram-pozitivnih i gram-negativnih sojeva s mehanizmima rezistencije specifičnima za tetracikline (tj. efluks posredovan tet(A), tet(B) i tet(K); ribosomski zaštitni proteini kodirani putem tet(M) i tet(Q)).
English: CYP3A4 inducers exert their effect in a time-dependent manner, and may take at least 2 weeks to reach maximal effect after introduction.
Croatian: Učinak induktora CYP3A4 ovisi o vremenu te može biti potrebno najmanje dva tjedna da se dosegne najveći učinak nakon uvođenja.
English: Eravacycline is also not affected by aminoglycoside inactivating or modifying enzymes.
Croatian: Na eravaciklin također ne utječu enzimi koji inaktiviraju ili modificiraju aminoglikozide.
English: 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.
Croatian: Dugoročna primjena drugih tetraciklina tijekom dojenja može dovesti do znatne apsorpcije u dojenčeta te se ne preporučuje zbog rizika od promjene boje zuba i odgode procesa okoštavanja u dojenčadi.
English: Eravacycline is not a substrate for the MepA pump in Staphylococcus aureus that has been described as a resistance mechanism for tigecycline.
Croatian: Eravaciklin nije supstrat za MepA pumpu u zlatnom stafilokoku (Staphylococcus aureus), koja je opisana kao mehanizam rezistencije za tigeciklin.
English: Xerava is an antibiotic medicine that contains the active substance eravacycline.
Croatian: Xerava je antibiotički lijek koji sadrži djelatnu tvar eravaciklin.
English: • Redness or swelling at the site of the injection
Croatian: • crvenilo ili oticanje na mjestu injekcije
English: PK parameters arithmetic mean (%CV)
Croatian: Farmakokinetički parametri aritmetička srednja vrijednost (%CV)
English: Long-term use of other similar antibiotic medicines by breast-feeding mothers can stain the child's teeth permanently.
Croatian: Dugoročna primjena drugih sličnih antibiotika u dojilja može prouzročiti trajne mrlje na zubima djeteta.
English: Women of childbearing potential should avoid becoming pregnant while receiving eravacycline.
Croatian: Žene reproduktivne dobi trebaju izbjegavati trudnoću dok primaju eravaciklin.
English: TP-6208 and TP-498 are not considered to be pharmacologically active.
Croatian: TP-6208 i TP-498 ne smatraju se farmakološki djelatnima.
English: 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).
Croatian: Simptomi na koje trebate obratiti pažnju uključuju osip, oticanje lica, osjećaj ošamućenosti ili slabosti, stezanje u prsima, poteškoće s disanjem, ubrzane srčane otkucaje ili gubitak svijesti (pogledajte također dio 4.).
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.
Croatian: U ispitivanjima plodnosti u mužjaka štakora eravaciklin primijenjen u dozi približno pet puta većoj od kliničke izloženosti (na temelju AUC-a) rezultirao je značajno smanjenim brojem trudnoća.
English: There are no human data on the effect of eravacycline on fertility.
Croatian: Nema kliničkih podataka o učincima eravaciklina na plodnost.
English: Date of first authorisation: 20 September 2018
Croatian: Datum prvog odobrenja: 20.
English: Ask your doctor for advice before breast-feeding your baby.
Croatian: Savjetujte se s liječnikom prije dojenja djeteta.
English: Environmental risk assessment studies have shown that Xerava may pose a risk for the aquatic compartment.
Croatian: Ispitivanja radi procjene rizika za okoliš pokazala su da Xerava može predstavljati rizik za vodene ekosustave.
English: What Xerava is used for
Croatian: Za što se Xerava koristi
English: - The active substance is eravacycline.
Croatian: - Djelatna tvar je eravaciklin.
English: • Inflammation of the pancreas which causes severe pain in the abdomen or back (pancreatitis)
Croatian: • upala gušterače koja uzrokuje snažnu bol u trbuhu ili leđima (pankreatitis)
English: 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.
Croatian: Mehanizam djelovanja eravaciklina uključuje ometanje sinteze bakterijskih proteina vezanjem na 30S ribosomsku podjedinicu, sprječavajući tako ugradnju aminokiselina u peptidne lance koji se produljuju.
English: Table 2 Mean (%CV) plasma pharmacokinetic parameters of eravacycline after single and multiple intravenous and in healthy adults
Croatian: Tablica 2 Srednje vrijednosti (%CV) farmakokinetičkih parametara eravaciklina u plazmi nakon jednokratne intravenske infuzije i višestrukih intravenskih infuzija u zdravih odraslih osoba
English: These include sensitivity to light, headaches, vision problems, or abnormal blood tests.
Croatian: One uključuju osjetljivost na svjetlost, glavobolje, probleme s vidom ili odstupanja u rezultatima krvnih pretraga.