FrancophonIA/ELRC3.0 huggingface dataset:
English: • Swelling of the tongue, face, lips or throat
Croatian: • oticanje jezika, lica, usnica ili grla
English: About 25% of the administered dose is eliminated as the inactive open ring form.
Croatian: Oko 25% primijenjene doze eliminira se u neaktivnom obliku otvorenog prstena.
English: The reconstituted solution is not for direct injection.
Croatian: Rekonstituirana otopina nije za direktno injiciranje.
English: If you have kidney problems, your doctor may lower your dose.
Croatian: Ako imate bubrežnih tegoba, liječnik Vam može smanjiti dozu.
English: Small amounts of this medicine may pass into the breast milk and it may affect the baby.
Croatian: Male količine ovog lijeka mogu proći u majčino mlijeko i utjecati na dijete.
English: Vaborem should not be used in children or adolescents under 18 years of age.
Croatian: Lijek Vaborem se ne smije primjenjivati u djece ili adolescenata mlađih od 18 godina.
English: 20 to 39
Croatian: 20 do 39
English: • Reduction in the way your kidneys work
Croatian: • smanjenje načina na koji rade vaši bubrezi
English: Because a risk to the newborns/infants cannot be excluded, breastfeeding must be discontinued prior to initiating therapy.
Croatian: Budući da se ne može isključiti rizik za novorođenče/dojenče, dojenje se mora prekinuti prije početka terapije.
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 imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: If this happens, do not take medicines that stop or slow bowel movement.
Croatian: Ako se to dogodi, nemojte uzimati lijekove koji zaustavljaju ili usporavaju pražnjenje crijeva.
English: 3 hours
Croatian: 3 sata
English: The safety and efficacy of meropenem/vaborbactam in children and adolescents younger than 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost meropenema/vaborbaktama u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
English: New infection
Croatian: Nova infekcija
English: Vaborem will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Croatian: Lijek Vaborem će Vam dati liječnik ili medicinska sestra, tako da nije vjerojatno da ćete dobiti pogrešnu dozu.
English: • medicines that weaken your body's immune system, such as tacrolimus, everolimus and cyclosporine
Croatian: • lijekovi koji oslabljuju Vaš imunološki sustav, kao što su takrolimus, everolimus i ciklosporin
English: The concentration time profiles are similar for ELF and plasma.
Croatian: Profili koncentracije tijekom vremena za ELF i plazmu su slični.
English: If you are given more Vaborem than you should
Croatian: Ako dobijete više lijeka Vaborem nego što ste trebali
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, reproduction toxicity or genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, reproduktivne toksičnosti ili genotoksičnosti.
English: Minimum Inhibitory Concentrations (mg/l) Susceptible
Croatian: Minimalne inhibicijske koncentracije (mg/l) Osjetljivi
English: It is particularly important to tell your doctor if you are taking any of the following medicines:
Croatian: Naročito je važno da obavijestite svog liječnika ako uzimate bilo koje od sljedećih lijekova:
English: In one additional patient, a serious adverse reaction of infusion related reaction was reported (0.3%).
Croatian: U jednog dodatnog bolesnika, prijavljena je ozbiljna nuspojava reakcije povezane s infuzijom (0,3%).
English: <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); unknown (cannot be estimated from the available data).
Croatian: (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Antibacterial activity in combination with other antibacterial agents
Croatian: Antibakterjiska aktivnost u kombinaciji s drugim antibakterijskim lijekovima
English: • Peptostreptococcus species (including P. micros, P anaerobius, P. magnus)
Croatian: • Peptostreptococcus species (uključujući P. micros, P anaerobius, P. magnus)
English: As a precautionary measure, it is preferable to avoid the use of Vaborem during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Vaborem tijekom trudnoće.
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Croatian: Odmah obavijestite svog liječnika ako imate bilo koju od sljedećih ozbiljnih nuspojava - možda trebate hitnu medicinsku pomoć:
English: This medicine can affect your liver.
Croatian: Ovaj lijek može djelovati na jetru.
English: • Meropenem belongs to group of antibiotics called “carbapenems”.
Croatian: • Meropenem pripada skupini antibiotika koji se nazivaju „karbapenemi“.
English: Although Vaborem can fight certain bacteria, there is a possibility that you may get a different infection caused by another organism during or after your treatment.
Croatian: Iako lijek Vaborem uspješno suzbija određene bakterije, postoji mogućnost da dobijete drukčiju infekciju uzrokovanu drugim organizmom tijekom ili nakon liječenja.
English: If a severe allergic reaction occurs, treatment with Vaborem must be discontinued immediately and adequate emergency measures must be initiated.
Croatian: Ako se pojavi teška alergijska reakcija, liječenje lijekom Vaborem mora se odmah prekinuti i moraju se započeti odgovarajuće mjere hitnog liječenja.
English: Meropenem alone is not known to interact with active transport systems.
Croatian: Nije poznato da meropenem stupa u interakciju sa sustavima aktivnog transporta.
English: It can kill many types of bacteria by preventing them from building the protective walls that surround their cells.
Croatian: Može ubiti brojne vrste bakterija tako što sprječava da izgrade zaštitne stijenke oko svoje stanice.
English: It may be due to bacteria called Clostridium difficile.
Croatian: Može biti izazvan bakterijom naziva Clostridium difficile.
English: It is unknown whether a potential interaction would result in increased or decreased plasma concentrations, and thus patients should be monitored both for signs of toxicity and lack of efficacy of the narrow therapeutic index drug.
Croatian: Nije poznato bi li moguća interakcija rezultirala povećanim ili smanjenim koncentracijama u plazmi, stoga je bolesnike potrebno pratiti kako bi se uočili znakovi toksičnosti i nedostatka djelotvornosti lijeka uskog terapijskog indeksa.
English: Recommended Dosage Regimen2
Croatian: Preporučeni režim doziranja2
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Croatian: Ovaj lijek se ne smije miješati s drugim lijekovima, osim onih navedenih u dijelu 6.6.
English: Alternative or additional antibacterial agents should be used when these pathogens are known or suspected to be contributing to the infectious process.
Croatian: Druge ili dodatne antibakterijske lijekove treba koristiti kada ti patogeni imaju utvrđen ili suspektan doprinos infektivnom procesu.
English: White to light yellow powder.
Croatian: Bijeli do svijetložuti prah.
English: Your doctor will monitor you closely for any new infections and give you another treatment if necessary.
Croatian: Vaš će liječnik pažljivo pratiti imate li nove infekcije i po potrebi započeti drugo liječenje.
English: • Swollen and red and irritated veins
Croatian: • otečene, crvene i nadražene vene
English: It blocks the action of an enzyme that allows some bacteria to resist the action of meropenem.
Croatian: Blokira djelovanje enzima koji omogućuje određenim bakterijama otpornost na djelovanje meropenema.
English: 10 to 19
Croatian: 10 do 19
English: • Haemolytic anaemia (a condition where red blood cells are damaged and reduced in number), which may make you feel tired and turn your skin and eyes yellow
Croatian: • hemolitička anemija (stanje u kojem su crvene krvne stanice oštećene i smanjenog broja), zbog čega se možete osjećati umorno, a koža i oči vam mogu postati žute boje
English: • you have ever suffered from seizures
Croatian: • ako se ikada imali napadaje
English: • Vaborbactam is a “beta lactamase inhibitor”.
Croatian: • Vaborbaktam je „inhibitor beta-laktamaze“.
English: The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibacterial agent to the increase in international normalised ratio (INR) is difficult to assess.
Croatian: Rizik može ovisiti o podležećoj infekciji, dobi i općem stanju bolesnika tako da je teško procijeniti doprinos antibakterijskog lijeka povećanju međunarodnog normaliziranog omjera (INR).
English: Patients who develop focal tremors, myoclonus, or seizures should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted.
Croatian: Bolesnici koji razviju žarišni tremor, mioklonus, ili napadaje moraju biti procijenjeni neurološki i stavljeni na antikonvulzivnu terapiju ako nije već uvedena.
English: What Vaborem is and what it is used for 2.
Croatian: Što je lijek Vaborem i za što se koristi 2.
English: Approximately 40-60% of a meropenem dose is excreted unchanged within 24 - 48 hours with a further 25% recovered as the microbiologically inactive hydrolysis product.
Croatian: Približno 40-60% doze meropenema izlučuje se u neizmijenjenom obliku unutar 24-48 sati, a daljnjih 25% izlučuje se kao mikrobiološki neaktivni proizvod hidrolize.
English: • a medicine used to treat seizures or given prior to a surgery or certain examinations inside your body such as a colonoscopy, called midazolam
Croatian: • lijek koji se primjenjuje za liječenje napadaja ili koji se daje prije kirurškog zahvata ili određenih pregleda unutar tijela kao što je kolonoskopija, naziva midazolam
English: 5 to 10 days2
Croatian: 5 do 10 dana2
English: If any of the above apply to you or you are not sure, talk to your doctor or nurse before using Vaborem.
Croatian: Ako se bilo koje od gore navedenog odnosi na Vas ili ako niste sigurni, razgovarajte se svojim liječnikom ili medicinskom sestrom prije uzimanja lijeka Vaborem.
English: • Complicated intra-abdominal infection (cIAI)
Croatian: • Komplicirane intraabdominalne infekcije (cIAI)
English: In vitro data suggest that vaborbactam may inhibit CYP2D6, and a risk for increased plasma concentrations of sensitive CYP2D6 substrates in vivo cannot be excluded.
Croatian: In vitro podaci upućuju da vaborbaktam može inhibirati CYP2D6, a ne može se isključiti rizik od povećanih koncentracija u plazmi osjetljivih supstrata CYP2D6 in vivo.
English: Hospital-acquired pneumonia (HAP), including VAP
Croatian: Bolnička pneumonija (HAP), uključujući VAP
English: Anaerobic micro-organisms:
Croatian: Anaerobni mikroorganizmi:
English: • oral anticoagulant medicines, such as warfarin (used to treat or prevent blood clots)
Croatian: • oralne antikoagulanse poput varfarina (primjenjuje se za liječenje ili sprječavanje zgrušavanja krvi)
English: • Abnormal feeling in the chest
Croatian: • abnormalni osjećaj u prsnom košu
English: Discontinuation of therapy with Vaborem and the administration of specific treatment for Clostridium difficile should be considered.
Croatian: Potrebno je razmotriti prekid terapije lijekom Vaborem i primjenu specifičnog liječenja za Clostridium difficile.
English: • A positive result from a test called“Coombs”used to identify haemolytic anemia (see above) or reaction of your immune system to Vaborem
Croatian: • pozitivan rezultat na testu koji se naziva „Coombsov test“ i koristi za otkrivanje hemolitičke anemije (vidjeti gore) ili reakcija Vašeg imunološkog sustava na lijek Vaborem
English: The plasma protein binding of vaborbactam is approximately 33%.
Croatian: Vezanje vaborbaktama na proteine plazme je približno 33%.
English: Patients with known seizure disorders should continue anticonvulsant therapy.
Croatian: Bolesnici s poznatim konvulzivnim poremećajima trebaju nastaviti antikonvulzijsku terapiju.
English: The number of vials used for a single dose will depend on the creatinine clearance (CrCl) of the patient.
Croatian: Broj bočica primijenjenih za jednu dozu lijeka ovisit će o klirensu kreatinina (CrCl) bolesnika.
English: There is no accumulation of meropenem or vaborbactam following multiple intravenous infusions administered every 8 hours for 7 days in subjects with normal renal function.
Croatian: Nema nakupljanja meropenema ili vaborbaktama nakon višestrukih intravenskih infuzija primijenjenih svakih 8 sati tijekom 7 dana u ispitanika s normalnom bubrežnom funkcijom.
English: Serious and occasionally fatal hypersensitivity reactions have been reported with meropenem and/or meropenem/vaborbactam (see sections 4.3 and 4.8).
Croatian: Ozbiljne i ponekad smrtonosne reakcije preosjetljivosti prijavljene su uz meropenem i/ili meropenem/vaborbaktam (vidjeti dijelove 4.3 i 4.8).
English: The medicinal product is supplied in packs of 6 vials.
Croatian: Lijek je isporučen u pakiranjima od 6 bočica.
English: Pharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH52
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje bakterijskih infekcija za sistemsku primjenu, karbapenemi, ATK oznaka: J01DH52
English: The reconstituted solution must be diluted before intravenous infusion.
Croatian: Rekonstituirana otopina mora se razrijediti prije intravenske infuzije.
English: The use of meropenem/vaborbactam may result in the overgrowth of non-susceptible organisms, which may require interruption of treatment or other appropriate measures.
Croatian: Neosjetljivi organizmi Primjena meropenema/vaborbaktama može rezultirati prekomjernim rastom neosjetljivih organizama, koji mogu zahtijevati prekid liječenja ili provedbu drugih odgovarajućih mjera.
English: The powder for concentrate for solution for infusion must be reconstituted and further diluted prior to use.
Croatian: Prašak za koncentrat za otopinu za infuziju mora se rekonstituirati i dodatno razrijediti prije primjene.
English: Simultaneous administration of antibacterial agents with warfarin may augment its anticoagulant effects.
Croatian: Istodobna primjena antibakterijskih lijekova s varfarinom može povećati njegove antikoagulacijske učinke.
English: The colour of the diluted solution is clear to light yellow.
Croatian: Boja razrijeđene otopine je bistra do svjetložuta.
English: The other ingredient is sodium carbonate.
Croatian: Drugi sastojak je natrijev karbonat.
English: The reconstituted vial should be further diluted immediately.
Croatian: Rekonstituiranu bočicu potrebno je odmah dodatno razrijediti.
English: After mixing gently to dissolve, the reconstituted meropenem/vaborbactam solution will have an approximate meropenem concentration of 0.05 g/ml and an approximate vaborbactam concentration of 0.05 g/ml.
Croatian: Nakon nježnog miješanja do otapanja, rekonstituirana otopina meropenema/vaborbaktama imat će približnu koncentraciju meropenema od 0,05 g/ml i približnu koncentraciju vaborbaktama od 0,05 g/ml.
English: Unknown: (frequency cannot be estimated from the available data)
Croatian: Nepoznato: (učestalost se ne može procijeniti iz dostupnih podataka)
English: This test looks for the presence of antibodies that can destroy red blood cells or may be affected by the response of your immune system to Vaborem.
Croatian: Taj test istražuje prisutnost protutijela koji mogu uništiti crvene krvne stanice, a na njega može utjecati odgovor vašeg imunološkog sustava na lijek Vaborem.
English: In a population pharmacokinetic analysis there was no effect of gender or race on the pharmacokinetics of meropenem and vaborbactam.
Croatian: U populacijskoj farmakokinetičkoj analizi nije bilo učinka spola ili rase na farmakokinetiku meropenema i vaborbaktama.
English: Vaborem is administered by intravenous infusion over 3 hours.
Croatian: Lijek Vaborem se primjenjuje intravenskom infuzijom u trajanju od 3 sata.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Vaborem in one or more subsets of the paediatric population in the treatment of infections due to Gramnegative bacteria (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Vaborem u jednoj ili više podskupina pedijatrijske populacije u liječenju infekcija uzrokovanih Gram-negativnim bakterijama (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: From a microbiological point of view, the medicinal product should be used immediately upon reconstitution and dilution.
Croatian: S mikrobiološkog stajališta, lijek je potrebno primijeniti odmah nakon rekonstitucije i razrjeđivanja.
English: Therefore, caution should be exercised when driving or using machines.
Croatian: Stoga je potreban oprez prilikom upravljanja vozilima i rada sa strojevima.
English: The most common adverse reactions that occurred among 322 patients from the pooled Phase 3 trials were headache (8.1%), diarrhoea (4.7%), infusion site phlebitis (2.2%) and nausea (2.2%).
Croatian: Sažetak sigurnosnog profila Najčešće nuspojave koje su se pojavile u 322 bolesnika iz sakupljenih i analiziranih rezultata ispitivanja faze 3 bile su glavobolja (8,1%), proljev (4,7%), flebitis na mjestu infuzije (2,2%) i mučnina (2,2%).
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to
Croatian: Učestalost prijavljivanja definirana je kao: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često
English: Vaborem is not chemically compatible with glucose-containing solutions.
Croatian: Lijek Vaborem nije kemijski kompatibilan s otopinama koje sadrže glukozu.
English: The chemical and physical in-use stability has been demonstrated for up to 4 hours at 25 °C or within 22 hours at 2 - 8 °C.
Croatian: Dokazana kemijska i fizička stabilnost lijeka u primjeni je do 4 sata pri temperaturi od 25 °C ili unutar 22 sata pri temperaturi od 2 °C do 8 °C.
English: Limited post-marketing experience with meropenem alone indicates that if adverse reactions occur following overdose, they are consistent with the adverse reaction profile described in section 4.8, are generally mild in severity and resolve on withdrawal or dose reduction.
Croatian: Ograničeno iskustvo nakon stavljanja lijeka u promet samo s meropenemom ukazuje da ako nakon predoziranja uslijede nuspojave, one su u skladu s profilom nuspojava opisanim u dijelu 4.8, općenito su blage po težini i povlače se prekidom primjene ili smanjenjem doze.
English: Infections due to aerobic Gram-negative organisms in patients with limited treatment options
Croatian: Infekcije uzrokovane aerobnim Gramnegativnim organizmima u bolesnika s ograničenim mogućnostima liječenja
English: Before initiating therapy with Vaborem, careful inquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
Croatian: Prije započinjanja liječenja lijekom Vaborem, potrebno je pažljivo istražiti prethodne reakcije preosjetljivosti na betalaktamske antibiotike.
English: The terminal half-life (t½) is 2.30 hours and 2.25 hours for meropenem and vaborbactam, respectively.
Croatian: Terminalni poluvijek (t½) je 2,30 sata za meropenem i 2,25 sata za vaborbaktam.
English: Severe adverse reactions were observed in two patients (0.6 %), one infusion related reaction and one blood alkaline phosphatase increased respectively.
Croatian: Teške nuspojave zabilježene su u dva bolesnika (0,6%), jedna reakcija povezana s infuzijom odnosno jedan porast alkalne fosfataze u krvi.
English: Meropenem does not have activity against methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus epidermidis (MRSE) or vancomycin-resistant Enterococci (VRE).
Croatian: Meropenem nema aktivnost protiv meticilin rezistentnih sojeva Staphylococcus aureus (MRSA) i Staphylococcus epidermidis (MRSE) ili vankomicin rezistentnih sojeva Enterococci (VRE).
English: • Swelling, redness and/or pain around the needle where the medicine is given into a vein
Croatian: • oticanje, crvenilo i/ili bol oko igle gdje je lijek primijenjen u venu
English: Vaborbactam does not inhibit class D carbapenemases such as OXA-48 or class B metallo-β-lactamases such as NDM and VIM (see section 5.1).
Croatian: Vaborbaktam ne inhibira karbapenemaze klase D kao što je OXA-48 ili metalo-β-laktamaze klase B kao što su NDM i VIM (vidjeti dio 5.1).
English: For susceptibility testing purposes, the concentration of vaborbactam is fixed at 8 mg/l.
Croatian: 1Za svrhe testova osjetljivosti, koncentracija vaborbaktama fiksirana je na 8 mg/l.
English: This may affect your ability to drive, use tools or machines.
Croatian: To može utjecati na Vašu sposobnost upravljanja vozilima, rada s alatima ili strojevima
English: Tell your doctor before using Vaborem if any of the above apply to you.
Croatian: Obratite se svom liječniku prije primjene lijeka Vaborem ako se ništa od gore navedenog ne odnosi na Vas.
English: Within each System Organ Class, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake klasifikacije organskih sustava nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: This leaflet was last revised in:
Croatian: Ova uputa je zadnji puta revidirana u: Ostali izvori informacija
English: There have been many reports of increases in the anticoagulant effects of orally administered anticoagulants, including warfarin in patients, who are concomitantly receiving antibacterial agents.
Croatian: Postoji veliki broj prijava povećanja antikoagulacijskih učinaka peroralno primijenjenih antikoagulansa, uključujući varfarin u bolesnika koji istodobno primaju antibakterijske lijekove.
English: • you are allergic to other carbapenem antibiotics (the group to which meropenem belongs).
Croatian: • ako ste alergični na druge antibiotike karbapenema (skupina kojoj pripada meropenem).
English: It acts by forming a covalent adduct with beta-lactamases and is stable to beta-lactamase-mediated hydrolysis.
Croatian: Djeluje tako što formira kovalentni produkt adicije s betalaktamazama i stabilan je na hidrolizu posredovanu beta-laktamazom.
English: • you are allergic to meropenem, vaborbactam or the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na meropenem, vaborbaktam ili neki drugi sastojak ovog lijeka (naveden u dijelu
English: The recommended dose is 2 vials (a total of 2 g meropenem and 2 g vaborbactam), given every 8 hours.
Croatian: Preporučena doza je 2 bočice (ukupno 2 g meropenema i 2 g vaborbaktama) primijenjenih svakih 8 sati.
English: The following adverse reactions have been reported with meropenem alone and/or identified during the Phase 3 trials with Vaborem.
Croatian: Sljedeće nuspojave prijavljene su sa samim meropenemom i/ili zabilježene tijekom ispitivanja faze 3
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: O tome treba voditi računa ako ste na dijeti s kontroliranim unosom natrija.
English: The effects of meropenem/vaborbactam on fertility in humans have not been studied.
Croatian: Nisu ispitani učinci meropenema/vaborbaktama na plodnost u ljudi.
English: (≥1/100 to <1/10)
Croatian: (≥1/100 i <1/10)
English: • Increase in the amount of enzymes produced by your liver called alanine aminotransferase or aspartate aminotransferase - shown in blood tests
Croatian: • porast u broju enzima koje proizvodi Vaša jetra naziva alanin aminotransferaza ili aspartat aminotransferaza - vidljivo iz krvnih pretraga
English: Meropenem is a substrate of OAT1 and OAT3 and as such, probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem.
Croatian: Meropenem je supstrat OAT1 i OAT3 te kao takav, probenecid se natječe s meropenemom za aktivnu tubularnu sekreciju i stoga inhibira izlučivanje meropenema putem bubrega.