FrancophonIA/ELRC3.0 huggingface dataset:
English: Rare - may affect up to 1 in 1,000 people: • Difficulty breathing (bronchospasm)
Croatian: Rijetke - mogu se javiti u do 1 na 1000 osoba: • Otežano disanje (bronhospazam)
English: This severe reaction has been reported as a rare side effect.
Croatian: Ova teška reakcija zabilježena je kao rijetka nuspojava.
English: Do not use Xydalba if you are allergic to dalbavancin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primjenjivati Xydalbu ako ste alergični na dalbavancin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: This medicine does not require any special storage conditions if kept unopened in the original container.
Croatian: Ovaj lijek ne zahtijeva posebne uvjete čuvanja, ako se čuva neotvoren u originalnom spremniku.
English: Metabolites have not been observed in significant amounts in human plasma.
Croatian: Metaboliti u ljudskoj plazmi nisu uočeni u značajnim količinama.
English: Important: Please refer to the Summary of Product Characteristics (SmPC) before prescribing.
Croatian: Važno: Molimo pogledajte Sažetak opisa svojstava lijeka (SmPC) prije propisivanja lijeka.
English: What Xydalba is and what it is used for
Croatian: Što je Xydalba i za što se koristi
English: Common - may affect up to 1 in 10 people: Headache
Croatian: Česte - mogu se javiti u do 1 na 10 osoba: • Glavobolja
English: Dalbavancin is reversibly bound to human plasma proteins, primarily to albumin.
Croatian: Dalbavancin se reverzibilno veže na proteine ljudske plazme, prvenstveno na albumin.
English: • If you have or have had kidney problems.
Croatian: • Ako imate ili ste imali tegoba s bubrezima.
English: It may affect up to 1 in 1,000 people.
Croatian: Može se pojaviti kod do 1 na 1000 osoba.
English: Contents of the pack and other information What Xydalba contains
Croatian: Sadržaj pakiranja i druge informacije Što Xydalba sadrži
English: These infusion reactions were transient (resolved within 1 hour post-dosing) and were attributed to histamine release.
Croatian: Ove reakcije na infuziju bile su prolazne (prošle su unutar 1 sat nakon doze) i bile su pripisane otpuštanju histamina.
English: Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA United Kingdom
Croatian: Seagoe Industrial Estate, Craigavon, Country Armagh BT63 5UA Ujedinjeno Kraljevstvo
English: Day 1: 281 (52)
Croatian: 1. dan: 281 (52)
English: There are no data on dalbavancin as an inhibitor of CYP2C8.
Croatian: Nema podataka o dalbavancinu kao inhibitoru CYP2C8.
English: The pharmacokinetics of dalbavancin are best described using a three-compartment model (α and β distributional phases followed by a terminal elimination phase).
Croatian: Farmakokinetika dalbavancina najbolje se opisuje pomoću modela s tri odjeljka (α i β faze distribucije nakon čega slijedi faza terminalne eliminacije).
English: This medicinal product must not be mixed with other medicinal products or intravenous solutions other than those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati s drugim lijekovima ili intravenskim otopinama osim onih navedenih u dijelu 6.6.
English: • An increase in alkaline phosphatase (an enzyme found in the body)
Croatian: • Povećanje razine alkalne fosfataze (enzima koji se nalazi u tijelu)
English: If you experience these types of reactions your doctor may decide to stop or slow the infusion.
Croatian: Ako imate ovu vrstu reakcije, Vaš liječnik može odlučiti prekinuti ili usporiti infuziju.
English: If you are given more Xydalba than you should
Croatian: Ako primite više Xydalbe nego što ste trebali
English: The volume of distribution at steady state was similar to the volume of extracellular fluid.
Croatian: Volumen distribucije u stanju dinamičke ravnoteže bio je sličan volumenu izvanstanične tekućine.
English: What Xydalba looks like and contents of the pack
Croatian: Kako Xydalba izgleda i sadržaj pakiranja
English: Approximately 20 % of the administered dose was excreted in faeces.
Croatian: Oko 20 % primijenjene doze je izlučeno u stolici.
English: AUC0-Day14
Croatian: AUC0-dan14
English: Reproductive toxicity studies in rats and rabbits showed no evidence of a teratogenic effect.
Croatian: Ispitivanja reproduktivne toksičnosti u štakora i kunića nisu dokazala teratogeni učinak.
English: The pharmacokinetics of dalbavancin were not significantly altered with age; therefore, dose adjustment is not necessary based on age (see section 4.2).
Croatian: Farmakokinetika dalbavancina nije se značajno mijenjala s dobi; prema tome, nije potrebno prilagođavanje doze na temelju dobi (vidjeti dio 4.2).
English: • Change in sense of taste
Croatian: • Promjena osjeta okusa
English: Xydalba must not be mixed with other medicinal products or intravenous solutions.
Croatian: Xydalba se ne smije miješati s drugim lijekovima ili intravenskim otopinama.
English: Xydalba is not recommended during pregnancy, unless the potential expected benefit clearly justifies the potential risk to the foetus.
Croatian: Ne preporučuje se koristiti lijek Xydalba tijekom trudnoće, osim ako potencijalna očekivana korist jasno opravdava potencijalni rizik za plod.
English: If you also have other bacteria that cause your infection, your doctor may decide to treat you with other antibiotics in addition to Xydalba.
Croatian: Ukoliko kod Vas infekciju uzrokuju i druge vrste bakterija, Vaš liječnik može odlučiti liječiti Vas drugim antibioticima uz Xydalbu.
English: Dalbavancin toxicity profile in juvenile rats was consistent with that previously observed in adult rats at the same dose (mg/kg /day) levels.
Croatian: Profil toksičnosti dalbavancina u mladih štakora bio je u skladu s onim prethodno uočenim kod odraslih štakora pri istoj razini doze (mg/kg/dan).
English: In vivo PK/PD relationship of dalbavancin for S. aureus was investigated using a neutropenic model of animal infection that showed that net reduction in the log10 of colony-forming units (CFU) was greatest when larger doses were given less frequently.
Croatian: In vivo PK/PD odnos dalbavancina za S. aureus ispitivan je pomoću neutropenijskog modela infekcije na životinjama koji je pokazao da je neto smanjenje log10 jedinica koje stvaraju koloniju (CFU) bilo najveće kad su se veće doze davale rjeđe.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kartonska kutija
English: Ask your doctor for advice before breast-feeding your baby.
Croatian: Obratite se svom liječniku za savjet prije dojenja djeteta.
English: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Ireland
Croatian: Allergan Pharmaceuticals International Ltd., Clonshaugh Business & Technology Park, Dublin 17, D17 E400, Irska
English: Chemical and physical in-use stability of Xydalba has been demonstrated for both the reconstituted concentrate and for the diluted solution for 48 hours at or below 25 °C.
Croatian: Dokazana kemijska i fizička stabilnost Xydalbe tijekom uporabe za rekonstituirani koncentrat i za razrijeđenu otopinu iznosi 48 sati na ili ispod 25 °C.
English: In this situation, you should not take medicines that stop or slow bowel movement.
Croatian: U tom slučaju, ne smijete uzimati lijekove koji zaustavljaju ili usporavaju rad crijeva.
English: The symptoms may become severe or may not go away and the stools may contain blood or mucus.
Croatian: Simptomi mogu postati teški ili mogu trajati, a stolica može sadržavati krv ili sluz.
English: If an allergic reaction to dalbavancin occurs, administration should be discontinued and appropriate therapy for the allergic reaction should be instituted.
Croatian: Ako se pojavi alergijska reakcija na dalbavancin, potrebno je prekinuti primjenu lijeka i započeti odgovarajuću terapiju za alergijsku reakciju.
English: Thus, the distributional half-life (t1/2β), which constitutes most of the clinically-relevant concentration-time profile, ranged from 5 to 7 days and is consistent with once-weekly dosing.
Croatian: Tako se distribucijski poluvijek (t1/2β), koji čini većinu klinički relevantnog profila koncentracija-vrijeme nalazi u rasponu od 5 do 7 dana i u skladu je s doziranjem jednom tjedno.
English: Instructions for reconstitution and dilution
Croatian: Upute za rekonstituciju i razrjeđivanje
English: Minimum inhibitory concentration (MIC) breakpoints determined by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are:
Croatian: Granične vrijednosti pri testiranju osjetljivosti Granične vrijednosti minimalne inhibitorne koncentracije (MIK) određene od strane Europskog povjerenstva za ispitivanje antimikrobne osjetljivosti (EUCAST) su:
English: Day 1: 411 (86)
Croatian: 1. dan: 411 (86)
English: The mean terminal elimination half-life (t1/2) was 372 (range 333 to 405) hours.
Croatian: Srednja vrijednost terminalnog poluvijeka eliminacije (t1/2) iznosila je 372 (raspon 333 do 405) sata.
English: Day 8: 141 (26)
Croatian: 8. dan: 141 (26)
English: If you miss a dose of Xydalba
Croatian: Ako propustite dozu Xydalbe
English: Other medicines and Xydalba
Croatian: Drugi lijekovi i Xydalba
English: Metabolism and nutrition disorders decreased appetite
Croatian: Poremećaji metabolizma i prehrane smanjeni apetit
English: It may affect up to 1 in 100 people.
Croatian: Može se pojaviti kod do 1 na 100 osoba.
English: There is no experience with dalbavancin in the treatment of severely immunocompromised patients.
Croatian: Nema iskustva s dalbavancinom u liječenju teško imunokompromitiranih bolesnika.
English: Pharmacotherapeutic group: antibacterials for systemic use, glycopeptide antibacterials, ATC code: J01XA04.
Croatian: Farmakoterapijska skupina: antibakterijski lijekovi za sistemsku primjenu, glikopeptidni antibakterijski lijekovi, ATK oznaka: J01XA04.
English: What you need to know before you are given Xydalba
Croatian: Što morate znati prije nego primite Xydalbu
English: Mean (SD) dalbavancin pharmacokinetic parameters using population PK analysis1 Parameter
Croatian: Prosječni (SD) farmakokinetički parametri dalbavancina korištenjem analize populacijske PK1
English: To avoid foaming, alternate between gentle swirling and inversion of the vial, until its contents are completely dissolved.
Croatian: Kako biste izbjegli pjenjenje, naizmjenično lagano okrećite i preokrećite bočicu, dok se njen sadržaj potpuno ne otopi.
English: Results from an in vitro receptor screening study do not indicate a likely interaction with other therapeutic targets or a potential for clinically relevant pharmacodynamic interactions (see section 5.1).
Croatian: Rezultati in vitro ispitivanja na receptorima na temelju probira (engl. receptor screening study) nisu ukazali na vjerojatnu interakciju s drugim terapijskim metama ili potencijal za klinički relevantne farmakodinamičke interakcije (vidjeti dio 5.1).
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the treatment with dalbavancin (see section 4.8).
Croatian: Stoga je važno uzeti u obzir tu dijagnozu u bolesnika kod kojih se pojavi proljev za vrijeme ili neposredno nakon liječenja dalbavancinom (vidjeti dio 4.8).
English: You and your doctor will decide if you will be given Xydalba.
Croatian: Vi i Vaš liječnik ćete odlučiti hoćete li uzimati Xydalbu.
English: Examples of such transporter inhibitors are boosted protease inhibitors, verapamil, quinidine, itraconazole, clarithromycin and cyclosporine.
Croatian: Primjeri takvih inhibitora transportera su pojačani inhibitori proteaze, verapamil, kinidin, itrakonazol, klaritromicin i ciklosporin.
English: You will be given Xydalba through a drip directly into your bloodstream through a vein (intravenously) over 30 minutes.
Croatian: Xydalbu ćete primiti kapanjem izravno u krvotok kroz venu (intravenski) tijekom 30 minuta.
English: Xydalba is to be administered via intravenous infusion, using a total infusion time of 30 minutes to minimise the risk of infusion-related reactions.
Croatian: Xydalba se primjenjuje intravenskom infuzijom kroz ukupno vrijeme infuzije od 30 minuta kako bi se smanjio rizik od reakcija povezanih s infuzijom.
English: Discard any portion of the reconstituted solution that remains unused.
Croatian: Bacite svu rekonstituiranu otopinu koja ostane neiskorištena.
English: • The active substance is dalbavancin.
Croatian: • Djelatna tvar je dalbavancin.
English: The safety profile of dalbavancin in the subjects aged between 12 and 16 years in this study was consistent with the safety profile observed in adults treated with dalbavancin.
Croatian: Sigurnosni profil dalbavancina u ispitanika u dobi između 12 i 16 godina u ovom ispitivanju bio je u skladu sa sigurnosnim profilom uočenim u odraslih liječenih dalbavancinom.
English: Xydalba will be given to you by a doctor or nurse.
Croatian: Lijek Xydalbu primijenit će Vam liječnik ili medicinska sestra.
English: You should not breastfeed when given Xydalba.
Croatian: Ne smijete dojiti dok uzimate Xydalbu.
English: Other side effects reported with Xydalba are listed below.
Croatian: Druge nuspojave prijavljene s Xydalbom navedene su u nastavku.
English: If the isolates with higher dalbavancin MICs represent stable phenotypes and are correlated with resistance to the other glycopeptides, then the likely mechanism would be an increase in the number of glycopeptide targets in nascent peptidoglycan.
Croatian: Ako izolati s višim MIK-om dalbavancina predstavljaju stabilne fenotipove i povezani su s rezistencijom na druge glikopeptide, tada bi vjerojatan mehanizam mogao biti porast broja glikopeptidnih ciljeva u nastajućem peptidoglikanu.
English: Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate, Dundalk,
Croatian: Almac Pharma Services (Irska) Limited Finnabair Industrial Estate, Dundalk,
English: • If you are suffering from diarrhoea, or you have previously suffered from diarrhoea when being treated with antibiotics.
Croatian: • Ako imate proljev ili ste prije imali proljev dok ste bili liječeni antibioticima.
English: In in vitro studies, no antagonism has been observed between dalbavancin and other commonly used antibiotics (i.e. cefepime, ceftazidime, ceftriaxone, imipenem, meropenem, amikacin, aztreonam, ciprofloxacin, piperacillin/tazobactam and trimethoprim/sulfamethoxazole), when tested against 12 species of Gram-negative pathogens (see section 4.5).
Croatian: U in vitro ispitivanjima, nije primijećen antagonizam između dalbavancina i drugih često korištenih antibiotika (npr. cefepim, ceftazidim, ceftriakson, imipenem, meropenem, amikacin, aztreonam, ciprofloksacin, piperacilin/tazobaktam i trimetoprim/sulfametoksazol) kad su se testirali na 12 vrsti gram-negativnih patogena (vidjeti dio 4.5).
English: Talk to your doctor, pharmacist or nurse if you get any of the following side effects:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri ako dobijete neku od sljedećih nuspojava:
English: Xydalba may have a minor influence on the ability to drive and use machines, as dizziness has been reported in a small number of patients (see section 4.8).
Croatian: Xydalba može imati mali utjecaj na sposobnost upravljanja vozilima i rada sa strojevima budući da je omaglica prijavljena kod malog broja bolesnika (vidjeti dio 4.8).
English: Co-administration with inhibitors of these transporters may increase the exposure to dalbavancin.
Croatian: Istodobna primjena s inhibitorima tih transportera može povećati izloženost dalbavancinu.
English: Depending on the condition of your kidney, your doctor may have to reduce your dose.
Croatian: Ovisno o stanju Vaših bubrega, Vaš liječnik će možda morati smanjiti Vašu dozu lijeka.
English: Treatment of overdose with dalbavancin should consist of observation and general supportive measures.
Croatian: Liječenje predoziranja dalbavancinom sastoji se od promatranja i općenito mjera potpore.
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Croatian: Nemojte uzimati nikakve lijekove za liječenje proljeva bez savjetovanja sa svojim liječnikom.
English: All Gram-negative bacteria are inherently resistant to dalbavancin.
Croatian: Sve gram-negativne bakterije urođeno su rezistentne na dalbavancin.
English: Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults (see sections 4.4 and 5.1).
Croatian: Xydalba je indicirana za liječenje akutnih bakterijskih infekcija kože i kožnih struktura u odraslih osoba (vidjeti dijelove 4.4 i 5.1).
English: The metabolic pathways responsible for producing these metabolites have not been identified; however, due to the relatively minor contribution of metabolism to the overall elimination of dalbavancin, drug-drug interactions via inhibition or induction of metabolism of dalbavancin are not anticipated.
Croatian: Metabolički putovi odgovorni za stvaranje tih metabolita nisu identificirani; međutim, zahvaljujući relativno malom doprinosu metabolizma ukupnoj eliminaciji dalbavancina, ne očekuju se interakcije lijekova putem inhibicije ili indukcije metabolizma dalbavancina.
English: Systemic exposures to dalbavancin are dose proportional following single doses over a range of 140 to 1120 mg, indicating linear pharmacokinetics of dalbavancin.
Croatian: Sistemska izloženost dalbavancinu je proporcionalna dozi nakon jednokratnih doza u rasponu od 140 do 1120 mg, što ukazuje na linearnu farmakokinetiku dalbavancina.
English: The plasma protein binding of dalbavancin is 93 % and is not altered as a function of drug concentration, renal insufficiency, or hepatic insufficiency.
Croatian: Vezanje dalbavancina na proteine plazme iznosi 93 % i ne mijenja se kao funkcija koncentracije lijeka, bubrežne ili jetrene insuficijencije.
English: Its mechanism of action in susceptible Gram-positive bacteria involves interruption of cell wall synthesis by binding to the terminal D-alanyl-D-alanine of the stem peptide in nascent cell wall peptidoglycan, preventing cross-linking (transpeptidation and transglycosylation) of disaccharide subunits resulting in bacterial cell death.
Croatian: Njegov mehanizam djelovanja na osjetljive gram-pozitivne bakterije podrazumijeva prekid sinteze stanične stijenke vezanjem na terminalni D-alanil-D-alanin osnovnog peptida u nastajućem peptidoglikanu stanične stijenke, sprječavajući unakrsno povezivanje (transpeptidaciju i transglikozilaciju) podjedinica disaharida što rezultira smrću bakterijske stanice.
English: However, dalbavancin is excreted in the milk of lactating rats and may be excreted in human breast milk.
Croatian: Međutim, dalbavancin se izlučuje u mlijeko štakora u laktaciji i mogao bi se izlučivati u majčino mlijeko u ljudi.
English: The following adverse reactions have been identified in Phase 2/3 clinical trials with dalbavancin.
Croatian: Sljedeće nuspojave su identificirane u kliničkim ispitivanjima faze 2/3 s dalbavancinom.
English: • Sudden swelling of your lips, face, throat or tongue; severe rash; itchiness; throat tightening; drop in blood pressure; difficulty in swallowing and /or difficulty in breathing.
Croatian: • Iznenadno oticanje usana, lica, grla ili jezika, teški osip, svrbež, stezanje u grlu, pad krvnog tlaka, poteškoće pri gutanju i/ili poteškoće pri disanju.
English: Xydalba is used to treat adults with infections of the skin or in the layers of flesh below the skin.
Croatian: Xydalba se koristi za liječenje odraslih osoba s infekcijama kože ili slojeva tkiva ispod kože.
English: In mixed infections in which Gram-negative bacteria are suspected patients should also be treated with an appropriate antibacterial agent(s) against Gram-negative bacteria (see section 5.1).
Croatian: Kad se kod mješovitih infekcija posumnja na gram-negativne bakterije, bolesnike također treba liječiti odgovarajućim antibakterijskim lijekovima protiv gram-negativnih bakterija (vidjeti dio 5.1).
English: There is limited data on safety and efficacy of dalbavancin when administered for more than two doses (one week apart).
Croatian: Podaci o sigurnosti i djelotvornosti dalbavancina kad se primjenjuje u više od dvije doze (u razmaku od jednog tjedna) su ograničeni.
English: Information on the efficacy and safety of dalbavancin in patients with creatinine clearance < 30 ml/min is limited.
Croatian: Podaci o djelotvornosti i sigurnosti dalbavancina u bolesnika s klirensom kreatinina < 30 ml/min su ograničeni.
English: Tell your doctor or nurse immediately if you are concerned that you are missing the 2nd dose.
Croatian: Odmah obavijestite svog liječnika ili medicinsku sestru ako ste zabrinuti da ste propustili drugu dozu.
English: The pharmacokinetics of dalbavancin have been characterised in healthy subjects, patients, and special populations.
Croatian: Farmakokinetika dalbavancina okarakterizirana je kod zdravih ispitanika, bolesnika i posebnih populacija.
English: Dalbavancin is not well absorbed orally; however, an impact on the gastrointestinal flora or mouth flora of a breast-feeding infant cannot be excluded.
Croatian: Dalbavancin se peroralno ne apsorbira dobro; međutim, ne može se isključiti utjecaj na gastrointestinalnu ili usnu floru dojenčeta.
English: The cause and the clinical significance of the decreased exposure in subjects with moderate and severe hepatic function are unknown.
Croatian: Uzrok i klinički značaj smanjene izloženosti kod ispitanika s umjerenim i teškim oštećenjem funkcije jetre su nepoznati.
English: Tabulated list of adverse reactions (Table 1)
Croatian: Tablični popis nuspojava (Tablica 1)
English: It kills these bacteria by interfering with the formation of bacterial cell walls.
Croatian: Te bakterije ubija sprečavanjem stvaranja bakterijskih staničnih stijenki.
English: Анджелини Фарма България ЕООД бул.
Croatian: АнджелиниФармаБългария ЕООД бул.
English: It is not known if dalbavancin is an inhibitor of transporters.
Croatian: Nije poznato je li dalbavancin inhibitor transportera.
English: Sodium chloride solutions may cause precipitation and must not be used for reconstitution or dilution (see section 6.6).
Croatian: Otopine natrijevog klorida mogu uzrokovati taloženje i ne smiju se koristiti za rekonstituciju ili razrjeđivanje (vidjeti dio 6.6).
English: The reconstituted concentrate must be a clear, colourless to yellow solution with no visible particles.
Croatian: Rekonstituirani koncentrat mora biti bistra, bezbojna do žuta otopina bez vidljivih čestica.
English: Studies in animals have shown reduced fertility (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su smanjenu plodnost (vidjeti dio 5.3).
English: • Abnormal liver function test
Croatian: • Poremećen test funkcije jetre
English: Diarrhoea during or after treatment If you develop diarrhoea during or after your treatment, tell your doctor at once.
Croatian: Ako dobijete proljev za vrijeme ili nakon Vašeg liječenja, odmah recite svom liječniku.
English: Elderly No dose adjustment is necessary (see section 5.2).
Croatian: Nije potrebno prilagođavanje doze (vidjeti dio 5.2).
English: Increased exposure to transporter substrates sensitive for inhibited transporter activity, such as statins and digoxin, cannot be excluded if combined with dalbavancin.
Croatian: Ne može se isključiti povećana izloženost supstratima transportera osjetljivim na inhibiciju aktivnosti transportera, kao što su statini i digoksin, ako se primjenjuju u kombinaciji s dalbavancinom.
English: Based on in vitro studies the activity of dalbavancin is not affected by other classes of vancomycin resistance genes.
Croatian: Na temelju in vitro ispitivanja, na aktivnost dalbavancina ne utječu druge skupine gena rezistencije na vankomicin.
English: Caution should be exercised when prescribing dalbavancin to patients with moderate or severe hepatic impairment (Child-Pugh B & C) as no data are available to determine appropriate dosing (see sections 5.2).
Croatian: Pri propisivanju dalbavancina bolesnicima s umjerenim ili teškim oštećenjem jetre (Child-Pugh B & C) potreban je oprez, jer nema raspoloživih podataka za određivanje odgovarajućeg doziranja (vidjeti dio 5.2).