FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor or nurse before receiving Tygacil:
Croatian: Razgovarajte sa svojim liječnikom ili medicinskom sestrom prije nego primite Tygacil:
English: In rats receiving single or multiple doses of
Croatian: Kod štakora koji su primali jednokratne ili višekratne doze
English: * single dose AUC0-∞, multiple dose AUC0-12h
Croatian: * jedna doza AUC0-∞,, višekratna doza AUC0-12h
English: Clinical cure was assessed between 10 and 21 days after the administration of the last dose of treatment.
Croatian: Kliničko izlječenje procijenjeno je između 10 i 21 dana nakon primjene posljednje doze terapije.
English: AUC was estimated to be 20 % higher in females than in males.
Croatian: Procjenjuje se da je AUC 20% veći kod žena nego kod muškaraca.
English: Consequently, use in children should be restricted to those clinical situations where no alternative antibacterial therapy is available.
Croatian: Posljedično, primjenu kod djece treba ograničiti na kliničke situacije u kojima nema dostupne alternativne antibakterijske terapije.
English: It is important that you tell your doctor if you are taking medicines to avoid an excess of blood clotting (named anticoagulants).
Croatian: Važno je da Vašeg liječnika obavijestite ukoliko uzimate lijekove protiv pretjeranog zgrušavanja krvi (pod nazivom antikoagulansi).
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you or your child. - Keep this leaflet.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primati ovaj lijek jer sadrži Vama ili Vašem djetetu važne podatke.
English: Tygacil must not be mixed with other medicinal products for which compatibility data are not available.
Croatian: Tygacil se ne smije miješati s drugim lijekovima za koje ne postoje podaci o kompatibilnosti.
English: Therefore, caution is advised when treating such patients.
Croatian: Stoga je potreban oprez prilikom liječenja ovih bolesnika.
English: Talk to your doctor about the need for an additional method of contraception while receiving Tygacil.
Croatian: Razgovarajte s Vašim liječnikom o potrebi za dodatnom kontracepcijskom metodom za vrijeme uzimanja Tygacila.
English: † see section 5.1, Breakpoints above.
Croatian: † vidjeti gore dio 5.1, Granične vrijednosti.
English: Of these patients, 77.8 % had surgically-apparent peritonitis.
Croatian: Među ovim bolesnicima, 77,8 % je imalo kirurški verificirani peritonitis.
English: Your doctor will monitor you closely for any potential infections and treat you if necessary.
Croatian: Vaš će Vas liječnik pažljivo nadzirati kako bi uočio moguće infekcije i po potrebi započeo s liječenjem.
English: Clinical Cure, mITT Population 0.75 mg/kg
Croatian: Kliničko izlječenje, populacija mITT 0,75 mg/kg
English: Tygacil is only used when your doctor thinks other antibiotics are not suitable.
Croatian: Tygacil se primjenjuje samo u kada Vaš liječnik smatra da drugi antibiotici nisu prikladni.
English: During treatment with Tygacil:
Croatian: Tijekom liječenja Tygacilom:
English: This dose is given intravenously (directly into your blood stream) over a period of 30 to 60 minutes.
Croatian: Ova se doza primjenjuje intravenski (putem vene izravno u Vaš krvotok) tijekom razdoblja od 30 do 60 minuta.
English: • If you have blockage of the bile ducts (cholestasis).
Croatian: • Ako imate blokadu žučovoda (kolestaza).
English: Ask your doctor for advice before breast-feeding your baby.
Croatian: Upitajte za savjet Vašeg liječnika prije nego što ćete dojiti Vaše dijete.
English: Patients should be closely monitored for the development of superinfection.
Croatian: Bolesnike je potrebno pažljivo nadzirati s obzirom na razvoj superinfekcija.
English: Efficacy data above shown should be viewed with caution as concomitant antibiotics were allowed in this study.
Croatian: Podaci o učinkovitosti navedeni gore trebaju se promatrati s oprezom jer su u ovom ispitivanju dopušteni istodobni antibiotici.
English: Gram-negative Aerobes Citrobacter freundii* Citrobacter koseri Escherichia coli* Klebsiella oxytoca*
Croatian: Gram-negativni aerobi Citrobacter freundii* Citrobacter koseri Escherichia coli* Klebsiella oxytoca*
English: Common ≥ 1/100 to < 1/10
Croatian: Često ≥ 1/100 do < 1/10
English: On average, it is estimated that less than 20 % of tigecycline is metabolised before excretion.
Croatian: Procjenjuje se da se prosječno manje od 20% tigeciklina metabolizira prije izlučivanja.
English: Streptococcus anginosus group* (includes S. anginosus, S. intermedius and S. constellatus) Streptococcus pyogenes*
Croatian: Streptococcus anginosus skupina* (uključuje S. anginosus, S. intermedius i S. constellatus) Streptococcus pyogenes*
English: Pseudomonas aeruginosa *denotes species against which it is considered that activity has been satisfactorily demonstrated in clinical studies.
Croatian: Pseudomonas aeruginosa *označava vrstu za koju se smatra da je aktivnost zadovoljavajuće dokazana u kliničkim ispitivanjima.
English: No specific information is available on the treatment of overdosage.
Croatian: Nisu dostupni specifični podaci o liječenju predoziranja.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving Tygacil.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete Tygacil.
English: Pharmacokinetic parameters are summarised in the table below.
Croatian: Farmakokinetički parametri sažeti su u tablici dolje.
English: Higher Cmax values than in adult patients were observed in several children in these studies.
Croatian: Veće vrijednosti Cmax nego u odraslih bolesnika primijećene su u nekoliko djece u tim ispitivanjima.
English: The causes of these findings remain unknown, but poorer efficacy and safety than the study comparators cannot be ruled out.
Croatian: Uzrok ovih nalaza ostaje nepoznat, no ne može se isključiti slabija djelotvornost i sigurnost primjene u odnosu na ispitivane usporedne lijekove.
English: What you need to know before you receive Tygacil
Croatian: Što morate znati prije nego počnete primati Tygacil
English: Tigecycline should not be used during pregnancy unless the clinical condition of the woman requires treatment with tigecycline.
Croatian: Tigeciklin se ne smije primjenjivati u trudnoći, osim ako kliničko stanje žene ne zahtijeva liječenje tigeciklinom.
English: The safety and efficacy of Tygacil in children under 8 years of age have not been established.
Croatian: Sigurnost i djelotvornost Tygacila u djece mlađe od 8 godina nije utvrđena.
English: It should be noted that the MIC distributions for organisms of the genera Bacteroides and Clostridium are wide and may include values in excess of 2 mg/L tigecycline.
Croatian: Treba napomenuti da je distribucija MIK-a za organizme rodova Bacteroides i Clostridium široka i može uključivati vrijednosti veće od 2 mg/l tigeciklina.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Croatian: Po potrebi je nužno potražiti savjet stručnjaka u slučaju da je lokalna prevalencija rezistencije takva da je korist od lijeka barem kod jednog tipa infekcija upitna.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje u promet gotovog lijeka.
English: Do not use Tygacil
Croatian: Nemojte primjenjivati Tygacil
English: Lifetime studies in animals to evaluate the carcinogenic potential of tigecycline have not been performed, but short-term genotoxicity studies of tigecycline were negative.
Croatian: Doživotna ispitivanja na životinjama s ciljem procjene karcinogenog potencijala tigeciklina nisu provedena, ali su kratkoročna ispitivanja genotoksičnosti tigeciklina bila negativna.
English: • If you are allergic to tigecycline, or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na tigeciklin, ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Tygacil will be given to you by a doctor or a nurse.
Croatian: Tygacil će Vam primijeniti liječnik ili medicinska sestra.
English: For anaerobic bacteria there is clinical evidence of efficacy in polymicrobial intra-abdominal infections, but no correlation between MIC values, PK/PD data and clinical outcome.
Croatian: Za anaerobne bakterije postoje klinički dokazi o djelotvornosti kod polimikrobnih intraabdominalnih infekcija, ali nema korelacije između vrijednosti MIK-a, podataka o PK/PD i kliničkog ishoda.
English: Indication n/N (%)
Croatian: Indikacija n/N (%)
English: Tigecycline shows a polyexponential elimination from serum with a mean terminal elimination half-life after multiple doses of 42 hours although high interindividual variability exists.
Croatian: Tigeciklin pokazuje polieksponencijsku eliminaciju iz seruma sa srednjim poluvijekom eliminacije nakon višekratnog doziranja od 42 sata, premda postoje velike interindividualne varijacije.
English: The summary of clinical response in the modified intent-to-treat (mITT) population results is shown in the following table.
Croatian: Sažetak kliničkog odgovora u izmijenjenim rezultatima populacije s namjerom za liječenje (mITT) prikazana je u sljedećoj tablici.
English: Cases have been reported in patients without known risk factors for pancreatitis.
Croatian: Slučajevi su prijavljeni u bolesnika bez poznatog čimbenika rizika za pankreatitis.
English: Commonly Susceptible Species
Croatian: Često osjetljive vrste
English: In patients (including paediatrics) with severe hepatic impairment (Child Pugh C), the dose of tigecycline should be reduced by 50%.
Croatian: U bolesnika (uključujući i pedijatrijske bolesnike) s teškim oštećenjem jetre (Child Pugh C), potrebno je smanjiti dozu tigeciklina za 50%.
English: • Although antibiotics including Tygacil fight certain bacteria, other bacteria and fungi may continue to grow.
Croatian: • Premda se antibiotici poput Tygacila koriste protiv određenih bakterija, druge vrste bakterija i gljivice mogu nastaviti rasti.
English: • In certain serious infections, your doctor may consider to use Tygacil in combination with other antibiotics.
Croatian: • Kod nekih ozbiljnih infekcija Vaš liječnik može razmotriti primjenu Tygacila u kombinaciji s drugim antibioticima.
English: • Laboratory measurements of decreased ability to form blood clots
Croatian: • Laboratorijske vrijednosti koje upućuju na smanjenu sposobnost stvaranja krvnih ugrušaka
English: Gram-positive Aerobes
Croatian: Gram-pozitivni aerobi
English: Infections and infestations sepsis/septic shock, pneumonia, abscess, infections
Croatian: Infekcije i infestacije sepsa/septički šok, pneumonija, apsces, infekcije
English: This is called overgrowth.
Croatian: To se naziva pretjeranim rastom tih mikroorganizama.
English: Tigecycline pharmacokinetics was investigated in two studies.
Croatian: Farmakokinetika tigeciklina ispitana je u dva ispitivanja.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tigecycline therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja tigeciklinom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: All patients received IV tigecycline for a minimum of 3 consecutive days to a maximum of 14 consecutive days, with the option to be switched to an oral antibiotic on or after day 4.
Croatian: Svi bolesnici primili su tigeciklin u venu najmanje 3 uzastopna dana do najviše 14 uzastopnih dana, uz opciju prelaska na oralni antibiotik četvrtog dana ili nakon četvrtog dana.
English: These vials are distributed to the hospital in a ten tray pack.
Croatian: Bočice se isporučuju bolnici u pakiranju od deset komada.
English: mg/L and R  2 mg/L
Croatian: mg/l i R >2 mg/l
English: The potential contribution of P-gp-mediated transport to the in vivo disposition of tigecycline is not known.
Croatian: Potencijalni doprinos transporta posredovanog P-gp-om na in vivo raspoloživost tigeciklina nije poznata.
English: C-tigecycline indicates that 59 % of the dose is eliminated by biliary/faecal excretion, and 33 % is excreted in urine.
Croatian: C-tigeciklina pokazuje da se 59% doze eliminira izlučivanjem putem žuči/stolice, dok se 33% izlučuje u urinu.
English: Gram-negative Aerobes
Croatian: Gram-negativni aerobi
English: The adverse reaction profile of tigecycline in these 25 subjects was generally consistent with that in adults.
Croatian: Profil štetnog djelovanja tigeciklina u tih 25 ispitanika općenito je bio dosljedan profilu odraslih.
English: The powder should be mixed in the vial with a small amount of solution.
Croatian: Prašak se mora promiješati u bočici s malom količinom otopine.
English: cIAI cSSTI Overall
Croatian: cIAI cSSTI
English: Other medicines and Tygacil Tell your doctor if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: • If you have poor or slow wound healing.
Croatian: • Ako imate ranu koja slabo ili sporo zacjeljuje.
English: Tygacil may prolong certain tests that measure how well your blood is clotting.
Croatian: Tygacil može produžiti vrijednosti određenih pretraga kojima se određuje stupanj zgrušavanja Vaše krvi.
English: The duration of therapy should be guided by the severity, site of the infection, and the patient's clinical response.
Croatian: Trajanje terapije ovisi o težini, mjestu infekcije te o kliničkom odgovoru bolesnika.
English: Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response (see sections 4.4 and 5.2).
Croatian: Bolesnike s teškim oštećenjem jetre (Child Pugh C) treba liječiti oprezno i kontrolirati s obzirom na terapijski odgovor (vidjeti dijelove 4.4 i 5.2).
English: Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects.
Croatian: Vaše jetre, Vaš liječnik može smanjiti dozu kako bi se izbjegle moguće nuspojave.
English: How Tygacil is given in this leaflet)
Croatian: Kako primjenjivati Tygacil u ovoj uputi)
English: Tigecycline was not teratogenic in the rat or rabbit.
Croatian: Tigeciklin nije bio teratogen za štakore ili kuniće.
English: There were no clinically relevant differences in the clearance of tigecycline between men and women.
Croatian: Ne postoje klinički relevantne razlike u klirensu tigeciklina između muškaraca i žena.
English: As a consequence, care should be paid to the rate of infusion of tigecycline in children and adolescents.
Croatian: Zbog toga je potrebno obratiti pozornost na brzinu infuzije tigeciklina u djece i odraslih.
English: Pharmacotherapeutic group: Antibacterials for systemic use, tetracyclines, ATC code: J01AA12.
Croatian: Farmakoterapijska skupina: antibakterijski lijekovi za sustavnu primjenu, tetraciklini, ATK oznaka: J01AA12.
English: This consists of severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation, which may occur during or after your treatment.
Croatian: On uključuje težak, uporan ili krvavi proljev udružen s bolovima u trbuhu ili vrućicom, što može biti znak ozbiljne upale crijeva do koje može doći za vrijeme ili poslije Vašeg liječenja.
English: This medicinal product is for single use only; any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Ovaj je lijek namijenjen za jednokratnu primjenu; neupotrijebljeni lijek i sav otpadni materijal mora se odbaciti u skladu s lokalnim propisima.
English: This may impair your ability to drive or operate machinery.
Croatian: To može utjecati na sposobnost upravljanja vozilima ili strojevima.
English: Tigecycline has decreased in vitro activity against Proteus, Providencia, and Morganella spp.
Croatian: Tigeciklin in vitro ima smanjenu aktivnost protiv sojeva Proteus, Providencia i Morganella spp.
English: What Tygacil is and what it is used for What you need to know before you receive Tygacil How Tygacil is given
Croatian: Što je Tygacil i za što se koristi Što morate znati prije nego počnete primati Tygacil Kako primjenjivati Tygacil Moguće nuspojave
English: • Your doctor will monitor you closely for the development of any other bacterial infections.
Croatian: • Vaš će liječnik pažljivo pratiti hoćete li dobiti druge bakterijske infekcije.
English: Tigecycline is administered intravenously and therefore has 100 % bioavailability.
Croatian: Tigeciklin se primjenjuje intravenski i stoga je bioraspoloživost 100%-tna.
English: • Low protein levels in the blood
Croatian: • Niska razina proteina u krvi
English: Liver function tests, coagulation parameters, haematology parameters, amylase and lipase should be monitored prior to treatment initiation with tigecycline and regularly while on treatment.
Croatian: Testovi funkcije jetre, koagulacijski parametri, hematološki parametri, amilaza i lipaza trebaju se pratiti prije početka liječenja tigeciklinom i redovito tijekom trajanja liječenja.
English: No overall differences in pharmacokinetics were observed between healthy elderly subjects and younger subjects (see section 4.2).
Croatian: Općenito nisu opažene razlike u farmakokinetici između zdravih starijih ispitanika i mlađih ispitanika (vidjeti dio 4.2).
English: In addition, tigecycline did not show NADPH-dependency in the inhibition of CYP2C9, CYP2C19, CYP2D6 and CYP3A, suggesting the absence of mechanism-based inhibition of these CYP enzymes.
Croatian: Dodatno, tigeciklin ne pokazuje ovisnost o NADPH pri inhibiranju CYP2C9, CYP2C19, CYP2D6 i CYP3A, što ukazuje na nepostojanje mehanizmom utemeljene inhibicije tih CYP enzima.
English: • Sepsis (severe infection in the body and blood stream)/septic shock (serious medical condition which can lead to multiple organ failure and death as a result of sepsis)
Croatian: • Sepsa (teška infekcija tijela i krvotoka)/septički šok (ozbiljno medicinsko stanje koje može dovesti do zatajenja više organa i smrti uslijed sepse)
English: In humans, the steady-state volume of distribution of tigecycline averaged 500 to 700 L (7 to 9 L/kg), indicating that tigecycline is extensively distributed beyond the plasma volume and concentrates into tissues.
Croatian: Kod ljudi je volumen distribucije tigeciklina u stanju dinamičke ravnoteže iznosio prosječno 500 do 700 l (7 do 9 l/kg), što upućuje na to da se tigeciklin opsežno distribuira izvan volumena plazme i koncentrira u tkivima.
English: Powder for solution for infusion (powder for infusion).
Croatian: Prašak za otopinu za infuziju (prašak za infuziju).
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: The in vitro plasma protein binding of tigecycline ranges from approximately 71 % to 89 % at concentrations observed in clinical studies (0.1 to 1.0 mcg/ml).
Croatian: In vitro vezanje tigeciklina na proteine plazme odvija se u rasponu od otprilike 71% do 89% pri koncentracijama koje su opažene u kliničkim ispitivanjima (0,1 do 1,0 g/ml).
English: Abdominal pain may be indicative of pancreatitis.
Croatian: Bol u abdomenu može indicirati pankreatitits.
English: There is no target-based cross-resistance between tigecycline and most classes of antibiotics.
Croatian: Ne postoji ciljno utemeljena križna rezistencija između tigeciklina i većine skupina antibiotika.
English: Species for which acquired resistance may be a problem Gram-negative Aerobes
Croatian: Vrste kod kojih stečena rezistencija može predstavljati problem
English: The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Croatian: Prevalencija stečene rezistencije za pojedine vrste može se razlikovati s obzirom na zemljopisni položaj i vrijeme, te su stoga poželjne lokalne informacije o rezistenciji, posebice ukoliko se radi o liječenju teških infekcija.
English: Tygacil should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1).
Croatian: Tygacil se može primjenjivati samo u situacijama kada alternativni antibiotici nisu prikladni (vidjeti dijelove 4.4, 4.8 i 5.1).
English: • Abscess (collection of pus), infections
Croatian: • Apsces (nakupina gnoja), infekcije
English: Blood and lymphatic system disorders prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT)
Croatian: Poremećaji krvi i limfnog sustava produženo aktivirano parcijalno tromboplastinsko vrijeme (APTV), produženo protrombinsko vrijeme (PV)
English: Antibiotic class effects
Croatian: Učinak klase antibiotika
English: • Tell your doctor immediately if you develop severe abdominal pain, nausea, and vomiting.
Croatian: • Odmah obavijestite liječnika ako razvijete jaku bol u abdomenu, mučninu i povraćanje.
English: Concurrent use of antibiotics with oral contraceptives may render oral contraceptives less effective.
Croatian: Istovremena primjena antibiotika s peroralnim kontraceptivima može umanjiti djelotvornost peroralnih kontraceptiva.
English: No data are available on whether tigecycline can cross the blood-brain barrier in humans.
Croatian: Nema dostupnih podataka o tome može li tigeciklin kod ljudi prolaziti kroz krvno-moždanu barijeru.
English: Abdominal pain is commonly reported in children as it is in adults.
Croatian: Bol u abdomenu često je prijavljivana u djece i u odraslih.
English: The results in a large study in patients with diabetic foot infection, showed that tigecycline was less effective than comparator, therefore, tigecycline is not recommended for use in these patients (see section 4.1).
Croatian: Rezultati velikog ispitivanja u bolesnika s infekcijom dijabetičkog stopala pokazali su da je tigeciklin bio manje učinkovit od terapije s kojom je uspoređivan, zbog toga se tigeciklin ne preporučuje za primjenu kod takvih bolesnika (vidjeti dio 4.1).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
English: Intravenous administration of tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting.
Croatian: Intravenska primjena tigeciklina u zdravih dobrovoljaca u jednokratnoj dozi od 300 mg tijekom 60 minuta dovelo je do povećane incidencije mučnine i povraćanja.
English: • Poor or slow wound healing
Croatian: • Slabo ili sporo zacjeljivanje rana
English: Bone discolouring was observed in rats which was not reversible after two weeks of dosing.
Croatian: Promjena boje kostiju opažena je kod štakora, no nije bila reverzibilna nakon dva tjedna doziranja.
English: If you develop another bacterial infection, your doctor may prescribe a different antibiotic specific for the type of infection present.
Croatian: Ako razvijete drugu bakterijsku infekciju, liječnik će vam možda prepisati drugi antibiotik usmjeren na tu vrstu infekcije.
English: Tygacil may interfere with the contraceptive pill (birth control pill).
Croatian: Tygacil može ometati učinak kontracepcijske tablete (tablete protiv začeća).
English: Uncommon ≥ 1/1,000 to
Croatian: Manje često ≥ 1/1000 do