FrancophonIA/ELRC3.0 huggingface dataset:
English: Although no effects on the breastfed newborns/infants are anticipated since the systemic exposure to fidaxomicin is low, a risk to the newborns/infants cannot be excluded.
Croatian: Iako se u dojene novorođenčadi/dojenčadi ne očekuju nikakvi učinci, budući da je sistemska izloženost fidaksomicinu niska, rizik za novorođenčad/dojenčad ne može se isključiti.
English: − ketoconazole (a medicine used to treat fungal infections)
Croatian: − ketokonazol (lijek koji se primjenjuje za liječenje gljivičnih infekcija)
English: Fidaxomicin (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure.
Croatian: Fidaksomicin (200 mg dvaput na dan) imao je mali, ali ne i klinički važan učinak na izloženost digoksinu.
English: DIFICLIR blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking DIFICLIR.
Croatian: Na razine DIFICLIR-a u krvi mogu utjecati ostali lijekovi koje uzimate i DIFICLIR može utjecati na razine ostalih lijekova u krvi.
English: In the two clinical trials of patients with CDI, 47.9% (479/999) of patients (per protocol population) were ≥65 years of age and 27.5% (275/999) of patients were treated with concomitant antibiotics during the study period.
Croatian: U dva klinička ispitivanja u bolesnika s infekcijom uzrokovanom bakterijom C. difficile, 47,9% (479/999) bolesnika (populacija liječena prema protokolu) bilo je u dobi od 65 ili više godina, a 27,5% (275/999) bolesnika bilo je liječeno istovremeno primijenjenim antibioticima tijekom razdoblja ispitivanja.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with fidaxomicin in one or more subsets of the paediatric population in enterocolitis caused by C. difficile (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja fidaksomicina u jednoj ili više podskupina pedijatrijske populacije u enterokolitisu uzrokovanom C. difficile (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: The volume of distribution in humans is unknown, due to very limited absorption of fidaxomicin.
Croatian: Volumen distribucije u ljudi nije poznat, zbog vrlo ograničene apsorpcije fidaksomicina.
English: − dizziness, headache
Croatian: − omaglica, glavobolja
English: − bloated feeling, wind (flatulence)
Croatian: − osjećaj nadutosti, vjetrovi (flatulencija)
English: The epidemiological cut-off value for fidaxomicin and C. difficile, distinguishing the wild-type population from isolates with acquired resistance traits, is ≥1.0 mg/L.
Croatian: Epidemiološka granična vrijednost za fidaksomicin i C. difficile, pomoću koje se populacija divljeg tipa razlikuje od izolata s osobinama stečene rezistencije, iznosi ≥ 1,0 mg/l.
English: Fidaxomicin is a topically acting drug that cannot be used to treat systemic infections; therefore the establishment of a clinical breakpoint is not relevant.
Croatian: Fidaksomicin je lijek s topikalnim djelovanjem koji se ne može primjenjivati za liječenje sistemskih infekcija; stoga utvrđivanje kliničkih graničnih vrijednosti nije svrsishodno.
English: You should not use DIFICLIR in combination with one of these medicines, unless your doctor tells you otherwise.
Croatian: Ne smijete primjenjivati DIFICLIR u kombinaciji s nekim od ovih lijekova, osim ako Vam liječnik nije savjetovao drugačije.
English: If you feel that you might have a severe allergic reaction such as trouble breathing (dyspnea), swelling of the face or throat (angioedema), severe rash or severe itching (pruritus), stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department (see section 4).
Croatian: Ako smatrate da možda imate jaku alergijsku reakciju, kao što je otežano disanje (dispneja), oticanje lica ili grla (angioedem), jaki osip ili jaki svrbež (pruritus), prestanite uzimati DIFICLIR i hitno potražite medicinski savjet od Vašeg liječnika, ljekarnika ili u hitnoj službi Vaše lokalne bolnice (pogledajte dio 4)..
English: The bioavailability in humans is unknown.
Croatian: Nije poznato kakva je bioraspoloživost u ljudi.
English: You should not take DIFICLIR if you are pregnant, unless your doctor tells you otherwise.
Croatian: Ne smijete uzimati DIFICLIR ako ste trudni, osim ako Vam liječnik nije savjetovao drugačije.
English: Specific mutations of RNA polymerase are associated with reduced susceptibility to fidaxomicin.
Croatian: Posebne mutacije RNK-polimeraze povezane su sa smanjenom osjetljivošću na fidaksomicin.
English: − dronedarone and amiodarone (medicines used to control the heartbeat)
Croatian: − dronedaron i amiodaron (lijekovi koji se primjenjuju za kontrolu srčanog ritma)
English: Gram negative organisms are intrinsically not susceptible to fidaxomicin.
Croatian: Gram negativni mikroorganizmi nisu intrinzički osjetljivi na fidaksomicin.
English: Other medicines and DIFICLIR Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: Following a single dose of 200 mg fidaxomicin, the majority of the administered dose (over 92%) was recovered in the stool as fidaxomicin or its metabolite OP-1118 (66%).
Croatian: Nakon primjene jednokratne doze od 200 mg fidaksomicina, veći dio primijenjene doze (više od 92%) bio je nađen u stolici u obliku fidaksomicina ili njegovog metabolita OP-1118 (66%).
English: No adverse reactions for acute overdose have been reported during clinical studies or from post-marketing data.
Croatian: Nije bilo prijavljenih nuspojava za slučajeve akutnog predoziranja tijekom kliničkih ispitivanja ili iz podataka dobivenih nakon stavljanja lijeka u promet.
English: There are no data available from the use of fidaxomicin in pregnant women.
Croatian: Nema dostupnih podataka o primjeni fidaksomicina u trudnica.
English: Twenty-four percent of patients met at least one of the following three criteria at baseline for scoring severity: body temperature >38.5°C, leukocyte count >15,000, or creatinine value ≥1.5 mg/dl.
Croatian: Na početku ispitivanja, 24% bolesnika zadovoljilo je najmanje jedan od sljedeća tri kriterija za bodovanje težine bolesti: tjelesna temperatura >38,5°C, broj leukocita >15 000 ili vrijednost kreatinina ≥1,5 mg/dl.
English: Also no crossresistance has been discovered with any other antibiotic class including β-lactams, macrolides, metronidazole, quinolones, rifampin, and vancomycin.
Croatian: Također, nije otkrivena niti ukrižena rezistencija na neku drugu skupinu antibiotika uključujući β-laktame, makrolide, metronidazol, kinolone, rifampin i vankomicin.
English: If you stop taking DIFICLIR
Croatian: Ako prestanete uzimati DIFICLIR
English: What DIFICLIR contains
Croatian: Što DIFICLIR sadrži
English: Fidaxomicin is an antibiotic belonging to the macrocyclic class of antibacterials.
Croatian: Fidaksomicin je antibiotik koji pripada skupini makrocikličkih antibakterijskih lijekova.
English: − verapamil (a medicine used to treat high blood pressure or to prevent chest pain attacks, or used following a heart attack to prevent another one)
Croatian: − verapamil (lijek koji se primjenjuje za liječenje povišenog krvnog tlaka ili sprječavanje napadaja boli u prsnom košu ili se primjenjuje nakon srčanog udara da bi se spriječio sljedeći)
English: The recommended dose is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days.
Croatian: Preporučena doza je jedna tableta (200 mg) dvaput na dan (jedna tableta svakih 12 sati) tijekom 10 dana.
English: Inhibition of the Clostridial RNA polymerase occurs at a concentration 20-fold lower than that for the E. coli enzyme (1 μM vs. 20 μM), partly explaining the significant specificity of fidaxomicin activity.
Croatian: Do inhibicije RNK-polimeraze klostridija dolazi pri koncentraciji koja je 20 puta niža od one za enzim E. coli (1 μM nasuprot 20 μM), što djelomično objašnjava značajnu specifičnost djelovanja fidaksomicina.
English: Fidaxomicin and OP-1118 levels were approximately 2 times higher in patients ≥ 65 years compared to patients < 65 years.
Croatian: Koncentracije fidaksomicina i OP-1118 bile su približno dvaput veće u bolesnika u dobi od 65 ili više godina u usporedbi s bolesnicima mlađima od 65 godina.
English: However, a larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilat cannot be excluded.
Croatian: Međutim, ne može se isključiti jači učinak na supstrate P-gp-a s nižom bioraspoloživošću koji su osjetljivi na inhibiciju crijevnog P-gp-a, kao što je dabigatran eteksilat.
English: In vitro metabolism studies showed that the formation of OP-1118 is not dependent on CYP450 enzymes.
Croatian: Ispitivanja metabolizma in vitro pokazala su da stvaranje OP-1118 ne ovisi o CYP450 enzimima.
English: The most common adverse reactions are vomiting, nausea and constipation.
Croatian: Najčešće nuspojave su povraćanje, mučnina i konstipacija.
English: It is unknown whether fidaxomicin and its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se fidaksomicin i njegovi metaboliti u majčino mlijeko.
English: − If you are allergic to fidaxomicin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati DIFICLIR − Ako ste alergični na fidaksomicin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Do not use this medicine after the expiry date which is stated on the carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji nakon „Rok valjanosti”.
English: If you forget to take DIFICLIR
Croatian: Ako ste zaboravili uzeti DIFICLIR
English: Co-administration of 200 mg fidaxomicin twice daily with a single dose of 10 mg rosuvastatin to healthy subjects did not have a clinically significant effect on the AUCinf of rosuvastatin.
Croatian: Istovremena primjena 200 mg fidaksomicina dva puta dnevno i jedne doze od 10 mg rosuvastatina kod zdravih ispitanika nisu imali klinički značajan utjecaj na AUCinf rosuvastatina.
English: Fidaxomicin does not induce or inhibit CYP450 enzymes in vitro.
Croatian: Fidaksomicin ne inducira i ne inhibira CYP450 enzime in vitro.
English: Patients with fulminant colitis and patients with multiple episodes (defined as more than one prior episode within the previous 3 months) of CDI were excluded in the studies.
Croatian: Bolesnici s fulminantnim kolitisom i bolesnici s višestrukim epizodama (što je bilo definirano kao više od jedne epizode u prethodna 3 mjeseca) infekcije uzrokovane bakterijom C. difficile bili su isključeni iz ispitivanja.
English: Limited data suggest that gender, weight and race do not have any major influence on the plasma concentration of fidaxomicin or OP-1118.
Croatian: Ograničeni podaci pokazuju da spol, tjelesna težina i rasa nemaju velikog utjecaja na koncentracije fidaksomicina i OP-1118 u plazmi.
English: Fidaxomicin has an MIC90 of 0.25 mg/L versus C. difficile, and its main metabolite, OP-1118, has an MIC90 of 8 mg/L.
Croatian: MIK90 fidaksomicina za C. difficile iznosi 0,25 mg/l, a MIK90 njegovog glavnog metabolita, OP-1118, iznosi 8 mg/l.
English: Capsule shaped tablets of 14 mm, white to off-white in colour, debossed with “FDX” on one side and “200” on the other side.
Croatian: Tablete u obliku kapsula od 14 mm, bijele do gotovo bijele boje, s utisnutim „FDX” na jednoj strani i „200” na drugoj strani.
English: Hepatobiliary disorders alanine aminotransferase increased
Croatian: Poremećaji jetre i žuči povišena alanin aminotransferaza
English: Limited data suggest that there is no major difference in plasma concentration of fidaxomicin or OP-1118 between patients with reduced renal function (creatinine clearance < 50 ml/min) and patients with normal renal function (creatinine clearance ≥ 50 ml/min).
Croatian: Ograničeni podaci pokazuju da nema velike razlike u koncentraciji fidaksomicina i OP-1118 u plazmi između bolesnika sa smanjenom funkcijom bubrega (klirens kreatinina <50 ml/min) i bolesnika s normalnom funkcijom bubrega (klirens kreatinina ≥50 ml/min).
English: The rate of recurrence (including relapses) was significantly lower with fidaxomicin (14.1% versus 26.0% with a 95% CI of [-16.8%, -6.8%]), however these trials were not prospectively designed to prove prevention of reinfection with a new strain.
Croatian: Stopa povrata (uključujući relapse) bila je značajno niža uz primjenu fidaksomicina (14,1% nasuprot 26,0% uz 95% CI od [-16,8%, -6,8%]).
English: Microcrystalline cellulose Pregelatinised starch (maize) Hydroxypropyl cellulose Butylated hydroxytoluene Sodium starch glycolate Magnesium stearate
Croatian: mikrokristalična celuloza prethodno geliran škrob (kukuruzni) hidroksipropilceluloza butilhidroksitoluen natrijev škroboglikolat magnezijev stearat
English: Some patients with hypersensitivity reactions reported a history of allergy to macrolides.
Croatian: U nekih bolesnika u kojih se javljaju reakcije preosjetljivosti također je prijavljena alergija na druge makrolide.
English: The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days.
Croatian: Preporučena doza je 200 mg (jedna tableta) dvaput na dan (jedanput svakih 12 sati) tijekom 10 dana.
English: Effect of fidaxomicin on other transporters
Croatian: Učinak fidaksomicina na ostale prijenosnike
English: INFORMATION IN BRAILLE dificlir
Croatian: 16. PODACI NA BRAILLEOVOM PISMU dificlir
English: DIFICLIR works by killing the bacteria that cause the infection and helps to reduce the associated diarrhoea.
Croatian: DIFICLIR djeluje tako što ubija te bakterije koje uzrokuju infekciju i pridonosi slabljenju proljeva koji prati tu infekciju.
English: Acute hypersensitivity reactions, such as angioedema and dyspnea, have been reported during post-marketing (see section 4.3 and 4.4).
Croatian: Akutne reakcije preosjetljivosti, kao što su angioedem i dispneja, bile su prijavljene u razdoblju nakon stavljanja lijeka u promet (vidjeti dijelove 4.3 i 4.4).
English: Fidaxomicin should be used with caution in patients with a known macrolides allergy.
Croatian: Fidaksomicin treba uzimati s oprezom u bolesnika s poznatom alergijom na makrolide.
English: Table 1 displays adverse reactions associated with twice daily administration of fidaxomicin in the treatment of C. difficile infection, reported in at least two patients, presented by system organ class.
Croatian: Tablica 1 prikazuje nuspojave povezane s primjenom fidaksomicina dvaput na dan zbog liječenja infekcije izazvane C. difficile, koje su bile zabilježene u najmanje dva bolesnika, prema klasifikaciji organskih sustava.
English: Fidaxomicin is bactericidal and inhibits RNA synthesis by bacterial RNA polymerase.
Croatian: Fidaksomicin je baktericidan i inhibira sintezu RNK bakterijskom RNK-polimerazom.
English: There are no known transferable elements that confer resistance to fidaxomicin.
Croatian: Nisu poznati prijenosni elementi koji sudjeluju u stvaranju rezistencije na fidaksomicin.
English: Driving and using machines DIFICLIR is not expected to affect your ability to drive, use tools or machines.
Croatian: Ne očekuje se da bi DIFICLIR mogao utjecati na Vašu sposobnost upravljanja vozilima ili rada s alatima ili strojevima.
English: It is not known whether fidaxomicin passes into breast milk, but it is not expected to do so.
Croatian: Iako nije poznato izlučuje li se fidaksomicin u majčino mlijeko, to se ne očekuje.
English: There was very limited accumulation of fidaxomicin or OP-1118 in plasma following administration of 200 mg fidaxomicin every 12 hours for 10 days.
Croatian: Akumulacija fidaksomicina i OP-1118 u plazmi bila je vrlo ograničena nakon primjene 200 mg fidaksomicina svakih 12 sati tijekom 10 dana.
English: A main metabolite, OP-1118, is formed through hydrolysis of the isobutyryl ester.
Croatian: Glavni metabolit, OP-1118, stvara se hidrolizom izobutirilnog estera.
English: How to take DIFICLIR
Croatian: Kako uzimati DIFICLIR
English: A severe allergic reaction may occur, including trouble breathing (dyspnea), swelling of the face or throat (angioedema), severe rash or severe itching (pruritus) (see section 2).
Croatian: Mogu se pojaviti jake alergijske reakcije uključujući probleme sa disanjem (dispneja), oticanje lica ili grla (angioedem), jak osip ili jak svrbež (pruritus) (pogledajte dio 2).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003-004
Croatian: EU/1/11/733/003-004
English: In vitro studies showed that fidaxomicin and the metabolite OP-1118 are inhibitors of the transporters BCRP, MRP2 and OATP2B1, but were not found to be substrates.
Croatian: Ispitivanja in vitro su pokazala da su fidaksomicin i njegov metabolit OP-1118 inhibitori prijenosnika BCRP, MRP2 i OATP2B1, ali nisu njihovi supstrati.
English: − cyclosporin (a medicine used to dampen down the body's immune reactions, used e.g. after an organ or bone marrow transplant, for psoriasis or eczema, or for rheumatoid arthritis or nephrotic syndrome)
Croatian: − ciklosporin (lijek koji se primjenjuje za potiskivanje imunoloških reakcija u Vašem tijelu, a daje se, npr. nakon presađivanja organa ili koštane srži, kod psorijaze ili ekcema ili reumatoidnog artritisa ili nefrotskog sindroma)
English: Cmax for fidaxomicin and OP-1118 in plasma were 22% and 33% lower following a high fat meal vs fasting, but the extent of exposure (AUC0-t) was equivalent.
Croatian: Cmax fidaksomicina u plazmi bila je 22% niža, a metabolita OP-1118 33% niža nakon obroka bogatog mastima u odnosu na njihove vrijednosti kod primjene fidaksomicina natašte, ali je stupanj izloženosti (AUC0-t) bio ekvivalentan.
English: In the pivotal clinical trials the rate of recurrence in the 30 days following treatment was assessed as a secondary endpoint.
Croatian: Stopa povrata infekcije u razdoblju od 30 dana nakon liječenja procijenjena je u pivotalnim kliničkim ispitivanjima kao sekundarna mjera ishoda.
English: Fidaxomicin is a narrow spectrum antimicrobial drug with bactericidal activity against C. difficile.
Croatian: Fidaksomicin je antimikrobni lijek uskog spektra s baktericidnim djelovanjem na C. difficile.
English: Do not stop taking DIFICLIR, unless your doctor has advised you to do so. Keep taking this medicine until the course is finished, even if you feel better.
Croatian: Nastavite uzimati ovaj lijek sve dok ne završite liječenje, čak i ako se osjećate bolje.
English: − certain blood tests might show changed levels, e.g. increased liver enzymes (alanine aminotransferase)
Croatian: − određene krvne pretrage mogu pokazati promjene u koncentraciji, npr. povišeni jetreni enzimi
English: DIFICLIR is used in adults to treat infections of the lining of the colon (large intestine) with certain bacteria called Clostridium difficile.
Croatian: DIFICLIR se primjenjuje u odraslih za liječenje infekcije sluznice debelog crijeva prouzročene bakterijom koja se zove Clostridium difficile.
English: Polyvinyl alcohol Titanium dioxide (E171) Talc
Croatian: Ovojnica: poli(vinilni alkohol) titanijev dioksid (E171) talk polietilenglikol lecitin (soja)
English: NAME OF THE MARKETING AUTHORISATION HOLDER Astellas
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Astellas
English: If you are allergic to macrolides (a class of antibiotics), ask your doctor for advice before using this medicine.
Croatian: Ako ste alergični na makrolide (vrsta antibiotika) potražite savjet svog liječnika prije uzimanja ovog lijeka.
English: Fidaxomicin is a locally acting drug.
Croatian: Fidaksomicin je lijek s lokalnim djelovanjem.
English: − erythromycin (a medicine used to treat ear, nose, throat, chest and skin infections)
Croatian: − eritromicin (lijek koji se primjenjuje za liječenje infekcija uha, nosa, grla, dišnog sustava i kože)
English: As a topical agent, systemic PK/PD relationships cannot be established, however in vitro data show fidaxomicin to have time-dependent bactericidal activity and suggest time over MIC may be the parameter most predicative of clinical efficacy.
Croatian: Budući da je topikalno sredstvo, sistemski farmakokinetički/farmakodinamički odnos ne može se ustanoviti, međutim, podaci in vitro pokazuju da fidaksomicin ima vremenski ovisno baktericidno djelovanje i da je vrijeme u kojem je koncentracija fidaksomicina iznad njegove minimalne inhibitorne koncentracije (MIK) parametar koji najbolje predviđa kliničku djelotvornost.
English: If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili mislite da biste mogli biti trudni, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Nervous system disorders dizziness, headache, dysgeusia
Croatian: Poremećaji živčanog sustava omaglica, glavobolja, disgeuzija
English: There are limited data available on the use of fidaxomicin in severe cases of the disease (e.g. pseudomembranous colitis).
Croatian: Dostupni podaci o primjeni fidaksomicina u teškim slučajevima ove bolesti (npr. pseudomembranozni kolitis) su ograničeni.
English: Effect of fidaxomicin on P-gp substrates
Croatian: Učinak fidaksomicina na P-gp supstrate
English: Under conditions of clinical use, fidaxomicin has no clinically relevant effect on the exposure of rosuvastatin, a substrate for OATP2B1 and BCRP (see section 4.5).
Croatian: U uvjetima kliničke primjene, fidaksomicin nema klinički značajan učinak na izloženost rosuvastatinu, supstratu za OATP2B1 i BCRP (vidjeti dio 4.5).
English: Tηλ: +30 210 8189900
Croatian: Ελλάδα Tηλ: +30 210 8189900
English: Table 1: Summary of adverse reactions by MedDRA system organ class
Croatian: Tablica 1: Sažetak nuspojava prema MedDRA klasifikaciji organskih sustava MedDRA klasifikacija organskih sustava
English: − dabigatran etexilat (a medicine used to prevent the formation of blood clots after hip or knee replacement surgery)
Croatian: − dabigatran eteksilat (lijek koji se primjenjuje za sprječavanje stvaranja krvnih ugrušaka nakon operacije ugradnje umjetnog kuka ili koljena)
English: PHARMACEUTICAL FORM AND CONTENTS 100 x 1 film-coated tablet.
Croatian: OBLIK I SADRŽAJ 100 x 1 filmom obložena tableta 20 x 1 filmom obložena tableta
English: Studies have demonstrated that fidaxomicin treatment did not affect Bacteroides concentrations or other major components of the microbiota in the faeces of CDI patients.
Croatian: Ispitivanja su pokazala da liječenje fidaksomicinom nije utjecalo na koncentracije vrste Bacteroides kao ni na druge glavne mikrobiote u stolici bolesnika s infekcijom uzrokovanom C. difficile.
English: In healthy adults, Cmax is approximately 9.88 ng/ml and AUC0-t is 69.5 ng•hr/ml following administration of 200 mg fidaxomicin, with a Tmax of 1.75 hours.
Croatian: Nakon primjene 200 mg fidaksomicina u zdravih odraslih osoba, Cmax iznosi približno 9,88 ng/ml, a AUC0-t 69,5 ng-hr/ml, uz Tmax od 1,75 sati.
English: Immune system disorders rash, pruritus hypersensitivity reactions (angioedema, dyspnea)
Croatian: Poremećaji imunološkog sustava osip, svrbež reakcije preosjetljivosti (angioedem, dispneja)
English: Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118.
Croatian: Istovremena primjena jednokratnih doza inhibitora P-gp-a ciklosporina A i fidaksomicina u zdravih dobrovoljaca rezultirala je četverostrukim povećanjem Cmax i dvostrukim povećanjem AUC-a fidaksomicina te povećanjem Cmax glavnog djelatnog metabolita OP1118 za 9,5 puta i AUC-a za 4 puta.
English: What DIFICLIR looks like and contents of the pack DIFICLIR 200 mg film-coated tablets are capsule shaped tablets, white to off-white in colour, with “FDX” on one side and “200” on the other side.
Croatian: DIFICLIR 200 mg filmom obložene tablete su tablete u obliku kapsule, bijele do gotovo bijele boje, s oznakom „FDX” na jednoj strani i „200” na drugoj strani.