FrancophonIA/ELRC3.0 huggingface dataset:
English: Take the tablet as soon as you remember, unless it is time for the next dose.
Slovenian: Vzemite tableto takoj, ko se spomnite, razen če je že čas za naslednji odmerek.
English: Description of the patient population in clinical trials
Slovenian: Opis populacije bolnikov v kliničnih preskušanjih
English: Take the medicine pack with you so the doctor knows what you have taken.
Slovenian: Pakiranje zdravila vzemite s seboj, da bo zdravnik vedel, kaj ste vzeli.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 5 December 2011
Slovenian: Datum prve odobritve: 5. december 2011
English: This is because it is not known whether fidaxomicin can harm your baby.
Slovenian: To je zato, ker ni znano, ali lahko fidaksomicin škoduje vašemu otroku.
English: The safety and efficacy of fidaxomicin in children aged below 18 years has not yet been established.
Slovenian: Varnost in učinkovitost fidaksomicina pri otrocih, mlajših od 18 let, še nista bili dokazani.
English: DIFICLIR can be taken with or without food.
Slovenian: Zdravilo DIFICLIR se lahko vzame s hrano ali brez nje.
English: Other possible side effects are the following:
Slovenian: Drugi možni neželeni učinki so:
English: The half life of fidaxomicin is approximately 8-10 h.
Slovenian: Razpolovna doba fidaksomicina je približno 8-10 ur.
English: In the pivotal clinical trials the rate of recurrence in the 30 days following treatment was assessed as a secondary endpoint.
Slovenian: V osrednjih kliničnih preskušanjih je bil ponovni pojav v 30. dneh po zdravljenju ocenjen kot druga končna točka.
English: Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Slovenian: Študije na živalih niso pokazale neposrednih ali posrednih škodljivih učinkov glede reprodukcijske toksičnosti.
English: The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so po pogostnosti opredeljeni kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000) ali zelo redki (<1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: If a severe allergic reaction occurs during treatment with DIFICLIR, the medicinal product should be discontinued and appropriate measures taken.
Slovenian: Če se med zdravljenjem z zdravilom DIFICLIR pojavi huda alergijska reakcija, je treba zdravilo ukiniti in sprejeti ustrezne ukrepe.
English: DIFICLIR should not be used in children or adolescents aged below 18 years as there is no information on this use in this population.
Slovenian: Zdravila DIFICLIR ne uporabljajte za otroke ali mladostnike do 18 let, ker pri tej skupini ni podatkov za to uporabo.
English: As a precautionary measure, it is preferable to avoid the use of DIFICLIR during pregnancy.
Slovenian: Iz previdnostnih razlogov je bolje, da zdravila DIFICLIR med nosečnostjo ne uporabljate.
English: If you have taken more tablets than you should have, talk to a doctor.
Slovenian: Če ste vzeli več tablet, kot bi morali, se posvetujte z zdravnikom.
English: − dry mouth, altered taste (dysgeusia)
Slovenian: − suha usta, spremenjen okus (disgevzija)
English: Your doctor will know whether your disease falls in the severe categories and will tell you whether this medicine is suitable for you.
Slovenian: Vaš zdravnik bo vedel, ali sodi vaša bolezen v kategorijo hudih obolenj in vam povedal, ali je to zdravilo za vas primerno.
English: Plasma levels appear to be elevated in the elderly (age ≥ 65 years).
Slovenian: Zdi se, da se koncentracije v plazmi povečajo pri starejših (≥ 65 let).
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.
Slovenian: Čeprav se učinkov na dojene novorojence/otroke ne pričakuje, ker je sistemska izpostavljenost fidaksomicinu majhna, tveganja za novorojenca/otroka ne moremo izključiti.
English: Specific mutations of RNA polymerase are associated with reduced susceptibility to fidaxomicin.
Slovenian: Specifične mutacije RNA polimeraze so povezane z zmanjšano občutljivostjo za fidaksomicin.
English: The clinical relevance of MRP2 inhibition is not yet known.
Slovenian: Klinični pomen zaviranja MRP2 še ni znan.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/733/003 100 x 1 film-coated tablet EU/1/11/733/004 20 x 1 film-coated tablet 13.
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/11/733/003 100 x 1 filmsko obložena tableta EU/1/11/733/004 20 x 1 filmsko obložena tableta
English: What DIFICLIR is and what it is used for
Slovenian: Kaj je zdravilo DIFICLIR in za kaj ga uporabljamo
English: Reproductive and fertility parameters showed no statistically significant differences in rats treated with fidaxomicin at doses up to 6.3 mg/kg/day (intravenous).
Slovenian: Parametri reprodukcije in plodnosti niso pokazali statistično pomembnih razlik pri podganah, ki so dobivale fidaksomicin v odmerkih do 6,3 mg/kg/dan (intravensko).
English: It is not known whether fidaxomicin passes into breast milk, but it is not expected to do so.
Slovenian: Ni znano, ali se fidaksomicin izloča v materino mleko, vendar se to ne pričakuje.
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.
Slovenian: V dveh kliničnih preskušanjih bolnikov s CDI je bilo 47,9 % (479/999) bolnikov (glede na populacijo v protokolu) starih ≥ 65 let in 27,5 % (275/999) bolnikov je bilo v obdobju trajanja študije sočasno zdravljenih z antibiotiki.
English: There are no data available from the use of fidaxomicin in pregnant women.
Slovenian: Podatki o uporabi fidaksomicina pri nosečnicah niso na voljo.
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.
Slovenian: Stopnja ponovnega pojava (vključno z recidivom) je bila značilno nižja s fidaksomicinom (14,1 % v primerjavi s 26,0 % s 95-% IZ [-16,8 %, -6,8 %]), vendar ta preskušanja niso bila zasnovana prospektivno, da bi dokazali preprečevanje ponovne okužbe z novim sevom.
English: Your doctor will tell you whether this medicine is suitable for you.
Slovenian: Zdravnik vam bo povedal, ali je to zdravilo primerno za vas.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from DIFICLIR therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom DIFICLIR, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: The volume of distribution in humans is unknown, due to very limited absorption of fidaxomicin.
Slovenian: Volumen porazdelitve pri ljudeh ni znan zaradi zelo omejene absorpcije fidaksomicina.
English: 4.7 Effects on ability to drive and use machines DIFICLIR has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo DIFICLIR nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Metabolism and nutrition disorders decreased appetite
Slovenian: Presnovne in prehranske motnje zmanjšan apetit
English: This metabolite also shows antimicrobial activity (see section 5.1).
Slovenian: Ta presnovek ima tudi antimikrobno delovanje (glejte poglavje 5.1)
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.
Slovenian: Vendar pa večjega učinka na substrate P-gp z nižjo biološko razpoložljivostjo, bolj dovzetne na zaviranje črevesnega P-gp, kot je dabigatran eteksilat, ni mogoče izključiti.
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship
Slovenian: Farmakokinetično/farmakodinamično (PK/PD) razmerje
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.
Slovenian: Študije so pokazale, da zdravljenje s fidaksomicinom ne vpliva na koncentracije Bacteroides ali drugih pomembnejših sestavin mikrobiotov v fecesu bolnikov s CDI.
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.
Slovenian: Epidemiološka mejna vrednost za fidaksomicin pri C. difficile, ki ločuje populacijo divjega tipa od izolatov s pridobljeno rezistenco, je ≥ 1,0 mg/l.
English: In that case, skip the missed dose.
Slovenian: V tem primeru preskočite pozabljeni odmerek.
English: Fidaxomicin (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure.
Slovenian: Fidaksomicin (200 mg dvakrat na dan) je imel majhen, a klinično nepomemben učinek na izpostavljenost digoksinu.
English: There are no known transferable elements that confer resistance to fidaxomicin.
Slovenian: Ni znanih prenosnih elementov, ki povzročajo odpornost za fidaksomicin.
English: DIFICLIR is available in:
Slovenian: Zdravilo DIFICLIR je na voljo v naslednjih pakiranjih:
English: INFORMATION IN BRAILLE dificlir
Slovenian: PODATKI V BRAILLOVI PISAVI dificlir
English: The recommended dose is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days.
Slovenian: Priporočeni odmerek je ena tableta (200 mg) dvakrat na dan (ena tableta vsakih 12 ur) 10 dni.
English: Gram negative organisms are intrinsically not susceptible to fidaxomicin.
Slovenian: Po Gramu negativni organizmi intrinzično niso občutljivi za fidaksomicin.
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, antibiotics, ATC code: A07AA12
Slovenian: Farmakoterapevtska skupina: antidiaroiki, protivnetna in protimikrobna zdravila, oznaka ATC: A07AA12.
English: DIFICLIR works by killing the bacteria that cause the infection and helps to reduce the associated diarrhoea.
Slovenian: Zdravilo DIFICLIR učinkuje tako, da ubije bakterijo, ki povzroča okužbo, s čimer pomaga zmanjšati z okužbo povezano drisko.
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.
Slovenian: Cmax za fidaksomicin in OP-1118 v plazmi je bil 22 % in 33 % nižji po zelo mastnem obroku v primerjavi z uporabo na tešče, obseg izpostavljenosti (AUC0-t) pa je bil enak.
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.
Slovenian: Do zaviranja klostridijske RNA polimeraze pride pri koncentraciji, ki je 20-krat nižja kot za encim E. coli (1 μM v primerjavi z 20 μM), kar delno pojasnjuje pomembno specifičnost delovanja fidoksamicina.
English: In vitro metabolism studies showed that the formation of OP-1118 is not dependent on CYP450 enzymes.
Slovenian: Študije presnove in vitro so pokazale, da nastajanje OP-1118 ni odvisno od encimov CYP450.
English: Some patients with hypersensitivity reactions reported a history of allergy to macrolides.
Slovenian: Nekateri bolniki s preobčutljivostnimi reakcijami so poročali tudi o alergijah na makrolide v preteklosti.
English: You can take DIFICLIR before, during or after meals.
Slovenian: Zdravilo DIFICLIR lahko vzamete pred obrokom, med njim ali po njem.
English: Only very low levels of OP-1118 and no fidaxomicin was detectable in human urine.
Slovenian: Le zelo malo OP-1118 in nič fidaksomicina so ugotovili v urinu pri človeku.
English: Fidaxomicin and OP-1118 levels were approximately 2 times higher in patients ≥ 65 years compared to patients < 65 years.
Slovenian: OP-1118 so bile približno dvakrat višje pri bolnikih ≥ 65 let starosti v primerjavi z bolniki, mlajšimi od 65 let.
English: If such reaction occurs, stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department.
Slovenian: Če se pojavi takšna reakcija, prenehajte jemati zdravilo DIFICLIR in nujno poiščite zdravstveno pomoč pri svojem zdravniku, farmacevtu ali urgentnem centru lokalne bolnišnice.
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).
Slovenian: Maloštevilni podatki kažejo, da ni bistvene razlike v koncentraciji fidaksomicina ali OP-1118 v plazmi med bolniki z zmanjšanim delovanjem ledvic (očistek kreatinina < 50 ml/min) in bolniki z normalnim delovanjem ledvic (očistek kreatinina ≥ 50 ml/min).
English: You should not use DIFICLIR in combination with one of these medicines, unless your doctor tells you otherwise.
Slovenian: Ne uporabljajte zdravila DIFICLIR v kombinaciji s katerim od teh tzdravil, razen če vam vaš zdravnik svetuje drugače.
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.
Slovenian: Sočasno dajanje 200 mg fidaksomicina dvakrat na dan z enkratnim odmerkom 10 mg rosuvastatina pri zdravih osebah ni imela klinično pomembnega učinka na AUCinf rosuvastatina.
English: If you forget to take DIFICLIR
Slovenian: Če ste pozabili vzeti zdravilo DIFICLIR
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).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij s fidaksomicinom za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: No dose adjustment is considered necessary.
Slovenian: Prilagajanje odmerka ni potrebno.
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.
Slovenian: Fidaksomicin ima MIC90 0,25 mg/l v primerjavi s C. difficile in njegov glavni presnovek, OP-1118, ima MIC90
English: Hypersensitivity reactions including severe angioedema have been reported (see section 4.8).
Slovenian: Poročali so o preobčutljivostnih reakcijah, vključno s hudim angioedemom (glejte poglavje 4.8).
English: Also no crossresistance has been discovered with any other antibiotic class including β-lactams, macrolides, metronidazole, quinolones, rifampin, and vancomycin.
Slovenian: Tudi navzkrižne rezistence s katerimkoli drugim antibiotikom, vključno z β-laktami, makrolidi, metronidazolom, kinoloni, rifampicinom in vankomicinom, niso ugotovili.
English: Driving and using machines DIFICLIR is not expected to affect your ability to drive, use tools or machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo DIFICLIR ne vpliva na sposobnost upravljanja vozil, uporabe orodja ali strojev.
English: Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate for the transporters OATP2B1 and BCRP.
Slovenian: Fidaksomicin nima klinično pomembnega učinka na izpostavljenost rosuvastatinu, substratu za prenašalca OATP2B1 in BCRP.
English: No extensive analysis of metabolites in plasma has been performed, due to low levels of systemic absorption of fidaxomicin.
Slovenian: Obsežna analiza presnovkov v plazmi ni bila narejena zaradi majhne sistemske absorpcije fidaksomicina.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnjo tableto.
English: Table 1: Summary of adverse reactions by MedDRA system organ class
Slovenian: Preglednica1: Povzetek neželenih učinkov zdravila po organskih sistemih MedDRA MedDRA organski sistem
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.
Slovenian: > 15.000 ali vrednost kreatinina ≥ 1,5 mg/dl. Bolniki s fulminantnim kolitisom in bolniki z več epizodami (opredeljenimi kot več kot ena predhodna epizoda v predhodnih 3 mesecih) CDI so bili iz študij izključeni.
English: Limited data suggest that gender, weight and race do not have any major influence on the plasma concentration of fidaxomicin or OP-1118.
Slovenian: Maloštevilni podatki kažejo, da spol, telesna masa in rasa nimajo večjega vpliva na koncentracijo fidaksomicina ali OP-1118 v plazmi.
English: DIFICLIR is used in adults to treat infections of the lining of the colon (large intestine) with certain bacteria called Clostridium difficile.
Slovenian: Zdravilo DIFICLIR se uporablja pri odraslih za zdravljenje okužb debelega črevesa z določenimi bakterijami, imenovanimi Clostridium difficile.
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.
Slovenian: In vitro študije so pokazale, da sta fidaksomicin in presnovek OP-1118 zaviralca prenašalcev BCRP, MRP2 in OATP2B1, vendar ni bilo ugotovljeno, da sta substrata.
English: Effect on the intestinal flora
Slovenian: Vpliv na črevesno floro
English: Nederland
Slovenian: Nizozemska
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).
Slovenian: Če menite, da imate morda hudo alergijsko reakcijo, ki se lahko kaže kot oteženo dihanje (dispneja), otekanje obraza ali grla (angioedem), hud izpuščaj ali hudo srbenje (pruritus), prenehajte jemati zdravilo DIFICLIR in nujno poiščite zdravstveno pomoč pri svojem zdravniku, farmacevtu ali urgentnem centru lokalne bolnišnice (glejte poglavje 4).
English: − The other ingredients are: Tablet core: microcrystalline cellulose, pregelatinised starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate and magnesium stearate Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol and lecithin (soy)
Slovenian: − Druge sestavine zdravila so: tabletno jedro: mikrokristalna celuloza, predgelirani škrob, hidroksipropilceluloza, butilhidroksitoluen, natrijev karboksimetil škrob, magnezijev stearat obloga: polivinil alkohol, titanov dioksid (E171), smukec, polietilenglikol, lecitin (sojin)
English: The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days.
Slovenian: Priporočeni odmerek je 200 mg (ena tableta) dvakrat na dan (ena tableta vsakih 12 ur) 10 dni.
English: If you are allergic to macrolides (a class of antibiotics), ask your doctor for advice before using this medicine.
Slovenian: Če ste alergični na makrolide (skupina antibiotikov), se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Fidaxomicin is an antibiotic belonging to the macrocyclic class of antibacterials.
Slovenian: Fidaksomicin je antibiotik, ki spada v makrociklično skupino antibiotikov.
English: It is unknown whether fidaxomicin and its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se fidaksomicin in njegovi presnovki izločajo v materino mleko.
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.
Slovenian: Preglednica 1 prikazuje neželene učinke, prikazane po organskih sistemih, pri dajanju fidaksomicina dvakrat na dan za zdravljenje okužbe s C. difficile, o katerih so poročali pri najmanj dveh bolnikih.
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).
Slovenian: Lahko pride do hude alergijske reakcije, vključno z oteženim dihanjem (dispneja), otekanjem obraza ali grla (angioedem), hud izpuščaj ali hudo srbenje (pruritus) (glejte poglavje 2).
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.
Slovenian: Pri zdravih odraslih je po odmerku 200 mg fidaksomicina Cmax približno 9,88 ng/ml, AUC0-t pa 69,5 ng-h/ml, s Tmax 1,75 ure.
English: Other medicines and DIFICLIR Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Effect of fidaxomicin on other transporters
Slovenian: Učinek fidaksomicina na druge prenašalce
English: DIFICLIR blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking DIFICLIR.
Slovenian: Druga zdravila, ki jih jemljete, lahko vplivajo na koncentracije zdravila DIFICLIR v krvi, in z jemanjem zdravila DIFICLIR lahko vplivate ne koncentracije drugih zdravil v krvi.
English: Fidaxomicin is bactericidal and inhibits RNA synthesis by bacterial RNA polymerase.
Slovenian: Fidaksomicin je baktericidno zdravilo in zavira sintezo RNA z bakterijsko RNA polimerazo.
English: PHARMACEUTICAL FORM AND CONTENTS 100 x 1 film-coated tablet.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 100 x 1 filmsko obložena tableta 20 x 1 filmsko obložena tableta
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.
Slovenian: farmakokinetičnega/farmakodinamičnega razmerja ni mogoče ugotoviti, vendar in vitro podatki kažejo, da ima fidaksomicin od časa odvisno baktericidno delovanje in da je čas nad MIC najboljši pokazatelj za napovedovanje klinične učinkovitosti.
English: Hepatobiliary disorders alanine aminotransferase increased
Slovenian: žolčnika in žolčevodov povečana alanin aminotransferaza
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.
Slovenian: Tablete v obliki 14 mm kapsule, bele ali skoraj bele barve, z vtisnjeno oznako “FDX” na eni strani in številko “200” na drugi strani.
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.
Slovenian: Izgled zdravila DIFICLIR in vsebina pakiranja DIFICLIR 200 mg filmsko obložene tablete so tablete v obliki kapsul, bele ali skoraj bele barve, z vtisnjeno oznako “FDX” na eni strani in številko “200” na drugi strani.
English: Polyvinyl alcohol Titanium dioxide (E171) Talc
Slovenian: Obloga: polivinilalkohol titanov dioksid (E171) smukec makrogol lecitin (sojin)