natgillin/translations-raw huggingface dataset:
They are for use only for species that have not been given a species-specific breakpoint and are not for use with species where interpretative criteria remain to be determined (Gram-negative anaerobes).
Uporabljajo se samo za vrste, pri katerih mejne vrednosti niso bile določene in se ne uporabljajo za vrste, pri katerih še niso določili merila (po Gramu negativni anaerobni mikroorganizmi).
Effect on the intestinal flora in humans
Vpliv na črevesno floro pri ljudeh
After a 400 mg dose, recovery from urine (approximately 19% for unchanged drug, approximately 2.5% for M1, and approximately 14% for M2) and faeces (approximately 25% of unchanged drug, approximately 36% for M1, and no recovery for M2) totalled to approximately 96%.
Po zaužitju 400 mg odmerka se z urinom (približno 19 % nespremenjenega zdravila, približno 2,5 % v obliki M1 in približno 14 % v obliki M2) in blatom (približno 25 % nespremenjenega zdravila, približno 36 % v obliki M1, v obliki M2 se ne izloča) izloči približno 96 % učinkovine.
Overall, the CHMP agreed that the benefit/risk balance of moxifloxacin in the PID indication over 14 days is positive.
V splošnem je CHMP sklenil, da je razmerje med koristmi in tveganji za moksifloksacin pri indikaciji pelvične vnetne bolezni v obdobju 14 dni pozitivno.
“Other” micro-organisms
drugi mikroorganizmi
In vitro Susceptibility Data
Podatki o občutljivosti in vitro
Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
Varnosti in učinkovitosti uporabe moksifloksacina pri otrocih in mladostnikih niso dokazovali (glejte poglavje 4.3).
In clinical trials the tablets have been studied for up to 14 days treatment.
V kliničnih študijah so raziskovali tablete pri zdravljenju, ki je trajalo do 14 dni.
Moxifloxacin is mainly bound to serum albumin.
Moksifloksacin se v glavnem veže na serumske albumine.
In terms of safety the longer treatment duration, the risk of effects on cartilage in young patients and the risk of QT-prolongation were of concern.
Z vidika varnosti so pomisleke vzbujali daljše trajanje zdravljenja, tveganje za učinke na hrustanec pri mladih bolnikih ter tveganje za podaljšanje intervala QT.
Although it is well known that monotherapy increases compliance, this example of combination therapy would not decrease compliance since the proposed cephalosporin would only have to be given once during the physician's visit and only moxifloxacin would have to be continued orally.
Čeprav je dobro znano, da monoterapija poveča komplianco, ta primer kombiniranega zdravljenja kompliance ne bi zmanjšal, saj bi bilo predlagani cefalosporin treba dati samo enkrat ob obisku pri zdravniku, nato pa bi se nadaljevalo peroralno jemanje zgolj moksifloksacina.
Concerning overall cardiac adverse events, no differences between short (up to 5 days) and longer duration (up to 15 days) of moxifloxacin therapy were observed.
Kar zadeva celokupne neželene učinke na srce, niso opazili razlik med kratkim (do 5 dni) in daljšim trajanjem (do 15 dni) zdravljenja z moksifloksacinom.
Cross-resistance is observed with other fluoroquinolones.
Opazili so navzkrižno odpornost z drugimi fluorokinoloni.
Impaired liver function was associated with higher exposure to M1 in plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers.
Oslabljeno jetrno funkcijo so povezovali z izpostavljenostjo večjim plazemskim koncentracijam M1, medtem ko je bila izpostavljenost nespremenjenemu zdravilu primerljiva z izpostavljenostjo pri zdravih prostovoljcih.
QT-prolongation is a known undesirable effect of moxifloxacin.
Podaljšanje intervala QT je znan neželen učinek moksifloksacina.
If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Če po treh dneh zdravljenja ni kliničnega izboljšanja, je treba znova pretehtati smiselnost zdravljenja.
[Invented name] tablets are for oral use.
Tablete [izmišljeno ime] so za peroralno uporabo.
The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Filmsko obloženo tableto je treba pogoltniti celo z dovolj tekočine, lahko pa se jo zaužije s hrano ali brez nje.
Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular reabsorption of the drug from the kidneys.
Ledvični očistek je približno 24 - 53 ml/min, kar kaže na delno tubulno reabsorpcijo zdravila v ledvicah.
In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug.
V poskusih in vitro in ex vivo so dokazali, da se ne glede na koncentracijo zdravila na plazemske beljakovine veže približno 40 - 42 % učinkovine.
Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin.
Mehanizmi odpornosti, ki inaktivirajo peniciline, cefalosporine, aminoglikozide, makrolide in tetracikline ne vplivajo na protimikrobno aktivnost moksifloksacina.
If so, stop taking [Invented name] and seek medical advice immediately.
V tem primeru takoj prenehajte jemati [izmišljeno ime] in poiščite zdravniško pomoč.
Following oral administration moxifloxacin is rapidly and almost completely absorbed.
Moksifloksacin se po peroralni uporabi absorbira hitro in skoraj popolnoma.
Consult your doctor if you wish to stop taking your tablets before the end of the course of treatment.
Posvetujte se s svojim zdravnikom, če želite z jemanjem tablet prenehati pred zaključkom zdravljenja.
If you are unsure about what to do, consult your doctor or pharmacist.
Če niste prepričani kako ukrepati, se posvetujte s svojim zdravnikom ali s farmacevtom.
The main unresolved areas of concern identified by Belgium were in terms of efficacy the emergence of moxifloxacin-resistant strains of N. gonorrhoeae and the feasibility of the treatment in the proposed indication in clinical practice.
Glavne nerešene zadeve, ki jih je kot pomislek navedla Belgija, so bile z vidika učinkovitosti pojavljanje sevov N. gonorrhoeae, odpornih na moksifloksacin, ter izvedljivost zdravljenja za predlagano indikacijo v klinični praksi.
If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
Če se znaki ne izboljšajo po treh dneh zdravljenja, se posvetujte z zdravnikom.
The CHMP considered that in general women treated for PID for up to 14 days are not at an increased risk of cardiac adverse events compared to the shorter treatment duration in the other indications.
CHMP je menil, da na splošno ženske, ki se zaradi pelvičnih vnetnih bolezni zdravijo do 14 dni, niso izpostavljene povečanemu tveganju neželenih učinkov na srce v primerjavi s krajšim trajanjem zdravljenja pri drugih indikacijah.
In this referral procedure, the CHMP focused on the risk of more frequent QT-prolongation in women in the light of the prolonged treatment regimen in PID (14 days vs. 5-10 days), on the risk of coadministration with other QT-affecting substances and on the possible adverse effects on cartilage in the treatment population.
V tem napotitvenem postopku se je CHMP osredotočil na tveganje za pogostejše podaljšanje intervala QT pri ženskah glede na podaljšano shemo zdravljenja pelvičnih vnetnih bolezni (14 dni v primerjavi s 5-10 dni), na tveganje sočasnega dajanja z drugimi snovmi, ki vplivajo na interval QT, ter na možne neželene učinke na hrustanec pri zdravljeni populaciji.
If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be performed.
Če se med zdravljenjem z moksifloksacinom pojavijo znaki srčne aritmije, je treba zdravljenje prekiniti in narediti EKG.
Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also effect susceptibility to moxifloxacin.
Drugi mehanizmi odpornosti, npr. ovire prepustnosti (pogosto pri Pseudomonas aeruginosa) in mehanizmi prehoda, lahko vplivajo na občutljivost za moksifloksacin.
Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones, ATC code: J01 MA 14
Farmakoterapevtska skupina: kinolonske protimikrobne učinkovine, fluorokinoloni, oznaka ATC: J01MA14
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
Priporočenega odmerka (400 mg enkrat na dan) se ne sme prekoračiti, zdravljenje pa ne sme trajati dlje, kot je za indikacijo priporočeno.
- [Invented name] may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (see section 4.
- [izmišljeno ime] lahko povzroči nenadno in hudo vnetje jeter, kar lahko povzroči smrtno nevarno jetrno odpoved (glejte poglavje 4.
The review of available guidelines and clinical efficacy data showed that moxifloxacin can be used for treatment of PID in the sense of a monotherapy only after results of microbiological testing are available.
Pregled razpoložljivih smernic in podatkov o klinični učinkovitosti je pokazal, da je moksifloksacin mogoče uporabljati za zdravljenje pelvičnih vnetnih bolezni v obliki monoterapije šele potem, ko so na voljo rezultati mikrobiološkega testiranja.
The MAH committed to monitor this adverse event in the next PSURS and committed to provide an updated Risk Management Plan taking into account the new indication mild to moderate PID.
Imetnik dovoljenja za promet z zdravilom se je zavezal, da bo ta neželeni učinek spremljal v prihodnjih PSUR-ih ter da bo predložil posodobljen načrt za obvladovanje tveganj, v katerem bo upoštevana nova indikacija za zdravljenje blagih do zmernih pelvičnih vnetnih bolezni.
The following changes in the intestinal flora were seen in volunteers following oral administration of moxifloxacin: Escherichia coli, Bacillus spp., Enterococcus spp., and Klebsiella spp.
Pri prostovoljcih so po peroralnem jemanju moksifloksacina opazili naslednje spremembe v črevesni flori: število Escherichia coli, Bacillus spp., Enterococcus spp.
* intravenous administration of a single 400 mg dose 1 10 h after administration
* intravenska aplikacija v enkratnem odmerku 400 mg 1 10 ur po zaužitju
The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/min.
Dejanski povprečni skupni očistek iz telesa po odmerku 400 mg je 179-246 ml/min.
Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B)
Staphylococcus aureus* (občutljivi za meticilin) Streptococcus agalactiae (skupina B)
[Invented name] is an antibiotic belonging to the quinolone family.
[izmišljeno ime] je antibiotik, ki sodi v skupino kinolonov.
days
10 dni
Aerobic Gram-negative micro-organisms Enterobacter cloacae* Escherichia coli*
aerobni, po Gramu negativni mikroorganizmi Enterobacter cloacae* Escherichia coli*
The analysis of the incidence of cardiac adverse events did not reveal any special subgroups of PID patients for whom moxifloxacin presents a greater risk than comparator treatments.
Analiza pogostosti neželenih učinkov na srce ni razkrila nobene posebne podskupine bolnikov s pelvičnimi vnetnimi boleznimi, za katere bi moksifloksacin pomenil večje tveganje kot primerjalna zdravila.
There is insufficient experience in the clinical use of moxifloxacin in patients with impaired liver function.
Izkušnje o klinični uporabi moksifloksacina pri bolnikih z oslabljeno jetrno funkcijo so pomanjkljive.
The pharmacokinetic properties of moxifloxacin are not significantly different in patients with renal impairment (including creatinine clearance > 20 ml/min/1.73 m2).
Farmakokinetika moksifloksacina se pri bolnikih z motnjami v delovanju ledvic (tudi z očistkom kreatinina > 20 ml/min/1,73 m2) pomembno ne razlikuje.
Available data demonstrated no evidence for increased cardiac morbidity related to oral moxifloxacin therapy when compared to comparator antibiotic therapy, especially in a younger female population, although in other trials QT interval prolongation and torsades de pointes were more common in women than in men.
Razpoložljivi podatki niso izkazovali dokazov za povečano srčno obolevnost, povezano s peroralnim zdravljenjem z moksifloksacinom, v primerjavi s primerjalnim zdravljenjem z antibiotiki, zlasti v populaciji mlajših žensk, čeprav so bili v drugih študijah podaljšanje intervala QT in „torsades de pointes“ pogostejši pri ženskah kot pri moških.
- [Invented name] may occasionally cause pain and inflammation of your tendons, particularly if you are elderly or if you are currently being treated with corticosteroids.
- [izmišljeno ime] lahko včasih povzroči bolečino in vnetje kit, predvsem pri starejših ali ob sočasnem zdravljenju s kortikosteroidi.
In addition, the risk of QTprolongation is already sufficiently addressed in the Product Information and will be adequately followed up by the MAH in the post-marketing setting.
Poleg tega je bilo tveganje za podaljšanje intervala QT že zadostno obravnavano v informacijah o zdravilu, imetnik dovoljenja za promet z zdravilom pa bo ta vidik ustrezno spremljal v okviru ureditve po pridobitvi dovoljenja za promet z zdravilom.
- If you are currently taking oral anti-coagulants (e.g. warfarin), it may be necessary for your doctor to monitor your blood clotting times.
- Če jemljete peroralne antikoagulante (npr. varfarin), so potrebne laboratorijske kontrole strjevanja krvi pri vašem zdravniku.
If you stop taking [Invented name] 400 mg film-coated tablets If you stop taking this medicine too soon your infection may not be completely cured.
Če ste prenehali jemati zdravilo [izmišljeno ime] 400 mg filmsko obložene tablete Če prenehate jemati to zdravilo prekmalu, okužba morda ne bo v celoti pozdravljena.
Susceptible Intermediate Resistant
organizem občutljiva vmesna odporna
The MRP variation application DE/H/155/01/II/38 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Vloga za odobritev spremembe po postopku medsebojnega priznavanja DE/H/155/01/II/38 je zadevala razširitev indikacije, tako da bi vključevala zdravljenje blagih do zmernih pelvičnih vnetnih bolezni tj. okužb zgornjega genitalnega trakta, vključno s salpingitisom in endometritisom.
- Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration.
- Poročali so o preobčutljivostnih in alergijskih reakcijah fluorokinolonov (tudi moksifloksacina) po prvi uporabi.
Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.
Kljub temu pa je treba bolnikom svetovati, naj se med zdravljenjem z moksifloksacinom izogibajo bodisi UV-sevanju bodisi pretirani in/ali močni sončni svetlobi.
- If you are elderly with existing kidney problems take care that your fluid intake is sufficient because dehydration may increase the risk of kidney failure.
- Če ste starejši in imate težave z ledvicami, poskrbite za zadosten vnos tekočine, kajti dehidracija lahko zveča tveganje za ledvično odpoved.
Information and recommendations regarding taking measures before prescribing moxifloxacin are adequately addressed in the ‘contraindications' and ‘warnings-precaution of use' sections of the SPC and PL.
Informacije in priporočila o ukrepih pred predpisovanjem moksifloksacina so ustrezno obravnavani v poglavjih „kontraindikacije“ in „opozorila - previdnostni ukrepi pri uporabi“ povzetka glavnih značilnosti zdravila in navodila za uporabo.
[Invented name] contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
[izmišljeno ime] vsebuje zdravilno učinkovino moksifloksacin, ki spada v skupino antibiotikov, imenovano fluorokinoloni.
You can take [Invented name] with or without food.
[izmišljeno ime] lahko zaužijete s hrano ali brez nje.
In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline.
Analiza elektrokardiogramov, ki so jih opravili v programu kliničnih študij, je pokazala, da moksifloksacin podaljša interval QTc za 6 msec, ± 26 msec (1,4 % v primerjavi z izhodiščno vrednostjo).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines besides [Invented name], including medicines obtained without a prescription.
Obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
[Invented name] 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
[izmišljeno ime] 400 mg filmsko obložene tablete so preučevali v kliničnih študijah, v katerih je zdravljenje trajalo največ 14 dni.
If you experience palpitations or irregular heart beat during the period of treatment, you should inform your doctor immediately.
Če imate med zdravljenjem palpitacije ali nepravilen srčni utrip, o tem takoj obvestite svojega zdravnika.
ANNEX III AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET (RELEVANT SECTIONS ONLY)
DODATEK III DODATKI K POVZETKU GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILU ZA UPORABO (LE ZADEVNA POGLAVJA)
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
- Bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/galaktoze ne smejo jemati tega zdravila.
The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section.
Ovrednotiti moramo koristi zdravljenja z moksifloksacinom (posebej pri manj hudih okužbah) glede na podatke, navedene v poglavju o opozorilih in previdnostnih ukrepih.
If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking [Invented name] immediately and consult your doctor.
Če se pojavi huda in trdovratna driska ali če v blatu opazite kri ali sluz, takoj prenehajte jemati [izmišljeno ime] in se posvetujte s svojim zdravnikom.
Therefore, do not take [Invented name] together with the following medicines: Medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
Ne jemljite zdravila [izmišljeno ime] sočasno z naslednjimi zdravili: zdravila, ki spadajo v skupino antiaritmikov (npr. kinidin, hidrokinidin, dizopiramid, amiodaron, sotalol, dofetilid, ibutilid), nevroleptiki (npr. fenotiazini, pimozid, sertindol, haloperidol, sultoprid), triciklični antidepresivi, nekatera protimikrobna zdravila (npr. sparfloksacin, intravenska oblika eritromicina, pentamidin, antimalariki, predvsem halofantrin), nekateri antihistaminiki (npr. terfenadin, astemizol, mizolastin) in druga zdravila (npr. cisaprid, intravenska oblika vinkamina, bepridil, difemanil).
The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the norA or pmrA genes seen in certain Gram-positive bacteria.
Navzočnost velike bicikloaminoskupine na položaju C7 ovira aktivni prehod, kar je povezano z geni norA ali pmrA v določenih po Gramu pozitivnih bakterijah.
- There is a rare chance that you may experience a severe, sudden allergic reaction (an anaphylactic reaction/shock) even with the first dose, with the following symptoms: tightness in the chest, feeling dizzy, feeling sick or faint, or experience dizziness on standing.
- Obstaja majhna verjetnost, da se že po prvi uporabi pojavi huda, nenadna alergijska reakcija (anafilaktična reakcija/šok) z naslednjimi znaki: tesnoba v prsnem košu, vrtoglavica, omedlevica ali omotica ob vstajanju.
To cover all etiologic agents of PID a combination with another antibiotic class such as the cephalosporins (e.g. ceftriaxone 250 mg intramuscular (IM) in a single dose) should be given empirically, which would be similar to other recommended treatment regimens given in combination.
Da bi lahko zajeli vse etiološke dejavnike pelvičnih vnetnih bolezni, je potrebna empirična aplikacija v kombinaciji z drugim razredom antibiotikov, kot so npr. cefalosporini (npr. ceftriakson 250 mg intramuskularno v enkratnem odmerku), kar bi bilo podobno kot pri drugih priporočenih shemah zdravljenja, ki se dajejo v kombinaciji.
However, as moxifloxacin inhibits both topoisomerase II and IV with similar activity in some Gram-positive bacteria, such bacteria may be resistant to other quinolones, but susceptible to moxifloxacin.
Kljub temu, da moksifloksacin pri nekaterih po Gramu pozitivnih bakterijah zavira topoizomerazo II in IV s podobnim učinkom, je lahko taka bakterija odporna proti drugim kinolonom, toda občutljiva za moksifloksacin.
He/she may wish to perform an ECG to measure your heart rhythm.
Če bo presodil, da je potrebno, vam bo posnel EKG, na podlagi katerega bo ovrednotil vaš srčni ritem.
Pseudomonas aeruginosa *Activity has been satisfactorily demonstrated in susceptible strains in clinical studies in the approved clinical indications.
odporni organizmi aerobni, po Gramu negativni mikroorganizmi Pseudomonas aeruginosa *Učinek na občutljive seve so zadovoljivo dokazali v kliničnih študijah pri odobrenih kliničnih indikacijah.
In clinical practice these cases are usually restricted to cases when a combination with an approved agent active against fluoroquinolone resistant N. gonorrhoeae is not possible or in cases of therapeutic failure with a different therapy.
V klinični praksi so taki primeri omejeni na primere, ko kombinacija z odobreno učinkovino proti N. gonorrhoeae, odporno na fluorokinolone, ni možna, ali na primere, ko drugo zdravljenje ni bilo uspešno.
concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/min/1.73 m2).
Z oslabitvijo ledvične funkcije se koncentracije presnovka M2 (glukoronid) povečajo do 2,5-krat (očistek kreatinina < 30 ml/min/1,73 m2).
Taking [Invented name] 400 mg film-coated tablets with food and drink The effect of [Invented name] is not influenced by food including dairy products.
Jemanje zdravila [izmišljeno ime] 400 mg filmsko obložene tablete skupaj s hrano in pijačo Hrana (vključno z mlečnimi izdelki) ne vpliva na učinke zdravila [izmišljeno ime].
In clinical Phase I and in vitro studies no metabolic pharmacokinetic interactions with other drugs undergoing Phase I biotransformation involving cytochrome P450 enzymes were observed.
V kliničnih študijah I. faze in v študijah in vitro niso opazili presnovnih farmakokinetičnih interakcij z drugimi zdravili, ki se biotransformirajo v I. fazi z encimi citokroma P 450.
Do not take [Invented name] if you are pregnant or breast-feeding.
Če ste noseči ali dojite, ne jemljite zdravila [izmišljeno ime].
Do not take [Invented name] 400 mg film-coated tablets - If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients (see section 6.
Ne jemljite zdravila [izmišljeno ime] 400 mg filmsko obložene tablete - če ste alergični na (preobčutljivi za) zdravilno učinkovino moksifloksacin, druge kinolone ali katerokoli sestavino (glejte poglavje 6.
Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.
Zaradi omejenih kliničnih podatkov je uporaba moksifloksacina kontraindicirana tudi pri bolnikih z oslabljeno jetrno funkcijo (Child Pugh C) in pri bolnikih z zvečanimi vrednostmi transaminaz (ki so več kot petkrat večje od normalnih).
The usual dose for adults is one 400 mg film-coated tablet once daily.
Običajen odmerek za odrasle je ena filmsko obložena tableta po 400 mg enkrat na dan.