natgillin/translations-raw huggingface dataset:
As regards the relief of symptoms, this was examined in both studies through the use of diary cards and investigator interviews.
Kar se tiče lajšanja simptomov, so ga pri obeh raziskavah preverjali s pomočjo dnevnikov in intervjujev raziskovalcev.
Treatment will usually be every day for 7 days.
Zdravljenje ponavadi traja 7 dni vsak dan.
Also contains lactose and aspartame.
Vsebuje tudi laktozo in aspartam.
Your condition may not have been fully healed and may reoccur if you do not finish your course of treatment.
Bolezen morda še ni povsem pozdravljena in se lahko ponovi, če ne dokončate zdravljenja.
Do not crush or chew these capsules or the content of an emptied capsule because this will stop them from working properly.
Kapsul ali njihove vsebine ne zdrobite in jih ne žvečite, ker bo to preprečilo pravilno delovanje.
A daily dose of 30 mg should not be exceeded in the elderly unless there are compelling clinical indications.
Dnevni odmerek 30 mg se pri starejših bolnikih ne sme preseči, razen kadar obstajajo nujne klinične indikacije.
This is also reflected in the SPC for lansoprazole.
To je razvidno tudi iz SPC za lansoprazol.
This is reflected in the SPC.
To je razvidno v SPC.
[To be completed nationally - Statement and phone number to be inserted based on national requirement for information on a toxicological service.]
[Izpolni država članica - Izjavo in telefonsko številko vnesite glede na lokalne zahteve o informacijah o toksikološki službi.]
Agopton should not be given to children.
Zdravilo Agopton se ne sme dajati otrokom.
If you are taking Agopton once a day, try to take it at the same time each day.
Če zdravilo Agopton jemljete enkrat na dan, ga poskusite jemati vsak dan ob istem času.
The doctor may have to adjust your dosage.
Morda vam bo moral prilagoditi odmerek.
• the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
• Povzetek glavnih značilnosti zdravila, označevanje in Navodila za uporabo, ki jih je predlagalo podjetje, so bili ocenjeni na podlagi predložene dokumentacije in znanstvene razprave v okviru odbora,
• Symptomatic gastroesophageal reflux disease (4.1 and 4.2)
• Simptomatska gastroezofagealna refluksna bolezen (4.1 in 4.2)
Agopton should be taken at least 30 minutes before food (see section 5.2).
Zdravilo Agopton je treba jemati vsaj 30 minut pred obrokom (glejte poglavje 5.2).
Further reductions are not practically possible and data may not allow simulations of PK/PD regarding the increase the dose-interval.
Nadaljnja zmanjšanja praktično niso možna in podatki morda ne dopuščajo simulacije farmakokinetike/farmakodinamike v zvezi s povečanjem odmernega intervala.
Relief of symptoms is obtained rapidly.
Simptomi se hitro ublažijo.
• 4.5 Interaction with other medicinal products and other forms of interaction
• 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
One study of the interaction with phenytoin has been submitted.
Predložena je bila ena raziskava o interakciji s fenitoinom.
• Food interaction
• Medsebojno delovanje s hrano
To give your medicine the best chance of working, take it at the right time and do not miss a dose.
Da bi zdravilo najbolje delovalo, ga vzemite ob ustreznem času in ne izpustite odmerka.
Almirall Prodesfarma, S.A. General Mitre, 151 08022 -Barcelona, Spain
Almirall Prodesfarma, S.A. General Mitre, 151 08022 Barcelona, Španija
The treatment duration is most commonly 7 days but sometimes up to 14 days.
Zdravljenje najpogosteje traja 7 dni, včasih pa tudi do 14 dni.
It was agreed that the indication should only mention “symptomatic gastroesophageal reflux disease”.
Dogovorjeno je bilo, naj indikacija omenja zgolj »simptomatsko gastroezofagealno refluksno bolezen«.
Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should regularly be performed in these patients.
Zaradi omejenih podatkov o varnosti bolnikov na vzdrževalnem zdravljenju, ki traja dlje kot eno leto, je treba redno preverjati zdravljenje ter temeljito oceniti tveganje in koristi.
The usual doses of Agopton for adults are given below.
Običajni odmerki zdravila Agopton za odrasle so navedeni spodaj.
Benefit/Risk consideration
Ocenjevanje razmerja med koristmi in tveganji
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF AGOPTON AND ASSOCIATED NAMES
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA AGOPTON IN Z NJIM POVEZANIH IMEN
The submitted data for the indication “symptomatic gastroesophageal reflux disease” support this the indication.
Predloženi podatki za indikacijo »simptomatska gastroezofagealna refluksna bolezen« podpirajo to indikacijo.
Also contains sucrose and mannitol (E421).
Vsebuje tudi saharozo in manitol (E 421).
The evaluation of the symptoms yielded less clear results than for the healing of the ulceration, and the results are inconsistent across the different symptoms/parameters and methods used to assess the symptoms.
Vrednotenje simptomov je podalo manj jasne rezultate kot zdravljenje razjed, rezultati pa pri vrednotenju različnih simptomov oz. parametrov ter metod, uporabljenih za oceno simptomov, niso konsistentni.
A study has shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 90% decrease in AUC and Cmax).
Študija je pokazala, da je sočasna uporaba lansoprazola (60 mg enkrat na dan) in atazanavira 400 mg pri zdravih prostovoljcih povzročila pomembno zmanjšanje izpostavljenosti atazanaviru (približno 90odstotno zmanjšanje vrednosti AUC in Cmax).
Seber Portuguesa Farmaceutica, SA Rua Norberto de Oliveira,1a 5 2675-130 Povoa de Santo Adriao, Portugal
Seber Portuguesa Farmaceutica, SA Rua Norberto de Oliveira,1a 5 2675-130 Povoa de Santo Adriao, Portugalska
A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).
Opravil bo krvno preiskavo, s katero bo preveril, ali je prisotno zmanjšanje števila belih krvničk (agranulocitoza).
Colitis, stomatitis
Kolitis, stomatitis
A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with lansoprazole should be made taking into account the benefit of breastfeeding to the child and the benefit of lansoprazole therapy to the woman.
Pri odločitvi, ali nadaljevati ali prekiniti dojenje oziroma ali nadaljevati ali prekiniti zdravljenje z lansoprazolom, je treba upoštevati korist dojenja za otroka in korist zdravljenja z lansoprazolom za žensko.
• the scope of the referral was the harmonisation of the Summary of Products Characteristics,
• Namen napotitve je bil usklajevanje Povzetkov glavnih značilnosti zdravila,
For the best results from your medicines you should take Agopton at least 30 minutes before food.
Za najboljše rezultate morate zdravilo Agopton jemati vsaj 30 minut pred obrokom.
While the results for the two doses of lansoprazole and for misoprostol are very similar, all three treatments were markedly better than placebo and this is confirmed by statistical analysis (p<0.001 for each active vs. placebo comparison).
Medtem ko so bili rezultati za oba odmerka lansoprazola in misoprostol zelo podobni, so se vsi trije načini zdravljenja odrezali bistveno bolje od placeba, kar potrjuje statistična analiza (p<0,001 za vsako učinkovino v primerjavi s placebom).
Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of Agopton and associated names is favourable for use relating to:
Na podlagi dokumentacije, ki jo je predložil imetnik dovoljenja za promet z zdravilom, ter znanstvene razprave v okviru Odbora je CHMP menil, da je razmerje med tveganji in koristmi za zdravilo Agopton in z njim povezana imena ugodno za uporabo v zvezi z:
Lansoprazole has not been marketed for use in children or adolescents in the EU.
Lansoprazol v EU nima dovoljenja za promet za uporabo pri otrocih ali mladostnikih.
Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).
Bolnike z zmerno do hudo boleznijo jeter je treba redno nadzorovati, priporoča pa se 50-odstotno zmanjšanje dnevnega odmerka (glejte poglavji 4.4 in 5.2).
Due to the fact that Agopton and associated names (lansoprazole) does not have the same Summary of Product Characteristics (SPC) in the various Member States in the European Union as a result of divergent national decisions, a harmonisation of the SPC for Agopton and associated names, throughout Europe has become necessary.
Z ozirom na dejstvo, da zdravilo Agopton in z njim povezana imena (lansoprazol) v različnih državah članicah EU nima istega Povzetka glavnih značilnosti zdravila (SPC), kar je posledica razhajajočih se nacionalnih odločitev, je prišlo do potrebe po uskladitvi SPC za zdravilo Agopton in z njim povezana imena po celotni Evropi.
The overall relief of the primary symptoms (epigastric pain and heartburn) were assessed.
Ocenjeno je bilo splošno lajšanje primarnih simptomov (epigastrična bolečina in zgaga).
The recommended dose should be 15-30 mg o.d. with recommendations regarding further investigation, should the patient not respond within 4 weeks.
Priporočeni odmerek naj bo 15 do 30 mg enkrat dnevno, s priporočilom za nadaljnje preiskave, če se bolnik ne odzove v roku 4 tednov.
Laboratoires TAKEDA SA 15, quai de Dion Bouton 92816 Puteaux cedex, France
Laboratoires TAKEDA SA 15, quai de Dion Bouton 92816 Puteaux cedex, Francija
Increase in liver enzyme levels
Zvišane ravni jetrnih encimov
Directions for re-constituting suspension from sachets:
Navodila za rekonstitucijo suspenzije iz vrečic:
46 quai de la Papee 75601 Paris Cedex 12, France
46 quai de la Papee 75601 Paris Cedex 12, Francija
Higher exposure for lansoprazole was also seen in newborns and babies up to an age of approx. 10 weeks.
Višja izpostavljenost lansoprazolu je bila opažena tudi pri novorojenčkih in dojenčkih starosti do približno 10 tednov.
The contents of one sachet should be reconstituted by stirring into 30 ml (two tablespoons) of tap water, and swallowed immediately.
Vsebino ene vrečice je treba rekonstituirati tako, da jo vmešate v 30 ml (dve žlici) vode in takoj pogoltnete.
However, the pharmacokinetic and pharmacodynamic data as well as clinical data for the use of lansoprazole in children are available in the literature.
Vendar pa so v literaturi na voljo farmakokinetični in farmakodinamični podatki, kakor tudi klinični podatki za uporabo lansoprazola pri otrocih.
Capsules should be swallowed whole with liquid.
Kapsule je treba pogoltniti cele, s tekočino.
The CHMP agrees that no information regarding the lansoprazole effects on phenytoin or carbamazepine is needed in the SPC.
CHMP se strinja, da v SPC ni potrebno navesti nobene informacije v zvezi z vplivom lansoprazola na fenitoin ali karbamazepín.
Steven-Johnson syndrome, toxic epidermal necrolysis
Steven-Johnsonov sindrom, toksična epidermalna nekroliza
The following side effects are very rare (occur in less than 1 in 10000 patients): - severe hypersensitivity reactions including shock.
Naslednji neželeni učinki so zelo redki (pojavijo se pri manj kot 1 bolniku od 10.000): - hude preobčutljivostne reakcije, vključno s šokom.
No clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interactions studies have been performed.
Klinično pomembnih interakcij med lansoprazolom in nesteroidnimi antirevmatiki niso ugotovili, vendar formalnih študij interakcij niso opravili.
However, at 4 weeks, the efficacy of the 15 mg dose was less than for the comparator at 8 weeks.
Vendar pa je bila učinkovitost 15 mg odmerka pri 4 tednih manjša od učinkovitosti primerjalnega zdravila pri 8 tednih.
CYP2C19 is subject to genetic polymorphism and 2-6 % of the population, called poor metabolisers (PMs), are homozygote for a mutant CYP2C19 allele and therefore lacks a functional CYP2C19 enzyme.
CYP2C19 je izpostavljen genetskemu polimorfizmu in 2-6 % populacije, t. i. bolniki s počasno presnovo (PM - Poor Metaboliser) so homozigoti za mutantni alel CYP2C19 in zato nimajo funkcionalnega encima CYP2C19.
It may be suitable for those who are unable to take clarithromycin as part of an eradication therapy, when local resistance rates to metronidazole are low.
Utegne pa biti primeren za tiste, ki v okviru eradikacijskega zdravljenja ne morejo jemati klaritromicina, če so lokalne stopnje rezistence na metronidazol nizke.
In conclusion, the efficacy data are considered too weak to support a paediatric indication of oesophagitis in children and adolescents.
Tako so podatki glede učinkovitosti ocenjeni kot prešibki, da bi podpirali pediatrično indikacijo za ezofagitis pri otrocih in mladostnikih.
Caution is advised when combining the two drugs.
Pri kombiniranju teh dveh zdravil se priporoča previdnost.
If the symptoms are not relieved within 4 weeks with a daily dose of 30 mg, further examinations are recommended.
Če se simptomi ne ublažijo v 4 tednih zdravljenja z odmerkom 30 mg na dan, se priporočajo nadaljnje preiskave.
If you are pregnant, breast-feeding or if there is a chance you might be pregnant ask your doctor for advice before taking this medicine.
Če ste noseči, dojite ali če obstaja verjetnost, da ste noseči, se pred začetkom jemanja tega zdravila posvetujte z zdravnikom.
Insomnia, hallucination, confusion
Insomnija, halucinacije, konfuznost
Hepatitis, jaundice
Hepatitis, zlatenica
Different disease concepts for “symptomatic gastroesophageal reflux disease” and other “functional diseases” e.g. “dyspepsia”, are established throughout Europe and reflected in different labelling.
Po Evropi so uveljavljena različna tolmačenja za »simptomatsko gastroezofagealno refluksno bolezen« in druge »funkcionalne bolezni«, npr. dispepsijo«, kar se odraža v različnem označevanju.
- very rarely Agopton may cause a reduction in the number of white blood cells and your resistance to infection may be decreased.
- Zdravilo Agopton lahko zelo redko povzroči zmanjšanje števila belih krvničk, kar lahko zmanjša odpornost na okužbe.
When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days) and appropriate use of antibacterial agents.
Pri iskanju ustreznega kombiniranega zdravljenja je treba upoštevati uradne lokalne smernice glede bakterijske rezistence, trajanja zdravljenja (najpogosteje 7 dni, vendar včasih 14 dni) in ustrezne uporabe antibiotikov.
The proportion remaining healed at 12 months in evaluable patients was 39% on placebo vs. 84 % on lansoprazole15 mg maintenance.
Delež ocenjevanih bolnikov, ki so ostali zdravi po 12 mesecih, je znašal 39 % pri placebu v primerjavi s 84 % za lansoprazol 15 mg kot vzdrževalno zdravljenje.
Effects of other drugs on lansoprazole
Učinki drugih zdravil na lansoprazol
John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH UK
John Wyeth & Brother Limited Trading as Wyeth Pharmaceuticals Huntercombe Lane South Taplow, Maidenhead Berkshire SL6 0PH Velika Britanija
• Dosage recommendation for the eradication of H. pylori differences: inclusion of specific recommendations on the antibiotics to be used
• Razlike v priporočilu za odmerjanje za eradikacijo H. pylori: Vključitev specifičnih priporočil za antibiotike, ki se naj uporabljajo
However, higher values for exposure will be expected in children below 1 year of age with the pharmaceutical forms that are commercially available.
Vendar pa se pri otrocih, starih manj kot eno leto, ob uporabi komercialno dosegljivih farmacevtskih oblik pričakujejo višje vrednosti izpostavljenosti.
Germany (referring Member State) identified the following issues, each affecting several sections of the SPC.
Nemčija (referenčna država članica) je opredelila v nadaljevanju naštete vidike, od katerih se vsak tiče več poglavij Povzetka glavnih značilnosti zdravila (SPC).
However the trial design and the results of the studies were not adequate to recommend the use of lansoprazole in for the treatment of oesophagitis in children.
Vendar pa zasnova raziskav in rezultati niso bili ustrezni, da bi bilo mogoče priporočiti uporabo lansoprazola za zdravljenje ezofagitisa pri otrocih.
15 mg once daily.
15 mg enkrat na dan.
This medicinal product is authorised in the Member States of the EEA under the following names:
Zdravilo je pridobilo dovoljenje za promet v državah članicah EGP pod naslednjimi imeni: Irska:
In the case of suspected overdose the patient should be monitored.
Če se sumi na preveliko odmerjanje, mora biti bolnik pod nadzorom.
Your doctor may perform or have performed an additional investigation called an endoscopy in order to diagnose your condition and/or exclude malignant disease.
Zdravnik bo morda opravil ali pa je opravil dodatno preiskavo, imenovano endoskopija, da bi ugotovil, katero bolezen imate ali izključil možnost raka ali oboje.
As short-term antisecretory treatment combined with eradication therapy is known to be associated with significantly improved healing rates over antisecretory treatment alone, testing for and eradication of H. pylori would be considered mandatory.
Glede na to, da je znano, da je kratkoročno antisekretorno zdravljenje v kombinaciji z eradikacijskim zdravljenjem povezano s pomembno izboljšanimi stopnjami celjenja v primerjavi z zgolj antisekretornim zdravljenjem, bi morala biti testiranje za H. pylori in eradikacija obvezna.
The clearance of lansoprazole is decreased in the elderly, with elimination half-life increased approximately 50% to 100%.
Očistek lansoprazola se pri starejših osebah zmanjša, razpolovni čas izločanja pa poveča za približno 50 do 100 %.
Important information about some of the ingredients of Agopton
Pomembne informacije o nekaterih sestavinah zdravila Agopton
Therefore, the use of lansoprazole during pregnancy is not recommended.
Uporaba lansoprazola med nosečnostjo torej ni priporočena.
If you are taking Agopton twice a day, you should have the first dose in the morning and the second dose in the evening.
Če zdravilo Agopton jemljete dvakrat na dan, vzemite prvi odmerek zjutraj, drugega pa zvečer.
Due to reduced clearance of lansoprazole in the elderly an adjustment of dose may be necessary based on individual requirements.
Zaradi zmanjšanega očistka lansoprazola pri starejših bo morda treba prilagoditi odmerek glede na potrebe vsakega bolnika posebej.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Študije na živalih ne nakazujejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
Lower eradication rates were seen using this combination than in regimens involving clarithromycin.
Pri tej kombinaciji so opazili nižjo stopnjo eradikacije kot pri režimih s klaritromicinom.
Sub-optimal results were obtained for children 1-11 years of age and pharmacodynamic as well as the efficacy results make dosing recommendations difficult.
Pri otrocih, starih od 1 do 11 let, so bili doseženi podoptimalni rezultati, farmakodinamika in rezultati glede učinkovitosti pa povzročajo težave pri izdelavi priporočil za odmerjanje.
This effect remains after adjustment for a range of covariates.
Učinek se ohrani tudi po popravku različnih kovariat.
Like all medicines, Agopton can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Agopton neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Lansoprazole reduces the plasma concentration of theophylline, which may decrease the expected clinical effect at the dose.
Lansoprazol zmanjša koncentracijo teofilina v plazmi, kar lahko zmanjša pričakovani klinični učinek odmerka.
Intake of food slows the absorption rate of lansoprazole and reduces the bioavailabilty by about 50%.
Vnos hrane upočasni absorpcijo lansoprazola in zmanjša biološko uporabnost za približno 50 %.
Cyanamid of Great Briain Ltd. Fareham Road, GOSPORT Hampshire PO13 0AS, UK
Cyanamid of Great Britain Ltd. Fareham Road, GOSPORT Hampshire PO13 0AS, Velika Britanija
The Maastricht Consensus states that treatment regimens for eradication of H. pylori should be simple, well tolerated and achieve an eradication rate of over 80% on an intention to treat basis.
V skladu z dogovorom s konference v Maastrichtu morajo biti režimi zdravljenja za eradikacijo bakterije H. pylori enostavni, bolniki jih morajo dobro prenašati ter dosegati morajo stopnjo eradikacije preko 80 % na osnovi namena zdravljenja (intention to treat).
If lansoprazole is used in combination with antibiotics for eradication therapy of H.pylori, then the instructions for the use of these antibiotics should also be followed.
Če se lansoprazol uporablja v kombinaciji z antibiotiki pri eradikaciji bakterije H. pylori, je treba upoštevati tudi navodila za uporabo teh antibiotikov.
Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered.
Zato je treba v primeru hude ali perzistentne driske ali obojega pretehtati možnost prekinitve zdravljenja.
Effects of lansoprazole on other drugs
Učinki lansoprazola na druga zdravila
Therefore the 15 mg dose cannot be recommended for healing of NSAID-associated gastric ulcers.
Posledično 15 mg odmerka ni mogoče priporočiti za celjenje razjed želodca, povezanih z jemanjem NSAID.
Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Izpostavljenost lansoprazolu je povečala povprečno izpostavljenost takrolimusu do 81 %.
Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulphydryl group of H+/K+ATPase causing inhibition of the enzyme activity.
Lansoprazol je koncentriran v parietalnih celicah in se aktivira v njihovem kislem okolju, kjer reagira s sulfidrilno skupino H+/K+ATPaze, kar povzroči zaviranje encimske aktivnosti.
• 4.6 Pregnancy and lactation
• 4.6 Nosečnost in dojenje
A study with 14C labelled lansoprazole indicated that approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the faeces.
Študija z lansoprazolom, označenim s 14C, je pokazala, da se približno ena tretjina uporabljenega označenega lansoprazola izloči z urinom, dve tretjini pa z blatom.
Netherlands Sanofi-Synthelabo B.V. / Aventis Pharma B.V. Kampenringweg 45 D-E (toren D en E), 2803 PE GOUDA, The Netherlands
/ Aventis Pharma B.V.Kampenringweg 45 D-E (toren D en E), 2803 PE GOUDA, Nizozemska
If you have any further questions on the use of this product, ask your doctor.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom.
Due to a marked reduction in atazanavir trough concentrations observed during concomitant use of omeprazole, use of PPIs is contraindicated in the SPC for Rayataz (atazanavir).
Z ozirom na izkazano zmanjšanje koncentracije atazanavirja, opaženo ob sočasni uporabi omeprazola, je uporaba ZPČ kontraindicirana v SPC za Reyataz (atazanavir).
Capsules may also be opened and granules mixed with 40 ml of apple juice for administration through a nasogastric tube (see section 5.2).
Kapsule se lahko odprejo in zrnca premešajo s 40 ml jabolčnega soka za uporabo z nazogastrično cevko (glejte poglavje 5.2).
For patients requiring 15 mg lansoprazole daily, either Agopton 15 mg capsules or Agopton 15 mg oro-dispersible tablets should be used.
Pri bolnikih, ki potrebujejo odmerek 15 mg lansoprazola na dan, je treba uporabiti zdravilo Agopton 15 mg kapsule ali Agopton 15 mg orodisperzibilne tablete.
Ketoconazole and itraconazole:
Ketokonazol in itrakonazol:
If the treatment fails the dose 30 mg once daily should be used.
Če zdravljenje ni uspešno, je treba uporabiti odmerek 30 mg enkrat na dan.