FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare: severe skin reactions perforation of the gullet (oesophagus - the tube that connects your mouth with your stomach) was reported in isolated cases
Slovenian: Zelo redki: hude kožne reakcije v posameznih primerih so poročali o perforaciji požiralnika (požiralnik je cev, ki povezuje usta z želodcem)
English: Patients should be given a calcium and vitamin D supplement if the diet is inadequate (see section
Slovenian: V primeru neustrezne prehrane morajo bolniki prejemati dodatek kalcija in vitamina D (glejte poglavje 4.4).
English: Use in impaired renal function
Slovenian: Uporaba pri bolnikih z motnjami v delovanju ledvic
English: Uncommon (≥1/1000, <1/100): Nausea, vomiting, gastritis, oesophagitis* oesophageal erosions*, melaena.
Slovenian: Občasni (≥1/1.000, <1/100): navzeja, bruhanje, gastritis, ezofagitis*, erozije požiralnika*, melena.
English: Alendronate can cause local irritation to the upper gastrointestinal mucosa.
Slovenian: Alendronat HEXAL lahko povzroči lokalno draženje sluznice zgornjega dela prebavil.
English: METHOD AND ROUTE OF ADMINISTRATION For oral use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za peroralno uporabo.
English: Gastric ulcer Oesophageal ulcer Musculoskeletal Musculoskeletal pain (bone, muscle or joints) Muscle cramps Neurological Headache
Slovenian: Razjeda požiralnika Mišično-skeletni Bolečina v mišicah in kosteh (kosti, mišice ali sklepi) Mišični krči
English: The active substance in Alendronate HEXAL 10 mg tablets, alendronic acid as sodium alendronate trihydrate, is a bisphosphonate that inhibits osteoclastic bone resorption without any direct effect on bone formation.
Slovenian: Zdravilna učinkovina zdravila Alendronat HEXAL10 mg tablete, alendronska kislina v obliki natrijevega alendronat trihidrata, spada med bifosfonate in zavira osteoklastično resorpcijo kosti brez neposrednega vpliva na tvorbo kosti.
English: Common (≥1/100, <1/10): Abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcers*, dysphagia*, abdominal distension, acid regurgitation.
Slovenian: Pogosti (≥1/100, <1/10): bolečina v trebuhu, dispepsija, zaprtje, driska, flatulenca, razjede požiralnika*, disfagija*, napet trebuh, regurgitacija kisline.
English: Treatment of post-menopausal osteoporosis.
Slovenian: Zdravljenje pomenopavzne osteoporoze.
English: Alendronate HEXAL is not recommended for use in children due to a lack of data on safety and efficacy.
Slovenian: Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporaba zdravila Alendronat HEXAL pri otrocih ni priporočljiva.
English: Severe bone, muscle and/or joint pain rash made worse by sunlight, transient flu-like symptoms, such as aching muscles, generally feeling unwell and sometimes with fever usually at the start of treatment hypersensitivity reactions including nettle rash and angio-oedema symptoms of low blood calcium levels including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
Slovenian: Redki: zamegljen vid, bolečina ali rdečina v očesu zožitev požiralnika (požiralnik je cev, ki povezuje usta z želodcem); razjede v ustih zaradi žvečenja ali sesanja tablet; želodčne ali peptične razjede (včasih hude ali s krvavitvijo), za katere pa ni znano, ali jih je povzročil Alendronat HEXAL; hude bolečine v kosteh, mišicah in/ali sklepih izpuščaj, ki ga poslabša izpostavljenost sončni svetlobi, prehodni gripi podobni simptomi, kot so bolečine v mišicah, splošno slabo počutje, včasih z zvišano telesno temperaturo, običajno ob začetku zdravljenja; preobčutljivostne reakcije, vključno s koprivnico in angioedemom; simptomi nizke ravni kalcija v krvi, vključno z mišičnimi krči ali spazmami in/ali mravljinčenjem v prstih ali okoli ust
English: Vomiting irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach black or tarlike stools rash itching redness of the skin
Slovenian: Občasni: slabost bruhanje draženje ali vnetje požiralnika (požiralnik je cev, ki povezuje usta z želodcem) ali želodca; črno ali katranu podobno blato izpuščaj srbečica pordela koža
English: No dose adjustment is necessary in patients with a glomerular filtration rate (GFR) greater than 35 ml/min.
Slovenian: Pri bolnikih, pri katerih je hitrost glomerulne filtracije (GFR) večja od 35 ml/min, prilagajanje odmerka ni potrebno.
English: Croscarmellose sodium
Slovenian: Premrežen natrijev karmelozat
English: Do not take Alendronate HEXAL - if you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other ingredients of Alendronate HEXAL - if you have certain problems with your gullet (oesophagus - the tube that connects your mouth with your stomach) such as narrowing or difficulty swallowing - if you cannot stand or sit upright for at least 30 minutes - if your doctor has told you that you have low blood calcium
Slovenian: Alendronat HEXAL, - če imate določene težave s požiralnikom (požiralnik je cev, ki povezuje usta in želodec), kot sta zožitev ali oteženo požiranje, - če ne morete stati ali pokončno sedeti vsaj 30 minut, - če vam je zdravnik povedal, da imate nizko vrednost kalcija v krvi.
English: Hypocalcaemia, hypophosphataemia and upper gastrointestinal side effects such as upset stomach, heartburn, oesophagitis, gastritis or ulcer can occur on oral overdosage.
Slovenian: Zaradi prevelikih peroralnih odmerkov lahko pride do hipokalcemije, hipofosfatemije in neželenih učinkov v zgornjem delu prebavil, kot so razdraženost želodca, zgaga, ezofagitis, gastritis ali razjeda.
English: Rare (≥1/10,000, <1/1000): Oesophageal stricture*, oropharyngeal ulceration*, upper gastrointestinal PUB (perforations, ulcers, bleeding), a causal relationship cannot be ruled out.
Slovenian: Redki (≥1/10.000, <1/1.000): zožitev požiralnika*, razjede ust in žrela*, PUK (perforacije, ulkusi ali krvavitve) v zgornjem delu prebavil, vzročne povezave ni mogoče izključiti.
English: Alendronate HEXAL tablets must be taken on an empty stomach immediately on rising in the morning, with plain water only, at least 30 minutes before the first food, drink or other medication of the day.
Slovenian: Da bi omogočili zadostno absorpcijo Alendronata HEXAL Alendronat HEXAL tablete je treba vzeti na prazen želodec takoj po jutranjem vstajanju izključno z navadno vodo in najmanj 30 minut pred zaužitjem prve hrane, pijače ali drugih zdravil v tem dnevu.
English: Prophylaxis of glucocorticoid-induced osteoporosis.
Slovenian: Profilaksa osteoporoze, povzročene z glukokortikoidi.
English: sucked or allowed to dissolve in the mouth on account of the risk of oropharyngeal ulceration.
Slovenian: Bolnik tablet ne sme žvečiti, sesati ali jih raztopiti v ustih, ker obstaja tveganje za razjedo v ustih in žrelu.
English: Uncommon (≥1/1000, <1/100): Rash, pruritus, erythema.
Slovenian: Občasni (≥1/1.000, <1/100): izpuščaj, srbenje, eritem.
English: Taking Alendronate HEXAL with food and drink It is likely that food and beverages (including mineral water) will make Alendronate HEXAL less effective if taken at the same time.
Slovenian: Verjetno je, da bosta hrana in pijača (vključno z mineralno vodo) zmanjšali učinkovitost zdravila Alendronat HEXAL, če ju boste vzeli istočasno.
English: Use in elderly patients:
Slovenian: Uporaba pri starejših
English: STATEMENT OF ACTIVE SUBSTANCE One tablet contains 10 mg alendronic acid (as sodium alendronate trihydrate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena tableta vsebuje 10 mg alendronske kisline (v obliki natrijevega alendronata trihidrata).
English: Talk to your doctor before you take Alendronate HEXAL if you have or have had pain or swelling of your gums and/or jaw, numbness of the jaw, if the jaw feels heavy or if you have lost a tooth.
Slovenian: Če imate ali ste imeli boleče ali otečene dlesni in/ali čeljust, omrtvičeno čeljust, če imate občutek teže v čeljusti ali ste izgubili zob, se pred jemanjem zdravila Alendronat HEXAL posvetujte z zdravnikom.
English: The patients should be instructed to discontinue alendronate and seek medical attention if they develop symptoms of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new/worsened heartburn.
Slovenian: Bolnike je treba poučiti, da v primeru pojava simptomov draženja požiralnika, kot so disfagija, bolečina pri požiranju, retrosternalna bolečina ali pojav oz. poslabšanje zgage, prekinejo jemanje Alendronata HEXAL in poiščejo zdravniško pomoč.
English: Abdominal distension Constipation Diarrhoea
Slovenian: Bolečina v trebuhu Dispepsija Regurgitacija kisline Navzeja
English: Oesophageal side effects (in some cases severe and requiring hospitalisation) such as oesophagitis, oesophageal ulcers or oesophageal erosions, in rare cases followed by oesophageal stricture, have been reported in patients receiving treatment with alendronate.
Slovenian: Pri bolnikih, ki so se zdravili z Alendronatom HEXAL, so poročali o neželenih učinkih v požiralniku (v nekaterih primerih hujših, ki so zahtevali hospitalizacijo), kot so ezofagitis, razjede ali erozije požiralnika, ki jim je v redkih primerih sledila zožitev požiralnika.
English: HOW TO STORE ALENDRONATE HEXAL
Slovenian: KAKO JEMATI ZDRAVILO ALENDRONAT HEXAL
English: MARKETING AUTHORISATION NUMBER(S) <[To be completed nationally]>
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET [Izpolni država članica]
English: Uncommon: ≥ 1/1,000 - < 1/100
Slovenian: Občasni (≥1/1.000 - <1/100)
English: In view of the indication, alendronate should not be used by breast-feeding women.
Slovenian: Zato ženske, ki dojijo, Alendronata HEXAL ne smejo uporabljati.
English: Alendronate is not recommended for patients with impaired renal function if the GFR is less than 35 ml/min, as there is no experience of this.
Slovenian: Bolnikom z motnjami v delovanju ledvic, pri katerih je hitrost glomerulne filtracije pod 35 ml/min, se zdravilo Alendronat HEXAL zaradi pomanjkanja izkušenj ne priporoča.
English: Belgium - Alendronate Sandoz Denmark - Alendonicht
Slovenian: Alendronate Sandoz
English: Content (concentration)
Slovenian: Farmacevtska oblika Pot uporabe zdravila Vsebina (koncentracija)
English: Nausea
Slovenian: Prebavni
English: Alendronic acid
Slovenian: Alendron-HEXAL
English: Rare: ≥ 1/10,000 - < 1/1,000
Slovenian: Redki (≥1/10.000 - <1/1.000)
English: What Alendronate HEXAL contains
Slovenian: Kaj vsebuje zdravilo Alendronat HEXAL
English: MARKETING AUTHORISATION HOLDER <[See Annex I - To be completed nationally]
Slovenian: IMETNIK DOVOLJENJA ZA PROMET [Glejte Dodatek I - Izpolni država članica]
English: Common: ≥ 1/100 - < 1/10
Slovenian: Pogosti (≥1/100 do <1/10)
English: Ear and labyrinth disorders: vertigo
Slovenian: Ušesne bolezni, vključno z motnjami labirinta: vrtoglavica
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene).
Slovenian: Pri bolnikih s sočasnimi dejavniki tveganja (npr. rak, kemoterapija, radioterapija, kortikosteroidi, slaba ustna higiena) je treba razmisliti o zobozdravstvenem pregledu pri ustreznem zobozdravniku.
English: Marketing Authorisation Holder and Manufacturer <[See Annex I - To be completed nationally]>
Slovenian: Imetnik dovoljenja za promet z zdravilom in izdelovalec [Glejte Dodatek I - Izpolni država članica]
English: Acid regurgitation Nausea
Slovenian: Želodčna razjeda
English: Glucocorticoid-induced osteoporosis
Slovenian: Flatulenca Gastritis
English: Dysphagia
Slovenian: Driska
English: Always take Alendronate HEXAL exactly as your doctor has told you.
Slovenian: Pri jemanju zdravila Alendronat HEXAL natančno upoštevajte zdravnikova navodila.
English: Bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates.
Slovenian: Pri bolnikih, ki so jemali difosfonate, so poročali o bolečinah v kosteh, sklepih in/ali mišicah.
English: Glucocorticoid-induced osteoporosis:
Slovenian: Osteoporoza, povzročena z glukokortikoidi:
English: You should not take Alendronate HEXAL if you are breast-feeding.
Slovenian: Ne jemljite zdravila Alendronat HEXAL, če dojite.
English: Musculoskeletal and connective tissue disorders:Osteonecrosis of the jaw has been reported in patients treated by bisphosphonates.
Slovenian: Pri bolnikih, ki so se zdravili z difosfonati, so poročali o osteonekrozi čeljusti.
English: Gastritis
Slovenian: Disfagija
English: BEFORE YOU TAKE ALENDRONATE HEXAL
Slovenian: Alendronat HEXAL
English: <[To be completed nationally]>
Slovenian: [Glejte Dodatek I - Izpolni država članica]
English: EU/1/14/965 /001 Ketoconazole HRA 200 mg Tablet
Slovenian: EU/1/14/965 /001 Ketoconazole HRA 200 mg Tableta
English: Oral use blister (PVC/alu)
Slovenian: Peroralna uporaba Pretisni omot (PVC/Al)
English: 11 October 2013 EMA/584237/2013
Slovenian: 11. oktober 2013 EMA/584237/2013
English: European legislation requires that there is a coordinated European approach when a Member State takes regulatory action in relation to a medicine that is authorised in more than one country.
Slovenian: Evropska zakonodaja zahteva, da se izvaja usklajen pristop po celi Evropi, kadar država članica sproži regulativni ukrep, povezan z zdravilom, ki je odobreno v več kot eni državi.
English: • If you have any questions, you should contact your doctor or pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: The Committee also considered the advice from a group of experts in the treatment of infections.
Slovenian: Odbor je prav tako upošteval nasvet skupine strokovnjakov za zdravljenje okužb.
English: References.
Slovenian: Referenčna literatura.
English: In order to ensure that these patients will not be left without treatment, national competent authorities may make these medicines available under controlled conditions.
Slovenian: Da bi zagotovili, da bodo ti bolniki še naprej prejemali zdravljenje, lahko nacionalni pristojni organi odobrijo uporabo teh zdravil pod nadzorovanimi pogoji.
English: • The onset of hepatotoxicity occurred generally between 1 and 6 months after starting treatment, but has also been reported earlier than 1 month after starting treatment, and at the recommended daily dose of 200 mg.
Slovenian: • Hepatotoksičnost se je navadno pojavila med 1 ter 6 meseci po začetku zdravljenja, vendar so o njej poročali tudi pred 1 mesecem po zdravljenju, in pri priporočenem odmerku 200 mg.
English: • Topical ketoconazole formulations have very low systemic absorption and may continue to be used as currently approved.
Slovenian: • Topične formulacije ketokonazola imajo zelo majhno sistemsko absorpcijo in se lahko še naprej uporabljajo, kot so trenutno odobrene.
English: Oral formulations of ketoconazole have been authorised in the EU via national procedures, and are currently available in several EU Member States under various trade names, including Nizoral and Fungoral.
Slovenian: Peroralne formulacije ketokonazola so se v EU odobrile z nacionalnimi postopki in so trenutno na voljo v več državah članicah EU pod različnimi trgovskimi imeni, vključno z zdraviloma Nizoral in Fungoral.
English: The review of oral ketoconazole was initiated in July 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Slovenian: Pregled peroralnega ketokonazola je bil julija 2011 sprožen na zahtevo Francije v skladu s členom 31
English: The CHMP was concerned that reports of liver injury occurred early after starting treatment with recommended doses, and it was not possible to identify measures to adequately reduce this risk.
Slovenian: Odbor CHMP je bil zaskrbljen, da so se poročila o poškodbah jeter pojavila kmalu po uvedbi zdravljenja s priporočenimi odmerki in da ni bilo mogoče določiti ukrepov, ki bi zadostno zmanjšali to tveganje.
English: • The risk minimisation measures proposed, such as limiting the treatment duration or restricting the use to patients refractory or intolerant to alternative treatments and to physicians experienced in treating rare fungal infections, were not considered sufficient to reduce the risk of hepatotoxicity to an acceptable level.
Slovenian: • Predlagani ukrepi za zmanjševanje tveganja, kot so omejitev trajanja zdravljenja ali omejitev uporabe na bolnike, ki so neodzivni na druga zdravljenja ali jih ne prenašajo, in na zdravnike z izkušnjami z zdravljenjem redkih glivičnih okužb, niso bili zadostni za zmanjšanje tveganja hepatotoksičnosti na sprejemljivo raven.
English: On 25 July 2013, the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) recommended that the marketing authorisations of oral ketoconazole-containing medicines should be suspended throughout the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila je 25. julija 2013 priporočil, da se dovoljenja za promet s peroralnimi zdravili, ki vsebujejo ketokonazol, začasno umaknejo po celotni Evropski uniji (EU).
English: The Committee also concluded that the clinical benefit of oral ketoconazole is uncertain as data on its effectiveness are limited and do not meet current standards, and alternative treatments are available.
Slovenian: Odbor je prav tako sklenil, da je klinična korist peroralnega ketokonazola negotova, saj so podatki o njegovi učinkovitosti omejeni in niso skladni s trenutnimi standardi, na voljo pa so tudi druge oblike zdravljenja.
English: To lift the suspension, the marketing authorisation holder for oral ketoconazole will have to provide convincing data that identify a group of patients in whom the benefits of the medicine outweigh their risks.
Slovenian: Za preklic začasnega umika mora imetnik dovoljenja za promet s peroralnim ketokonazolom predložiti prepričljive podatke, s katerimi se bo ugotovila skupina bolnikov, pri katerih koristi zdravila odtehtajo njegova tveganja.
English: The Agency's recommendations are based on a review by the Committee for Medicinal Products for Human Use (CHMP), which looked at available data on the benefits of oral ketoconazole and the risk of hepatotoxicity from pre-clinical and clinical studies, post-marketing spontaneous case reports, epidemiological studies and the scientific literature.
Slovenian: Priporočila Evropske agencije za zdravila temeljijo na pregledu Odbora za zdravila za uporabo v humani medicini (CHMP), ki je preučil razpoložljive podatke o koristih peroralnega ketokonazola in tveganju hepatotoksičnosti iz predkliničnih ter kliničnih študij, spontanih poročil o primerih v obdobju trženja, epidemioloških študij in znanstvene literature.
English: The CHMP opinion was sent to the European Commission, which endorsed it and adopted a final legally binding decision valid throughout the EU on 11 October 2013.
Slovenian: Odbor CHMP je mnenje predložil Evropski komisiji, ki ga je potrdila in dne 11. oktobra 2013 sprejela končni pravno zavezujoči sklep, veljaven v celotni EU.
English: Taking into account the increased rate of liver injury and the availability of alternative antifungal treatments, the CHMP concluded that the benefits did not outweigh the risks.
Slovenian: Upoštevajoč povečano število poškodb jeter in dostopnost drugih antimikotičnih terapij je odbor CHMP sklenil, da koristi ne odtehtajo tveganj.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision valid throughout the EU.
Slovenian: Mnenje odbora CHMP je bilo poslano Evropski komisiji, ki je izdala končni pravno zavezujoči sklep, veljaven po celotni EU.
English: The review of oral ketoconazole was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted the EMA's final opinion.
Slovenian: Pregled peroralnega ketokonazola je opravil Odbor za zdravila za uporabo v humani medicini (CHMP) pri Evropski agenciji za zdravila, pristojnemu za vsa vprašanja, povezana z zdravili za uporabo v humani medicini, ki je sprejel končno mnenje agencije.
English: Ketoconazole taken orally (by mouth) has been authorised in the EU since 1980, and later topical (on the skin) formulations, such as creams, ointments and shampoos, have become available.
Slovenian: Peroralni (z zaužitjem skozi usta) ketokonazol je v EU odobren od leta 1980, pozneje pa je sledila še odobritev topičnih (kožnih) formulacij, kot so kreme, mazila in zdravilni šamponi.
English: Doctors should no longer prescribe oral ketoconazole and should review patients' treatment options.
Slovenian: Zdravniki ne smejo več predpisovati peroralnega ketokonazola in morajo ponovno proučiti možnosti zdravljenja bolnikov.
English: The CHMP concluded that the risk of liver injury is greater than the benefits in treating fungal infections.
Slovenian: Odbor CHMP je sklenil, da je tveganje poškodbe jeter večje od koristi pri zdravljenju glivičnih okužb.
English: Ketoconazole is an antifungal medicine used to treat infections caused by dermatophytes and yeasts.
Slovenian: Ketokonazol je antimikotik, ki se uporablja za zdravljenje okužb, ki jih povzročajo dermatofiti in kvasovke.
English: Garcia Rodriguez et al. A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs.
Slovenian: A cohort study on the risk of acute liver injury among users of ketoconazole and other antifungal drugs.
English: The European Medicines Agency is aware that ketoconazole is used off-label for treating patients with Cushing's syndrome.
Slovenian: Evropska agencija za zdravila se zaveda, da se ketokonazol uporablja za zdravljenje bolnikov s Cushingovim sindromom, za kar ni indiciran.
English: Consequently, the French agency asked the EMA to carry out a full assessment of the benefitrisk balance of oral ketoconazole-containing medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Slovenian: Posledično je francoska agencija Evropsko agencijo za zdravila zaprosila za popolno oceno razmerja med tveganji in koristmi peroralnih zdravil, ki vsebujejo ketokonazol, ter izdajo mnenja o tem, ali naj se dovoljenja za promet z zdravilom obdržijo, spremenijo, začasno umaknejo ali ukinejo.
English: • Oral (by mouth) ketoconazole has been suspended following a review of data showing higher liver toxicity with this medicine compared with other antifungal medicines.
Slovenian: • Peroralni (z zaužitjem skozi usta) ketokonazol se je začasno umaknil iz prometa po pregledu podatkov, ki je pokazal veliko jetrno toksičnost pri tem zdravilu v primerjavi z drugimi antimikotiki (zdravili proti glivicam).
English: • Although the potential for hepatotoxicity is a class effect with azole antifungals, the data assessed show that the incidence and seriousness of hepatotoxicity is higher with ketoconazole than with other antifungal agents.1 Reported cases of hepatotoxicity included hepatitis, cirrhosis and liver failure with fatal outcomes or requiring liver transplantation.
Slovenian: • Čeprav je morebitna hepatotoksičnost učinek razreda azolnih antimikotikov, je ocena podatkov pokazala, da sta incidenca in resnost hepatotoksičnosti večji pri ketokonazolu kot pri drugih antimikotikih.1 Poročani primeri hepatotoksičnosti so vključevali hepatitis, cirozo in jetrno odpoved s smrtnimi izidi ali potrebo po presaditvi jeter.
English: Benefit of oral ketoconazole does not outweigh risk of liver injury in fungal infections
Slovenian: Korist peroralnega ketokonazola ne odtehta tveganja jetrne poškodbe pri glivičnih okužbah
English: • If you are taking topical formulations of ketoconazole (such as creams, ointments and shampoos), you can continue your treatment, as the amount of ketoconazole absorbed throughout the body is very low with these formulations.
Slovenian: • Če jemljete topične formulacije ketokonazola (kot so kreme, mazila in zdravilni šamponi), lahko nadaljujete zdravljenje, saj je količina ketokonazola, ki se absorbira po telesu, v teh formulacijah zelo majhna.