FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/18/1273/002 EU/1/18/1273/004 EU/1/18/1273/009 EU/1/18/1273/010 EU/1/18/1273/011 EU/1/18/1273/012 EU/1/18/1273/013 EU/1/18/1273/014 EU/1/18/1273/015
Slovenian: Prasugrel Mylan 10 mg: EU/1/18/1273/002 EU/1/18/1273/004 EU/1/18/1273/009 EU/1/18/1273/010 EU/1/18/1273/011 EU/1/18/1273/012 EU/1/18/1273/013 EU/1/18/1273/014 EU/1/18/1273/015
English: carton only:
Slovenian: Samo na škatli: PC:
English: CV death
Slovenian: Srčno-žilna smrt
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Slovenian: Shranjujte pri temperaturi do 25 °C.
English: Table 1: Incidence of Non-CABG related bleedinga (% Patients)
Slovenian: Preglednica 1: Incidenca krvavitev, nepovezanih z aortokoronarnim obvodom a
English: You will start the treatment with a single dose of 60 mg.
Slovenian: Običajen odmerek zdravila Prasugrel Mylan je 10 mg na dan. Vaše zdravljenje boste začeli z enkratnim odmerkom 60 mg.
English: Your doctor may wish you to stop taking Prasugrel Mylan temporarily due to the increased risk of bleeding
Slovenian: Vaš zdravnik vam bo morda naročil, da začasno prenehate jemati zdravilo
English: Prasugrelb + ASA (N=5001)
Slovenian: ASK (N = 5001)
English: Talk to your doctor before taking Prasugrel Mylan.
Slovenian: Pred začetkom jemanja zdravila Prasugrel Mylan se posvetujte z zdravnikom.
English: EU/1/18/1273/001 EU/1/18/1273/003 EU/1/18/1273/005 EU/1/18/1273/006 EU/1/18/1273/007 EU/1/18/1273/008
Slovenian: Prasugrel Mylan 5 mg: EU/1/18/1273/001 EU/1/18/1273/003 EU/1/18/1273/005 EU/1/18/1273/006 EU/1/18/1273/007 EU/1/18/1273/008
English: It was to be used in combination with other medicines.
Slovenian: Uporabljalo naj bi se v kombinaciji z drugimi zdravili.
English: It was to be available as capsules (120 mg).
Slovenian: Na voljo naj bi bilo v obliki kapsul (120 mg).
English: Remaining clinical trials were expected to finish on schedule by July 2014.
Slovenian: Preostala klinična preskušanja naj bi se zaključila do julija 2014, kot je bilo predvideno.
English: 27 June 2014 EMA/354906/2014 EMEA/H/C/003720
Slovenian: EMA/445627/2014 EMEA/H/C/003720
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Slovenian: Vlogo so umaknili potem, ko je CHMP ocenil začetno dokumentacijo, ki jo je predložila družba, in oblikoval seznam vprašanj.
English: In addition, results of tests on capsules stored in nonrefrigerated conditions showed that they did not dissolve as expected, which could affect the release of the active substance from the capsule.
Slovenian: Poleg tega so rezultati preskusov na kapsulah, ki niso bile hranjene v hladilniku, pokazali, da se kapsule niso raztopile v skladu s pričakovanji, kar bi lahko vplivalo na sproščanje zdravilne učinkovine iz nje.
English: The company presented data including the results of three main studies involving 1,705 patients with chronic hepatitis C, in which faldaprevir was compared with placebo (a dummy treatment) when added to two other medicines for hepatitis C, peginterferon and ribavirin.
Slovenian: Družba je predložila podatke, med katerimi so bili tudi rezultati treh glavnih študij, v katere so vključili 1 705 bolnikov s kroničnim hepatitisom C in v katerih so primerjali faldaprevir in placebo (zdravilo brez zdravilne učinkovine), ki so ju dodajali dvema drugima zdraviloma za hepatitis C, peginterferonu in ribavirinu.
English: The main measure of effectiveness was the number of patients whose blood tests did not show any sign of hepatitis C virus 12 weeks after
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih preiskave krvi 12 tednov po končanem zdravljenju niso pokazale nobenih znakov virusa hepatitisa C. V četrti študiji, v katero so
English: In its letter notifying the Agency of the withdrawal of application, the company stated that since several new treatments for hepatitis C had become available after the application was first made, there was no longer an unmet medical need for such a medicine.
Slovenian: Družba je v dopisu, s katerim agencijo obvešča o umiku vloge, navedla, da je od prvotne predložitve vloge bilo danih na voljo več novih zdravil za hepatitis C, tako da je potreba po tovrstnem zdravilu izpolnjena.
English: On 10 June 2014, Boehringer Ingelheim International GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Faldaprevir Boehringer Ingelheim, for the treatment of hepatitis C.
Slovenian: Družba Boehringer Ingelheim International GmbH je dne 10. junija 2014 uradno obvestila Odbor za zdravila za uporabo v humani medicini (CHMP), da želi umakniti vlogo za pridobitev dovoljenja za promet z zdravilom Faldaprevir Boehringer Ingelheim, namenjenim zdravljenju hepatitisa C.
English: Several varieties (genotypes) of hepatitis C virus exist: Faldaprevir Boehringer Ingelheim was intended to be used against genotype 1.
Slovenian: Obstaja več vrst (genotipov) virusa hepatitisa C: zdravilo Faldaprevir Boehringer Ingelheim naj bi se uporabljalo proti genotipu 1.
English: A fourth study involving 308 patients examined the effects of treatment with Faldeprevir Boehringer Ingelheim in patients who also had HIV infection.
Slovenian: vključili 308 bolnikov, so proučili učinke zdravljenja z zdravilom Faldaprevir Boehringer Ingelheim pri bolnikih, ki so bili okuženi tudi z virusom HIV.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Faldaprevir Boehringer Ingelheim could not have been approved for the treatment of hepatitis C. The Committee had concerns regarding the starting materials used for the manufacture of the active substance.
Slovenian: Na podlagi pregleda podatkov je CHMP v času umika izrazil določene zadržke in je začasno menil, da zdravila Faldaprevir Boehringer Ingelheim ni mogoče odobriti za zdravljenje hepatitisa C. Odbor je imel pomisleke glede vhodnih snovi, ki so bile uporabljene za izdelavo zdravilne učinkovine.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Faldaprevir Boehringer Ingelheim.
Slovenian: Družba je obvestila odbor CHMP, da umik nima nobenih posledic za bolnike, ki trenutno sodelujejo v kliničnih preskušanjih zdravila Faldaprevir Boehringer Ingelheim.
English: Faldaprevir Boehringer Ingelheim is an antiviral medicine that contains the active substance faldaprevir.
Slovenian: Faldaprevir Boehringer Ingelheim je protivirusno zdravilo, ki vsebuje zdravilno učinkovino faldaprevir.
English: Faldaprevir Boehringer Ingelheim was expected to be used to treat adults with chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
Slovenian: Zdravilo Faldaprevir Boehringer Ingelheim naj bi se uporabljalo za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom C (infekcijsko boleznijo, ki jo povzroča virus hepatitisa C in ki prizadene jetra).
English: Therefore, up to the time of the withdrawal, the CHMP was of the opinion that due to the concerns about quality the benefits of Faldaprevir Boehringer Ingelheim did not outweigh its risks.
Slovenian: Zato je CHMP v času umika menil, da zaradi pomislekov glede kakovosti koristi zdravila Faldaprevir Boehringer Ingelheim ne odtehtajo z njim povezanih tveganj.
English: The active substance in Faldaprevir Boehringer Ingelheim, faldaprevir, blocks the action of an enzyme called ‘NS3/4A serine protease' in the hepatitis C virus, which is essential for the virus to multiply.
Slovenian: Zdravilna učinkovina v zdravilu Faldaprevir Boehringer Ingelheim, faldaprevir, zavira delovanje encima v virusu hepatitisa C, imenovanega „serinska proteaza NS3/4A“, ki ima ključno vlogo pri razmnoževanju virusa.
English: What is Faldaprevir Boehringer Ingelheim?
Slovenian: Kaj je zdravilo Faldaprevir Boehringer Ingelheim?
English: How is Faldaprevir Boehringer Ingelheim expected to work?
Slovenian: Kako naj bi zdravilo Faldaprevir Boehringer Ingelheim delovalo?
English: What was Faldaprevir Boehringer Ingelheim expected to be used for?
Slovenian: Za kaj naj bi se zdravilo Faldaprevir Boehringer Ingelheim uporabljalo?
English: 4 years
Slovenian: 4 leti
English: >R (Resistant)
Slovenian: >R (Odporni)
English: [Mechanism of interaction]
Slovenian: [mehanizem interakcije]
English: Difference in proportions and the 95% confidence interval (CI)
Slovenian: Razlike v deležih in 95odstotni interval zaupanja (IZ)
English: The following instructions apply to both treatment and prophylaxis
Slovenian: Naslednja navodila veljajo tako za zdravljenje kot tudi za profilakso
English: • Existing symptomatic arrhythmias.
Slovenian: • obstoječe simptomatske aritmije
English: Success at day 180*
Slovenian: Uspešnost na 180. dan*
English: Date of latest renewal: 8th February 2018
Slovenian: Datum prve odobritve: 16. maj 2013 Datum zadnjega podaljšanja: 8. februarja 2018
English: Maximum increase in prothrombin time was approximately 2-fold
Slovenian: največje podaljšanje protrombinskega časa je bilo približno 2-kratno
English: Clinical efficacy defined as partial or complete response, has been demonstrated for Aspergillus spp.
Slovenian: Klinična učinkovitost, opredeljena kot delni ali popolni odziv, je bila dokazana za Aspergillus spp.,
English: Oral Contraceptives*
Slovenian: Peroralni kontraceptivi*
English: This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100% mortality).
Slovenian: Ta študija je potrdila izsledke zgodnejše, prospektivne študije, v kateri so ugotovili pozitiven izid pri preiskovancih z dejavniki tveganja za slabo prognozo, vključno z boleznijo presadka proti gostitelju in, še posebej, možganskimi okužbami (ki so običajno povezane s skoraj 100-odstotno umrljivostjo).
English: Other Candida spp.4
Slovenian: Druge Candida spp.4
English: Frequency categories are expressed as: 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: Pogostnosti pojavljanja neželenih učinkov so opredeljene po naslednjih skupinah: zelo pogosti (≥ 1/10), pogosti (> 1/100 in < 1/10), občasni (> 1/1.000 in < 1/100), redki (> 1/10.000 in < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: If you take more Voriconazole Accord than you should If you take more tablets than prescribed (or if someone else takes your tablets) you must seek medical advice or go to the nearest hospital casualty department immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Vorikonazol Accord, kot bi smeli Če vzamete več tablet, kot je predpisano (ali če kdo drug vzame vaše tablete), morate takoj poiskati zdravniški nasvet ali se takoj zglasiti v ambulanti za nujno pomoč najbližje bolnišnice.
English: The recommended dose for children and teenagers is as follows:
Slovenian: Priporočeni odmerek za otroke in najstnike je:
English: Seven (3 complete, 4 partial responses) of 17 patients were successfully treated with voriconazole.
Slovenian: Sedem (3 popolni, 4 delni odzivi) od 17 bolnikov je bilo uspešno zdravljenih z vorikonazolom.
English: Contraindicated (see section 4.3)
Slovenian: Kontraindicirano (glejte poglavje 4.3)
English: Interactions between voriconazole and other medicinal products are listed in the table below (once daily as “QD”, twice daily as “BID”, three times daily as “TID” and not determined as “ND”).
Slovenian: Interakcije med vorikonazolom in drugimi zdravili so navedene v spodnji preglednici (enkrat na dan kot »QD«, dvakrat na dan kot »BID«, trikrat na dan kot »TID« in ni določeno kot »ND«).
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Slovenian: Smer puščice za vsak farmakokinetični parameter temelji na 90-odstotnem intervalu zaupanja razmerja geometrične srednje vrednosti, ki je lahko znotraj (↔), pod (↓) ali nad (↑) območjem 80-125 %.
English: Macrolide antibiotics Erythromycin (1 g BID)
Slovenian: Makrolidni antibiotiki eritromicin (1 g BID)
English: Prophylaxis in adults and children
Slovenian: Profilaksa pri odraslih in otrocih
English: Do not take Voriconazole Accord If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Vorikonazol Accord Če ste alergični na vorikonazol ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • Sinus bradycardia.
Slovenian: • sinusna bradikardija
English: Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180days after HSCT.
Slovenian: Uspešnost je bila opredeljena kot zmožnost nadaljevanja profilakse s preiskovanim zdravilom 100 dni po HSCT (brez prekinitve > 14 dni) in preživetje 180 dni po HSCT brez dokazane ali verjetne IGO.
English: This metabolite has minimal antifungal activity and does not contribute to the overall efficacy of voriconazole.
Slovenian: Ta presnovek deluje minimalno antimikotično in ne prispeva k celotni učinkovitosti vorikonazola.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: The pharmacokinetics of voriconazole have been characterised in healthy subjects, special populations and patients.
Slovenian: Farmakokinetika vorikonazola je bila opredeljena pri zdravih osebah, posebnih populacijah in bolnikih.
English: Children and adolescents Voriconazole Accord should not be given to children younger than 2 years of age.
Slovenian: Otroci in mladostniki Zdravila Vorikonazol Accord ne smejo dobiti otroci, mlajši od 2 let.
English: One study enrolled 31 patients with possible, proven or probable invasive aspergillosis (IA), of whom 14 patients had proven or probable IA and were included in the MITT efficacy analyses.
Slovenian: 31 bolnikov z možno, potrjeno ali verjetno invazivno aspergilozo (IA), od katerih je 14 bolnikov imelo potrjeno ali verjetno IA in so jih vključili v analize učinkovitosti MITT.
English: If any of these side effects persist or are troublesome, please tell your doctor.
Slovenian: Če je katerikoli od teh neželenih učinkov trdovraten ali moteč, povejte svojemu zdravniku.
English: Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended and the dose of anticoagulants should be adjusted accordingly.
Slovenian: Priporočljivo je pozorno nadziranje protrombinskega časa ali drugih primernih koagulacijskih testov in ustrezno prilagoditi odmerjanje antikoagulantov.
English: Considering the assumed limited gastro-enteric transit time in paediatric patients, the absorption of tablets may be different in paediatric compared to adult patients.
Slovenian: Upoštevaje domnevno omejeni gastro-enterični čas prehoda pri pediatričnih bolnikih je mogoče, da je absorpcija iz tablet pri pediatričnih bolnikih drugačna kot pri odraslih.
English: Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial responses) of 7 patients with S. prolificans infection.
Slovenian: Uspešen odziv na zdravljenje z vorikonazolom so ugotovili pri 16 (6 popolnih, 10 delnih odzivov) od 28 bolnikov, okuženih s S. apiospermum, in pri 2 (oba delna odziva) od 7 bolnikov, okuženih s S. prolificans.
English: Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
Slovenian: S profilakso s preiskovanim zdravilom so pričeli takoj po HSCT: 224 preiskovancev je prejemalo vorikonazol, 241 pa itrakonazol.
English: For Caucasians and Blacks the prevalence of poor metabolisers is 3-5 %.
Slovenian: Med belci in črnci je prevalenca oseb z zmanjšano presnovo 3-5 %.
English: Ritonavir (protease inhibitor)
Slovenian: Ritonavir (zaviralec proteaze)
English: It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines.
Slovenian: Zelo pomembno je, da obvestite svojega zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli zdravilo, tudi če ste ga dobili brez recepta, ali zdravilo rastlinskega izvora.
English: Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin
Slovenian: Filmska obloga hipromeloza titanov dioksid (E171) laktoza monohidrat triacetin
English: It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF),, as an increased sensitivity of skin to the sun's UV rays can occur.
Slovenian: Pomembno je, da pokrijete izpostavljene predele kože in uporabljate kremo za zaščito pred soncem z visokim zaščitnim faktorjem, ker se lahko pojavi povečana občutljivost kože na sončne UV žarke.
English: The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials.
Slovenian: Varnostni profil vorikonazola pri odraslih temelji na integrirani varnostni podatkovni bazi več kot 2.000 oseb (vključno s 1.655 odraslimi bolniki v terapevtskih raziskavah in dodatnih 270 odraslih v preskušanjih profilakse).
English: Voriconazole Accord film-coated tablets are to be taken at least one hour before, or one hour following, a meal.
Slovenian: Zdravilo Vorikonazol Accord filmsko obložene tablete je treba vzeti vsaj eno uro pred jedjo ali najmanj eno uro po jedi.
English: Astemizole, cisapride, pimozide, quinidine and terfenadine
Slovenian: Astemizol, cisaprid, pimozid, kinidin in terfenadin
English: Non-Steroidal AntiInflammatory Drugs (NSAIDs)
Slovenian: Nesteroidna protivnetna zdravila (NSAID)
English: A satisfactory global response (complete or partial resolution of all attributable symptoms, signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazoletreated patients compared to 31% of patients treated with comparator.
Slovenian: Zadovoljiv globalni odziv (popolno ali delno izginotje vseh izhodiščno prisotnih pripisljivih simptomov, znakov, rentgenoloških/bronhoskopskih nenormalnosti) so ugotovili pri 53 % bolnikov, zdravljenih z vorikonazolom, in pri 31 % bolnikov, zdravljenih s primerjalnim zdravilom.
English: 1 Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
Slovenian: Ni dovolj dokazov 1 Sevi z vrednostmi MIK nad mejno vrednostjo Občutljivo (S) so redki, oziroma o njih še niso poročali.
English: However, as there were only 9 cases available for EUCAST analysis, there is currently insufficient evidence to set clinical breakpoints for C. krusei.
Slovenian: primerov za EUCAST analizo, je zaenkrat premalo dokazov za postavitev kliničnih mejnih vrednosti za C. krusei.
English: A positive association between mean, maximum or minimum plasma voriconazole concentration and efficacy in therapeutic studies was not found and this relationship has not been explored in prophylaxis studies.
Slovenian: Pozitivne povezave med povprečno, največjo ali najmanjšo koncentracijo vorikonazola v plazmi ter učinkovitostjo v terapevtskih študijah niso ugotovili, , v študijah profilakse pa te povezave niso raziskovali.
English: • Cardiomyopathy, in particular when heart failure is present.
Slovenian: • kardiomiopatija, posebej ob prisotnem popuščanju srca
English: Patients receiving Voriconazole Accord must be carefully monitored for hepatic toxicity.
Slovenian: Bolnike, ki dobivajo zdravilo Vorikonazol Accord, je treba skrbno nadzorovati glede hepatotoksičnosti.
English: If Voriconazole Accord is continued, however, dermatologic evaluation should be performed on a systematic and regular basis, to allow early detection and management of premalignant lesions.
Slovenian: Če pa se zdravljenje z zdravilom Vorikonazol Accord nadaljuje, je treba bolnike redno in sistematično dermatološko ocenjevati, da se omogoči zgodnje odkrivanje in obravnavanje predrakavih lezij.
English: Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation [HSCT]), should be monitored closely during Voriconazole Accord treatment.
Slovenian: Bolnike, še posebej otroke, z dejavniki tveganja za akutni pankreatitis (npr. nedavna kemoterapija, presaditev matičnih krvotvornih celic [HSCT - Haematopoietic Stem Cell Transplantation]) je treba med zdravljenjem z zdravilom Vorikonazol Accord skrbno nadzorovati.
English: AUCτ, AUCt and AUC0-∞represent area under the curve over a dosing interval, from time zero to the time with detectable measurement and from time zero to infinity, respectively.
Slovenian: AUCτ, AUCt in AUC0- predstavljajo površino pod krivuljo preko odmernega intervala, površino pod krivuljo od časa nič do časa detekcije in površino pod krivuljo od časa nič do neskončnosti.
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C03 Mode of action
Slovenian: Farmakoterapevtska skupina: antimikotiki za sistemsko zdravljenje, derivati triazola oznaka ATC: J02AC03
English: It is recommended that all patients, including children, avoid exposure to direct sunlight during Voriconazole Accord treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Slovenian: Priporočljivo je, da se vsi bolniki, vključno z otroci, med zdravljenjem z zdravilom Vorikonazol Accord izogibajo izpostavljenosti neposredni sončni svetlobi in sledijo ukrepom, kot so zaščitna oblačila in krema za zaščito pred soncem z visokim zaščitnim faktorjem.
English: The effect of voriconazole on either erythromycin or azithromycin is unknown
Slovenian: Učinek vorikonazola na eritromicin ali azitromicin ni znan.
English: Voriconazole was shown to be effective against the following rare fungal pathogens:
Slovenian: Dokazano je bilo, da je vorikonazol učinkovit proti naslednjim redkim glivičnim patogenom:
English: In addition Voriconazole Accord has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Slovenian: Poleg tega je bilo zdravilo Vorikonazol Accord povezano s fototoksičnostjo, vključno z reakcijami, kot so efelide, lentigo, aktinična keratoza in psevdoporfirija.
English: Other HIV Protease Inhibitors (e.g., saquinavir, amprenavir and nelfinavir)*
Slovenian: Drugi zaviralci proteaze HIV (kot so sakvinavir, amprenavir in nelfinavir)*
English: The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to<18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Slovenian: Varnost vorikonazola so raziskali pri 228 pediatričnih bolnikih, starih od 2 do < 12 let (169) in od 12 do < 18 let (119), ki so vorikonazol v kliničnih preskušanjih dobivali za profilakso (183) in terapijo (105).
English: If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis.
Slovenian: Če se vam pojavijo zgoraj opisane težave s kožo, vas bo zdravnik morda napotil k dermatologu, ki se po posvetu lahko odloči, da je za vas pomembno, da ga redno obiskujete.