natgillin/translations-raw huggingface dataset:
For the patients who continued in the study and provided efficacy data at 1 year, the TAC was 24 g/day in the Selincro group (n=78) and 47 g/day in the placebo group (n=29). 
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 1. letu, je bila TAC 24 g/dan v Selincro skupini (n=78) in 47 g/dan v placebo skupini (n=29).
For HDDs there were 23 days/month at baseline in the Selincro group (n=171) and 23 days/month at baseline in the placebo group (n=167). 
V izhodišču je bilo HDDs 23 dni/mesec v Selincro skupini (n=171) in 23 dni/mesec v placebo skupini (n=167).
Selincro is for oral use. 
Zdravilo Selincro je namenjeno peroralni uporabi.
For HDDs there were 23 days/month at baseline in the Selincro group (n=148) and 22 days/month at baseline in the placebo group (n=155). 
V izhodišču je bilo HDDs 23 dni/mesec v Selincro skupini (n=148) in 22 dni/mesec v placebo skupini (n=155).
No dose adjustment is recommended for patients with mild or moderate renal impairment (see sections 4.4 and 5.2). 
Za bolnike z blago do zmerno okvaro jeter ni priporočenega prilagajanja odmerka (glejte poglavji 4.4 in 5.2).
For HDDs there were 19 days/month at baseline in the Selincro-group (n=141) and19 days/month at baseline in the placebo group (n=42). 
V izhodišču je bilo HDDs 19 dni/mesec v Selincro skupini (n=141) in 19 dni/mesec v placebo skupini (n=42).
For patients with mild, moderate or severe renal impairment the AUC for nalmefene was 1.1 times, 1.4 times and 2.4 times higher, respectively. 
AUC za nalmefen je bila 1,1-krat večja za bolnike z blago okvaro ledvic, 1,4-krat večja za bolnike z zmerno okvaro ledvic in 2,4-krat večja za bolnike s hudo okvaro ledvic.
For the patients who continued in the study and provided efficacy data at 1 year, the number of HDDs was 5 days/month in the Selincro group (n=78) and 10 days/month in the placebo group (n= 29). 
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 1. letu, je bilo število HDDs 5 dni/mesec v Selincro skupini (n=78) in 10 dni/mesec v placebo skupini (n=29).
For the patients who continued in the study and provided efficacy data at Month 6, the TAC was 40 g/day in the Selincro-group (n=85) and 57 g/day in the placebo group (n=114). 
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 6. mesecu, je bila TAC 40 g/dan v Selincro skupini (n=85) in 57 g/dan v placebo skupini (n=114).
For the patients who continued in the study and provided efficacy data at Month 6, the number of HDDs was 10 days/month in the Selincro group (n=103) and 12 days/month in the placebo group (n=111). 
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 6. mesecu, je bilo število HDDs 10 dni/mesec v Selincro skupini (n=103) in 12 dni/mesec v placebo skupini (n=111).
For the patients who continued in the study and provided efficacy data at Month 6, the TAC was 44 g/day in the Selincro group (n=103) and 52 g/day in the placebo group (n=111). 
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 6. mesecu, je bila TAC 44 g/dan v Selincro skupini (n=103) in 52 g/dan v placebo skupini (n=111).
Restlessness 
Nespečnost
For the patients who continued in the study and provided efficacy data at Month 6, the number of HDDs was 9 days/month in the Selincro group (n=85) and 14 days/month in the placebo group (n=114). 
Za bolnike, ki so nadaljevali v študiji in zagotovili podatke o učinkovitosti pri 6. mesecu, je bilo število HDDs 9 dni/mesec v Selincro skupini (n=85) in 14 dni/mesec v placebo skupini (n=114).
Fatigue Asthenia 
Utrujenost Astenija
Nalmefene was shown to have skin sensitisation potential in the Local Lymph Node Assay in mice after topical application. 
Lokalna analiza limfnih vozlov pri miših je pokazala, da ima nalmefen potencial za povzročanje preobčutljivosti kože po topikalni uporabi.
How to store Selincro 
Shranjevanje zdravila Selincro
Opioid administration 
Uporaba opioidov
Comorbidity 
Komorbidnost
Tablet coating 
filmsko obložena tableta (tableta)
Sleep disorder 
Ledvična okvara
Dissociation 
Odmerjanje
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom zdravljenje raka.
This means that Topotecan Hospira is similar to a ‘reference medicine' already authorised in the European Union (EU). 
To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU).
This is repeated every 21 days for six courses or until the disease gets worse. 
To ponavljamo na vsakih 21 dni, vsega skupaj šestkrat ali dokler se stanje bolezni ne poslabša.
For full details, see the Summary of Product Characteristics (also part of the EPAR). 
Za vse podrobnosti glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
The full EPAR for Topotecan Hospira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Topotecan Hospira je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This document is a summary of the European Public Assessment Report (EPAR) for Topotecan Hospira. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Topotecan Hospira.
For more information about treatment with Topotecan Hospira, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Topotecan Hospira preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The patient's blood levels of white blood cells, platelets and haemoglobin should be checked before treatment, to ensure that they are above set minimum levels. 
Pred zdravljenjem je treba preveriti bolnikove ravni belih krvnih celic, trombocitov in hemoglobina za zagotovitev, da te presegajo najnižje določene ravni.
It is also used together with cisplatin (another anticancer medicine) to treat women with cervical cancer (cancer of the cervix), when the cancer has come back after radiotherapy, or when the disease is at an advanced stage (stage IVB: the cancer has spread beyond the cervix). 
Zdravilo se uporablja tudi skupaj z zdravilom cisplatin (drugo vrsto zdravila proti raku) za zdravljenje žensk z rakom materničnega vratu, če se je rak znova pojavil po že končanem zdravljenju z obsevanjem ali če je bolezen v napredovalem stadiju (stadij IVB: rak se je razširil zunaj materničnega vratu).
The European Commission granted a marketing authorisation valid throughout the EU for Topotecan Hospira on 10 June 2010. 
Evropska komisija je dovoljenje za promet z zdravilom Topotecan Hospira, veljavno po vsej Evropski uniji, izdala 10. junija 2010.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Topotecan Hospira. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Treatment with Topotecan Hospira should only be given under the supervision of a doctor experienced in the use of chemotherapy. 
Zdravljenje z zdravilom Topotecan Hospira lahko poteka samo pod nadzorom zdravnika, ki ima izkušnje z uporabo kemoterapije.
The CHMP concluded that, in accordance with EU requirements, Topotecan Hospira has been shown to be comparable to Hycamtin. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Topotecan Hospira primerljivo zdravilu Hycamtin.
When used with cisplatin in cervical cancer, Topotecan Hospira is given on days 1, 2 and 3 (with cisplatin given on day 1). 
Kadar se pri zdravljenju raka materničnega vratu zdravilo Topotecan Hospira uporablja skupaj s cisplatinom, se daje na 1., 2. in 3. dan (cisplatin se daje na 1. dan).
Because Topotecan Hospira produces the same levels of the active substance in the body as the reference medicine, its benefit and risk are taken as being the same as the reference medicine's. 
Ker zdravilo Topotecan Hospira vsebuje isto zdravilno učinkovino kot referenčno zdravilo, se šteje, da so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
The reference medicine Hycamtin is available as a powder to be made up into a solution for infusion and not as a concentrate. 
Referenčno zdravilo Hycamtin je na voljo v obliki praška za pripravo raztopine za infundiranje in ne v obliki koncentrata.
For lung cancer, Topotecan Hospira is given every day for five days with a three-week interval between the start of each course. 
Pri pljučnem raku se zdravilo Topotecan Hospira daje vsak dan pet dni zapored, čemur sledi tritedenski premor pred pričetkom novega ciklusa zdravljenja.
The dose of Topotecan Hospira to be used depends on the type of cancer that it is being used to treat and the patient's weight and height. 
Odmerek zdravila Topotecan Hospira je odvisen od vrste raka, ki ga zdravimo, ter bolnikove telesne mase in višine.
What are the benefit and risk of Topotecan Hospira? 
Kakšne so koristi in tveganja, povezani z zdravilom Topotecan Hospira?
Topotecan Hospira is a ‘hybrid medicine'. 
Topotecan Hospira je „hibridno zdravilo“.
Other information about Topotecan Hospira: 
Druge informacije o zdravilu Topotecan Hospira:
The Committee recommended that Topotecan Hospira be given marketing authorisation. 
Priporočil je, da se za zdravilo Topotecan Hospira izda dovoljenje za promet.
Topotecan Hospira also affects non-cancer cells, which causes side effects. 
Zdravilo Topotecan Hospira vpliva tudi na nerakave celice, kar povzroča neželene učinke.
The active substance in Topotecan Hospira, topotecan, is an anticancer medicine that belongs to the group ‘topoisomerase inhibitors'. 
Zdravilna učinkovina v zdravilu Topotecan Hospira, topotekan, je zdravilo za zdravljenje raka, ki spada v skupino zaviralcev topoizomeraze.
Topotecan Hospira is a concentrate that is made up into a solution for infusion (drip into a vein). 
Zdravilo Topotecan Hospira je koncentrat za pripravo raztopine za infundiranje (kapalne infuzije v veno).
Topotecan Hospira is used on its own to treat small cell lung cancer, when the cancer has relapsed (come back). 
Zdravilo Topotecan Hospira se uporablja samostojno za zdravljenje drobnoceličnega raka pljuč, kadar se rakavo obolenje ponovi.
Infusions should be carried out in a specialised cancer ward. 
Infundiranje je treba izvajati na specializiranem oddelku za
Why has Topotecan Hospira been approved? 
Zakaj je bilo zdravilo Topotecan Hospira odobreno?
The doses may need to be adjusted or other medicines given to the patients, when the level of white blood cells remains particularly low. 
Če je raven belih krvnih celic še posebno nizka, je treba odmerke prilagoditi ali bolniku začeti dajati druga zdravila.
No additional studies were needed as Topotecan Hospira is given by infusion and contains the same active substance as the reference medicine, Hycamtin. 
Zdravilo Topotecan Hospira se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Hycamtin, zato niso bile potrebne nobene dodatne študije.
How has Topotecan Hospira been studied? 
Kako je bilo zdravilo Topotecan Hospira raziskano?
What is Topotecan Hospira? 
Kaj je zdravilo Topotecan Hospira?
How is Topotecan Hospira used? 
Kako se zdravilo Topotecan Hospira uporablja?
What is Topotecan Hospira used for? 
Za kaj se zdravilo Topotecan Hospira uporablja?
How does Topotecan Hospira work? 
Kako zdravilo Topotecan Hospira deluje?
It is used on its own when other treatments have not worked or are not suitable. 
Samostojno se uporablja, kadar druga zdravljenja niso delovala ali niso primerna.
Further information on Kanjinti can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Več informacij o zdravilu Kanjinti je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This means that Kanjinti is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU. 
To pomeni, da je zelo podobno drugemu biološkemu zdravilu („referenčnemu zdravilu“), ki je že odobreno v EU.
What measures are being taken to ensure the safe and effective use of Kanjinti? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Kanjinti?
The infusion may cause allergic reactions, so the patient should be monitored during and after the infusion. 
Infuzija lahko povzroči alergijske reakcije, zato je treba bolnika spremljati med infundiranjem in po njem.
Kanjinti can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should). 
Zdravilo Kanjinti lahko povzroča kardiotoksičnost (škoduje srcu), vključno s srčnim popuščanjem (srce ne deluje tako dobro, kot bi moralo).
• metastatic breast cancer (cancer that has spread to other parts of the body). 
• metastatskega raka dojk (raka, ki se je razširil na druge dele telesa).
An overview of Kanjinti and why it is authorised in the EU 
Pregled zdravila Kanjinti in zakaj je odobreno v EU
The most common or serious side effects with Kanjinti are heart problems, reactions related to the Kanjinti infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems. 
Najpogostejši ali resni neželeni učinki zdravila Kanjinti so težave s srcem, reakcije, povezane z infundiranjem zdravila Kanjinti, zmanjšana količina krvnih celic (zlasti belih krvnih celic), okužbe in težave s pljuči.
As for all medicines, data on the use of Kanjinti are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Kanjinti stalno spremljajo.
Care should be taken if it is given to patients who already have heart problems or high blood pressure, and all patients need to be monitored during and after treatment to check their heart. 
Posebna pozornost je potrebna, če se zdravilo daje bolnikom, ki že imajo težave s srcem ali visok krvni tlak, vse bolnike pa je treba med zdravljenjem in po njem spremljati glede delovanja srca.
What benefits of Kanjinti have been shown in studies? 
Kakšne koristi zdravila Kanjinti so se pokazale v študijah?
Kanjinti is a cancer medicine used to treat the following conditions: 
Kanjinti je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje naslednjih bolezni:
In addition, one study involving 696 patients with early breast cancer that overexpressed HER2 showed that Kanjinti was effective in treating the condition. 
Poleg tega je ena študija, v katero je bilo vključenih 696 bolnikov z zgodnjim rakom dojke, ki je čezmerno izražal beljakovino HER2, pokazala, da je zdravilo Kanjinti učinkovito pri zdravljenju te bolezni.
Why is Kanjinti authorised in the EU? 
Zakaj je bilo zdravilo Kanjinti odobreno v EU?
Side effects reported with Kanjinti are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Kanjinti, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
What is Kanjinti and what is it used for? 
Kaj je zdravilo Kanjinti in za kaj se uporablja?
The dose depends on the patient's body weight, on the condition being treated and on whether Kanjinti is given every week or every 3 weeks. 
Odmerek je odvisen od telesne mase bolnika, od zdravljene bolezni in od tega, ali se zdravilo Kanjinti daje vsak teden ali vsake tri tedne.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kanjinti have been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Kanjinti upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
For more information about using Kanjinti, see the package leaflet or contact a doctor or pharmacist. 
Za več informacij glede uporabe zdravila Kanjinti glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Kanjinti must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients. 
Zdravila Kanjinti ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) trastuzumab, mišje beljakovine ali na katero koli drugo sestavino zdravila.
By attaching to HER2, trastuzumab activates cells of the immune system, which then kill the tumour cells. 
Trastuzumab ob vezavi na beljakovino HER2 aktivira celice imunskega sistema, ki nato uničijo tumorske celice.
Kanjinti can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines. 
Predpisovanje in izdaja zdravila Kanjinti je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z uporabo zdravil za zdravljenje raka.
After treatment of up to a year, 48% of those given Kanjinti (172 of 358) and 41% of those given the reference medicine Herceptin (137 of 338) had no invasive cancer cells in the breasts or surrounding lymph nodes. 
Po zdravljenju, ki je trajalo do enega leta, se invazivne rakave celice niso pojavile v dojkah ali okoliških bezgavkah pri 48 % (172 od 358) bolnikov, ki so prejemali zdravilo Kanjinti, in pri 41 % (137 od 338) bolnikov, ki so prejemali referenčno zdravilo Herceptin.
For cancers that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Kanjinti is used before surgery in combination with chemotherapy and then again after surgery on its own; 
Pri lokalno napredovalih rakih (vključno z vnetnimi tumorji) ali rakih, širših od 2 cm, se zdravilo Kanjinti uporablja pred kirurškim posegom v kombinaciji s kemoterapijo in nato samostojno po posegu;
What are the risks associated with Kanjinti? 
Kakšna tveganja so povezana z zdravilom Kanjinti?
In the light of all the data provided the difference was not assessed to be relevant and it was concluded that Kanjinti would behave in the same way as Herceptin in its approved indications. 
Na podlagi vseh predloženih podatkov razlike niso ocenili kot pomembne in so zaključili, da se bo zdravilo Kanjinti pri odobrenih indikacijah vedlo enako kot zdravilo Herceptin.
HER2 is overexpressed in about a quarter of breast cancers and a fifth of gastric cancers. 
Beljakovina HER2 je čezmerno izražena pri približno četrtini rakov dojk in petini rakov želodca.
It is given by infusion (drip) into a vein over 90 minutes every week or every 3 weeks for breast cancer, and every 3 weeks for gastric cancer. 
Zdravilo se daje z 90-minutnim infundiranjem (kapalno infuzijo) v veno vsak teden ali vsake tri tedne pri raku dojk in vsake tri tedne pri raku želodca.
Other information about Kanjinti 
Druge informacije o zdravilu Kanjinti
• early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable. 
• zgodnjega raka dojk (kadar se je rak razširil znotraj dojke ali v podpazdušne žleze, ne pa na druge dele telesa) po kirurškem posegu, kemoterapiji (z zdravili za zdravljenje raka) in radioterapiji (zdravljenju z obsevanjem), če je smiselno.
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Kanjinti has been shown overall to have a comparable quality, safety and effectiveness to Herceptin. 
Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU glede podobnih bioloških zdravil dokazano, da je zdravilo Kanjinti po kakovosti, varnosti in učinkovitosti primerljivo zdravilu Herceptin.
For early breast cancer, treatment is given for a year or until the disease comes back, and for metastatic breast or gastric cancer, treatment is continued for as long as it remains effective. 
Pri zgodnjem raku dojk zdravljenje poteka eno leto ali dokler se bolezen ne ponovi, pri metastatskem raku dojk in raku želodca pa traja, dokler je učinkovito.
The reference medicine for Kanjinti is Herceptin. 
Referenčno zdravilo za zdravilo Kanjinti je zdravilo Herceptin.
Because Kanjinti is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Kanjinti. 
Zdravilo Kanjinti je „podobno biološko zdravilo“, zato študij o učinkovitosti in varnosti trastuzumaba, izvedenih z zdravilom Herceptin, z zdravilom Kanjinti ni treba ponavljati.
The active substance in Kanjinti, trastuzumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to the HER2 protein. 
Učinkovina v zdravilu Kanjinti, trastuzumab, je monoklonsko protitelo (vrsta beljakovine), ki je bilo zasnovano tako, da prepozna beljakovino HER2 in se veže nanjo.
Studies have also shown that giving Kanjinti produces similar levels of the active substance in the body to giving Herceptin. 
Študije so pokazale tudi, da zdravilo Kanjinti vzpostavi podobne ravni učinkovine v telesu kot zdravilo Herceptin.
Kanjinti is a ‘biosimilar medicine'. 
Zdravilo Kanjinti je „podobno biološko zdravilo“.
Laboratory studies comparing Kanjinti with Herceptin have shown that the active substance in Kanjinti is highly similar to that in Herceptin in terms of structure, purity and biological activity. 
Laboratorijske študije, v katerih so zdravilo Kanjinti primerjali z zdravilom Herceptin, so pokazale, da je učinkovina zdravila Kanjinti po zgradbi, čistosti in biološkem delovanju zelo podobna učinkovini v zdravilu Herceptin.
Therefore, the Agency's view was that, as for Herceptin, the benefit of Kanjinti outweighs the identified risk and it can be authorised. 
Menila je, da koristi zdravila Kanjinti enako kot pri zdravilu Herceptin odtehtajo znana tveganja in se zdravilo lahko odobri.
How does Kanjinti work? 
Kako zdravilo Kanjinti deluje?
How is Kanjinti used? 
Kako se zdravilo Kanjinti uporablja?
Kanjinti contains the active substance trastuzumab. 
Zdravilo Kanjinti vsebuje učinkovino trastuzumab.
Kanjinti can only be used when the cancer ‘overexpresses HER2': this means that the cancer produces a protein called HER2 in large quantities on the cancer cells. 
Zdravilo Kanjinti se uporablja le, kadar rakavo tkivo dokazano čezmerno izraža receptorje HER2.
• Problems with balance or coordination 
• težave z ravnotežjem ali koordinacijo
Compatibility with other concentrations is unknown. 
Združljivost z drugimi koncentracijami ni znana.
These precautions are also applicable to children. 
Ti previdnostni ukrepi veljajo tudi za otroke.
>R (Resistant) 
>R (odporni)
Total parenteral nutrition: 
Popolna parenteralna prehrana:
Frequency not known (cannot be estimated from available data) 
Neznana (ni mogoče oceniti iz razpoložljivi h podatkov)
However, some may be serious and need medical attention. 
Po drugi strani pa so nekateri lahko resni in zahtevajo zdravniško nego.
Not studied clinically. 
Niso klinično preučili.
Therefore, every attempt should be made to identify Candida to species level. 
Zato je treba storiti vse za to, da bi identificirali Candido do ravni vrste.
Treatment duration should be as short as possible depending on the patient's clinical and mycological response. 
Trajanje zdravljenja mora biti čim krajše, odvisno od bolnikovega kliničnega in mikološkega odziva.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: {27 May 2015} 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: {27. maj 2015}
Clinical Experience Successful outcome in this section is defined as complete or partial response. 
Klinične izkušnje Uspešen izid je v tem delu opredeljen kot popoln ali delen odziv.
• You have had an allergic reaction to other azoles. 
• ste kdaj doživeli alergijsko reakcijo na druge azole.
The asterisk (*) indicates a two-way interaction. 
Zvezdica (*) označuje dvosmerno interakcijo.