FrancophonIA/ELRC3.0 huggingface dataset:
English: Azomyr relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Slovenian: Zdravilo Azomyr lajša simptome alergijskega rinitisa (vnetje nosnih poti zaradi alergije, na primer seneni nahod ali alergija na pršice) pri odraslih in mladostnikih, starih 12 let in več.
English: Azomyr 5 mg orodispersible tablet
Slovenian: Azomyr 5 mg orodisperzibilna tableta
English: Azomyr 5 mg orodispersible tablets
Slovenian: Azomyr 5 mg orodisperzibilne tablete
English: The recommended dose is 2.5 ml (½ of a 5 ml spoonful) of oral solution once a day.
Slovenian: Priporočeni odmerek zdravila Azomyr je 10 ml (5 mg) peroralne raztopine enkrat na dan.
English: Azomyr 5 mg orodispersible tablets desloratadine
Slovenian: Azomyr 5 mg orodisperzibilne tablete desloratadin
English: How to store Azomyr orodispersible tablet
Slovenian: Shranjevanje zdravila Azomyr orodisperzibilna tableta
English: What measures are being taken to ensure the safe and effective use of Ledaga?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ledaga?
English: This means that it is similar to a ‘reference medicine' (in this case Caryolysine) containing the same active substance and used for the same purpose.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“ (v tem primeru zdravilu Caryolysine), ki vsebuje enako zdravilno učinkovino in se ga uporablja v enake namene.
English: Ledaga was effective in 58% of patients (76 patients out of 130) after at least 6 months of treatment compared with 48% of patients (62 out of 130) using the ointment.
Slovenian: Zdravilo Ledaga je bilo po vsaj šestih mesecih zdravljenja učinkovito pri 58 % (76 od 130) bolnikov v primerjavi z 48 % (62 od 130) bolnikov, ki so uporabljali mazilo.
English: Ledaga chlormethine
Slovenian: Ledaga klormetin
English: This is a summary of the European public assessment report (EPAR) for Ledaga.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Ledaga.
English: The most common side effects with Ledaga (which may affect more than 1 in 10 people) are dermatitis (skin inflammation with reddening, rash, pain and burning sensation), skin infection and itching.
Slovenian: Najpogostejši neželeni učinki zdravila Ledaga (ki lahko prizadenejo več kot 1 osebo od 10 ) so dermatitis (vnetje kože z rdečico, izpuščaji, bolečinami in pekočim občutkom), okužba kože in srbenje.
English: Effectiveness was measured as complete or partial improvement in the ‘CAILS' score, which takes into account different features of the cancer, such as the size and appearance of the skin damage.
Slovenian: Učinkovitost je bila izmerjena kot popolno ali delno izboljšanje po sestavljeni oceni indeksa resnosti poškodb (CAILS), ki upošteva različne lastnosti raka, kot sta obseg in videz poškodb na koži.
English: Alkylating agents work by attaching to the DNA of cells while the cells are dividing.
Slovenian: Alkilirajoče učinkovine delujejo tako, da se pritrdijo na DNK celic, medtem ko se celice delijo.
English: Treatment should be stopped if patients develop blisters or open sores.
Slovenian: Zdravljenje je treba prekiniti, če se pri bolnikih razvijejo mehurji ali odprte rane.
English: What are the risks associated with Ledaga?
Slovenian: Kakšna so tveganja, povezana z zdravilom Ledaga?
English: The company that markets Ledaga will supply materials to prevent accidental contact with the medicine, especially in the eye and the inside of the nose and mouth.
Slovenian: Družba, ki trži zdravilo Ledaga, bo priskrbela potrebščine, ki bodo preprečevale naključne stike z zdravilom, predvsem z očmi in notranjostjo nosu ter ust.
English: What is Ledaga and what is it used for?
Slovenian: Kaj je zdravilo Ledaga in za kaj se uporablja?
English: In addition, a study involving 260 patients found that Ledaga was at least as effective as an ointment containing the same amount of chlormethine.
Slovenian: Poleg tega je študija, ki je vključevala 260 bolnikov, pokazala, da je zdravilo Ledaga vsaj tako učinkovito kot mazilo, ki vsebuje enako količino klormetina.
English: What benefits of Ledaga have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Ledaga izkazalo v študijah?
English: The Committee recommended that Ledaga be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Ledaga odobri za uporabo v EU.
English: It is not intended to provide practical advice on how to use Ledaga.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: As a result, cancer cells cannot divide and they eventually die.
Slovenian: Rakave celice se tako ne morejo deliti in posledično odmrejo.
English: Treatment with Ledaga should be started by a doctor with appropriate experience.
Slovenian: Zdravljenje z zdravilom Ledaga mora uvesti zdravnik z ustreznimi izkušnjami.
English: Because the number of patients with this skin cancer is low, the disease is considered ‘rare', and Ledaga was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2012.
Slovenian: Ker je bolnikov s tem kožnim rakom malo, velja ta bolezen za redko, zato je bilo zdravilo Ledaga 22. maja 2012 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Other information about Ledaga
Slovenian: Druge informacije o zdravilu Ledaga
English: Ledaga is a ‘hybrid medicine'.
Slovenian: Zdravilo Ledaga je „hibridno zdravilo“.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ledaga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Ledaga je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Why is Ledaga approved?
Slovenian: Zakaj je bilo zdravilo Ledaga odobreno?
English: The materials will include a sealable, child-resistant plastic bag for safely storing the medicine in a refrigerator, together with a patient alert card with instructions on the correct way to apply the medicine.
Slovenian: Te potrebščine bodo vključevale plastično vrečko za varno shranjevanje zdravila v hladilniku, ki jo bo mogoče zatesniti in bo varna za otroke, ter opozorilno kartico za bolnika z navodili, kako pravilno uporabljati zdravilo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Ledaga has shown comparable safety and effectiveness to Caryolysine and has shown satisfactory quality.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je zdravilo Ledaga pokazalo primerljivo raven varnosti in učinkovitosti kot zdravilo Caryolysine in zadovoljivo kakovost.
English: For more information about treatment with Ledaga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Ledaga preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ledaga have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Ledaga upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: The full EPAR for Ledaga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Ledaga je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For practical information about using Ledaga, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Ledaga naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: The ointment's effectiveness was considered comparable to that of the reference medicine, Caryolysine.
Slovenian: Učinkovitost mazila je bila primerljiva z učinkovitostjo referenčnega zdravila Caryolysine.
English: The company provided data from the published literature showing that chlormethine, the active substance in Ledaga, is effective in treating mycosis fungoides-type cutaneous T-cell lymphoma.
Slovenian: Družba je predstavila podatke iz objavljene literature, ki kažejo, da je klormetin, zdravilna učinkovina v zdravilu Ledaga, učinkovit pri zdravljenju kožnega T-celičnega limfoma vrste mycosis fungoides.
English: The difference between Ledaga and Caryolysine is that Ledaga is available as a gel and Caryolysine was available as a liquid for diluting before applying to the skin.
Slovenian: Razlika med zdraviloma Ledaga in Caryolysine je v tem, da je zdravilo Ledaga na voljo kot gel, zdravilo Caryolysine pa kot tekočina, ki se jo pred nanosom na kožo razredči.
English: How is Ledaga used?
Slovenian: Kako se zdravilo Ledaga uporablja?
English: Therefore, the CHMP's view was that, as for Caryolysine, the benefits outweigh the identified risks.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Caryolysine odtehtajo znana tveganja.
English: Ledaga is a medicine used to treat adults with a skin cancer called mycosis fungoides-type cutaneous T-cell lymphoma.
Slovenian: Ledaga je zdravilo, ki se uporablja za zdravljenje kožnega T-celičnega limfoma vrste mycosis fungoides pri odraslih.
English: The active substance in Ledaga, chlormethine, belongs to the group of cancer medicines called ‘alkylating agents'.
Slovenian: Zdravilna učinkovina zdravila Ledaga, klormetin, spada v skupino zdravil proti raku, ki so znane kot alkilirajoče učinkovine.
English: The medicine contains the active substance chlormethine.
Slovenian: Zdravilo Ledaga vsebuje zdravilno učinkovino klormetin.
English: Ledaga can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila Ledaga je le na recept.
English: Ledaga, which is available as a gel, is applied as a thin film to the affected areas of the skin once a day.
Slovenian: Tanko plast zdravila Ledaga, ki je na voljo kot gel, se nanese na prizadete dele kože enkrat na dan. Treba ga je nanesti previdno, da ne doseže delov kože, ki jih bolezen ni prizadela.
English: How does Ledaga work?
Slovenian: Kako zdravilo Ledaga deluje?
English: This summary was last updated in 03-2017
Slovenian: Ledaga EMA/880957/2016
English: • Take your capsule at about the same time each day.
Slovenian: • Kapsulo vzemite vsak dan približno ob istem času.
English: *Event refers to disease progression or death due to any reason.
Slovenian: * Izraz dogodek se nanaša na napredovanje bolezni ali smrt iz kateregakoli vzroka.
English: • has menstruated at any time during the previous 12 consecutive months,
Slovenian: • je imela menstruacijo kadarkoli v zadnjih zaporednih 12 mesecih,
English: Tell your doctor if you notice any changes in your skin.
Slovenian: Povejte svojemu zdravniku, če opazite kakršnekoli spremembe na koži.
English: These can alert your doctor to possible changes in the function of some parts of your body, for example:
Slovenian: To lahko vašega zdravnika opozori na morebitne spremembe delovanja nekaterih organov, na primer:
English: This interaction is not expected to be clinically significant.
Slovenian: Navedena interakcija predvidoma ni klinično pomembna.
English: - Never give this medicine to anyone else.
Slovenian: - Tega zdravila nikoli ne dajajte komu drugemu.
English: • disturbed sense of taste or strange taste in the mouth
Slovenian: • motnje okušanja ali nenavaden okus v ustih
English: It may lead to the death of a baby before it is born or shortly after being born.
Slovenian: Lahko povzroči smrt otroka še pred rojstvom ali kmalu po njegovem rojstvu.
English: • vitamin B3, also known as niacin
Slovenian: • vitamin B3, ki ga imenujemo tudi niacin,
English: • The need for adequate contraception and definition of adequate contraception
Slovenian: • potrebo po ustrezni kontracepciji in opredelitev ustrezne kontracepcije
English: Sonidegib was evaluated in rats and dogs.
Slovenian: Sonidegib so ocenjevali na podganah in psih.
English: NE: not estimable
Slovenian: NE: vrednosti ni mogoče oceniti (angl. not estimable)
English: The normal growth of cells is controlled by various chemical signals.
Slovenian: Normalno razmnoževanje celic nadzorujejo različni kemični signali.
English: Very common: may affect more than 1 in 10 people
Slovenian: Zelo pogosti: lahko se pojavijo pri več kot 1 od 10 bolnikov
English: In case of pregnancy or missed menstrual periods
Slovenian: V primeru nosečnosti ali izostanka menstruacije
English: • Emergency contact phone numbers
Slovenian: • kontaktne telefonske številke za nujne primere
English: Patients should be instructed never to give this medicinal product to another person.
Slovenian: Bolnikom je treba naročiti, naj tega zdravila nikoli ne dajejo komu drugemu.
English: Children and adolescents (under 18 years of age)
Slovenian: Otroci in mladostniki (stari manj kot 18 let)
English: Results show a lack of significant efficacy despite the enrichment strategy focussed on Hh-activated medulloblastoma.
Slovenian: Rezultati kažejo pomanjkanje opazne učinkovitosti kljub strategiji obogatitve, osredotočeni na Hh-aktiviran meduloblastom.
English: • Check list for healthcare professional ensuring that patients receive the appropriate counselling
Slovenian: • kontrolni seznam za zdravstvene delavce, ki zagotavlja, da bolniki prejmejo ustrezno svetovanje
English: Your doctor will test you for pregnancy:
Slovenian: Zdravnik bo poskrbel, da boste opravili test nosečnosti:
English: It is important to check with your doctor whether there is a risk that you could become pregnant.
Slovenian: Pomembno je, da z zdravnikom ugotovita, ali pri vas obstaja tveganje za zanositev.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 14 August 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM 14. avgust 2015
English: • if you are allergic to sonidegib or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na sonidegib ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Talk to your doctor or pharmacist regarding where to return the capsules.
Slovenian: Z zdravnikom ali farmacevtom se posvetujte, komu morate vrniti kapsule.
English: • surgical sterilisation.
Slovenian: • kirurška sterilizacija.
English: Your doctor may need to change your dose, or stop your treatment temporarily or permanently.
Slovenian: Zdravnik vam bo morda spremenil odmerek ali pa prekinil zdravljenje začasno ali dokončno.
English: You must also use one barrier method, such as:
Slovenian: Poleg tega morate uporabljati tudi eno od pregradnih metod, kot sta:
English: 20 months after their final dose
Slovenian: 20 mesecev po prejemu zadnjega odmerka
English: • National specific requirements as agreed with the National Competent Authority regarding:
Slovenian: • nacionalno specifične zahteve, ki jih je odobril nacionalni organ, pristojen za zdravila in zadevajo:
English: • absence of menstrual periods
Slovenian: • izostanek menstruacij
English: Odomzo may have an impact on fertility in men and women.
Slovenian: Zdravilo Odomzo lahko vpliva na plodnost pri moških in ženskah.
English: • swelling of the face, lips, tongue or throat
Slovenian: • otekanje v obraz, ustnice, jezik ali žrelo oziroma grlo
English: The majority of adverse effects of sonidegib can be attributed to its pharmacological mechanism of action on developmental pathways and effects in rats and dogs were similar.
Slovenian: Večino neželenih učinkov sonidegiba je mogoče pripisati njegovemu farmakološkemu mehanizmu delovanja na razvojne procese in tudi učinki na podganah in psih so bili podobni.
English: You must follow the contraception instructions contained in this leaflet.
Slovenian: Upoštevati morate navodila glede kontracepcije, ki so navedena v tem navodilu za uporabo.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji,
English: Efficacy and safety of sonidegib have been studied in two clinical studies involving a total of 62 paediatric patients.
Slovenian: Učinkovitost in varnost sonidegiba so preučevali v dveh kliničnih študijah, ki sta skupaj vključevali 62 pediatričnih bolnikov.
English: Pregnancy testing
Slovenian: Nosečnostni testi
English: Stop taking Odomzo and tell your doctor straight away if you notice any of the following as these could be signs of an allergic reaction:
Slovenian: Takoj prenehajte jemati zdravilo Odomzo in obvestite zdravnika, če pride do katere od naslednjih težav, saj so to lahko znaki alergijske reakcije:
English: Pregnancy and breast-feeding (see sections 4.4 and 4.6).
Slovenian: Nosečnost in dojenje (glejte poglavji 4.4 in 4.6).
English: Blood donation
Slovenian: Darovanje krvi
English: • Safety advice for men
Slovenian: • varnostne nasvete za moške
English: Most effects occurred close to the intended human exposures.
Slovenian: Do večine učinkov je prišlo pri približno enaki izpostavljenosti kot je predvidena pri ljudeh.
English: Elderly (≥65 years)
Slovenian: Starejši ljudje (stari najmanj 65 let)
English: Usually this type of cancer appears on sun-damaged skin, does not spread and can be cured.
Slovenian: Ta vrsta raka običajno vznikne na koži, ki je poškodovana od sonca, se pa ta vrsta raka običajno ne širi in jo je mogoče ozdraviti.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Risk of severe birth defects.
Slovenian: DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA Tveganje za hude prirojene napake.
English: This was also true for grade 3/4 adverse reactions, except fatigue.
Slovenian: Tako je bilo tudi s pogostnostjo neželenih učinkov 3. oziroma 4. stopnje, razen pri utrujenosti.
English: PHARMACEUTICAL FORM AND CONTENTS Hard capsules
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA trde kapsule
English: Responder (Complete Response/Partial Response) Stable Disease
Slovenian: odzivni bolnik (popolni/delni odziv) stabilna bolezen napredovanje bolezni ni znano
English: In the pivotal study, 29.1% of patients discontinued due to adverse events, which were mostly mild or moderate (see section 4.8).
Slovenian: V ključni študiji je 29,1 % bolnikov prekinilo zdravljenje zaradi neželenih dogodkov, ki so bili večinoma blago ali zmerno izraženi (glejte poglavje 4.8).
English: The effect of renal impairment on the systemic exposure of sonidegib has not been studied.
Slovenian: Vpliva okvare ledvic na sistemsko izpostavljenost sonidegibu niso proučevali.
English: Do not change your dose without talking to your doctor.
Slovenian: Ne spreminjajte odmerka, ne da bi se posvetovali s svojim zdravnikom.
English: • Information for men
Slovenian: • informacije za moške
English: EU/1/15/1030/002
Slovenian: EU/1/15/1030/001 EU/1/15/1030/002
English: Additional information on the above points can be found in the sections “Pregnancy”, “Breast-feeding”, “Fertility” and “Contraception for women and men”.
Slovenian: Več informacij o zgoraj navedenem lahko najdete v poglavjih "Nosečnost", "Dojenje", "Plodnost" in "Kontracepcija za ženske in moške".
English: • if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Odomzo Pregnancy Prevention Programme.
Slovenian: • če obstaja možnost, da bi zanosili, ne morete ali ne želite pa upoštevati potrebnih ukrepov za preprečevanje nosečnosti, ki so navedeni v Programu preprečevanja nosečnosti pri uporabi zdravila
English: • low level of haemoglobin (needed to transport oxygen in the blood)
Slovenian: • znižana vrednost hemoglobina (ki je potreben za prenos kisika po krvi),
English: For healthcare professionals
Slovenian: Za zdravstvene delavce
English: The recommended dose is 200 mg (1 capsule) a day.
Slovenian: Priporočeni odmerek je 200 mg (1 kapsula) na dan.
English: This will help you to remember when to take your medicine.
Slovenian: Na ta način ne boste pozabili, kdaj morate vzeti zdravilo.
English: For a composite Complete Response, all modalities used for assessment had to demonstrate absence of tumour.
Slovenian: Pri sestavljeni oceni celotnega odziva so morale vse preiskovalne metode potrditi odsotnost tumorja.
English: The following are recommended forms of highly effective methods
Slovenian: Priporočene oblike zelo učinkovitih metod kontracepcije
English: • Intrauterine device (IUD)
Slovenian: • maternični vložek (IUD)
English: Among these women, amenorrhoea was observed in 1 patient (20%).
Slovenian: Med temi ženskami so amenorejo opažali pri 1 bolnici (20 %).
English: • He must always use the recommended contraception (see the “Contraception” section below and section 4.6).
Slovenian: • mora vedno uporabljati priporočene kontracepcijske metode (glejte spodaj poglavje "Kontracepcija" in poglavje 4.6),
English: No efficacy and safety data are available in patients with severe renal impairment.
Slovenian: O učinkovitosti in varnosti uporabe zdravila pri bolnikih s hudo okvaro ledvic ni na voljo nobenih podatkov.
English: Your doctor will discuss with you the best method of contraception for you.
Slovenian: Z zdravnikom se pogovorite, katera od kontracepcijskih metod je za vas najboljša.
English: If you are taking any of these, your doctor might need to prescribe an alternative medicine for you.
Slovenian: Če uporabljate katerokoli od navedenih zdravil, vam bo zdravnik morda moral predpisati drugo zdravilo.
English: The evaluation of safety in the paediatric population is based on data from 16 adult and 60 paediatric patients from Study CLDE225X2104 and 16 adult and 2 paediatric patients from Study CLDE225C2301.
Slovenian: Ocena varnosti uporabe pri pediatrični populaciji temelji na podatkih pri 16 odraslih in 60 pediatričnih bolnikih iz študije CLDE225X2104 ter 16 odraslih in 2 pediatričnih bolnikih iz študije CLDE225C2301.
English: Odomzo should not be used in children and adolescents below the age of 18.
Slovenian: Zdravila Odomzo ni dovoljeno uporabljati pri otrocih in mladostnikih, mlajših od 18 let.
English: Please refer to these documents for further information.
Slovenian: V navedenih dveh dokumentih lahko najdete dodatne informacije.
English: Benefit of continued treatment should be regularly assessed, with the optimal duration of therapy varying for each individual patient.
Slovenian: Pri bolnikih je treba redno ocenjevati koristi nadaljnjega zdravljenja, saj je optimalno trajanje zdravljenja pri vsakem posameznem bolniku drugačno.
English: Do not exceed the recommended dose prescribed by your doctor.
Slovenian: Ne prekoračite odmerka, ki vam ga je predpisal zdravnik.
English: • She must not take Odomzo if she is pregnant or plans to become pregnant.
Slovenian: • ne sme jemati zdravila Odomzo, če je noseča ali načrtuje nosečnost,
English: • Description of the pregnancy prevention programme and categorisation of patients based on sex and childbearing potential
Slovenian: • opis programa preprečevanja nosečnosti in kategorizacijo bolnikov glede na spol in zmožnost zanositve
English: 12 months a Full analysis set included all randomised patients (intent-to-treat population).
Slovenian: za 6 mesecev za 12 mesecev a Skupina bolnikov za celotno analizo vključuje vse randomizirane bolnike (populacijo z namenom zdravljenja,
English: Steady state was reached approximately 4 months after starting sonidegib.
Slovenian: Do stanja dinamičnega ravnovesja je prišlo približno 4 mesece po začetku odmerjanja sonidegiba.