FrancophonIA/ELRC3.0 huggingface dataset:
English: Three MSs SPC stated: “there is experience with repeated courses of Daivobet up to 52 weeks” which was supported by study MCB 0102 INT.
Slovenian: Tri države članice so v povzetku glavnih značilnosti zdravila navedle: „obstajajo izkušnje s ponovljenimi zdravljenji z zdravilom Daivobet v trajanju do 52 tednov,“ kar je potrdila študija MCB 0102 INT. Imetnik dovoljenja za promet z zdravilom je predlagal izbris tega stavka, vendar je CHMP menil, da je vključitev tega podatka v usklajen povzetek glavnih značilnosti zdravila koristna.
English: Based on data from clinical trials and postmarket use the following adverse reactions are listed for Daivobet gel.
Slovenian: Za Daivobet gel se na podlagi kliničnih preskušanj in uporabe zdravila na trgu navajajo naslednji neželeni učinki.
English: One gram of gel contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Slovenian: En g gela vsebuje 50 mikrogramov kalcipotriola (v obliki monohidrata) in 0,5 mg betametazona (v obliki dipropionata).
English: Eye disorders Uncommon
Slovenian: Draženje oči Občasni draženje oči
English: Through occlusion the effect can be enhanced due to increased penetration of the stratum corneum.
Slovenian: Pod okluzijo se lahko njihov učinek okrepi zaradi povečanega prehajanja skozi poroženelo plast povrhnjice, kar pa obenem poveča možnost nastanka neželenih učinkov.
English: The following less serious side effects have been reported for Daivobet Common side effects (affect less than 1 in 10 people) - Itching.
Slovenian: Pogosti neželeni učinki (pojavijo se pri manj kot pri 1 od 10 bolnikov) - srbenje.
English: Some serious side effects are known to be caused by betamethasone (a strong steroid), one of the ingredients in Daivobet.
Slovenian: Betametazon (močan steroid), ki je ena izmed učinkovin v zdravilu Daivobet, lahko povzroči nekaj resnih neželenih učinkov.
English: please tell your doctor or pharmacist.
Slovenian: O jemanju zdravil se posvetujte z zdravnikom ali s farmacevtom.
English: Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally] calcipotriol/betamethasone
Slovenian: Daivobet in z njim povezana imena (glejte Prilogo I) 50 mikrogramov/0,5 mg/g mazilo [glejte Prilogo I - izpolni država članica] kalcipotriol/betametazon
English: Serum calcium is, however, quickly normalised when treatment is discontinued.
Slovenian: Ko zdravljenje prekinemo, se koncentracija kalcija v serumu hitro normalizira.
English: Czech Republic LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
Slovenian: Češka republika LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
English: The wording in the national SPCs of several MS largely was reflected in MRP SPC.
Slovenian: Besedila nacionalnih povzetkov glavnih značilnosti zdravila v več državah članicah se je v veliki meri odražalo v povzetku glavnih značilnosti zdravila iz postopka medsebojnega priznavanja.
English: Based on data from clinical trials and postmarket use the following adverse reactions are listed for Daivobet ointment.
Slovenian: Za Daivobet mazilo se na podlagi kliničnih preskušanj in uporabe zdravila na trgu navajajo naslednji neželeni učinki.
English: The following serious effects have been reported for Daivobet:
Slovenian: V zvezi z uporabo zdravila Daivobet so poročali o naslednjih resnih neželenih učinkih.
English: Luxembourg LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
Slovenian: Luksemburg LEO Pharmaceutical Products Ltd. A/S (LEO Pharma A/S) Industriparken 55
English: The CHMP endorsed the MAH proposal for the harmonised wording.
Slovenian: CHMP je potrdil predlagano usklajeno besedilo imetnika dovoljenja za promet z zdravilom.
English: Other ingredients:
Slovenian: DRUGI PODATKI
English: Daivobet gel in bottles of 15 g, 30 g and 60 g
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Daivobet gel v plastenkah po 15 g, 30 g in 60 g
English: Moreover, reduction in offspring survival, body weight and body weight gain was observed.
Slovenian: Tudi preživetje in telesna masa mladičev sta se zmanjšala, mladiči pa so tudi počasneje pridobivali na masi, medtem ko se plodnost ni poslabšala.
English: All the affected scalp areas may be treated with Daivobet gel.
Slovenian: Daivobet gel lahko uporabljamo na vseh prizadetih delih lasišča.
English: Primary response criteria were controlled disease according to the IGA at week 4 and week 8.
Slovenian: Za primerjavo so uporabljali betametazondipropionat gel, kalcipotriol gel in gel brez učinkovine, vse enkrat na dan. Primarni kriterij za oceno odgovora je bila nadzorovana bolezen, merjeno po smernicah IGA 4. in 8. teden.
English: If you notice this, stop taking Daivobet and tell your doctor as soon as possible - Impact on the metabolic control of diabetes mellitus (if you have diabetes you may experience fluctuations in the blood gluclose levels).
Slovenian: - okužbe (ker lahko pride do oslabitve delovanja vašega imunskega sistema, ki se bori proti okužbam), - pustulozna psoriaza (rdeča koža z rumenkastimi mehurčki, največkrat na dlaneh in stopalih), če opazite ta neželeni učinek, prenehajte z uporabo zdravila Daivobet in čimprej obvestite svojega zdravnika, - vpliv na nadzor sladkorne bolezni (če imate sladkorno bolezen, boste morda opazili nihanje ravni glukoze v krvi).
English: STATEMENT OF ACTIVE SUBSTANCE(S) One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En g gela vsebuje 50 mikrogramov kalcipotriola (v obliki monohidrata) in 0,5 mg betametazona (v obliki dipropionata).
English: Approximately 1 in 10 people may experience side effects but most of these are reactions at the site where the ointment has been applied and are usually mild and temporary.
Slovenian: Neželeni stranski učinki se pojavijo približno pri 1 od 10 bolnikov, večinoma pa se pojavijo lokalno, na mestu nanosa mazila.
English: Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g gel [See Annex I - To be completed nationally] calcipotriol/betamethasone
Slovenian: Daivobet in z njim povezana imena (glejte Prilogo I) 50 mikrogramov/500 mikrogramov v 1 g gel [glejte Prilogo I - izpolni država članica] kalcipotriol/betametazon
English: EXP
Slovenian: Ciper
English: Marketing Authorisation Holder
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: If you notice the above or any other changes in your health while taking this medicine, tell your doctor.
Slovenian: Obvestite svojega zdravnika, če med uporabo tega zdravila opazite katerega od zgoraj naštetih neželenih učinkov ali če opazite kakršnokoli drugo spremembo vašega zdravstvenega stanja.
English: NAME OF THE MEDICINAL PRODUCT Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally]
Slovenian: Daivobet in z njim povezana imena (glejte Prilogo I) 50 mikrogramov/500 mikrogramov v 1 g mazila [glejte Prilogo I - izpolni država članica]
English: Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g ointment [See Annex I - To be completed nationally] Calcipotriol/betamethasone
Slovenian: Daivobet in z njim povezana imena (glejte Prilogo I) 50 mikrogramov/500 mikrogramov v 1 g mazila [glejte Prilogo I - izpolni država članica] kalcipotriol/betametazon
English: Another randomised, investigator-blinded clinical study including 312 patients with scalp psoriasis of at least moderate severity according to the IGA investigated use of Daivobet gel once daily compared with Daivonex Scalp solution twice daily for up to 8 weeks.
Slovenian: V drugi randomizirani, slepi (za preizkuševalca) klinični študiji je sodelovalo 312 bolnikov z vsaj zmerno psoriazo na lasišču, merjeno po kriteriju IGA.
English: NAME OF THE MEDICINAL PRODUCT Daivobet and associated names (see Annex I) 50 micrograms/0.5 mg/g gel [See Annex I - To be completed nationally]
Slovenian: Daivobet in z njim povezana imena (glejte Prilogo I) 50 mikrogramov/500 mikrogramov v 1 g gela [glejte Prilogo I - izpolni država članica]
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Slovenian: Podlaga za dopolnilo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo Ob upoštevanju naslednjega:
English: Always use Daivobet exactly as your doctor has told you.
Slovenian: Pri uporabi zdravila Daivobet natančno upoštevajte zdravnikova navodila.
English: Psoriasis is caused by your skin cells being produced too quickly.
Slovenian: Luskavica se pojavi, kadar nove celice kože nastajajo hitreje, kot je normalno.
English: Dermatitis
Slovenian: Odmerjanje
English: The European Commission granted a marketing authorisation valid throughout the European Union for Dacogen on 20 September 2012.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Dacogen, veljavno po vsej Evropski uniji, izdala 20. septembra 2012.
English: Dacogen decitabine
Slovenian: Dacogen decitabin
English: At least 4 treatment cycles are recommended but they can be continued for as long as the AML remains under control.
Slovenian: Priporočeni so 4 cikli zdravljenja, lahko pa se nadaljujejo, dokler je AML pod nadzorom.
English: Treatment was given for as long as patients benefited from it.
Slovenian: Zdravljenje se je izvajalo toliko časa, dokler je bolnikom koristilo.
English: These enzymes promote the development and progression of cancer.
Slovenian: Ti so odgovorni za spodbujanje razvoja in napredovanja raka.
English: What measures are being taken to ensure the safe and effective use of Dacogen?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Dacogen?
English: In a 4-week treatment cycle, Dacogen is given daily for the first 5 days.
Slovenian: Cikel zdravljenja traja štiri tedne, v katerem se zdravilo Dacogen daje dnevno prvih 5 dni.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Dacogen have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo zdravstveni delavci in bolniki upoštevati za varno in učinkovito uporabo zdravila Dacogen, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Patients receiving Dacogen lived for an average of 7.7 months compared with 5.0 months for patients receiving supportive care or treatment with cytarabine.
Slovenian: Bolniki, ki so prejemali zdravilo Dacogen, so živeli v povprečju 7,7 meseca v primerjavi s 5 meseci pri bolnikih, ki so prejemali podporno zdravljenje ali zdravljenje s citarabinom.
English: This is a summary of the European public assessment report (EPAR) for Dacogen.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Dacogen.
English: For more information about treatment with Dacogen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Dacogen preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Dacogen 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 za zdravilo Dacogen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The CHMP decided that Dacogen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: CHMP je zaključil, da so koristi zdravila Dacogen večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
English: If a patient develops certain severe side effects, the doctor may decide to delay or stop Dacogen treatment.
Slovenian: Če se pri bolniku pojavijo določeni resni neželeni učinki, se lahko zdravnik odloči za odložitev ali ukinitev zdravljenja z zdravilom Dacogen.
English: This means that it is similar to cytidine deoxynucleoside, a fundamental component of the DNA (genetic material) of cells.
Slovenian: To pomeni, da je podoben citidinskemu deoksinukleozidu, temeljni sestavini DNK (genskega materiala) celic.
English: In the body, decitabine is converted into decitabine triphosphate, which is then incorporated into the DNA where it blocks the activity of enzymes called DNA methyltransferases (DNMTs).
Slovenian: V telesu se decitabin pretvori v decitabin trifosfat, ki se nato vgradi v DNK, kjer zavira delovanje encimov, imenovanih DNA-metiltransferaze (DNMT).
English: It is used in patients who are not eligible for standard induction chemotherapy (initial treatment with cancer medicines).
Slovenian: Uporablja se pri bolnikih, za katere standardna indukcijska kemoterapija (začetno zdravljenje z zdravili za zdravljenje raka) ni primerna.
English: Because the number of patients with AML is low, the disease is considered ‘rare', and Dacogen was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2006.
Slovenian: Ker je bolnikov z AML malo, velja ta bolezen za redko, zato je bilo zdravilo Dacogen 8. junija 2006 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: What benefit has Dacogen shown during the studies?
Slovenian: Kakšne koristi je zdravilo Dacogen izkazalo med študijami?
English: Dacogen is used to treat adults with newly diagnosed acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Slovenian: Zdravilo Dacogen se uporablja za zdravljenje odraslih z novo diagnosticirano akutno mieloično levkemijo (AML), vrsto raka, ki prizadene bele krvne celice.
English: The CHMP noted that the improvement in survival with Dacogen in patients with AML was modest but relevant, as the benefits of current treatments are limited in patients who are not eligible for standard induction chemotherapy.
Slovenian: CHMP je ugotovil, da je bilo izboljšanje preživetja pri uporabi zdravila Dacogen pri bolnikih z AML skromno, vendar pomembno, saj so koristi trenutno dostopnih zdravil za bolnike, za katere standardna indukcijska kemoterapija ni primerna, omejene.
English: Other information about Dacogen
Slovenian: Druge informacije o zdravilu Dacogen:
English: 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 Dacogen.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Dacogen, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: By blocking DNMTs, decitabine will prevent the increase of tumour cells and lead to their death.
Slovenian: Z zaviranjem DNMT bo decitabin preprečil deljenje tumorskih celic in tako povzročil njihovo odmrtje.
English: Dacogen is given as an infusion into a vein over one hour.
Slovenian: Zdravilo Dacogen se daje kot infuzija v veno, ki traja eno uro.
English: The dose is calculated using the patient's height and weight.
Slovenian: Odmerek se izračuna na podlagi telesne višine in mase bolnika.
English: There were no major safety concerns with Dacogen and the overall safety profile was similar to that of low-dose cytarabine but some side effects such as infections and neutropenia were more common with Dacogen.
Slovenian: Pri zdravilu Dacogen ni prišlo do večjih pomislekov glede varnosti, celotni varnostni profil pa je bil podoben profilu nizkega odmerka citarabina, z izjemo nekaterih neželenih učinkov, kot so okužbe in nevtropenija, ki so bili pri zdravilu Dacogen pogostejši.
English: Dacogen was compared with either supportive care (any medicine or technique to help patients, excluding cancer medicines or surgery) or low-dose cytarabine (another cancer medicine).
Slovenian: Zdravilo Dacogen so primerjali bodisi s podpornim zdravljenjem (katero koli zdravilo ali tehnika za pomoč bolnikom razen zdravil za zdravljenje raka ali kirurškega posega) bodisi z nizkim odmerkom citarabina (drugega zdravila za zdravljenje raka).
English: As it is not known whether the active substance is excreted in breast milk, in the event that a patient is breastfeeding, they must discontinue breastfeeding if they require treatment with Dacogen.
Slovenian: Ker ni znano, ali se zdravilna učinkovina izloča v materino mleko, mora bolnica, če doji, prekiniti z dojenjem v primeru, da potrebuje zdravljenje z zdravilom Dacogen.
English: Treatment with Dacogen should be started under the supervision of a doctor who has experience in the use of chemotherapy.
Slovenian: Zdravljenje z zdravilom Dacogen mora uvesti in nadzorovati zdravnik, ki ima izkušnje z uporabo kemoterapije.
English: Dacogen has been studied in one main study involving 485 adults, who were newly diagnosed with AML but were not eligible for standard induction chemotherapy.
Slovenian: Zdravilo Dacogen so proučevali v eni glavni študiji pri 485 odraslih z novo diagnosticirano AML, ki pa niso bili primerni za standardno indukcijsko kemoterpaijo.
English: The full EPAR for Dacogen 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 Dacogen je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Dacogen must not be used in people who are breastfeeding.
Slovenian: Zdravilo Dacogen se ne sme uporabljati pri ženskah, ki dojijo.
English: What is the risk associated with Dacogen?
Slovenian: Kakšna tveganja so povezana z zdravilom Dacogen?
English: It contains the active substance decitabine.
Slovenian: Vsebuje zdravilno učinkovino decitabin.
English: For the full list of all restrictions and side effects reported with Dacogen, see the package leaflet.
Slovenian: Za celoten seznam omejitev in neželenih učinkov, o katerih so poročali pri uporabi zdravila Dacogen, glejte navodilo za uporabo.
English: The most common serious side effects (seen in more than 20% of patients) include pneumonia (lung infection), thrombocytopenia, neutropenia (low blood count of neutrophils, a type of white blood cell), febrile neutropenia (low white blood cell count with fever) and anaemia.
Slovenian: Najpogostejši resni neželeni učinki (opaženi pri več kot 20 % bolnikov) so pljučnica (okužba pljuč), trombocitopenija, nevtropenija (nizko število nevtrofilcev, vrste bele krvnih celic), febrilna nevtropenija (nizko število belih krvnih celic, ki ga spremlja povišana telesna temperatura) in anemija.
English: Why has Dacogen been approved?
Slovenian: Zakaj je bilo zdravilo Dacogen odobreno?
English: The active substance in Dacogen, decitabine, is a cytidine deoxynucleoside analogue.
Slovenian: Zdravilna učinkovina v zdravilu Dacogen, decitabin, je „analog citidinskega deoksinukleozida“.
English: The most common side effects with Dacogen (seen in more than 35% of patients) are fever, anaemia (low red blood cell count) and thrombocytopenia (low blood platelet count).
Slovenian: Najpogostejši neželeni učinki zdravila Dacogen (opaženi pri več kot 35 % bolnikov) so povišana telesna temperatura, anemija (nizko število rdečih krvnih celic) in trombocitopenija (nizko število krvnih ploščic).
English: Dacogen is a powder that is made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Dacogen je prašek za pripravo raztopine za infundiranje (kapalne infuzije v veno).
English: What is Dacogen?
Slovenian: Kaj je zdravilo Dacogen?
English: What is Dacogen used for?
Slovenian: Za kaj se zdravilo Dacogen uporablja?
English: How has Dacogen been studied?
Slovenian: Kako je bilo zdravilo Dacogen raziskano?
English: How does Dacogen work?
Slovenian: Kako zdravilo Dacogen deluje?
English: How is Dacogen used?
Slovenian: Kako se zdravilo Dacogen uporablja?
English: Dacogen can only be obtained with a prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept.
English: Previously known as Zenas.
Slovenian: Prej znano kot Zenas.
English: It is available as tablets (10 mg).
Slovenian: Na voljo je v obliki tablet (10 mg).
English: The name of the medicine was changed to Firdapse on 28 January 2010.
Slovenian: Ime zdravila je bilo 28. januarja 2010 spremenjeno v Firdapse.
English: This means that because the disease is rare, it has not been possible to obtain complete information about Firdapse.
Slovenian: To pomeni, da zaradi redkosti bolezni ni bilo mogoče pridobiti vseh informacij o njem.
English: Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo, in posodobila ta povzetek, če bo to potrebno.
English: What measures are being taken to ensure the safe and effective use of Firdapse?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Firdapse?
English: The European Commission granted a marketing authorisation valid throughout the EU for Zenas on 23 December 2009.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Zenas, veljavno po vsej Evropski uniji, izdala 23. decembra 2009.
English: The recommended starting dose of Firdapse is 15 mg per day, which can be increased by 5 mg every four to five days up to a maximum of 60 mg per day.
Slovenian: Priporočeni začetni odmerek zdravila Firdapse je 15 mg na dan, ki se lahko povečuje po 5 mg vsake štiri do pet dni do največ 60 mg na dan.
English: It must also not be used with medicines that have a narrow therapeutic window.
Slovenian: Prav tako se ne sme uporabljati z zdravili z ozkim terapevtskim oknom.
English: Other information about Firdapse
Slovenian: Druge informacije o zdravilu Firdapse
English: Firdapse amifampridine
Slovenian: amifampridin
English: This document is a summary of the European public assessment report (EPAR) for Firdapse.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Firdapse.
English: A risk management plan has been developed to ensure that Firdapse is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Firdapse je bil pripravljen načrt obvladovanja tveganj.
English: Another study combined data from the two published studies and looked at compound muscle action potential (CMAP).
Slovenian: V drugi študiji so združili podatke iz dveh objavljenih študij in preverili sestavljeni mišični akcijski potencial (CMAP).
English: The company will ensure that all healthcare professionals who are expected to use the medicine are provided with information on how to enter their patients in the registry.
Slovenian: Zagotovila bo, da bodo vsi zdravstveni delavci, ki bodo uporabljali zdravilo, prejeli informacije o načinu vnašanja njihovih bolnikov v register.
English: The company that makes Firdapse will provide further data from studies on cancer in experimental models.
Slovenian: Družba, ki proizvaja zdravilo Firdapse bo predložila dodatne podatke iz študij raka na poskusnih modelih.
English: For more information about treatment with Firdapse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Firdapse preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: What is the risk associated with Firdapse?
Slovenian: Kakšna tveganja so povezana z zdravilom Firdapse?
English: A medicine with a narrow therapeutic window can easily cause side effects if given at a dose a little higher than the recommended dose.
Slovenian: Zdravilo z ozkim terapevtskim oknom lahko v odmerku, nekoliko višjem od priporočenega, zlahka povzroči neželene učinke.