FrancophonIA/ELRC3.0 huggingface dataset:
English: Because the number of patients with EPP is low, the disease is considered ‘rare', and Scenesse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 May 2008.
Slovenian: Ker je bolnikov z EPP malo, velja ta bolezen za redko, zato je bilo zdravilo Scenesse 8. maja 2008 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni).
English: Scenesse is only prescribed by specialist doctors in recognised centres for treating EPP and should only be used by doctors who have been properly trained.
Slovenian: Zdravilo Scenesse predpisujejo le specialisti v priznanih centrih za zdravljenje EPP, uporabljajo pa ga lahko samo zdravniki, ki so ustrezno usposobljeni.
English: What are the risks associated with Scenesse?
Slovenian: Kakšna tveganja so povezana z zdravilom Scenesse?
English: What benefits of Scenesse have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Scenesse izkazalo v študijah?
English: One Scenesse implant is injected under the patient's skin once every 2 months, before and during periods of high sunlight exposure, e.g. from spring to autumn.
Slovenian: En implantat zdravila Scenesse se injicira bolniku pod kožo vsaka 2 meseca, pred obdobji visoke izpostavljenosti soncu in med njimi, npr. od pomladi do jeseni.
English: In addition, the company that markets Scenesse will ensure that doctors receive educational material and are trained in how to use the medicine.
Slovenian: Poleg tega bo družba, ki trži zdravilo Scenesse, zagotovila, da bodo zdravniki prejeli izobraževalno gradivo in bodo deležni usposabljanja za uporabo zdravila.
English: The most common side effects seen in studies with Scenesse were nausea (feeling sick), headache and reactions at the implant site (such as discoloration, pain and redness).
Slovenian: Najpogostejši neželeni učinki, opaženi v študijah z zdravilom Scenesse, so bili navzea (slabost), glavobol in reakcije na mestu implantata (kot so sprememba barve, bolečina in rdečica).
English: What information is still awaited for Scenesse?
Slovenian: Katere informacije o zdravilu Scenesse še pričakujemo?
English: Daily records of exposure to sunlight between 10 am and 6 pm showed that patients treated with Scenesse spent on average 116 hours in direct sunlight without experiencing pain during the six-month period compared with 61 hours for patients treated with placebo.
Slovenian: Dnevno beleženje izpostavljenosti sončni svetlobi med 10. in 16. uro v obdobju šestih mesecev je pokazalo, da so bolniki, ki so prejemali zdravilo Scenesse, na neposredni sončni svetlobi v povprečju prebili 116 ur, ne da bi občutili bolečino, v primerjavi z 61 urami pri bolnikih, ki so prejemali placebo.
English: In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light.
Slovenian: Pri bolnikih z EPP lahko izpostavljenost svetlobi povzroči simptome, kot sta bolečina in otekanje kože, zaradi česar bolniki ne morejo preživljati časa na prostem ali v prostorih z močno svetlobo.
English: Three implants per year are recommended;
Slovenian: Priporočeni so trije implantati letno, dovoljeni pa največ štirje.
English: Scenesse must not be used in patients with reduced liver or kidney function.
Slovenian: Zdravila Scenesse ne smejo uporabljati bolniki z zmanjšanim delovanjem jeter ali ledvic.
English: Scenesse is an implant used to treat patients with erythropoietic protoporphyria (EPP), a rare disease that causes intolerance to light.
Slovenian: Zdravilo Scenesse je implantat, ki se uporablja za zdravljenje bolnikov z eritropoetsko protoporfirijo (EPP), redko boleznijo, ki povzroča preobčutljivost za svetlobo.
English: For more information on how to use Scenesse, see the summary of product characteristics (also part of the EPAR).
Slovenian: Za več informacij o uporabi zdravila Scenesse glejte povzetek glavnih značilnosti zdravila (ki je prav tako del EPAR).
English: Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition.
Slovenian: Protoporfirin IX je fototoksičen in pri ljudeh s to boleznijo ob izpostavljenosti svetlobi povzroča boleče reakcije.
English: The full EPAR and risk management plan summary for Scenesse 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) in povzetek načrta obvladovanja tveganj za zdravilo Scenesse sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Scenesse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Scenesse večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: This is because it has not been possible to obtain complete information about the benefits of Scenesse, in part due to the rarity of the disease.
Slovenian: Do tega je prišlo zato, ker - med drugim zaradi redkosti bolezni - ni bilo mogoče pridobiti vseh informacij o njegovih koristih.
English: This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells.
Slovenian: Ta pigment, imenovan evmelanin, se tvori med izpostavljenostjo sončni svetlobi, da prepreči prodiranje svetlobe v celice.
English: In the study, involving 93 patients with EPP, patients were treated with either Scenesse or a placebo (a dummy treatment) over a six-month period.
Slovenian: V njej je sodelovalo 93 bolnikov z EPP, ki so šest mesecev prejemali bodisi zdravilo Scenesse bodisi placebo (zdravilo brez zdravilne učinkovine).
English: Patients should be observed for allergic reactions for 30 minutes after the injection of each implant.
Slovenian: Bolnike je treba po injiciranju posameznega implantata opazovati še 30 minut, saj se v tem času lahko razvije alergijska reakcija.
English: For the full list of all side effects and restrictions with Scenesse, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov in omejitev pri zdravilu Scenesse glejte navodilo za uporabo.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Scenesse, including information on the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila Scenesse in navodilo za njegovo uporabo vključene informacije o varnosti, vključno z informacijami o previdnostnih ukrepih, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Scenesse contains the active substance afamelanotide.
Slovenian: Zdravilo Scenesse vsebuje zdravilno učinkovino afamelanotid.
English: Since Scenesse has been approved under exceptional circumstances, the company that markets Scenesse will provide longer-tem data on the benefits and safety of the medicine from an EU registry of patients taking the medicine.
Slovenian: Ker je zdravilo Scenesse pridobilo dovoljenje za promet v izjemnih okoliščinah, bo družba, ki ga trži, zagotovila dolgoročne podatke o koristih in varnosti zdravila iz registra bolnikov v EU, ki prejemajo zdravilo.
English: By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.
Slovenian: Zdravilo Scenesse spodbuja tvorbo evmelanina v koži ter posledično zmanjšuje prodiranje svetlobe skozi kožo in tako pomaga preprečiti boleče reakcije.
English: The active substance in Scenesse, afamelanotide, is similar to a hormone in the body known as alphamelanocyte stimulating hormone, which stimulates the production of a brown-black pigment in the skin.
Slovenian: Zdravilna učinkovina zdravila Scenesse, afamelanotid, je podobna telesnemu hormonu, imenovanemu alfa-melanocit stimulirajoči hormon, ki spodbuja tvorbo rjavo-črnega pigmenta v koži.
English: For practical information about using Scenesse, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Scenesse naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: How does Scenesse work?
Slovenian: Kako zdravilo Scenesse deluje?
English: For more information about treatment with Scenesse, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Scenesse preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Although the additional time spent in sunlight was small, the Committee considered the possible improvements in quality of life, the unmet medical need in patients with EPP, and the mild side effects seen during short-term treatment with the medicine in deciding to recommend approval for Scenesse in the EU.
Slovenian: Čeprav je bil dodaten čas, preživet na sončni svetlobi, kratek, je Odbor pri odločitvi, da priporoči odobritev uporabe zdravila Scenesse v EU, upošteval možno izboljšanje kakovosti življenja, neizpolnjene zdravstvene potrebe pri bolnikih z EPP in blage neželene učinke, opažene med kratkotrajnim zdravljenjem z zdravilom.
English: The CHMP noted that Scenesse led to an increase in the amount of time patients could spend in direct sunlight without experiencing pain.
Slovenian: CHMP je ugotovil, da je zdravilo Scenesse bolnikom omogočilo daljše preživljanje časa na neposredni sončni svetlobi, ne da bi občutili bolečino.
English: Scenesse has been shown in a study to lead to an increase in the amount of time patients can spend in sunlight.
Slovenian: Študija je pokazala, da zdravilo Scenesse podaljšuje čas, ki ga bolniki lahko preživijo na sončni svetlobi.
English: How is Scenesse used?
Slovenian: Kako se zdravilo Scenesse uporablja?
English: Over 24 weeks
Slovenian: V obdobju 24 tednov
English: However, Cmax increases by 15-23%.
Slovenian: Vendar pa se Cmax poveča za 15-23 %.
English: Date of first authorisation: 20 July 2011 Date of latest renewal: 18 May 2017
Slovenian: Datum prve odobritve: 20. julij 2011 Datum zadnjega podaljšanja: 18. maj 2017
English: ≥20% improvement
Slovenian: ≥20 % izboljšanje
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Slovenian: Ne pričakuje se, da bi majhno zmanjšanje AUC zmanjšalo terapevtsko učinkovitost.
English: There is limited safety information in these patients.
Slovenian: Informacij o varnosti za te bolnike je malo.
English: − The other ingredients are:
Slovenian: − Druge sestavine zdravila so:
English: The usual dosing regimen should always be followed.
Slovenian: Vedno je treba upoštevati običajni režim odmerjanja.
English: Frequencies are defined 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 so opredeljene kot: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); zelo redki (<1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: The safety and efficacy of Fampyra in children aged 0 to 18 years have not been established.
Slovenian: Varnosti in učinkovitosti zdravila Fampyra pri otrocih, starih med 0 in 18 let, niso ugotavljali.
English: • Feeling weak and tired
Slovenian: • občutek oslabelosti in utrujenosti
English: Creatinine clearance can be estimated using the Cockroft-Gault formula.
Slovenian: Očistek kreatinina se lahko oceni s formulo Cockroft-Gault.
English: − if you are prone to infections
Slovenian: − če ste nagnjeni k okužbam.
English: You may also notice other effects not listed here.
Slovenian: Opazite lahko tudi druge učinke, ki tukaj niso našteti.
English: Do not give Fampyra to children or adolescents under the age of 18 years.
Slovenian: Zdravila Fampyra ne dajajte otrokom ali mladostnikom, starim manj kot 18 let.
English: In animal studies no effects on fertility were seen.
Slovenian: V študijah na živalih niso opazili vpliva na plodnost.
English: 43% Risk difference: 10.4%
Slovenian: 43 % razlika tveganja: 10,4 %
English: Children and in adolescents
Slovenian: Otroci in mladostniki
English: Do not take more than two tablets in a day.
Slovenian: Ne jemljite več kot dveh tablet na dan.
English: Fampridine has a volume of distribution of approximately 2.6 l/kg.
Slovenian: Volumen porazdelitve fampridina je približno 2,6 l/kg.
English: • Upset stomach
Slovenian: • vznemirjen želodec
English: Reports of hypertension have also been received.
Slovenian: Obstajajo tudi poročila o hipertenziji.
English: − if you are taking a medicine called cimetidine
Slovenian: − če jemljete zdravilo, imenovano cimetidin.
English: However, no increased risk for malformations or adverse effects on fertility was noted.
Slovenian: Vendar pa niso opazili večjega tveganja za malformacije ali neželene učinke na plodnost.
English: Athlone, Co. Westmeath Ireland
Slovenian: Athlone, Co. Westmeath
English: Duration of double-blind treatment was 24 weeks with a 2 week post-treatment follow-up.
Slovenian: Dvojno slepo zdravljenje je trajalo 24 tednov z 2-tedenskim spremljanjem po zdravljenju.
English: It is unknown whether fampridine is excreted in human or animal milk.
Slovenian: Ni znano, ali se fampridin izloča v materino mleko pri človeku ali pri živali.
English: Fampridine has a narrow therapeutic index.
Slovenian: Fampridin ima ozek terapevtski indeks.
English: Do not take the tablets more often than every 12 hours.
Slovenian: Tablet ne jemljite pogosteje kot vsakih 12 ur.
English: 1171 LP Badhoevedorp The Netherlands
Slovenian: 1171 LP Badhoevedorp
English: The improvement appeared rapidly (within weeks) after starting Fampyra.
Slovenian: Izboljšanje se je pojavilo hitro (v nekaj tednih) po začetku jemanja zdravila
English: After 2 to 4 weeks the treatment will be reassessed.
Slovenian: Po 2 do 4 tednih bo učinke zdravljenja ponovno ocenil.
English: Fampridine is not a substrate for P-glycoprotein.
Slovenian: Fampridin ni substrat za P-glikoprotein.
English: A responder was defined as a patient who consistently had a faster walking speed for at least three visits out of a possible four during the double blind period as compared to the maximum value among five off-treatment visits.
Slovenian: Odzivna oseba je bila opredeljena kot bolnik, ki je konsistentno hodil hitreje vsaj v treh od možnih štirih obiskov v dvojno slepem obdobju preskušanja v primerjavi z največjo hitrostjo, doseženo med petimi obiski, ki niso sodili v obdobje zdravljenja.
English: Clinical studies of Fampyra did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.
Slovenian: V klinične študije z zdravilom Fampyra ni bilo vključenih dovolj bolnikov, starih 65 let in več, da bi se ugotovilo, ali je njihov odziv drugačen kot pri mlajših bolnikih.
English: *Intent to treat population = 633; LSM = Least square mean
Slovenian: *Populacija z namenom zdravljenja = 633; LSM = povprečje najmanjših kvadratov (Least Squares Mean)
English: Older people:
Slovenian: Starejši ljudje:
English: OCT2 is the transporter responsible for the active secretion of fampridine.
Slovenian: OCT2 je prenašalec, odgovoren za aktivno izločanje fampridina.
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code: N07XX07.
Slovenian: Farmakoterapevtska skupina: druga zdravila za živčevje, oznaka ATC: N07XX07.
English: Fampyra with food and drink
Slovenian: Zdravilo Fampyra skupaj s hrano in pijačo
English: The difference in the Berg Balance Scale (BBS; a measure of static balance), was not statistically significant.
Slovenian: Medtem ko razlika v rezultatu glede na Bergovo lestvico ravnotežja (Berg Balance Scale - BBS; merilo statičnega ravnotežja) ni bila statistično značilna.
English: Particular attention should be given to patients with a previous history of allergic reactions.
Slovenian: Posebno pozornost je treba nameniti bolnikom z alergijskimi reakcijami v anamnezi.
English: These clinical signs were not unexpected and represent exaggerated pharmacology of fampridine.
Slovenian: Ti klinični znaki niso bili nepričakovani in predstavljajo pretiran farmakološki odziv na fampridin.
English: Before starting treatment and during treatment your doctor may check that your kidneys are working properly.
Slovenian: Pred začetkom zdravljenja in med njim bo morda zdravnik preveril, ali vaše ledvice pravilno delujejo.
English: This is consistent with fampridine's pharmacological activity.
Slovenian: To je v skladu s farmakološko aktivnostjo fampridina.
English: If an anaphylactic or other serious allergic reaction occurs, Fampyra should be discontinued and not restarted.
Slovenian: Če se pojavi anafilaktična ali druga resna alergijska reakcija, je treba uporabo zdravila Fampyra prekiniti in z njo ne nadaljevati.
English: Study 218MS305 was conducted in 636 subjects with multiple sclerosis and walking disability.
Slovenian: Študijo 218MS305 so opravili pri 636 bolnikih z multiplo sklerozo in nezmožnostjo hoje.
English: • Flu (influenza)
Slovenian: • gripa (influenca)
English: Renal clearance (CLR 370 ml/min) is substantially greater than glomerular filtration rate due to combined glomerular filtration and active excretion by the renal OCT2 transporter.
Slovenian: Ledvični očistek (CLR 370 ml/min) je znatno višji kot stopnja glomerularne filtracije zaradi kombinirane glomerularne filtracije in aktivnega izločanja prek ledvičnega transporterja OCT2.
English: What Fampyra is and what it is used for
Slovenian: Kaj je zdravilo Fampyra in za kaj ga uporabljamo
English: • Initial prescription should be limited to two to four weeks of therapy as clinical benefits should generally be identified within two to four weeks after starting Fampyra
Slovenian: • Na začetku je treba zdravljenje omejiti na dva do štiri tedne, saj se klinične koristi praviloma pokažejo v roku dveh do štirih tednov po uvedbi zdravila Fampyra.
English: − if you feel aware of your heartbeat (palpitations)
Slovenian: − če se zavedate bitja svojega srca (palpitacije).
English: − if you are allergic to fampridine or any of the other ingredients of this medicine (listed in section 6)
Slovenian: − če ste alergični na fampridin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The safety of Fampyra has been evaluated in randomised controlled clinical studies, in open label long term studies and in the post marketing setting.
Slovenian: Varnost zdravila Fampyra so ocenili v randomiziranih kontroliranih kliničnih študijah, v odprtih dolgoročnih študijah in po začetku trženja.
English: • Worsening of nerve pain in the face (trigeminal neuralgia)
Slovenian: • poslabšanje bolečine živca na obrazu (nevralgija trigeminalnega živca)
English: This medicine is thought to work by letting signals pass down the nerve more normally, which allows you to walk better.
Slovenian: Zdravilo deluje tako, da omogoča normalnejši pretok signala po živcu, kar vam omogoča, da bolje hodite.
English: The clinical relevance of these findings remains to be elucidated, but a causal relationship with fampridine treatment cannot be excluded.
Slovenian: Klinični pomen teh izsledkov je treba še pojasniti, toda vzročnega razmerja z zdravljenjem s fampridinom ni mogoče izključiti.
English: Biotransformation:
Slovenian: Biotransformacija
English: Alkermes Pharma Ireland Ltd, Monksland, Athlone, Co. Westmeath, Ireland
Slovenian: Proizvajalec: Alkermes Pharma Ireland Ltd, Monksland, Athlone, Co. Westmeath, Irska
English: Presumably, by enhancing action potential formation, more impulses might be conducted in the central nervous system.
Slovenian: Domneva se, da se lahko s povečanim nastajanjem akcijskega potenciala v osrednji živčni sistem prevede več impulzov.
English: Your doctor will give you an initial prescription for 2 to 4 weeks.
Slovenian: Zdravnik vam lahko na začetku predpiše zdravilo za 2 do 4 tedne.
English: Viral infection1
Slovenian: virusna infekcija1
English: Side effects are listed below by frequency:
Slovenian: Neželeni učinki so našteti spodaj po pogostnosti:
English: See section 4.
Slovenian: 1Glejte poglavje 4.4.
English: Adverse reactions are presented below by system organ class and absolute frequency.
Slovenian: Neželeni učinki so spodaj razvrščeni po organskih sistemih in absolutni pogostnosti.
English: In post-marketing experience, serious hypersensitivity reactions (including anaphylactic reaction) have been reported, the majority of these cases occurred within the first week of treatment.
Slovenian: Iz izkušenj v obdobju trženja zdravila so poročali o resnih preobčutljivostnih reakcijah (vključno z anafilaktično reakcijo), pri čemer se je večina primerov zgodila v prvem tednu zdravljenja.
English: One tablet in the morning and one tablet in the evening (12 hours apart).
Slovenian: Ena tableta zjutraj in ena tableta zvečer (v razmiku 12 ur).
English: Improvements generally appeared within 2 to 4 weeks of initiation of treatment, and disappeared within 2 weeks of treatment cessation.
Slovenian: Izboljšanje se je na splošno pokazalo v 2 do 4 tednih po uvedbi zdravljenja in izzvenelo v 2 tednih po prenehanju zdravljenja.
English: The recommended dose is one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening).
Slovenian: Priporočeni odmerek je ena 10 mg tableta dvakrat dnevno, ki jo je treba vzeti z 12-urnim razmikom (ena tableta zjutraj in ena tableta zvečer).
English: It must not be divided, crushed, dissolved, sucked or chewed.
Slovenian: Ne smejo se deliti, drobiti, topiti, sesati ali žvečiti.
English: In post-marketing experience, there have been reports of seizure, the frequency is not known (cannot be estimated from the available data).
Slovenian: Iz izkušenj po trženju poročajo o epileptičnih napadih z neznano pogostnostjo (ni mogoče oceniti iz razpoložljivih podatkov).
English: The maximum plasma concentration (Cmax) and, to a smaller extent, area under the plasma concentration-time curve (AUC) increase proportionately with dose.
Slovenian: Največja koncentracija v plazmi (Cmax) in, v manjšem obsegu, površina pod krivuljo plazemske koncentracije v odvisnosti od časa (AUC), narašča sorazmerno z odmerkom.
English: Other side effects at high doses include cases of cardiac arrhythmias (for example, supraventricular tachycardia and bradycardia) and ventricular tachycardia as a consequence of potential QT prolongation.
Slovenian: Drugi neželeni učinki pri visokih odmerkih vključujejo primere srčnih aritmij (na primer, supraventrikularna tahikardija in bradikardija) in ventrikularna tahikardija kot posledica možnega podaljšanja QT.
English: If you experience one or more of the following allergic (hypersensitivity) symptoms: swollen face, mouth, lips, throat or tongue, reddening or itching of the skin, chest tightness and breathing problems stop taking Fampyra and see your doctor immediately.
Slovenian: Če opazite enega ali več od naslednjih alergijskih (preobčutljivostnih) simptomov: otekel obraz, usta, ustnice, grlo ali jezik, rdečina ali srbečica kože, stiskanje v prsnem košu ali težave z dihanjem, prenehajte jemati zdravilo Fampyra in pojdite takoj k zdravniku.
English: Fampyra should be taken without food, on an empty stomach.
Slovenian: Zdravilo Fampyra jemljite brez hrane na prazen želodec.
English: Patients with renal impairment have higher plasma concentrations which are associated with increased adverse reactions, in particular neurological effects.
Slovenian: Bolniki z okvaro ledvic imajo višje koncentracije v plazmi, kar je povezano s povečanjem neželenih učinkov, zlasti nevroloških učinkov.
English: Other medicines that affect the kidneys
Slovenian: Druga zdravila, ki vplivajo na ledvice
English: This leaflet was last revised in
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.