FrancophonIA/ELRC3.0 huggingface dataset:
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 - 14) included a total of 252 outpatients.
Slovenian: V temeljni klinični študiji pri skupini 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo (3-14 točk na lestvici Kratkega preskusa spoznavnih sposobnosti (KPSS oz. MMSE ali "Mini-mental State Examination")) ob vključitvi je zdravljenje z memantinom v monoterapiji pokazalo izboljšanje v primerjavi s placebom, v obdobju 6 mesečnega zdravljenja (analiza opazovanih bolnikov, lestvice Vtis sprememb na osnovi kliničnega intervjuja (CIBIC-plus - "Clinician's Interview-Based Impression of
English: Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Slovenian: Bolnik naj sedem dni jemlje eno in pol 10 mg filmsko obloženo tableto (15 mg) na dan. Od 4. tedna dalje:
English: Week 3 (day 15-21): The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days.
Slovenian: Bolnik mora sedem dni jemati 1,5 ml raztopine (15 mg) na dan, kar ustreza trem navpičnim pritiskom navzdol.
English: Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablet (15 mg) per day for 7 days.
Slovenian: Bolnik naj sedem dni jemlje eno 10 mg na dan filmsko obloženo tableto (10 mg) na dan. 3. teden (15.-21. dan):
English: If the pump does not function properly, consult your doctor or a pharmacist.Lock the dosing pump after using Axura.
Slovenian: Po uporabi zdravila Axura zaklenite odmerno črpalko.
English: EXP {MM/YYYY} See embossed stamp.
Slovenian: Uporabno do: {MM/LLLL} Glejte odtis na robu.
English: EMEA Number Invented Name Strength Pharmaceutical Form
Slovenian: Št. EMEA Trgovsko ime Moč Farmacevtska oblika
English: Packaging Content Package size Withdraw al period
Slovenian: Vsebina Velikost pakiranja
English: Route of administration
Slovenian: Način dajanja Pakiranje
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration and marketing authorisation holders in the Member States
Slovenian: Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila in imetnikov dovoljenja za promet z zdravilom v državah članicah
English: 2730-097 Barcarena Portugal
Slovenian: 2730-097 Barcarena
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
Slovenian: Luksemburg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
English: AstraZeneca Kft., 1113 Budapest, Bocskai út 134-146., Hungary
Slovenian: Bocskai út 134-146., Hungary
English: AstraZeneca S.p.A. Palazzo Volta, Via F. Sforza 20080 Basiglio (MI), Italy
Slovenian: Palazzo Volta, Via F. Sforza 20080 Basiglio (MI), Italy
English: Rua Humberto Madeira, 7, Queluz de Baixo
Slovenian: Rua Humberto Madeira, 7,
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
Slovenian: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium
English: 4 days (including the day of administration)
Slovenian: 4 dni (vključno z dnem apliciranja)
English: Control, N = 10
Slovenian: kontrolna skupina, N = 10
English: • Some medicine may be present in your tears.
Slovenian: • se nekaj zdravila lahko izloči v vaše solze.
English: Study 301 was an open-label, randomised, controlled study.
Slovenian: Študija 301 je bila odprta, randomizirana in kontrolirana študija.
English: Phase 3 study
Slovenian: Študija faze 3
English: 31 subjects were enrolled, 13 males and 18 females.
Slovenian: Vključenih je bilo 31 preiskovancev, 13 moških in 18 žensk.
English: It is important that you take this medicine according to the instructions given.
Slovenian: Zelo pomembno je, da to zdravilo jemljete v skladu z danimi navodili.
English: 30 June 2030
Slovenian: 30. junij 2030
English: • Tell your doctor if you have an active infection of any sort.
Slovenian: • povejte zdravniku, če imate kakršno koli vrsto aktivne okužbe.
English: 10 subjects were randomised to the control (non-intervention) group.
Slovenian: 10 preiskovancev so randomizirali v kontrolno (neintervencijsko) skupino.
English: The effects of this medicine on pregnancy and the unborn child are not known.
Slovenian: Učinkov tega zdravila na nosečnost in nerojenega otroka ne poznamo.
English: Your doctor will talk to you about the anaesthesia and how it will be given to you.
Slovenian: Vaš zdravnik vam bo povedal vse potrebno o anesteziji in o tem, kako vam jo bodo dali.
English: Vertical dotted lines represent additional 25% above and below the box.
Slovenian: Navpične črtkane črte predstavljajo nadaljnjih 25 % vrednosti nad oziroma pod okvirjem.
English: System organ class / Frequency
Slovenian: Organski sistem / pogostnost
English: Do not stop taking the medicine without first talking to your doctor.
Slovenian: Ne prenehajte jemati tega zdravila, ne da bi se prej posvetovali s svojim zdravnikom.
English: The testing of each subject was videotaped and assessed by independent graders.
Slovenian: Izvajanje testa vsakega preiskovanca so dokumentirali na videoposnetek, vse pa so ocenili neodvisni ocenjevalci.
English: • Summary of Product Characteristics (SmPC);
Slovenian: • Povzetek glavnih značilnosti zdravila (SmPC),
English: What Luxturna is and what it is used for
Slovenian: Kaj je zdravilo Luxturna in za kaj ga uporabljamo
English: This medicinal product must not be administered by intravitreal injection.
Slovenian: Tega zdravila se ne sme aplicirati z intravitrealno injekcijo.
English: Your doctor may be able to help reduce any discomfort caused by these temporary disturbances.
Slovenian: Morda vam bo lahko pomagal zmanjšati neprijetne občutke, ki jih lahko povzročijo te prehodne motnje.
English: There are no known clinically significant interactions.
Slovenian: S tem zdravilom ni nobenih znanih klinično pomembnih interakcij.
English: Immunomodulatory regimen
Slovenian: Imunomodulatoren režim
English: The interval between injection to the eyes for each subject was from 6 to 18 days.
Slovenian: Časovni interval med injekcijama v eno in drugo oko pri posameznem preiskovancu je bil od 6 do 18 dni.
English: This will be repeated on your other eye at least 6 days afterwards.
Slovenian: Celoten postopek bo ponovil še na drugem očesu po najmanj 6 dneh.
English: Patients may resume swimming and strenuous activity, after a minimum of one to two weeks, on the advice of their healthcare professional.
Slovenian: S plavanjem in naporno telesno dejavnostjo lahko bolniki spet začnejo po najmanj enem ali dveh tednih po posvetu z zdravstvenim delavcem.
English: If you are given more Luxturna than you should be As this medicine is given to you by a doctor, it is unlikely that you will be given too much.
Slovenian: Če bi prejeli večji odmerek zdravila Luxturna, kot bi smeli Ker vam bo to zdravilo dajal vaš zdravnik, je malo verjetno, da ga boste prejeli preveč.
English: Any exposed wounds should be covered before handling.
Slovenian: Vse odprte rane je treba pred rokovanjem z zdravilom pokriti.
English: The adverse reactions are listed by system organ class and frequency using the following convention: 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: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti po naslednjem dogovoru: 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: Serious adverse reactions related to the administration procedure were reported in three subjects during the clinical programme.
Slovenian: O resnih neželenih učinkih v povezavi s postopkom apliciranja so poročali pri treh osebah v poteku programa kliničnih študij.
English: You should follow these precautions for 14 days.
Slovenian: Ta previdnostni ukrep morate upoštevati 14 dni.
English: No dose adjustment is required in these patients (see section 5.2).
Slovenian: Prilagajanje odmerjanja pri teh bolnikih ni potrebno (glejte poglavje 5.2).
English: Information on how to obtain the special formats will be provided in the patient card.
Slovenian: Informacije o možnosti dostopanja do vsebin v posebnih oblikah bodo navedene na bolnikovi kartici.
English: Please talk to your doctor before travelling.
Slovenian: Pred potovanjem se pogovorite z zdravnikom.
English: The average age was 15 years (range 4 to 44 years), including 64% paediatric subjects (n=20, age from 4 to 17 years) and 36% adults (n=11).
Slovenian: Povprečna starost preiskovancev je bila 15 let (od 4 do 44 let), pri čemer je bilo 64 % preiskovancev pediatričnih bolnikov (n=20, v starosti od 4 do 17 let), 36 % pa je bilo odraslih (n=11).
English: The qualified staff (i.e. vitreoretinal surgeons and pharmacists) at the treatment centres should be provided with educational materials including:
Slovenian: Kvalificiranemu osebju (to je vitreoretinalnim kirurgom in farmacevtom) v terapevtskih centrih je treba priskrbeti izobraževalno gradivo, kar vključuje:
English: • You should avoid air travel or other travel to high elevations until advised by your doctor.
Slovenian: • se morate izogibati potovanju z letalom in drugim potovanjem v kraje z visoko nadmorsko višino, dokler vam to odsvetuje zdravnik.
English: The virus used to deliver the gene does not cause disease in humans.
Slovenian: Virus, ki je v zdravilu uporabljen kot prenašalec gena, pri ljudeh ne povzroča bolezni.
English: Damage to the tissues of the eye may be accompanied by bleeding and swelling and an increased risk of infection.
Slovenian: Poškodbo očesnih tkiv pri posegu lahko spremlja krvavitev in oteklina ter povečano tveganje za okužbo.
English: Patients and their caregivers should be provided with the patient information pack, including:
Slovenian: Bolnikom in njihovim negovalcem je treba priskrbeti informacijski komplet za bolnika, ki vključuje:
English: Ocular or periocular infection.
Slovenian: Okužba očesa ali periokularna okužba.
English: Voretigene neparvovec has minor influence on the ability to drive and use machines.
Slovenian: Voretigen neparvovek ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: These steps are critical in the biological conversion of a photon of light into an electrical signal within the retina.
Slovenian: Ti koraki so bistvenega pomena za biološko pretvorbo fotona svetlobe v električni signal v mrežnici.
English: One subject in the control group withdrew consent and was discontinued from the study.
Slovenian: En preiskovanec iz kontrolne skupine je odstopil od privolitve v sodelovanje in je izstopil iz študije.
English: If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before being treated with Luxturna.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali medicinsko sestro, preden prejmete zdravilo Luxturna.
English: In the Phase 3 study, the MLMT used seven levels of illumination ranging from 400 lux to 1 lux (corresponding to, for example, a brightly lit office down to a moonless summer night).
Slovenian: V študiji faze 3 so pri testiranju MLMT uporabili sedem stopenj osvetlitve od 400 luksov do 1 luksa (kar ustreza osvetlitvi na primer v dobro osvetljeni pisarni do zmanjšanja osvetlitve na raven poletne noči brez mesečine).
English: • Change of the electrical activity of the heart
Slovenian: • motnje električne aktivnosti srca
English: Patients treated with Luxturna should not donate blood, organs, tissues and cells for transplantation.
Slovenian: Bolniki, ki prejmejo zdravilo Luxturna, ne smejo darovati krvi, organov, tkiv ali celic za presaditev.
English: Each box represents the middle 50% of distribution of MLMT score change.
Slovenian: Vsak okvir predstavlja srednjih 50 % distribucije sprememb ocene pri testu MLMT.
English: Your doctor may delay your treatment until your infection is gone because this medicine may make it more difficult for you to fight an infection.
Slovenian: Zdravnik bo verjetno odložil vaše zdravljenje, dokler okužba ne bo odpravljena, saj se zaradi tega zdravila telo težje bori proti okužbi.
English: D30, D90, D180: 30, 90 and 180 days after start of study;
Slovenian: D30, D90, D180: 30, 90 oziroma 180 dni po začetku študije;
English: No clinical data on the effect of the medicinal product on fertility are available.
Slovenian: Na voljo ni nobenih kliničnih podatkov o vplivu zdravila na plodnost.
English: Precaution to be taken before manipulating or administering the medicinal product This medicinal product contains genetically modified organisms.
Slovenian: Previdnostni ukrepi, potrebni pred rokovanjem z zdravilom ali dajanjem zdravila To zdravilo vsebuje gensko spremenjene organizme.
English: After receiving Luxturna:
Slovenian: Po prejemu zdravila Luxturna:
English: All participants had a clinical diagnosis of Leber congenital amaurosis, and some may have also had prior or additional clinical diagnoses, including retinitis pigmentosa.
Slovenian: Vsi preiskovanci so imeli klinično diagnozo Lebrove kongenitalne amavroze, nekateri pa so lahko imeli tudi že prej postavljene oziroma druge klinične diagnoze, med drugim pigmentno retinopatijo.
English: BL: baseline;
Slovenian: BL (Baseline) = izhodišče;
English: Before Luxturna treatment is started, your doctor may prescribe a medicine that will suppress your immune system (the body's natural defences) so that it will not try to fight the Luxturna when it is given.
Slovenian: Pred začetkom zdravljenja z zdravilom Luxturna vam bo zdravnik verjetno predpisal zdravilo, ki bo zavrlo delovanje vašega imunskega sistema (naravno obrambo telesa), da se ta ne bi poskušal obrniti proti zdravilu Luxturna, ko ga boste prejeli.
English: Children and adolescents Luxturna has not been studied in children under four years of age.
Slovenian: Otroci in mladostniki Zdravila Luxturna niso proučevali pri otrocih, ki so bili stari manj kot štiri leta.
English: If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Luxturna.
Slovenian: Če za vas velja karkoli od zgoraj navedenega ali če o tem niste prepričani, se pogovorite z zdravnikom, preden prejmete zdravilo Luxturna.
English: Luxturna will be stored by the healthcare professionals at your healthcare facility.
Slovenian: Za shranjevanje zdravila Luxturna poskrbijo zdravstveni delavci v zdravstveni ustanovi.
English: Warnings and precautions Before receiving treatment with Luxturna:
Slovenian: Opozorila in previdnostni ukrepi Pred prejemom zdravila Luxturna:
English: Improvement in full-field light sensitivity was maintained for up to 3 years after exposure to voretigene neparvovec.
Slovenian: Izboljšana občutljivost celotnega vidnega polja na svetlobo se je ohranila do 3 leta po izpostavljenosti voretigen neparvoveku.
English: VIAL LABEL (CONCENTRATE)
Slovenian: NALEPKA NA VIALI (KONCENTRAT)
English: Adequate anaesthesia should be given to the patient prior to the procedure.
Slovenian: Pred izvedbo postopka je treba bolniku dati ustrezno anestezijo.
English: • Increase in intraocular pressure.
Slovenian: • zvišanje intraokularnega tlaka.
English: During treatment with this medicine, the doctor inserts an air bubble in the eye, which is slowly absorbed by your body.
Slovenian: V okviru zdravljenja s tem zdravilom vam zdravnik v oko vbrizga zračni mehurček, ki ga telo nato počasi absorbira.
English: Results of full-field light sensitivity testing at the first study year: white light [Log10(cd.s/m2)] are shown in Table 5 below.
Slovenian: Rezultati pri testiranju občutljivosti celotnega vidnega polja na belo svetlobo [log10 (cd.s/m 2)] v prvem študijskem letu so prikazani v preglednici 5 spodaj.
English: The long-term safety and efficacy of Luxturna were assessed in a Phase 1 safety and dose escalation study (101), in which 12 subjects received unilateral subretinal injections of voretigene neparvovec; a follow-on study (102) in which voretigene neparvovec was administered to the contralateral eye in 11 of the 12 subjects who participated in the dose escalation study; a one-year, open-label Phase 3 controlled study (301) in which 31 subjects were randomised at two sites; and the continuation of the Phase 3 study, in which the 9 control subjects crossed over and received the intervention.
Slovenian: Dolgoročno varnost in učinkovitost zdravila Luxturna so ocenjevali v študiji faze 1 za oceno varnosti s stopnjevanjem odmerka (študiji 101), v kateri je 12 preiskovancev enostransko (v eno oko) prejelo subretinalne injekcije voretigen neparvoveka, v nadaljevalni študiji (študiji 102), v kateri so 11 od 12 preiskovancev, ki so sodelovali v študiji s stopnjevanjem odmerka, aplicirali voretigen neparvovek v kontralateralno oko, v enoletni odprti kontrolirani študiji faze 3 (študiji 301), v kateri so v dveh študijskih centrih randomizirali 31 preiskovancev, in v nadaljevanju študije faze 3, v katerem je 9 kontrolnih preiskovancev prešlo v drugo študijsko skupino in prejemalo intervencijsko zdravljenje.
English: • Breakdown of the surgical wound
Slovenian: • razprtje kirurške rane
English: Transient and low-level vector shedding may occur in patient tears (see section 5.2).
Slovenian: Vektor prehodno in v majhnih količinah lahko prehaja v bolnikove solze (glejte poglavje 5.2).
English: It is not known whether it passes into breast milk.
Slovenian: Ni znano, ali zdravilo lahko prehaja v materino mleko.
English: To reduce the potential for immunogenicity patients should receive systemic corticosteroids before and after the subretinal injection of voretigene neparvovec to each eye (see section 4.2).
Slovenian: Za zmanjševanje možnosti za imunogenost morajo bolniki pred in po subretinalnem injiciranju voretigen neparvoveka v vsako oko prejeti sistemske kortikosteroide (glejte poglavje 4.2).
English: You will not be given Luxturna if you are allergic to voretigene neparvovec or any of the other ingredients of this medicine (listed in section 6) if you have an eye infection if you have eye inflammation
Slovenian: Zdravila Luxturna ne boste prejeli: če ste alergični na voretigen neparvovek ali katero koli sestavino tega zdravila (navedeno v poglavju 6), če imate očesno okužbo, če imate vnetje v očesu.
English: • You should avoid strenuous physical activity because of an increased risk of injury to the eye.
Slovenian: • se morate izogibati napornim telesnim dejavnostim zaradi povečanega tveganja za poškodbo očesa.
English: Active intraocular inflammation.
Slovenian: Aktivno intraokularno vnetje.
English: For single administration by subretinal injection into one (1) eye.
Slovenian: Za enkratno odmerjanje s subretinalno injekcijo v eno (1) oko.
English: Change in MLMT score
Slovenian: Sprememba ocene pri testu MLMT
English: vector genomes (vg).
Slovenian: vektorskih genomov (vg).
English: If it does occur, your doctor will treat the symptoms as necessary.
Slovenian: Če bi do tega kljub vsemu prišlo, vas bi zdravnik ustrezno zdravil glede na simptome, ki bi jih imeli.
English: No adjustment in dosage is necessary for paediatric patients.
Slovenian: Prilagajanje odmerjanja pri pediatričnih bolnikih ni potrebno.
English: Store at ≤-65 ºC.
Slovenian: Shranjujte pri temperaturi ≤ -65 ºC.
English: Prior to launch of LUXTURNA in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority (NCA).
Slovenian: Pred prihodom zdravila LUXTURNA na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, kar vključuje izbiro medijev za komuniciranje in načine distribucije vsebin ter vse druge vidike programa.
English: What Luxturna is and what it is used for What you need to know before you are given Luxturna How Luxturna is given to you Possible side effects
Slovenian: Kaj je zdravilo Luxturna in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Luxturna Kako prejmete zdravilo Luxturna Možni neželeni učinki
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from voretigene neparvovec therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z voretigen neparvovekom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: The vector shedding and biodistribution were evaluated in tears from both eyes, serum and whole blood of subjects in the Phase 3 clinical study.
Slovenian: Izločanje vektorja v solze in njegovo biološko porazdelitev so ocenjevali v solzah iz obeh očes, serumu in polni krvi preiskovancev v klinični študiji faze 3.
English: Over time, accumulation of toxic precursors leads to the death of retinal pigment epithelial cells, and subsequently to progressive photoreceptor cell death.
Slovenian: Kopičenje toksičnih predstopenj sčasoma povzroči smrt celic pigmentnega epitelija mrežnice in nato progresivno smrt fotoreceptorskih celic.
English: What you need to know before you are given Luxturna
Slovenian: Kaj morate vedeti, preden boste prejeli zdravilo Luxturna
English: Unopened frozen vials
Slovenian: Zaprte zamrznjene viale
English: This leaflet is available as an audio file and in a large print from the web site: http://www.voretigeneneparvovec.support
Slovenian: To navodilo za uporabo je na voljo v obliki avdio datoteke, v povečanem formatu pa ga je mogoče tudi natisniti s spletne strani: http://www.voretigeneneparvovec.support
English: Proper aseptic techniques should always be used for the preparation and administration of Luxturna.
Slovenian: Pri pripravljanju in apliciranju zdravila Luxturna je treba vedno uporabljati ustrezne aseptične tehnike.
English: The development or worsening of cataracts is a known complication of the eye surgery that will be required before you receive Luxturna.
Slovenian: Razvoj ali poslabšanje katarakte je znan zaplet pri očesnem posegu, ki ga je treba izvesti, preden prejmete zdravilo Luxturna.
English: Nonclinical biodistribution
Slovenian: Neklinična biološka porazdelitev
English: Patients should be instructed to contact their healthcare professional if visual disturbances persist.
Slovenian: Bolnikom je treba naročiti, naj obvestijo zdravstvenega delavca, če motnje vida ne izzvenijo.
English: Table 5 Full-field light sensitivity testing
Slovenian: Preglednica 5 Testiranje občutljivosti celotnega vidnega polja na svetlobo