FrancophonIA/ELRC3.0 huggingface dataset:
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, but should normally not be longer than 36 hours at 2°C - 8°C followed by up to 6 hours at room temperature up to a maximum of 25°C.
Slovenian: Zdravilo se praviloma sme shraniti za največ 36 ur pri temperaturi 2-8 °C in nato za največ 6 ur pri sobni temperaturi, ki ne sme presegati 25 °C.
English: How to store Mepsevii
Slovenian: Kako boste dobili zdravilo Mepsevii
English: Each vial of 5 mL concentrate contains 10 mg vestronidase alfa.
Slovenian: Ena viala s 5 ml koncentrata vsebuje 10 mg vestronidaze alfa.
English: Slowly add Mepsevii to the infusion bag using care to avoid agitation, ensuring liquid to liquid contact without generating bubbles or turbulence.
Slovenian: Tekočini se morata zmešati, ne da bi prišlo do mehurčkov ali turbulence.
English: Mepsevii is considered high in sodium.
Slovenian: Zdravilo Mepsevii velja za zdravilo z visoko vsebnostjo natrija.
English: Each mL of concentrate contains 2 mg vestronidase alfa*.
Slovenian: En ml koncentrata vsebuje 2 mg vestronidaze alfa*.
English: Posology
Slovenian: Koprivnica
English: The clinical program for vestronidase alfa included 23 treatment naïve patients with MPS VII from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
Slovenian: starih od 5 mesecev do 25 let, z MPS VII v 4 kliničnih preskušanjih, ki so do 132 tednov prejemali vestronidazo alfa v odmerkih do 4 mg/kg enkrat na dva tedna.
English: This medicinal product contains 17.8 mg sodium per vial and is administered in sodium chloride 9 mg/mL (0.9%) solution for infusion (see section 6.6).
Slovenian: Dieta z omejitvijo natrija To zdravilo vsebuje 17,8 mg natrija na vialo in se daje v 0,9-odstotni raztopini natrijevega klorida
English: Each mL of sterile concentrate contains 2 mg vestronidase alfa.
Slovenian: En ml sterilnega koncentrata vsebuje 2 mg vestronidaze alfa.
English: Each mL of concentrate contains 2 mg vestronidase alfa.
Slovenian: En ml koncentrata vsebuje 2 mg vestronidaze alfa.
English: Common side effects (may affect up to 1 in 10 people): - Itching of the skin (pruritus) - Loose stools (diarrhoea) - Rash - Fever with involuntary contractions of muscles of face or limbs (febrile convulsion)
Slovenian: - izpuščaj - zvišana telesna temperatura z nehotenim krčenjem mišic obraza ali okončin (vročinski krči)
English: Study UX003-CL203 (referred to as Study 203) is an ongoing open-label, uncontrolled single arm study that enrolled eight patients less than 5 years of age at a dose of 4 mg/kg vestronidase alfa every two weeks for 48 weeks of treatment period and additional weeks during optional continuation period to evaluate reduction of urinary GAG excretion, growth velocity and hepatosplenomegaly.
Slovenian: V njej sodeluje 8 bolnikov, mlajših od 5 let, ki so v obdobju zdravljenja 48 tednov dobivali vestronidazo alfa v odmerku 4 mg/kg na vsaka dva tedna in imajo možnost dodatnih tednov izbirnega podaljšanja zdravljenja.
English: The risks and benefits of readministering vestronidase alfa should be considered following a severe hypersensitivity reaction.
Slovenian: Po hudi preobčutljivostni reakciji je treba pretehtati tveganja in koristi ponovnega zdravljenja z vestronidazo alfa.
English: Colourless to slightly yellow solution.
Slovenian: koncentrat za raztopino za infundiranje (sterilen koncentrat) Brezbarvna do rahlo rumena raztopina.
English: Talk to your doctor before you are given Mepsevii.
Slovenian: Preden dobite zdravilo Mepsevii, se posvetujte z zdravnikom.
English: Febrile Convulsion
Slovenian: Bolezni živčevja
English: Special populations
Slovenian: Posebne skupine bolnikov Starejši bolniki
English: Clinical efficacy and safety
Slovenian: KLINIČNI PODATKI
English: After the injection, the pressure within the eye should be checked.
Slovenian: Po injiciranju je treba preveriti tlak v očesu.
English: Further information on Eylea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Eylea so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The diseases cause the gradual loss of the central part of a person's vision.
Slovenian: Bolezen povzroči postopno izgubo osrednjega dela vida.
English: Eylea received a marketing authorisation valid throughout the EU on 22 November 2012.
Slovenian: Za zdravilo Eylea je bilo 22. novembra 2012 izdano dovoljenje za promet, veljavno po vsej EU.
English: It can also attach to other proteins such as placental growth factor (PlGF).
Slovenian: Veže se lahko tudi na druge beljakovine, kot je placentni rastni dejavnik (PlGF).
English: What measures are being taken to ensure the safe and effective use of Eylea?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Eylea?
English: Therefore, the Agency decided that Eylea's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Agencija je zaključila, da so koristi zdravila Eylea večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces.
Slovenian: Rumena pega zagotavlja osrednji vid, ki je potreben za zaznavanje podrobnosti med vsakdanjimi opravili, na primer pri vožnji avtomobila, branju in prepoznavanju obrazov.
English: How often the injections are given depends on the condition being treated and the response of the patient to treatment.
Slovenian: Pogostost dajanja injekcije je odvisna od bolezni, ki jo zdravimo, in odziva bolnika na zdravljenje.
English: Both studies also looked at the maintenance of the effect in the second year of treatment, during which the number of injections and the time between injections were adjusted depending on the vision and changes within the eye.
Slovenian: V obeh študijah so proučevali tudi vzdrževanje tega učinka v drugem letu zdravljenja, med katerim sta bila število injekcij in časovni razmik med posameznimi injekcijami prilagojena glede na vid in spremembe znotraj očesa.
English: The Agency further noted that there were no major or unexpected safety concerns with Eylea.
Slovenian: Nadalje je agencija ugotovila, da ni večjih ali nepričakovanih pomislekov glede varnosti pri uporabi zdravila Eylea.
English: As for all medicines, data on the use of Eylea are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Eylea stalno spremljajo.
English: What benefits of Eylea have been shown in studies?
Slovenian: Kakšne koristi zdravila Eylea so se pokazale v študijah?
English: An overview of Eylea and why it is authorised in the EU
Slovenian: Pregled zdravila Eylea in zakaj je odobreno v EU
English: Other information about Eylea
Slovenian: Druge informacije o zdravilu Eylea
English: By blocking these factors, aflibercept reduces the growth of the blood vessels and controls the leakage and swelling.
Slovenian: Aflibercept z zaviranjem teh dejavnikov zmanjšuje rast krvnih žil ter nadzoruje iztekanje iz njih in otekanje.
English: Why is Eylea authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Eylea odobreno v EU?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eylea have also been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Eylea upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Side effects reported with Eylea are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Eylea, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: This effect was maintained at 52 weeks, despite less frequent administration of Eylea between week 24 and 52.
Slovenian: Učinki so bili vidni še v 52. tednu kljub manj pogostim injekcijam zdravila Eylea med 24. in 52. tednom.
English: The pre-filled syringe contains more than the recommended dose, therefore when preparing the injection, the doctor must expel the excess volume from the syringe and ensure the injection of the correct dose.
Slovenian: Napolnjena injekcijska brizga vsebuje večji odmerek od priporočenega, zato mora zdravnik pri pripravi injekcije iztisniti odvečno količino iz brizge in zagotoviti injiciranje ustreznega odmerka.
English: Eylea is a medicine used to treat adults with:
Slovenian: Zdravilo Eylea je zdravilo za zdravljenje odraslih bolnikov z:
English: What is Eylea and what is it used for?
Slovenian: Kaj je zdravilo Eylea in za kaj se uporablja?
English: The company that markets Eylea will provide up-to-date educational material for doctors (to minimise the risks associated with the injection in the eye) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Slovenian: Podjetje, ki trži zdravilo Eylea, bo zagotovilo izobraževalno gradivo za zdravnike (da bi tako čim bolj zmanjšali tveganja, povezana z injiciranjem v oko) in bolnike (da bi lahko prepoznali morebitne resne neželene učinke in tako vedeli, kdaj naj poiščejo nujno pomoč pri zdravniku).
English: During the second year of treatment, the effectiveness was generally maintained, with a majority of patients receiving injections at an extended dosing interval of 10 weeks, although a small number of patients occasionally needed more frequent injections (such as monthly).
Slovenian: Med drugim letom zdravljenja je učinkovitost na splošno ostala enaka, pri čemer je večina bolnikov prejemala injekcije v daljšem desettedenskem razmiku odmerjanja, manjše število bolnikov pa je občasno potrebovalo pogostejše injiciranje (na primer vsak mesec).
English: • impaired vision due to macular oedema caused by diabetes;
Slovenian: • okvaro vida zaradi makularnega edema, ki ga povzroča sladkorna bolezen;
English: Eylea is given as an injection of 2 mg into the affected eye, repeated as appropriate at intervals of a month or more.
Slovenian: Zdravilo Eylea se daje kot injekcija 2 mg v prizadeto oko, po potrebi s ponavljanjem v razmikih enega meseca ali več.
English: What are the risks associated with Eylea?
Slovenian: Kakšna tveganja so povezana z zdravilom Eylea?
English: Eylea was either given once a month, or once every other month after the first five monthly injections.
Slovenian: Zdravilo Eylea so bolniki prejemali bodisi enkrat na mesec bodisi vsak drugi mesec po prejetju petih mesečnih injekcij.
English: In contrast, in patients given laser treatment the improvement after a year was only about 1 letter.
Slovenian: Za primerjavo se je stanje pri bolnikih, ki so prejeli lasersko zdravljenje, po enem letu izboljšalo samo za okoli eno črko.
English: For more information about how Eylea is used, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Eylea glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: Eylea was shown to be as effective as ranibizumab in maintaining vision in patients with wet AMD: looking at the results of the two studies together, the proportions of patients who maintained vision were 96.1% (517 out of 538), 95.4% (533 out of 559) and 95.3% (510 out of 535) for 0.5 mg Eylea every four weeks, 2 mg Eylea every four weeks and 2 mg Eylea every eight weeks, respectively, compared with 94.4% (508 out of 538) of patients treated with ranibizumab every four weeks.
Slovenian: Glede na rezultate obeh študij skupaj je bil delež bolnikov, ki so ohranili vid, 96,1 % (517 od 538 bolnikov) pri injiciranju 0,5 mg zdravila Eylea vsake štiri tedne, 95,4 % (533 od 559 bolnikov) pri injiciranju 2 mg zdravila Eylea vsake štiri tedne in 95,3 % (510 od 535 bolnikov) pri injiciranju 2 mg zdravila Eylea vsakih osem tednov v primerjavi s 94,4 % (508 od 538) bolnikov, zdravljenih z ranibizumabom vsake štiri tedne.
English: • impaired vision due to myopic choroidal neovascularisation (a severe type of short-sightedness where the eyeball continues to grow, becoming longer than it should be).
Slovenian: • okvaro vida zaradi miopične horoidalne neovaskularizacije, ki jo povzroča kratkovidnost (resna oblika kratkovidnosti, pri kateri zrklo še naprej raste in postane daljše, kot bi smelo biti).
English: Eylea contains the active substance aflibercept.
Slovenian: Zdravilo Eylea vsebuje učinkovino aflibercept.
English: The main measure of effectiveness was the proportion of patients who maintained vision (defined as losing less than 15 letters in a standard eye test) after the first year of treatment.
Slovenian: Glavno merilo učinkovitosti je bilo delež bolnikov, ki so ohranili vid (kar je bilo opredeljeno kot zmanjšanje števila pravilno prebranih črk za manj kot 15 črk pri standardnem očesnem testu) po prvem letu zdravljenja.
English: These compared monthly injections of Eylea 2 mg with a sham injection using a syringe without a needle.
Slovenian: V teh so primerjali mesečno injiciranje zdravila Eylea v odmerku 2 mg z injekcijo placeba, pri kateri se uporabi brizga brez igle.
English: Aflibercept is an engineered protein that has been designed to attach to and block the effects of a substance called vascular endothelial growth factor A (VEGF-A).
Slovenian: Aflibercept je umetno ustvarjena beljakovina, ki je bila zasnovana tako, da se veže na snov, imenovano žilni endotelijski rastni dejavnik A (VEGF-A), in zavira njene učinke.
English: The benefit was largely maintained with as-needed treatment up to 52 weeks, although some of the benefit seemed to be lost when patients were treated and followed up for longer periods than this.
Slovenian: Pri zdravljenju po potrebi so se koristni učinki večinoma ohranili do 52 tednov, čeprav se je pri zdravljenju in spremljanju bolnikov v obdobju, daljšem od tega, zdelo, da so se nekatere koristi izgubile.
English: Two further main studies involving 872 patients with diabetic macular oedema looked at the effect of Eylea compared with laser treatment.
Slovenian: V dveh dodatnih študijah, v kateri je bilo vključenih 872 bolnikov z makularnim edemom, ki ga povzroča sladkorna bolezen, so proučevali učinke zdravila Eylea v primerjavi z laserskim zdravljenjem.
English: Myopic choroidal neovascularisation
Slovenian: Miopična horoidalna neovaskularizacija
English: Subsequent results from a supportive study indicated the effectiveness of extended treatment intervals in patients with wet AMD.
Slovenian: Poznejši rezultati iz podporne študije so pokazali učinkovitost podaljšanih razmikov zdravljenja pri bolnikih z vlažno obliko starostne degeneracije rumene pege.
English: The studies compared Eylea (given either as 0.5 mg every four weeks, 2 mg every four weeks or 2 mg every eight weeks, all after three initial monthly doses) with ranibizumab, another treatment for AMD which was given by injection into the eye every four weeks.
Slovenian: V študijah so zdravilo Eylea (dano bodisi v odmerku 0,5 mg vsake štiri tedne, 2 mg vsake štiri tedne ali 2 mg vsakih osem tednov, v vseh primerih po treh začetnih mesečnih odmerkih) primerjali z ranibizumabom, drugo obliko zdravljenja starostne degeneracije rumene pege, ki se daje z injiciranjem v oko vsake štiri tedne.
English: Eylea is available as prefilled syringes or vials containing a solution for intravitreal injection (injection into the vitreous humour, the jelly-like fluid inside the eye).
Slovenian: Zdravilo Eylea je na voljo v obliki napolnjenih injekcijskih brizg ali vial, ki vsebujejo raztopino za intravitrealno injiciranje (injiciranje v steklovino, želatini podobno tekočino v očesu).
English: The pre-filled syringe and the vial are for single use only.
Slovenian: Napolnjena injekcijska brizga in viala sta le za enkratno uporabo.
English: Serious injection-related side effects (which have occurred in less than 1 in around 2,000 injections) include blindness, endophthalmitis (serious infection or inflammation inside the eye), cataracts, increased intraocular pressure, vitreous haemorrhage (bleeding into the jelly-like fluid in the eye, causing temporary loss of vision) and vitreous or retinal detachment.
Slovenian: Resni neželeni učinki, povezani z injiciranjem (ki so se pojavili pri manj kot 1 na približno 2 000 injekcij), vključujejo slepoto, endoftalmitis (hudo vnetje ali vnetje v očesu), katarakte, povečan tlak v očesu, krvavitev v steklovini (v želatini podobni snovi v očesu, ki povzroči začasno izgubo vida) in odstop steklovine ali mrežnice.
English: In all the studies, the main measure of effectiveness was the proportion of patients who responded and whose vision improved by 15 or more letters on an eye test after 24 weeks of treatment.
Slovenian: V vseh študijah je bilo glavno merilo učinkovitosti delež bolnikov, ki so se na zdravljenje odzvali in pri katerih se je vid po 24 tednih zdravljenja izboljšal za 15 ali več črk na očesnem testu.
English: It can only be obtained with a prescription and must be given by a qualified doctor who is experienced in giving intravitreal injections.
Slovenian: Predpisovanje in izdaja zdravila Eylea je le na recept, injicirati pa ga mora usposobljen zdravnik, ki ima izkušnje z dajanjem intravitrealnih injekcij.
English: The European Medicines Agency noted that for wet AMD Eylea was as effective as ranibizumab in maintaining patients' vision after the first year of treatment.
Slovenian: Evropska agencija za zdravila je ugotovila, da je bilo zdravilo Eylea pri vlažni obliki starostne degeneracije rumene pege pri ohranjanju vida bolnikov po prvem letu zdravljenja enako učinkovito kot ranibizumab.
English: • the ‘wet' form of age-related macular degeneration (AMD), a disease which affects the central part of the retina (called the macula) at the back of the eye.
Slovenian: • „vlažno“ obliko starostne degeneracije rumene pege, tj. bolezni, ki prizadene osrednji del mrežnice (imenovan rumena pega) v zadnjem delu očesa.
English: VEGF-A and PlGF are involved in stimulating the abnormal growth of blood vessels in patients with AMD, certain types of macular oedema and myopic choroidal neovascularisation.
Slovenian: VEGF-A in PIGF sodelujeta pri spodbujanju nenormalne rasti krvnih žil pri bolnikih s starostno degeneracijo rumene pege, določenih vrst makularnih edemov in miopične horoidalne neovaskularizacije, ki jo povzroča kratkovidnost.
English: The most common side effects (affecting at least 1 in 20 patients) reported with Eylea are conjunctival haemorrhage (bleeding from the small blood vessels on the surface of the eye at the site of injection), reduced vision, eye pain, vitreous detachment (detachment of the jelly-like substance inside the eye), cataract (clouding of the lens), vitreous floaters (small particles or spots in the vision) and increased intraocular pressure (increased pressure inside the eye).
Slovenian: Najpogostejši neželeni učinki (ki se lahko pojavijo pri najmanj 1 od 20 bolnikov), o katerih so poročali pri uporabi zdravila Eylea, so krvavitev pod očesno veznico (krvavitev iz žilic na površini očesa na mestu injiciranja), poslabšan vid, bolečine v očesu, odstop steklovine (odstop želatini podobne snovi v očesu), katarakta (motnjava leče), motnjave v steklovini (majhni delci ali pikice pred očmi) in povišan intraokularni tlak (povišan tlak v očesu).
English: Another main study involving 181 patients with macular oedema due to BRVO compared monthly injections of Eylea 2 mg with laser treatment.
Slovenian: V drugi glavni študiji, v kateri je sodelovalo 181 bolnikov z makularnim edemom, ki je posledica zapore veje vene, so mesečno injiciranje zdravila Eylea v odmerku 2 mg primerjali z laserskim zdravljenjem.
English: In addition, the company will carry out a study investigating extended treatment intervals with Eylea in diabetic macular oedema, as well as a study looking at the effects of Eylea treatment when given on an as-needed basis in wet AMD.
Slovenian: Poleg tega bo izvedlo študijo, v kateri bo proučilo podaljšane razmike med zdravljenjem z zdravilom Eylea pri makularnem edemu, ki je posledica sladkorne bolezni, in študijo, v kateri bo proučilo učinke zdravljenja s tem zdravilom, če se uporabi po potrebi pri vlažni obliki starostne degeneracije rumene pege.
English: The main measure of effectiveness in both studies was the change in the number of letters that could be read in an eye test after one year of treatment.
Slovenian: Glavno merilo učinkovitosti v obeh študijah je bila sprememba števila črk, ki so jih bolniki lahko na očesnem testu prebrali po enoletnem zdravljenju.
English: Eylea must not be used in patients who have or are thought to have ocular or periocular infections (infections in or around the eyes), or in patients who have severe inflammation inside the eye. For the full list of restrictions,see the package leaflet.
Slovenian: Zdravilo Eylea se ne sme uporabljati pri bolnikih, ki imajo ali utegnejo imeti okularno ali periokularno okužbo (okužbo v očesu ali v okolici očesa), in bolnikih, ki imajo hudo vnetje v očesu.
English: Eylea was investigated in two main studies involving a total of around 2,400 patients with the wet form of AMD.
Slovenian: Zdravilo Eylea je bilo raziskano v dveh glavnih študijah, v kateri je bilo vključenih približno 2 400 bolnikov z vlažno obliko starostne degeneracije rumene pege.
English: How does Eylea work?
Slovenian: Kako zdravilo Eylea deluje?
English: The wet form of AMD is caused by choroidal neovascularisation (the abnormal growth of blood vessels under the macula), which may leak fluid and blood and cause swelling;
Slovenian: Vlažno obliko starostne degeneracije rumene pege povzroča horoidalna neovaskularizacija (nenormalna rast krvnih žil pod rumeno pego), pri kateri lahko iztekata tekočina in kri, kar povzroči otekanje;
English: The main measure of effectiveness was the change in the number of letters that could be read in an eye test after 24 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba števila črk, ki so jih bolniki lahko na očesnem testu prebrali po 24 tednih zdravljenja.
English: In the study in myopic choroidal neovascularisation, the average number of letters patients could read in an eye test before treatment was about 56; patients given Eylea could read on average 12 more letters after 24 weeks of treatment whereas in patients given sham injections the total number of letters they could read decreased on average by 2.
Slovenian: V študiji pri horoidalni neovaskularizaciji, ki jo povzroča kratkovidnost, je bilo povprečno število črk, ki so jih bolniki lahko prebrali na očesnem testu pred začetkom zdravljenja, okrog 56; bolniki, ki so prejeli zdravilo Eylea, so lahko po 24 tednih zdravljenja v povprečju prebrali 12 črk več, medtem ko se je pri bolnikih, ki so prejeli injekcijo placeba, število črk, ki so jih lahko prebrali, v povprečju zmanjšalo za dve.
English: In addition the Agency considered that Eylea was beneficial in improving vision of patients with macular oedema resulting from CRVO, BRVO or diabetes as well as patients with myopic choroidal neovascularisation.
Slovenian: Poleg tega je agencija menila, da je bilo zdravilo Eylea učinkovito tudi pri izboljšanju vida bolnikov z makularnim edemom, ki je posledica zapore osrednje mrežnične vene, zapore veje vene ali sladkorne bolezni, in bolnikov z miopično horoidalno neovaskularizacijo, ki jo povzroča kratkovidnost.