FrancophonIA/ELRC3.0 huggingface dataset:
English: After dilution: Chemical and physical in-use stability of the diluted medicinal product has been demonstrated for up to 36 hours under refrigeration at 2°C - 8°C followed by up to 6 hours at room temperature up to a maximum of 25°C.
Croatian: 36 sati u uvjetima čuvanja u hladnjaku pri temperaturi od 2°C do 8°C nakon čega je slijedilo do 6 sati na sobnoj temperaturi do najviše 25°C.
English: After the first hour, the rate can be increased to infuse the remainder of the solution for infusion over 3 hours as tolerated according to the recommended rate guidelines in Table 2.
Croatian: Nakon prvog sata brzina infuzije se može povećati kako bi se primijenio ostatak otopine za infuziju tijekom 3 sata, sukladno podnošljivosti prema smjernicama za preporučenu brzinu navedenima u Tablici 2. Brzinu infuzije moguće je smanjiti, privremeno ili trajno prekinuti u slučaju reakcija preosjetljivosti
English: Mepsevii 2 mg/mL concentrate for solution for infusion vestronidase alfa
Croatian: Mepsevii 2 mg/ml koncentrat za otopinu za infuziju vestronidaza alfa
English: Serious hypersensitivity reactions, including anaphylaxis, have been reported with vestronidase alfa; therefore, appropriate medical support should be readily available when vestronidase alfa is administered.
Croatian: Reakcije preosjetljivosti uključujući anafilaksiju Uz primjenu vestronidaze alfa prijavljene su ozbiljne reakcije preosjetljivosti, uključujući anafilaksiju.
English: The above calculated dose diluted 1:1 in sodium chloride 9 mg/mL (0.9%) solution for injection should be added to a new empty infusion bag.
Croatian: Prethodno izračunatu dozu razrijeđenu 1:1 u 0,9 %-tnoj otopini natrijeva klorida za injekciju (9 mg/ml) dodajte u novu,
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.
Croatian: Klinička djelotvornost i sigurnost Klinički program za vestronidazu alfa uključivao je 23 bolesnika s mukopolisaharidozom VII koji prethodno nisu bili liječeni iz 4 klinička ispitivanja u dobi od 5 mjeseci do 25 godina, koji su primali vestronidazu alfa u dozama do 4 mg/kg jedanput svaka dva tjedna tijekom do 132 tjedna.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva koprivnjača osip pruritus vrlo često često često
English: - Your doctor may give (or have given) you some medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Croatian: - Vaš liječnik može Vam davati (ili Vam je dao) neke lijekove za sprječavanje alergijskih reakcija kao što su antihistaminici, kortikosteroidi ili antipiretike, lijekove za snižavanje temperature.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava febrilne konvulzije*
English: Anaphylactoid reaction Very common
Croatian: Poremećaji imunološkog sustava anafilaktoidna reakcija vrlo često
English: It is important to administer vestronidase alfa according to the recommended infusion rate schedule (see Table 2 in section 6.6).
Croatian: Vestronidazu alfa važno je primijeniti u skladu s preporučenim rasporedom za brzinu infuzije (vidjeti
English: MPS VII diagnosis was confirmed by GUS enzyme activity assay for 5 patients, by genotyping for 3 patients, and via both enzyme assay and genotyping for 4 patients.
Croatian: genotipizacijom za 3 bolesnika, te i putem određivanja enzima i genotipizacijom za 4 bolesnika.
English: Type I) with a rubber stopper with fluoro-resin coating, and an aluminium over seal with a plastic flip-off cap.
Croatian: Bezbojna staklena bočica (Ph. Eur. tip I) s gumenim čepom obloženim slojem fluorosmole i aluminijskim prstenom s plastičnim poklopcem.
English: Your doctor may give (or have given) you other medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Croatian: Vaš liječnik može vam davati (ili vam daje) druge lijekove za liječenje alergijskih reakcija kao što su antihistaminici, kortikosteroidi ili antipiretike, lijekove za snižavanje temperature.
English: The pharmacokinetics of vestronidase alfa were evaluated in a total of 19 MPS VII patients including 15 paediatric patients and 4 adults from 3 clinical trials.
Croatian: 5.2 Farmakokinetička svojstva Farmakokinetika vestronidaze alfa procijenjena je kod ukupno 19 bolesnika s MPS VII uključujući
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.
Croatian: 4 mg/kg vestronidaze alfa svaka dva tjedna tijekom 48 tjedana razdoblja liječenja te tijekom dodatnih tjedana neobveznog razdoblja nastavka za procjenu smanjenja urinarnog izlučivanja GAG-a, brzine rasta i hepatosplenomegalije.
English: Your doctor may also give (or have given) you other medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Croatian: Vaš liječnik može Vam davati i (ili Vam je dao) druge lijekove za sprječavanje alergijskih reakcija kao što su antihistaminici, kortikosteroidi ili antipiretike, lijekove za snižavanje temperature.
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)
Croatian: Česte nuspojave (mogu se javiti u 1 na 10 osoba): - svrbež kože (pruritus) - rijetka stolica (proljev) - osip
English: Adverse reactions are presented by System Organ Class and frequency.
Croatian: Nuspojave su prikazane prema klasifikaciji organskih sustava i učestalosti.
English: Total Number of Mepsevii Vials
Croatian: Ukupni broj bočica lijeka Mepsevii
English: Package leaflet: Information for the user Mepsevii 2 mg/mL concentrate for solution for infusion vestronidase alfa This medicine is subject to additional monitoring.
Croatian: Uputa o lijeku: Informacije za korisnika Mepsevii 2 mg/ml koncentrat za otopinu za infuziju vestronidaza alfa
English: Each vial of 5 mL concentrate contains 10 mg vestronidase alfa.
Croatian: Jedna bočica od 5 ml koncentrata sadrži 10 mg vestronidaze alfa.
English: Mepsevii 2 mg/mL sterile concentrate vestronidase alfa
Croatian: Mepsevii 2 mg/ml sterilni koncentrat vestronidaza alfa i.v. primjena nakon razrjeđivanja
English: How Mepsevii is given
Croatian: Kako se primjenjuje lijek Mepsevii
English: Do not use if the solution is discoloured or if there is particulate matter in the solution.
Croatian: Otopinu nemojte upotrebljavati ako je promijenila boju ili sadrži vidljive čestice.
English: It is not known whether vestronidase alfa is excreted in human milk, but systemic exposure via breast-milk is not expected.
Croatian: no ne očekuje se sistemska izloženost putem majčinog mlijeka.
English: Mepsevii is considered high in sodium.
Croatian: Smatra se da lijek Mepsevii sadrži izrazito visoke količine natrija.
English: Polysorbate 20
Croatian: 4.8 Nuspojave
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 5 mL VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Each mL of concentrate contains 2 mg vestronidase alfa.
Croatian: Jedan ml koncentrata sadrži 2 mg vestronidaze alfa.
English: Each mL of sterile concentrate contains 2 mg vestronidase alfa.
Croatian: Jedan ml sterilnog koncentrata sadrži 2 mg vestronidaze alfa.
English: Primary Endpoint
Croatian: Primarna mjera ishoda
English: They may include an allergic reaction (see section 4).
Croatian: Mogu obuhvaćati alergijsku reakciju
English: Prior to withdrawing Mepsevii from the vial, visually inspect for particulate matter and discolouration.
Croatian: 4. Prije povlačenja lijeka Mepsevii iz bočice, vizualno pregledajte kako biste isključili prisutnost vidljivih čestica i promjenu boje.Otopina koncentrata lijeka Mepsevii za infuziju treba biti bezbojna do žućkasta.
English: Each mL of concentrate contains 2 mg vestronidase alfa*.
Croatian: Jedan mililitar koncentrata sadrži 2 mg vestronidaze alfa*.
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).
Croatian: Ovaj lijek sadrži 17,8 mg natrija u jednoj bočici te se primjenjuje u otopini za infuziju od 9 mg/ml
English: Immune system disorders
Croatian: Poremećaji probavnog sustava proljev često
English: What you need to know before you are given Mepsevii You must not be given Mepsevii:
Croatian: Ne smijete uzimati Mepsevii:
English: Concentrate for solution for infusion 1 vial (5 mL)
Croatian: 1 bočica (5 ml)
English: Elderly
Croatian: Sljedivost
English: The procedure should be carried out under sterile conditions.
Croatian: Postupak je potrebno provoditi u sterilnim uvjetima.
English: After the injection, the pressure within the eye should be checked.
Croatian: Nakon injekcije, potrebno je provjeriti tlak unutar oka.
English: This overview was last updated in 08-2018.
Croatian: Ovaj pregled informacija posljednji je put ažuriran u: 08-2018.
English: Further information on Eylea can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Eylea možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Wet AMD
Croatian: Vlažni AMD
English: The diseases cause the gradual loss of the central part of a person's vision.
Croatian: Bolesti uzrokuju postupni gubitak središnjeg vida osobe.
English: Eylea is a medicine used to treat adults with:
Croatian: Eylea je lijek koji se koristi za liječenje odraslih osoba oboljelih od:
English: Eylea received a marketing authorisation valid throughout the EU on 22 November 2012.
Croatian: Lijek Eylea dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 22. studenoga 2012.
English: The macula provides central vision that is needed to see detail for everyday tasks such as driving, reading and recognising faces.
Croatian: Makula osigurava središnji vid koji je potreban za uočavanje detalja za potrebe obavljanja svakodnevnih zadataka poput upravljanja vozilom, čitanja i prepoznavanja lica.
English: The Agency further noted that there were no major or unexpected safety concerns with Eylea.
Croatian: Agencija je utvrdila da ne postoje velika ili neočekivana sigurnosna pitanja povezana s lijekom Eylea.
English: It can also attach to other proteins such as placental growth factor (PlGF).
Croatian: Može se vezati i za druge proteine kao što je čimbenik rasta placente (PlGF).
English: What is Eylea and what is it used for?
Croatian: Što je Eylea i za što se koristi?
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.
Croatian: Napunjene štrcaljke sadrže više od preporučene doze, stoga pri pripremi injekcije liječnik mora izbaciti višak volumena iz štrcaljke i paziti da bude ubrizgana pravilna doza.
English: What measures are being taken to ensure the safe and effective use of Eylea?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Eylea?
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).
Croatian: Tijekom druge godine liječenja učinkovitost se uglavnom nastavila, s tim da je većina bolesnika primala injekcije u produženim intervalima doziranja od 10 tjedana, iako je manji broj bolesnika povremeno trebao češće injekcije (primjerice mjesečno).
English: The pre-filled syringe and the vial are for single use only.
Croatian: Napunjena štrcaljka i bočica samo su za jednokratnu upotrebu.
English: In contrast, in patients given laser treatment the improvement after a year was only about 1 letter.
Croatian: Suprotno tome, u bolesnika liječenih laserskim zahvatom poboljšanje nakon godine dana bilo je za otprilike samo 1 slovo.
English: Other information about Eylea
Croatian: Ostale informacije o lijeku Eylea
English: How often the injections are given depends on the condition being treated and the response of the patient to treatment.
Croatian: Učestalost davanja injekcija ovisi o stanju koje se liječi i odgovoru bolesnika na liječenje.
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.
Croatian: Oba su ispitivanja istražila i održavanje učinka u drugoj godini nakon liječenja, kada su broj injekcija i vrijeme između injekcija prilagođeni ovisno o vidu i promjenama unutar oka.
English: Side effects reported with Eylea are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Eylea pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
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.
Croatian: Glavna mjera učinkovitosti bila je udio bolesnika koji su zadržali vid (definirano kao gubitak manje od 15 slova na standardnom ispitivanju vida) nakon prve godine liječenja.
English: As for all medicines, data on the use of Eylea are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Eylea kontinuirano se prate.
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.
Croatian: Korist se u velikoj mjeri zadržala kod liječenja prema potrebi u trajanju do 52 tjedna, iako se čini da se korist donekle izgubila kad su bolesnici liječeni i praćeni u duljem razdoblju od navedenog.
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.
Croatian: Lijek Eylea pokazao se jednako učinkovitim kao ranibizumab u održavanju vida u bolesnika s vlažnim AMD-om: uspoređujući rezultate dva ispitivanja, udio bolesnika koji je zadržao vid iznosio je 96,1 % (517 od 538), 95,4 % (533 od 559) i 95,3 % (510 od 535) za lijek Eylea u dozi od 0,5 mg svaka četiri tjedna, lijek Eylea u dozi od 2 mg svaka četiri tjedna, odnosno lijek Eylea u dozi od 2 mg svakih osam tjedana, u usporedbi s 94,4 % (508 od 538) bolesnika liječenih ranibizumabom svaka četiri tjedna.
English: Eylea was either given once a month, or once every other month after the first five monthly injections.
Croatian: Lijek Eylea primjenjivan je jednom mjesečno ili jednom u dva mjeseca nakon prvih pet injekcija davanih jednom mjesečno.
English: An overview of Eylea and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Eylea i zašto je odobren u EU-u
English: Eylea contains the active substance aflibercept.
Croatian: Eylea sadrži djelatnu tvar aflibercept.
English: For more information about how Eylea is used, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Eylea, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Why is Eylea authorised in the EU?
Croatian: Zašto je lijek Eylea odobren u EU-u?
English: • impaired vision due to macular oedema caused by diabetes;
Croatian: • oštećenja vida zbog makularnog edema kojeg uzrokuje dijabetes;
English: It can only be obtained with a prescription and must be given by a qualified doctor who is experienced in giving intravitreal injections.
Croatian: Izdaje se samo na recept i smije ga primjenjivati samo za to osposobljen liječnik s iskustvom u davanju intravitrealnih injekcija.
English: What are the risks associated with Eylea?
Croatian: Koji su rizici povezani s lijekom Eylea?
English: Subsequent results from a supportive study indicated the effectiveness of extended treatment intervals in patients with wet AMD.
Croatian: Kasniji rezultati pomoćnog ispitivanja pokazali su učinkovitost produljenog intervala liječenja u bolesnika s vlažnim AMD-om.
English: This effect was maintained at 52 weeks, despite less frequent administration of Eylea between week 24 and 52.
Croatian: Ovaj se učinak održao do 52. tjedna, usprkos rjeđoj primjeni lijeka Eylea između 24. i 52. tjedna.
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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Eylea nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
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.
Croatian: Europska agencija za lijekove zaključila je da je lijek Eylea u slučaju vlažnog AMD-a bio podjednako učinkovit kao ranibizumab u održavanju vida bolesnika nakon prve godine liječenja.
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).
Croatian: Tvrtka koja stavlja lijek Eylea u promet dostavit će ažurirani materijal za obuku za liječnike (kako bi se smanjili rizici povezani s injekcijom u oko) i bolesnike (tako da mogu prepoznati sve ozbiljne nuspojave i znati kada potražiti hitnu liječničku pomoć).
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.
Croatian: • „vlažnog” oblika senilne makularne degeneracije (AMD), bolesti koja utječe na središnji dio mrežnice (naziva se makula) u stražnjem dijelu oka.
English: Macular oedema following retinal vein occlusion
Croatian: Makularni edem nakon okluzije retinalne vene
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).
Croatian: • oštećenja vida zbog neovaskularizacije žilnice kod kratkovidnosti (teški oblik kratkovidnosti pri kojem očna jabučica nastavlja rasti i postaje izduženijom nego što bi trebala biti).
English: Therefore, the Agency decided that Eylea's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je stoga zaključila da koristi lijeka Eylea nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: By blocking these factors, aflibercept reduces the growth of the blood vessels and controls the leakage and swelling.
Croatian: Blokiranjem tih čimbenika aflibercept smanjuje rast krvnih žila te kontrolira istjecanje tekućina iz krvnih žila i oticanje.
English: Diabetic macular oedema
Croatian: Dijabetički makularni edem
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.
Croatian: U ispitivanjima je uspoređena primjena lijeka Eylea (primjenjivan u dozi od 0,5 mg svaka četiri tjedna, 2 mg svaka četiri tjedna ili 2 mg svakih osam tjedana, sve nakon tri početne mjesečne doze) s ranibizumabom, drugim lijekom za AMD, koji se primjenjuje injekcijom u oko svaka četiri tjedna.
English: Eylea is given as an injection of 2 mg into the affected eye, repeated as appropriate at intervals of a month or more.
Croatian: Lijek Eylea daje se u obliku injekcije od 2 mg u zahvaćeno oko te se postupak ponavlja prema potrebi u razmacima od mjesec dana ili više.
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;
Croatian: Vlažni oblik AMD-a uzrokovan je neovaskularizacijom žilnice (nenormalnim rastom krvnih žila ispod makule), što može uzrokovati propuštanje tekućine i krvi te oticanje;
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.
Croatian: U svim ispitivanjima glavna mjera učinkovitosti bila je udio bolesnika koji su odgovorili na liječenje i u kojih se vid poboljšao za 15 ili više slova na ispitivanju vida provedenom nakon 24 tjedna liječenja.
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.
Croatian: Ozbiljne nuspojave povezane s primjenom injekcije (koje su se pojavile u manje od 1 na oko 2 000 injekcija) uključuju sljepoću, endoftalmitis (ozbiljna infekcija ili upala unutar oka), kataraktu, povišeni tlak unutar oka, krvarenje u staklovinu (krvarenje u želatinastu tekućinu u oku, koje uzrokuje privremeni gubitak vida) i odignuće staklovine ili mrežnice.
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.
Croatian: Nadalje, tvrtka će provesti ispitivanje povezano s produljenim intervalima primjene lijeka Eylea kod dijabetičkog makularnog edema, kao i ispitivanje povezano s učincima liječenja lijekom Eylea kada se daje prema potrebi u slučaju vlažnog AMD-a.
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.
Croatian: VEGF-A i PlGF uključeni su u stimulaciju abnormalnog rasta krvnih žila u bolesnika s AMD-om, nekim vrstama makularnog edema i neovaskularizacijom žilnice kod kratkovidnosti.
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).
Croatian: Aflibercept je industrijski proizveden protein čija je namjena vezanje za tvar pod nazivom vaskularni endotelni čimbenik rasta A (VEGF-A) te blokiranje njegovih učinaka.
English: These compared monthly injections of Eylea 2 mg with a sham injection using a syringe without a needle.
Croatian: U ovim su ispitivanjima uspoređene mjesečne injekcije lijeka Eylea u dozi od 2 mg s fiktivnom injekcijom pomoću štrcaljke bez igle.