FrancophonIA/ELRC3.0 huggingface dataset:
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).
Croatian: Lijek Eylea dostupan je u napunjenim štrcaljkama ili bočicama koje sadrže otopinu za intravitrealnu injekciju (ubrizgavanje u staklasto tijelo, tekućinu poput želatine unutar oka).
English: What benefits of Eylea have been shown in studies?
Croatian: Koje su koristi od lijeka Eylea utvrđene u ispitivanjima?
English: Another main study involving 181 patients with macular oedema due to BRVO compared monthly injections of Eylea 2 mg with laser treatment.
Croatian: U još jednom glavnom ispitivanju, koje je obuhvatilo 181 bolesnika s makularnim edemom kao posljedicom BRVO-a, uspoređene su mjesečne injekcije lijeka Eylea od 2mg s laserskim liječenjem.
English: Two further main studies involving 872 patients with diabetic macular oedema looked at the effect of Eylea compared with laser treatment.
Croatian: U dvama daljnjim ispitivanjima kojima je bilo obuhvaćeno 872 bolesnika s dijabetičkim makularnim edemom ispitan je učinak lijeka Eylea u usporedbi s laserskim liječenjem.
English: Eylea was also investigated in two other main studies involving 366 patients with macular oedema following CRVO.
Croatian: Lijek Eylea ispitivan je također u drugim dvama glavnim ispitivanjima koja su obuhvatila 366 bolesnika s makularnim edemom kao posljedicom CRVO-a.
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).
Croatian: Najčešće nuspojave (koje se mogu pojaviti u najmanje 1 na 20 osoba) zabilježene pri primjeni lijeka Eylea bile su krvarenje u spojnicu (krvarenje iz manjih krvnih žila na površini oka na mjestu primjene injekcije), smanjena oštrina vida, bol u oku, odignuće staklovine (odignuće želatinaste tvari unutar oka), katarakta (zamagljenje leće), „mušice” u staklovini (male čestice ili točkice u vidu) i povišeni intraokularni tlak (povišeni tlak unutar oka).
English: How is Eylea used?
Croatian: Kako se Eylea koristi?
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.
Croatian: Glavna mjera učinkovitosti u oba ispitivanja bila je promjena u broju slova koja je bolesnik mogao pročitati u ispitivanju vida nakon jedne godine liječenja.
English: How does Eylea work?
Croatian: Kako djeluje Eylea?
English: In patients with diabetic macular oedema, the average number of letters they could read in an eye test before treatment was about 59 to 60; in patients given Eylea monthly this improved by around 12 letters, and in those given Eylea every other month by around 11 letters.
Croatian: Kod bolesnika s dijabetičkim makularnim edemom, prosječni broj slova koja su mogli pročitati na ispitivanju vida prije liječenja kretao se između 59 i 60 slova; u bolesnika liječenih mjesečno lijekom Eylea stanje se poboljšalo za otprilike 12 slova, a u bolesnika liječenih lijekom Eylea svaki drugi mjesec za oko 11 slova.
English: • impaired vision due to macular oedema (swelling) that follows blockage of either the main vein carrying blood from the retina (known as central retinal vein occlusion, CRVO) or of smaller branch veins (known as branch retinal vein occlusion, BRVO);
Croatian: • oštećenja vida zbog makularnog edema (oticanje) koje nastaje nakon začepljenja glavne vene koja odvodi krv iz mrežnice (poznato pod nazivom okluzija centralne retinalne vene - CRVO) ili manjih ogranaka vene (poznato pod nazivom okluzija ogranka retinalne vene - BRVO).
English: Eylea was investigated in two main studies involving a total of around 2,400 patients with the wet form of AMD.
Croatian: Lijek Eylea ispitivan je u dvama glavnim ispitivanjima koja su obuhvatila otprilike 2 400 bolesnika s vlažnim oblikom AMD-a.
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.
Croatian: Glavna mjera učinkovitosti bila je promjena u broju slova koja je bolesnik mogao pročitati u ispitivanju vida nakon 24 tjedna liječenja.
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.
Croatian: Eylea se ne smije koristiti u bolesnika koji imaju ili za koje se smatra da imaju okularne ili periokularne upale (upale u očima ili oko očiju), ili u bolesnika koji imaju teške upale unutar oka.
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.
Croatian: Nadalje, Agencija smatra da je lijek Eylea povoljno djelovao na poboljšanje vida bolesnika s makularnim edemom kao posljedicom CRVO-a, BRVO-a ili dijabetesa, kao i u bolesnika s neovaskularizacijom žilnice kod kratkovidnosti.
English: For BRVO, around 53% of patients given Eylea had an improvement of 15 letters or more in the eye test at week 24, compared with 27% of patients who received laser treatment.
Croatian: Za BRVO, u oko 53 % bolesnika koji su primali lijek Eylea zabilježeno je poboljšanje od 15 slova ili više u ispitivanju vida u 24. tjednu, u usporedbi s 27 % bolesnika koji su liječeni laserskim zahvatom.
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.
Croatian: U ispitivanju neovaskularizacije žilnice kod kratkovidnosti, bolesnici su prije liječenja na ispitivanju vida mogli pročitati prosječno oko 56 slova; bolesnici koji su primali lijek Eylea mogli su u prosjeku pročitati 12 slova više nakon 24 tjedna liječenja, dok se u bolesnika koji su primali fiktivne injekcije broj slova koja su mogli pročitati smanjio u prosjeku za 2 slova.
English: In myopic choroidal neovascularisation, Eylea was investigated in a main study involving 122 patients, which compared Eylea with a sham injection.
Croatian: Lijek Eylea za liječenje neovaskularizacije žilnice kod kratkovidnosti ispitivan je u glavnom ispitivanju koje je obuhvatilo 122 bolesnika i u kojem se lijek Eylea usporedio s primjenom fiktivne injekcije.
English: For CRVO, overall about 60% of patients given Eylea had an improvement of 15 letters or more in the eye test at week 24, compared with 17% of those given sham injections.
Croatian: Za CRVO, u oko 60 % bolesnika koji su primali lijek Eylea zabilježeno je poboljšanje od 15 slova ili više u ispitivanju vida u 24. tjednu, u usporedbi sa 17 % bolesnika koji su primali fiktivne injekcije.
English: The studies in patients with macular oedema following CRVO also looked at the effects of treatment on an as-needed basis after 24 weeks.
Croatian: U ispitivanjima provedenim u bolesnika s makularnim edemom kao posljedicom CRVO-a, promatrali su se i učinci postignuti nakon 24 tjedna kada je lijek primjenjivan prema potrebi.
English: Myopic choroidal neovascularisation
Croatian: Neovaskularizacija žilnice kod kratkovidnosti
English: Eylea also produced a significant improvement in vision in patients with macular oedema following CRVO and BRVO.
Croatian: Primjenom lijeka Eylea postiglo se značajno poboljšanje vida u bolesnika s makularnim edemom kao posljedicom CRVO-a ili BRVO-a.
English: For the full list of side effects of Eylea, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Eylea potražite u uputi o lijeku.
English: (Invented) name
Croatian: Broj odobrenja (Zaštićeno ime)
English: Content Pack size
Croatian: Unutarnje pakiranje Sadržaj
English: 7 multi-dose vials
Croatian: 7 višedoznih bočica
English: Eye drops, solution Ocular use vial (glass)
Croatian: Kapi za oko, otopina
English: 1 ml
Croatian: Okularno bočica (staklo) 1 ml
English: 1 tube
Croatian: 1 tuba
English: Cutaneous use tube (alu)
Croatian: Tuba (Al)
English: Pack size
Croatian: Topikalna primjena
English: What you need to know before you take <active substance>:
Croatian: Što morate znati prije nego počnete uzimati <djelatnu tvar>:
English: Rare: hypersensitivity reactions
Croatian: Rijetko: reakcije preosjetljivosti
English: There have been reports of severe skin reactions associated with the administration of <active substance>.
Croatian: Prijavljene su teške kožne reakcije povezane s primjenom <djelatne tvari>.
English: If you develop a skin rash (including lesions of the mucous membranes such as mouth, throat, nose, eyes, genitals), stop using <invented name> and contact your doctor immediately.
Croatian: Ako razvijete kožni osip (uključujući oštećenja sluznica poput sluznica u ustima, grlu, nosu, očima, spolnim organima) prestanite upotrebljavati <tvorničko ime> i odmah se obratite liječniku.
English: You can also report side effects directly via [the national reporting system listed in Appendix V*].
Croatian: Nuspojave možete prijaviti izravno putem [nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V*].
English: 4.8 Adverse events
Croatian: 4.8 Nuspojave
English: If symptoms or signs of a progressive skin rash (sometimes associated with blisters or mucosal lesions) are present, <active substance> treatment should be discontinued immediately and medical advice should be sought.
Croatian: Ako su prisutni simptomi ili znakovi progresivnog kožnog osipa (ponekad povezanog s nastankom mjehurića ili oštećenjima sluznice), potrebno je odmah prekinuti liječenje <djelatnom tvari> i potražiti medicinsku pomoć.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Nadležna tijela zemlje članice, u suradnji s referentnom zemljom članicom i u skladu s postupcima navedenim u poglavlju 4 naslova III Direktive 2001/83/EZ, mogu naknadno, na odgovarajući način, ažurirati podatke o lijeku.
English: Healthcare professionals are asked to report any suspected adverse reactions via [the national reporting system listed in Appendix V*].
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem [nacionalnog sustava prijave nuspojava navedenog u Dodatku V*.]
English: [The below paragraph should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
Croatian: [Odlomak u nastavku teksta mora biti naveden u ovom dijelu za sve lijekove koji sadrže ambroksol i bromheksin]
English: These amendments to the relevant sections of the Summary of Product Characteristics, labelling and package leaflet is the outcome of the referral procedure.
Croatian: Ove izmjene odgovarajućih dijelova sažetka opisa svojstava lijeka, označavanja i upute o lijeku proizlaze iz arbitražnog postupka.
English: Rare: rash, urticaria
Croatian: Rijetko: osip, urtikarija
English: [The following warning should be reflected in this section for all ambroxol- and bromhexine-containing medicinal products]
Croatian: [U ovom dijelu potrebno je navesti sljedeće upozorenje za sve lijekove koji sadrže ambroksol i bromheksin ]
English: [The following sub-heading should appear at the end of this section] Reporting of side effects
Croatian: [Na kraju ovog dijela potrebno je navesti sljedeći podnaslov ] Prijavljivanje nuspojava
English: Not known: anaphylactic reactions including anaphylactic shock, angioedema and pruritus Skin and subcutaneous tissue disorders
Croatian: Nepoznato: anafilaktičke reakcije uključujući anafilaktički šok, angioedem i pruritus Poremećaji kože i potkožnog tkiva
English: There have been reports of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN) and acute generalised exanthematous pustulosis (AGEP) associated with the administration of <active substance>.
Croatian: Prijavljene su teške kožne reakcije poput polimorfnog eritema, Steven-Johnsonovog sindroma (SJS)/toksične epidermalne nekrolize (TEN) i akutne generalizirane egzantematozne pustuloze (AGEP) povezane s primjenom <djelatne tvari>.
English: B. Package Leaflet [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Croatian: Uputa o lijeku [Postojeći podaci o lijeku izmijenit će se za sve lijekove u Dodatku I (odgovarajuće umetanje, zamjena ili brisanje teksta) kako bi se naveo usuglašen tekst kako slijedi u nastavku]
English: Not known: frequency cannot be estimated from the available data Anaphylactic reactions including anaphylactic shock, angioedema (rapidly developing swelling of the skin, subcutaneous, mucosa or submucosal tissues) and pruritus Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalised exanthematous pustulosis).
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka anafilaktičke reakcije uključujući anafilaktički šok, angioedem (brzorazvijajuće oticanje kože, potkožnih, mukoznih i submukoznih tkiva) i pruritus Teške kožne nuspojave (uključujući polimorfni eritem, Steven-Johnsonov sindrom/toksičnu epidermalnu nekrolizu i akutnu generaliziranu egzantematoznu pustulozu).
English: A. Summary of Product Characteristics [For all products in Annex I, the existing product information shall be amended (insertion, replacement or deletion of the text, as appropriate) to reflect the agreed wording as provided below]
Croatian: Sažetak opisa svojstava lijeka [Postojeći podaci o lijeku izmijenit će se za sve lijekove u Dodatku I (odgovarajuće umetanje, zamjena ili brisanje teksta) kako bi se naveo usuglašen tekst kako slijedi u nastavku]
English: Rare: may affect up to 1 in 1,000 people:
Croatian: Rijetko: mogu se javiti u do 1 na 1000 osoba: reakcije preosjetljivosti osip, urtikarija
English: Not known: Severe cutaneous adverse reactions (including erythema multiforme, Stevens-Johnson syndrome/toxic epidermal necrolysis and acute generalized exanthematous pustulosis).
Croatian: Nepoznato: teške kožne nuspojave (uključujući polimorfni eritem, Steven-Johnsonov sindrom/toksičnu epidermalnu nekrolizu i akutnu generaliziranu egzantematoznu pustulozu).
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Croatian: Izmjene odgovarajućih dijelova sažetka opisa svojstava lijeka i upute o lijeku
English: Warnings and precautions
Croatian: Prijavljivanje sumnji na nuspojavu
English: 60 minutes, every 2 weeks.
Croatian: 60 minuta, i to svaka 2 tjedna.
English: NR: Not Reached
Croatian: ND: nije dosegnuto
English: Date of first authorisation: 21 September 2018
Croatian: Datum prvog odobrenja: 21. rujna 2018.
English: Grade 2 for > 1 week
Croatian: 2. stupanj tijekom > 1 tjedna
English: • It is very important that you do not miss a dose of this medicine.
Croatian: • Vrlo je važno je da ne propustite primiti dozu ovoga lijeka.
English: No changes
Croatian: Bez promjena
English: • Your doctor will decide how many treatments you need.
Croatian: • Vaš će liječnik odlučiti koliko puta trebate primiti lijek.
English: Unopened vial 3 years.
Croatian: Neotvorena bočica 3 godine
English: The analysis of OS was performed approximately 13 months after the primary analysis of PFS.
Croatian: Analiza OS-a provedena je približno 13 mjeseci nakon primarne analize PFS-a.
English: See Table 3 and Figures 1 and 2.
Croatian: Vidjeti tablicu 3 i slike 1 i 2.
English: • if you are allergic to durvalumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
Croatian: • ako ste alergični na durvalumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6. ‘Sadržaj pakiranja i druge informacije').
English: Steady state was achieved at approximately 16 weeks.
Croatian: Stanje dinamičke ravnoteže postignuto je nakon približno 16 tjedana.
English: • Do not co-administer other medicinal products through the same infusion line.
Croatian: • Nemojte primjenjivati druge lijekove istom infuzijskom linijom.
English: PFS2 is defined as the time from the date of randomisation until the date of second progression (defined by local standard clinical practice) or death.
Croatian: PFS2 definiran je kao vrijeme od datuma randomizacije do datuma druge progresije (definirane lokalnom standardnom kliničkom praksom) ili smrti.
English: Events/N (%) IMFINZI
Croatian: Događaji/N (%) IMFINZI
English: PFS and OS results are summarised in Figures 3, 4, 5 and 6.
Croatian: Rezultati za PFS i OS sažeto su prikazani na slikama 3, 4, 5 i 6.
English: • you have an autoimmune disease (an illness where the body's immune system attacks its own cells);
Croatian: • ako imate autoimunu bolest (bolest kod koje imunosni sustav tijela napada vlastite stanice)
English: Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms.
Croatian: Liječnik će Vam možda dati druge lijekove koji sprječavaju pojavu težih komplikacija i pomažu ublažiti simptome.
English: The time to onset was 42 days.
Croatian: Vrijeme do nastupa iznosilo je 42 dana.
English: The diluted solution must not be frozen.
Croatian: Razrijeđena otopina ne smije se zamrzavati.
English: Treatment must be initiated and supervised by a physician experienced in the treatment of cancer.
Croatian: Liječenje mora započeti i nadzirati liječnik koji ima iskustva s liječenjem raka.
English: No overall differences in safety were reported between elderly (≥ 65 years) and younger patients.
Croatian: Nisu prijavljene ukupne razlike u sigurnosti između starijih osoba (≥ 65 godina) i mlađih bolesnika.
English: What IMFINZI is and what it is used for
Croatian: Što je IMFINZI i za što se koristi
English: <Other sources of information>
Croatian: Ostali izvori informacija
English: Children and adolescents IMFINZI should not be used in children and adolescents below 18 years of age.
Croatian: Djeca i adolescenti IMFINZI se ne smije koristiti u djece ni adolescenata mlađih od 18 godina.
English: Grade 3 or 4, or any Grade with positive biopsy
Croatian: 3. ili 4. stupanj ili bilo koji stupanj uz pozitivan biopsijski nalaz
English: However, if you have side effects that affect your ability to concentrate and react, you should be careful when driving or operating machines.
Croatian: Međutim, ako imate nuspojave koje utječu na Vašu sposobnost koncentracije i reagiranja, budite oprezni pri upravljanju vozilima ili radu sa strojevima.
English: This includes herbal medicines and medicines obtained without a prescription.
Croatian: To uključuje biljne lijekove i lijekove koje ste nabavili bez recepta.
English: ATC code: L01XC28
Croatian: ATK oznaka: L01XC28
English: Tumour assessments were conducted every 8 weeks for the first 12 months and then every 12 weeks thereafter.
Croatian: Ocjene tumora provodile su se svakih 8 tjedana tijekom prvih 12 mjeseca, a zatim svakih 12 tjedana.
English: Fertility There are no data on the potential effects of durvalumab on fertility in humans or animals.
Croatian: Plodnost Nema podataka o mogućim učincima durvalumaba na plodnost kod ljudi ili životinja.
English: Symptomatic treatment, see section 4.8
Croatian: Simptomatsko liječenje, vidjeti dio 4.8
English: IMFINZI works by helping your immune system fight your cancer.
Croatian: IMFINZI djeluje tako da pomaže Vašem imunosnom sustavu u borbi protiv raka.
English: Ninety-two percent of patients had received a total dose of 54 to 66 Gy of radiation.
Croatian: Devedeset i dva posto (92%) bolesnika primilo je ukupnu dozu zračenja od 54 do 66 Gy.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of IMFINZI.
Croatian: Većina njih, uključujući teške reakcije, povukla se nakon uvođenja odgovarajuće terapije ili prekida primjene lijeka IMFINZI.
English: PD-L1 Unknown
Croatian: PD-L1 status nepoznat
English: Gärtunavägen
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: However, a potential risk to the breast-fed child cannot be excluded.
Croatian: Međutim, ne može se isključiti rizik za dojenče.
English: The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL.
Croatian: Konačna koncentracija razrijeđene otopine treba biti između 1 mg/ml i 15 mg/ml.
English: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court
Croatian: AstraZeneca Pharmaceuticals LP Frederick Manufacturing Center (FMC) 633 Research Court Frederick,
English: It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Croatian: Preporučuje se nastaviti liječenje klinički stabilnih bolesnika s inicijalnim pokazateljima progresije bolesti sve dok se progresija bolesti ne potvrdi.
English: Night sweats
Croatian: • noćno znojenje
English: IMFINZI will be given to you in a hospital or clinic under the supervision of an experienced doctor.
Croatian: IMFINZI ćete primati u bolnici ili klinici, pod nadzorom iskusnog liječnika.
English: If no improvement within 3 to 5 days despite corticosteroids, promptly start additional immunosuppressive therapy.
Croatian: Ako ne dođe do poboljšanja unutar 3 - 5 dana unatoč primjeni kortikosteroida, potrebno je odmah uvesti dodatnu imunosupresijsku terapiju.
English: The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka IMFINZI kod djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: The corresponding frequency category for each ADR is defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); not known (cannot be estimated from available data).
Croatian: Odgovarajuća učestalost pojavljivanja za svaku nuspojavu definirana je kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Other medicines and IMFINZI
Croatian: Drugi lijekovi i IMFINZI
English: In humans, antibodies may be transferred to breast milk, but the potential for absorption and harm to the newborn is unknown.
Croatian: Kod ljudi može doći do prijenosa protutijela u majčino mlijeko, ali mogućnost apsorpcije i štete za novorođenče nije poznata.
English: Warnings and precautions Talk to your doctor before you are given IMFINZI if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego primite IMFINZI:
English: It is to be administered as an intravenous infusion solution over 60 minutes (see section 6.6).
Croatian: Primjenjuje se u obliku intravenske infuzije tijekom razdoblja od 60 minuta (vidjeti dio 6.6).
English: Talk to your doctor straight away if you get any of the following side effects, that have been reported in clinical trials with durvalumab, and includes the serious side effects listed in section 2:
Croatian: Odmah razgovarajte sa svojim liječnikom ako primijetite bilo koju od sljedećih nuspojava koje su prijavljene u kliničkim ispitivanjima durvalumaba, uključujući ozbiljne nuspojave navedene u dijelu 2.:
English: 6545CG Nijmegen, Netherlands
Croatian: 6545CG Nijmegen, Nizozemska