FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘3' on either side of the breakline on one side and breakline on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, plosnate, ukošenih rubova s oznakama „I” i „3” s dviju strana razdjelne crte na jednoj strani te s razdjelnom crtom na drugoj strani tablete.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/728/009-010 (30/100 tablets in alu/alu blister)
Croatian: EU/1/11/728/009-010 (30/100 tableta u Al/Al blisterima)
English: The tablets are white to off-white, round, flat faced, bevel edged, with inscription ‘I' and ‘2' on either side of the breakline on one side and breakline on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, plosnate, ukošenih rubova s oznakama „I” i „2” s dviju strana razdjelne crte na jednoj strani te s razdjelnom crtom na drugoj strani tablete.
English: 1 dose (0.5 ml) contains approximately: Human Papillomavirusa Type 6 L1 proteinb,c aHuman Papillomavirus = HPV bL1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
Croatian: L1 protein u obliku čestica nalik virusu proizvedenih u stanicama kvasca (Saccharomyces cerevisiae CANADE 3C-5 (soj 1895) tehnologijom rekombinantne DNA. adsorbiran na adjuvans amorfni aluminijev hidroksifosfat sulfat (225 mikrograma Al).
English: Packaging
Croatian: Sastav
English: The recommended dose is 0.5 mg per kg body weight which the patient should take once.
Croatian: Preporučena doza je 0,5 mg po kilogramu tjelesne težine i bolesnik je uzima jednom.
English: In terms of safety, the main concern was that the medicine may change heart rhythm.
Croatian: U pogledu sigurnosti primjene, glavna je zabrinutost bila ta da lijek može izmijeniti srčani ritam.
English: Overall, the side effects were mostly mild and short-lasting, with no need for a specific treatment.
Croatian: Ukupno gledano, nuspojave su većinom bile blage i kratkotrajne te nije bilo potrebe za posebnim liječenjem.
English: However this risk is considered small as patients take only one dose of the medicine and are supervised by their doctor.
Croatian: Međutim, taj se rizik smatra niskim jer bolesnici uzimaju samo jednu dozu lijeka, i to pod nadzorom liječnika.
English: The doctor then takes blood samples 45, 60 and 90 minutes later to see how much growth hormone the body has produced.
Croatian: Liječnik potom uzima uzorke krvi 45, 60 i 90 minuta kasnije kako bi utvrdio koliku je količinu hormona rasta tijelo proizvelo.
English: It is not used to treat patients with the condition.
Croatian: Ne primjenjuje se za liječenje bolesnika s tim stanjem.
English: Further information on Macimorelin Aeterna Zentaris can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/macimorelin-aeterna-zentaris.
Croatian: Više informacija o lijeku Macimorelin Aeterna Zentaris nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/macimorelin-aeterna-zentaris.
English: This means that, although Macimorelin Aeterna Zentaris might not diagnose all cases of disease, it can help to confirm presence of the disease.
Croatian: To znači da, premda se uz pomoć lijeka Macimorelin Aeterna Zentaris ne mogu dijagnosticirati svi slučajevi bolesti, on može pridonijeti potvrdi postojanja bolesti.
English: The study involved 166 adults who had either a high, intermediate or low likelihood of having growth hormone deficiency, or who were confirmed not to have growth hormone deficiency.
Croatian: Ispitivanjem je bilo obuhvaćeno 166 odraslih osoba kod kojih je vjerojatnost nedostatka hormona rasta bila visoka, srednja ili niska, ili kod kojih je potvrđeno da nemaju nedostatak hormona rasta.
English: The level of growth hormone in the blood is then measured and indicates whether or not the body is able to produce growth hormone.
Croatian: Potom se mjeri razina hormona rasta u krvi i pokazuje može li tijelo proizvesti hormon rasta ili ne.
English: It is used by doctors to diagnose growth hormone deficiency, a condition where the patient does not have enough growth hormone.
Croatian: Primjenjuju ga liječnici kako bi dijagnosticirali nedostatak hormona rasta, stanja u kojem bolesnik nema dovoljnu količinu hormona rasta.
English: On the whole, Macimorelin Aeterna Zentaris has fewer side effects than the comparator test, which temporarily lowers the level of sugar in the blood.
Croatian: Sve u svemu, Macimorelin Aeterna Zentaris ima manje nuspojava od usporednog testa kojim se privremeno smanjuje razina šećera u krvi.
English: Overall, 94% of people who tested negative for growth hormone deficiency with ITT also tested negative with Macimorelin Aeterna Zentaris; 74% of people who tested positive with ITT also tested positive with Macimorelin Aeterna Zentaris.
Croatian: Ukupno gledajući, 94 % osoba koje su bile negativne na nedostatak hormona rasta putem ITT-a bile su negativne i u testiranju lijekom Macimorelin Aeterna Zentaris; 74 % osoba koje su bile pozitivne nakon testiranja putem ITT-a bile su pozitivne i nakon testiranja lijekom Macimorelin Aeterna Zentaris.
English: EMA considered that it is a priority to avoid over-diagnosis of adult growth hormone deficiency and that Macimorelin Aeterna Zentaris helps confirm positive diagnosis and so avoid unnecessary treatment of patients with a false positive test result.
Croatian: EMA je smatrala da je najvažnije izbjeći pretjerano dijagnosticiranje nedostatka hormona rasta u odraslih osoba, kao i činjenicu da lijek Macimorelin Aeterna Zentaris pridonosi u potvrdi pozitivne dijagnoze, čime se izbjegava nepotrebno liječenje bolesnika s lažno pozitivnim rezultatom testa.
English: For more information about using Macimorelin Aeterna Zentaris, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Macimorelin Aeterna Zentaris pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Side effects reported with Macimorelin Aeterna Zentaris are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Macimorelin Aeterna Zentaris pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Macimorelin Aeterna Zentaris have 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 Macimorelin Aeterna Zentaris nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The most common side effects with Macimorelin Aeterna Zentaris (which may affect up to 1 in 10 people) are a bitter or metallic taste, tiredness, headache, nausea (feeling sick), dizziness, diarrhoea and feeling hot. Macimorelin Aeterna Zentaris may also cause a change in heart rhythm.
Croatian: Najčešće nuspojave lijeka Macimorelin Aeterna Zentaris (koje se mogu javiti u do 1 na 10 osoba) jesu gorak okus ili okus metala u ustima, umor, glavobolja, mučnina (slabost), omaglica, proljev i osjećaj vrućine.
English: The active substance in Macimorelin Aeterna Zentaris, macimorelin, stimulates the release of growth hormone into the blood by activating receptors (targets) found on cells in the pituitary gland, a gland located at the base of the brain.
Croatian: Djelatna tvar u lijeku Macimorelin Aeterna Zentaris, macimorelin, stimulira otpuštanje rasta hormona u krv aktivacijom receptora (ciljnih mjesta) koji se nalaze na stanicama hipofize, žlijezde smještene u donjem dijelu mozga.
English: What measures are being taken to ensure the safe and effective use of Macimorelin Aeterna Zentaris?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Macimorelin Aeterna Zentaris?
English: Among them, 140 were tested with both Macimorelin Aeterna Zentaris and ITT.
Croatian: Ukupno 140 od njih testirano je i lijekom Macimorelin Aeterna Zentaris i putem ITT-a.
English: Macimorelin Aeterna Zentaris is available as granules that are dissolved in water and taken by mouth.
Croatian: Lijek Macimorelin Aeterna Zentaris dostupan je u obliku granula koje se otapaju u vodi i uzimaju kroz usta.
English: As for all medicines, data on the use of Macimorelin Aeterna Zentaris are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Macimorelin Aeterna Zentaris kontinuirano se prate.
English: Macimorelin Aeterna Zentaris is a medicine used to test the ability of the body to produce growth hormone.
Croatian: Macimorelin Aeterna Zentaris je lijek za ispitivanje sposobnosti tijela da proizvodi hormon rasta.
English: An overview of Macimorelin Aeterna Zentaris and why it is authorised in the EU
Croatian: Pregled lijeka Macimorelin Aeterna Zentaris i zašto je odobren u EU-u
English: Macimorelin Aeterna Zentaris can only be obtained with a prescription and its use must be supervised by a healthcare professional experienced in diagnosing growth hormone deficiency.
Croatian: Lijek Macimorelin Aeterna Zentaris izdaje se samo na liječnički recept, a njegovu primjenu mora nadzirati zdravstveni radnik s iskustvom u dijagnosticiranju nedostatka hormona rasta.
English: What is Macimorelin Aeterna Zentaris and what is it used for?
Croatian: Što je Macimorelin Aeterna Zentaris i za što se primjenjuje?
English: Macimorelin Aeterna Zentaris was compared with another test commonly used to diagnose growth hormone deficiency, called insulin tolerance test (ITT), in one main study.
Croatian: Lijek Macimorelin Aeterna Zentaris u jednom je glavnom ispitivanju uspoređen s drugim testom koji se obično primjenjuje za dijagnosticiranje nedostatka hormona rasta, a naziva se test tolerancije inzulina (ITT).
English: EMA therefore decided that Macimorelin Aeterna Zentaris's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi od lijeka Macimorelin Aeterna Zentaris nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Other information about Macimorelin Aeterna Zentaris
Croatian: Ostale informacije o lijeku Macimorelin Aeterna Zentaris
English: Why is Macimorelin Aeterna Zentaris authorised in the EU?
Croatian: Zašto je lijek Macimorelin Aeterna Zentaris odobren u EU-u?
English: Macimorelin Aeterna Zentaris contains the active substance macimorelin.
Croatian: Macimorelin Aeterna Zentaris sadrži djelatnu tvar macimorelin.
English: What are the risks associated with Macimorelin Aeterna Zentaris?
Croatian: Koji su rizici povezani s lijekom Macimorelin Aeterna Zentaris?
English: For the full list of side effects and restrictions with Macimorelin Aeterna Zentaris, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Macimorelin Aeterna Zentaris potražite u uputi o lijeku.
English: Macimorelin Aeterna Zentaris gave a similar number of negative test results for growth hormone deficiency as a comparator test; however, it gives fewer positive test results than the comparator.
Croatian: Testiranje lijekom Macimorelin Aeterna Zentaris proizvelo je sličan broj negativnih rezultata za nedostatak hormona rasta kao i usporedno ispitivanje.
English: How does Macimorelin Aeterna Zentaris work?
Croatian: Kako djeluje Macimorelin Aeterna Zentaris?
English: How is Macimorelin Aeterna Zentaris used?
Croatian: Kako se primjenjuje Macimorelin Aeterna Zentaris?
English: What benefits of Macimorelin Aeterna Zentaris have been shown in studies?
Croatian: Koje su koristi od lijeka Macimorelin Aeterna Zentaris utvrđene u ispitivanjima?
English: Macimorelin Aeterna Zentaris received a marketing authorisation valid throughout the EU on 11 January 2019.
Croatian: Macimorelin Aeterna Zentaris (macimorelin) EMA/820056/2018
English: Your injection could take about 15 seconds.
Croatian: Injiciranje može trajati oko 15 sekundi.
English: This may vary depending on whether you are an adult or a child.
Croatian: To može varirati ovisno o tome jeste li odrasla osoba ili dijete.
English: Please discuss this with your doctor.
Croatian: Molimo razgovarajte o tome sa svojim liječnikom.
English: At the final analysis, 1,653 deaths were reported.
Croatian: U konačnoj analizi prijavljena su 1653 smrtna slučaja.
English: The healthcare professional's educational material should contain the following key elements:
Croatian: Edukacijski materijal za zdravstvenog radnika treba sadržavati sljedeće ključne elemente:
English: • Serious allergic reactions which may include:
Croatian: • ozbiljne alergijske reakcije koje mogu uključivati:
English: It is important to tell your doctor if you:
Croatian: Važno je da obavijestite svojeg liječnika ako ste:
English: Poorly controlled hypertension.
Croatian: Loše kontrolirana hipertenzija.
English: Date of latest renewal: 19 May 2006
Croatian: Datum zadnje obnove odobrenja: 19. svibnja 2006.
English: study (study 20010184).
Croatian: (ispitivanje 20010184).
English: Placental transfer was minimal.
Croatian: Prijenos kroz placentu bio je minimalan.
English: This will make the injection more comfortable.
Croatian: Tako će injiciranje biti ugodnije.
English: 15 seconds
Croatian: 15 sekundi
English: • Allergic reactions
Croatian: • alergijske reakcije
English: Do not use a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: A risk to the suckling child cannot be excluded.
Croatian: Ne može se isključiti rizik za dijete koje se doji.
English: 30 minutes
Croatian: 30 minuta
English: The instructions for use, handling and disposal are given in section 6.6.
Croatian: Upute za uporabu, rukovanje i zbrinjavanje navedeni su u dijelu 6.6.
English: Food and drink do not affect Aranesp.
Croatian: Hrana i piće ne utječu na Aranesp.
English: Driving and using machines
Croatian: Vožnja i upravljanje strojevima
English: Your blood pressure will also be checked regularly, particularly at the beginning of your treatment.
Croatian: Redovito će biti kontroliran i Vaš krvni tlak, osobito na početku liječenja.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati lijek jer sadrži Vama važne podatke.
English: There may be local guidelines for disposal.
Croatian: Možda su dostupne lokalne smjernice za zbrinjavanje.
English: Important: Do not touch the red start button yet.
Croatian: Važno: Nemojte još dirati crveni gumb.
English: Do not use Aranesp if you think it has been frozen.
Croatian: Ne koristite Aranesp ako mislite da je bio zamrznut.
English: Important: Needle is inside
Croatian: Važno: Igla se nalazi unutra
English: Correction phase:
Croatian: Faza korekcije:
English: • think you may be pregnant; or
Croatian: • mislite da biste mogli biti trudni,
English: Maintenance phase:
Croatian: Faza održavanja:
English: These serious skin rashes are often preceded by fever and/or flu-like symptoms.
Croatian: Ovim ozbiljnim kožnim osipima često prethodi vrućica i/ili simptomi nalik gripi.
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10); često (≥ 1/100 do < 1/10); manje često (≥ 1/1000 do < 1/100); rijetko (≥ 1/10 000 do < 1/1000); vrlo rijetko (< 1/10 000); nepoznato (ne može se procijeniti na temelju raspoloživih podataka).
English: As with all growth factors, there is a concern that epoetins could stimulate the growth of tumours.
Croatian: Kao kod svih faktora rasta, postoji bojazan da epoetini mogu stimulirati rast tumora.
English: • a new Aranesp pre-filled syringe; and
Croatian: • novu Aranesp napunjenu štrcaljku; i
English: Important: When you remove the pre-filled pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose.
Croatian: Važno: Nakon što odvojite brizgalicu od kože, a prozor nije postao žut ili ako izgleda kao da se lijek nastavlja injicirati, to znači da niste primijenili cijelu dozu.
English: Window turns yellow when the injection is done
Croatian: Prozor postane žut kada injiciranje završi
English: This may be associated with life-threatening complications of the cardiovascular system.
Croatian: To može biti povezano s po život opasnim komplikacijama kardiovaskularnog sustava.
English: Deficiencies of iron, folic acid or vitamin B12 reduce the effectiveness of ESAs and should therefore be corrected.
Croatian: Manjak željeza, folne kiseline ili vitamina B12 smanjuje djelotvornost LSE te se stoga mora ispraviti.
English: Amgen Manufacturing Limited PO Box 4060, Road 31 km 24.6 Juncos, PR 00777-4060
Croatian: Amgen Manufacturing Limited PO Box 4060, Road 31 km 24.6 Juncos, PR 00777-4060 Portoriko
English: The target haemoglobin concentration in two studies was > 13 g/dL; in the remaining three studies it was 12-14 g/dL.
Croatian: Ciljna koncentracija hemoglobina u 2 studije bila je >13 g/dl; u ostale 3 studije bila je 12-14 g/dl.
English: Using Aranesp with food and drink
Croatian: Uzimanje lijeka Aranesp s hranom i pićem
English: Because it will take your body some time to make more red blood cells, it will be about four weeks before you notice any effect.
Croatian: Budući da Vašem tijelu treba vremena za stvaranje više crvenih krvnih stanica, zamijetit ćete učinak tek za otprilike četiri tjedna.
English: To avoid bending the needle, gently pull the cap from the needle without twisting as shown in pictures 1 and 2.
Croatian: Da biste izbjegli savijanje igle, pažljivo skinite pokrov s igle bez okretanja, kao što je prikazano na slikama 1. i 2.
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako primjenjujete ili ste nedavno primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: What Aranesp is and what it is used for
Croatian: Što je Aranesp i za što se koristi
English: The injections will be given by a healthcare professional.
Croatian: Injekciju će Vam dati zdravstveni djelatnik.
English: Adverse reactions were determined based on pooled data from eight randomised, double-blind,
Croatian: Nuspojave su određene na temelju prikupljenih podataka iz osam randomiziranih dvostruko slijepih,
English: Treatment with Aranesp is divided into two stages, correction and maintenance phase.
Croatian: Liječenje lijekom Aranesp podijeljeno je na 2 faze: fazu korekcije i fazu održavanja.
English: See also section 2.
Croatian: Pogledajte također dio 2.
English: Aranesp works in exactly the same way as the natural hormone erythropoietin.
Croatian: Aranesp djeluje na potpuno isti način kao prirodni hormon eritropoetin.
English: A systematic review has also been performed involving more than 9,000 cancer patients participating in 57 clinical trials.
Croatian: Također je proveden sustavni pregled koji je uključio više od 9000 bolesnika s rakom koji su sudjelovali u 57 kliničkih ispitivanja.
English: • plan to get pregnant.
Croatian: • planirate trudnoću.
English: • Shortness of breath (allergic bronchospasm)
Croatian: • nedostatak zraka (alergijski bronhospazam)
English: It is important to tell your doctor if you are taking either of these medicines.
Croatian: Važno je da obavijestite svojeg liječnika ako koristite neki od ovih lijekova.
English: Effect on tumour growth
Croatian: Učinak na rast tumora
English: The carcinogenic potential of darbepoetin alfa has not been evaluated in long-term animal studies.
Croatian: Karcinogeni potencijal darbepoetina alfa nije bio procijenjen u dugoročnim ispitivanjima na životinjama.
English: Epoetins are not approved in the management of anaemia associated with hepatitis C.
Croatian: Epoetini nisu odobreni za liječenje anemije povezane s hepatitisom C.
English: In the absence of incompatibility studies, this medicinal product must not be mixed or administered as an infusion with other medicinal products.
Croatian: Zbog nedostatka ispitivanja inkompatibilnosti, ovaj lijek se ne smije miješati ili primijeniti kao infuzija s drugim lijekovima.
English: Before you inject Aranesp you must do the following:
Croatian: Prije injiciranja lijeka Aranesp morate učiniti sljedeće:
English: Guidance is given separately for adult and paediatric patients.
Croatian: Uputa je dana odvojeno za odrasle i pedijatrijske bolesnike.
English: • Do not put the cap back on used needles, as you may accidentally prick yourself.
Croatian: • Ne vraćajte pokrov na korištene igle jer bi se mogli slučajno ubosti.
English: Despite these molecular changes, darbepoetin alfa retains a very narrow specificity for the erythropoietin receptor.
Croatian: Unatoč tim molekularnim promjenama, darbepoetin alfa zadržava vrlo usku specifičnost za receptor eritropoetina.
English: Check the appearance of Aranesp.
Croatian: Provjerite izgled lijeka Aranesp.
English: Do not administer more than one dose.
Croatian: Ne smije se primijeniti više od jedne doze.
English: Do not touch the needle or push the plunger.
Croatian: Ne dirajte iglu i ne gurajte klip.
English: C Gather all the materials needed for your injection.
Croatian: C Pripremite sav pribor potreban za davanje injekcije.
English: Find a comfortable, well-lit, clean surface and put all the equipment you need within reach.
Croatian: Nađite pogodnu, dobro osvijetljenu, čistu površinu i stavite sav potrebni pribor na dohvat ruke.
English: In some cases, your doctor may recommend that you take iron supplements.
Croatian: U nekim slučajevima liječnik vam može preporučiti uzimanje nadomjestaka željeza.
English: On a clean, well-lit work surface, place the:
Croatian: Na čistu, dobro osvijetljenu radnu površinu stavite sljedeće:
English: Bioavailability is 37% with subcutaneous administration.
Croatian: Bioraspoloživost je 37% pri supkutanoj primjeni.
English: Do not touch the cleaned area of the skin
Croatian: Ne dirajte očišćeni dio kože.
English: Adverse events at very high doses were all considered to be related to an exaggerated pharmacological effect (decreased tissue perfusion due to increased blood viscosity).
Croatian: Smatra se da su svi štetni događaji kod vrlo visokih doza povezani s pretjeranim farmakološkim učinkom (smanjena perfuzija tkiva zbog povećane viskoznosti krvi).
English: Hypersensitivity reactions were also very common in the placebo groups.
Croatian: Reakcije preosjetljivosti su također bile vrlo česte u placebo grupama.
English: No alteration of fertility was detected.
Croatian: Nisu uočene nikakve promjene u plodnosti.
English: Pharmacokinetic parameters did not change on multiple dosing over 12 weeks (dosing every week or every two weeks).
Croatian: Farmakokinetički parametri nisu se mijenjali kod višestrukog doziranja tijekom 12 tjedana (doziranje svaki tjedan ili svaki drugi tjedan).
English: Depending on your individual situation a blood transfusion may be preferable.
Croatian: Ovisno o Vašem pojedinačnom slučaju transfuzija krvi može biti prikladnija.
English: If you experience these symptoms you should contact your doctor who will determine the best course of action to treat your anaemia.
Croatian: Ako primijetite te simptome, morate se obratiti svom liječniku koji će odrediti najbolji način za liječenje Vaše anemije.
English: If someone else is injecting for you, they can also use the back of your arms.
Croatian: Ako Vam netko drugi daje injekciju, može to činiti i u stražnji dio nadlaktice.
English: 2 Frequency cannot be estimated from the available data.
Croatian: 2 Učestalost se ne može procijeniti iz dostupnih podataka.