FrancophonIA/ELRC3.0 huggingface dataset:
English: The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holders:
Croatian: Nadležna državna tijela koja koordinira referentna država članica pobrinut će se da nositelji odobrenja ispune sljedeće uvjete:
English: As part of this study the MAH shall actively obtain reports of abuse, misuse, diversion and dependence in children with ADHD from poison centres, drug monitoring centres, other databases, publicly available information in the literature and online.
Croatian: Kao dio ovog ispitivanja nositelj odobrenja će aktivno prikupljati izvješća o zloporabi, pogrešnoj uporabi, diverziji i ovisnosti u djece s ADHD-om iz centara za kontrolu otrova, centara za praćenje lijekova, drugih baza podataka, javno dostupnih informacije u literaturi i na mreži.
English: The applicant shall submit an updated RMP taking into consideration the following recommendations: 1. section VI.2.5 Documentation for public summary should include a summary of risk minimisation measures by safety concern.
Croatian: Podnositelj zahtjeva predati će ažurirani plan upravljanja rizicima uzimajući u obzir sljedeće preporuke: 1. Dio VI.2.5. Dokumentacije za javni sažetak treba uključivati sažetak mjera smanjivanja rizika zbog sigurnosne bojazni.
English: The applicant shall conduct a PASS to evaluate the long-term safety profile of dexamfetamine in children with ADHD, specifically targeting key issues such as cardiovascular events, growth and psychiatric related adverse events.
Croatian: Podnositelj zahtjeva će provesti PASS-a kako bi se procijenio dugoročni profil sigurnosti deksamfetamina u djece s ADHD-om s posebnim naglaskom na ciljna, ključna pitanja poput kardiovaskularnih događaja, rasta i psihijatrijskih nuspojava.
English: 3. annex 7: should include the text of a proposed follow up form to be used for specific adverse event follow-up.
Croatian: 3. Dodatak 7.: treba uključivati tekst predloženog obrasca praćenja koji će se koristiti za praćenje specifičnih nuspojava.
English: The applicant shall undertake a DUS to follow the use of prescribed dexamfetamine in the European Union using multiple data sources.
Croatian: Nositelj odobrenja će poduzeti provedbu studije iskorištenja lijeka kako bi se pratila uporaba deksamfetamina u Europskoj uniji uporabom više izvora podataka.
English: 2. annex 2 should include the proposed text of the package leaflet in addition to the proposed SmPC.
Croatian: 2. Dodatak 2. treba uključivati predloženi tekst Upute o lijeku pored predloženog Sažetka opisa svojstava lijeka.
English: Strength Pharmaceuti cal form
Croatian: Farmaceutsk i oblik
English: (Invente d) name
Croatian: (Zaštiće no) ime
English: Route of administratio n
Croatian: Put primjene Unutarnje pakovanje
English: It is given once a week for the first 2 cycles and less frequently in subsequent cycles.
Croatian: Daje se jedanput tjedno tijekom prva dva ciklusa i manje često u narednim ciklusima.
English: Treatment is given in 28-day cycles.
Croatian: Terapija se daje u ciklusima od 28 dana.
English: What is Empliciti and what is it used for?
Croatian: Što je Empliciti i za što se koristi?
English: Further information on Empliciti can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/empliciti.
Croatian: Više informacija o lijeku Empliciti dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/empliciti.
English: Empliciti received a marketing authorisation valid throughout the EU on 11 May 2016.
Croatian: Lijek Empliciti dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 11. svibnja 2016.
English: The dose of Empliciti depends on the patient's weight.
Croatian: Doza lijeka Empliciti ovisi o tjelesnoj težini bolesnika.
English: What measures are being taken to ensure the safe and effective use of Empliciti?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Empliciti?
English: The European Medicines Agency therefore decided that Empliciti's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Empliciti nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: The most common side effects with Empliciti (which may affect more than 1 in 10 people) are headache, tiredness, fever, diarrhoea, sore throat, nose and throat infections, cough, pneumonia (lung infection), low levels of white blood cells and weight loss.
Croatian: Najčešće nuspojave lijeka Empliciti (mogu se javiti u više od 1 na 10 osoba) jesu glavobolja, umor, vrućica, proljev, grlobolja, infekcije nosa i grla, kašalj, pneumonija (upala pluća), niske razine bijelih krvnih stanica i gubitak težine.
English: Although side effects, particularly infections, were more common with Empliciti, the risks on the whole appear manageable.
Croatian: Iako se pokazalo da su nuspojave, osobito infekcije, bile češće kod primjene lijeka Empliciti, u cjelini se pokazalo da se rizici mogu kontrolirati.
English: Other information about Empliciti
Croatian: Ostale informacije o lijeku Empliciti
English: Side effects reported with Empliciti are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Empliciti pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Why is Empliciti authorised in the EU?
Croatian: Zašto je lijek Empliciti odobren u EU-u?
English: What are the risks associated with Empliciti?
Croatian: Koji su rizici povezani s lijekom Empliciti?
English: To prevent infusion reactions, the patient is given an anti-inflammatory medicine, an antihistamine and paracetamol before every infusion.
Croatian: Kako bi se spriječile reakcije na infuziju, bolesniku se prije svake infuzije daje protuupalni lijek, antihistaminik i paracetamol.
English: All patients had previously received other treatments but the treatments had not worked or the cancer had come back.
Croatian: Svi su bolesnici prethodno primali druge terapije koji nisu djelovale ili kod kojih se rak vratio.
English: As for all medicines, data on the use of Empliciti are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Empliciti kontinuirano se prate.
English: An overview of Empliciti and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Empliciti i zašto je odobren u EU-u
English: In addition, the cancer cleared partially or completely in 79% of patients treated with the Empliciti combination compared with 66% of patients treated with the other two medicines.
Croatian: Nadalje, djelomičan ili potpuni nestanak raka zabilježen je kod 79 % bolesnika koji su liječeni terapijom koja je uključivala kombinaciju s lijekom Empliciti u usporedbi s 66 % bolesnika koji su liječeni samo s druga dva lijeka.
English: Patients' previous treatment should have included the multiple myeloma medicines lenalidomide and a class of medicines called proteasome inhibitors (e.g. bortezomib, carfilzomib and ixazomib).
Croatian: Prethodno liječenje bolesnika trebalo je uključivati lijekove za multipli mijelom lenalidomid i razred lijekova naziva inhibitori proteasoma (npr. bortezomib, karfilzomib i iksazomib).
English: Treatment must be started and supervised by a doctor experienced in treating multiple myeloma, and the medicine can only be obtained with a prescription.
Croatian: Liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju multiplog mijeloma, a lijek se izdaje samo na recept.
English: For more information about using Empliciti, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Empliciti pročitajte uputu o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Empliciti 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 Empliciti nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Elotuzumab also attaches to SLAMF7 on the cancer cells, making them more vulnerable to attack by the immune cells.
Croatian: Elotuzumab se vezuje i za SLAMF7 na stanicama raka što ih čini podložnijima napadu imunosnih stanica.
English: In patients who had already been treated with at least two treatments including a proteasome inhibitor and lenalidomide (and the treatment had not worked or the disease had come back), Empliciti plus pomalidomide and dexamethasone delayed worsening of the disease, compared with just pomalidomide and dexamethasone.
Croatian: U bolesnika koji su već liječeni s najmanje dvije terapije, uključujući inhibitor proteasoma i lenalidomid (i terapija nije djelovala ili se bolest vratila), lijek Empliciti s pomalidomidom i deksametazonom odgodio je pogoršanje bolesti u usporedbi s liječenjem sa samo pomoaldomidom i deksametazonom.
English: It is used together with two other medicines (lenalidomide and dexamethasone) and is given to adults who have received at least one previous cancer treatment.
Croatian: Primjenjuje se zajedno s druga dva lijeka (lenalidomidom i deksametazonom) i daje se odraslim osobama koje su prethodno primile najmanje jednu terapiju protiv raka.
English: A second main study involved 117 multiple myeloma patients who had received at least two other treatments previously, including a proteasome inhibitor and lenalidomide.
Croatian: Drugo glavno ispitivanje obuhvatilo je 117 bolesnika koji boluju od multiplog mijeloma koji su prethodno primili barem još dvije druge terapije, uključujući inhibitor proteasoma i lenalidomid.
English: Adding Empliciti to lenalidomide and dexamethasone can delay the worsening of multiple myeloma and improve clearance of the cancer in patients whose disease did not improve with previous treatment or whose disease came back.
Croatian: Dodavanje lijeka Empliciti lenalidomidu i deksametazonu može odgoditi pogoršanje multiplog mijeloma i poboljšati povlačenje raka u bolesnika kod kojih prethodne terapije nisu bile uspješne ili kod kojih se bolest vratila.
English: The active substance in Empliciti, elotuzumab, is a monoclonal antibody that attaches to SLAMF7, a protein on immune cells, causing the cells to attack the multiple myeloma cancer cells and thereby slow down the disease.
Croatian: Djelatna tvar u lijeku Empliciti, elotuzumab, monoklonsko je protutijelo koje se vezuje za SLAMF7, protein na imunosnim stanicama, i uzrokuje da te stanice napadaju stanice raka multiplog mijaloma i tako usporavaju bolest.
English: The average time before the disease got worse was 18.5 months in patients treated with the Empliciti combination compared with 14.3 months in those treated with just lenalidomide and dexamethasone.
Croatian: Prosječno vrijeme prije nego što se bolest pogoršala bilo je 18,5 mjeseci u bolesnika koji su liječeni kombinacijom s lijekom Empliciti u usporedbi s 14,3 mjeseca u bolesnika koji su liječeni samo lenalidomidom i deksametazonom.
English: What benefits of Empliciti have been shown in studies?
Croatian: Koje su koristi od lijeka Empliciti utvrđene u ispitivanjima?
English: The patient is also given other cancer medicines (dexamethasone with either lenalidomide or pomalidomide) during each cycle.
Croatian: Bolesnik prima i druge lijekove protiv raka (deksametazon s lenalidomidom ili pomalidomidom) tijekom svakog ciklusa.
English: In a main study of 646 multiple myeloma patients a combination of Empliciti plus lenalidomide and dexamethasone was compared with only lenalidomide and dexamethasone.
Croatian: U glavnom ispitivanju na 646 bolesnika koji boluju od multiplog mijeloma kombinacija lijeka Empliciti s lenalidomidom i deksametazonom uspoređivana je sa samo lenalidomidom i deksametazonom.
English: Empliciti is given as an infusion (drip) into a vein.
Croatian: Empliciti se daje putem intravenske infuzije (ukapavanje).
English: Patients treated with a combination of Empliciti plus pomalidomide and dexamethasone lived on average for over 5.5 months longer without their disease getting worse compared with patients treated with pomalidomide and dexamethasone.
Croatian: Bolesnici koji su liječeni kombinacijom lijeka Empliciti s pomalidomidom i deksametazonom živjeli su u prosjeku više od 5,5 mjeseci duže bez pogoršanja bolesti u usporedbi s bolesnicima koji su liječeni samo pomalidomidim i deksametazonom.
English: Empliciti contains the active substance elotuzumab.
Croatian: Empliciti sadrži djelatnu tvar elotuzumab.
English: Empliciti is also used together with the medicines pomalidomide and dexamethasone to treat multiple myeloma that was previously treated with at least two other treatments but the cancer had come back.
Croatian: Empliciti se koristi i sa lijekovima pomalidomidom i deksametazonom za terapiju protiv multiplog mijeloma koji je prethodno liječen najmanje dvjema drugim terapijama, ali se rak vratio.
English: Empliciti is a medicine for treating multiple myeloma (a cancer of the bone marrow).
Croatian: Empliciti je lijek za liječenje multiplog mijeloma (raka koštane srži).
English: How does Empliciti work?
Croatian: Kako djeluje Empliciti?
English: For the full list of side effects and restrictions of Empliciti, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s primjenom lijeka Empliciti potražite u uputi o lijeku.
English: If you see more than one drop:
Croatian: Ako vidite više od jedne kapi:
English: It may harm them,
Croatian: NAVOĐENJE DJELATNE(IH )TVARI
English: If it is not, do not use.
Croatian: Ako nije, nemojte je upotrijebiti.
English: • unusual taste in the mouth
Croatian: • neobičan okus u ustima
English: What do the arrows mean?
Croatian: Što znače strelice?
English: The arrows mean you are ready for the next step.
Croatian: Strelice znače da ste spremni za sljedeći korak.
English: Date of first authorisation: 20 November 2006 Date of latest renewal: 22 July 2016
Croatian: Datum prvog odobrenja: 20. studenog 2006. Datum posljednje obnove odobrenja: 22. srpnja 2016.
English: Please keep this possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving a car or using machines).
Croatian: Imajte ovaj mogući problem na umu u svim situacijama u kojima biste mogli ugroziti sebe i druge (npr. vožnja automobila ili rukovanje strojevima).
English: • loss of energy and strength
Croatian: • gubitak energije i snage
English: Continue to follow your food and exercise plan.
Croatian: Nastavite provoditi svoj plan prehrane i tjelovježbe.
English: It is not known if this medicine may harm your unborn child.
Croatian: Nije poznato može li ovaj lijek naštetiti Vašem nerođenom djetetu.
English: Do not change your dose unless your doctor has told you to.
Croatian: Nemojte mijenjati dozu ako Vam to nije rekao liječnik.
English: - How to inject this medicine.
Croatian: - Kako injicirati ovaj lijek.
English: Do not throw away.
Croatian: Nemojte ga baciti.
English: Replace the needle and repeat the step above.
Croatian: Zamijenite iglu i ponovite gore navedeni korak.
English: Do not inject another dose.
Croatian: Nemojte injicirati drugu dozu.
English: It will not harm you or affect your dose.
Croatian: Neće Vam naškoditi niti utjecati na Vašu dozu.
English: When the pen is empty, you cannot use it again.
Croatian: Kada se brizgalica isprazni, ne možete je ponovno upotrijebiti.
English: Do not give this medicine to children and adolescents less than 18 years as there is no experience with this medicine in this age group.
Croatian: Nemojte primjenjivati ovaj lijek u djece i adolescenata mlađih od 18 godina, jer nema iskustava s primjenom ovog lijeka u ovoj dobnoj skupini.
English: - Two pre-filled pens are available.
Croatian: - Dostupne su dvije napunjene brizgalice.
English: Lipid profiles should be monitored regularly.
Croatian: Treba redovito kontrolirati lipidni status.
English: Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.2, međutim nije moguće dati preporuku o doziranju.
English: • No.
Croatian: • Ne.
English: Twice daily
Croatian: Dvaput na dan.
English: • You may not have received your full dose.
Croatian: • Možda niste primili cijelu dozu.
English: Weight loss of this rate may have harmful consequences.
Croatian: Ovako brz gubitak težine može imati štetne posljedice.
English: You should see your doctor immediately if you experience symptoms such as
Croatian: Odmah se javite svom liječniku ako primijetite simptome kao što su:
English: This incidence was not statistically significant when adjusted for survival.
Croatian: Ova incidencija nije bila statistički značajna nakon korekcije za preživljenje.
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, as it should not be used during pregnancy.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek, jer se ne smije koristiti tijekom trudnoće.
English: • You are now ready for your first dose of Byetta.
Croatian: • Sada ste spremni za prvu dozu lijeka Byetta.
English: Also contains metacresol.
Croatian: Također sadrži metakrezol.
English: − Some antibiotics may need to be taken an hour before your Byetta injection.
Croatian: - Neke antibiotike ćete možda trebati uzimati jedan sat prije injekcije lijeka Byetta.
English: UNIQUE IDENTIFIER -2D BARCODE
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD
English: What Byetta is and what it is used for
Croatian: Što je Byetta i za što se koristi
English: A small drop of liquid may appear.
Croatian: Možda će se pojaviti kapljica tekućine.
English: Other medicines and Byetta
Croatian: Drugi lijekovi i Byetta
English: • Go to Section 3, Step 3, for instructions on how to inject your first routine dose.
Croatian: • Prijeđite na Dio 3., Korak 3., za upute o tome kako injicirati prvu redovnu dozu.
English: These instructions do not take the place of talking with your healthcare professional about your medical condition or your treatment.
Croatian: Ove upute ne zamjenjuju razgovor sa zdravstvenim radnikom o Vašoj bolesti ili liječenju.
English: This medicine is for you; never share a Byetta pen with others.
Croatian: Ovaj je lijek namijenjen Vama; nikada nemojte dijeliti Byetta brizgalicu s drugim osobama.
English: The safety and efficacy of exenatide in children and adolescents under 18 years of age have not been established (see section 5.2).
Croatian: Sigurnost i djelotvornost eksenatida kod djece i adolescenata mlađih od 18 godina nisu ustanovljene (vidjeti dio 5.2).
English: Animal studies did not indicate direct harmful effects with respect to fertility or pregnancy.
Croatian: Istraživanja na životinjama nisu ukazala izravne štetne učinke u pogledu s obzirom na plodnost ili graviditet.
English: Note: A small air bubble will not harm you or affect your dose.
Croatian: Napomena: Mali mjehurić zraka Vam neće naškoditi niti utjecati na Vašu dozu.
English: Help will be needed by a person trained to use the pen.
Croatian: Bit će im potrebna pomoć osobe koja je obučena za uporabu brizgalice.
English: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA United Kingdom
Croatian: AstraZeneca UK Limited Silk Road Business Park, Macclesfield, Cheshire, SK10 2NA Ujedinjeno Kraljevstvo
English: Spontaneous reports data (unknown denominator)
Croatian: Podaci iz spontanih prijava (nepoznati nazivnik)
English: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co. Clare Ireland
Croatian: Swords Laboratories T/A Lawrence Laboratories Unit 12 Distribution Centre, Shannon Industrial Estate, Shannon, Co.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, or genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza i genotoksičnosti.
English: If you feel you should stop using this medicine, consult your doctor first.
Croatian: Ako smatrate da trebate prestati primjenjivati ovaj lijek, prvo se posavjetujte sa svojim liječnikom.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to  1/10), uncommon ( 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja 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: How can I tell when the injection is complete?
Croatian: Kako ću znati da je injiciranje dovršeno?
English: In the absence of compatibility studies this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja inkompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima.
English: Ask your doctor if the time at which you take any tablets should be changed because this medicine slows stomach emptying and can affect medicines that need to pass through the stomach quickly, e.g.
Croatian: Upitajte svog liječnika trebate li promijeniti vrijeme uzimanja bilo kojih tableta, jer ovaj lijek usporava pražnjenje želuca i može utjecati na lijekove koji moraju brzo proći kroz želudac, npr.
English: Why are there air bubbles in the cartridge?
Croatian: Zašto se u ulošku nalaze mjehurići zraka?
English: Hypoglycaemia may reduce your ability to concentrate.
Croatian: Hipoglikemija može umanjiti sposobnost koncentracije.
English: • Follow these steps to reset your pen for your next injection:
Croatian: • Slijedite ove korake kako biste ponovno namjestili brizgalicu za sljedeće injiciranje:
English: What if I cannot pull, turn, or push the dose knob?
Croatian: Što trebam učiniti ako ne mogu povući, okretati ili pritisnuti gumb za doziranje?
English: • Yes.
Croatian: • Da.
English: Follow the steps next to the matching symbol.
Croatian: Slijedite korake navedene uz odgovarajući simbol.
English: The injection is complete when:
Croatian: Injiciranje je dovršeno:
English: If you use more of this medicine than you should, talk to a doctor or go to a hospital right away.
Croatian: Ako primijenite više ovog lijeka nego što ste trebali, odmah se obratite se liječniku ili otiđite u bolnicu.
English: Rare Very rare Not known
Croatian: Često Manje često Rijetko Vrlo rijetko
English: If you use more Byetta than you should
Croatian: Ako primijenite više lijeka Byetta nego što ste trebali
English: Consult with your healthcare professional about how to handle a partial dose.
Croatian: Posavjetujte se sa zdravstvenim radnikom o tome kako postupiti u slučaju primjene djelomične doze.
English: It should be injected under the skin and not into a vein or into the muscle.
Croatian: Lijek se mora injicirati pod kožu, a ne u venu ili u mišić.
English: These reductions in HbA1c were generally observed at 12 weeks after initiation of treatment.
Croatian: Navedena sniženja HbA1c u pravilu su primijećena u 12. tjednu nakon početka liječenja.
English: • The needle may be clogged, bent, or incorrectly attached.
Croatian: • Igla je možda začepljena, savijena ili nije pravilno pričvršćena.
English: If an injection is missed, the treatment should be continued with the next scheduled dose.
Croatian: Ako se injekcija propusti, liječenje treba nastaviti sljedećom predviđenom dozom.
English: The mean age of subjects was 59 years and the mean duration of diabetes was 12.3 years.
Croatian: Prosječna dob ispitanika iznosila je 59 godina, a prosječno trajanje šećerne bolesti 12,3 godine.