FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant presented data from a main study involving 135 patients with systemic mastocytosis who had severe symptoms including at least one of the following four: itching, hot flushes, depression and tiredness.
Croatian: Podnositelj zahtjeva dostavio je podatke iz glavnog ispitivanja koje je obuhvaćalo 135 bolesnika oboljelih od sistemske mastocitoze koji su imali teške simptome, uključujući barem jedan od sljedećih četiriju simptoma: svrbež, navale vrućine, depresiju i umor.
English: Masipro was expected to be used to treat adults with systemic mastocytosis, a disease in which there are too many mast cells (a type of white blood cell) in the skin, bones and various body organs, causing symptoms such as itchy skin, hot flushes, palpitations, fainting, bone pain, tiredness, vomiting, diarrhoea and depression.
Croatian: Lijek Masipro trebao se primjenjivati u liječenju odraslih osoba oboljelih od sistemske mastocitoze, bolesti pri kojoj se u koži, kostima i različitim organima nalazi previše mastocita (vrsta bijelih krvnih stanica), što uzrokuje simptome kao što su svrbež kože, navale vrućine, palpitacije, nesvjestica, bol u kostima, umor, povraćanje, proljev i depresija.
English: The active substance in Masipro, masitinib, is a tyrosine kinase inhibitor.
Croatian: Djelatna tvar lijeka Masipro, masitinib, inhibitor je tirozin-kinaze.
English: This means that it blocks enzymes known as tyrosine kinases, which can be found in some receptors in mast cells including
Croatian: To znači da blokira enzime poznate pod nazivom tirozin-kinaze, koji se mogu pronaći u nekim receptorima mastocita, uključujući one koji su uključeni u poticanje rasta i dijeljenja stanica.
English: Masipro is a medicine that contains the active substance masitinib.
Croatian: Masipro je lijek koji sadrži djelatnu tvar masitinib.
English: The company informed the CHMP that there are no consequences for patients in clinical trials or compassionate use programmes.
Croatian: Tvrtka je obavijestila CHMP da nema posljedica za bolesnike koji su uključeni u klinička ispitivanja ili programe milosrdnog davanja lijekova.
English: What was Masipro expected to be used for?
Croatian: Za što se Masipro trebao primjenjivati?
English: Masipro was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 16 November 2004 for mastocytosis.
Croatian: Masipro je uvršten na popis lijekova za rijetke bolesti dana 16. studenog 2004. za mastocitozu.
English: Therefore, the CHMP was of the opinion that the benefits of Masipro did not outweigh its risks and recommended that it be refused marketing authorisation.
Croatian: Stoga je CHMP smatrao da koristi lijeka Masipro ne nadmašuju s njim povezane rizike te je preporučio odbijanje odobrenja za stavljanje lijeka u promet.
English: On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Masipro, intended for the treatment of systemic mastocytosis.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) donio je negativno mišljenje i preporučio odbijanje odobrenja za stavljanje u promet lijeka Masipro, koji je namijenjen liječenju sistemske mastocitoze.
English: Further information on the orphan designation can be found here.
Croatian: Ovdje možete pronaći dodatne informacije o uvrštenju lijekova za rijetke bolesti.
English: EU/1/98/069/020 Plavi
Croatian: blister (PVC/PVDC/Al) 84 tablete blister (Al/alu)
English: Package size
Croatian: 84 tablete
English: They involved over 5,000 people from 4 years of age.
Croatian: Ispitivanjima je bilo obuhvaćeno više od 5 000 osoba od navršenih 4 godine nadalje.
English: This will help to protect against the disease caused by the virus.
Croatian: To pomaže u zaštiti od bolesti koju uzrokuje virus.
English: The immune system will then be able to respond more quickly when it is exposed to the virus again.
Croatian: Imunosni sustav može zatim brže reagirati pri ponovnom izlaganju virusu.
English: The vaccine can only be obtained with a prescription and should be used according to official recommendations.
Croatian: Cjepivo se izdaje samo na liječnički recept te se treba primjenjivati u skladu sa službenim preporukama.
English: Further information on Flucelvax Tetra can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Flucelvax-tetra
Croatian: Više informacija o lijeku Flucelvax Tetra nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Flucelvax-tetra
English: Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season in the northern hemisphere.
Croatian: Svake godine Svjetska zdravstvena organizacija (SZO) izdaje preporuke o sojevima virusa gripe koje bi trebalo uključiti u cjepiva za nadolazeću sezonu gripe na sjevernoj hemisferi.
English: When a person is given the vaccine, the immune system recognises the virus proteins as ‘foreign' and makes defences against them.
Croatian: Nakon što osoba primi cjepivo, imunosni sustav prepoznaje proteine virusa kao „strane” te protiv njih proizvodi obranu.
English: The most common side effects with Flucelvax Tetra (which may affect more than 1 in 10 people) are pain at the injection site, reddening of the skin and hardening at the injection site, headache, tiredness and muscle pain.
Croatian: Najčešće nuspojave pri primjeni lijeka Flucelvax Tetra (koje se mogu pojaviti u više od 1 na 10 osoba) su bol na mjestu primjene injekcije, crvenilo kože i otvrdnuće na mjestu primjene injekcije, glavobolja, umor i bol u mišićima.
English: The recommended dose is one single injection into a muscle (0.5 ml), preferably in the upper arm.
Croatian: Preporučena doza je jedna injekcija (od 0,5 ml) koja se ubrizgava u mišić , po mogućnosti u nadlakticu.
English: Historically, seasonal flu vaccines have contained three strains of flu: one influenza A-H1N1 virus, one influenza AH3N2 virus, and one influenza B virus.
Croatian: Povijesno gledano, sezonska cjepiva protiv gripe sadržavala su tri soja gripe: jedan virus influence AH1N1, jedan virus influence A-H3N2 i jedan virus influence B.
English: Flucelvax Tetra contains proteins from four different inactivated influenza A and B virus strains (type A-H1N1, type A-H3N2 and two type B strains), chosen based on the official recommendation for the annual flu season.
Croatian: Flucelvax Tetra sadržava žive proteine iz četiriju različitih inaktiviranih sojeva virusa influence A i B (tip A-H1N1, tip A-H3N2 i dva tipa soja B), odabranih na temelju službene preporuke za godišnju sezonu gripe.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Flucelvax Tetra 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 Flucelvax Tetra nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Side effects reported with Flucelvax Tetra are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Flucelvax Tetra pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What measures are being taken to ensure the safe and effective use of Flucelvax Tetra?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Flucelvax Tetra?
English: One of the vaccines was Optaflu, a previously authorised vaccine which contains three of the four strains of influenza in Flucelvax Tetra and whose effectiveness in preventing flu is well established.
Croatian: Jedno od cjepiva bilo je Optaflu, prethodno odobreno cjepivo koje sadržava tri od četiriju sojeva influence u cjepivu Flucelvax Tetra i čija je učinkovitost u sprječavanju gripe dobro utvrđena.
English: For more information about using Flucelvax Tetra, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Flucelvax Tetra pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The European Medicines Agency therefore decided that Flucelvax Tetra's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Flucelvax Tetra nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Flucelvax Tetra is available as a suspension for injection in a pre-filled syringe.
Croatian: Lijek Flucelvax Tetra dostupan je kao suspenzija za injekciju u napunjenoj štrcaljki.
English: The viruses used to produce Flucelvax Tetra are grown in mammalian cells.
Croatian: Virusi koji se upotrebljavaju za dobivanje cjepiva Flucelvax Tetra uzgajaju se u stanicama sisavaca.
English: As for all medicines, data on the use of Flucelvax Tetra are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Flucelvax Tetra kontinuirano se prate.
English: Other information about Flucelvax Tetra
Croatian: Ostale informacije o lijeku Flucelvax Tetra
English: Flucelvax Tetra contains proteins from the surface of four different strains of flu virus.
Croatian: Flucelvax Tetra sadržava proteine iz površine četiriju različitih sojeva virusa gripe.
English: An overview of Flucelvax Tetra and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Flucelvax Tetra i zašto je odobren u EU-u
English: Results showed that Flucelvax Tetra lead to similar levels of protective antibodies as the comparator vaccines in people from 9 years of age.
Croatian: Rezultati su pokazali da primjenom cjepiva Flucelvax Tetra nastaje slična razina zaštitnih protutijela, kao i kod usporednih cjepiva u osoba starijih od 9 godina.
English: The composition of Flucelvax Tetra will be updated annually according to WHO and EU recommendations.
Croatian: Flucelvax Tetra svake će se godine mijenjati kako bi se uskladio s preporukama SZO-a i EU-a.
English: Why is Flucelvax Tetra authorised in the EU?
Croatian: Zašto je lijek Flucelvax Tetra odobren u EU-u?
English: What is Flucelvax Tetra and what is it used for?
Croatian: Što je Flucelvax Tetra i za što se primjenjuje?
English: Flucelvax Tetra is as effective as the comparator vaccines at stimulating immune responses against the 4 strains included in the vaccine in people from 9 years of age.
Croatian: Lijek Flucelvax Tetra jednako je učinkovit kao i usporedna cjepiva u poticanju imunosnog sustava na odgovor protiv četiriju sojeva uključenih u cjepivo u osoba starijih od 9 godina.
English: The other vaccine is based on Optaflu but contains the other B strain of Flucelvax Tetra.
Croatian: Drugo se cjepivo temelji na cjepivu Optaflu, no sadržava drugi soj virusa influence B iz cjepiva Flucelvax Tetra.
English: What are the risks associated with Flucelvax Tetra?
Croatian: Koji su rizici povezani s lijekom Flucelvax Tetra?
English: Flucelvax Tetra is a vaccine.
Croatian: Flucelvax Tetra je cjepivo.
English: Flucelvax Tetra is a vaccine used to protect adults and children from 9 years of age against influenza (flu).
Croatian: Flucelvax Tetra je cjepivo za sprječavanje influence (gripe) u odraslih i djece od navršenih 9 godina nadalje.
English: Together the comparator vaccines contain the four strains of influenza in Flucelvax Tetra.
Croatian: Usporedna cjepiva zajedno sadržavaju četiri soja virusa influence iz cjepiva Flucelvax Tetra.
English: Influenza is mainly caused by two kinds of influenza virus, known as influenza A and B. Each of these circulate as different strains and subtypes, which change over time.
Croatian: Svaka od ove dvije vrste virusa cirkulira kao drukčiji soj i podtip, koji se mijenja tijekom vremena.
English: The studies assessed the ability of the vaccines to stimulate an immune response against influenza, by measuring the production of protective antibodies.
Croatian: U ispitivanjima se mjerenjem proizvodnje zaštitnih protutijela ocjenjivala sposobnost cjepiva da potakne imunosni odgovor protiv influence.
English: For the full list of side effects and restrictions with Flucelvax Tetra, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Flucelvax Tetra potražite u uputi o lijeku.
English: Flucelvax Tetra includes an additional B virus strain.
Croatian: Cjepivo Flucelvax Tetra obuhvaća dodatni soj virusa influence B.
English: How does Flucelvax Tetra work?
Croatian: Kako djeluje Flucelvax Tetra?
English: What benefits of Flucelvax Tetra have been shown in studies?
Croatian: Koje su koristi od lijeka Flucelvax Tetra utvrđene u ispitivanjima?
English: Flucelvax Tetra was compared with two comparator vaccines in 2 main studies.
Croatian: U dvama glavnim ispitivanjima cjepivo Flucelvax Tetra uspoređeno je s dvama usporednim cjepivima.
English: How is Flucelvax Tetra used?
Croatian: Kako se Flucelvax Tetra koristi?
English: The inclusion of two influenza B strains in Flucelvax Tetra can provide a broader protection against influenza B. In terms of safety, side effects with Flucelvax Tetra are similar to those observed with vaccines containing three influenza strains and are mostly mild to moderate in severity.
Croatian: U pogledu sigurnosti primjene, nuspojave lijeka Flucelvax Tetra slične su onima uočenim pri primjeni cjepiva koja sadržavaju tri soja influence te su uglavnom blage do umjerene.
English: Liprolog Mix is a mixture of these two formulations.
Croatian: Liprolog Mix je kombinacija ove dvije formulacije.
English: The full EPAR for Liprolog can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Liprolog nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Patients can inject themselves with this medicine if they have been trained appropriately.
Croatian: Bolesnici si mogu sami injicirati lijek ako su prošli odgovarajuću obuku.
English: What measures are being taken to ensure the safe and effective use of Liprolog?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Liprolog?
English: • Liprolog: insulin lispro solution, available in a standard or a higher strength (100 or 200 units/ml);
Croatian: • Liprolog: otopina inzulina lispro, dostupna u standardnoj ili snažnijoj jačini (100 ili 200 jedinica/ml);
English: This is a summary of the European public assessment report (EPAR) for Liprolog.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Liprolog.
English: By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.
Croatian: Kontrolirajući razine glukoze u krvi smanjuju se simptomi i komplikacije šečerne bolesti.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Liprolog on 1 August 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Liprolog na snazi u Europskoj uniji od 1. kolovoza 2001.
English: Liprolog was originally studied in eight clinical trials including 2951 patients with type 1 diabetes (when the body cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively).
Croatian: Liprolog je prvotno ispitan u osam kliničkih ispitivanja koja su obuhvatila 2951 bolesnika sa šećernom bolesti tipa 1 (kada tijelo ne može proizvoditi inzulin) ili šećernom bolesti tipa 2 (kada tijelo ne može učinkovito proizvoditi inzulin).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Liprolog.
Croatian: Pojašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet i svoje preporuke u vezi s uvjetima za uporabu za lijek Liprolog.
English: For more information about treatment with Liprolog, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Liprolog pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: What is the risk associated with Liprolog?
Croatian: Koji su rizici povezani s lijekom Liprolog?
English: Insulin lispro is very slightly different from human insulin.
Croatian: Inzulin lispro se neznatno razlikuje od ljudskog inzulina.
English: Liprolog Mix, Liprolog Basal and Liprolog 200 units/ml should never be given into a vein.
Croatian: Liprolog Mix, Liprolog Basal i Liprolog 200 jedinica/ml ne smiju se nikada primjenjivati u venu.
English: Diabetes is a disease in which the body does not produce enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Croatian: Šećerna bolest je bolest u slučaju koje tjelo ne proizvodi dovoljnu količinu inzulina za kontrolu razina glukoze u krvi ili u slučaju kada tijelo ne može učinkovito iskoristiti inzulin.
English: Liprolog 100 units/ml may also be given by continuous infusion using an insulin pump or into a vein.
Croatian: Liprolog 100 jedinica/ml može se primjenivati kontinuiranom infuzijom primjenom inzulinske pumpe ili u venu.
English: Liprolog insulin lispro
Croatian: Liprolog inzulin lispro
English: Liprolog and Liprolog Mix are normally given shortly before a meal, but they can be given just after a meal if necessary.
Croatian: Mix se normalno primjenjuju neposredno prije obroka, no mogu se primjeniti i neposredno nakon obroka, ukoliko je to potrebno.
English: The active substance in Liprolog, insulin lispro, is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce insulin lispro.
Croatian: Djelatna tvar lijeka Liprolog, inzulin lispro, proizvodi se metodom poznatom pod nazivom „tehnologija rekombinatne DNK“: proizvode ga bakterije u koje je umetnut gen (DNK), zbog kojeg proizvode inzulin lispro.
English: Studies also looked at the use of Liprolog in 542 patients aged between two and 19 years, and the use of Liprolog in combination with sulphonylureas.
Croatian: Ispitivanja su također istražila primjenu lijeka Liprolog u 542 bolesnika u dobi između dvije i 19 godina, te primjenu lijeka u kombinaciji sa sulfonilurejima.
English: Why has Liprolog been approved?
Croatian: Zašto je Liprolog odobren?
English: Insulin lispro is available as Liprolog in the soluble form, which acts more or less immediately after injection, and as Liprolog Basal in the ‘protamine suspension' form, which is absorbed much more slowly so that it works for longer.
Croatian: Inzulin lispro dostupan je kao Liprolog u topivom obliku, koji djeluje više ili manje neposredno nakon ubrizgavanja, te kao Liprolog Basal u obliku „suspenzije protamina“, koji se apsorbira mnogo sporije tako da dulje djeluje.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Croatian: Zamjenski inzulin djeluje na isti način kao i inzulin koji se prirodno proizvodi i pomaže glukozi da uđe u stanice iz krvi.
English: LiprologLiprolog doses might need to be adjusted when given with other medicines that may have an effect on blood glucose levels.
Croatian: Postoji mogućnost potrebe za prilagodbom doze lijeka Liprolog u slučaju primjene s ostalim lijekovima koji mogu imati učinak na razine glukoze u krvi.
English: A risk management plan has been developed to ensure that Liprolog is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Liprolog.
English: Liprolog is a replacement insulin which is very similar to the insulin made by the body.
Croatian: Liprolog je zamjenski inzulin koji je vrlo sličan inzulinu kojeg proizvodi tijelo.
English: Liprolog 200 units/ml must only be injected under the skin, using the KwikPen device in which it is supplied.
Croatian: Liprolog 200 jedinica/ml smije se ubrizgavati samo supkutano primjenom uređaja KwikPen, u kojem se isporučuje.
English: The studies measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled, and ‘fasting' blood glucose levels (measured when the patient had not eaten for at least eight hours).
Croatian: Ispitivanja su izmjerila razine tvari u krvi naziva glikozilirani hemoglobin (HbA1c), koji ukazuju na stupanj kontrole glukoze u krvi, i razine glukoze u krvi natašte (izmjereno u trenutku kada bolesnik nije jeo najmanje osam sati).
English: • Liprolog Basal: insulin lispro protamine suspension;
Croatian: • Liprolog Basal: suspenzija inzulina lispro protamina;
English: The difference means that insulin lispro is absorbed faster by the body than human regular insulin, and can therefore act faster.
Croatian: Razlika je u tome da tijelo brže apsorbira inzulin lispro u odnosu na normalan ljudski inzulin te stoga ovaj inzulin može brže djelovati.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Liprolog, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Liprolog nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is Liprolog?
Croatian: Što je Liprolog?
English: Other information about Liprolog
Croatian: Ostale informacije o lijeku Liprolog
English: Liprolog can be used with a longer-acting insulin or with sulphonylureas (a group of diabetes medicines that are taken by mouth).
Croatian: Liprolog se može koristiti s dugodjelujućim inzulinom ili sa sulfonilurejima (grupom lijekova za šečernu bolest koji se uzimaju peroralno).
English: In addition, the company that makes Liprolog has provided information to patients and healthcare professionals to remind them that there are two strengths of Liprolog and to advise them on how to use them safely to avoid medication errors.
Croatian: Nadalje, proizvođač lijeka Liprolog dostavio je informacije bolesnicima i zdravstvenim djelatnicima kako bi ih podsjetio da postoje dvije jačine lijeka Liprolog, te savjete o sigurnoj primjeni kako bi se izbjegle pogreške prilikom primjene lijeka.
English: The Committee for Medicinal products for Human Use (CHMP) decided that Liprolog's benefits are greater than its risks for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis, and for the initial stabilisation of diabetes mellitus.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Liprolog nadmašuju s njim povezane rizike u slučaju liječenja bolesnika sa šećernom bolešću kojima je za održavanje normalne homeostaze glukoze potreban inzulin i za početnu stabilizaciju šećerne bolesti.
English: Liprolog is supplied in vials, cartridges and prefilled pens (Liprolog KwikPen).
Croatian: Liprolog se isporučuje u bočicama, ulošcima i napunjenim brizgalicama (Liprolog KwikPen).
English: The effectiveness of Liprolog was compared with that of Humulin R (a soluble recombinant DNA human insulin), when added to long-acting insulins given once or twice a day.
Croatian: Djelotvornost lijeka Liprolog uspoređena je s djelotvornošću lijeka Humulin R (topivim humanin inzulinom rekombinantne DNK) prilikom dodavanja dugodjelujućih inzulina jednom ili dva put na dan.
English: Liprolog is a range of solutions and suspensions for injection.
Croatian: Liprolog obuhvaća raspon otopina i suspenzija za injekciju.