FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Duavive 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 Duavive nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Duavive?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Duavive?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duavive on 16 December 2014.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Duavive na snazi u Europskoj uniji od 16. prosinca 2014.
English: What are the risks associated with Duavive?
Croatian: Koji su rizici povezani s lijekom Duavive?
English: Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out.
Croatian: Vezano uz sigurnu primjenu, dugoročan rizik od endometrijske hiperplazije nije u potpunosti istražen, te je CHMP preporučio provođenje dodatnih ispitivanja.
English: It is not intended to provide practical advice on how to use Duavive.
Croatian: Svrha sažetka nije davati praktične savjete o korištenju lijeka Duavive.
English: This is a summary of the European public assessment report (EPAR) for Duavive.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Duavive.
English: The most common side effect with Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach ache).
Croatian: Najčešće nuspojave lijeka Duavive (mogu se javiti u više od 1 na 10 osoba) su abdominalna bol (bol u trbuhu).
English: It is used in women who still have their uterus (womb) and who cannot be treated with progestogen-containing medicines (medicines derived from the hormone called progesterone).
Croatian: Koristi se u žena koje još uvijek imaju svoj uterus (maternicu) te koje se ne mogu liječiti lijekovima koji sadrže progestogen (lijekovima izvedenima iz hormona naziva progesteron).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duavive's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučilo je da koristi od lijeka Duavive nadmašuju s njim povezane rizike te je preporučilo njegovo odobrenje za korištenje u Europskoj uniji.
English: It must also not be used in women who have, are likely to have or have had breast cancer or other cancers that are known to be oestrogen-dependent.
Croatian: Ne smije se također koristiti u žena koje imaju, za koje je izgledno da su imale ili su imale rak dojke ili druge oblike raka za koje je izgledno da su povezani s estrogenom.
English: Other information about Duavive
Croatian: Ostale informacije o lijeku Duavive
English: Duavive conjugated oestrogens / bazedoxifene
Croatian: Duavive konjugirani estrogeni / bazedoksifen
English: A risk management plan has been developed to ensure that Duavive is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Duavive.
English: Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.
Croatian: Budući da je uočeno terapijsko djelovanje bilo manjih razmjera u odnosu na ono uočeno s alternativnim terapijama (terapijama koje sadrže progestogen, stoga je CHMP zaključio da se Duavive treba rezervirati samo za žene koje ne mogu uzimati alternativne terapije.
English: It must not be used in women who have had a stroke or heart attack.
Croatian: Ne smije se primjenjivati u žena koje su imale moždani udar ili infarkt miokarda.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Duavive, 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 Duavive nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Some women must not use Duavive including those who have had problems with venous thromboembolism (blood clots in the veins) such as deep-vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal-vein thrombosis (a blood clot at the back of the eye), or are at an increased risk of such problems.
Croatian: Određene žene ne smiju koristiti Duavive, uključujući one koje imaju problema s venskom tromboembolijom (krvnim ugrušcima u venama), primjerice duboka venska tromboza (DVT), plućna embolija (krvni ugrušak u plućima) i retinalna venska tromboza (krvni ugrušak u pozadini oka), ili su izloženi povećanom riziku od navedenih problema.
English: It replaces the oestrogen hormones that are no longer produced naturally in women who have been through the menopause, thereby alleviating symptoms such as hot flushes.
Croatian: Zamjenjuje hormone estrogena koji se više ne stvaraju prirodnim putem u žena koje su prošle kroz menopauzu, te tako uklanja simptome poput navala vrućine.
English: Duavive was compared with placebo (a dummy treatment) in two main studies in 996 women who have been through the menopause, investigating the effects on either hot flushes or vulvovaginal atrophy (dryness, irritation and soreness around the genital area).
Croatian: Duavive je uspoređen s placebom (lažnim liječenjem) u dva glavna ispitivanja u 996 žena u postmenopauzi, koja su istražila djelovanje na navale vrućine ili vulvovaginalnu atrofiju (suhoću, nadraženost i bol u blizini genitalnog područja).
English: Because studies with the higher strength combination did not sufficiently show that this strength was more effective than the approved strength of Duavive, the company withdrew its application for the former.
Croatian: Budući da ispitivanjima s kombinacijama većih jačina nije u dostatnoj mjeri potvrđeno da ova jačina ima veći učinak u odnosu na odobrenu jačinu lijeka Duavive, tvrtka je povukla zahtjev za prethodno.
English: How is Duavive used?
Croatian: Kako se Duavive koristi?
English: Duavive is a medicine used for the treatment of symptoms (such as hot flushes) caused by low blood levels of the female hormone oestrogen in women who have been through the menopause.
Croatian: Duavive je lijek koji se koristi za liječenje simptoma (poput navala vrućine) uzrokovanih niskim raznima ženskog hormona estrogena u krvi u žena koje su prošle kroz menopauzu.
English: Treatment with Duavive also led to a greater average fall in the daily severity score of hot flushes than placebo treatment: 0.9 versus 0.3.
Croatian: Liječenje lijekom Duavive također je rezultiralo većim prosječnim padom u dnevnom rezultatu ozbiljnosti navala vrućina u odnosu na liječenje placebom: 0,9 u odnosu na 0,3.
English: For more information about treatment with Duavive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Duavive pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: Similar results were seen with a higher strength of conjugated oestrogen (0.625 mg) plus bazedoxifene 20 mg when compared with placebo.
Croatian: Slični su rezultati uočeni s većim jačinama konjugiranog estrogena (0,625 mg) plus bazedoksifen 20 mg u odnosu na placebo.
English: Duavive can only be obtained with a prescription.
Croatian: Duavive se izdaje samo na liječnički recept.
English: The CHMP also noted that long-term use of Duavive is associated with a risk of stroke and venous thromboembolism which is similar to the risk with conjugated oestrogens and bazedoxifene when used alone.
Croatian: CHMP je također napomenuo da je dugoročna primjena lijeka Duavive povezana s rizikom od moždanog udara i venske tromboembolije što je slično riziku od konjugiranih estrogena i bazedoksifena kada se koriste kao monoterapija.
English: One of the active substances in Duavive, conjugated oestrogens, works as hormone replacement therapy.
Croatian: Jedna od djelatnih tvari lijeka Duavive, konjugirani estrogeni, djeluju kao hormonska zamjenska terapija.
English: Duavive contains two active substances: conjugated oestrogens and bazedoxifene.
Croatian: Duavive sadrži dvije djelatne tvari: konjugirane estrogene i bazedoksifen.
English: However, oestrogens used alone can cause hyperplasia (growth) of the endometrium (lining of the womb) which could lead to endometrial cancer.
Croatian: No, estrogeni koji se koriste kao monoterapija mogu uzrokovati hiperplaziju (rast) endometrijuma (ovojnice maternice) što može rezultirati endometrijskim karcinomom.
English: Duavive therefore also contains the active substance bazedoxifene, which blocks the effects of oestrogens on the womb and so reduces the risk of endometrial cancer.
Croatian: Stoga, Duavive također sadrži djelatnu tvar bazedoksifen, koja inhibira djelovanje estrogena na maternicu te tako smanjuje rizik od endometrijskog karcinoma.
English: Conjugated oestrogens have been available for many years as hormone replacement therapy and bazedoxifene has been authorised in 2009 for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Croatian: Konjugirani estrogeni dostupni su već dugi niz godina kao hormonska zamjenska terapija, a bazedoksifen je odobren za stavljanje u promet 2009. godine za liječenje osteoporoze (bolesti koja čini kosti lomljivima) u žena u postmenopauzi.
English: It is available as modified release tablets (containing 0.45 mg conjugated oestrogens and 20 mg bazedoxifene) which release bazedoxifene immediately and conjugated oestrogens over a longer period of time.
Croatian: Dostupan je kao tablete s prilagođenim oslobađanjem (koje sadrže 0,45 mg konjugiranih estrogena i 20 mg bazedoksifena) koje neposredno oslobađaju bazedoksifen, a konjugirane estrogene tijekom duljeg razdoblja.
English: Duavive was shown to improve the symptoms caused by lack of oestrogen in postmenopausal women when compared with placebo.
Croatian: Utvrđeno je da Duavive poboljšava simptome uzrokovane manjkom estrogena u žena u postmenopauzi u odnosu na placebo.
English: The study looking at the effects of Duavive on vulvovaginal atrophy found an improvement in some of the signs of vaginal atrophy but not in the most bothersome symptoms when compared with placebo.
Croatian: Ispitivanjem kojima je istraženo djelovanje lijeka Duavive na vulvovaginalnu atrofiju utvrđeno je poboljšanje u određenim znakovima vaginalne atrofije, no ne i u slučaju simptoma koji su uzrokovali najviše smetnji bolesnicama u usporedbi s placebom.
English: For practical information about using Duavive, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Duavive pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Duavive have been shown in studies?
Croatian: Koje su koristi lijeka Duavive utvrđene u ispitivanjima?
English: In the study investigating the effects on hot flushes, treatment with Duavive (conjugated oestrogen 0.45 mg and bazedoxifene 20 mg) over 12 weeks reduced the average daily number of moderate and severe hot flushes by 7.6 compared with 4.9 for placebo.
Croatian: U ispitivanju koje je istražilo djelovanje na navale vrućine, terapija lijekom Duavive (konjugirani estrogen 0,45 mg i bazedoksifen 20 mg) primijenjena tijekom 12 tjedana smanjila je dnevni broj umjerenih do ozbiljnih navala vrućine za 7,6 u usporedbi sa 4,9 za placebo.
English: An additional study also looked at the effects of Duavive on osteoporosis.
Croatian: Dodatno je ispitivanje istražilo djelovanje lijeka Duavive na osteoporozu.
English: Duavive is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.
Croatian: Duavive je predviđen za primjenu samo u žena koje se nalaze u postmenopauzi, tako da se ne smije koristi u žena reproduktivne dobi.
English: For the full list of all side effects and restrictions with Duavive, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja za lijek Duavive potražite u uputi o lijeku.
English: How does Duavive work?
Croatian: Kako djeluje Duavive?
English: One of the studies also looked at the effects of Duavive on osteoporosis; however, as there was no benefit of Duavive over the individual components the company withdrew its application for Duavive in the treatment of osteoporosis.
Croatian: No, budući da nema većih koristi od lijeka Duavive u odnosu na pojedinačne komponente, tvrtka je povukla zahtjev za lijek Duavive za liječenje osteoporoze.
English: Further information on NovoEight can be found on the Agency's website: ema.europa.eu/en/medicines/human/EPAR/novoeight.
Croatian: Više informacija o lijeku NovoEight dostupno je na internetskim stranicama Agencije: ema.europa.eu/en/medicines/human/EPAR/novoeight.
English: NovoEight (turoctocog alfa)
Croatian: NovoEight (turoktokog alfa)
English: These inhibitors are antibodies that the immune system (the body's natural defences) produces against factor VIII.
Croatian: Ti su inhibitori antitijela koje imunosni sustav (prirodna obrana tijela) proizvodi protiv faktora VIII.
English: What measures are being taken to ensure the safe and effective use of NovoEight?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka NovoEight?
English: What is NovoEight and what is it used for?
Croatian: Što je NovoEight i za što se koristi?
English: Other information about NovoEight
Croatian: Ostale informacije o lijeku NovoEight
English: An overview of NovoEight and why it is authorised in the EU
Croatian: Pregled informacija o lijeku NovoEight i zašto je odobren u EU-u
English: NovoEight was rated as ‘excellent' or ‘good' at treating 116 of the 126 bleeding episodes.
Croatian: NovoEight je ocijenjen kao „odličan” ili „dobar” u liječenju 116 od 126 epizoda krvarenja.
English: The European Medicines Agency decided that NovoEight'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 NovoEight nadmašuju s njim povezane rizike te da može biti odobren za primjenu u EU-u.
English: When used for the treatment of spontaneous bleeding, NovoEight was rated as ‘excellent' or ‘good' at treating 403 of 499 of the bleeding episodes.
Croatian: Pri primjeni za liječenje spontanih epizoda krvarenja, lijek NovoEight ocijenjen je kao „odličan” ili „dobar” u liječenju 403 od 499 epizoda krvarenja.
English: In the first study involving 150 patients aged 12 years and above, adolescents who used NovoEight to prevent bleeding had an average of 5.55 bleeding episodes per year and adults had an average of 6.68 bleeding episodes per year.
Croatian: U prvom ispitivanju koje je obuhvatilo 150 bolesnika u dobi od 12 godina i starijih, adolescenti koji su primali NovoEight za sprječavanje krvarenja imali su u prosjeku 5,55 epizoda krvarenja godišnje, dok su odrasli u prosjeku iskusili 6,68 epizoda krvarenja godišnje.
English: Hypersensitivity (allergic) reactions can occur rarely with NovoEight and may in some cases progress to severe allergic reactions.
Croatian: Pri primjeni lijeka NovoEight rijetko su prijavljivane reakcije preosjetljivosti (alergijske reakcije), no u nekim se slučajevima mogu razviti ozbiljne alergijske reakcije.
English: As for all medicines, data on the use of NovoEight are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka NovoEight kontinuirano se prate.
English: In addition, 89.4% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Croatian: Nadalje, 89,4 % epizoda krvarenja povuklo se nakon 1 do 2 doze lijeka NovoEight.
English: In the second study involving 63 children less than 12 years of age, children treated with NovoEight had an average of 5.33 bleeding episodes per year.
Croatian: U drugom ispitivanju koje je obuhvatilo 63 djece mlađe od 12 godina, djeca na terapiji lijekom NovoEight iskusila su prosječno 5,33 epizoda krvarenja godišnje.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of NovoEight 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 NovoEight nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: NovoEight can only be obtained with a prescription, and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.
Croatian: NovoEight se izdaje samo na recept, a liječenje je potrebno započeti pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: NovoEight received a marketing authorisation valid throughout the European Union on 13 November
Croatian: Lijek NovoEight dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 13. studenoga
English: What are the risks associated with NovoEight?
Croatian: Koji su rizici povezani s lijekom NovoEight?
English: NovoEight is available for injection into a vein.
Croatian: NovoEight se daje injekcijom kao injekcija u venu.
English: The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient's age and condition.
Croatian: Doza i učestalost liječenja ovise o tome primjenjuje li se za liječenje ili za sprječavanje krvarenja, kao i o težini hemofilije, jačini i mjestu krvarenja te dobi i stanju bolesnika.
English: Side effects reported with NovoEight are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek NovoEight pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The medicine contains the active substance turoctocog alfa.
Croatian: Lijek sadrži djelatnu tvar turoktokog alfa.
English: The active substance in NovoEight, turoctocog alfa, works in the same way as natural factor VIII and helps the blood to clot.
Croatian: Djelatna tvar u lijeku NovoEight, turoktokog alfa, djeluje na isti način kao prirodni faktor VIII te pomaže u zgrušavanju krvi.
English: In addition, 95.2% of the bleeding episodes resolved after 1 to 2 doses of NovoEight.
Croatian: Nadalje, 95,2% epizoda krvarenja povuklo se nakon 1 do 2 doze lijeka NovoEight.
English: For continuing treatment, the doctor may adjust the dose and frequency of injection according to the blood levels of factor VIII.
Croatian: Za nastavak terapije liječnik može prilagoditi dozu i učestalost injekcija na temelju razina faktora VIII u krvi.
English: For more information about using NovoEight, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka NovoEight pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: The Agency concluded that NovoEight is effective for treating and preventing bleeding episodes, with effects similar to other factor VIII products.
Croatian: Agencija je zaključila da je NovoEight učinkovit u liječenju i sprječavanju epizoda krvarenja, s učincima sličnima drugim lijekovima koji sadrže faktor VIII.
English: Why is NovoEight authorised?
Croatian: Zašto je lijek NovoEight odobren?
English: Some patients may develop factor VIII inhibitors, which can cause the medicine to stop working, resulting in a loss of bleeding control.
Croatian: U nekih se bolesnika mogu razviti inhibitori faktora VIII zbog kojih lijek prestaje djelovati, što za posljedicu ima gubitak kontrole nad krvarenjem.
English: The safety profile of NovoEight was also considered similar to other factor VIII products.
Croatian: Sigurnosni profil lijeka NovoEight također se smatra sličnim sigurnosnom profilu drugih lijekova koji sadrže faktor VIII.
English: Patients with haemophilia A lack factor VIII, which prevents blood from clotting and can cause problems such as bleeding in the joints, muscles or internal organs.
Croatian: Bolesnicima s hemofilijom A nedostaje faktor VIII, zbog čega se krv ne može zgrušavati, što uzrokuje probleme poput krvarenja u zglobovima, mišićima ili unutarnjim organima.
English: What benefits of NovoEight have been shown in studies?
Croatian: Koje su koristi od lijeka NovoEight utvrđene u ispitivanjima?
English: How is NovoEight used?
Croatian: Kako se NovoEight koristi?
English: Patients or their carers may be able to inject NovoEight themselves once they have been trained.
Croatian: Nakon obuke bolesnici ili njihovi njegovatelji mogu samostalno davati injekcije lijeka NovoEight.
English: NovoEight is a medicine used to treat and prevent bleeding in patients with haemophilia A an inherited bleeding disorder caused by lack of factor VIII.
Croatian: NovoEight je lijek koji se primjenjuje za liječenje i sprječavanje krvarenja u bolesnika s hemofilijom A (nasljednim poremećajem krvarenja uzrokovanim nedostatkom faktora VIII).
English: How does NovoEight work?
Croatian: Kako djeluje NovoEight?
English: NovoEight was effective at preventing and treating bleeding episodes in two main studies involving a total of 213 patients with haemophilia A. Neither study compared NovoEight with any other medicines.
Croatian: Učinkovitost lijeka NovoEight u sprječavanju i liječenju epizoda krvarenja utvrđena je u dvama glavnim ispitivanjima u kojima je sudjelovalo ukupno 213 bolesnika s hemofilijom A.
English: NovoEight must not be used in patients who are allergic to hamster protein.
Croatian: Lijek NovoEight ne smije se primjenjivati u bolesnika koji su alergični na bjelančevinu hrčka.
English: NovoEight is used to correct the factor VIII deficiency by replacing the missing factor VIII, thereby giving temporary control of the bleeding disorder.
Croatian: NovoEight nadomješta nedostatak faktora VIII u organizmu, čime se omogućuje privremena kontrola poremećaja krvarenja.
English: This makes it hard to breathe.
Croatian: To otežava disanje.
English: Avoid breathing through your nose.
Croatian: Izbjegavajte disanje kroz nos.
English: This leaflet was last revised in .
Croatian: Ova uputa je zadnji puta revidirana u .
English: Sit in a relaxed, upright position.
Croatian: Sjednite u opuštenom, uspravnom položaju.
English: All these may be signs of an allergic reaction.
Croatian: Sve to mogu biti znakovi alergijske reakcije.
English: What if I need to stop my treatment before I've finished?
Croatian: Što ako moram prekinuti liječenje prije dovršetka?
English: Use this medicine immediately after preparation.
Croatian: Primijenite ovaj lijek neposredno nakon priprave.
English: In-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika.
English: This pack is not to be sold separately.
Croatian: Ovo pakiranje ne smije se prodavati zasebno.
English: Overall, 539 patients (78% adults) were treated in these studies.
Croatian: Ukupno je 539 bolesnika (78% odraslih) bilo liječeno u ovim ispitivanjima.
English: Begin your treatment.
Croatian: Početak liječenja.
English: The following pack sizes are available:
Croatian: Dostupna su pakiranja sljedećih veličina:
English: Adults and children 6 years and older
Croatian: Odrasli i djeca u dobi od 6 godina i starija
English: What Cayston is and what it is used for
Croatian: Što je Cayston i za što se koristi
English: Currently available data are described in section 5.1 but no recommendation on posology can be given.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1 međutim nije moguće dati preporuku o doziranju.