FrancophonIA/ELRC3.0 huggingface dataset:
English: Name and address of the manufacturer responsible for batch release Nycomed Danmark ApS
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Blood calcium increased Uncommon
Croatian: Povećanje serumskog kalcija Manje često
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1.61 mg parathyroid hormone and 1.13 ml solvent (14 doses)
Croatian: 1,61 mg paratireoidnog hormona i 1,13 ml otapala (14 doza) OSTALO
English: Measuring of the calcium levels in the blood and/or urine Your doctor will check your response to the treatment at regular intervals.
Croatian: Vaš će liječnik redovito kontrolirati odgovor na terapiju.
English: Citric acid monohydrate Sodium chloride
Croatian: Prašak manitol citratna kiselina hidrat natrijev klorid kloridna kiselina, razrijeđena (za prilagodbu pH)
English: If you get any side effects talk to your doctor or pharmacist.
Croatian: Ako primjetite bilo koju nuspojavu obavijestite svog liječnika ili ljekarnika.
English: SUBSTANCE AND MANUFACTURING AUTHORISATION
Croatian: OBLIK I SADRŽAJ
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Preotact 100 micrograms powder and solvent for solution for injection Parathyroid hormone
Croatian: Uputa o lijeku: Informacija za korisnika Preotact 100 mikrograma prašak i otapalo za otopinu za injekciju u napunjenoj brizgalici Paratireoidni hormon
English: What Preotact contains -The active substance is parathyroid hormone.
Croatian: Djelatna tvar je paratireoidni hormon.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 1.61 mg parathyroid hormone corresponding to 14 doses.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNIH TVARI Svaka napunjena brizgalica sadrži 1,61 mg paratireoidnog hormona što odgovara 14 doza.
English: NAME OF THE MEDICINAL PRODUCT Preotact 100 micrograms powder and solvent for solution for injection in a pre-filled pen.
Croatian: Preotact 100 mikrograma prašak i otapalo za otopinu za injekciju u napunjenoj brizgalici
English: • You can store the mixed pre-filled pen for up to 7 days at room temperature, between 2-25°C.
Croatian: • Napunjena brizgalica u kojoj je lijek izmiješan se smije čuvati do 7 dana na sobnoj temperaturi,
English: Renal and urinary disorders Very common
Croatian: Konstipacija Dispepsija Dijarea
English: General disorders and administration site conditions Common
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: Headache
Croatian: Utjecaj
English: This overview was last updated in 09-2014.
Croatian: Ovaj sažetak je posljednji put ažuriran u 09. 2014.
English: Further information on Eliquis can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Više informacija o lijeku Eliquis nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Thrombin is central to the process of blood clotting.
Croatian: Trombin ima ključnu ulogu u procesu zgrušavanja krvi.
English: This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin.
Croatian: To znači da onemogućuje djelovanje faktora Xa, enzima koji sudjeluje u proizvodnji trombina.
English: What measures are being taken to ensure the safe and effective use of Eliquis?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Eliquis?
English: It is available as tablets (2.5 mg, 5 mg).
Croatian: Lijek Eliquis dostupan je u obliku tableta (2,5 mg, 5 mg).
English: For more information about using Eliquis, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Eliquis, pogledajte uputu o lijeku ili se obratite liječniku ili ljekarniku.
English: Eliquis (apixaban)
Croatian: Eliquis (apiksaban)
English: Eliquis received a marketing authorisation valid throughout the EU on 18 May 2011.
Croatian: Lijek Eliquis dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 18. svibnja 2011.
English: The most frequent side effects with Eliquis (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haemorrhage (bleeding), haematoma (a collection of blood under the skin), contusion (bruising), nausea (feeling sick), low blood pressure (hypotension), epistaxis (nose bleeds), haematuria (blood in urine), low blood platelet counts (thrombocytopenia), blood tests showing alanine aminotransferase and gamma-glutamyltransferase increase and skin rash.
Croatian: Najčešće nuspojave koje nastaju uzimanjem lijeka Eliquis (zabilježene u 1 do 10 bolesnika na 100) jesu anemija (niski broj crvenih krvnih stanica), hemoragija (krvarenje), hematom (nakupljanje krvi ispod kože), kontuzija (modrice), mučnina (osjećaj slabosti), niski krvni tlak (hipotenzija), epistaksa (krvarenje iz nosa), hematurija (krv u mokraći), niski broj trombocita (trombocitopenija), krvne pretrage koje ukazuju na povišenje aspartat aminotransferaze, povišenje gama-glutamiltransferaze i kožni osip.
English: Similarly, patients with atrial fibrillation are at high risk of clots forming in the heart, which can reach the brain where they can cause a stroke.
Croatian: Slično tome, bolesnici s fibrilacijom atrija izloženi su visokom riziku od stvaranja ugrušaka u srcu, koji mogu doći do mozga i uzrokovati moždani udar.
English: Other information about Eliquis
Croatian: Ostale informacije o lijeku Eliquis
English: By blocking factor Xa, it reduces the levels of thrombin in the blood, which reduces the risk of blood clots forming in the arteries and veins.
Croatian: Blokiranjem faktora Xa smanjuje razine trombina u krvi, čime se smanjuje rizik od stvaranja krvnih ugrušaka u arterijama i venama.
English: Eliquis must not be used in patients who are actively bleeding, or who have liver disease which leads to problems with blood clotting and an increased risk of bleeding.
Croatian: Eliquis se ne smije primjenjivati u bolesnika s aktivnim krvarenjem ili koji imaju bolest jetre koja uzrokuje probleme sa zgrušavanjem krvi i povećani rizik od krvarenja.
English: The recommended dose is one 2.5 mg tablet taken by mouth twice a day, usually for over one month (32 to 38 days) after a hip replacement or for 10 to 14 days after a knee replacement.
Croatian: Preporučena doza je jedna tableta od 2,5 mg peroralno dvaput na dan, najčešće tijekom više od mjesec dana (32 do 38 dana) nakon ugradnje umjetnog kuka, odnosno tijekom 10 do 14 dana nakon ugradnje umjetnog koljena.
English: The company that markets Eliquis will provide educational material for healthcare professionals expected to prescribe Eliquis that addresses the risk of bleeding during treatment.
Croatian: Tvrtka koja stavlja lijek Eliquis u promet dostavit će edukativne materijale za zdravstvene radnike za koje se očekuje da će propisivati lijek Eliquis s informacijama o upravljanju rizikom od krvarenja tijekom liječenja.
English: Side effects reported with Eliquis are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Eliquis pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What is Eliquis and what is it used for?
Croatian: Što je Eliquis i za što se primjenjuje?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eliquis have also 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 Eliquis nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is used in patients who have one or more risk factors, such as having had a previous stroke, having high blood pressure, diabetes, heart failure or being 75 years old or over.
Croatian: Primjenjuje se u bolesnika s jednim ili više čimbenika rizika, kao što su prethodna epizoda moždanog udara, visoki krvni tlak, dijabetes, zatajenje srca ili starost iznad 75 godina.
English: The European Medicines Agency decided that Eliquis' 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 Eliquis nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Patients undergoing hip or knee replacement surgery, who have had a recent trauma, or are confined to bed are at a high risk of blood clots forming in the veins, which can be dangerous and even fatal if they move to another part of the body such as the lungs.
Croatian: Bolesnici na kojima se izvodi zahvat ugradnje umjetnog kuka ili koljena, koji su nedavno doživjeli traumu ili moraju ležati, izloženi su visokom riziku od krvnih ugrušaka koji nastaju u venama, što može biti opasno, pa čak i smrtonosno ako prijeđu u neki drugi dio tijela, kao što su pluća.
English: As for all medicines, data on the use of Eliquis are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Eliquis kontinuirano se prate.
English: Some of these side effects are not seen with all the uses of Eliquis.
Croatian: Neke od tih nuspojava nisu uočene sa svim oblicima primjene lijeka Eliquis.
English: In patients undergoing a knee replacement, the corresponding numbers were 15% (147 out of 976) for Eliquis compared with 24% (243 out of 997) for enoxaparin.
Croatian: U bolesnika koji su prošli zahvat ugradnje umjetnog koljena odgovarajuće brojke iznosile su 15 % (147 od 976) za Eliquis u usporedbi s 24 % (243 od 997) za enoksaparin.
English: For patients who have had a hip or knee replacement, treatment with Eliquis should be started 12 to 24 hours after the operation.
Croatian: Bolesnici na kojima je izveden zahvat ugradnje umjetnog kuka ili koljena trebali bi započeti liječenje lijekom Eliquis 12 do 24 sata nakon zahvata.
English: 2.3% of patients taking Eliquis (2.5 mg twice a day) experienced a clot or died, compared with 9.3% of patients taking placebo.
Croatian: 2,3 % bolesnika koji su uzimali Eliquis (2,5 mg dvaput dnevno) doživjelo je ugrušak ili je umrlo, u usporedbi s 9,3 % bolesnika koji su uzimali placebo.
English: The yearly rates in the second study were 1.6% for patients taking Eliquis and 3.6% for patients taking aspirin.
Croatian: Godišnje stope u drugom ispitivanju iznosile su 1,6 % za bolesnike koji su uzimali Eliquis, odnosno 3,6 % za bolesnike koji su uzimali aspirin.
English: Eliquis was also effective at treating deep vein thrombosis and pulmonary embolism and preventing their reoccurrence in two main studies.
Croatian: Eliquis je također bio učinkovit u liječenju duboke venske tromboze i plućne embolije i sprječavanju njihova ponavljanja u dvama glavnim ispitivanjima.
English: An overview of Eliquis and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Eliquis i zašto je odobren u EU-u
English: Eliquis can only be obtained with a prescription.
Croatian: Eliquis se izdaje samo na liječnički recept.
English: Why is Eliquis authorised in the EU?
Croatian: Zašto je lijek Eliquis odobren u EU-u?
English: For the treatment of deep vein thrombosis and pulmonary embolism, the recommended dose is 10 mg twice a day for the first week, followed by 5 mg twice a day for at least 3 months.
Croatian: Kod liječenja duboke venske tromboze i plućne embolije preporučena doza iznosi 10 mg dvaput dnevno tijekom prvog tjedna, nakon čega slijedi 5 mg dvaput dnevno najmanje 3 mjeseca.
English: The medicine must also not be used in patients with conditions putting them at risk of major bleeding, such as an ulcer in the gut, or in patients being treated with other anticoagulant medicines except in specific circumstances (see summary of product characteristics).
Croatian: Nadalje, lijek se ne smije primjenjivati kod bolesnika koji pate od stanja zbog kojih su pod rizikom od značajnog krvarenja, kao što je čir na crijevima, ili koji se liječe drugim antikoagulansima, osim u određenim okolnostima (vidjeti sažetak opisa svojstava lijeka).
English: Additionally, Eliquis is used to prevent stroke (caused by blood clots in the brain) and blood clots in other organs in adults with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Croatian: Dodatno, Eliquis se primjenjuje za sprječavanje moždanog udara (izazvanog krvnim ugrušcima u mozgu) i krvnih ugrušaka u drugim organima u odraslih bolesnika s fibrilacijom atrija (nepravilnim brzim kontrakcijama gornjih srčanih šupljina).
English: What are the risks associated with Eliquis?
Croatian: Koji su rizici povezani s lijekom Eliquis?
English: It is also used in adults to treat deep vein thrombosis (blood clot in a deep vein, usually in the leg) and pulmonary embolism (clot in a blood vessel supplying the lungs), and to prevent their reoccurrence.
Croatian: Također se primjenjuje u odraslih osoba za liječenje duboke venske tromboze (krvnog ugruška u dubokoj veni, najčešće u nozi) i plućne embolije (ugruška u krvnim žilama koje opskrbljuje pluća) i kako bi se spriječilo njihovo ponavljanje.
English: 2.3% of patients treated with Eliquis had a clot or died, compared with 2.7% of patients treated with enoxaparin plus warfarin, showing that Eliquis was as effective as the comparator treatment.
Croatian: 2,3 % bolesnika liječenih lijekom Eliquis doživjelo je ugrušak ili je umrlo, u usporedbi s 2,7 % bolesnika liječenih enoksaparinom uz varfarin, što pokazuje da je Eliquis učinkovit kao komparator.
English: For patients with atrial fibrillation at risk of stroke or blood clots, the recommended dose is 5 mg taken twice a day.
Croatian: Za bolesnike s fibrilacijom atrija kod kojih postoji rizik od moždanog udara ili krvnih ugrušaka preporučena doza iznosi 5 mg dvaput dnevno.
English: Eliquis was effective at preventing blood clots in the veins following a hip or knee replacement in two main studies involving a total of 8,464 patients.
Croatian: Eliquis je bio učinkovit u sprječavanju krvnih ugrušaka u venama nakon kirurškog zahvata ugradnje umjetnog kuka ili koljena u dvama glavnim ispitivanjima koja su obuhvaćala ukupno 8 464 bolesnika.
English: In the treatment study conducted in 5,395 patients, Eliquis was compared with enoxaparin followed by warfarin; the main measure of effectiveness was based on the number of patients who either had blood clots in the veins of the legs or lungs or died because of this during the treatment period.
Croatian: U ispitivanju liječenja provedenom na 5 395 bolesnika Eliquis je uspoređen s enoksaparinom, nakon čega je slijedio varfarin; glavna mjera učinkovitosti temeljila se na broju bolesnika koji su imali krvne ugruške u venama nogu ili u plućima ili koji su umrli zbog tih ugrušaka tijekom razdoblja liječenja.
English: The medicine's effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during the treatment period.
Croatian: Učinkovitost lijeka izmjerena je s obzirom na broj bolesnika koji su imali probleme povezane sa stvaranjem ugrušaka u venama ili koji su umrli zbog bilo kojeg uzroka tijekom razloga liječenja.
English: To prevent deep vein thrombosis and pulmonary embolism from reoccurring, the recommended dose is 2.5 mg twice a day.
Croatian: Za sprječavanje ponovnog nastanka duboke venske tromboze i plućne embolije, preporučena doza iznosi 2,5 mg dvaput dnevno.
English: The main measures of effectiveness were based on the number of strokes or clotting events that occurred during treatment.
Croatian: Glavne mjere učinkovitosti temeljile su se na broju moždanih udara ili nastanka ugrušaka tijekom liječenja.
English: How does Eliquis work?
Croatian: Kako djeluje Eliquis?
English: Eliquis contains the active substance apixaban.
Croatian: Eliquis sadrži djelatnu tvar apiksaban.
English: In the prevention study in 2,482 patients, Eliquis was compared with placebo (a dummy treatment) and its effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during treatment.
Croatian: U ispitivanju prevencije provedenom na 2 482 bolesnika Eliquis je uspoređen s placebom (prividno liječenje), a njegova je učinkovitost izmjerena uzimajući u obzir broj bolesnika koji su imali probleme povezane s nastankom ugrušaka u venama ili koji su umrli zbog bilo kojeg uzroka tijekom liječenja.
English: Eliquis is a medicine used to prevent venous thromboembolism (blood clots in the veins) in adults following a hip or knee replacement operation.
Croatian: Eliquis je lijek koji se koristi za sprječavanje venske tromboembolije (krvnih ugrušaka u venama) u odraslih osoba nakon kirurškog zahvata ugradnje umjetnog kuka ili koljena.
English: In both studies, Eliquis was compared with enoxaparin (another medicine used to prevent blood clots).
Croatian: Eliquis je u obama ispitivanjima uspoređen s enoksaparinom (koji je također lijek koji se primjenjuje za sprječavanje krvnih ugrušaka).
English: The active substance in Eliquis, apixaban, is a ‘factor Xa inhibitor'.
Croatian: Djelatna tvar lijeka Eliquis, apiksaban, inhibitor je faktora Xa.
English: In the study comparing Eliquis with warfarin, 1.3 % of the patients taking Eliquis had a stroke or clotting event every year compared with 1.6% of the patients taking warfarin.
Croatian: U ispitivanju u kojem je Eliquis uspoređen s varfarinom 1,3 % bolesnika koji su uzimali Eliquis doživjelo je moždani udar ili krvni ugrušak svake godine u usporedbi s 1,6 % bolesnika koji su uzimali varfarin.
English: In patients undergoing a hip replacement, 1.4% of the patients who completed treatment with Eliquis (27 out of 1,949) had a clotting event or died from any cause, compared with 3.9% (74 out of 1,917) of the patients taking enoxaparin.
Croatian: U bolesnika koji su prošli zahvat ugradnje umjetnog kuka 1,4 % bolesnika koji su dovršili liječenje lijekom Eliquis (27 od 1 949) doživjelo je nastanak ugruška ili je umrlo zbog bilo kojeg uzroka, u usporedbi s 3,9 % (74 od 1917) bolesnika koji su uzimali enoksaparin.
English: What benefits of Eliquis have been shown in studies?
Croatian: Koje su koristi od lijeka Eliquis utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions with Eliquis, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Eliquis potražite u uputi o lijeku.
English: How is Eliquis used?
Croatian: Kako se Eliquis primjenjuje?
English: Eliquis was also shown to be effective in preventing strokes and arterial blood clots in patients with atrial fibrillation in two main studies: the first (in 18,201 patients) compared Eliquis with another medicine, warfarin, while the second (in 5,598 patients) compared Eliquis with aspirin.
Croatian: 201 bolesnika) Eliquis je uspoređen s drugim lijekom, varfarinom, dok je u drugom (provedenom na 5 598 bolesnika) uspoređen s aspirinom.
English: This summary was last updated in 01-2018.
Croatian: Sažetak je posljednji put ažuriran u 01. 2018.
English: The full EPAR for Faslodex can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Faslodex nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is 500 mg given once a month, with an additional 500-mg dose two weeks after the first dose.
Croatian: Preporučena je doza 500 mg jedanput mjesečno, uz jednu dodatnu dozu od 500 mg dva tjedna nakon primjene prve doze.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Faslodex on 10 March 2004.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Faslodex u promet koje je na snazi u Europskoj uniji od 10. ožujka 2004.
English: This is a summary of the European public assessment report (EPAR) for Faslodex.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Faslodex.
English: What measures are being taken to ensure the safe and effective use of Faslodex?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Faslodex?
English: The dose is given as two injections, each given into the muscle of one buttock over one to two minutes.
Croatian: Doza se primjenjuje u obliku dviju injekcija koje se daju u isti mišić stražnjice tijekom jedne do dvije minute.
English: Faslodex is available as a solution for injection in prefilled syringes (250 mg).
Croatian: Lijek Faslodex dostupan je kao otopina za injekciju u napunjenim štrcaljkama (250 mg).
English: The European Medicines Agency concluded that the benefits seen in studies with Faslodex are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Faslodex zabilježene u ispitivanjima nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: Faslodex is an anti-oestrogen medicine used to treat advanced or metastatic breast cancer (cancer that has spread to other parts of the body) in the following patients:
Croatian: Faslodex je anti-estrogen koji se primjenjuje za liječenje uznapredovalog ili metastatskog raka dojke (rak koji se proširio na druge dijelove tijela) u sljedećih bolesnica:
English: It is not intended to provide practical advice on how to use Faslodex.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Faslodex.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Faslodex 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 Faslodex nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: In women with this type of breast cancer, Faslodex is used in combination with palbociclib (another cancer medicine).
Croatian: U žena s ovom vrstom raka dojke Faslodex se primjenjuje u kombinaciji s palbociklibom (drugi lijek protiv raka).
English: In addition, the medicine is effective in combination with palbociclib in patients with HR-positive, HER-2 negative breast cancer.
Croatian: Osim toga, lijek je učinkovit u kombinaciji s palbociklibom u bolesnica s HR-pozitivnim i HER2-negativnim rakom dojke.
English: Other information about Faslodex
Croatian: Ostale informacije o lijeku Faslodex
English: It blocks the receptors for oestrogen on cells and causes the number of oestrogen receptors to fall.
Croatian: On blokira receptore za estrogen na stanicama i prouzročuje smanjivanje broja estrogenskih receptora.
English: Faslodex must not be used in women who are pregnant or breast-feeding, or in patients who have severe liver disease.
Croatian: Lijek Faslodex ne smije se primjenjivati u žena koje su trudne ili doje, kao ni u bolesnica s teškom bolesti jetre.
English: The most common serious side effects were low levels of white and red blood cells, low levels of blood platelets, infections, increased liver enzyme levels and tiredness.
Croatian: Najčešće su zabilježene ozbiljne nuspojave niske razine bijelih i crvenih krvnih stanica, nizak broj krvnih pločica, infekcije, povišene razine jetrenih enzima i umor.
English: • women with a type of breast cancer known as ‘HR-positive, HER-2 negative cancer' who have previously had hormonal treatment.
Croatian: • u žena s vrstom raka dojke poznatim pod nazivom „HR-pozitivni, HER2-negativni rak” koje su prethodno primile hormonsku terapiju.
English: What is Faslodex and what is it used for?
Croatian: Što je Faslodex i za što se koristi?
English: The active substance in Faslodex, fulvestrant, is an anti-oestrogen.
Croatian: Djelatna tvar u lijeku Faslodex jest fulvestrant, anti-estrogen.