FrancophonIA/ELRC3.0 huggingface dataset:
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Multaq 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 Multaq uključene su i u sažetak opisa svojstava i uputu o lijeku.
English: Why is Multaq approved?
Croatian: Zašto je lijek Multaq odobren?
English: For more information about treatment with Multaq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Multaq pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Multaq contains the active substance dronedarone.
Croatian: Multaq sadrži djelatnu tvar dronedaron.
English: In September 2011 this indication was restricted to the maintenance of normal heart rhythm in ‘persistent' or ‘paroxysmal' atrial fibrillation after normal heart rhythm has been restored.
Croatian: U rujnu 2011. ova je indikacija ograničena na održavanje normalnog srčanog ritma u slučaju „perzistentne” ili „paroksizmalne” fibrilacije atrija nakon što se uspostavi normalan srčani ritam.
English: A sixth study (PALLAS) compared Multaq with placebo in patients over 65 years of age with permanent atrial fibrillation and several risk factors.
Croatian: U šestom ispitivanju (PALLAS) Multaq je uspoređen s placebom u bolesnika starijih od 65 godina s permanentnom fibrilacijom atrija i nekoliko čimbenika rizika.
English: The fifth study compared Multaq with placebo in almost 5,000 patients.
Croatian: U petom ispitivanju Multaq je uspoređen s placebom u gotovo 5000 bolesnika.
English: The most common side effects with Multaq (seen in more than 1 patient in 10) are increased blood levels of creatinine (a breakdown product of muscle), a prolonged ‘QTc Bazett' (an alteration of the electrical activity of the heart) and congestive heart failure (a type of heart disease), but this side effect occurred at a similar rate in patients who took placebo in clinical studies.
Croatian: Najčešće su nuspojave lijeka Multaq (primijećene u više od 1 na 10 bolesnika) povišene razine kreatinina u krvi (proizvod razgradnje u mišiću), produljenje QTc-intervala prema Bazettu (promjena električne aktivnosti srca) i kongestivno zatajenje srca (vrsta bolesti srca), ali stopa pojave ove nuspojave bila je slična onoj u bolesnika koji su uzimali placebo u kliničkim ispitivanjima.
English: The fourth study compared Multaq with amiodarone (another medicine used to prevent atrial fibrillation) in 504 patients.
Croatian: U četvrtom ispitivanju Multaq je uspoređen s amiodaronom (još jednim lijekom za sprječavanje fibrilacije atrija) u 504 bolesnika.
English: The first three studies, involving, 1,411 patients, found that Multaq was more effective than placebo (a dummy treatment) at preventing atrial fibrillation.
Croatian: U prva tri ispitivanja koja su uključivala 1411 bolesnika, pokazalo se da je Multaq sprječavao fibrilaciju atrija učinkovitije od placeba (prividno liječenje).
English: Multaq was originally approved to prevent atrial fibrillation from coming back or to lower the heart rate in adults who have had or have non-permanent atrial fibrillation.
Croatian: Multaq je prvenstveno odobren za sprječavanje ponovne pojave fibrilacije atrija ili za usporavanje srčanog ritma u odraslih osoba koje su imale ili imaju nepermanentnu fibrilaciju atrija.
English: EPAR summary for the public
Croatian: EPAR, sažetak za javnost dronedaron
English: The study found that in patients taking Multaq, there were fewer hospital admissions for cardiovascular disorders (problems affecting the heart and blood vessels), particularly those related to atrial fibrillations.
Croatian: U ispitivanju je ustanovljeno da je među bolesnicima koji su uzimali Multaq bilo manje onih koji su hospitalizirani zbog kardiovaskularnih poremećaja (tegoba koje su zahvaćale srce i krvne žile), a osobito poremećaja povezanih s fibrilacijom atrija.
English: It is not intended to provide practical advice on how to use Multaq.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Multaq.
English: How is Multaq used?
Croatian: Kako se Multaq koristi?
English: The active substance in Multaq, dronedarone, works mainly by blocking channels through which charged particles of potassium flow in and out of the heart muscle cells.
Croatian: Djelatna tvar u lijeku Multaq, dronedaron, djeluje uglavnom blokiranjem kanala kroz koje nabijene čestice kalija ulaze i izlaze iz stanica srčanog mišića.
English: It gave further support for the use of Multaq to maintain normal heart rhythm and to reduce the heart rate.
Croatian: Time se dobila dodatna podrška za primjenu lijeka Multaq za održavanje normalnog srčanog ritma i smanjenje brzog rada srca.
English: By reducing the flow of potassium through the channels, Multaq slows down contractions in the atria and so prevents fibrillation and lowers the heart rate.
Croatian: Smanjenjem protoka kalija kroz kanale, Multaq usporava kontrakcije u atriju i time sprječava fibrilaciju te usporava otkucaje srca.
English: Multaq must not be taken with medicines that can cause torsades de pointes (a type of rapid heart beat), or with dabigatran (a medicine to prevent blood clotting).
Croatian: Multaq se ne smije uzimati s lijekovima koje mogu prouzročiti torsades de pointes (vrsta ubrzanih srčanih otkucaja) niti s dabigatranom (lijek za sprječavanje stvaranja krvnih ugrušaka).
English: Multaq should not be given to patients with left ventricular systolic dysfunction (a problem affecting the left side of the heart) or patients who have or have had heart failure (when the heart cannot pump enough blood around the body).
Croatian: Multaq se ne smije davati bolesnicima sa sistoličkom disfunkcijom lijeve klijetke (tegoba koja zahvaća lijevu stranu srca) niti bolesnicima koji boluju ili su bolovali od zatajenja srca (kada srce svojim pumpanjem ne može tijelo opskrbiti dovoljnom količinom krvi).
English: There were six main studies of Multaq in adults who had had atrial fibrillation.
Croatian: Provedeno je šest glavnih ispitivanja lijeka Multaq u odraslih s fibrilacijom atrija.
English: For the full list of restrictions, see the package leaflet.
Croatian: Potpuni popis ograničenja potražite u uputu o lijeku.
English: Heart rate was reduced by an average of 11.0 beats per minute in patients taking Multaq compared to 0.7 beats per minute in patients taking placebo.
Croatian: U bolesnika koji su uzimali Multaq, brzina otkucaja srca smanjila se za prosječno 11,0 otkucaja u minuti u usporedbi s 0,7 otkucaja u minuti u bolesnika koji su uzimali placebo.
English: For practical information about using Multaq, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Multaq bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: What benefits of Multaq have been shown in studies?
Croatian: Koje su koristi lijeka Multaq dokazane u ispitivanjima?
English: The prescriber guide will help healthcare professionals to use Multaq safety and to select patients for whom it is appropriate.
Croatian: Vodič će pomoći zdravstvenim radnicima da Multaq primjenjuju sigurno te da izabiru bolesnike za koje je taj lijek prikladan.
English: Multaq is an antiarrhythmic medicine used to maintain normal heart rhythm in adults whose normal heart rhythm has been restored after a period of paroxysmal or persistent atrial fibrillation.
Croatian: Multaq je antiaritmik koji se primjenjuje za održavanje normalnog srčanog ritma u odraslih u kojih je nakon razdoblja paroksizmalne ili perzistentne fibrilacije atrija ponovno uspostavljen normalni srčani ritam.
English: Patients who have had previous liver or lung injury following treatment with amiodarone (another antiarrhythmic medicine) must not be given Multaq.
Croatian: Multaq se ne smije davati bolesnicima koji su prije imali ozljedu jetre ili pluća nakon liječenja amiodaronom (drugi antiaritmik).
English: However, more patients taking amiodarone had to stop treatment because of side effects.
Croatian: Međutim, među bolesnicima koji su morali prekinuti liječenje zbog nuspojava, bilo je više onih koji su uzimali amiodaron.
English: How does Multaq work?
Croatian: Kako djeluje Multaq?
English: For the full list of all side effects reported with Multaq, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Multaq potražite u uputi o lijeku.
English: What measures are being taken to ensure the safe use of Multaq?
Croatian: Koje se mjere poduzimaju kako bi se zajamčila sigurna primjena lijeka
English: Date of first authorisation: 18 January 2016
Croatian: Datum prvog odobrenja: 18 siječnja 2016.
English: The expiry date refers to the last day of that month.
Croatian: Rok valjanosti se odnosi na posljednji dan navedenog mjeseca.
English: The pH is between 7.0 and 8.0.
Croatian: pH vrijednost je između 7,0 i 8,0.
English: Your condition will be closely monitored during treatment.
Croatian: Vaše će stanje biti pomno praćeno tijekom liječenja.
English: Other medicines and Armisarte
Croatian: Drugi lijekovi i Armisarte
English: Store and transport refrigerated (2°C to 8°C).
Croatian: Lijek čuvati i prevoziti u hladnjaku (2°C to 8°C).
English: Nerviano, Milan Italy
Croatian: Nerviano, Milan Italija
English: Inactive vaccines should be used where possible.
Croatian: Kad god je moguće treba koristiti inaktivirana cjepiva.
English: RO-011171 Bucharest Romania
Croatian: RO-011171 Bucharest Rumunjska
English: Armisarte should not been used if there are any signs of particles.
Croatian: Armisarte se ne smije koristiti ako postoje ikakve naznake čestica.
English: Contents of the pack and other information What Armisarte contains
Croatian: Sadržaj pakiranja i druge informacije Što Armisarte sadrži
English: *Definition of frequency terms: Very common - ≥10%; Common - >5% and <10%.
Croatian: * Definicije pojmova učestalosti: vrlo često - ≥ 10%; često - > 5% i < 10%.
English: - if you are allergic to pemetrexed or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na pemetreksed ili neki drugi sastojak ovoga lijeka (naveden u dijelu 6).
English: Your doctor will discuss with you the potential risk of taking Armisarte during pregnancy.
Croatian: Liječnik će s Vama razgovarati o mogućem riziku primjene lijeka Armisarte u trudnoći.
English: What Armisarte looks like and contents of the pack
Croatian: Kako Armisarte izgleda i sadržaj pakiranja
English: Talk to your doctor or hospital pharmacist before receiving Armisarte.
Croatian: Obratite se svom liječniku ili bolničkom ljekarniku prije nego primite lijek Armisarte.
English: Armisarte is a medicine used in the treatment of cancer.
Croatian: Armisarte je lijek koji se koristi za liječenje raka.
English: Based on the planned date of your infusion of Armisarte and/or on the status of your kidney function, your doctor needs to advise you on which medicines you can take and when you can take them.
Croatian: Ovisno o planiranom datumu primjene infuzije lijeka Armisarte i/ili Vašoj bubrežnoj funkciji, liječnik Vam mora reći koje lijekove možete uzimati i kada ih možete uzimati.
English: When using Armisarte in combination with cisplatin:
Croatian: Kad se Armisarte primjenjuje u kombinaciji s cisplatinom:
English: Vials may or may not be sheathed in a protective sleeve.
Croatian: Bočice mogu i ne moraju biti obložene zaštitnim ovojem.
English: < 1/100), Rare (≥ 1/10,000 to < 1/1,000), Very rare (< 1/10,000) and not known (cannot be estimated from available data).
Croatian: rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Armisarte has finished.
Croatian: Cisplatin se također primjenjuje infuzijom u jednu od vena i daje se približno 30 minuta nakon završetka infuzije lijeka Armisarte.
English: The dose of Armisarte is 500 milligrams for every square metre of your body's surface area.
Croatian: Doza lijeka Armisarte je 500 miligrama po svakom kvadratnom metru Vaše površine tijela.
English: Store and transport refrigerated.
Croatian: Lijek čuvati i prevoziti u hladnjaku.
English: What you need to know before you use Armisarte Do not use Armisarte
Croatian: Što morate znati prije nego počnete primati Armisarte
English: Between patient variability in clearance is moderate at 19.3%.
Croatian: Varijabilnost klirensa između pojedinih bolesnika je umjerena i iznosi 19,3%.
English: Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Croatian: Statistički značajan za neinferiornost, a cijeli interval pouzdanosti za HR nalazi se znatno ispod granice neinferiornosti od 1,17645 (p < 0,001).
English: You must take at least 5 doses during the seven days before the first dose of Armisarte.
Croatian: Morate uzeti barem 5 doza tijekom 7 dana prije prve doze lijeka Armisarte.
English: The European Medicines Agency has waived the obligation to submit the results of studies with pemetrexed in all subsets of the paediatric population in the granted indications (see section 4.2).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka pemetreksed u svim podskupinama pedijatrijske populacije za odobrene indikacije (vidjeti dio 4.2).
English: Pemetrexed should not be used during pregnancy unless clearly necessary, after a careful consideration of the needs of the mother and the risk for the foetus (see section 4.4).
Croatian: Pemetreksed se ne smije primjenjivati u trudnoći, osim ako to je doista nužno i tek nakon što se pažljivo razmotre potrebe majke i mogući rizik za plod (vidjeti dio 4.4).
English: The use of Armisarte should be avoided during pregnancy.
Croatian: Primjena lijeka Armisarte mora se izbjegavati tijekom trudnoće.
English: If you currently have or have previously had problems with your kidneys, talk to your doctor or hospital pharmacist as you may not be able to receive Armisarte.
Croatian: Ako trenutno imate ili ste prethodno imali problema s bubrezima, obratite se svom liječniku ili bolničkom ljekarniku jer možda nećete smjeti primati lijek Armisarte.
English: Each pack of Armisarte contains one vial.
Croatian: Svako pakiranje lijeka Armisarte sadrži jednu bočicu.
English: You will also receive an injection of vitamin B12 (1000 micrograms) in the week before administration of Armisarte and then approximately every 9 weeks (corresponding to 3 courses of Armisarte treatment).
Croatian: Također ćete dobiti injekciju vitamina B12 (1000 mikrograma) u tjednu prije primjene lijeka Armisarte i zatim otprilike svakih 9 tjedana (što odgovara 3 ciklusa liječenja lijekom Armisarte).
English: You will always receive Armisarte by infusion into one of your veins.
Croatian: Lijek Armisarte uvijek ćete primiti infuzijom u jednu od vena.
English: Armisarte contains trometamol as an excipient.
Croatian: Armisarte sadrži trometamol kao pomoćnu tvar.
English: Calculate the dose and the number of Armisarte vials needed.
Croatian: Izračunajte dozu i potreban broj bočica lijeka Armisarte.
English: You must contact your doctor immediately if you notice any of the following: - Fever or infection (common): if you have a temperature of 38°C or greater, sweating or other signs of infection(since you might have less white blood cells than normal which is very common).
Croatian: Morate se odmah javiti svom liječniku ako primijetite bilo što od sljedećeg: - vrućicu ili infekciju (često): ako Vam je tjelesna temperatura 38°C ili viša, ako se znojite ili imate neke druge znakove infekcije (jer broj bijelih krvnih stanica može biti niži od normalnog,
English: Like other chemotherapy medicines Armisarte is not recommended with live attenuated vaccines.
Croatian: Kao i kod drugih lijekovi za kemoterapiju, ne preporučuje se primjena lijeka Armisarte uz živa atenuirana cjepiva.
English: Patients with renal impairment (Standard Cockcroft and Gault formula or Glomerular Filtration Rate measured Tc99m-DPTA serum clearance method)
Croatian: Bolesnici s oštećenjem bubrega (klirens izračunat standardnom Cockcroftovom i Gaultovom formulom ili mjerenjem brzine glomerularne filtracije serumskog Tc99m-DPTA)
English: Pemetrexed N=265
Croatian: Pemetreksed N = 265
English: There is no relevant use of Armisarte in the paediatric population
Croatian: Armisarte nema relevantne primjene u pedijatrijskoj populaciji.
English: First line doublet therapy containing pemetrexed was not included.
Croatian: Nije bila uključena prva linija dvojne terapije koja je sadržavala lijek pemetreksed.
English: Armisarte can be prescribed to you if you have lung cancer at an advanced stage if your disease has responded to treatment or it remains largely unchanged after initial chemotherapy.
Croatian: Armisarte Vam se može propisati ako imate rak pluća u uznapredovaloj fazi i ako je Vaša bolest reagirala na liječenje ili ostala uglavnom nepromijenjena nakon početne kemoterapije.
English: Armisarte must only be diluted with 5% glucose solution, without preservative.
Croatian: Armisarte smije biti razrijeđen jedino 5%-tnom otopinom glukoze, bez konzervansa.
English: Common Pain Oedema Renal Disorders Common Renal disorders**** Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT=serum glutamic oxaloacectic aminotransferase; SGPT=serum glutamic pyruvic aminotransferase.
Croatian: Kratice: ALT = alanin aminotransferaza; AST = aspartat aminotransferaza; CTCAE = Zajednička terminologija za nuspojave; NCI = Nacionalni institut za rak; SGOT = serumska glutamat-oksaloctena aminotransferaza; SGPT = serumska glutamat piruvična aminotransferaza.
English: Pemetrexed + cisplatin Gemcitabine + cisplatin
Croatian: PEMETREKSED + cisplatin gemcitabin + cisplatin
English: What Armisarte is and what it is used for
Croatian: Što je Armisarte i za što se koristi
English: A total of 213 patients (48.3%) completed ≥ 6 cycles and a total of 103 patients (23.4%) completed ≥ 10 cycles of treatment with pemetrexed.
Croatian: Ukupno je 213 bolesnika (48,3%) završilo ≥ 6 ciklusa, dok su 103 bolesnika (23,4%) završila ≥ 10 ciklusa liječenja lijekom pemetreksed.
English: If you have an accumulation of fluid around your lungs, your doctor may decide to remove the fluid before giving you Armisarte.
Croatian: Ako Vam se oko pluća nakupila tekućina, liječnik može odlučiti ukloniti tu tekućinu prije primjene lijeka Armisarte.
English: Trometamol is incompatible with cisplatin resulting in degradation of cisplatin.
Croatian: Trometamol je inkompatibilan sa cisplatinom što uzrokuje degradaciju cisplatina.
English: At the time of this final survival analysis, 28.7% of patients were alive or lost to follow up on the pemetrexed arm versus 21.7% on the placebo arm.
Croatian: U vrijeme ove konačne analize preživljenja 28,7% bolesnika u skupini liječenoj lijekom pemetreksed bilo je živo ili izgubljeno iz praćenja, u odnosu na 21,7% bolesnika u skupini koja je primala placebo.
English: You must continue taking the folic acid for 21 days after the last dose of Armisarte.
Croatian: Morate nastaviti uzimati folatnu kiselinu još najmanje 21 dan nakon posljednje doze lijeka Armisarte.
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in 426 cancer patients with a variety of solid tumours at doses ranging from 0.2 to 838 mg/m2 infused over a 10 minute period.
Croatian: Farmakokinetička svojstva pemetrekseda nakon primjene u monoterapiji ispitana su u 426 onkoloških bolesnika s različitim solidnim tumorima, pri dozama od 0,2 do 838 mg/m2 primijenjenima u infuziji tijekom 10 minuta.
English: If you have been recently vaccinated, please tell your doctor, as this can possibly cause bad effects with Armisarte.
Croatian: Ako ste nedavno cijepljeni, obavijestite o tome svog liječnika jer to može izazvati štetne učinke uz primjenu lijeka Armisarte.
English: Therefore, patients should receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving treatment.
Croatian: Iz tog razloga bolesnici moraju primiti odgovarajući antiemetik i hidrataciju prije i/ili nakon primjene terapije.
English: Intravenous lines should be flushed after administration of Armisarte.
Croatian: Intravenske linije treba isprati nakon primjene lijeka Armisarte.
English: Progression free survival (months)
Croatian: Preživljenje bez progresije bolesti (mjeseci)
English: Adjusted hazard ratio (HR) (95% CI)
Croatian: Prilagođeni omjer hazardahazarda (HR) (95% CI)
English: Armisarte should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Croatian: Armisarte se mora primjenjivati u obliku intravenske infuzije u trajanju od 10 minuta prvog dana svakog 21-dnevnog ciklusa.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka prije primjene odgovornost su korisnika i ne bi trebali biti dulji od 24 sata na temperaturi od 2°C do 8°C, osim ako razrjeđivanje nije provedeno u kontroliranim i validiranim aseptičkim uvjetima.
English: Corticosteriods: your doctor will prescribe you steroid tablets (equivalent to 4 milligram of dexamethasone twice a day) that you will need to take on the day before, on the day of, and the day after Armisarte treatment.
Croatian: Kortikosteroidi: liječnik će Vam propisati tablete kortikosteroida (ekvivalentne dozi deksametazona od 4 mg dvaput na dan) koje ćete morati uzeti dan prije, na sam dan i dan nakon primjene lijeka
English: Taking into account the PRAC Assessment Report on the PSUR(s) for pemetrexed, the scientific conclusions of CHMP are as follows:
Croatian: (PSUR) za pemetreksed, znanstveni zaključci CHMP-a su sljedeći:
English: A total of 169 patients (47.1 %) completed ≥ 6 cycles maintenance treatment with pemetrexed, representing at least 10 total cycles of pemetrexed.
Croatian: Ukupno je 169 (47,1%) bolesnika završilo ≥ 6 ciklusa terapije održavanja lijekom pemetreksed, što znači da su primili najmanje 10 ciklusa lijeka pemetreksed.
English: Frequency estimate: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to
Croatian: Procjena učestalosti: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100);
English: This medicine is for single use only; any unused solution must be disposed of in accordance with local requirements.
Croatian: Lijek je isključivo za jednokratnu primjenu; neiskorištenu otopinu valja zbrinuti sukladno lokalnim propisima.
English: Armisarte concentrate for solution for infusion (sterile concentrate) is a clear, colourless to slightly yellowish or yellow-greenish solution.
Croatian: Armisarte koncentrat za otopinu za infuziju (sterilni koncentrat) je bistra, bezbojna do blago žućkasta ili žuto-zelenkasta otopina.
English: Armisarte 25 mg/ml concentrate for solution for infusion will always be given to you by a healthcare professional.
Croatian: Armisarte 25 mg/ml koncentrat za otopinu za infuziju će Vam uvijek dati zdravstveni radnik.
English: A hospital pharmacist, nurse or doctor will have mixed the Armisarte concentrate with 5% glucose solution for injection before it is given to you.
Croatian: Prije primjene, bolnički ljekarnik, medicinska sestra ili liječnik će pomiješati Armisarte s 5%-tnom otopinom glukoze za injekciju.