FrancophonIA/ELRC3.0 huggingface dataset:
English: Conditions you need to look out for
Croatian: Stanja na koja trebate obratiti pozornost
English: May cause severe allergic reactions.
Croatian: Može uzrokovati ozbiljne alergijske reakcije.
English: Wash your hands thoroughly with soap and water and dry them with a towel.
Croatian: Dobro operite ruke sapunom i vodom i obrišite ih ručnikom.
English: You should inject at about the same time each day.
Croatian: Lijek treba primijeniti otprilike u isto vrijeme svakog dana.
English: There are two types of syringes:
Croatian: Dvije su vrste štrcaljki:
English: Signs include:
Croatian: Znakovi uključuju:
English: Date of first authorisation: 21 March 2002 Date of latest renewal: 21 March 2007
Croatian: Datum prvog odobrenja: 21.ožujak 2002. Datum posljednje obnove odobrenja: 21.ožujak 2007.
English: ATC code: B01AX05
Croatian: ATK oznaka: B01AX05
English: • the syringe has not been opened or damaged
Croatian: • da štrcaljka nije otvarana ili oštećena
English: Death, MI or TVR at Day 30
Croatian: Smrt, MI ili TVR 30. dana
English: Concomitant oral anticoagulation treatment should be initiated as soon as possible and usually within 72 hours.
Croatian: Istovremeno liječenje oralnim antikoagulansima treba započeti što je prije moguće, a obično unutar 72 sata.
English: Other medicines and Arixtra
Croatian: Drugi lijekovi i Arixtra
English: Do not use this medicine:
Croatian: Ovaj lijek se ne smije upotrijebiti:
English: The average duration of administration in clinical trials was 7 days and the clinical experience from treatment beyond 10 days is limited.
Croatian: Prosječno trajanje liječenja u kliničkim ispitivanjima bilo je 7 dana, a kliničko iskustvo s liječenjem duljim od 10 dana je ograničeno.
English: The elderly population is at increased risk of bleeding.
Croatian: U starijoj populaciji povećan je rizik od krvarenja.
English: If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primijenite ovaj lijek.
English: Follow-up continued up to Day 77.
Croatian: Praćenje je organizirano tijekom 77 dana.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako su Vam rekli Vaš liječnik ili ljekarnik.
English: • if you are 75 years old or older
Croatian: • ako ste stariji od 75 godina
English: • if you have opened a syringe and you do not use it straightaway.
Croatian: • ako ste otvorili štrcaljku, a ne namjeravate je odmah upotrijebiti.
English: 10 mg once a day.
Croatian: 10 mg jednom na dan.
English: MI or TVR at Day 30
Croatian: MI ili TVR 30. dana
English: • if you are bleeding excessively
Croatian: • ako jako krvarite
English: Treatment should be initiated as soon as possible following diagnosis and continued for up to a maximum of 8 days or until hospital discharge if that occurs earlier.
Croatian: Liječenje treba započeti što je prije moguće nakon postavljanja dijagnoze i nastaviti ga najdulje 8 dana ili do otpusta iz bolnice, ako uslijedi ranije.
English: Standard Dose UFH N = 1002
Croatian: Standardna doza UFH N = 1002
English: Gender - No gender differences were observed after adjustment for body weight.
Croatian: Spol - nisu zabilježene razlike obzirom na spol nakon prilagodbe prema tjelesnoj težini.
English: Do not inject a double dose to make up for a forgotten dose.
Croatian: Nemojte injicirati dvostruku dozu kako biste nadoknadili propuštenu dozu.
English: The median duration of treatment in this study was 3.5 days.
Croatian: Medijan trajanja liječenja u ovom ispitivanju je iznosio 3,5 dana.
English: Arixtra has not been tested in children and adolescents under the age of 17 years.
Croatian: Arixtra nije ispitivana u djece i adolescenata mlađih od 17 godina.
English: As a result, the concentration of fondaparinux is expressed as milligrams (mg).
Croatian: Stoga se koncentracija fondaparinuksa izražava u miligramima (mg).
English: The distribution volume of fondaparinux is limited (7-11 litres).
Croatian: Distribucija Volumen raspodjele fondaparinuksa je ograničen (7-11 litara).
English: • if you have a bacterial heart infection
Croatian: • ako imate bakterijsku infekciju srca
English: Prevention of VTE following Surgery
Croatian: Prevencija VTE nakon operacije
English: Odds Ratio1 (95%CI)
Croatian: Omjer vjerojatnosti1 (95% CI)
English: The elimination half-life (t½) is about 17 hours in healthy young subjects and about 21 hours in healthy elderly subjects.
Croatian: Poluvrijeme eliminacije (t½) iznosi oko 17 sati u zdravih mladih osoba, a oko 21 sat u starijih zdravih osoba.
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in swallowing or breathing
Croatian: • oticanje, ponekad lica ili usta (angioedem), što uzrokuje otežano gutanje ili disanje
English: At higher doses, moderate changes in aPTT can occur.
Croatian: Pri višim dozama može doći do umjerenih promjena APTV-a.
English: → Tell your doctor if you think any of these applies to you.
Croatian: Recite liječniku ako mislite da se nešto od navedenog odnosi na Vas.
English: • Patients who are to undergo surgery or other invasive procedures
Croatian: • Bolesnici koji se podvrgavaju operativnom zahvatu ili drugim invazivnim postupcima
English: Types of safety syringe
Croatian: Tipovi sigurnosnih štrcaljki
English: The majority of patients were Hispanic (67%) and 58% were male.
Croatian: Većina bolesnika je bila hispanskog porijekla (67%), a dječaka je bilo 58%.
English: TVR - target vessel revascularization
Croatian: TVR - revaskularizacija ciljne k. žile (engl. target vessel revascularization)
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: Adverse reactions in patients treated for VTE1
Croatian: Nuspojave u bolesnika liječenih zbog VTE1
English: Overdose associated with bleeding complications should lead to treatment discontinuation and search for the primary cause.
Croatian: Predoziranje povezano s komplikacijama krvarenja zahtijeva prekid liječenja i potragu za osnovnim uzrokom.
English: Over 4,874 patients were studied in controlled Phase II and III clinical studies.
Croatian: Više od 4874 bolesnika ispitivano je u kontroliranim kliničkim ispitivanjima Faze II i III.
English: No studies on the effect on the ability to drive and to use machines have been performed.
Croatian: Nisu provedena ispitivanja o utjecaju na sposobnost upravljanja vozilima i strojevima.
English: The syringes are pre-filled with the exact dose you need.
Croatian: Štrcaljka je napunjena sa točnom dozom lijeka koju trebate.
English: This will help to reduce the discomfort at the injection site.
Croatian: To će umanjiti neugodu na mjestu uboda.
English: The majority of patients (88%) achieved target fondaparinux concentrations at 4 hours after the first dose of fondaparinux.
Croatian: Većina bolesnika (88%) je postigla ciljne koncentracije fondaparinuksa nakon 4 sata od primjene prve doze lijeka.
English: Low Dose UFH N = 1024
Croatian: Niska doza UFH N = 1024
English: Instructions for use
Croatian: Upute za upotrebu
English: This medicinal product is for single use only.
Croatian: Ovaj lijek je namijenjen za jednokratnu uporabu.
English: Although not fully evaluated, there is no evidence of fondaparinux metabolism and in particular no evidence for the formation of active metabolites.
Croatian: Iako nije u cijelosti ocijenjen, nema dokaza o metaboliziranju fondaparinuksa, a osobito nema dokaza o stvaranju aktivnih metabolita.
English: Elimination of fondaparinux decreases with weight.
Croatian: Eliminacija fondaparinuksa se smanjuje s tjelesnom težinom.
English: Body weight - Plasma clearance of fondaparinux increases with body weight (9% increase per 10 kg).
Croatian: Tjelesna težina - klirens iz plazme fondaparinuksa povećava se s povećanjem tjelesne težine (povećanje od 9% na 10 kg).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: For additional instructions for use and handling and disposal see section 6.6.
Croatian: Za dodatne upute za primjenu, rukovanje i odlaganje vidjeti dio 6.6.
English: • Keep this medicine out of the sight and reach of children
Croatian: • Ovaj lijek čuvajte izvan pogleda i dohvata djece.
English: No conclusion can be drawn with regard to clinical efficacy in this uncontrolled study.
Croatian: Ne mogu se izvoditi zaključci iz ovog nekontroliranog ispitivanja u pogledu kliničke djelotvornosti.
English: Release the plunger and the needle will automatically withdraw from the skin and go back into the security sleeve where it will be locked permanently (picture F).
Croatian: Otpustite klip i igla će se automatski izvući iz kože i povući u zaštitni valjak, gdje će biti trajno zatvorena (Slika F).
English: The incidence of symptomatic VTE, including PE was not significantly different between treatment groups.
Croatian: Incidencija simptomatskih VTE, uključujući PE nije se značajno razlikovala između skupina.
English: Treatment should be continued for at least 5 days and until adequate oral anticoagulation is established (International Normalised Ratio 2 to 3).
Croatian: Liječenje treba nastaviti najmanje 5 dana, te dok se ne uspostavi adekvatno liječenje oralnim antikoagulansima (internacionalni normalizirani omjer (INR) 2 do 3).
English: This is shown in Picture 3 at the beginning of these instructions
Croatian: To je prikazano na slici 3 koja se nalazi na početku uputa za primjenu.
English: Tell your doctor if you are allergic to latex before being treated with Arixtra.
Croatian: Recite svom liječniku ako ste alergični na lateks gumu prije nego primijenite lijek Arixtra.
English: There is no known antidote to fondaparinux.
Croatian: Nema poznatog antidota za fondaparinuks.
English: • Do not touch the needle or allow it to touch any surface before the injection.
Croatian: • Ne dodirujte iglu i pazite da igla ne dotakne nikakvu površinu prije injiciranja.
English: Severe allergic reactions (anaphylaxis): These are very rare in people (up to 1 in 10,000) taking Arixtra.
Croatian: Teške alergijske reakcije (anafilaksija): One su vrlo rijetke u osoba (manje od 1 na 10 000) koje uzimaju lijek Arixtra.
English: The injection should not be given unless haemostasis has been established (see section 4.4).
Croatian: Injekciju se ne smije dati ukoliko nije uspostavljena odgovarajuća hemostaza (vidjeti dio 4.4).
English: Hold the syringe firmly by the finger grip.
Croatian: Čvrsto držite štrcaljku za hvatište za prst.
English: • increase in the amount of non-protein nitrogen in the blood
Croatian: • porast razine neproteinskog dušika u krvi
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: To treat some types of heart attack, a health professional may give the first dose into a vein (intravenously).
Croatian: U liječenju nekih oblika srčanog udara liječnik prvu dozu može dati u venu (intravenski).
English: The whole length of the needle should be inserted perpendicularly into a skin fold held between the thumb and the forefinger; the skin fold should be held throughout the injection.
Croatian: Iglu treba uvesti cijelom dužinom okomito u nabor kože koji se drži između palca i kažiprsta; nabor kože treba držati cijelo vrijeme injiciranja.
English: Latex Allergy
Croatian: Alergija na lateks
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA
English: • fainting or dizziness, low blood pressure
Croatian: • nesvjestica ili omaglica, niski krvni tlak
English: There are no data available on the effect of fondaparinux on human fertility.
Croatian: Nema raspoloživih podataka o učinku fondaparinuksa na plodnost u ljudi.
English: After the injection hold the syringe in one hand by gripping the security sleeve, use the other hand to hold the finger grip and pull firmly back.
Croatian: Nakon injiciranja držite štrcaljku u jednoj ruci povlačeći zaštitni valjak, s drugom rukom držite hvatač za prst te čvrsto povucite natrag.
English: Do not dispose of the used syringe in the household waste.
Croatian: Upotrijebljenu štrcaljku nemojte baciti u kućni otpad.
English: Spinal / Epidural anaesthesia
Croatian: Spinalna/epiduralna anestezija
English: Animal studies do not show any effect on fertility.
Croatian: Studije na životinjama ne pokazuju utjecaj na plodnost.
English: One type of syringe has an automatic needle protection system and the other type has a manual needle protection system.
Croatian: Jedan tip štrcaljke ima automatski sustav zaštite od igle, a drugi tip ima ručni sustav zaštite od igle.
English: Rare: post-operative wound infection
Croatian: Rijetko: postoperativna infekcija rane
English: Do not throw away any medicines or syringes via wastewater or household waste.
Croatian: Nikada nemojte nikakve lijekove bacati u otpadne vode ili kućni otpad.
English: The difference in mortality was statistically significant in stratum 1 (placebo comparator) but not in stratum 2 (UFH comparator).
Croatian: Razlika u mortalitetu bila je statistički značajna u stratumu 1 (u usporedbi s placebom), ali ne i u stratumu 2 (u usporedbi s nefrakcioniranim heparinom).
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: Choose a place in the lower abdominal (tummy) area, at least 5 cm below your belly button (picture A).
Croatian: Izaberite mjesto na donjem dijelu trbuha, najmanje 5 cm ispod pupka (Slika A).
English: The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due to a reduction of asymptomatic distal DVT.
Croatian: Razlika između skupina u ukupnom broju VTE, koja nije statistički značajna, uglavnom je nastala zbog manjeg broja asimptomatskih distalnih DVT.
English: Of the patients treated with a thrombolytic, 84% were treated with a non-fibrin specific agent (primarily streptokinase).
Croatian: Od bolesnika koji su primali trombolitike, 84% ih je liječeno nespecifičnim fibrinolitičkim agensima (prvenstveno streptokinazom).
English: • If you are not sure what to do, ask your doctor or pharmacist.
Croatian: • Ako niste sigurni što učiniti, upitajte svog liječnika ili ljekarnika.
English: You should continue Arixtra treatment for as long as your doctor has told you, since Arixtra prevents development of a serious condition.
Croatian: Liječenje lijekom Arixtra trebate nastaviti onoliko dugo koliko Vam je preporučio liječnik, jer Arixtra sprječava razvoj ozbiljnih komplikacija.
English: • Arixtra does not have to be kept in the fridge.
Croatian: • Lijek Arixtra ne morate čuvati u hladnjaku.
English: Treatment of Pulmonary Embolism
Croatian: Liječenje plućne embolije
English: Arixtra is used to:
Croatian: Arixtra se koristi:
English: Elderly patients - No dosing adjustment is necessary.
Croatian: Stariji bolesnici - nije potrebna prilagodba doziranja.
English: However, studies performed in Asian (Japanese) healthy subjects did not reveal a different pharmacokinetic profile compared to Caucasian healthy subjects.
Croatian: Međutim, studija provedena na zdravim osobama u Aziji (Japanci), nije pokazala drugačiji farmakokinetski profil u usporedbi sa zdravim bijelcima.
English: What Arixtra is and what it is used for
Croatian: Što je Arixtra i za što se koristi
English: • Do not inject Arixtra into muscle.
Croatian: • Nemojte lijek Arixtra ubrizgavati u mišić.
English: The diagnosis was confirmed by objective testing (lung scan, pulmonary angiography or spiral CT scan).
Croatian: Dijagnoza je potvrđena objektivnim testovima (sken pluća, angiografija pluća ili spiralni CT).
English: Therefore the physician should determine if the benefit of treatment outweighs the risk (see sections 4.2 and 4.3).
Croatian: Stoga liječnik treba odlučiti da li korist od liječenja nadmašuje rizik (vidjeti dio 4.2 i
English: The majority of endpoint events were diagnosed by a prescheduled venography and consisted mainly of distal DVT, but the incidence of proximal DVT was also significantly reduced.
Croatian: Većina događaja mjere ishoda dijagnosticirana je prethodno planiranom venografijom i obuhvaćala je uglavnom distalnu DVT, no i incidencija proksimalne DVT je bila značajno smanjena.
English: These instructions are for both types of syringes (automatic and manual needle protection system).
Croatian: Ove upute vrijede za oba tipa štrcaljki (s automatskim i ručnim sigurnosnim sustavom za iglu).
English: Treatment should be continued until the risk of venous thrombo-embolism has diminished, usually until the patient is ambulant, at least 5 to 9 days after surgery.
Croatian: Liječenje treba nastaviti do smanjenja rizika od venske tromboembolije, obično dok bolesnik ponovno ne postane pokretan, a najmanje 5-9 dana nakon operacije.
English: The active substance is:
Croatian: Djelatna tvar je:
English: • treat some types of heart attack and severe angina (pain caused by narrowing of the arteries in the heart).
Croatian: • za liječenje nekih oblika srčanog udara i teške angine pektoris (boli uzrokovane suženjem srčanih arterija)
English: Fondaparinux does not bind significantly to other plasma proteins, including platelet factor 4 (PF4).
Croatian: Fondaparinuks se ne veže značajno na druge proteine plazme, uključujući trombocitni faktor 4 (PF4).
English: The risk of these rare events may be higher with postoperative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Croatian: Rizik od nastupa tih rijetkih događaja može se povećati postoperativnom uporabom trajnih epiduralnih katetera ili istodobnom primjenom drugih lijekova koji utječu na hemostazu.
English: Fondaparinux is administered by deep subcutaneous injection while the patient is lying down.
Croatian: Fondaparinuks se primjenjuje dubokom supkutanom injekcijom dok bolesnik leži.
English: If administered via a minibag, the infusion should be given over 1 to 2 minutes.
Croatian: Ako se primjenjuje mala količina otopine iz vrećice, infuziju treba davati kroz 1-2 minute.
English: Race - Pharmacokinetic differences due to race have not been studied prospectively.
Croatian: Rasa - farmakokinetske razlike među rasama nisu prospektivno ispitivane.
English: What you need to know before you use Arixtra
Croatian: Što morate znati prije nego počnete primjenjivati lijek Arixtra
English: If fondaparinux sodium is added to a 0.9% saline minibag it should ideally be infused immediately, but can be stored at room temperature for up to 24 hours.
Croatian: Ako se fondaparinuksnatrij dodaje u malu vrećicu 0,9 % fiziološke otopine trebalo bi ga primijeniti odmah, ali se može čuvati pri sobnoj temperaturi najdulje do 24 sata.
English: • wound infection
Croatian: • infekcija rane
English: Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, France.
Croatian: Aspen Notre Dame de Bondeville, 1 rue de l'Abbaye, F-76960 Notre Dame de Bondeville, Francuska
English: The mortality benefit shown in the fondaparinux group was maintained until the end of follow-up at Day 180.
Croatian: Smanjeni mortalitet zabilježen u skupini liječenoj fondaparinuksom održan je do kraja razdoblja praćenja od 180 dana.
English: Fondaparinux is excreted to 64 - 77 % by the kidney as unchanged compound.
Croatian: Fondaparinuks se 64 - 77 % izlučuje putem bubrega u neizmijenjenom obliku.
English: • Arixtra is given by injection under the skin (subcutaneously) into a skin fold of the lower abdominal area.
Croatian: • Arixtra se daje injekcijom pod kožu (supkutano) u kožni nabor na području donjeg dijela trbuha.
English: Fondaparinux does not inhibit CYP450s (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4) in vitro.
Croatian: Fondaparinuks ne inhibira enzime CYP450 (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6,
English: The baseline characteristics and duration of fondaparinux treatment were comparable in both UFH
Croatian: Ishodišne karakteristike i trajanje liječenja fondaparinuksom su bile usporedive za obje UFH skupine.
English: The most common adverse reactions were bleeding complications (see section 4.4).
Croatian: Najčešće nuspojave bile su komplikacije zbog krvarenja (vidjeti dio 4.4).
English: Your weight
Croatian: Vaša tjelesna težina
English: A similar pattern is observed in DVT and PE treatment patients.
Croatian: Sličan uzorak je zabilježen u liječenju DVT i PE.
English: The repeated dose and reproduction toxicity studies did not reveal any special risk but did not provide adequate documentation of safety margins due to limited exposure in the animal species.
Croatian: Ispitivanja toksičnosti ponovljenih doza i reproduktivne toksičnosti nisu pokazala nikakav posebni rizik, ali zbog ograničene izloženosti ispitivanih životinjskih vrsta ne dokumentiraju dovoljno sigurnosne granice.
English: Peri-PCI major bleeding or death,
Croatian: Peri-PCI veliko krvarenje ili smrt,
English: Two patients had reports of bleeding during the study.
Croatian: U dva je bolesnika prijavljeno krvarenje tijekom trajanja ispitivanja.
English: The fondaparinux dose (10 mg) in the interaction studies was higher than the dose recommended for the present indications.
Croatian: ispitivanjima interakcija doza fondaparinuksa (10 mg) je bila veća od preporučene doze za sadašnje indikacije.
English: Treatment should be continued for a minimum of 30 days and up to a maximum of 45 days in patients at high risk of thromboembolic complications (see sections 4.4 and 5.1).
Croatian: Liječenje treba provoditi tijekom minimalno 30 dana do maksimalno 45 dana u bolesnika s visokim rizikom od nastanka tromboembolijskih komplikacija (vidjeti dio 4.4 i 5.1).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and genotoxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja farmakološke sigurnosti i genotoksičnosti.
English: Some other medicines may affect the way that Arixtra works or be affected by Arixtra.
Croatian: Neki drugi lijekovi mogu utjecati na djelovanje lijeka Arixtra ili obrnuto.
English: Contact your doctor or pharmacist for advice as soon as possible because of the increased risk of bleeding.
Croatian: Obavijestite svog liječnika ili ljekarnika što je prije moguće zbog povećanog rizika od krvarenja.
English: The majority of events were asymptomatic distal DVT.
Croatian: većini slučajeva radilo se o asimptomatskoj DVT.
English: The mean treatment duration was 6.2 days on fondaparinux.
Croatian: Prosječno trajanje liječenja iznosilo je 6,2 dana za bolesnike na fondaparinuksu.
English: The associated 5th and 95th percentiles are, respectively, 0.97 and 1.92 for Cmax (mg/l), and 0.24 and 0.95 for Cmin (mg/l).
Croatian: Pridružena 5. i 95. percentila je 0,97 i 1,92 za Cmax (mg/l), te 0,24 i 0,95 za Cmin (mg/l).
English: There are no adequate data from the use of fondaparinux in pregnant women.
Croatian: Nema adekvatnih podataka o primjeni fondaparinuksa u trudnica.