FrancophonIA/ELRC3.0 huggingface dataset:
English: All the undesirable effects, primary and secondary, resulting from excessive pharmacological activity were reversible.
Croatian: Sve nuspojave, primarne i sekundarne koje su proizašle iz prekomjerne farmakološke aktivnosti bile su reverzibilne.
English: • Tabulated information on dosing by body weight of patient.
Croatian: • Tabelirane informacije o doziranju prema tjelesnoj težini bolesnika.
English: Comparison of the single and repeated dose studies revealed that toxicity was related primarily to duration of exposure.
Croatian: Ispitivanja usporedbe jednokratne ili ponavljane doze pokazala su da je toksičnost primarno povezana s trajanjem izloženosti.
English: Treatment should be stopped if bleeding is observed or suspected.
Croatian: Liječenje treba prekinuti ako se primijeti ili sumnja na krvarenje.
English: • severe uncontrolled hypertension
Croatian: • teškom nekontroliranom hipertenzijom
English: The results do not suggest pharmacodynamic interactions with these medicinal products.
Croatian: Rezultati ne ukazuju na farmakodinamičke interakcije s ovim lijekovima.
English: The doctor will decide how much Angiox you receive, and will prepare the medicine.
Croatian: Liječnik će odlučiti koliko ćete Angioxa primiti i on će pripremiti lijek.
English: Clearance (ml/min/kg)
Croatian: Klirens (ml/min/kg)
English: Relative Risk [95% CI]
Croatian: Relativan rizik [95% CI]
English: Angiox should not be used during pregnancy, unless clearly necessary.
Croatian: Angiox se ne smije primijeniti tijekom trudnoće osim ako je jasno da je neophodan.
English: There is no known antidote to bivalirudin but its effect wears off quickly (T½ is 25 ± 12 minutes).
Croatian: Ne postoji poznati antidot na bivalirudin, no njegov učinak brzo prolazi (T½ je 25 ± 12 minuta).
English: Talk to your doctor before using Angiox.
Croatian: Obratite se svom liječniku prije nego primijenite Angiox.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, or toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosti, farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, ili reproduktivne toksičnosti.
English: Elimination follows a first order process with a terminal half-life of 25  12 minutes in patients with normal renal function.
Croatian: Eliminacija slijedi proces prvog reda s terminalnim poluvijekom od 25  12 minuta u bolesnika s normalnom funkcijom bubrega.
English: The most frequent event was a haematoma <5 cm at puncture site.
Croatian: Najučestaliji događaj bio je hematom <5 cm na mjestu uboda.
English: • subacute bacterial endocarditis
Croatian: • subakutnim bakterijskim endokarditisom
English: If you get any of the following, (potentially less serious), side effects:
Croatian: Ako dobijete bilo koju od sljedećih, (potencijalno manje ozbiljnih), nuspojava:
English: The use of the Angiox dosing card is recommended as a quick reference guide.
Croatian: Uporaba kartice za doziranje Angioxa preporučuje se kao brzi referentni vodič.
English: Enoxaparin was used as comparator in ACUITY only.
Croatian: Enoksaparin je upotrijebljen kao komparator samo u ispitivanju ACUITY.
English: This dosing regimen is required to achieve and maintain the plasma concentration required for effective ischaemic protection during PCI.
Croatian: Ovaj raspored doziranja potreban je za postizanje i održavanje plazmatske koncentracije potrebne za učinkovitu ishemičku zaštitu tijekom PCI postupka.
English: This is administered and supervised by a doctor experienced in caring for patients with heart disease.
Croatian: Primjenjuje ga i nadzire liječnik iskusan u liječenju bolesnika s bolestima srca.
English: WHAT ANGIOX IS AND WHAT IT IS USED FOR
Croatian: ŠTO JE ANGIOX I ZA ŠTO SE KORISTI
English: Bivalirudin inhibits each of these thrombin effects.
Croatian: Bivalirudin inhibira svaki od tih učinaka trombina.
English: No dose adjustment is needed.
Croatian: Nije potrebna prilagodba doze.
English: - if you have, or have had, difficulty with your blood clotting (a low platelet count).
Croatian: - ako imate, ili ste imali, poteškoća sa zgrušavanjem krvi (nizak broj trombocita).
English: Angiox should not be used during pregnancy unless the clinical condition of the woman requires treatment with bivalirudin.
Croatian: Angiox se ne smije primjenjivati tijekom trudnoće osim ako kliničko stanje žene ne zahtijeva liječenje bivalirudinom.
English: The ACT vs concentration data suggest a trend for a lower concentration response curve for adults as compared to older children (6 years to < 16 years) and younger children (2 years to <6 years), and for older children compared to infants (31 days to <24 months) and neonates (birth to 30 days).
Croatian: Podaci o odnosu ACT-a naspram koncentracije upućuju na trend niže krivulje koncentracija-odgovor u odraslih u usporedbi sa starijom djecom (od 6 godina do <16 godina) i mlađom djecom (2 godine do <6 godina), te u starije djece u usporedbi s dojenčadi (od 31 dana do <24 mjeseci) i novorođenčadi (od rođenja do 30 dana).
English: Antithrombotics are medicines which prevent the formation of blood clots (thrombosis).
Croatian: Antitrombotici lijekovi su lijekovi koji sprječavaju stvaranje krvnih ugrušaka (tromboze).
English: Bleeding Definitions
Croatian: Definicije krvarenja
English: This dosing pattern was associated with increased in-hospital ischaemic events (MACE).
Croatian: Taj način doziranja povezan je s povećanim bolničkim događajima ishemije (MACE).
English: The bioavailability of bivalirudin for intravenous use is complete and immediate.
Croatian: Biološka dostupnost bivalirudina za intravensku primjenu kompletna je i trenutna.
English: The dosing cards will contain the following key information:
Croatian: Kartice za doziranje sadržavat će sljedeće ključne informacije:
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
Croatian: • Uoči svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera koristi/rizika, odnosno kada je omjer koristi/rizika rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili smanjenja rizika).
English: Angiox is only given when a patient is in hospital.
Croatian: Angiox se primjenjuje samo dok je bolesnik u bolnici.
English: • In the ImproveR registry bolus dosing (without subsequent infusion) was observed in EU clinical practice.
Croatian: • U ImproveR registru opaženo je bolus doziranje (bez naredne infuzije) u EU kliničkoj praksi.
English: Throughout your treatment, the doctor will check you for any signs of bleeding.
Croatian: Vašeg liječenja liječnik će provjeravati svaki znak krvarenja.
English: The concentration-time profile following intravenous administration is well described by a twocompartment model.
Croatian: Profil koncentracija-vrijeme nakon intravenske primjene dobro je opisan dvokomponentnim modelom.
English: There was no statistically significant difference in the rates of stent thrombosis between treatment arms at 30 days (p=0.3257) and 1 year (p=0.7754).
Croatian: Nije bilo statistički značajne razlike u stopama tromboze stenta između grupa liječenih ispitanika nakon 30 dana (p=0,3257) i 1 godine (p=0,7754).
English: Angiox is used to treat patients:
Croatian: Angiox se koristi za liječenje bolesnika:
English: - if you are allergic to bivalirudin or any of the other ingredients of this medicine (listed in section 6) or hirudins (other blood thinning medicines).
Croatian: - ako ste alergični na bivalirudin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) ili na hirudine (druge lijekove za razrjeđivanje krvi).
English: • Allergic reactions,- are uncommon (may affect up to 1 in 100 people) and usually not serious but can become severe under some circumstances, and in rare cases may be fatal due to low blood pressure (shock).
Croatian: • Alergijske reakcije su manje česte (mogu zahvatiti do 1 na 100 osoba) i obično nisu ozbiljne, ali mogu pod određenim okolnostima postati teške, a u rijetkim slučajevima i fatalne zbog niskog krvnog tlaka (šok).
English: Approximately 66% of patients were pre-treated with unfractionated heparin.
Croatian: Otprilike 66% bolesnika prethodno je liječeno nefrakcioniranim heparinom.
English: See section 6.2 for the summary of compatible and incompatible concentrations of these compounds.
Croatian: Pogledajte dio 6.2 za sažetak kompatibilnih i inkompatibilnih koncentracija ovih tvari.
English: What Angiox looks like and contents of the pack
Croatian: Kako Angiox izgleda i sadržaj pakiranja
English: • if you have been treated before with medicines similar to Angiox (e.g. lepirudin).
Croatian: • ako ste prethodno bili liječeni lijekovima sličnim Angioxu (npr. lepirudin).
English: 30 day Composite MACE
Croatian: Kompozitni za 30 dana MACE
English: An increase in the activated clotting time (ACT) may be used as an indication that a patient has received bivalirudin.
Croatian: Porast u aktiviranom vremenu zgrušavanja (ACT, engl. activated clotting time) može se upotrijebiti kao pokazatelj da je bolesnik primio bivalirudin.
English: • Angina or chest pain
Croatian: • angina ili bol u prsima
English: • Bleeding and bruising at the puncture site (after PCI treatment) may be painful.
Croatian: • Krvarenje i nastanak modrica na mjestu uboda (nakon PCI zahvata) može biti bolno.
English: OUTER CARTON (pack of 10 vials)
Croatian: VANJSKA KUTIJA (pakiranje od 10 bočica)
English: • active bleeding or increased risk of bleeding because of haemostasis disorders and/or irreversible coagulation disorders
Croatian: • aktivnim krvarenjem ili povećanom opasnosti od krvarenja zbog hemostatskih poremećaja i/ili trajnih poremećaja koagulacije.
English: About 20% of bivalirudin is excreted unchanged in the urine.
Croatian: Otprilike 20% bivalirudina izlučuje se nepromijenjeno mokraćom.
English: As Angiox is a hospital only medicine, storage of Angiox is the responsibility of healthcare professionals.
Croatian: Budući da je Angiox isključivo bolnički lijek, čuvanje lijeka Angiox odgovornost je zdravstvenih djelatnika.
English: Approximately 77% of patients had recurrent ischaemia, approximately 70% had dynamic ECG changes or elevated cardiac biomarkers, approximately 28% had diabetes and approximately 99% of patients underwent angiography within 72 hours.
Croatian: Otprilike 77% bolesnika imalo je rekurentnu ishemiju, otprilike 70% imalo je dinamičke promjene EKG-a ili povišene srčane biološke markere, otprilike 28% imalo je dijabetes, a otprilike 99% bolesnika podvrgnuto je angiografiji u roku od 72 sata.
English: Following angiographic assessment, patients were triaged to either medical management (33%), PCI (56%) or CABG (11%).
Croatian: Nakon angiografske procjene, bolesnike se trijažiralo za konzervativno liječenje (33%), PCI skupinu (56%) ili CABG (11%).
English: Death
Croatian: Smrt
English: • if you are having radiation treatment in the vessels that supply blood to the heart (treatment called beta or gamma brachytherapy).
Croatian: • ako primate radioterapiju u žilama koje dovode krv do srca (liječenje nazvano beta ili gama brahiterapija).
English: Angiox has no or negligible influence on the ability to drive and use machines.
Croatian: Angiox ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The ACT increased in all patients - from neonates to older children as well as adults- with increasing bivalirudin concentrations.
Croatian: ACT se povećao u svih bolesnika - od novorođenčadi do starije djece te u odraslih - s povećanjem koncentracija bivalirudina.
English: • Anaemia (a low blood cell count)
Croatian: • anemija (nizak broj krvnih stanica)
English: Ischaemic Components All cause death
Croatian: Komponente ishemije Smrt zbog bilo kojeg uzroka
English: Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Croatian: Ispitivanja na životinjama nedostatna su za konačan zaključak o učinku na trudnoću, razvoj embrija/fetusa, porod ili neonatalni razvoj (vidjeti dio 5.3).
English: All 5 events were associated with additional cardiac procedures employing heparin anticoagulation (n=3) or with infections (n=2).
Croatian: Svih 5 slučajeva bilo je povezano s dodatnim postupcima na srcu pri kojima se koristila antikoagulacija heparinom (n= 3) ili s infekcijama (n= 2).
English: The clinical utility of ACT in neonates and children should be considered with caution considering their developmental haematological state.
Croatian: Kliničku korist ACT-a u novorođenčadi i djece treba razmotriti uz oprez vodeći računa o njihovom razvojnom hematološkom statusu.
English: Toxicity in animals upon repeated or continuous exposure (1 day to 4 weeks at exposure levels of up to 10 times the clinical steady state plasma concentration) was limited to exaggerated pharmacological effects.
Croatian: Toksičnost za životinje nakon ponavljane ili kontinuirane izloženosti (1 dan do 4 tjedna kod razine izloženosti do 10 puta više od kliničke koncentracije lijeka u plazmi u stanju dinamičke ravnoteže) ograničena je na pojačane farmakološke učinke.
English: Solutions containing particulate matter should not be used.
Croatian: Otopine koje sadrže čestice ne smiju se upotrijebiti.
English: Bleeding is more likely to occur when Angiox is used in combination with other anticoagulant or antithrombotic medicines (see section 2 ‘Taking other medicines').
Croatian: Vjerojatnije je da će se krvarenje pojaviti kada je Angiox primijenjen u kombinaciji s drugim antikoagulansima ili antitrombotskim lijekovima (pogledajte dio 2 „Uzimanje drugih lijekova“).
English: Bivalirudin does not bind to plasma proteins (other than thrombin) or to red blood cells.
Croatian: Bivalirudin se ne veže na proteine plazme (osim trombina) ni crvene krvne stanice.
English: Other frequently reported adverse events were decreased pedal pulse, catheter site haemorrhage, abnormal pulse, and nausea (8.2%, 7.3%, 6.4% and 5.5%, respectively).
Croatian: Drugi često prijavljeni štetni događaji bili su usporeni puls na stopalu, krvarenje na mjestu katetera, abnormalni puls i mučnina (8,2%, 7,3%, 6,4% odnosno 5,5%).
English: Pharmacodynamic models indicated that this effect is due to a higher baseline ACT in neonates and infants than in older children.
Croatian: Farmakodinamički modeli ukazali su da je taj učinak posljedica više početne vrijednosti ACT-a u novorođenčadi i dojenčadi nego u starije djece.
English: Platelets, bleeding and clotting
Croatian: Trombociti, krvarenje i zgrušavanje
English: The MAH shall agree on the dosing card together with a communication plan, with the National Competent Authority in each Member State prior to distribution in the Member State.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet sporazumjet će se o kartici za doziranje i komunikacijskom planu s nacionalnim nadležnim tijelom svake zemlje članice prije distribucije u dotičnu zemlju članicu.
English: Bivalirudin is intended for short-term administration and therefore no data on the long-term carcinogenic potential of bivalirudin are available.
Croatian: Bivalirudin je namijenjen kratkotrajnoj primjeni pa nema dostupnih podataka o njegovu dugotrajnom kancerogenom potencijalu.
English: Bivalirudin is rapidly distributed between plasma and extracellular fluid.
Croatian: Bivalirudin se brzo distribuira između plazme i ekstracelularne tekućine.
English: The corresponding clearance is about 3.4  0.5 ml/min/kg.
Croatian: Odgovarajući klirens otprilike je 3,4  0,5 ml/min/kg.
English: The bolus dose should not be changed from the posology described under ACS or PCI above.
Croatian: Bolus dozu ne treba mijenjati od doziranja koje je prethodno opisano za ACS ili PCI.
English: Such a reaction is uncommon (may affect up to 1 in 100 people).
Croatian: Takva reakcija nije česta (može zahvatiti do 1 na 100 osoba).
English: Educational material includes a slide deck presentation, dosing cards as described in the risk minimization measures in the RMP, and a copy of the SmPC.
Croatian: Obrazovni materijal uključuje prezentaciju sa slajdovima, kartice za doziranje kao što je opisano u mjerama minimizacije rizika u RMP-u i kopiju Sažetka opisa svojstava lijeka.
English: Angiox is contraindicated in patients with:
Croatian: Angiox je kontraindiciran u bolesnika sa:
English: - if you have, or have recently had, any bleeding from your stomach, intestines, bladder or other organs, for example, if you have noticed abnormal blood in your stools or urine (except from
Croatian: - ako imate, ili ste nedavno imali, krvarenje iz želuca, crijeva, mokraćnog mjehura i drugih organa, primjerice, ako ste primijetili abnormalnu pojavu krvi u stolici ili mokraći (osim od menstrualnog krvarenja).
English: o while you are in hospital: tell the doctor or nurseo after you've left hospital: first seek advice from your doctor.
Croatian: o dok ste u bolnici: obavijestite liječnika ili medicinsku sestruo nakon što ste napustili bolnicu: prvo potražite savjet od svog liječnika.
English: *Superiority p-value.
Croatian: *p-vrijednost za superiornost
English: In order to ensure the correct use of Angiox and to avoid medication errors, the MAH shall ensure that all prescribers who are expected to prescribe/use Angiox are provided with training on dosing and administration.
Croatian: Kako bi se osigurala ispravna uporaba Angioxa i izbjegle medikacijske pogreške, nositelj odobrenja za stavljanje gotovog lijeka u promet osigurat će da svi od kojih se očekuje da će propisati/koristiti Angiox budu podučeni o doziranju i primjeni tog lijeka.
English: • INR test (warfarin blood test result) increased (see Section 2, Other medicines and Angiox)
Croatian: • povišeni rezultati INR testa (rezultati varfarina u krvi) (vidjeti dio 2, Drugi lijekovi i Angiox)
English: Date of first authorisation: 20.09.2004 Date of latest renewal: 23.06.2014
Croatian: Datum posljednje obnove: 23.06.2014.
English: UFH/Enox
Croatian: UFH/Enoks
English: However, bivalirudin was not mutagenic or clastogenic in standard assays for such effects.
Croatian: Bivalirudin se nije pokazao kao mutagen ili klastogen u standardnim testovima za takve učinke.
English: In clinical study TMC-BIV-07-01, the pharmacodynamic response as measured by ACT was consistent with adult studies.
Croatian: U kliničkom ispitivanju TMC-BIV-07-01, farmakodinamički odgovor izmjeren pomoću ACT-a bio je u skladu s ispitivanjima u odraslih.
English: What Angiox contains
Croatian: Što Angiox sadrži
English: If, after this, you then need percutaneous coronary intervention (PCI) treatment, the dosage will be increased to:
Croatian: Ako nakon toga idete na perkutanu koronarnu intervenciju (PCI), doza će biti povećana na:
English: In all clinical studies bleeding data were collected separately from adverse reactions and are summarised in Table 6 together with the bleeding definitions used for each study.
Croatian: U svim kliničkim ispitivanjima podaci o krvarenju sakupljani su odvojeno od nuspojava na lijek i prikazani su u sažetku u tablici 6 zajedno s definicijama krvarenja upotrijebljenih za pojedino ispitivanje.
English: • Do not use bivalirudin without first diluting it.
Croatian: • Ne koristiti bivalirudin bez prethodnog razrjeđivanja.
English: From the knowledge of their mechanism of action, combined use of anti-coagulant medicinal products (heparin, warfarin, thrombolytics or antiplatelet agents) can be expected to increase the risk of bleeding.
Croatian: Prema onome što je poznato o mehanizmu njihovog djelovanja, kombiniranom uporabom antikoagulansa (heparin, varfarin, trombolitici ili antitrombocitni lijekovi) može se očekivati povećati rizik od krvarenja.
English: High risk patient characteristics of the ACUITY population that mandated angiography within 72 hours were balanced across the three treatment arms.
Croatian: Visokorizični bolesnici u ACUITY populaciji čije su karakteristike zahtijevale angiografiju u roku od 72 sata bili su proporcionalno raspodijeljeni u sve tri grupe ispitanika.
English: Angiox is for injection, followed by infusion (drip), into a vein (never into a muscle).
Croatian: Angiox je namijenjen za injekciju, nakon čega slijedi infuzija (drip) u venu (nikada u mišić).
English: Angiox is not intended for intramuscular use.
Croatian: Angiox nije namijenjen intramuskularnoj uporabi.
English: This may, rarely, result in a stroke or be fatal.
Croatian: To može u rijetkim slučajevima, rezultirati moždanim udarom ili biti smrtonosno.
English: The arterial sheath can be removed 2 hours after discontinuation of the bivalirudin infusion without anticoagulation monitoring.
Croatian: Arterijska uvodnica može se odstraniti 2 sata nakon prestanka infuzije bivalirudina bez nadzora antikoagulacije.
English: • Thrombosis (blood clot) is an uncommon side effect (may affect up to 1 in 100 people) which may result in serious or fatal complications such as heart attack.
Croatian: • Tromboza (krvni ugrušak) je manje česta nuspojava (može zahvatiti do 1 na 100 osoba) koja može uzrokovati ozbiljne ili smrtonosne komplikacije, kao što je srčani udar.
English: Caution should be exercised in patients previously treated with lepirudin who had developed lepirudin antibodies.
Croatian: Potreban je oprez u bolesnika prethodno liječenih lepirudinom koji su razvili protutijela na lepirudin.
English: - The active substance is bivalirudin.
Croatian: - Djelatna tvar je bivalirudin.
English: The slide deck will contain the following key information:
Croatian: Skup slajdova sadržavat će sljedeće ključne informacije:
English: • Reperfusion injury (no or slow reflow): impaired flow in the heart arteries after they have been reopened
Croatian: • ozljeda reperfuzije (izostanak ili usporeni ponovni protok krvi): oštećeni protok krvi u srčanim arterijama nakon njihovog ponovnog otvaranja
English: For further information regarding the use of bivalirudin with or without a GP IIb/IIIa inhibitor, please see section 5.1.
Croatian: Za dodatne informacije o korištenju bivalirudina sa ili bez inhibitora GP IIb/IIIa vidjeti dio 5.1.
English: 2Major bleeding was defined using the ACUITY bleeding scale.
Croatian: 2Veliko krvarenje definirano je uporabom ljestvice krvarenja ACUITY.
English: • who are having surgery to treat blockages in their blood vessels (angioplasty and/or percutaneous coronary intervention - PCI).
Croatian: • koji imaju operaciju zbog blokade u krvnim žilama (angioplastiku i/ili perkutanu koronarnu intervenciju - PCI).
English: Although most bleeding associated with bivalirudin occurs at the site of arterial puncture in patients undergoing PCI, haemorrhage can occur at any site during therapy.
Croatian: Iako se većina krvarenja povezana s bivalirudinom pojavljuje na arterijskom ubodnom mjestu, u bolesnika podvrgnutih PCI-ju, krvarenje se može pojaviti na bilo kojem mjestu tijekom liječenja.
English: Undesirable effects that resulted from prolonged physiological stress in response to a non-homeostatic state of coagulation were not seen after short exposure comparable to that in clinical use, even at much higher doses.
Croatian: Nuspojave koje su proizašle iz produljenog fiziološkog stresa kao odgovora na nehomeostatsko stanje koagulacije nisu opažene nakon kratke izloženosti u odnosu na nuspojave u kliničkoj uporabi, čak i kod viših doza.
English: CONTENTS OF THE PACK AND OTHER INFORMATION
Croatian: SADRŽAJ PAKIRANJA I DRUGE INFORMACIJE
English: They may begin with limited symptoms such as itching, redness of the skin, rash or small bumps on the skin.
Croatian: Mogu započeti ograničenim simptomima kao što je osip, svrbež, crvenilo kože ili male kvržice na koži.
English: 1-year Composite ischaemia
Croatian: 1 godina Kompozitna ishemija
English: Dose adjustments for this age group should be on the basis of renal function, see section 4.2.
Croatian: Podešavanje doze za ovu starosnu grupu treba temeljiti na funkciji bubrega, vidjeti dio 4.2. Spol