FrancophonIA/ELRC3.0 huggingface dataset:
English: Lymphopenia
Croatian: Limfopenija
English: Day 3
Croatian: PRILOG III.
English: Lymphopenia and shingles
Croatian: Limfopenija i herpes zoster
English: Dose
Croatian: Doza
English: EXPIRY DATE
Croatian: Popis nuspojava
English: while on therapy with other DMDs,
Croatian: dok su uzimali terapiju drugim DMD-ovima,
English: Day 2
Croatian: PRILOG II.
English: You will be tested to see if you have any infections before you start MAVENCLAD treatment.
Croatian: Prije nego što započnete liječenje lijekom MAVENCLAD, provest će Vam se pretrage da se provjeri imate li kakve infekcije.
English: The recommended dose is:
Croatian: Preporučena doza je:
English: Avoid vigorous mixing.
Croatian: Izbjegavajte snažno miješanje.
English: very rare (<1/10,000).
Croatian: vrlo rijetko (< 1/10 000).
English: Do not use without dilution.
Croatian: Nemojte koristiti bez razrjeđivanja.
English: • severe allergic reactions,
Croatian: • teške alergijske reakcije,
English: Sorbitol is a source of fructose.
Croatian: Sorbitol je izvor fruktoze.
English: Tell your doctor immediately if you notice any of the following:
Croatian: Odmah obavijestite svog liječnika ako primijetite bilo što od sljedećeg:
English: In clinical studies, healthy volunteers received up to two times the proposed daily dose.
Croatian: U kliničkim ispitivanjima zdravi dobrovoljci dobivali su do dva puta predloženu dnevnu dozu.
English: The dose given depends on your weight.
Croatian: Dobivena doza ovisi o Vašoj tjelesnoj težini.
English: The doctor will decide if you will need to be treated for longer periods.
Croatian: Liječnik će odlučiti trebate li se liječiti duže vremena.
English: • You are, or you think you may be at increased risk of bleeding.
Croatian: • ako imate, ili mislite da biste mogli imati povećan rizik od krvarenja.
English: No dose adjustment is needed for these populations.
Croatian: Nije potrebno prilagođavati dozu za te populacije.
English: This medicine will be given to you by a healthcare professional.
Croatian: Ovaj će Vam lijek dati zdravstveni radnik.
English: Bleeding can be serious, and fatal outcomes have been reported.
Croatian: Krvarenje može biti ozbiljno, a prijavljeni su smrtni ishodi.
English: No dose adjustment is needed in elderly (≥75 years) patients.
Croatian: Nije potrebno prilagođavati dozu u starijih (≥ 75 godina) bolesnika.
English: Use with other anticoagulant agents
Croatian: Primjena s drugim antikoagulansima
English: Your doctor will decide how to treat you, including stopping the medicine and monitoring for signs of side effects.
Croatian: Vaš liječnik će odlučiti kako Vas liječiti, uključujući prekid davanja lijeka i praćenje radi uočavanja znakova nuspojava.
English: Initial excretion was rapid, such that approximately 50% of the administered radioactivity was recovered in the first 24 hours, and 75% was recovered by 48 hours.
Croatian: Početno izlučivanje bilo je brzo, tako da je približno 50% primijenjene radioaktivnosti pronađeno u prvih 24 sata, a 75% je pronađeno do 48 sati.
English: Ensure the bolus is completely administered before the start of PCI.
Croatian: Uvjerite se da je bolus primijenjen u potpunosti prije početka PCI.
English: Bleeding is the most likely pharmacological effect of overdose.
Croatian: Krvarenje je najvjerojatniji farmakološki učinak predoziranja.
English: Risk of bleeding
Croatian: Rizik od krvarenja
English: The median duration of cangrelor infusion was 129 minutes.
Croatian: Medijan trajanja infuzije kangrelora iznosio je 129 minuta.
English: Date of first authorisation: 23 March 2015 Date of latest renewal:
Croatian: Datum prvog odobrenja: 23 ožujak 2015.
English: This dilution will generate a concentration of 200 micrograms/mL and should be sufficient for at least two hours of dosing as required.
Croatian: To će razrjeđivanje dati koncentraciju od 200 mikrograma/ml i treba biti dovoljno za najmanje dva sata doziranja po potrebi.
English: • Bleeding under the skin or around the eye,
Croatian: • Krvarenje ispod kože ili oko očiju,
English: Kengrexal is not recommended for children and adolescents under 18 years.
Croatian: Kengrexal se ne preporučuje za djecu i adolescente mlađe od 18 godina.
English: In this study, semen analysis was conducted after 8 weeks of continuous treatment.
Croatian: U tom je ispitivanju analiza sjemena provedena nakon 8 tjedana neprekidnog liječenja.
English: Cytochrome P450 (CYP)
Croatian: Citokrom P450 (CYP)
English: See section 4.2 for information on paediatric use.
Croatian: Vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni.
English: Contents of the pack and other information What Kengrexal contains
Croatian: Sadržaj pakiranja i druge informacije Što Kengrexal sadrži
English: What Kengrexal is and what it is used for
Croatian: Što je Kengrexal i za što se koristi
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja pripremljenog lijeka prije primjene odgovornost su korisnika.
English: Instructions for preparation
Croatian: Upute za pripremu
English: ** Transfusion was uncommon 101/12,565 (0.8%).
Croatian: ** transfuzija je bila manje česta 101/12 565 (0,8%)
English: At the discretion of the physician, the infusion may be continued for a total duration of four hours, see section 5.1.
Croatian: Prema odluci liječnika, infuzija se smije nastaviti do ukupnog trajanja od četiri sata, vidjeti dio 5.1.
English: Mean clearance was approximately 43.2 L/kg.
Croatian: Srednji klirens bio je približno 43,2 l/kg.
English: The doctor will decide how much Kengrexal you receive, and will prepare the medicine.
Croatian: Liječnik će odlučiti koliko ćete lijeka Kengrexal primiti i pripremit će lijek.
English: Death/MI/IDR/ST
Croatian: Smrt/MI/IDR/ST
English: Non-clinical data reveal no special safety risk for humans based on studies of safety pharmacology, mutagenicity and clastogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju ispitivanja sigurnosne farmakologije, mutagenosti i klastogenog potencijala.
English: Kengrexal is available in packs of 10 vials.
Croatian: Kengrexal je dostupan u pakiranjima od 10 bočica.
English: The bioavailability of cangrelor is complete and immediate.
Croatian: Bioraspoloživost kangrelora je potpuna i trenutna.
English: These effects were not apparent at lower doses and were reversible following cessation of dosing.
Croatian: Ti učinci nisu bili vidljivi pri nižim dozama i bili su reverzibilni nakon prekida primjene doze.
English: • You have ever suffered from an allergic reaction to Kengrexal or any of its constituents.
Croatian: • ako ste ikada imali alergijsku reakciju na Kengrexal ili bilo koji od njegovih sastojaka;
English: Carcinogenicity studies have not been performed.
Croatian: Nisu provedena ispitivanja kancerogenosti.
English: Table 1 depicts adverse reactions that have been identified based upon a pooling of combined data from all CHAMPION studies.
Croatian: Tablica 1 prikazuje nuspojave koje su zabilježene na temelju objedinjavanja kombiniranih podataka iz svih ispitivanja CHAMPION.
English: • swollen face.
Croatian: • i oticanje lica.
English: 48155 Münster Germany
Croatian: 48155 Münster
English: Of the recovered material, 58% was found in urine and the remaining 35% was found in faeces, presumably following biliary excretion.
Croatian: Od pronađenog materijala, 58% je nađeno u mokraći, a preostalih 35% je nađeno u stolici, vjerojatno nakon izlučivanja putem žuči.
English: Multiple related adverse reaction terms have been grouped together in the table and include medical terms as described below: a.
Croatian: Više povezanih termina nuspojava grupirano je zajedno u tablici i uključuju medicinske termine kao što je opisano u nastavku: a.
English: The bolus and infusion should be initiated prior to the procedure and continued for at least two hours or for the duration of the procedure, whichever is longer.
Croatian: Bolus i infuziju se mora započeti prije postupka i nastaviti najmanje dva sata ili tijekom trajanja postupka, ovisno o tome što traje duže.
English: These included cases of anaphylactic reactions/shock and angioedema (see section 4.8).
Croatian: To je uključivalo slučajeve anafilaktičkih reakcija/šoka i angioedema (vidjeti dio 4.8).
English: • bleeding from the penis, ear or pre-existing skin tumours.
Croatian: • krvarenje iz penisa, uha ili već postojećih tumora kože.
English: If you use more Kengrexal than you should
Croatian: Ako primijenite više lijeka Kengrexal nego što ste trebali
English: Talk to your doctor before using Kengrexal if:
Croatian: Obratite se svom liječniku prije nego primijenite Kengrexal:
English: The safety and efficacy of cangrelor in children aged less than 18 years has not been established.
Croatian: Pedijatrijska populacija Sigurnost i djelotvornost kangrelora u djece mlađe od 18 godina nisu ustanovljene.
English: Possible implications for the in vivo situation have not been investigated, but caution is advised when cangrelor is to be combined with a BCRP substrate.
Croatian: Moguće implikacije za in vivo situaciju nisu ispitane, ali se preporučuje oprez kada se kangrelor kombinira sa supstratom BCRP-a.
English: • Allergic reaction (a rash, itching, throat tightening/swelling, swelling of the tongue or lips, difficulty breathing).
Croatian: • Alergijska reakcija (osip, svrbež, stezanje/oticanje grla, oticanje jezika ili usana, poteškoće s disanjem).
English: Kengrexal contains sodium and sorbitol
Croatian: Kengrexal sadrži natrij i sorbitol
English: Other medicines and Kengrexal
Croatian: Drugi lijekovi i Kengrexal
English: • Bleeding from anywhere in the body.
Croatian: • Krvarenje iz bilo kojeg dijela tijela.
English: If side effects occur, they may need medical attention.
Croatian: Ako se pojave nuspojave, možda će zahtijevati medicinsku pomoć.
English: Female fertility was not affected at any dose.
Croatian: Na plodnost u ženki nije utjecala nijedna doza.
English: This medicinal product contains 52.2 mg sorbitol in each vial.
Croatian: Ovaj lijek sadrži 52,2 mg sorbitola u jednoj bočici.
English: In vitro inhibition of BCRP by the metabolite ARC-69712XX at clinically relevant concentrations has been observed.
Croatian: Opažena je in vitro inhibicija BCRP-a od strane metabolita ARC-69712XX pri klinički značajnim koncentracijama.
English: - If you have recently undergone major surgery or suffered from any form of serious physical trauma such as a bone fracture or road traffic accident.
Croatian: - ako ste nedavno podvrgnuti većem kirurškom zahvatu ili ste imali bilo koji oblik ozbiljne fizičke traume, npr. prijelom kosti ili prometnu nesreću;
English: Pharmacokinetic/pharmacodynamic relationship(s)
Croatian: Farmakokinetički/farmakodinamički odnos(i)
English: If bleeding occurs appropriate supportive measures should be taken, which may include stopping the medicinal product so platelet function can return.
Croatian: Ako dođe do krvarenja, moraju se poduzeti prikladne potporne mjere, koje mogu uključivati prekid primjene lijeka tako da se funkcija trombocita može ponovno uspostaviti.
English: Significant reductions in death/MI/IDR/ST and ST observed in the cangrelor group at 48 hours were maintained at 30 days (Table 4).
Croatian: Značajna smanjenja u smrti/MI/IDR/ST i ST opažena u skupini s kangrelorom nakon 48 sati održana su nakon 30 dana (tablica 4).
English: - If you have any further questions, ask your doctor.
Croatian: Ako imate dodatnih pitanja, obratite se liječniku.
English: GP IIb/IIIa inhibitors were permitted for bailout use only and were used in 2.9% of patients.
Croatian: Inhibitori GPIIb/IIIa bili su dopušteni samo za primjenu u nuždi (tzv."bailout" primjenu) i korišteni su u 2,9%
English: Acetylsalicylic acid, heparin, nitrogycerin
Croatian: Acetilsalicilatna kiselina, heparin, nitroglicerin
English: If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine.
Croatian: Ako imate nasljedno nepodnošenje fruktoze, rijetki genetski poremećaj, ne smijete primiti ovaj lijek.
English: • Active bleeding or increased risk of bleeding, because of impaired haemostasis and/or irreversible coagulation disorders or due to recent major surgery/trauma or uncontrolled severe hypertension.
Croatian: • Aktivno krvarenje ili povećan rizik od krvarenja, zbog narušene hemostaze i/ili ireverzibilnih poremećaja koagulacije ili uslijed nedavne veće operacije/traume ili nekontrolirane teške hipertenzije.
English: The other ingredients are mannitol, sorbitol and sodium hydroxide for pH-adjustment.
Croatian: Drugi sastojci su manitol, sorbitol i natrijev hidroksid za podešavanje pH.
English: In patients undergoing PCI, standard procedural adjunctive therapy should be implemented (see section 5.1).
Croatian: U bolesnika koji se podvrgavaju PCI mora se provesti standardna proceduralna dodatna terapija (vidjeti dio 5.1).
English: b In CHAMPION PHOENIX, GUSTO Mild was defined as other bleeding requiring intervention but not requiring blood transfusion or causing haemodynamic compromise.
Croatian: b U ispitivanju CHAMPION PHOENIX, blagi GUSTO bio je definiran kao druga krvarenja koja zahtijevaju intervenciju, ali ne zahtijevaju transfuziju krvi niti uzrokuju narušavanje hemodinamike.
English: Administration of 600 mg clopidogrel immediately after the cessation of the cangrelor infusion results in the anticipated full pharmacodynamic effect.
Croatian: Primjena 600 mg klopidogrela odmah nakon prekida infuzije kangrelora rezultira očekivanim potpunim farmakodinamičkim učinkom.
English: Your treatment with Kengrexal will be supervised by a doctor experienced in caring for patients with heart disease.
Croatian: Vaše će liječenje lijekom Kengrexal nadzirati liječnik s iskustvom u liječenju bolesnika s bolestima srca.
English: • dyspnoea (shortness of breath),
Croatian: • dispneja (nedostatak zraka),
English: Platelets are very small cells in the blood that can clump together and help the blood to clot.
Croatian: Trombociti su vrlo male stanice u krvi koje mogu zajedno tvoriti nakupine i pomoći zgrušavanju krvi.
English: There is no antidote to Kengrexal, however, the pharmacokinetic half-life of Kengrexal is three to six minutes.
Croatian: Ne postoji protulijek za Kengrexal, međutim, farmakokinetički poluvijek lijeka Kengrexal je tri do šest minuta.
English: Patients 100 kg and over will require a minimum of two bags.
Croatian: Bolesnicima tjelesne težine od 100 kg i više trebat će najmanje dvije vrećice.
English: (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000),
Croatian: Kategorije učestalosti prikazane su prema sljedećim odrednicama: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000),
English: The pharmacokinetic properties of cangrelor have been evaluated and found to be linear in patients and healthy volunteers.
Croatian: Procijenjena su farmakokinetička svojstva kangrelora i utvrđeno je da su linearna u bolesnika i zdravih dobrovoljaca.
English: Mix the bag thoroughly.
Croatian: Temeljito promiješajte sadržaj vrećice.
English: Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „Rok valjanosti“/„EXP“.
English: Tell your doctor if you are taking other medicines that may increase the risk of side effects such as bleeding including blood thinners (anticoagulants e.g. warfarin).
Croatian: Obavijestite svog liječnika ako uzimate druge lijekove koji mogu povećati rizik od nuspojava, primjerice krvarenja, uključujući lijekove za razrjeđivanje krvi (antikoagulanse, npr. varfarin).
English: Effects on fertility, ability to produce a pregnancy with female partner(s), sperm morphology and sperm motility were observed in the male rat fertility study when cangrelor was administered at human equivalent doses equal to 1.8 fold the recommended PCI dose.
Croatian: Učinci na plodnost, sposobnost postizanja trudnoće sa ženskom partnericom(ama), morfologiju i motilitet spermija opaženi su u ispitivanju plodnosti provedenom na mužjacima štakora kada je kangrelor primijenjen u ljudskim ekvivalentnim dozama jednakim 1,8 puta preporučene PCI doze.
English: • Any history of stroke or transient ischaemic attack (TIA).
Croatian: • Bilo kakva anamneza moždanog udara ili tranzitorne ishemijske atake (TIA) .
English: Chiesi Bulgaria EOOD Teл.
Croatian: Chiesi Bulgaria EOOD
English: You may receive acetylsalicylic acid (ASA) while you are treated with Kengrexal or another type of anti-platelet medicine (e.g., clopidogrel) before and after you are treated with Kengrexal.
Croatian: Možda dobijete acetilsalicilatnu kiselinu (ASK) dok se liječite lijekom Kengrexal ili drugu vrstu antitrombocitnog lijeka (npr. klopidogrel) prije i nakon liječenja lijekom Kengrexal.
English: Allergic reaction is a rare side effect of treatment with Kengrexal (may affect up to 1 in 1,000 people) but may be potentially serious.
Croatian: Alergijska reakcija je rijetka nuspojava liječenja lijekom Kengrexal (može se javiti u do 1 na 1000 osoba), ali može biti ozbiljna.
English: Table 4:
Croatian: Tablica 4:
English: No baseline demographic factor altered the relative risk of bleeding with cangrelor.
Croatian: Nijedan demografski čimbenik na početku ispitivanja nije promijenio relativni rizik od krvarenja s kangrelorom.
English: Coagulation time abnormal, prothrombin time prolonged.
Croatian: abnormalno vrijeme koagulacije, produženo protrombinsko vrijeme d.
English: Platelet function is restored within 60 minutes of stopping infusion.
Croatian: Funkcija trombocita se ponovno uspostavlja unutar 60 minuta od prekida infuzije.
English: Table 3:
Croatian: Tablica 3:
English: • bleeding in the eye, brain (including stroke), pelvis and lung,
Croatian: • krvarenje u oku, mozgu (uključujući moždani udar), zdjelici i plućima,
English: Alternatively, a loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see section 4.5.
Croatian: Alternativno, udarna doza tikagrelora ili prasugrela, ali ne i klopidogrela, smije se primijeniti do 30 minuta prije završetka infuzije, vidjeti dio 4.5.
English: What Kengrexal looks like and contents of the pack
Croatian: Kako Kengrexal izgleda i sadržaj pakiranja
English: You must tell your doctor before receiving this medicine if you have HFI.
Croatian: Morate reći svom liječniku prije nego primite ovaj lijek ako imate nasljedno nepodnošenje fruktoze.
English: Cangrelor should be used with caution in these patients.
Croatian: Kangrelor treba primjenjivati uz oprez u tih bolesnika.
English: Following the intravenous administration of a 2 micrograms/kg/min infusion of [3H] cangrelor to healthy male volunteers, 93% of total radioactivity was recovered.
Croatian: 2 mikrograma/kg/min infuzije [3H] kangrelora u zdravih muških dobrovoljaca, pronađeno je 93% od ukupne radioaktivnosti.
English: In clinical trials, the maximum accidental overdose was 10 times (bolus) or 3.5 times the infusion dose normally administered and bleeding was the most frequently observed adverse event.
Croatian: U kliničkim ispitivanjima, maksimalno slučajno predoziranje bilo je 10 puta (bolus) ili 3,5 puta veće od uobičajeno primijenjene infuzijske doze, a najčešće opaženi štetni događaj bio je krvarenje.
English: Swirl gently until all material is dissolved.
Croatian: Nježno okrećite bočicu dok se sav prašak ne otopi.
English: Sometimes clots can form within a damaged blood vessel such as in an artery in the heart and this can be very dangerous as the clot can cut off the blood supply (a thrombotic event), causing a heart attack (myocardial infarction).
Croatian: Ponekad se ugrušci mogu stvoriti unutar oštećene krvne žile, npr. arterije u srcu i to može biti vrlo opasno jer ugrušak može prekinuti dotok krvi (trombotički događaj) i prouzročiti srčani udar (infarkt miokarda).
English: Patients can be transitioned from cangrelor to prasugrel when prasugrel is administered immediately following discontinuation of the cangrelor infusion or up to one hour before, optimally at 30 minutes before the end of the cangrelor infusion to limit recovery of platelet reactivity.
Croatian: Bolesnici se mogu prebaciti s kangrelora na prasugrel kada se prasugrel primjenjuje neposredno nakon prekida infuzije kangrelora ili do jednog sata prije, u najboljem slučaju 30 minuta prije kraja infuzije kangrelora da bi se ograničio oporavak reaktivnosti trombocita.
English: No pharmacokinetic or pharmacodynamic interaction with cangrelor was observed in an interaction study with aspirin, heparin, or nitroglycerin.
Croatian: Nisu opažene farmakokinetičke niti farmakodinamičke interakcije s kangrelorom u ispitivanju interakcija s aspirinom, heparinom ili nitroglicerinom.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: The bolus and infusion should be administered from the infusion solution.
Croatian: Bolus i infuziju treba primijeniti iz infuzijske otopine.
English: Mannitol
Croatian: Manitol
English: For example, if you have a medical condition that affects blood clotting or because of another medical condition that may increase the risk of bleeding such as a recent serious injury, any recent surgery, history of a stroke or a transient ischaemic attack or recent bleeding from your stomach or gut.
Croatian: Primjerice, ako imate medicinsko stanje koje utječe na zgrušavanje krvi ili zbog drugog medicinskog stanja koje može povećati rizik od krvarenja, primjerice nedavnu ozbiljnu ozljedu, bilo kakav nedavni kirurški zahvat, moždani udar ili tranzitornu ishemijsku ataku u povijesti bolesti ili nedavno krvarenje iz želuca ili crijeva;
English: Cerebral haemorrhage, cerebrovascular accident.
Croatian: krvarenje u mozgu, cerebrovaskularni incident e.
English: Patients can be transitioned from cangrelor to ticagrelor without interruption of antiplatelet effect.
Croatian: Bolesnici se mogu prebaciti s kangrelora na tikagrelor bez prekida antitrombocitnog učinka.
English: • bleeding leading to decreases in blood volume or red blood cell numbers,
Croatian: • krvarenje koje dovodi do smanjenja volumena krvi ili broja crvenih krvnih stanica,
English: White to off-white lyophilised powder.
Croatian: Bijeli do gotovo bijeli liofilizirani prašak.
English: Pharmacotherapeutic group: Platelet aggregation inhibitors excluding heparin, ATC code: B01AC25.
Croatian: Farmakoterapijska skupina: Inhibitori agregacije trombocita, izuzev heparina, ATK oznaka: B01AC25.
English: No clinically relevant interruption of P2Y12 inhibition was observed in phase III studies when 600 mg clopidogrel was administered immediately after discontinuation of the cangrelor infusion.
Croatian: Nije opažen klinički značajan prekid inhibicije P2Y12 u ispitivanjima faze 3 kada je 600 mg klopidogrela primijenjeno neposredno nakon prekida infuzije kangrelora.
English: Cangrelor has a half-life of three to six minutes.
Croatian: Kangrelor ima poluvijek od tri do šest minuta.
English: Paediatric population Cangrelor has not been evaluated in a paediatric population (see sections 4.2 and 5.1).
Croatian: Kangrelor nije ispitivan u pedijatrijskoj populaciji (vidjeti dijelove 4.2 i 5.1).
English: Kengrexal has no or negligible influence on the ability to drive and use machines.
Croatian: Kengrexal ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.