FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodiumfree'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Key Secondary Endpoint
Croatian: Ključni sekundarni ishod
English: • balloon-like swelling in an artery or wall of the heart, which involves only a few layers of the vessel walls,
Croatian: • proširenje u stijenci arterije ili srca koje izgleda poput balončića, a zahvaća samo nekoliko slojeva stijenke krvnih žila,
English: A pharmacodynamic interaction study has also been conducted with cangrelor and ticagrelor.
Croatian: Ispitivanje farmakodinamičkih interakcija također je provedeno s kangrelorom i tikagrelorom.
English: Patients with HFI cannot break down fructose, which may cause serious side effects.
Croatian: Bolesnici s nasljednim nepodnošenjem fruktoze ne mogu razgraditi fruktozu sadržanu u ovom lijeku, što može uzrokovati ozbiljne nuspojave.
English: Although most bleeding associated with the use of cangrelor occurs at the site of arterial puncture, haemorrhage can occur at any site.
Croatian: Iako se većina krvarenja povezanih s primjenom kangrelora pojavljuje na mjestu punkcije arterije,
English: Clopidogrel N=5,469 OR (95% CI)
Croatian: klopidogrel N= 5469 OR (95%-tni CI)
English: How to store Kengrexal
Croatian: Kako primjenjivati Kengrexal
English: Onset of P2Y12 inhibition occurs rapidly upon cangrelor administration.
Croatian: Početak inhibicije P2Y12 događa se ubrzo nakon primjene kangrelora.
English: Table 2: Non-CABG-related bleeding GUSTO bleeding, n (%) CHAMPION pooled
Croatian: Tablica 2: Krvarenje koje nije povezano sa CABG Krvarenje prema kriterijima GUSTO, n (%) Objedinjeni podaci iz ispitivanja CHAMPION Kangrelor
English: Ecchymosis (petechiae, purpura)
Croatian: Poremećaji kože i potkožnog tkiva ekhimoza (petehije, purpura)
English: - If you have ever had a stroke, or a ‘mini-stroke' (also known as a transient ischaemic attack, TIA) caused by the temporary interruption of the blood supply to the brain.
Croatian: - ako imate nekontrolirani vrlo visok krvni tlak; - ako ste ikada imali moždani udar, ili mali moždani udar (još poznat pod nazivom tranzitorna ishemijska ataka, TIA) prouzročen privremenim prekidom dotoka krvi u mozak.
English: Bivalirudin, low molecular weight heparin, fondaparinux, and GP IIb/IIIa inhibitors
Croatian: Bivalirudin, heparin male molekulske mase, fondaparinuks i inhibitori glikoproteinskih (GP) receptora Iib/IIIa
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: Kengrexal is for injection, followed by infusion (drip), into a vein.
Croatian: Kengrexal je namijenjen za injekciju nakon koje slijedi infuzija (kapanje) u venu.
English: Any GUSTO bleeding Severe/life-threatening Moderate
Croatian: Bilo kakvo krvarenje prema kriterijima GUSTO Teško/opasno po život
English: There are no or limited amount of data from the use of Kengrexal in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni lijeka Kengrexal u trudnica ograničeni.
English: Metabolism of cangrelor is not dependent on CYPs and CYP isoenzymes are not inhibited by therapeutic concentrations of cangrelor or its major metabolites.
Croatian: Metabolizam kangrelora ne ovisi o enzimima CYP, terapijske koncentracije kangrelora niti njegovih glavnih metabolita ne inhibiraju izoenzime CYP-a.
English: Cangrelor N=5,462
Croatian: kangrelor N= 5462
English: Kengrexal contains cangrelor, a direct P2Y12 platelet receptor antagonist that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo.
Croatian: Kengrexal sadrži kangrelor, izravan antagonist receptora P2Y12 trombocita koji blokira aktivaciju i agregaciju trombocita izazvanu adenozin difosfatom (ADP) in vitro i ex vivo.
English: Clopidogrel N=5,457 OR (95% CI)
Croatian: klopidogrel N= 5457 OR (95%-tni CI)
English: The most common adverse reactions with cangrelor include mild and moderate bleeding and dyspnoea.
Croatian: Najčešće nuspojave s kangrelorom uključuju blago i umjereno krvarenje i dispneju.
English: • You suffer from impaired kidney function or require dialysis.
Croatian: • ako imate oštećenu funkciju bubrega ili Vam je potrebna dijaliza;
English: Rash, pruritus, urticaria f
Croatian: osip, svrbež, urtikarija f angioedem
English: • heavy menstrual bleeding,
Croatian: • teško menstruacijsko krvarenje,
English: In pivotal studies conducted in patients undergoing PCI, events of acute renal failure (0.1%), renal failure (0.1%) and increased serum creatinine (0.2%) were reported to occur after administration of cangrelor in clinical trials (see section 4.8).
Croatian: U pivotalnim ispitivanjima provedenima u bolesnika podvrgnutih PCI, prijavljeni su događaji akutnog zatajenja bubrega (0,1%), zatajenja bubrega (0,1%) i porasta kreatinina u serumu (0,2%) nakon primjene kangrelora u kliničkim ispitivanjima (vidjeti dio 4.8).
English: CABG: Coronary Artery Bypass Graft Surgery; GUSTO: Global Use of Strategies to Open Coronary Arteries; w/o: without a In the CHAMPION pooled analysis, GUSTO Mild was defined as other bleed not requiring blood transfusion or causing haemodynamic compromise.
Croatian: Global Use of Strategies to Open Coronary Arteries, globalna primjena strategija za otvaranje okludiranih arterija a U analizi objedinjenih ispitivanja CHAMPION, blagi GUSTO bio je definiran kao druga krvarenja koja ne zahtijevaju transfuziju krvi niti uzrokuju narušavanje hemodinamike.
English: Cardiac tamponade
Croatian: Srčana tamponada
English: Haematuria, blood urine present, urethral haemorrhage.
Croatian: hematurija, prisutnost krvi u mokraći, uretralno krvarenje f.
English: Cangrelor N=5,470
Croatian: kangrelor N= 5470
English: In pivotal studies conducted in patients undergoing PCI, there were more intracranial bleeds at 30 days with cangrelor (0.07%) than with clopidogrel (0.02%), of which 4 bleeds with cangrelor and 1 bleed with clopidogrel were fatal.
Croatian: U pivotalnim ispitivanjima provedenima u bolesnika podvrgnutih PCI, bilo je više intrakranijalnih krvarenja nakon 30 dana s kangrelorom (0,07%) nego s klopidogrelom (0,02%), od kojih su 4 krvarenja s kangrelorom i 1 krvarenje s klopidogrelom imala smrtni ishod.
English: In pivotal studies conducted in patients undergoing PCI, there were more cardiac tamponades at 30 days with cangrelor (0.12%) than with clopidogrel (0.02%), (see section 4.8).
Croatian: U pivotalnim ispitivanjima provedenima u bolesnika podvrgnutih PCI, bilo je više srčanih tamponada nakon 30 dana s kangrelorom (0,12%) nego s klopidogrelom (0,02%), (vidjeti dio 4.8).
English: The GUSTO bleeding scale was measured in the CHAMPION (PHOENIX, PLATFORM, and PCI) clinical trials.
Croatian: U kliničkim ispitivanjima CHAMPION (PHOENIX, PLATFORM i PCI) izmjerena su krvarenja prema kriterijima skale GUSTO.
English: In pivotal studies conducted in patients undergoing PCI, GUSTO (Global Use of Strategies to Open Occluded Arteries), moderate and mild bleeding events were more common in patients treated with cangrelor than in patients treated with clopidogrel, see section 4.8.
Croatian: U pivotalnim ispitivanjima provedenim u bolesnika podvrgnutih PCI, događaji umjerenih i blagih krvarenja prema GUSTO kriterijima (engl., Global Use of Strategies to Open Occluded Arteries), bili su češći u bolesnika liječenih kangrelorom nego u bolesnika liječenih klopidogrelom, vidjeti dio 4.8.
English: The bolus volume should be administered rapidly (<1 minute), from the diluted bag via manual intravenous push or pump.
Croatian: (< 1 minute), iz vrećice s razrijeđenom otopinom, ručno brzom intravenskom injekcijom ili pumpom.
English: The powder should be reconstituted immediately prior to dilution and use.
Croatian: Prašak se mora rekonstituirati neposredno prije razrjeđivanja i primjene.
English: No dose adjustment is needed in patients with mild, moderate or severe renal insufficiency (see sections 4.4 and 5.2).
Croatian: U bolesnika s blagim, umjerenim ili teškim oštećenjem bubrežne funkcije nije potrebno prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
English: Intracranial haemorrhage
Croatian: Intrakranijalno krvarenje
English: Powder for concentrate for solution for injection/infusion in a glass vial.
Croatian: Prašak za koncentrat za otopinu za injekciju/infuziju u staklenoj bočici.
English: IDR a p-values based on Chi-squared test.
Croatian: Tromboza stenta Smrt MI IDR a p-vrijednosti na temelju Hi-kvadrat testa.
English: • Bleeding leading to fluid around the heart, blood in the chest cavity or bleeding from the nose,
Croatian: • Krvarenje koje dovodi do nakupljanja tekućine oko srca, krvi u prsnoj šupljini ili krvarenja iz nosa, u probavnom traktu, trbuhu ili mokraći ili iz mjesta injekcije ili katetera,
English: Haemorrhage intracranial d *
Croatian: Poremećaji živčanog sustava intrakranijalno krvarenje d *
English: Clopidogrel (N=12,542)
Croatian: Klopidogrel (N= 12 542)
English: After reconstitution 1 mL of concentrate contains 10 mg cangrelor and after dilution 1 mL of solution contains 200 micrograms cangrelor.
Croatian: Nakon rekonstitucije, 1 ml koncentrata sadrži 10 mg kangrelora, a nakon razrjeđivanja, 1 ml otopine sadrži 200 mikrograma kangrelora.
English: In CHAMPION PHOENIX, cangrelor significantly reduced (relative risk reduction 22%; absolute risk reduction 1.2%) the primary composite endpoint of all-cause mortality, MI, IDR, and ST compared to clopidogrel at 48 hours (Table 3).
Croatian: 22%; smanjenje apsolutnog rizika 1,2%) primarni kompozitni ishod mortaliteta svih uzroka, infarkta miokarda (MI), revaskularizacije potaknute ishemijom (IDR) i tromboze stenta (ST) u usporedbi s klopidogrelom nakon 48 sati (tablica 3).
English: Retroperitoneal haemorrhage,* peritoneal haematoma, gastrointestinal haemorrhage a
Croatian: Poremećaji probavnog sustava retroperitonealno krvarenje,* peritonealni hematom, krvarenje u probavnom sustavu a
English: Thrombotic events at 48 hours in CHAMPION PHOENIX (mITT population) Cangrelor vs. Clopidogrel n (%)
Croatian: Trombotički događaji nakon 48 sati u ispitivanju CHAMPION PHOENIX (populacija mITT)
English: Kengrexal 50 mg powder for concentrate cangrelor
Croatian: Kengrexal 50 mg prašak za koncentrat kangrelor
English: Thrombotic events at 30 days in CHAMPION PHOENIX (mITT population) Cangrelor vs. Clopidogrel n (%)
Croatian: Trombotički događaji nakon 30 dana u ispitivanju CHAMPION PHOENIX (populacija mITT)
English: In pivotal studies conducted in patients undergoing PCI dyspnoea (including exertional dyspnoea) occurred more commonly in patients treated with cangrelor (1.3%) than clopidogrel (0.4%).
Croatian: U pivotalnim ispitivanjima provedenima u bolesnika podvrgnutih PCI, dispneja (uključujući dispneju u naporu) je zabilježena češće u bolesnika liječenih kangrelorom (1,3%) nego klopidogrelom (0,4%).
English: Very rare side effects: may affect up to 1 in 10,000 people
Croatian: Vrlo rijetke nuspojave: mogu se javiti u do 1 na 10 000 osoba
English: IDR a Primary endpoint from logistic regression adjusted for loading dose and patient status.
Croatian: Tromboza stenta Smrt MI IDR a Primarni ishod iz logističke regresije prilagođen za udarnu dozu i status bolesnika. p-vrijednosti za sekundarne ishode na temelju Hi-kvadrat testa.
English: Infections and infestations
Croatian: Infekcije i infestacije infekcija hematoma
English: • fluid discharge from injection or catheter sites.
Croatian: • iscjedak tekućine iz mjesta injekcije ili katetera.
English: Clopidogrel (N=5,527)
Croatian: Klopidogrel (N= 5527)
English: Using Kengrexal reduces the risk that this procedure will cause a clot to form and block the blood vessels again.
Croatian: Primjena lijeka Kengrexal smanjuje rizik od stvaranja ugruška prouzročenog tim postupkom i ponovnog začepljenja krvne žile.
English: Following the administration of a 30 microgram/kg bolus followed by a 4 microgram/kg/min infusion, platelet inhibition is observed within two minutes.
Croatian: Nakon primjene bolusa u dozi od 30 mikrograma/kg iza kojeg slijedi infuzija u dozi od 4 mikrograma/kg/min, inhibicija trombocita opažena je unutar dvije minute.
English: - If you have a medical condition that is currently causing bleeding such as bleeding from the stomach or intestines or you have a condition which makes you more prone to uncontrolled bleeding (impaired haemostasis or irreversible coagulation disorders).
Croatian: - ako ste alergični na kangrelor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6); - ako imate medicinsko stanje koje trenutno uzrokuje krvarenje, npr. krvarenje iz želuca ili crijeva, ili imate stanje zbog kojeg ste skloniji nekontroliranom krvarenju (narušena hemostaza ili ireverzibilni poremećaji koagulacije);
English: Cangrelor exhibits inhibition of activation and aggregation of platelets as shown by aggregometry (light transmission and impedance), point-of care assays, such as the VerifyNow P2Y12 test, VASP-P and flow cytometry.
Croatian: Kangrelor inhibira aktivaciju i agregaciju trombocita kako pokazuju agregometrija (propusnost svjetla i impedancija), pretrage uz bolesnika (engl. point-of care assays), primjerice VerifyNow P2Y12 test,
English: Treatment with Kengrexal may increase the risk of cardiac tamponade.
Croatian: Liječenje lijekom Kengrexal može povećati rizik od srčane tamponade.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava anemija, trombocitopenija
English: • bleeding from the site of wounds,
Croatian: • krvarenje iz rane,
English: Rare side effects: may affect up to 1 in 1,000 people
Croatian: Rijetke nuspojave: mogu se javiti u do 1 na 1000 osoba
English: After dilution 1 mL contains 200 micrograms cangrelor.
Croatian: Nakon razrjeđivanja, 1 ml sadrži 200 mikrograma kangrelora.
English: Each vial contains 50 mg cangrelor.
Croatian: Jedna bočica sadrži 50 mg kangrelora.
English: Each vial contains cangrelor tetrasodium corresponding to 50 mg cangrelor.
Croatian: Jedna bočica sadrži kangrelortetranatrij što odgovara 50 mg kangrelora.
English: Powder for concentrate for solution for injection/infusion.
Croatian: Prašak za koncentrat za otopinu za injekciju/infuziju.
English: p-value a
Croatian: pvrijednost a
English: After reconstitution 1 mL of concentrate contains 10 mg cangrelor.
Croatian: Nakon rekonstitucije, 1 ml koncentrata sadrži 10 mg kangrelora.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE
English: Uncommon side effects: may affect up to 1 in 100 people
Croatian: Manje česte nuspojave: mogu se javiti u do 1 na 100 osoba
English: After reconstitution 1 mL contains 10 mg cangrelor.
Croatian: Nakon rekonstitucije, 1 ml sadrži 10 mg kangrelora.
English: Sodium hydroxide (for pH-adjustment)
Croatian: 6.1 Popis pomoćnih tvari manitol sorbitol natrijev hidroksid (za podešavanje pH)
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Kengrexal Lijek čuvajte izvan pogleda i dohvata djece.
English: • 4 micrograms per kilogram body weight per minute by infusion (drip), for at least 2 hours.
Croatian: • injekcija od 30 mikrograma po kilogramu tjelesne težine, nakon koje odmah slijedi • infuzija (kapanje) od 4 mikrograma po kilogramu tjelesne težine po minuti tijekom najmanje 2
English: Sodium
Croatian: Natrij
English: Treatment with Kengrexal may increase the risk of bleeding.
Croatian: Liječenje lijekom Kengrexal može povećati rizik od krvarenja.
English: Anaphylactic reaction (anaphylactic shock), hypersensitivity
Croatian: (anafilaktički šok), preosjetljivost
English: Cangrelor (N=5,529)
Croatian: Kangrelor (N= 5529)
English: Haematocrit decreased, haemoglobin decreased**
Croatian: Pretrage snižen hematokrit, snižen hemoglobin**
English: Package leaflet: Information for the patient Kengrexal 50 mg powder for concentrate for solution for injection/infusion cangrelor
Croatian: Uputa o lijeku: Informacije za bolesnika Kengrexal 50 mg prašak za koncentrat za otopinu za injekciju/infuziju kangrelor
English: Any GUSTO bleeding
Croatian: Bilo kakvo krvarenje prema kriterijima GUSTO
English: Moderate
Croatian: Umjereno
English: Primary Endpoint
Croatian: Primarni ishod
English: Treatment with Kengrexal may increase the risk of intracranial haemorrhage.
Croatian: Liječenje lijekom Kengrexal može povećati rizik od intrakranijalnog krvarenja.
English: Intravenous use
Croatian: Za intravensku primjenu
English: Hypersensitivity reactions may occur after treatment with Kengrexal.
Croatian: Nakon liječenja lijekom Kengrexal može doći do reakcija preosjetljivosti.
English: Kengrexal 50 mg powder for concentrate for solution for injection/infusion cangrelor
Croatian: Kengrexal 50 mg prašak za koncentrat za otopinu za injekciju/infuziju kangrelor
English: After dilution 1 mL of solution contains 200 micrograms cangrelor.
Croatian: Nakon razrjeđivanja, 1 ml otopine sadrži 200 mikrograma kangrelora.
English: Aseptic procedures should be used for the preparation of Kengrexal.
Croatian: Za pripremu lijeka Kengrexal moraju se primjenjivati aseptičke tehnike.
English: Tel: + 386-1-43 00 901
Croatian: Chiesi Slovenija d.o.o. Tel: + 386-1-43 00 901
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja dispneja (dispneja u naporu)
English: Wound haemorrhage, vascular pseudoaneurysm
Croatian: Krvožilni poremećaji hematom < 5 cm, krvarenje hemodinamska nestabilnost krvarenje iz rane, vaskularna pseudoaneurizma
English: Upper gastrointestinal haemorrhage, mouth haemorrhage, gingival bleeding, oesophageal haemorrhage, duodenal ulcer haemorrhage, haematemesis, lower gastrointestinal haemorrhage, rectal haemorrhage, haemorrhoidal haemorrhage, haematochezia.
Croatian: krvarenje u gornjem dijelu probavnog sustava, krvarenje u ustima, krvarenje iz desni, krvarenje u jednjaku, krvarenje iz duodenalnog ulkusa, hematemeza, krvarenje u donjem dijelu probavnog sustava, rektalno krvarenje, hemoroidalno krvarenje, hematohezija b.
English: Impairment of fertility
Croatian: Oštećenje plodnosti
English: Kengrexal 50 mg powder for concentrate for solution for injection/infusion
Croatian: Kengrexal 50 mg prašak za koncentrat za otopinu za injekciju/infuziju.
English: Ear and labyrinth disorders
Croatian: Poremećaji uha i labirinta krvarenje u uhu
English: Immune system disorders
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija
English: Marketing Authorisation Holder
Croatian: Nositelj odobrenja za stavljanje lijeka u promet
English: Skin neoplasm bleeding
Croatian: krvarenje iz kožne novotvorine
English: Epistaxis, haemoptysis
Croatian: epistaksa, hemoptiza plućno krvarenje
English: Chiesi Hungary Kft. Tel.: +36-1-429 1060
Croatian: Tel.: +36-1-429 1060
English: Cangrelor (N=12,565)
Croatian: (N= 12 565)
English: The recommended dose of Kengrexal for patients undergoing PCI is a 30 micrograms/kg intravenous bolus followed immediately by 4 micrograms/kg/min intravenous infusion.
Croatian: 30 mikrograma/kg nakon kojeg odmah slijedi intravenska infuzija u dozi od 4 mikrograma/kg/min.
English: Tel: + 421 259300060
Croatian: Chiesi Slovakia s.r.o. Tel: + 421 259300060
English: Powder for concentrate for solution for injection/infusion 10 vials
Croatian: Prašak za koncentrat za otopinu za injekciju/infuziju
English: Effects on renal function
Croatian: Učinci na bubrežnu funkciju
English: If you get any side effects, talk to your doctor.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika.
English: Angioedema
Croatian: Dojenje
English: Intravenous use after reconstitution and dilution.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za intravensku primjenu nakon rekonstitucije i razrjeđivanja.
English: Contusion
Croatian: Doziranje
English: Tel.: + 48 22 620 1421
Croatian: Chiesi Poland Sp. z.o.o. Tel.: + 48 22 620 1421
English: Eye haemorrhage
Croatian: Poremećaji oka krvarenje u oku
English: Following the administration of a 30 micrograms/kg bolus followed by a 4 micrograms/kg/min infusion (the PCI dose), platelet inhibition is observed within two minutes.
Croatian: Nakon primjene bolusa od 30 mikrograma/kg iza kojeg slijedi infuzija od 4 mikrograma/kg/min (PCI
English: Disposal
Croatian: Zbrinjavanje
English: Pulmonary haemorrhage
Croatian: Srčani poremećaji srčana tamponada
English: • bruising,
Croatian: CABG: engl.
English: Treatment with Kengrexal may increase the risk of dyspnoea.
Croatian: Liječenje lijekom Kengrexal može povećati rizik od dispneje.
English: Application site bleeding, catheter site haemorrhage or haematoma, infusion site haemorrhage or haematoma.
Croatian: krvarenje na mjestu primjene, krvarenje ili hematom na mjestu uvođenja katetera, krvarenje ili hematom na mjestu infuzije c.
English: • You have been told by your doctor that you have an intolerance to some sugars.
Croatian: • ako imate poteškoće s disanjem, primjerice astmu; • ako Vam je liječnik rekao da ne podnosite neke šećere.
English: Elderly
Croatian: pvrijednost
English: Rare
Croatian: Često
English: Other changes
Croatian: Ostale izmjene
English: The European Commission issued a decision on this opinion on 26/6/17.
Croatian: Europska komisija objavila je odluku o tom mišljenju dana 26/6/17.
English: The amended information to doctors and patients is available here.
Croatian: Izmijenjene informacije za liječnike i bolesnike dostupne su ovdje.
English: What is Vepesid?
Croatian: Što je Vepesid?
English: Vepesid is marketed in 16 EU member States (Austria, Belgium, Croatia, Denmark, Estonia, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Romania, Slovenia, Spain, Sweden and the United Kingdom) as well as in Norway.
Croatian: Lijek Vepesid stavljen je u promet u 16 država članica EU-a (Austriji, Belgiji, Danskoj, Estoniji, Finskoj, Hrvatskoj, Irskoj, Italiji, Luksemburgu, Nizozemskoj, Njemačkoj, Rumunjskoj, Sloveniji, Španjolskoj, Švedskoj i Ujedinjenoj Kraljevini) te u Norveškoj.
English: 4.3 Contra-indications
Croatian: 4.3 Kontraindikacije
English: What are the conclusions of the CHMP?
Croatian: Koje je zaključke donio CHMP?
English: The usual dose of Vepesid is 100 to 200 mg per m2 of body surface area for 5 days in a row or 200 mg/m2/day on days 1, 3 and 5 every 3 to 4 weeks.
Croatian: Uobičajena doza lijeka Vepesid jest 100 do 200 mg po m2 površine tijela pet dana za redom ili 200 mg/m2 prvog, trećeg i petog dana svaka tri do četiri tjedna.
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Croatian: Direktive 2001/83/EZ
English: Why was Vepesid reviewed?
Croatian: Zašto je Vepesid ponovno ocjenjivan?
English: • non-epithelial ovarian cancer.
Croatian: • neepitelijalnog raka jajnika.
English: Vepesid is authorised in the EU via national procedures.
Croatian: Lijek Vepesid odobren je u EU-u u okviru nacionalnih postupaka.
English: • small-cell lung cancer;
Croatian: • raka pluća malih stanica;
English: Vepesid is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Croatian: Vepesid je lijek protiv raka koji se primjenjuje za liječenje: raka testisa, raka pluća, raka jajnika i raka krvi (Hodgkinova i ne-Hodgkinova limfoma i akutne mijeloične leukemije).
English: Other sections of the SmPC harmonised include section 4.4 (special warnings and precautions), section 4.6 (fertility, pregnancy and lactation) and section 4.8 (undesirable effects).
Croatian: Ostali dijelovi usklađenog sažetka opisa svojstava lijeka uključuju dio 4.4. (posebna upozorenja i mjere opreza pri uporabi), dio 4.6. (plodnost, trudnoća i dojenje) i dio 4.8. (nuspojave).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Vepesid in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija za propisivanje lijeka Vepesid u Europskoj uniji (EU).