FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported adverse reactions with Bretaris Genuair were headache (6.6%) and nasopharyngitis (5.5%).
Croatian: Sažetak sigurnosnog profila Najčešće prijavljene nuspojave lijeka Bretaris Genuair bile su glavobolja (6,6%) i nazofaringitis
English: STEP 2: Inhale your medicine
Croatian: 2. KORAK: Inhalirajte lijek
English: Efficacy was assessed by measures of lung function and symptomatic outcomes such as breathlessness, disease-specific health status, use of rescue medication and occurrence of exacerbations.
Croatian: Djelotvornost je procijenjena mjerenjem funkcije pluća i simptomatskim ishodima poput nedostatka zraka, zdravstvenog stanja specifičnog za bolest, uzimanja lijeka za brzo ublažavanje simptoma i pojave egzacerbacija.
English: If you have any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for assistance.
Croatian: Ako imate bilo kakvih pitanja o tome kako koristiti inhalator, obratite se svom liječniku, ljekarniku ili medicinskoj sestri za pomoć.
English: After 6 months treatment, the mean improvement in morning pre-dose (trough) FEV1 compared to placebo was 128 mL (95% CI=85-170; p<0.0001).
Croatian: Nakon 6 mjeseci liječenja, srednje poboljšanje FEV1 mjerenog prije jutarnje doze (najniža koncentracija lijeka) u usporedbi s placebom bilo je 128 ml (95% CI=85-170; p<0,0001).
English: Following repeated inhalations, the systemic exposure of aclidinium bromide has been observed to be similar in Japanese and Caucasian patients.
Croatian: Zabilježeno je da je sistemska izloženost aklidinijevu bromidu, nakon ponovljenih inhalacija slična u Japanaca i bijelaca.
English: 58.7% were male and 90.7% were Caucasian, with a mean postbronchodilator FEV1 of 47.9% of predicted value and a mean CAT (COPD Assessment Test) of 20.7.
Croatian: Među ispitanicima je njih 58,7% bilo muškog spola, a 90,7% bijele rase, dok je srednja vrijednost FEV1 nakon primjene bronhodilatatora iznosila 47,9% predviđene vrijednosti, a srednja vrijednost rezultata upitnika za ocjenu KOPB-a (engl.
English: This makes it easier for chronic obstructive pulmonary disease (COPD) patients to breathe.
Croatian: To olakšava disanje oboljelima od kronične opstruktivne plućne bolesti (KOPB).
English: Therefore, no dose adjustment and no additional monitoring are required for renally-impaired COPD patients.
Croatian: Stoga nije potrebno prilagođavati dozu niti provoditi dodatno praćenje KOPB bolesnika s oštećenjem bubrega.
English: Acute intoxication by inadvertent medicinal product ingestion of aclidinium bromide is unlikely due to its low oral bioavailability and the breath-actuated dosing mechanism of the Genuair inhaler.
Croatian: Akutno trovanje nehotičnim gutanjem aklidinijeva bromida malo je vjerojatno zbog njegove slabe oralne bioraspoloživosti i mehanizma doziranja udisanjem putem Genuair inhalatora.
English: In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide are not substrates or inhibitors of P-glycoprotein.
Croatian: Ispitivanja in vitro su pokazala da aklidinijev bromid i metaboliti aklidinijeva bromida nisu supstrati ni inhibitori P-glikoproteina.
English: Bretaris Genuair did not increase the MACE risk in patients with COPD compared to placebo when added to current background therapy (hazard ratio (HR) 0.89; 95% CI: 0.64, 1.23).
Croatian: Bretaris Genuair nije povećao rizik od MACE događaja u bolesnika s KOPB-om u odnosu na placebo kada se primjenjivao kao dodatak postojećoj osnovnoj terapiji (omjer hazarda [engl. hazard ratio, HR]: 0,89; 95% CI: 0,64; 1,23).
English: The effect of aclidinium bromide on the occurrence of major adverse cardiovascular events (MACE) was assessed in a randomised, double-blind, placebo-controlled, parallel-group study in 3630 adult patients between 40 and 91 years of age with moderate to very severe COPD, treated for up to 36 months.
Croatian: Ispitivanje dugoročne sigurnosti i djelotvornosti tijekom razdoblja do 3 godine Učinak aklidinijeva bromida na nastup velikih štetnih kardiovaskularnih događaja (engl. major adverse cardiovascular events, MACE) ocjenjivao se u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju s paralelnim skupinama provedenom u 3630 odraslih bolesnika u dobi između 40 i 91 godine starosti s umjerenim do vrlo teškim KOPB-om, koji su liječeni do 36 mjeseci.
English: Method of administration For inhalation use.
Croatian: Način primjene Za primjenu inhalacijom.
English: Elderly No dose adjustments are required for elderly patients (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu za starije bolesnike (vidjeti dio 5.2).
English: Additionally, no clinically relevant adverse reactions were observed following 7-day twice daily dosing of up to 800 µg aclidinium bromide in healthy subjects.
Croatian: Osim toga nisu zabilježene klinički značajne nuspojave nakon doze do 800 µg aklidinijeva bromida koja se u zdravih ispitanika primjenjivala dvaput dnevno tijekom 7 dana.
English: Bretaris Genuair 322 micrograms inhalation powder
Croatian: Bretaris Genuair 322 mikrograma, prašak inhalata
English: Steady-state plasma levels were attained within seven days of twice daily dosing.
Croatian: Razine u plazmi u stanju dinamičke ravnoteže postignute su unutar sedam dana od početka doziranja dvaput dnevno.
English: Each delivered dose (the dose leaving the mouthpiece) contains 375 µg aclidinium bromide equivalent to 322 µg of aclidinium.
Croatian: Svaka isporučena doza (doza oslobođena iz nastavka za usta) sadrži 375 µg aklidinijeva bromida što odgovara 322 µg aklidinija.
English: Studies in rats have shown slight reductions in fertility only at dose levels much higher than the maximum human exposure to aclidinium bromide (see section 5.3).
Croatian: Ispitivanja na štakorima su pokazala blago smanjenu plodnost pri puno višim dozama od maksimalne izloženosti aklidinijevom bromidu u ljudi (vidjeti dio 5.3).
English: Do not use the Bretaris Genuair if you notice that the pack is damaged or shows signs of tampering.
Croatian: Ovaj lijek ne smijete upotrijebiti ako primijetite da je pakovanje oštećeno ili su vidljivi znakovi neovlaštenog otvaranja.
English: Disease-Specific Health Status and Symptomatic Benefits Bretaris Genuair provided clinically meaningful improvements in breathlessness (assessed using the Transition Dyspnoea Index [TDI]) and disease-specific health status (assessed using the St. George's Respiratory Questionnaire [SGRQ]).
Croatian: Transition Dyspnoea Index, TDI]) i zdravstvenog stanja povezanog s bolešću (procijenjenog pomoću St. George's respiratornog upitnika; eng. St. George's Respiratory Questionnaire [SGRQ]).
English: Each delivered dose contains 375 micrograms aclidinium bromide equivalent to 322 micrograms of aclidinium.
Croatian: Svaka odmjerna doza sadrži 375 mikrograma aklidinijeva bromida što odgovara 322 mikrograma aklidinija.
English: Aclidinium bromide may have minor influence on the ability to drive and use machines.
Croatian: Aklidinijev bromid malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: EXP To be used within 90 days of opening the pouch.
Croatian: Rok valjanosti Upotrijebiti u roku od 90 dana nakon otvaranja vrećice.
English: In a 3-week crossover, randomised, placebo-controlled clinical study Bretaris Genuair was associated with a statistically significant improvement in exercise endurance time in comparison to placebo of 58 seconds (95% CI=9-108; p=0.021; pre-treatment value: 486 seconds).
Croatian: U trotjednom, ukriženom, randomiziranom, placebom kontroliranom kliničkom ispitivanju, primjena Bretaris Genuaira bila je povezana sa statistički značajnim poboljšanjem u vremenu izdržanog fizičkog napora od 58 sekundi, u usporedbi s placebom (95% CI=9-108; p=0,021; vrijednost prije početka liječenja: 486 sekundi).
English: In vitro studies have shown that aclidinium bromide or the metabolites of aclidinium bromide at the therapeutic dose are not expected to cause interactions with active substances that are substrates of Pglycoprotein (P-gp) or active substances metabolised by cytochrome P450 (CYP450) enzymes and esterases (see section 5.2).
Croatian: Ispitivanja in vitro su pokazala da se ne očekuju interakcije aklidinijeva bromida ili metabolita aklidinijeva bromida u terapijskim dozama s djelatnim tvarima koje su supstrati P-glikoproteina (P-gp) ili djelatnim tvarima koje se metaboliziraju putem citokroma P450 (CYP 450) i esterazama (vidjeti dio
English: The frequencies assigned to the undesirable effects listed below are based on crude incidence rates of adverse reactions (i.e. events attributed to Bretaris Genuair) observed with Bretaris Genuair 322 µg (636 patients) in the pooled analysis of one 6-month and two 3-month randomised, placebo-controlled clinical trials.
Croatian: Učestalost nuspojava u nastavku temelji se na grubim stopama incidencije (tj. događajima koji se pripisuju lijeku Bretaris Genuair), zabilježenih s Bretaris Genuair 322 µg (636 bolesnika) u združenoj analizi jednog 6-mjesečnog i dva 3-mjesečna randomizirana, placebom kontrolirana klinička ispitivanja.
English: (Figure N), or
Croatian: (Slika N)
English: Aclidinium bromide demonstrated kinetic linearity and a time-independent pharmacokinetic behaviour in the therapeutic range.
Croatian: Aklidinijev bromid je, u terapijskom rasponu doza, pokazao linearnu farmakokinetiku i farmakokinetičke osobine neovisne o vremenu.
English: EU/1/12/781/001 30 doses
Croatian: EU/1/12/781/001 30 doza
English: How to store Bretaris Genuair Contents of the pack and other information Instructions for Use
Croatian: Sadržaj pakiranja i druge informacije Upute za uporabu
English: Patients in the aclidinium bromide group had a 18% relative reduction of the risk of an exacerbation (HR 0.82; 95% CI [0.73, 0.92], p<0.001).
Croatian: Među bolesnicima iz skupine liječene aklidinijevim bromidom zabilježeno je relativno smanjenje rizika od egzacerbacije za 18% (HR: 0,82; 95% CI [0,73 - 0,92], p < 0,001).
English: c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).
Croatian: c) Da biste skinuli kapicu, lagano pritisnite strelice na njezinim bočnim stranama i povucite kapicu (Slika B).
English: EU/1/12/781/002 60 doses
Croatian: EU/1/12/781/002 60 doza
English: The Genuair inhaler device is white coloured with an integral dose indicator and a green dosage button.
Croatian: Genuair inhalator je bijele boje s ugrađenim pokazivačem doze i zelenim gumbom za doziranje.
English: In addition, Bretaris Genuair showed a statistically significant reduction of 35% in the rate of hospitalisations due to COPD exacerbations while on-treatment during the first year compared with placebo (RR 0.65; 95% CI 0.48 to 0.89; p=0.006).
Croatian: Uz to, Bretaris Genuair omogućio je statistički značajno smanjenje stope hospitalizacija zbog egzacerbacija KOPB-a tijekom prve godine liječenja za 35% u usporedbi s placebom (RR: 0,65; 95% CI: 0,48 - 0,89; p=0,006).
English: What Bretaris Genuair is
Croatian: Što je Bretaris Genuair
English: Inhaler label
Croatian: Naljepnica na inhalatoru
English: 1.6 Make sure the control window is now green (Figure G).
Croatian: Uvjerite se da je kontrolni prozorčić sada zelene boje (Slika G).
English: Patients treated with Bretaris Genuair showed a statistically significant reduction of 22% compared to placebo (rate ratio [RR] 0.78; 95% CI 0.68 to 0.89; p<0.001).
Croatian: U bolesnika liječenih lijekom Bretaris Genuair zabilježeno je statistički značajno smanjenje za 22% u odnosu na placebo (omjer stopa [engl. rate ratio, RR]: 0,78; 95% CI: 0,68 - 0,89; p < 0,001).
English: Go to ‘STEP 2: Inhale your medicine'.
Croatian: KORAK: Inhalirajte lijek'.
English: Keep the inhaler inside the pouch until the administration period starts.
Croatian: Čuvajte inhalator u vrećici do početka primjene lijeka.
English: Therefore, no dose adjustment is required for elderly COPD patients.
Croatian: Stoga za starije KOPB bolesnike nije potrebna prilagodba doze.
English: No dose adjustment is required for hepatically-impaired COPD patients.
Croatian: Nije potrebno prilagođavati dozu za KOPB bolesnike s oštećenom jetrom.
English: It is white-coloured with an integral dose indicator and a green dosage button.
Croatian: Bijele je boje s ugrađenim pokazivačem doze i zelenim gumbom za doziranje.
English: Keep the Genuair inhaler inside the pouch until the administration period starts.
Croatian: Genuair inhalator čuvajte u vrećici do početka primjene lijeka.
English: Do not tilt.
Croatian: Menarini Kft.
English: Carton containing 1 inhaler with 30 doses.
Croatian: Kutija koja sadrži 1 inhalator sa 30 doza.
English: The median time on-treatment in the Bretaris Genuair and placebo groups was 1.1 and 1 year, respectively.
Croatian: Medijan trajanja liječenja iznosio je 1,1 godinu u skupini liječenoj lijekom Bretaris Genuair, a 1 godinu u onoj koja je primala placebo.
English: In addition, no clinically significant effects of Bretaris Genuair on cardiac rhythm were observed on 24-hour Holter monitoring after 3 months treatment of 336 patients (of whom 164 received Bretaris Genuair 322 µg twice daily).
Croatian: Osim toga, 24-satnim Holter motrenjem nakon 3 mjeseca liječenja 336 bolesnika (od kojih je 164 primalo Bretaris Genuair od 322 µg dvaput dnevno), nisu zabilježeni značajni učinci lijeka Bretaris Genuair na srčani ritam.
English: The median time on-study in the Bretaris Genuair and placebo groups was approximately 1.4 and 1.3 years, respectively.
Croatian: Medijan trajanja sudjelovanja u ispitivanju iznosio je približno 1,4 godine u skupini liječenoj lijekom Bretaris Genuair te 1,3 godine u skupini koja je primala placebo.
English: 2.6 Slowly breathe out away from the inhaler.
Croatian: 2.6 Odmaknite inhalator i polako izdahnite.
English: Do not take an extra dose even if you do not taste or feel anything after inhaling.
Croatian: Čak i ako nakon inhaliranja ne osjetite ništa od toga, nemojte primijeniti još jednu dozu.
English: Renal impairment No dose adjustments are required for patients with renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu za bolesnike s oštećenjem bubrega (vidjeti dio 5.2).
English: How to store Bretaris Genuair
Croatian: Kako primjenjivati Bretaris Genuair
English: You should discard your inhaler if you lose the cap.
Croatian: Ako izgubite kapicu, bacite inhalator.
English: Hepatic impairment No dose adjustments are required for patients with hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu za bolesnike s oštećenjem jetre (vidjeti dio 5.2).
English: Bretaris Genuair 322 micrograms inhalation powder aclidinium (aclidinium bromide)
Croatian: Bretaris Genuair 322 mikrograma, prašak inhalata aklidinij (aklidinijev bromid)
English: Carton containing 1 inhaler with 60 doses.
Croatian: Kutija koja sadrži 1 inhalator sa 60 doza.
English: Carton containing 3 inhalers each with 60 doses.
Croatian: Kutija koja sadrži 3 inhalatora sa po 60 doza.
English: What Bretaris Genuair is used for
Croatian: Za što se koristi Bretaris Genuair
English: The terminal elimination half-life and effective half-life of aclidinium bromide are approximately 14 hours and 10 hours, respectively, following inhalation of twice daily 400 µg doses in COPD patients.
Croatian: Nakon inhalacije doze od 400 µg dvaput dnevno, u bolesnika sa KOPB-om, terminalno poluvrijeme eliminacije aklidinijeva bromida je približno 14 sati, dok je efektivno poluvrijeme približno 10 sati.
English: Inhaled aclidinium bromide acts locally in the lungs to antagonise M3 receptors of airway smooth muscle and induce bronchodilation.
Croatian: M3 receptora glatkih mišića dišnih puteva i izaziva bronhodilataciju.
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku ili ljekarniku.
English: Pack sizes supplied:
Croatian: Veličine pakiranja:
English: The low absolute bioavailability of inhaled aclidinium bromide (<5%) is because aclidinium bromide undergoes extensive systemic and pre-systemic hydrolysis whether deposited in the lung or swallowed.
Croatian: Nakon taloženja u plućima ili nakon gutanja aklidinijev bromid prolazi opsežnu sistemsku i predsistemsku hidrolizu što za posljedicu ima nisku apsolutnu bioraspoloživost inhaliranog aklidinijeva bromida (<5%).
English: Refer to the Instructions for Use for instructions on how to use the Genuair inhaler.
Croatian: Za upute kako koristiti Genuair inhalator pogledajte Upute za uporabu.
English: Laboratori Guidotti S.p.A. Tel: +39- 050 971011
Croatian: Tel: +39- 050 971011
English: Mouthpiece
Croatian: Omaglica
English: Hepatically-impaired patients
Croatian: Bolesnici s oštećenjem bubrega
English: Ask your doctor or pharmacist if you are not sure.
Croatian: Ako niste sigurni, pitajte svojeg liječnika ili ljekarnika.
English: Mean Change from baseline
Croatian: Srednja promjena od početne vrijednosti
English: Dizziness
Croatian: Svrbež
English: Preferred term Frequency
Croatian: Klasifikacija organskih sustava Preporučeni izraz
English: 726/2004, initiated by the European Commission.
Croatian: Uredbe (EZ) br. 726/2004, kojeg je pokrenula Europska komisija.
English: Annex IV
Croatian: Prilog IV
English: Therefore the European Commission triggered a procedure under Article 20 of Regulation (EC) No 726/2004 on 27 November 2013.
Croatian: Stoga je Europska komisija pokrenula postupak u skladu sa člankom 20. Uredbe (EZ) br. 726/2004 dana 27. studenog
English: The incidence of arterial thrombotic events (per 100 patient years) remains relatively constant.
Croatian: Incidencija arterijskih trombotičkih događaja (na 100 bolesnika godišnje) ostaje relativno konstantna.
English: Risk minimisation measures
Croatian: Mjere za smanjivanje rizika
English: The Marketing Authorisation was granted by the European Commission on 1 July 2013 for the following indications in adult patients:
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka u promet dana 1. srpnja 2013. za sljedeće indikacije u odraslih bolesnika s:
English: Serious cardiac failure events have occurred in a total of 23 patients (5.1%).
Croatian: Ozbiljna zatajenja srca nastupila su u ukupno 23 bolesnika (5,1%).
English: • Discontinuation of treatment if haematologic response has not occurred by 3 months.
Croatian: • prekid liječenja, ako hematološki odgovor nije nastupio do 3. mjeseca.
English: Non-clinical issues
Croatian: Neklinički problemi
English: It is therefore unclear whether the maintenance of response observed in this particular group of patients can be generalised to the CP-CML population.
Croatian: Stoga nije jasno može li se generalizirati održavanje odgovora u ovoj posebnoj grupi bolesnika za CP-CML populaciju.
English: A total of 81 (18%) patients on the phase 2 study (n=449) have experienced serious vascular occlusive events and overall, a total of 101 patients (23%) have experienced vascular occlusive events (serious and non-serious).
Croatian: Ukupno 81 (18%) bolesnik u ispitivanju faze 2 (n=449) iskusio je ozbiljne vaskularne okluzije, dok je općenito ukupno 101 bolesnik (23%) iskusio vaskularne okluzije (ozbiljne i neozbiljne).
English: The Product Information for Iclusig was revised to include the following:
Croatian: Informacije za lijek Iclusig revidirane su kako bi uključivale sljedeće:
English: In October 2013, the EMA was informed that the rate of vascular occlusive events was higher than observed in the clinical trials that supported the initial marketing authorisation.
Croatian: U listopadu 2013. godine, EMA je obaviještena da je stopa vaskularnih okluzija veća od stope uočene u kliničkim ispitivanjima koja su podržala prvotno odobrenje za stavljanje lijeka u promet.
English: An additional risk minimisation activity was required by the PRAC.
Croatian: PRAC je zatražio dodatne aktivnosti za smanjivanje rizika.
English: Ponatinib is a tyrosine kinase inhibitor (TKI), designed with the purpose of inhibiting the kinase activity of native BCR-ABL, and all mutant variants, including ‘gatekeeper' T315I.
Croatian: Ponatinib je inhibitor tirozin-kinaze (TKI), dizajniran sa ciljem inhibiranja aktivnosti kinaze nativnog BCR-ABL-a, kao i svih mutiranih varijacija, uključujući „čuvara“ T315I.
English: Clinical issues
Croatian: Klinički problemi
English: • Additional warnings about hypertension, cardiac failure and risk of bleeding with anti-clotting agents.
Croatian: • dodatna upozorenja o hipertenziji, srčanom zatajenju i riziku od krvarenja sa lijekovima protiv grušanja.
English: However these data include a relatively small number of patients, most of which had been dose reduced due to adverse events, and follow-up time is limited.
Croatian: No, ovi podaci uključuju relativno mali broj bolesnika, u većine kojih je doza smanjena uslijed nuspojava, a razdoblje kontrole je bilo ograničeno.
English: • The PRAC reviewed all data presented by the MAH on the safety and efficacy of Iclusig, as well as the views expressed by the oncology scientific advisory group.
Croatian: • PRAC pregledao sve podatke dostavljene od strane nositelja odobrenja o sigurnosti i djelotvornosti lijeka Iclusig, kao i mišljenja izražena od strane znanstvene savjetodavne grupe za onkologiju.
English: It is therefore appropriate to reinforce existing recommendations for the cardiovascular status of the patient to be assessed before initiating treatment.
Croatian: Stoga je primjereno pojačati postojeće preporuke za kardiovaskurani status bolesnika čija je procjene potrebna prije pokretanja terapije.
English: • Updated information on adverse reactions.
Croatian: • ažurirane informacije o nuspojavama.
English: • Updated recommendations to assess cardiovascular status and consider alternative treatments where appropriate.
Croatian: • ažurirane preporuke za ocjenu kardiovaskularnog statusa i razmatranje alternativnih metoda liječenja, kada je to primjereno.
English: In view of the high risk for vascular occlusive events, the PRAC considered that it should be made clear in the product information that ponatinib should be discontinued in patients who do not respond to treatment (no haematologic response by 3 months).
Croatian: U svjetlu visokog rizika od vaskularne okluzije, PRAC je zaključio kako je potrebno pojasniti u informacijama o proizvodu da je potrebno prekinuti primjenu ponatiniba u bolesnika koji ne odgovaraju na liječenje (nema hematološkog odgovora do 3. mjeseca).
English: A type II variation was submitted and additional risk minimisation measures such as updates to the product information were put in place.
Croatian: Dostavljena je varijacija tipa II, te su predložene dodatne mjere za smanjivanje rizika, poput primjerice ažuriranja informacija o proizvodu.
English: While these data can be useful for physicians considering dose reduction, it is currently considered insufficient to adopt a formal recommendation for dose reduction in patients who have not experienced an adverse event.
Croatian: Iako ovi podaci mogu biti korisni za liječnika koji razmatra smanjivanje doze, trenutno se nedostatnim smatra usvajanje službene preporuke za smanjivanje doze u bolesnika koji nemaju nuspojave.
English: • The PRAC considered Iclusig (ponatinib) in the procedure under Article 20 of Regulation (EC) No
Croatian: • PRAC razmotrio lijek Iclusig (ponatinib) u sklopu postupka provedenog sukladno članku 20.
English: • The PRAC took note of the serious risk of vascular occlusive events associated with Iclusig, which is likely to be dose-related.
Croatian: • PRAC razmotrio ozbiljan rizik od vaskularnih okluzija povezan s lijekom Iclusig, koje su vrlo vjerojatno povezane s dozom.
English: There is also an association between vascular occlusive events and a risk of cardiac failure as a secondary event.
Croatian: Postoji također veza između vaskularne okluzije i rizika od srčanog zatajenja kao sekundarnog događaja.
English: Nevertheless the Committee agreed that it is important to reflect these data in the product information.
Croatian: Bez obzira na navedeno, Odbor je suglasan s važnošću prezentiranja ovih podataka u uputi o lijeku.