natgillin/translations-raw huggingface dataset:
The safety of continuation or resumption of Herceptin in patients who experience cardiac dysfunction has not been prospectively studied. 
Sigurnost kontinuirane ili ponovne primjene lijeka Herceptin u bolesnika u kojih se razvila disfunkcija srca nije prospektivno ispitana.
The difference in serious adverse event rates between formulations was mainly due to infections with or without neutropenia (4.4 % versus 8.1 %) and cardiac disorders (0.7 % versus 1.7 %); 
Razlika u stopama ozbiljnih štetnih događaja između tih dviju formulacija uglavnom je bila posljedica infekcija, praćenih neutropenijom ili bez nje (4,4% naspram 8,1%) i srčane poremećaje (0,7% naspram 1,7%)
Patients who develop asymptomatic cardiac dysfunction may benefit from more frequent monitoring (e.g. every 6-8 weeks). 
Bolesnicima koji razviju asimptomatsku disfunkciju srca mogli bi koristiti češći pregledi (primjerice, svakih 6-8 tjedana).
Like all medicines, Herceptin can cause side effects, although not everybody gets them. 
Kao i svi lijekovi, Herceptin može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
If the patient misses a dose of Herceptin subcutaneous formulation, it is recommended to administer the next 600 mg dose (i.e. the missed dose) as soon as possible. 
Ako bolesnik propusti primiti dozu supkutane formulacije lijeka Herceptin, preporučuje se što prije dati sljedeću dozu od 600 mg (tj. propuštenu dozu).
After transfer of the solution to the syringe, it is recommended to replace the transfer needle by a syringe closing cap to avoid drying of the solution in the needle and not compromise the quality of the medicinal product. 
Nakon prebacivanja otopine u štrcaljku, preporučuje se zamijeniti iglu korištenu za prijenos zaštitnim zatvaračem za štrcaljku kako bi se izbjeglo sušenje otopine u igli i narušavanje kvalitete lijeka.
These events have occasionally been fatal and may occur as part of an infusion-related reaction or with delayed onset. 
Ti su slučajevi ponekad imali smrtni ishod, a mogu se pojaviti u sklopu infuzijskih reakcija ili s odgođenim nastupom.
The efficacy results from the interim efficacy analysis crossed the protocol pre-specified statistical boundary for the comparison of 1-year of Herceptin versus observation. 
Rezultati djelotvornosti iz privremene analize djelotvornosti nadmašili su prethodno definiranu statističku graničnu vrijednost za usporedbu skupine liječene lijekom Herceptin tijekom 1 godine naspram opservacija.
The recommended dose for Herceptin subcutaneous formulation is 600 mg irrespective of the patient's body weight. 
Preporučena doza formulacije lijeka Herceptin za supkutanu primjenu iznosi 600 mg, neovisno o tjelesnoj težini bolesnika.
On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the Herceptin infusion. 
U vrlo rijetkim slučajevima infuzijski i plućni simptomi pojavili su se nakon više od 6 sati od početka infuzije lijeka Herceptin.
If during treatment, you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear. 
Ukoliko tijekom liječenja primijetite simptome poput zimice ili vrućice, ne smijete upravljati vozilima niti rukovati strojevima sve dok se ti simptomi ne povuku.
Death (OS event) 
Smrt (događaj ukupnog preživljenja)
The preoperative chemotherapy regimen consisted of docetaxel (75 mg/m²) followed by FEC (5FU, epirubicin and cyclophosphamide) at a standard dose. 
Predoperacijski kemoterapijski protokol obuhvaćao je docetaksel (75 mg/m2), a nakon njega FEC (5FU, epirubicin i ciklofosfamid) u standardnoj dozi.
If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Herceptin. 
Ako je moguće, uputno je izbjegavati primjenu antraciklinske terapije do 7 mjeseci nakon prestanka primjene lijeka Herceptin.
• prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents. 
• Priprema se mora provesti u komori s laminarnim protokom ili mikrobiološkom zaštitnom kabinetu uz standardne mjere opreza za sigurno rukovanje lijekovima za intravensku primjenu.
The 13week study was performed to confirm that the change in route of administration and the use of the novel excipient recombinant human hyaluronidase (rHuPH20) did not have an effect on the Herceptin safety characteristics. 
Trinaestotjedno istraživanje provedeno je kako bi se potvrdilo da promjena puta primjene te primjena nove pomoćne tvari, rekombinantne humane hijaluronidaze (rHuPH20) ne utječu na sigurnosne značajke lijeka Herceptin.
How to store Herceptin Herceptin will be stored by the health professionals at the hospital or clinic. 
Herceptin će čuvati zdravstveni radnici u bolnici ili klinici.
Your doctor will monitor your heart regularly during and after treatment but you should tell your doctor immediately if you notice any of the above symptoms. 
Liječnik će Vam tijekom i nakon liječenja redovito kontrolirati srce, ali ako primijetite neki od gore navedenih simptoma, o tome odmah obavijestite svog liječnika.
* Observed with combination therapy following anthracyclines and combined with taxanes 
* Opaženo u kombinacijskoj terapiji nakon antraciklina i u kombinaciji s taksanima.
Herceptin should not be mixed or diluted with other products. 
Herceptin se ne smije miješati niti razrjeđivati s drugim lijekovima.
The difference between formulations was mainly observed during the adjuvant treatment phase (monotherapy) and was mainly due to postoperative wound infections, but also to various other infections such as respiratory tract infections, acute pyelonephritis and sepsis. 
Razlika između formulacija uglavnom je primijećena tijekom faze adjuvantnoga liječenja (monoterapija), a prvenstveno je bila posljedica poslijeoperacijskih infekcija rane, ali i raznih drugih infekcija, poput infekcija dišnog sustava, akutnog pijelonefritisa i sepse.
The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1 % versus 4.6 % in the 1-year treatment arm). 
Stopa asimptomatske disfunkcije srca bila je povećana u skupini liječenoj tijekom 2 godine (8,1% naspram 4,6% u skupini liječenoj tijekom 1 godine).
Most of the patients (79 %) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF. 
U većine bolesnica (79%) u kojih se u tim ispitivanjima razvila srčana disfunkcija došlo je do poboljšanja nakon što su primile standardnu terapiju za kongestivno zatajenje srca.
Median follow-up 8 years** 
8 godina**
If you experience any of the above symptoms when your treatment with Herceptin has finished, you should see your doctor and tell them that you have previously been treated with Herceptin. 
Ako se neki od gore navedenih simptoma jave nakon prestanka liječenja lijekom Herceptin, javite se svojem liječniku i recite mu da ste prethodno bili liječeni lijekom Herceptin.
• Post-operative wound infections (severe and/or serious): 1.7 % versus 3.0 % for the intravenous formulation versus subcutaneous formulation, respectively; 
• poslijeoperacijske infekcije rane (teške i/ili ozbiljne): 1,7% za intravensku formulaciju naspram 3,0% za supkutanu formulaciju)
Severe anaphylactic reactions requiring immediate additional intervention can occur usually during either the first or second infusion of Herceptin (see section 4.4) and have been associated with a fatal outcome. 
Teške anafilaktičke reakcije koje zahtijevaju dodatnu hitnu intervenciju obično se javljaju tijekom 1. ili 2. infuzije lijeka Herceptin (vidjeti dio 4.4) i mogu završiti smrtnim ishodom.
Results were consistent with the known safety profile for Herceptin intravenous and Herceptin subcutaneous formulations. 
Rezultati su bili u skladu s poznatim sigurnosnim profilom formulacija lijeka Herceptin za intravensku i supkutanu primjenu.
In general, CISH is considered positive if there are more than 5 copies of the HER2 gene per nucleus in greater than 50 % of tumour cells. 
Općenito, CISH se smatra pozitivnim ako postoji više od pet kopija HER2 gena po jezgri u više od 50 % tumorskih stanica.
• Tumour lysis syndrome (a group of metabolic complications occurring after cancer treatment characterized by high blood levels of potassium and phosphate, and low blood levels of calcium). 
• Sindrom tumorske lize (skup metaboličkih komplikacija koje se javljaju nakon terapije za rak, a očituju se visokim razinama kalija i fosfata te niskim razinama kalcija u krvi).
Your doctor may consider switching your Herceptin intravenous treatment to Herceptin subcutaneous treatment (and vice versa) if considered appropriate for you. 
Vaš će liječnik možda razmotriti mogućnost da Vas prebaci s liječenja intravenskom formulacijom lijeka Herceptin na liječenje supkutanom formulacijom lijeka Herceptin (i obrnuto), ako bude smatrao da je to prikladno za Vas.
Recombinant human hyaluronidase (rHuPH20) L-histidine 
Rekombinantna humana hijaluronidaza (rHuPH20) L-histidin
Body weight and serum alanine aminotransferase (SGPT/ALT) showed a statistically significant influence on PK, however, simulations demonstrated that no dose adjustments are required in EBC patients. 
Tjelesna težina i razina alanin aminotransferaze u serumu (SGPT/ALT) imale su statistički značajan utjecaj na farmakokinetiku, ali simulacije su pokazale da nije potrebno prilagođavati dozu u bolesnika s ranim rakom dojke.
• dry mouth and skin 
• suhoća usta i kože
• one is given as an infusion into a vein (intravenous infusion) 
• jedan koji se daje putem infuzije u venu (intravenskom infuzijom)
Reversibility of severe CHF (defined as a sequence of at least two consecutive LVEF values ≥50 % after the event) was evident for 71.4 % of Herceptin-treated patients. 
Reverzibilnost teškog kongestivnog zatajenja srca (definirana kao slijed od najmanje dviju uzastopnih vrijednosti LVEF ≥ 50% nakon događaja) bila je primjetna u 71,4% bolesnika liječenih lijekom Herceptin.
If the first dose is well tolerated the next doses may be given over 30 minutes (see section 2 under “Warnings and precautions”). 
sljedeće se doze mogu primijeniti u infuziji trajanja 30 minuta (pogledajte dio 2 pod "Upozorenja i mjere opreza").
Herceptin is for single-use only. 
Herceptin je namijenjen samo za jednokratnu primjenu.
No incompatibilities between Herceptin and polyvinylchloride, polyethylene or polypropylene bags have been observed. 
Nisu primijećene inkompatibilnosti između lijeka Herceptin i polivinilkloridnih, polietilenskih ili polipropilenskih vrećica.
• Serious adverse events (most of which were identified because of in-patient hospitalisation or prolongation of existing hospitalisation): 14.1 % for the intravenous formulation versus 21.5 % for the subcutaneous formulation. 
• ozbiljni štetni događaji (većina je identificirana zahvaljujući hospitalizaciji bolesnika ili produljenju postojeće hospitalizacije): 14,1% uz intravensku naspram 21,5% uz supkutanu formulaciju.
Herceptin treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy (see section 4.4), and should be administered by a healthcare professional only. 
Liječenje lijekom Herceptin smije započeti samo liječnik s iskustvom u primjeni citotoksične kemoterapije (vidjeti dio 4.4), a lijek smije primijeniti samo zdravstveni radnik.
1Palpitation 
1palpitacije
Placental transfer of trastuzumab during the early (days 20-50 of gestation) and late (days 120-150 of gestation) fetal development period was observed. 
Primijećeno je da trastuzumab prolazi kroz posteljicu za vrijeme ranog (20.-50. dan gestacije) i kasnog (120.-150. dan gestacije) perioda fetalnog razvoja.
(vs. AC→D) (BCIRG 006) 
(naspram AC→D) (BCIRG 006)
Other side effects that have been reported with Herceptin use: frequency cannot be estimated from the available data 
Ostale nuspojave koje su prijavljene pri primjeni lijeka Herceptin: učestalost se ne može procijeniti iz dostupnih podataka
• Your doctor will advise you of the risks and benefits of taking Herceptin during pregnancy. 
• Liječnik će Vam objasniti rizike i koristi primjene lijeka Herceptin tijekom trudnoće.
Single doses of up to 960 mg of Herceptin subcutaneous formulation have been administered with no reported untoward effects. 
Primijenjene su jednokratne doze do 960 mg lijeka Herceptin u supkutanoj formulaciji, pri čemu nisu prijavljeni štetni učinci.
The local reactions included erythema, pruritus, oedema, rash and pain at the site of the injection. 
Lokalne reakcije uključivale su eritem, pruritus, edem, osip i bol na mjestu primjene injekcije.
The mean Ctrough at the subcutaneous pre- dose cycle 18 was 90.7 µg/mL and is similar to that of cycle 13, suggesting no further increase after cycle 13. 
Srednja vrijednost Ctrough prije supkutane primjene lijeka u 18. ciklusu iznosila je 90,7 µg/ml i bila je sličan onoj u 13. ciklusu, što ukazuje na to da nakon 13. ciklusa koncentracije više ne rastu.
As animal reproduction studies are not always predictive of human response, Herceptin should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus. 
Budući da se na temelju ispitivanja provedenih na životinjama ne može pouzdano predvidjeti odgovor kod ljudi, primjenu lijeka Herceptin u trudnoći treba izbjegavati osim ako je moguća korist za majku veća od moguće opasnosti za fetus.
Herceptin has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone. 
Herceptin je, u randomiziranom, otvorenom ispitivanju faze III ToGA (BO18255), u kombinaciji s kemoterapijom uspoređivan sa samom kemoterapijom.
For overall survival, the HR was 0.75 (95 % CI 0.51-1.11) in the IHC 2+/FISH+ group and the HR was 0.58 (95 % CI 0.41-0.81) in the IHC 3+/FISH+ group. 
HR za ukupno preživljenje je bio 0,75 (95% CI 0,51-1,11) u skupini IHC 2+/FISH+ i 0,58 (95% CI 0,41-0,81) u skupini IHC 3+/FISH+.
It has been associated with a fatal outcome. 
Povezuje se sa smrtnim ishodima.
The difference was not statistically significant, however more than half of the patients in the anastrozole alone arm crossed over to a Herceptin containing regimen after progression of disease. 
Razlika nije bila statistički značajna, no više od polovine bolesnica koje su primale samo anastrozol, nakon progresije bolesti počelo je primati terapiju koja je uključivala Herceptin.
After aseptic reconstitution with sterile water for injection, chemical and physical stability of the reconstituted solution has been demonstrated for 48 hours at 2°C - 8°C. 
Nakon aseptičke rekonstitucije sa sterilnom vodom za injekcije, kemijska i fizička stabilnost rekonstituirane otopine dokazana je tijekom 48 sati na temperaturi od 2 do 8°C.
Your doctor may prescribe Herceptin for the treatment of breast cancer when: 
Vaš liječnik Vam može propisati Herceptin za liječenje raka dojke ako:
Talk to your doctor, pharmacist or nurse before you are given Herceptin if: 
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Herceptin:
Patients treated with Herceptin are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction. 
U bolesnika liječenih lijekom Herceptin postoji povećan rizik od razvoja kongestivnog zatajenja srca (engl. congestive heart failure, CHF) (klase II-IV prema New York Heart Association [NYHA]) ili asimptomatske disfunkcije srca.
Once transferred from the vial to the syringe the medicinal product is physically and chemically stable for 28 days at 2°C - 8°C and for 6 hours (cumulative time in the vial and the syringe) at ambient temperature (max. 30°C) in diffused daylight. 
Nakon prebacivanja iz bočice u štrcaljku, lijek je fizikalno i kemijski stabilan tijekom 28 dana na temperaturi od 2°C - 8°C te tijekom 6 sati (ukupno uzevši vrijeme u bočici i u štrcaljki) na sobnoj temperaturi (maks.
Upon opening of the vial, the solution should be used immediately. 
Nakon otvaranja bočice otopinu treba odmah upotrijebiti.
If a pregnant woman is treated with Herceptin, or if a patient becomes pregnant while receiving Herceptin or within 7 months following the last dose of Herceptin, close monitoring by a multidisciplinary team is desirable. 
Ako se lijekom Herceptin liječi trudnicu, ili ako bolesnica zatrudni tijekom liječenja lijekom Herceptin ili unutar 7 mjeseci nakon posljednje doze lijeka Herceptin, poželjno je pažljivo praćenje od strane multidisciplinarnog tima.
• Hypertension: 4.7 % versus 9.8 % for the intravenous formulation versus subcutaneous formulation respectively. 
• hipertenzija: 4,7% uz intravensku naspram 9,8% uz supkutanu formulaciju.
Very rarely, patients with severe breathing difficulties before treatment have died when they were given Herceptin. 
Vrlo rijetko su bolesnici koji su i prije liječenja imali znatne poteškoće s disanjem preminuli nakon primjene lijeka Herceptin.
Risk factors for a cardiac event identified in four large adjuvant studies included advanced age (> 50 years), low LVEF (<55%) at baseline, prior to or following the initiation of paclitaxel treatment, decline in LVEF by 10-15 points, and prior or concurrent use of anti-hypertensive medicinal products. 
Faktori rizika za srčani događaj utvrđeni u četiri velika ispitivanja adjuvantnog liječenja uključivali su stariju dob (> 50 godina), nizak LVEF (< 55%) na početku liječenja, prije ili nakon početka liječenja paklitakselom, pad LVEF-a za 10-15 bodova te prethodnu ili istodobnu primjenu antihipertenziva.
Bioavailability of trastuzumab given as the subcutaneous formulation was estimated to be 77.1%, and the first order absorption rate constant was estimated to be 0.4 day-1. 
Procijenjena bioraspoloživost trastuzumaba primijenjenog u supkutanoj formulaciji iznosila je 77,1%, dok je procijenjena konstanta brzine apsorpcije prvog reda iznosila 0,4 dana-1.
In this section, the following categories of frequency have been used: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare 
U ovom dijelu, za prikaz nuspojava prema učestalosti korišteni su sljedeći kriteriji: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000), vrlo rijetko
The highest rate of cardiac dysfunction was seen in patients receiving Herceptin concurrently with anthracycline/cyclophosphamide (27 %), and was significantly higher than for anthracycline/cyclophosphamide alone (7 % - 10 %). 
Najviša stopa srčane disfunkcije zabilježena je u bolesnica koje su primale Herceptin istodobno s antraciklinom/ciklofosfamidom (27%), što je bilo značajno više nego kod primjene samo antraciklina/ciklofosfamida (7% - 10%).
• pain in the arms and/or legs 
• bol u rukama i/ili nogama
The systemic reactions included hypersensitivity, hypotension, tachycardia, cough, and dyspnoea. 
Sistemske reakcije uključivale su preosjetljivost, hipotenziju, tahikardiju, kašalj i dispneju.
METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use only after reconstitution and dilution Read the package leaflet before use. 
NAČIN I PUT(EVI) PRIMJENE LIJEKA Samo za intravensku primjenu nakon rekonstitucije i razrjeđivanja Prije uporabe pročitajte uputu o lijeku.
Other side effects can occur at any time during treatment with Herceptin, not just related to an infusion. 
Ostale nuspojave mogu se pojaviti bilo kada tijekom liječenja lijekom Herceptin, a ne samo u svezi s infuzijom.
For instructions on use and handling of Herceptin subcutaneous formulation refer to section 6.6. 
Za upute o uporabi i rukovanju lijekom Herceptin u supkutanoj formulaciji vidjeti dio 6.6.
Switching treatment between Herceptin intravenous and Herceptin subcutaneous formulations and vice versa, using the three-weekly (q3w) dosing regimen, was investigated in study MO22982 (see section 4.8). 
Prelazak s liječenja intravenskom formulacijom lijeka Herceptin na supkutane formulacije lijeka Herceptin i obrnuto, uz trotjedni režim doziranja (q3w), istraživao se u ispitivanju MO22982 (vidjeti dio 4.8).
Experience of concurrent administration of trastuzumab with low dose anthracycline regimens is currently limited to two trials (MO16432 and BO22227). 
Iskustvo s istodobnom primjenom trastuzumaba i protokola s niskim dozama antraciklina zasada je ograničeno na dva ispitivanja (MO16432 and BO22227).
Regimen Primary tumor type 
Režim Vrsta primarnog tumora
Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8 % to 34.0 % for IHC and 7.1 % to 42.6 % for FISH. 
Ispitivanja stupnja ekspresije HER2 u bolesnika s rakom želuca uporabom imunohistokemije (IHC) i fluorescentne in-situ hibridizacije (FISH) ili kromogene in-situ hibridizacije (CISH) pokazala su veliku varijabilnost ekspresije HER2 u rasponu od 6,8% do 34,0% kod IHC-a i od 7,1% do 42,6% kod FISH-a.
In a method comparison study (study D008548) a high degree of concordance (>95 %) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients. 
U ispitivanju uspoređivanja metoda (ispitivanje D008548) u bolesnika s rakom želuca ustanovljen je visok stupanj podudarnosti (> 95 %) za SISH i FISH metode utvrđivanja genske amplifikacije HER2.
Herceptin subcutaneous formulation contains recombinant human hyaluronidase (rHuPH20), an enzyme used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. 
Herceptin u supkutanoj formulaciji sadrži rekombinantnu humanu hijaluronidazu (rHuPH20), enzim koji se koristi za povećanje disperzije i apsorpcije istodobno primijenjenih lijekova pri supkutanoj primjeni.
Do not breast-feed your baby during Herceptin therapy and for 7 months after the last dose of Herceptin as Herceptin may pass to your baby through your breast milk. 
Nemojte dojiti dijete za vrijeme terapije lijekom Herceptin ni 7 mjeseci nakon posljednje doze lijeka jer se Herceptin preko vašeg mlijeka može prenijeti na vaše dijete.
Severe adverse events (defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE grade ≥3) version 3.0) were equally distributed between both Herceptin formulations (52.3 % versus 53.5 % in the intravenous formulation versus subcutaneous formulation respectively). 
Teški štetni događaji (definirani prema verziji 3.0 Općih terminoloških kriterija za štetne događaje Nacionalnog instituta za rak (NCI CTCAE ≥ 3)) bili su jednako zastupljeni kod primjene obiju formulacija lijeka Herceptin (52,3% uz intravensku formulaciju naspram 53,5% uz supkutanu formulaciju).
Due to the significant impact of body weight on trastuzumab clearance and the use of a fixed dose for the subcutaneous administration the difference in exposure between subcutaneous and intravenous administration was dependent on body weight: in patients with a body weight < 51 kg, mean steady state AUC of trastuzumab was about 80% higher after subcutaneous than after intravenous treatment whereas in the highest BW group (> 90 kg) AUC was 20% lower after subcutaneous than after intravenous treatment. 
Zbog značajnog utjecaja tjelesne težine na klirens trastuzumaba i činjenice da se za supkutanu primjenu koristi fiksna doza, razlika u izloženosti između supkutane i intravenske primjene ovisila je o tjelesnoj težini: u bolesnica tjelesne težine < 51 kg srednja vrijednost AUC-a trastuzumaba u stanju dinamičke ravnoteže bila je približno 80% viša nakon supkutane primjene nego nakon intravenske terapije, dok je u skupini s najvećom tjelesnom težinom (> 90 kg) AUC bio 20% niži nakon supkutane primjene u odnosu na intravensku terapiju.
If LVEF percentage drops ≥10 points from baseline AND to below 
Ako postotak LVEF-a padne za ≥ 10 bodova ispod početne vrijednosti