natgillin/translations-raw huggingface dataset:
A total of 1,250 patients underwent PCI within 72 hours after randomisation, in which case they received intravenous unfractionated heparin to maintain an activated clotting time (ACT) of 300-350 seconds.
Ukupno je 1250 bolesnika podvrgnuto PCI unutar 72 sata nakon randomizacije, i tada su primili nefrakcionirani heparin intravenski kako bi se održalo aktivno vrijeme zgrušavanja (ACT) od 300-350 sekundi.
In the same population, plasma elimination half-life is approximately 2.5 hours, plasma clearance 55 to 80 ml/kg/hr and volume of distribution of approximately 185 to 260 ml/kg.
U istoj populaciji, poluvrijeme eliminacije iz plazme je približno 2,5 sata, klirens plazme je 55 do 80 ml/kg/h i volumen distribucije je približno 185 do 260 ml/kg.
What Eptifibatide Accord is and what it is used for What you need to know before you are given Eptifibatide Accord How to use Eptifibatide Accord
Što je Eptifibatid Accord i za što se koristi Što morate znati prije nego počnete primati Eptifibatid Accord Kako primjenjivati Eptifibatid Accord
In healthy subjects, renal excretion accounted for approximately 50 % of total body clearance; approximately 50 % of the amount cleared is excreted unchanged.
U zdravih ispitanika, izlučivanje putem bubrega je odgovorno za oko 50 % ukupnog tjelesnog klirensa; približno 50 % od te količine se izlučuje nepromijenjeno.
It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes.
Koristi se u bolesnika s teškom koronarnom insuficijencijom, koja se definira kao spontana i nedavna bol u prsima s elektrokardiografskim abnormalnostima ili biološkim promjenama.
How to store Eptifibatide Accord Contents of the pack and other information
Kako čuvati Eptifibatid Accord Sadržaj pakiranja i druge informacije
Results on the primary endpoint were principally attributed to the occurrence of myocardial infarction.
Rezultati primarne mjere ishoda prvenstveno su bili pripisani nastupu infarkta miokarda.
There are no adequate data from the use of eptifibatide in pregnant women.
Nema dovoljno podataka o primjeni eptifibatida u trudnica.
At the recommended therapeutic dose, as administered in the PURSUIT trial involving nearly 11,000 patients, bleeding was the most common complication encountered during eptifibatide therapy.
U preporučenim terapijskim dozama primijenjenim u PURSUIT ispitivanju koje je uključivalo gotovo 11 000 bolesnika, krvarenje je bila najčešća komplikacija tijekom terapije eptifibatidom.
In PURSUIT, bleeding and non-bleeding events were collected from hospital discharge to the 30 day visit.
U PURSUIT ispitivanju prikupljani su podaci za krvarenja i događaje nevezane uz krvarenja nakon otpusta iz bolnice do kontrolne posjete 30. dana.
Cardiac arrest, congestive heart failure, atrial fibrillation, hypotension, and shock, which are commonly reported events from the PURSUIT trial, were events related to the underlying disease.
Kardijalni arest, kongestivno zatajenje srca, fibrilacija atrija, hipotenzija i šok koji se ubrajaju u česte nuspojave iz PURSUIT ispitivanja, bile su događaji vezani uz osnovnu bolest.
Unlike the approved posology in the EU, all patients in this trial were administered a double bolus before the infusion (see section 5.1).
Za razliku od odobrenog načina doziranja lijeka u EU, svi su bolesnici u tom ispitivanju primali dvostruku bolus dozu prije infuzije (vidjeti dio 5.1).
Please refer to the Normosol R Summary of Product Characteristics for details on its composition.
Molimo pogledati Sažetak opisa svojstava lijeka Normosol R otopine za detaljni sastav iste.
GUSTO severe/life threatening bleeding was uncommon and comparable in both treatment groups (0.8 %).
Prema GUSTO kriterijima, jako/životno ugrožavajuće krvarenje je bilo manje često i usporedivo u pojavnosti za obje ispitivane skupine (0,8 %).
The 180/1.3 arm was stopped after an interim analysis, as prespecified in the protocol, when the two active-treatment arms appeared to have a similar incidence of bleeding.
Krak 180/1,3 prekinut je nakon interim analize predviđene planom ispitivanja, kad se ustanovilo da dva aktivno liječena kraka imaju sličnu incidenciju krvarenja.
To avoid the possibility of interactions with other medicines please tell your doctor or hospital pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Obavijestite svog liječnika ili bolničkog ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
Of the patients in PURSUIT, 13 % were managed with PCI during eptifibatide infusion, of whom approximately 50 % received intracoronary stents; 87 % were managed medically (without PCI during eptifibatide infusion).
Od bolesnika uključenih u PURSUIT, 13 % je imalo PCI tijekom infuzije eptifibatida, od kojih je u oko 50 % ugrađen intrakoronarni stent; 87 % je primalo samo lijekove (bez PCI tijekom infuzije eptifibatida).
In the PURSUIT trial, there were 9 patients who received bolus and/or infusion doses more than double the recommended dose, or who were identified by the investigator as having received an overdose.
U ispitivanju PURSUIT, 9 je bolesnika primilo doze bolusa i/ili infuzije koje su bile više nego dvostruko veće od onih preporučenih, ili za koje je ispitivač ustanovio da su primili preveliku dozu.
If serious bleeding occurs that is not controllable with pressure, the Eptifibatide Accord infusion should be stopped immediately and any unfractionated heparin that is given concomitantly.
Dođe li do ozbiljnog krvarenja koje se ne da zaustaviti pritiskom, valja odmah prekinuti infuziju Eptifibatid Accorda i nefrakcioniranog heparina koji se istodobno primjenjuje.
Eptifibatide, a synthetic cyclic heptapeptide containing six amino acids, including one cysteine amide and one mercaptopropionyl (desamino cysteinyl) residue, is an inhibitor of platelet aggregation and belongs to the class of RGD (arginine-glycine-aspartate)-mimetics.
Eptifibatid, sintetski ciklički heptapeptid koji sadrži šest aminokiselina, uključujući jedan cisteinamid i jednu reziduu merkaptopropionila (dezaminocisteinil), je inhibitor agregacije trombocita i pripada klasi RGD (arginin-glicin-aspartat)-mimetika.
What Eptifibatide Accord is and what it is used for 2.
Što je Eptifibatid Accord i za što se koristi 2.
- skin rash (such as hives).
− osip kože (kao što je koprivnjača).
In patients undergoing PCI, measure the ACT also.
Ako se bolesnik podvrgava PCI, treba mjeriti i ACT.
When followed by a 2.0 microgram/kg/min continuous infusion, this regimen produces a > 80 % inhibition of ADP-induced ex vivo platelet aggregation, at physiologic calcium concentrations, in more than 80 % of patients.
Kad se nastavno primjeni 2,0 mikrograma/kg/min kontinuiranom infuzijom, ovaj režim dovodi do > 80 % inhibicije ex vivo ADP-om inducirane agregacije trombocita, pri fiziološkim koncentracijama kalcija, u više od 80 % bolesnika.
Eptifibatide Accord is intended for use with acetylsalicylic acid and unfractionated heparin.
Eptifibatid Accord je namijenjen za primjenu zajedno s acetilsalicilatnom kiselinom i nefrakcioniranim heparinom.
In ESPRIT, bleeding events were reported at 48 hours, and non-bleeding events were reported at 30 days.
U ESPRIT ispitivanju krvarenja su procjenjivana nakon 48 sati, a događaji nevezani uz krvarenja 30. dana.
Teratology studies have been performed by continuous intravenous infusion of eptifibatide in pregnant rats at total daily doses of up to 72 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis) and in pregnant rabbits at total daily doses of up to 36 mg/kg/day (about 4 times the recommended maximum daily human dose on a body surface area basis).
Provedena su teratološka ispitivanja kontinuiranom intravenskom infuzijom eptifibatida nosećim ženkama štakora u ukupnim dnevnim dozama do 72 mg/kg/dan (oko 4 puta većoj od maksimalne preporučene dnevne doze za ljude, mjereno prema površini tijela) i kunića u ukupnoj dnevnoj dozi do 36 mg/kg/dan (isto oko 4 puta većoj od maksimalne preporučene dnevne doze za ljude, mjereno prema površini tijela).
Use in patients with more severe renal impairment is contraindicated (see section 4.3).
Primjena u bolesnika s težim oštećenjem bubrega je kontraindicirana (vidjeti dio 4.3).
Thrombocytopenia and Immunogencity related to GP IIb/IIIa inhibitors
Trombocitopenija i imunogeničnost vezana uz GP IIb/IIIa inhibitore
The majority of adverse reactions experienced by patients treated with eptifibatide were generally related to bleeding or to cardiovascular events that occur frequently in this patient population.
Većina nuspojava u bolesnika liječenih eptifibatidom obično je vezana uz krvarenja ili kardiovaskularne pojave koje su česte u toj populaciji bolesnika.
During treatment with eptifibatide in this study, minor bleeding was a very common complication (> 1/10, or 13.1 % for eptifibatide versus 7.6 % for placebo).
Tijekom liječenja eptifibatidom u ovom ispitivanju manje krvarenje je bilo vrlo česta komplikacija (>1/10 ili 13,1 % uz eptifibatid u odnosu na 7,6 % uz placebo).
Haemoglobin, haematocrit, and platelet count are to be monitored as well within 6 hours after start of therapy and at least once daily thereafter while on therapy (or more often if there is evidence of a marked decrease).
Hemoglobin, hematokrit i broj trombocita treba također provjeriti i unutar 6 sati od početka liječenja, a nakon toga najmanje jednom dnevno tijekom samog liječenja (ili češće ako postoje dokazi značajnog pada).
The infusion was continued until hospital discharge, until the time of coronary artery bypass grafting (CABG) or for up to 72 hours, whichever occurred first.
Infuzija se nastavila do otpusta iz bolnice, do početka operacije ugradnje premosnice koronarne arterije (CABG) ili do najviše 72 sata, ovisno o tome što se dogodilo prije.
Pharmacotherapeutic group: Antithrombotic agent (platelet aggregation inhibitors excl. heparin), ATC code: B01AC16
Farmakoterapijska skupina: Antitrombotici (inhibitori agregacije trombocita izuzev heparina), ATK oznaka: B01AC16
Thrombocytopenia occurring after first exposure to a GPIIb/IIIa inhibitor may be explained by the fact that antibodies are naturally present in some normal individuals.
Trombocitopenija koja se javlja nakon prvog izlaganja inhibitoru GPIIb/IIIa može biti objašnjena činjenicom da se takva antitijela prirodno mogu naći u pojedinih, inače zdravih osoba.
Not relevant, as Eptifibatide Accord is intended for use only in hospitalised patients.
Nije značajno, budući da je Eptifibatid Accord namijenjen liječenju isključivo hospitaliziranih bolesnika.
Since either repeat exposure with any GP IIb/IIIa ligand-mimetic agent (like abciximab or eptifibatide) or first-time exposure to a GP IIb/IIIa inhibitor may be associated with immune-mediated thrombocytopenic responses, monitoring is required, i.e. platelet counts should be monitored prior to treatment, within 6 hours of administration, and at least once daily thereafter while on therapy and immediately at clinical signs of unexpected bleeding tendency.
Obzirom da ponovna izloženost bilo kojem GP IIb/IIIa ligand-mimetiku (poput abciksimaba ili eptifibatida) ili prva izloženost GP IIb/IIIa inhibitoru može biti povezano s imunološki posredovanim odgovorom u vidu trombocitopenije, praćenje je neophodno, tj. broj trombocita potrebno je provjeriti prije početka liječenja, unutar 6 sati od početka primjene, a nakon toga najmanje jednom dnevno tijekom samog liječenja ili i odmah ako nastupe klinički znakovi neočekivanog krvarenja.
Other medicines and Eptifibatide Accord
Drugi lijekovi i Eptifibatid Accord
- if you have had a brain tumour or a condition that affects the blood vessels around the brain.
− ako ste imali tumor na mozgu ili stanje koje utječe na krvne žile oko mozga.
The ESPRIT trial used a simplified regimen of heparin during PCI that consisted of an initial bolus of 60 units/kg, with a target ACT of 200 - 300 seconds.
U studiji ESPRIT koristio se pojednostavljeni režim primjene heparina tijekom PCI koji se sastojao od inicijalnog bolusa od 60 jedinica/kg, s ciljnim ACT od 200 - 300 sekundi.
- if you had a major operation or severe injury during the past 6 weeks.
− ako ste imali veliki operativni zahvat ili tešku ozljedu tijekom proteklih 6 tjedana.
Before using, the vial contents should be inspected.
Prije primjene, sadržaj bočice treba pregledati.
What you need to know before you are given Eptifibatide Accord Do not use Eptifibatide Accord:
Što morate znati prije nego počnete primati Eptifibatid Accord Nemojte primjenjivati Eptifibatid Accord:
- anaemia (decreased number of red blood cells).
− anemija (smanjeni broj crvenih krvnih stanica).
Compared to placebo, eptifibatide administered as 180/2.0 significantly reduced the incidence of the primary endpoint events (table 1): this represents around 15 events avoided for 1,000 patients treated:
U usporedbi s placebom, eptifibatid primijenjen u dozi od 180/2,0 značajno je smanjio incidenciju događaja primarne mjere ishoda (Tablica 1), što predstavlja oko 15 izbjegnutih događaja na
The reduction in the incidence of endpoint events in patients receiving eptifibatide appeared early during treatment.
Smanjenje incidencije događaja mjere ishoda u bolesnika koji su primali eptifibatid dogodilo se u ranoj fazi liječenja.
Bleeding is most common at the arterial access site in patients undergoing percutaneous arterial procedures.
Krvarenje je najčešće na mjestu krvožilnog pristupa u bolesnika koji se podvrgavaju perkutanim arterijskim intervencijama.
Because of its short half-life and rapid clearance, the activity of eptifibatide may be halted readily by discontinuing the infusion.
Zbog kratkog poluvijeka i vrlo brzog klirensa, djelovanje eptifibatida može se brzo zaustaviti prekidanjem infuzije.
What you need to know before you are given Eptifibatide Accord 3.
Što morate znati prije nego počnete primjati Eptifibatid Accord 3.
It is contraindicated in patients with clinically significant hepatic impairment.
Kontraindiciran je u bolesnika s klinički značajnim oštećenjem jetrene funkcije.
There was no excessive bleeding in any of these patients, although one patient undergoing CABG surgery was reported as having had a moderate bleed.
Niti jedan od tih bolesnika nije pretjerano krvario, iako je zabilježeno da je jedan bolesnik koji je imao operaciju ugradnje srčane premosnice umjereno krvario.
Toxicology studies conducted with eptifibatide include single and repeated dose studies in the rat, rabbit and monkey, reproduction studies in the rat and rabbit, in vitro and in vivo genetic toxicity studies, and irritation, hypersensitivity and antigenicity studies.
Toksikološke studije provedene s eptifibatidom uključuju ispitivanja s pojedinačnim ili ponavljanim dozama na štakorima, kunićima i majmunima, ispitivanja utjecaja na reprodukciju štakora i kunića, in vitro i in vivo ispitivanja genotoksičnosti, te ispitivanja iritacije, preosjetljivosti i antigeničnosti.
Measurements of ADP-induced ex vivo platelet aggregation at physiologic calcium concentrations (Dphenylalanyl-L-prolyl-L-arginine chloromethyl ketone anticoagulant) in patients presenting with unstable angina and Non Q-Wave Myocardial Infarction showed a concentration-dependent inhibition with an IC50 (50 % inhibitory concentration) of approximately 550 ng/ml and an IC80 (80 % inhibitory concentration) of approximately 1,100 ng/ml.
Mjerenja ADP-om inducirane ex vivo agregacije trombocita pri fiziološkim koncentracijama kalcija (D-fenilalanil-Lprolil-L-arginin klorometil keton antikoagulans) u bolesnika s nestabilnom anginom i infarktom miokarda bez Q-zupca pokazala su inhibiciju ovisnu o koncentraciji s IC50 (50 % inhibitorne koncentracije) od približno 550 ng/ml i IC80 (80 % inhibitorne koncentracije) od približno 1100 ng/ml.
Clinical Trials
KLINIČKI PODACI
Unlike the approved posology in the EU, the study used a double bolus of study drug (separated by 10 minutes) before the infusion.
Za razliku od odobrenog načina doziranja u EU, u ovom je ispitivanju korištena primjena dvostrukog bolusa ispitivanog lijeka (u razmaku od 10 minuta) prije kontinuirane infuzije.
GUSTO moderate or severe/life threatening bleeding occurred significantly more often with early routine eptifibatide (7.4 % vs. 5.0 % in delayed provisional eptifibatide group; p <0.001).
GUSTO umjereno ili jako/životno ugrožavajuće krvarenje se javljalo značajno češće uz ranu rutinsku primjenu eptifibatida (7,4 % naspram 5,0 % pri odgođenoj privremenoj primjeni eptifibatida; p <0,001).
The most common bleeding complications were associated with cardiac invasive procedures (coronary artery bypass grafting (CABG)-related or at femoral artery access site).
Najčešće su krvarenja kao komplikacije bile povezane s invazivnim kardijalnim procedurama (povezane s ugradnjom premosnice koronarne arterije - CABG ili na mjestu punkcije femoralne arterije).
No genotoxic effects were observed with eptifibatide.
Nije zabilježena genotoksičnost eptifibatida.
ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with eptifibatide Therapy) was a double-blind, randomised, placebo-controlled trial (n= 2,064) for nonurgent PCI with intracoronary stenting.
ESPRIT (Enhanced Suppression of the Platelet IIb/IIIa Receptor with eptifibatide Therapy) je bila dvostruko slijepa, randomizirana, placebom kontrolirana studija (n= 2064) za neurgentne PCI s ugradnjom intrakoronarnog stenta.
There is limited therapeutic experience with eptifibatide in patients for whom thrombolytic therapy is generally indicated (e.g. acute transmural myocardial infarction with new pathological Q-waves or elevated ST-segments or left bundle branch block in the ECG).
Ograničeno je terapijsko iskustvo s eptifibatidom u bolesnika za koje je općenito indicirana trombolitička terapija (npr. akutni transmuralni infarkt miokarda s novim patološkim Q zupcima ili povišenim ST-segmentom ili blokom lijeve grane u EKG-u).
Administration of eptifibatide by intravenous bolus and infusion causes up to a 5-fold increase in bleeding time.
Davanje eptifibatida intravenskim bolusom i infuzijom uzrokuje produljenje vremena krvarenja do
Before using, inspect the vial contents.
Prije upotrebe provjerite sadržaj bočice.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Nositelj odobrenja za stavljanje lijeka u promet i proizvođač Nositelj odobrenja za stavljanje lijeka u promet:
Cardiac arrest, ventricular fibrillation, ventricular tachycardia, congestive heart failure, atrioventricular block, atrial fibrillation.
Srčani poremećaji Često kardijalni arest, fibrilacija ventrikula, ventrikularna tahikardija, kongestivno zatajenje srca, atrioventrikularni blok, fibrilacija atrija
What Eptifibatide Accord looks like and contents of the pack
Kako Eptifibatid Accord izgleda i sadržaj pakiranja
This should be taken into consideration by patients on a controlled sodium diet.
Bolesnici koji su na dijeti s kontroliranim unosom natrija trebaju ovo uzeti u obzir.
− if you have recently had bleeding from your stomach, intestines, bladder or other organs, for example if you have seen abnormal blood in your stool or urine (except from menstrual bleeding)
− ako ste nedavno imali krvarenje iz želuca, crijeva, mokraćnog mjehura ili drugih organa, na primjer ako ste uočili abnormalnu pojavu krvi u stolici ili mokraći (osim menstrualnog krvarenja) u proteklih 30 dana.
Eptifibatide Accord inhibits platelet aggregation, but does not appear to affect the viability of platelets.
Eptifibatid Accord inhibira agregaciju trombocita, ali čini se da ne utječe na sposobnost preživljavanja trombocita.
What Eptifibatide Accord is and what it is used for
Što je Eptifibatid Accord i za što se koristi
Eptifibatide Accord is an antithrombotic agent that acts by inhibition of platelet aggregation; therefore the patient must be observed carefully for indications of bleeding during treatment (see section 4.8).
Eptifibatid Accord je antitrombotik koji djeluje inhibicijom agregacije trombocita; stoga bolesnika treba pomno nadzirati zbog naznaka krvarenja tijekom liječenja (vidjeti dio 4.8.).
Solution for infusion 100 ml
Otopina za infuziju 100 ml
The need for blood transfusions was increased modestly by eptifibatide treatment (11.8 % versus 9.3 % for placebo).
Liječenje eptifibatidom neznatno je povećalo potrebu za transfuzijom krvi (11,8 % prema 9,3 % za placebo).
The primary endpoint of the trial was death (D), MI, urgent target vessel revascularisation (UTVR), and acute antithrombotic rescue with GP IIb/IIIa inhibitor therapy (RT) within 48 hours of randomisation.
Primarna mjera ishoda ispitivanja bila je smrt, infarkt miokarda, hitna revaskularizacija ciljne krvne žile (UTVR) i akutna antitrombotska hitna intervencija inhibitorom GP IIb/IIIa (RT) unutar 48 sati od randomizacije.
Patients most likely to benefit from eptifibatide treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina.
Bolesnici kojima će eptifibatid vjerojatno najviše koristiti su oni pod visokim rizikom od razvoja infarkta miokarda unutar prva 3-4 dana nakon nastupa akutne angine.
MI was identified per the CK-MB core laboratory criteria.
Infarkt miokarda određivao se prema CK-MB osnovnim laboratorijskim kriterijima.
In the subgroup of patients undergoing PCI, major bleeding was observed commonly, in 9.7 % of eptifibatide -treated patients vs. 4.6 % of placebo-treated patients.
U podskupini bolesnika koji su išli na PCI, veliko krvarenje zabilježeno je često, u 9,7 % bolesnika liječenih eptifibatidom naspram 4,6 % bolesnika koji su primali placebo.
Eptifibatide Accord is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.
Eptifibatid Accord je indiciran za sprječavanje ranog infarkta miokarda u odraslih osoba koji imaju nestabilnu anginu ili infarkt miokarda bez Q-zupca, u kojih se posljednja epizoda boli u prsima dogodila u posljednja 24 sata i koji imaju promjene u elektrokardiogramu (EKG) i/ili povišene srčane enzime.
On the day of PCI, prior to catheterization, 53.2 % received a thienopyridine (clopidogrel 52.7 %; ticlopidine 0.5 %) - mostly as a loading dose (300 mg or more).
Na dan PCI, prije kateterizacije, 53,2 % bolesnika dobilo je tienopiridin (klopidogrel 52,7 %; tiklopidin 0,5 %) - većinom kao udarnu dozu (300 mg ili više).
After removal of the introducer sheath, careful haemostasis must be ensured under close observation.
Nakon vađenja uvodnice treba osigurati dobru hemostazu i pomno je nadzirati.
− serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs)
− ozbiljno krvarenje (na primjer krvarenje u trbušnoj šupljini, u mozgu i u pluća).
319, Pinner Road, Harrow Middlesex HA1 4HF United Kingdom
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It is not known whether eptifibatide is excreted in human milk.
Nije poznato izlučuje li se eptifibatid u majčino mlijeko.
If the patient requires semi-elective surgery, stop the eptifibatide infusion at an appropriate time to allow time for platelet function to return towards normal.
Ako je bolesniku potrebna poluelektivna operacija, infuziju eptifibatida treba prekinuti dovoljno rano da se funkcija trombocita vrati na normalnu.
Eptifibatide and thrombolytic agents
Eptifibatid i trombolitici
− minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with surgical procedures).
− manja ili velika krvarenja (npr. krv u mokraći, krv u stolici, krv u povraćenom sadržaju ili krvarenje pri kirurškom zahvatu).
If you are breast-feeding a baby, breast-feeding should be interrupted during the treatment period.
Ako dojite, potrebno je prekinuti dojenje tijekom perioda liječenja.