FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Portrazza, necitumumab, is a monoclonal antibody (a type of protein) designed to recognise and attach to EGFR on the surface of the cancer cells.
Croatian: Djelatna tvar u lijeku Portrazza, necitumumab, jest monoklonsko protutijelo (vrsta proteina) osmišljeno za prepoznavanje EGFR-a na površini stanica raka i vezivanje za njega.
English: For practical information about using Portrazza, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Portrazza pročitajte u uputi o lijeku ili se obratite svom liječniku ili ljekarniku.
English: There was no improved survival in patients with non-EGFR cancer cells.
Croatian: U bolesnika sa stanicama raka bez-EGFR-a nije bilo poboljšanja u pogledu preživljavanja.
English: How does Portrazza work?
Croatian: Kako djeluje Portrazza?
English: How is Portrazza used?
Croatian: Kako se Portrazza koristi?
English: Portrazza contains the active substance necitumumab.
Croatian: Portrazza sadrži djelatnu tvar necitumumab.
English: For the full list of all side effects reported with Portrazza, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Portrazza potražite u uputi o lijeku.
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Croatian: Ako bol potraje dulje od 12 sati nakon liječničkog pregleda, treba ponovo potražiti pomoć liječnika.
English: This overview was last updated in May 2018.
Croatian: Pregled je posljednji put ažuriran u 05. 2018.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger - this could result in the loss of the finger if prompt medical attention is not given.
Croatian: Slučajno ubrizgavanje može prouzročiti jaku bol i oticanje, naročito ako se cjepivo ubrizgava u zglob ili prst, što može rezultirati gubitkom zahvaćenog prsta ako se ne pruži hitna medicinska pomoć.
English: Further information on Porcilis PCV M Hyo can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Croatian: Više informacija o VMP-u Porcilis PCV M Hyo nalazi se na internetskim stranicama Agencije:ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The repeated dose vaccination often gave slightly better results than the single vaccination.
Croatian: Ponovljeno cijepljenje drugom dozom uglavnom je dalo nešto bolje rezultate nego cijepljenje samo jednom dozom.
English: • Porcine circovirus type 2 (PCV2) infections can produce clinical signs such as weight loss or failure to grow, enlarged lymph nodes, difficulty in breathing, diarrhoea, pale skin and jaundice (yellowing of the skin).
Croatian: • Infekcije cirkovirusom svinje tipa 2 (PCV2) mogu prouzročiti kliničke znakove kao što su gubitak tjelesne težine ili prestanak rasta, povećani limfni čvorovi, teškoće pri disanju, proljev, blijeda koža i žutica (žutilo kože).
English: In three of the studies there was a third similar-sized group of pigs that were vaccinated using the two-dose schedule.
Croatian: U trima od tih ispitivanja, treća skupina s otprilike jednakim brojem svinja, cijepljena je prema režimu od dvije doze cjepiva.
English: • Infection with the bacterium Mycoplasma hyopneumoniae in pigs causes a disease of the airways called enzootic pneumonia.
Croatian: • Infekcija bakterijom Mycoplasma hyopneumoniae u svinja uzrokuje bolest dišnih putova koja se naziva enzootska pneumonija.
English: The vaccine is given to pigs from three days of age as two injections into the neck muscle at least 18 days apart, or from three weeks of age as a single injection into the neck muscle.
Croatian: Cjepivo se daje svinjama starijima od tri dana kao dvije injekcije u mišić vrata s razmakom od najmanje 18 dana ili svinjama starijim od tri tjedna kao jedna injekcija u mišić vrata.
English: The European Medicines Agency decided that Porcilis PCV M Hyo's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove je odlučila da koristi od VMP-a Porcilis PCV M Hyo nadmašuju s njim povezane rizike te se može izdati odobrenje za njegovu primjenu u EU-u.
English: Porcilis PCV M Hyo contains the adjuvants light mineral oil and aluminium hydroxide to enhance the immune response.
Croatian: Porcilis PCV M Hyo sadrži kao adjuvans lako mineralno ulje i aluminijev hidroksid kako bi se pojačao imunosni odgovor.
English: Porcilis PCV M Hyo is an emulsion containing mineral oil.
Croatian: Porcilis PCV M Hyo je emulzija koja sadrži mineralno ulje.
English: The vaccine contains small amounts of a protein from PCV2 and whole Mycoplasma hyopneumoniae bacteria that have been killed (inactivated) so that they do not cause disease.
Croatian: Cjepivo sadrži male količine bjelančevine iz virusa PCV2 i cijelu bakteriju Mycoplasma hyopneumoniae, koji su umrtvljeni (inaktivirani) da ne bi doveli do pojave bolesti.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption.
Croatian: Razdoblje karencije je vrijeme koje treba proći od primjene VMP-a do klanja životinje i korištenja mesa za prehranu ljudi.
English: When Porcilis PCV M Hyo is given to pigs the animals' immune system recognises the virus protein and bacteria as ‘foreign' and makes antibodies against them.
Croatian: Kada se Porcilis PCV M Hyo daje svinjama, imunosni sustav životinje prepoznaje virusnu bjelančevinu i bakteriju kao „strana tijela” te proizvodi protutijela protiv njih.
English: Porcilis PCV M Hyo received a marketing authorisation valid throughout the EU for Porcilis PCV M Hyo on 7 November 2014.
Croatian: Za VMP Porcilis PCV M Hyo izdano je odobrenje za stavljanje u promet koje je za Porcilis PCV M Hyo na snazi u Europskoj uniji od 7. studenoga 2014.
English: The most common side effect (seen in more than 1 in 10 pigs) with Porcilis PCV M Hyo is a short-lived increase in body temperature of up to 2 °C on the day of vaccination.
Croatian: Najčešća nuspojava VMP-a Porcilis PCV M Hyo (može se javiti u više od 1 na 10 životinja) bila je kratkotrajni porast tjelesne temperature do 2 °C na dan cijepljenja.
English: Porcilis PCV M Hyo is a vaccine.
Croatian: Porcilis PCV M Hyo je cjepivo.
English: The two-dose vaccination schedule is recommended when PCV2 and/or Mycoplasma hyopneumoniae infections occur early.
Croatian: Režim cijepljenja od dvije doze preporučuje se kada se infekcije virusom PCV2 ili bakterijom Mycoplasma hyopneumoniae pojave rano.
English: Other information about Porcilis PCV M Hyo
Croatian: Ostale informacije o VMP-u Porcilis PCV M Hyo
English: Why is Porcilis PCV M Hyo authorised in the EU?
Croatian: Zašto je Porcilis PCV M Hyo odobren u EU-u?
English: The field studies showed that both single and repeated vaccination with Porcilis PCV M Hyo reduced PCV2 levels in the blood and the severity of lung damage (lesions) caused by Mycoplasma hyopneumoniae as well as the loss of daily weight gain during the finishing period (the fattening period prior to slaughter).
Croatian: Ispitivanja na farmama pokazala su da je i režim s jednom dozom cjepiva i ponovljeno cijepljenje VMP-om Porcilis PCV M Hyo smanjilo razine PCV2 u krvi i težinu oštećenja pluća (lezija) prouzročenih bakterijom Mycoplasma hyopneumoniae kao i gubitak dnevnog prirasta težine tijekom završnog razdoblja tova (razdoblje tovljenja prije klanja).
English: In each study around 300 suckling piglets were vaccinated once with Porcilis PCV M Hyo and a second similar-sized group of piglets received a dummy injection.
Croatian: U svakom je ispitivanju oko 300 praščića cijepljeno jedanput VMP-om Porcilis PCV M Hyo, dok je druga skupina, s otprilike jednakim brojem praščića, primila injekciju placeba (prividnog liječenja).
English: The withdrawal period for Porcilis PCV M Hyo is zero days.
Croatian: Razdoblje karencije za Porcilis PCV M Hyo iznosi nula dana.
English: For more information about using Porcilis PCV M Hyo, see the package leaflet or contact your veterinarian or pharmacist.
Croatian: Za dodatne informacije o primjeni VMP-a Porcilis PCV M Hyo pročitajte uputu o VMP-u, odnosno obratite se veterinaru ili ljekarniku.
English: Laboratory studies in pigs showed that with two-dose vaccination the vaccine had its full effect against PCV2 by 18 days after first injection and against Mycoplasma hyopneumoniae by three weeks after the second injection, whilst with single-dose vaccination the vaccine had its full effect against PCV2 by two weeks and against Mycoplasma hyopneumoniae by four weeks.
Croatian: Laboratorijska ispitivanja u svinja pokazala su da je primjenom cjepiva u dvije doze cjepivo postiglo puni učinak protiv virusa PCV2 za 18 dana poslije prve injekcije, a protiv bakterije Mycoplasma hyopneumoniae tri tjedna nakon druge injekcije, dok je primjenom jedne doze cjepiva puni učinak cjepiva protiv virusa PCV2 postignut dva tjedna, a protiv bakterije Mycoplasma hyopneumoniae četiri tjedna nakon cijepljenja.
English: The effectiveness of Porcilis PCV M Hyo was investigated in 10 field studies involving pig farms where signs of PCV2 and/or Mycoplasma hyopneumoniae infections had been detected.
Croatian: Učinkovitost VMP-a Porcilis PCV M Hyo ispitivana je u 10 terenskih ispitivanja provedenih na farmama svinja na kojima su utvrđeni znakovi infekcija virusom PCV2 ili bakterijom Mycoplasma hyopneumoniae.
English: Porcilis PCV M Hyo is available as an injection and can only be obtained with a prescription.
Croatian: Porcilis PCV M Hyo dostupan je kao emulzija za injekciju i izdaje se samo na veterinarski recept.
English: What are the risks associated with Porcilis PCV M Hyo?
Croatian: Koji su rizici povezani s VMP-om Porcilis PCV M Hyo?
English: Porcilis PCV M Hyo is a veterinary vaccine used to protect pigs against two separate infections, caused by porcine circovirus and Mycoplasma hyopneumoniae.
Croatian: Porcilis PCV M Hyo veterinarsko je cjepivo koje se upotrebljava za zaštitu svinja od dviju zasebnih infekcija prouzročenih cirkovirusom svinje i bakterijom Mycoplasma hyopneumoniae.
English: Porcilis PCV M Hyo contains porcine circovirus type 2 (PCV2) subunit antigen (a protein derived from part of the virus) and an inactivated (killed) strain of Mycoplasma hyopneumoniae bacteria.
Croatian: Porcilis PCV M Hyo sadrži pojedinačni antigen (bjelančevinu dobivenu od dijela virusa) cirkovirusa svinja tipa 2 (PCV2) i inaktiviran (umrtvljen) soj bakterije Mycoplasma hyopneumoniae.
English: With two-dose vaccination, protection against PCV2 starts at 18 days after the first injection and for Mycoplasma hyopneumoniae it starts 3 weeks after the second injection.
Croatian: Uz režim cijepljenja od dvije doze, zaštita od virusa PCV2 počinje 18 dana poslije prve injekcije, a zaštita od bakterije Mycoplasma hyopneumoniae počinje 3 tjedna poslije druge injekcije.
English: What is Porcilis PCV M Hyo and what is it used for?
Croatian: Što je Porcilis PCV M Hyo i za što se primjenjuje?
English: With both vaccination schedules protection lasted 22 weeks after (the last) injection for PCV2 and 21 weeks after (the last) injection for Mycoplasma hyopneumoniae.
Croatian: Kod oba režima cijepljenja zaštita je trajala 22 tjedna nakon (zadnje) injekcije protiv virusa PCV2 i 21 tjedan nakon (zadnje) injekcije protiv bakterije Mycoplasma hyopneumoniae.
English: With single-dose vaccination, protection against PCV2 starts at two weeks after the injection and for Mycoplasma hyopneumoniae it starts four weeks after the injection.
Croatian: Uz režim cijepljenja od jedne doze zaštita od virusa PCV2 počinje dva tjedna poslije injekcije, a zaštita od bakterije Mycoplasma hyopneumoniae počinje četiri tjedna poslije injekcije.
English: How does Porcilis PCV M Hyo work?
Croatian: Kako djeluje Porcilis PCV M Hyo?
English: What benefits of Porcilis PCV M Hyo have been shown in studies?
Croatian: Koje su koristi od VMP-a Porcilis PCV M Hyo utvrđene u ispitivanjima?
English: Porcilis PCV M Hyo (Porcine circovirus and Mycoplasma hyopneumoniae vaccine, inactivated)
Croatian: Porcilis PCV M Hyo (inaktivirano cjepivo protiv cirkovirusa svinje i bakterije Mycoplasma hyopneumoniae) Pregled VMP-a Porcilis PCV M Hyo i zašto je odobren u EU-u
English: How is Porcilis PCV M Hyo used?
Croatian: Kako se Porcilis PCV M Hyo koristi?
English: These improvements were not statistically significant.
Croatian: To poboljšanje nije bilo statistički značajno.
English: The median follow-up duration was 22.9 months.
Croatian: Medijan trajanja praćenja iznosio je 22,9 mjeseci.
English: Date of first authorisation: 11/11/2016
Croatian: Datum prvog odobrenja: 11/11/2016
English: - If you are pregnant or trying to become pregnant.
Croatian: − ako ste trudni ili pokušavate zatrudnjeti
English: The higher than approved dose used in the study did not fully explain these findings.
Croatian: Viša doza lijeka od odobrene korištena u ovom ispitivanju nije u potpunosti objasnila ove rezultate.
English: Hazard Ratio [95% CI]
Croatian: Omjer hazarda [95% CI]
English: Available data are described in sections 5.1 and 5.2 but no recommendation on a posology can be made.
Croatian: Dostupni podaci opisani su u dijelovima 5.1 i 5.2, ali nije moguće dati preporuku o doziranju.
English: The usual dose is one tablet in the morning and one tablet in the evening.
Croatian: Uobičajena doza je jedna tableta ujutro i jedna tableta navečer.
English: If this happens, contact your doctor immediately.
Croatian: Ako se to dogodi, odmah se obratite svom liječniku.
English: Store below 25 °C.
Croatian: Čuvati na temperaturi ispod 25°C.
English: Other side effects have also been reported:
Croatian: Prijavljene su i druge nuspojave:
English: Fewer than 1% of patients changed their daily routine or discontinued the treatment in relation with phosphenes.
Croatian: Manje od 1% bolesnika mijenjalo je svoju svakodnevnu rutinu ili prekinulo liječenje zbog fosfena.
English: 032266 Bucharest Romania
Croatian: 032266 Bukurešt Rumunjska
English: In this way Ivabradine Zentiva helps to control and reduce the number of angina attacks.
Croatian: Na taj način, Ivabradine Zentiva pomaže kontrolirati i smanjiti broj napadaja angine.
English: - If you have heart failure which has recently become worse.
Croatian: − ako imate zatajivanje srca koje se nedavno pogoršalo
English: - If you are a woman able to have children and not using reliable contraception.
Croatian: − ako ste žena koja može zatrudnjeti a ne koristite pouzdanu kontracepciju
English: Tablets must be taken orally twice daily, i.e. once in the morning and once in the evening during meals (see section 5.2).
Croatian: Tablete se moraju uzimati peroralno dvaput na dan, tj. jedanput ujutro i jedanput navečer, uz obroke (vidjeti dio 5.2).
English: - Severe hypotension (< 90/50 mmHg).
Croatian: Teška hipotenzija (< 90/50 mmHg)
English: - Barbiturates (for difficult sleeping or epilepsy).
Croatian: − barbiturate (za poteškoće sa spavanjem ili epilepsiju)
English: Visual function
Croatian: Vidna funkcija
English: Therefore the intake of grapefruit juice should be avoided.
Croatian: Stoga treba izbjegavati konzumiranje soka od grejpa.
English: All phosphenes resolved during or after treatment, of which a majority (77.5%) resolved during treatment.
Croatian: Svi su se fosfeni povukli tijekom ili nakon liječenja, a većina od njih (77,5%) tijekom liječenja.
English: It participates in the temporal resolution of the visual system, by curtailing the retinal response to bright light stimuli.
Croatian: Ona sudjeluje u vremenskoj rezoluciji vidnog sustava, skraćujući odgovor mrežnice na jake svjetlosne podražaje.
English: If this happens to you, be careful when driving or using machines at times when there could be sudden changes in light intensity, especially when driving at night.
Croatian: Ako se to dogodi Vama, budite pažljivi kada upravljate vozilom ili radite sa strojevima u vrijeme kada bi moglo doći do iznenadnih promjena intenziteta svjetlosti, osobito tijekom vožnje noću.
English: Angina is more likely to happen when the heart beats faster in situations such as exercise, emotion, exposure to the cold or after eating.
Croatian: Veća je vjerojatnost da će angina nastupiti kada srce kuca brže, u situacijama kao što su fizički napor, snažne emocije, izloženost hladnoći ili nakon jela.
English: Ivabradine has been studied in clinical trials involving nearly 45,000 participants.
Croatian: Ivabradin se ispitivao u kliničkim ispitivanjima u kojima je sudjelovalo gotovo 45 000 osoba.
English: If you forget to take a dose of Ivabradine Zentiva, take the next dose at the usual time.
Croatian: Ako zaboravite uzeti dozu lijeka Ivabradine Zentiva, uzmite sljedeću dozu u uobičajeno vrijeme.
English: - If you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section 6).
Croatian: − ako ste alergični na ivabradin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The absolute bioavailability of the film-coated tablets is around 40%, due to first-pass effect in the gut and liver.
Croatian: Apsolutna bioraspoloživost filmom obloženih tableta iznosi približno 40%, zbog učinka prvog prolaza kroz crijeva i jetru.
English: Women that need treatment with ivabradine should stop breastfeeding, and choose for another way of feeding their child.
Croatian: Žene kojima je potrebno liječenje ivabradinom moraju prestati dojiti i odabrati drugi način hranjenja djeteta.
English: The most common adverse reactions with this medicine are dose dependent and related to its mode of action:
Croatian: Najčešće nuspojave zabilježene kod primjene ovog lijeka ovisne su o dozi i povezane s načinom njegova djelovanja:
English: This leads to a reduction in cardiac workload and myocardial oxygen consumption.
Croatian: To dovodi do smanjenja radnog opterećenja srca i potrošnje kisika u miokardu.
English: Other long-term repeat dose and carcinogenicity studies revealed no clinically relevant changes.
Croatian: U drugim dugoročnim ispitivanjima ponovljenih doza i kancerogenosti nisu otkrivene klinički značajne promjene.
English: Bradycardia was reported by 3.3% of patients particularly within the first 2 to 3 months of treatment initiation.
Croatian: Bradikardija je prijavljena u 3,3% bolesnika, osobito unutar prva 2 do 3 mjeseca nakon uvođenja liječenja.
English: Ivabradine should therefore be used with precaution in this population.
Croatian: Ivabradin stoga treba primjenjivati uz oprez u toj populaciji.
English: Ivabradine Zentiva is not intended for use in children and adolescents younger than 18 years.
Croatian: Djeca Ivabradine Zentiva nije namijenjen djeci ni adolescentima mlađima od 18 godina.
English: Patients with hypotension
Croatian: Bolesnici s hipotenzijom
English: If you are pregnant and have taken Ivabradine Zentiva, talk to your doctor.
Croatian: Ako ste trudni a uzeli ste Ivabradine Zentiva, obratite se svom liječniku.
English: Food delayed absorption by approximately 1 hour, and increased plasma exposure by 20 to 30%.
Croatian: Hrana je usporila apsorpciju za približno 1 sat te povećala izloženost u plazmi za 20 - 30%.
English: They generally occur within the first two months of treatment after which they may occur repeatedly and resolve during or after treatment.
Croatian: Obično se javljaju unutar prva dva mjeseca liječenja, nakon čega se mogu ponavljati i nestati tijekom ili nakon liječenja.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i kancerogenog potencijala.
English: Ivabradine (N = 3,241) n (%)
Croatian: Ivabradin (N = 3241) n (%)
English: If there is no improvement in symptoms of angina within 3 months after start of treatment, treatment of ivabradine should be discontinued.
Croatian: Ako se ne postigne poboljšanje simptoma angine unutar 3 mjeseca od početka liječenja, liječenje ivabradinom mora se prekinuti.
English: The effects on blood pressure and peripheral vascular resistance were minor and not clinically significant.
Croatian: Učinci na krvni tlak i periferni vaskularni otpor bili su minorni i nisu bili klinički značajni.
English: - AV-block of 3
Croatian: AV-blok 3. stupnja
English: Severe bradycardia should be treated symptomatically in a specialised environment.
Croatian: Tešku bradikardiju treba liječiti simptomatski u specijaliziranom okruženju.
English: They are usually triggered by sudden variations in light intensity.
Croatian: Obično ih izazivaju iznenadne promjene intenziteta svjetlosti.
English: No pharmacokinetic differences (AUC and Cmax) have been observed between elderly (≥ 65 years) or very elderly patients (≥ 75 years) and the overall population (see section 4.2).
Croatian: Nisu primijećene razlike u farmakokinetici (AUC i Cmax) između starijih (≥ 65 godina) ili znatno starijih bolesnika (≥ 75 godina) i ukupne populacije (vidjeti dio 4.2).
English: If you think that the effect of Ivabradine Zentiva is too strong or too weak, talk to your doctor or pharmacist.
Croatian: Ako mislite da je učinak lijeka Ivabradine Zentiva prejak ili preslab, razgovarajte sa svojim liječnikom ili ljekarnikom.
English: • Bepridil (to treat angina pectoris).
Croatian: • bepridil (za liječenje angine pektoris)
English: The calendar printed on the blister containing the tablets should help you remember when you last took a tablet of Ivabradine Zentiva.
Croatian: Kalendarski dani otisnuti na blisteru koji sadrži tablete trebali bi Vam pomoći da zapamtite kada ste zadnji put uzeli tabletu lijeka Ivabradine Zentiva.
English: Phosphenes were generally reported to be of mild to moderate intensity.
Croatian: Općenito je prijavljeno da su fosfeni bili blagog do umjerenog intenziteta.
English: Caution should be exercised in patients with retinitis pigmentosa.
Croatian: Potreban je oprez u bolesnika koji imaju retinitis pigmentosa.
English: There was no evidence of pharmacological tolerance (loss of efficacy) developing during treatment nor of rebound phenomena after abrupt treatment discontinuation.
Croatian: Nije bilo dokaza pojave farmakološke tolerancije (gubitka djelotvornosti) tijekom liječenja niti povratnih fenomena nakon naglog prekida liječenja.
English: Atrial fibrillation - cardiac arrhythmias
Croatian: Fibrilacija atrija - srčane aritmije
English: Ivabradine Zentiva should be taken during meals.
Croatian: Ivabradine Zentiva treba uzimati tijekom obroka.
English: The metabolism of this active metabolite also involves CYP3A4.
Croatian: Metabolizam tog aktivnog metabolita također uključuje CYP3A4.
English: The intake of the tablet during meals is recommended in order to decrease intra-individual variability in exposure (see section 4.2).
Croatian: Preporučuje se tablete uzimati tijekom obroka kako bi se smanjila intraindividualna varijabilnost izloženosti (vidjeti dio 4.2).
English: - If you suffer from very low blood pressure.
Croatian: − ako imate vrlo nizak krvni tlak
English: In addition, discontinuation of treatment should be considered if there is only limited symptomatic response and when there is no clinically relevant reduction in resting heart rate within three months.
Croatian: Osim toga, prekid liječenja treba razmotriti kada postoji samo ograničen odgovor s obzirom na simptome i kada se ne postigne klinički značajno smanjenje srčane frekvencije u mirovanju unutar tri mjeseca.
English: These studies have shown embryotoxic and teratogenic effects (see section 5.3).
Croatian: Ta su ispitivanja pokazala embriotoksične i teratogene učinke (vidjeti dio 5.3).
English: Under physiological conditions, ivabradine is rapidly released from tablets and is highly water-soluble (> 10 mg/mL).
Croatian: U fiziološkim se uvjetima ivabradin brzo oslobađa iz tableta te je vrlo topljiv u vodi (> 10 mg/ml).