FrancophonIA/ELRC3.0 huggingface dataset:
English: In some cases (e.g. if you are elderly), your doctor may prescribe half the dose i.e., one half 5 mg tablet of Ivabradine Accord 5 mg (corresponding to 2.5 mg ivabradine) in the morning and one half 5 mg tablet in the evening.
Croatian: U nekim slučajevima (npr. kod starijih osoba) postoji mogućnost da Vam liječnik propiše pola doze, t.j. jednu polovicu tablete Ivabradin Accord 5 mg (što odgovara količini 2,5 mg ivabradina) ujutro i jednu polovicu tablete Ivabradin Accord 5 mg uvečer.
English: The starting dose should not exceed one tablet of Ivabradine Accord 5 mg twice daily.
Croatian: Početna doza ne smije prelaziti jednu tabletu Ivabradin Accord 5 mg dva puta na dan.
English: The usual recommended starting dose is one tablet of Ivabradine Accord 5 mg twice daily increasing if necessary to one tablet of Ivabradine Accord 7.5 mg twice daily.
Croatian: Uobičajena doza je jedna tableta Ivabradin Accorda od 5 mg dva puta na dan, koja se, ako je potrebno, povećava na jednu tabletu Ivabradin Accorda od 7,5 mg dva puta na dan.
English: The tablets are available in Aluminium/ Aluminium perforated unit dose blister in pack-sizes of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 or 112x1 tablets.
Croatian: Tablete su dostupne u aluminij/aluminij perforiranim blisterima s jediničnim dozama u veličinama pakiranja od 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 ili 112x1 tableta.
English: Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Croatian: Ivabradin je indiciran u kroničnom zatajenju srca stupnja II do IV NYHA klasifikacije sa sistoličkom disfunkcijom, u bolesnika u sinusnom ritmu sa srčanom frekvencijom ≥ 75 otkucaja u minuti u kombinaciji sa standardnom terapijom uključujući terapiju s beta-blokatorom ili kada je primjena beta-blokatora kontraindicirana ili se ne podnosi (vidjeti dio 5.1).
English: Ivabradine Accord film-coated tablets are available in Aluminium/ Aluminium perforated unit dose blister in pack sizes of 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 or 112x1 tablets.
Croatian: Ivabradin Accord filmom obložene tablete dostupne su u aluminij/aluminij perforiranim blisterima s jediničnim dozama u veličinama pakiranja od 14x1, 28x1, 56x1, 84x1, 98x1, 100x1 ili 112x1 tableta.
English: Ivabradine influences on retinal function.
Croatian: Ivabradin utječe na funkciju mrežnice.
English: - The other ingredients in the tablet core are: lactose anhydrous, magnesium stearate (E470b), pregelatinised starch (maize), colloidal hydrated silica (E551), and in the tablet coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 4000, talc (E553b), yellow iron oxide (E172), red iron oxide (E172).
Croatian: - Pomoćne tvari u jezgri tablete su: bezvodna laktoza, magnezijev stearat (E470b), prethodno geliran škrob (kukuruzni), hidratizirani koloidni silicijev dioksid (E551); a u ovojnici tablete: poli(vinilni alkohol) (E1203), titanijev dioksid (E171), makrogol 4000, talk (E553b), žuti željezov oksid (E172), crveni željezov oksid (E172).
English: WESSLING Hungary Kft., Anonymus u. 6., Budapest, 1045, Hungary
Croatian: 6., Budapest, 1045, Mađarska
English: - if your resting heart rate before treatment is too slow (below 70 beats per minute); - if you are suffering from cardiogenic shock (a heart condition treated in hospital); - if you suffer from a heart rhythm disorder; - if you are having a heart attack; - if you suffer from very low blood pressure; - if you suffer from unstable angina (a severe form in which chest pain occurs very frequently and with or without exertion); - if you have heart failure which has recently become worse; - if your heartbeat is exclusively imposed by your pacemaker; - if you suffer from severe liver problems; - if you are already taking medicines for the treatment of fungal infections (such as ketoconazole,
Croatian: otkucaja u minuti); - ako bolujete od kardiogenog šoka (medicinsko stanje koje se liječi u bolnici); - ako bolujete od poremećaja srčanog ritma; - ako imate srčani udar; - ako imate niski krvni tlak; - ako imate nestabilnu anginu pektoris (težak oblik angine pektoris u kojoj se bolovi u prsnom košu javljaju vrlo često uz napor, ali i bez napora); - ako imate zatajenje srca koje se nedavno pogoršalo; - ako imate elektrostimulator (pacemaker); - ako imate teške bolesti jetre; - ako uzimate lijekove za liječenje gljivičnih infekcija (kao što su ketokonazol, itrakonazol),
English: Ivabradine Accord 5 mg film-coated tablets EU/1/17/1190/001
Croatian: Ivabradin Accord 5 mg filmom obložene tablete EU/1/17/1190/001
English: Irregular heart beats.
Croatian: Nepravilni otkucaji srca.
English: In the subgroup of patients with HR ≥ 75 bpm (n=4150), a greater reduction was observed in the primary composite endpoint of 24 % (hazard ratio: 0.76, 95%CI [0.68;0.85] - p<0.0001) and for other secondary endpoints, including all cause death (hazard ratio: 0.83, 95%CI [0.72;0.96] - p=0.0109) and CV death (hazard ratio: 0.83, 95%CI [0.71;0.97] - p=0.0166).
Croatian: U podskupini bolesnika sa srčanom frekvencijom ≥ 75/min (n=4 150), zabilježeno je izraženije smanjenje primarnog kompozitnog ishoda od 24% (omjer hazarda (HR): 0,76, 95%CI [0,68;0,85] - p<0,0001) kao i za ostale sekundarne ishode, uključujući smrt zbog svih uzroka (omjer hazarda (HR): 0,83, 95%CI [0.72;0.96] - p=0,0109) i smrt zbog kardiovaskularnih uzroka (omjer hazarda (HR): 0,83, 95%CI [0.71;0.97] - p=0,0166).
English: How does Ivabradine Accord work?
Croatian: Kako djeluje Ivabradin Accord?
English: Salmon-coloured, triangular shaped, approximately 7.30 mm in length, 6.769 mm in width, film-coated tablets debossed with “FK” on one side and “1” on other side.
Croatian: Trokutasta filmom obložena tableta boje lososa, dužine približno 7,30 mm i širine 6,769 mm, s utisnutom oznakom „FK“ na jednoj strani i „1“ na drugoj.
English: Ivabradine Accord 7.5 mg film-coated tablets EU/1/17/1190/008
Croatian: Ivabradin Accord 7,5 mg filmom obložene tablete EU/1/17/1190/008
English: Acute myocardial infarction
Croatian: Akutni infarkt miokarda
English: In a 1277-patients randomised placebo-controlled study, ivabradine demonstrated a statistically significant additional efficacy on response to treatment (defined as a decrease of at least 3 angina attacks per week and/or an increase in the time to 1 mm ST segment depression of at least 60 s during a treadmill ETT) on top of amlodipine 5 mg o.d. or nifedipine GITS 30 mg o.d. at the trough of drug activity (12 hours after oral ivabradine intake) over a 6-week treatment period (OR = 1.3, 95% CI [1.0-1.7]; p=0.012).
Croatian: U randomiziranom, placebom kontroliranom ispitivanju na 1277 bolesnika, primjena ivabradina uz postojeću primjenu amlodipina od 5 mg jednom dnevno ili nifedipina GITS (gastrointestinalni terapijski sustav) od 30 mg jednom dnevno pri najnižoj koncentraciji lijeka (12 sati nakon uzimanja ivabradina peroralno) pokazala je statistički značajnu dodatnu djelotvornost u odgovoru na liječenje (definiran kao smanjenje od najmanje 3 napadaja angine na tjedan i/ili povećanje vremena do depresije ST segmenta za 1 mm od najmanje 60 s za vrijeme testa opterećenja) tijekom 6 tjedana liječenja (omjer šansi (OR) = 1,3, 95% CI [1,0-1,7]; p=0,012).
English: 0.5% of patients experienced a severe bradycardia below or equal to 40 bpm.
Croatian: 0,5% bolesnika imalo je tešku bradikardiju s brojem otkucaja u minuti ispod ili jednako
English: Lactose anhydrous Magnesium stearate (E470b) Starch, pregelatinised (maize) Silica, colloidal hydrated (E551)
Croatian: Jezgra laktoza, bezvodna magnezijev stearat (E470b) škrob, prethodno geliran (kukuruzni) silicijev dioksid, koloidni, hidratizirani (E551)
English: Other secondary endpoints: - All cause death - Death from HF - Hospitalisation for any cause - Hospitalisation for CV reason
Croatian: Drugi sekundarni ishodi: - smrt zbog svih uzroka - smrt zbog zatajenja srca - hospitalizacija zbog bilo kojeg 1231 (37,98) uzroka - hospitalizacija zbog KV uzroka 977 (30,15)
English: In the subgroup of patients with HR ≥ 75 bpm and on the recommended target dose of beta-blocker, no statistically significant benefit was observed on the primary composite endpoint (hazard ratio: 0.97, 95%CI [0.74;1.28]) and other secondary endpoints, including hospitalisation for worsening heart failure (hazard ratio: 0.79, 95% CI [0.56;1.10]) or death from heart failure (hazard ratio: 0.69, 95% CI [0.31;1.53]).
Croatian: U podskupini bolesnika sa srčanom frekvencijom ≥ 75/min koji primaju preporučenu ciljnu dozu beta-blokatora nije zabilježena značajna korist za primarni kompozitni ishod (omjer hazarda (HR): 0,97, 95%CI [0,74;1,28]) niti za ostale sekundarne ishode uključujući hospitalizaciju zbog pogoršanja zatajenja srca (omjer hazarda (HR): 0,79, 95% CI [0,56;1,10]) ili smrt zbog zatajenja srca (omjer hazarda (HR): 0,69, 95% CI [0,31;1,53]).
English: What Ivabradine Accord looks like and contents of the pack Ivabradine Accord 5 mg film-coated tablets are salmon-coloured, oblong shaped ,film-coated tablets scored on both sides, debossed with “FK” on one side and “2” on other side.
Croatian: Kako Ivabradin Accord izgleda i sadržaj pakiranja Ivabradin Accord 5 mg filmom obložene tablete su duguljaste filmom obložene tablete boje lososa s razdjelnom crtom na obje strane, s utisnutom oznakom „FK“ na jednoj strani i „2“ na drugoj strani.
English: Combination with strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin per os, josamycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone (see sections 4.5 and 5.2)
Croatian: Istodobna primjena s inhibitorima citokroma P450 3A4 kao što su azolni antimikotici (ketokonazol, itrakonazol), makrolidni antibiotici (klaritromicin, eritromicin per os, jozamicin, telitromicin), inhibitori proteaze HIV-a (nelfinavir, ritonavir) i nefazodon (vidjeti dijelove 4.5 i 5.2)
English: Do not take Ivabradine Accord if you are breast-feeding (see “Do not take Ivabradine Accord”).
Croatian: Ne uzimajte Ivabradin Accord ako dojite (vidjeti “Nemojte uzimati Ivabradin Accord”).
English: The environmental risk assessment of ivabradine has been conducted in accordance to European guidelines on ERA.
Croatian: Procjena rizika za okoliš (ERA) Procjena rizika koji ivabradin može imati na okoliš provedena je u skladu s Europskim smjernicama o procjeni rizika koji lijek može imati na okoliš.
English: How to take Ivabradine Accord
Croatian: Kako uzimati Ivabradin Accord
English: Do not take Ivabradine Accord - if you are allergic to ivabradine or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati Ivabradin Accord - ako ste alergični na ivabradin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.); - ako Vam je srčana frekvencija u mirovanju prije liječenja prespora (manje od 70
English: They can also be described as a halo, coloured flashes, image decomposition or multiple images.
Croatian: Mogu se također opisati kao aureola, raznobojni bljeskovi,
English: 5 How to store Ivabradine Accord 6.
Croatian: Kako čuvati Ivabradin Accord 6.
English: Ivabradine Accord 7.5 mg film-coated tablets are salmon-coloured, triangular shaped, film-coated tablets debossed with “FK” on one side and “1”on other side.
Croatian: Ivabradin Accord 7,5 mg filmom obložene tablete su trokutaste filmom obložene tablete boje lososa s utisnutom oznakom „FK“ na jednoj strani i „1“ na drugoj strani.
English: This increase in heart rate can cause the chest pain in people who suffer from angina.
Croatian: U ljudi koji boluju od angine, to povećanje srčane frekvencije može uzrokovati bol u prsnom košu.
English: OTHER
Croatian: Ili
English: 56x1 film-coated tablets
Croatian: 56x1 filmom obložena tableta
English: Polyvinyl alcohol (E1203) Titanium dioxide (E171) Macrogol 4000
Croatian: Film ovojnica poli(vinilni alkohol) (E1203) titanijev dioksid (E171) makrogol 4000 talk (E553b) željezov oksid, žuti (E172) željezov oksid, crveni (E172)
English: Excipient with known effect: Each 7.5 mg film-coated tablet contains 108 mg lactose (as anhydrous).
Croatian: Pomoćna tvar s poznatim učinkom: Jedna filmom obložena tableta od 7,5 mg sadrži 108 mg laktoze (bezvodne).
English: QT prolonging medicinal products - Cardiovascular QT prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol,
Croatian: Lijekovi koji produljuju QT-interval - Kardiovaskularni lijekovi koji produljuju QT-interval (npr. kinidin, disopiramid, bepridil,
English: Ivabradine Accord 7.5 mg film-coated tablets
Croatian: Ivabradin Accord 7,5 mg filmom obložene tablete
English: How to store Ivabradine Accord
Croatian: Kako čuvati Ivabradin Accord
English: Ivabradine has low affinity for CYP3A4, shows no clinically relevant CYP3A4 induction or inhibition and is therefore unlikely to modify CYP3A4 substrate metabolism or plasma concentrations.
Croatian: Ivabradin ima nizak afinitet za CYP3A4, ne pokazuje klinički relevantnu CYP3A4
English: 98x1 film-coated tablets
Croatian: 98x1 filmom obložena tableta
English: Excipient with known effect: Each 5 mg film-coated tablet contains 72 mg lactose (as anhydrous).
Croatian: Pomoćna tvar s poznatim učinkom: Jedna filmom obložena tableta od 5 mg sadrži 72 mg laktoze (bezvodne).
English: 84x1 film-coated tablets
Croatian: 84x1 filmom obložena tableta
English: Salmon-coloured, oblong shaped, approximately 8.50 mm in length, 4.50 mm in width, film-coated tablets scored on both sides, debossed with “FK” on one side and “2” on other side.
Croatian: Ivabradin Accord 5 mg filmom obložene tablete Duguljaste filmom obložene tablete boje lososa, dužine približno 8,50 mm i širine 4,50 mm, s razdjelnom crtom na obje strane, s utisnutom oznakom „FK“ na jednoj strani i „2“ na drugoj.
English: 28x1 film-coated tablets
Croatian: 28x1 filmom obložena tableta
English: Pacemaker dependent (heart rate imposed exclusively by the pacemaker) Unstable angina
Croatian: Bolesnici s ugrađenim elektrostimulatorom (broj otkucaja srca isključivo ovisi o pacemakeru)
English: 14x1 film-coated tablets
Croatian: 14x1 filmom obložena tableta
English: Combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties (see section 4.5)
Croatian: Istodobna primjena s verapamilom ili diltiazemom koji su umjereni inhibitori CYP3A4 s učinkom na smanjenje srčane frekvencije (vidjeti dio 4.5) Trudnoća, dojenje i žene reproduktivne dobi koje ne koriste prikladne mjere kontracepcije (vidjeti dio 4.6)
English: Hypotension, possibly related to bradycardia
Croatian: Hipotenzija, moguće povezana s bradikardijom
English: One film-coated tablet contains 5 mg ivabradine (as hydrochloride) One film-coated tablet contains 7.5 mg ivabradine (as hydrochloride)
Croatian: Jedna filmom obložena tableta sadrži 5 mg ivabradina (u obliku ivabradinklorida) Jedna filmom obložena tableta sadrži 7,5 mg ivabradina (u obliku ivabradinklorida)
English: Ivabradine Accord 5 mg film-coated tablets Ivabradine Accord 7.5 mg film-coated tablets ivabradine
Croatian: Ivabradin Accord 5 mg filmom obložene tablete Ivabradin Accord 7,5 mg filmom obložene tablete ivabradin
English: Ivabradine Accord 5 mg: one film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Croatian: Ivabradin Accord 5 mg: jedna filmom obložena tableta sadrži 5 mg ivabradina (u obliku ivabradinklorida).
English: Ivabradine Accord 7.5 mg: one film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
Croatian: Ivabradin Accord 7,5 mg: jedna filmom obložena tableta sadrži 7,5 mg ivabradina (u obliku ivabradinklorida).
English: - Hypericum perforatum or St John's Wort (herbal treatment for depression) - QT prolonging medicines to treat either heart rhythm disorders or other conditions : - quinidine, disopyramide, ibutilide, sotalol, amiodarone (to treat heart rhythm disorders) - bepridil (to treat angina pectoris) - certain types of medicines to treat anxiety, schizophrenia or other psychoses (such as pimozide,
Croatian: Ako uzimate neke od slijedećih lijekova, svakako o tome obavijestite svog liječnika koji bi trebao prilagoditi dozu Ivabradin Accorda ili pratiti liječenje: - flukonazol (antifungik) - rifampicin (antibiotik) - barbiturati (za otežano spavanje ili epilepsiju) - fenitoin (za epilepsiju) - Hypericum perforatum ili Gospina trava (biljna terapija za depresiju) - lijekovi koji produljuju QT-interval i primjenjuju se za liječenje poremećaja srčanog ritma ili drugih bolesti: - kinidin, dizopiramid, ibutilid, sotalol, amiodaron (za liječenje poremećaja srčanog ritma) - bepridil (za liječenje angine pektoris) - lijekovi za liječenje anksioznosti, shizofrenije ili drugih psihoza (kao što su pimozid, ziprasidon, sertindol) - antimalarici (kao npr. meflokin ili halofantrin) - intravenski eritromicin (antibiotik) - pentamidin (antiparazitik) - cisaprid (za liječenje gastro-ezofagealnog refluksa) - Neke vrste diuretika koji mogu uzrokovati sniženje razine kalija u krvi, poput furosemida, hidroklorotiazida, indapamida (koriste se za liječenje edema, povišenog krvnog tlaka).
English: Ivabradine Accord 5 mg film-coated tablets Ivabradine Accord 7.5 mg film-coated tablets
Croatian: Ivabradin Accord 5 mg filmom obložene tablete Ivabradin Accord 7,5 mg filmom obložene tablete
English: Ivabradine Accord 5 mg film-coated tablets One film-coated tablet contains 5 mg ivabradine (as hydrochloride).
Croatian: Ivabradin Accord 5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 5mg ivabradina (u obliku ivabradinklorida).
English: Ivabradine Accord 7.5 mg film-coated tablets One film-coated tablet contains 7.5 mg ivabradine (as hydrochloride).
Croatian: Ivabradin Accord 7,5 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 7,5 mg ivabradina (u obliku ivabradinklorida).
English: Stroke
Croatian: Apsorpcija
English: A 20% heart rate reduction, without bradycardia, was achieved by 69.9% of patients in the ivabradine group versus 12.2% in the placebo group during the titration period of 2 to 8 weeks (Odds Ratio: E = 17.24, 95% CI [5.91 ; 50.30]).
Croatian: U 69,9% bolesnika koji su primali ivabradin postignuto je 20% sniženje broja otkucaja srca bez bradikardije u usporedbi s 12,2% bolesnika u skupini koja je primala placebo tijekom titracije doza u razdoblju od 2 do 8 tjedana (omjer izgleda E = 17,24, 95% CI [5,91; 50,30]) Srednje doze ivabradina koje su omogućile postizanje sniženje broja otkucaja srca za 20% su 0,13 ± 0,04 mg/kg/dan dva puta na dan, 0,10 ± 0,04 mg/kg/dan dva puta na dan i 4,1 ± 2,2 mg dva puta na dan u starosnim podskupinama [1-3] godine, [3-18] godina i s <40 kg te [3-18] godina i s ≥ 40 kg.
English: Talk to your doctor or pharmacist before taking Ivabradine Accord - if you suffer from heart rhythm disorders (such as irregular heartbeat, palpitation, increase in chest pain) or sustained atrial fibrillation (a type of irregular heartbeat), or an abnormality of electrocardiogram (ECG) called ‘long QT syndrome', - if you have symptoms such as tiredness, dizziness or shortness of breath (this could mean that your heart is slowing down too much), - if you suffer from symptoms of atrial fibrillation (pulse rate at rest unusually high (over 110 beats per minute) or irregular, without any apparent reason, making it difficult to measure), - if you have had a recent stroke (cerebral attack), - if you suffer from mild to moderate low blood pressure, - if you suffer from uncontrolled blood pressure, especially after a change in your antihypertensive treatment, - if you suffer from severe heart failure or heart failure with abnormality of ECG called ‘bundle branch block', - if you suffer from chronic eye retinal disease, - if you suffer from moderate liver problems, - if you suffer from severe renal problems.
Croatian: otkucaja u minuti) ili nepravilan, bez jasnog razloga, što otežava njegovo mjerenje), - ako ste nedavno imali moždani udar, - ako imate blago ili umjereno niski krvni tlak, - ako bolujete od visokog krvnog tlaka koji nije dobro kontroliran, osobito nakon promjene u terapiji - ako bolujete od teškog kroničnog srčanog zatajenja ili srčanog zatajenja s abnormalnošću
English: Ivabradine efficacy was fully maintained throughout the 3- or 4-month treatment periods in the efficacy trials.
Croatian: U ispitivanjima djelotvornosti, ivabradin se pokazao učinkovit tijekom perioda liječenja u trajanju od
English: Breast-feeding
Croatian: Bradikardija
English: nd degree
Croatian: Rok valjanosti
English: Once the container has been opened, the contents should be used immediately.
Croatian: Nakon otvaranja spremnika, sadržaj treba upotrijebiti odmah.
English: Follow all of your doctor's instructions carefully.
Croatian: Pažljivo se pridržavajte liječnikovih uputa.
English: However, in the case of an overdose, you will receive the appropriate treatment.
Croatian: Međutim, u slučaju predoziranja, primit ćete odgovarajuće liječenje.
English: The following information is intended for the healthcare specialist charged with your care.
Croatian: Sljedeće informacije namijenjene su zdravstvenim radnicima koji su zaduženi za skrb o vama.
English: The safety and efficacy of LysaKare in children less than 18 years have not been established.
Croatian: Sigurnost i djelotvornost lijeka LysaKare u djece mlađe od 18 godina nije ustanovljena.
English: You will not have to store this medicine.
Croatian: Ne morate čuvati ovaj lijek.
English: The frequencies are categorised as follows: 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 (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalosti su klasificirane na sljedeći način: 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 (<1/10 000) te nije poznato (ne može se procijeniti iz dostupnih podataka).
English: It is therefore unlikely that you will receive more of the infusion than you should as your doctor will monitor you during the treatment.
Croatian: Stoga nije vjerojatno da ćete primiti više infuzije nego što biste trebali jer će vaš liječnik pratiti vaše liječenje.
English: This medicine should not be given to children and adolescents under 18 years old because it is not known whether it is safe and effective in this age group.
Croatian: Ovaj se lijek ne primjenjuje u djece i adolescenata mlađih od 18 godina jer nije poznato je li siguran i djelotvoran u ovoj dobnoj skupini.
English: Do not reconnect partially used bags.
Croatian: Nemojte ponovno spajati djelomično iskorištene vrećice.
English: According to limited available data maximum levels should be reached approximatively by 4 to 5 hours after start of the infusion and should return to normal levels by 24 hours.
Croatian: Prema ograničenim dostupnim podacima, maksimalne razine trebale bi se doseći otprilike 4 do 5 sati nakon početka infuzije te bi se trebale vratiti na normalne razine za 24 sata.
English: This may indicate that the product is unstable or that the solution has become contaminated.
Croatian: To može značiti da je lijek nestabilan ili da je otopina postala kontaminirana.
English: The correct storage, use and disposal of this medicine are under the responsibility of the specialist in appropriate premises.
Croatian: Ispravno čuvanje, uporaba i zbrinjavanje ovog lijeka odgovornost su specijaliste u odgovarajućim ustanovama.
English: What you need to know before you take LysaKare 3.
Croatian: Što morate znati prije nego primite LysaKare 3.
English: Follow your doctor's advice on how much fluid to drink on the day of your treatment so you stay well hydrated.
Croatian: Pridržavajte se savjeta svog liječnika o količini tekućine koju trebate popiti na dan primjene lijeka tako da ostanete dobro hidrirani.
English: Not known (frequency cannot be estimated from the available data):
Croatian: • mučnina i povraćanje Nepoznato (učestalost se ne može procijeniti iz dostupnih podataka):
English: An ECG should be performed prior to discharging the patient.
Croatian: Potrebno je napraviti EKG prije nego se bolesnik otpusti.