FrancophonIA/ELRC3.0 huggingface dataset:
English: Currently available data are described in section 5.1 but no recommendation or posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelu 5.1, međutim nije moguće dati preporuku o doziranju.
English: Other medicines and INOmax
Croatian: Drugi lijekovi i INOmax
English: The prospectively defined primary endpoint was the receipt of ECMO.
Croatian: Prospektivno definiran primarni krajnji ishod bilo je uvođenje ECMO.
English: Prior to launch of the new indication of the product in each Member State, the Marketing Authorisation Holder shall agree the content and format of the educational material with the national competent authority.
Croatian: Prije pokretanja nove indikacije za lijek u svakoj od država članica, nositelj odobrenja dogovorit će sadržaj i oblik edukacijskog materijala s nadležnim nacionalnim tijelima.
English: The duration of therapy is variable, but typically less than four days.
Croatian: Trajanje liječenja može biti različito, ali obično je kraće od četiri dana.
English: Follow-up exams at 18-24 months of age were similar between the two groups with respect to mental, motor, audiologic, and neurologic evaluations.
Croatian: Kontrolni pregledi u dobi od 18 do 24 mjeseca bili su slični u obje skupine u smislu procjene mentalnih, motoričkih, audioloških i neuroloških funkcija.
English: In case of insufficient response the dose may be titrated after a minimum of 10 minutes.
Croatian: U slučaju nezadovoljavajućeg odgovora doza se može titrirati nakon najmanje 10 minuta.
English: Hypoxia b,d
Croatian: Hipotenzijaa,b,d
English: Ask your doctor or pharmacist for advice before taking any medicine.
Croatian: Obratite se liječniku ili ljekarniku prije uzimanja bilo kakvih lijekova.
English: The adverse events collected occurred at similar incidence rates in both groups.
Croatian: Zabilježene nuspojave pojavljivale su se u sličnom broju u obje skupine.
English: This leaflet was last revised in MM/YYYY.
Croatian: Ova uputa je zadnji put revidirana MM/GGGG.
English: Bradycardiab (following abrupt discontinuation of therapy)
Croatian: Bradikardijab (nakon naglog prekida terapije)
English: However, therapy with INOmax may last longer.
Croatian: Međutim, liječenje INOmax-om može trajati i dulje.
English: Marketing Authorisation Holder and Manufacturer
Croatian: Nositelj odobrenja za stavljanje u promet i proizvođač
English: What you need to know before you begin a treatment with INOmax
Croatian: Što morate znati prije nego počne liječenje INOmax-om
English: The frequency and number of adverse events were similar in the two study groups.
Croatian: Učestalost i broj nuspojava bili su slični u obje ispitivane skupine.
English: However, the presence of nitrogen dioxide and moisture creates an aggressive atmosphere.
Croatian: Međutim, prisutnost dušikovog dioksida i vlage stvara agresivnu atmosferu.
English: - If you (as the patient) or your child (as the patient) are allergic (hypersensitive) to nitric oxide or any other ingredients of INOmax.
Croatian: Obavijestite svog liječnika ako Vi (kao bolesnik) ili Vaše dijete (kao bolesnik) uzimate ili ste nedavno uzimali bilo koje druge lijekove, uključujući one koji se nabavljaju bez recepta.
English: Your doctor will take care to check that the blood can carry enough oxygen when you are taking these medicines.
Croatian: Vaš će liječnik provjeriti prenosi li krv dovoljno kisika tijekom uzimanja tih lijekova.
English: Pack sizes:
Croatian: Veličine pakiranja:
English: Pharmacotherapeutic group: Other respiratory system products, ATC code R07AX01.
Croatian: Farmakoterapijska skupina: Drugi lijekovi za respiratorni sustav, ATK oznaka R07AX01.
English: The overall number of death at week 36 was slightly higher in the iNO group; 53/395 (13.4 %) as compared to control 42/397 (10.6 %).
Croatian: Ukupni broj smrtnih ishoda u 36. tjednu bio je neznatno viši u skupini koja je dobivala iNO; 53/395 (13,4%) u usporedbi s kontrolnom skupinom 42/397 (10,6%).
English: BRAILLE Justification for not including Braille accepted
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma
English: Consideration should be given to discontinuation of treatment if no beneficial physiological effects are apparent after a 30-minute trial of therapy.
Croatian: Potrebno je razmotriti prekid terapije ako nema primjetnih korisnih fizioloških učinaka 30 minuta nakon primjene lijeka.
English: The combined used with other vasodilators (e.g. sildenafil) is not extensively studied.
Croatian: Kombinirana primjena s drugim vazodilatatorima (npr. sildenafil) nije detaljnije ispitivana.
English: From a corrosion point of view the supply system can be divided into two zones: 1) From the gas cylinder valve to the humidifier (dry gas) and 2) From the humidifier to outlet (moist gas which may contain NO2).
Croatian: U pogledu korozije sustav za dopremu može se podijeliti u dvije zone: 1) od spremnika za plin do ovlaživača (suhi plin) i 2) od ovlaživača do izlaza (vlažni plin koji može sadržavati NO2).
English: There is in general no need for scavenging of excess gas, the work place ambient air quality should however be considered and trace concentrations of NO or NO2/NOx must not exceed set national occupational exposure limits.
Croatian: Općenito nema potrebe za čišćenjem suvišnog plina, ali se mora uzeti u obzir kvaliteta zraka na radnom mjestu, a koncentracije NO ili NO2/NOx u tragovima ne smiju premašivati ograničenja postavljena u propisima u okviru nacionalnog radnog zakonodavstva.
English: Special patient populations
Croatian: Posebne populacije bolesnika
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: 77772828 ή +357-22482330
Croatian: Τηλ. 77772828 ή +357-22482330
English: A particular attention should be also turned to the fastening of the pressure regulator so as to avoid the risks of accidental failures.
Croatian: Posebna pažnja također se mora posvetiti učvršćenju regulatora tlaka kako bi se izbjegla opasnost slučajnog zatajenja rada uređaja.
English: Date of last renewal: 01/06/2006
Croatian: Datum posljednje obnove odobrenja: 01.06.2006.
English: Pregnancy and breastfeeding
Croatian: Trudnoća i dojenje
English: INOmax should be used in ventilated newborn infants expected to require support >24 hours.
Croatian: INOmax treba koristiti u ventilirane novorođenčadi koja će trebati potpomognutu ventilaciju >24 sata.
English: Butyl rubber, polyamide, and polyurethane should not be used.
Croatian: Ne smiju se koristiti butilna guma, poliamid i poliuretan.
English: The concentrations of methaemoglobin in the blood should be monitored, see section 4.2.
Croatian: Potrebno je pratiti koncentracije methemoglobina u krvi, vidjeti dio 4.2.
English: Side effects that may be seen but the frequency is not known (frequency cannot be estimated from the available data) are:
Croatian: Nuspojave koje se mogu primijetiti, ali njihova učestalost nije poznata (učestalost se ne može utvrditi iz dostupnih podataka) su sljedeće:
English: PHARMACEUTICAL FORM Inhalation gas.
Croatian: OBLIK Plin inhalata.
English: Manufacturer Linde France Z.I.
Croatian: Linde France Z.I.
English: Most of it traverses the pulmonary capillary bed where it combines with haemoglobin that is 60 % to 100 % oxygen-saturated.
Croatian: Veći dio prelazi u plućnu kapilarnu mrežu, gdje se veže s hemoglobinom koji je zasićen kisikom od 60% do 100%.
English: Storage is supervised by the specialists at the hospital.
Croatian: Skladištenje mora nadzirati stručno osoblje u bolnici.
English: Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizicima, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: In the pivotal clinical trials, the starting dose was 20 ppm.
Croatian: U pivotalnim kliničkim ispitivanjima početna je doza bila 20 ppm.
English: Elevated NO2 may cause acute lung injury.
Croatian: Povećani NO2 može prouzročiti akutno oštećenje pluća.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Of the 97 patients treated with INOmax, 2(2 %) were withdrawn from study drug due to methaemoglobin levels >4 %.
Croatian: Od 97 bolesnika koji su dobivali INOmax, 2 (2%) povučeno je iz ispitivanja zbog razina methemoglobina >4%.
English: Attempts to wean INOmax should be made after the ventilator support is substantially decreased or after 96 hours of therapy.
Croatian: Odvikavanje od INOmax-a potrebno je pokušati nakon značajnog smanjenja primjene ventilacijske potpore ili nakon 96 sati liječenja.
English: Treatment may be initiated at any time point in the peri-operative course to lower pulmonary pressure.
Croatian: Liječenje se može započeti u bilo kojem trenutku tijekom perioperativnog razdoblja kako bi se smanjio plućni tlak.
English: Empty gas cylinders will be collected by the supplier.
Croatian: Prazne spremnike za plin prikuplja dobavljač.
English: Treatment with INOmax should not be stopped suddenly.
Croatian: Liječenje INOmax-om ne smije se naglo prekidati.
English: The European Medicines Agency has waived the obligation to submit the results of studies with INOmax in all subsets of the paediatric population in persistent pulmonary hypertension and other pulmonary heart disease.
Croatian: Europska agencija za lijekove izuzela je obvezu dostavljanja rezultata ispitivanja INOmax-a na svim podskupinama pedijatrijske populacije za trajnu pulmonalnu hipertenziju i druge pulmonalne srčane bolesti.
English: If you get any side effects, talk to your doctor or pharmacist or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ili ljekarnika ili medicinsku sestru.
English: What INOmax contains
Croatian: Što INOmax sadrži
English: Significantly fewer neonates in the INOmax group required ECMO compared to the control group (31 % vs. 57 %, p<0.001).
Croatian: ECMO je bio potreban značajno manjem broju novorođenčadi u skupini s INOmax-om u usporedbi s kontrolnom skupinom (31% u usporedbi s 57%, p<0,001).
English: The Marketing Authorisation Holder (MAH) should ensure that, at launch of the new indication, all Healthcare Professionals who are expected to use and/or prescribe INOmax as part of the treatment of peri- or post- operative pulmonary hypertension in adults and children in conjunction to heart surgery are provided with an Educational pack.
Croatian: Nositelj odobrenja mora osigurati da prilikom pokretanja nove indikacije svi zdravstveni radnici za koje se očekuje da će koristiti i/ili propisivati INOmax kao dio liječenja perioperativne ili postoperativne pulmonalne hipertenzije u odraslih i djece u vezi s operacijom srca dobiju edukacijski paket.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: The power supply for the monitoring equipment should be independent of the delivery device function.
Croatian: Napajanje opreme za praćenje mora biti neovisno o funkciji uređaja za dopremu plina.
English: Monitoring formation of nitrogen dioxide (NO2)
Croatian: Praćenje stvaranja dušikovog dioksida (NO2)
English: - the good condition of the material should be checked before use - the gas cylinders should be fixedly stowed away in order to avoid untimely fall - the valve should be fully open when used but not be opened with violence - a defective valve should neither be used nor be repaired.
Croatian: - prije upotrebe potrebno je provjeriti da je oprema u dobrom stanju - spremnici s plinom moraju biti fiksirani u okomitom položaju kako bi se izbjegla opasnost od pada - tijekom upotrebe ventil mora biti u potpunosti otvoren, ali se ne smije otvarati na silu - neispravan ventil ne smije se upotrebljavati niti popravljati.
English: In children and adults with high blood pressure in the lungs, connected with heart surgery, INOmax is usually given for 24-48 hours.
Croatian: Djeci i odraslim osobama s visokim krvnim tlakom u plućima povezanim s operacijom srca, INOmax se obično daje 24-48 sati.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: In clinical studies treatment was often initiated before separation from Cardio Pulmonary Bypass.
Croatian: U kliničkim ispitivanjima liječenje se često započinjalo prije odvajanja s kardiopulmonalne premosnice.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, even after you or your child leave the hospital, please tell your doctor.
Croatian: Ako se bilo koja nuspojava pogorša ili primijetite bilo kakve nuspojave koje nisu navedene u ovoj uputi o lijeku, čak i nakon otpuštanja iz bolnice, obratite se svojem liječniku.
English: Your or your child's doctor will undertake monitoring of nitrogen dioxide and in case of elevated values the INOmax therapy will be adjusted, decreased accordingly.
Croatian: Vaš liječnik ili liječnik Vašeg djeteta pratit će vrijednosti dušikovog dioksida i, u slučaju povećanih vrijednosti, na odgovarajući način prilagoditi odnosno smanjiti dozu
English: Higher exposures have not been investigated.
Croatian: Više razine izloženosti nisu ispitane.
English: At the end of treatment, the doctor will slowly lower the amount of INOmax being given to you or your child, so that the circulation in the lungs is able to adjust to oxygen/air without INOmax.
Croatian: Na kraju liječenja liječnik će postupno smanjiti količinu INOmax-a koju primate Vi ili Vaše dijete kako bi se cirkulacija u plućima mogla prilagoditi kisiku/zraku bez INOmax-a.
English: The overall occurrence of intraventricular haemorrhage was 114 (28.9 %) among the iNO treated as compared to 91 (22.9 %) among the control neonates.
Croatian: Ukupna incidencija intraventrikularnog krvarenja bila je 114 (28,9%) u skupini koja je dobivala iNO u usporedbi s 91 (22,9%) u kontrolnoj skupini novorođenčadi.
English: If it is judged that clinical response is inadequate at 4-6 hours after starting INOmax, the following should be considered.
Croatian: U slučaju neadekvatnog odgovora 4-6 sati nakon uvođenja INOmax-a, potrebno je razmotriti sljedeće.
English: Discontinuation of therapy
Croatian: Prekid terapije
English: INOmax is given in dose of 10 to 20 ppm, (maximal dose 20 ppm in children and 40 ppm in adults) part per million of the gas that you or your child inhale.
Croatian: INOmax se primjenjuje u dozama od 10 do 20 ppm, (maksimalna doza za djecu je 20 ppm, a za odrasle 40 ppm) što označava broj dijelova na milijun, plina koji Vi ili Vaše dijete udišete.
English: Side effects that may be seen, but uncommonly (affects between 1 user in 100 and 1 user in 1000) are: increase in methaemoglobin, thus reduced oxygen carrying capacity.
Croatian: Nuspojave koje se mogu primijetiti, ali nisu česte (pojavljuju se između 1 na 100 korisnika i 1 na 1000 korisnika) su sljedeće: povećanje methemoglobina, čime se smanjuje sposobnost prenošenja kisika.
English: Do not use INOmax
Croatian: Nemojte koristiti INOmax
English: The average time to reach peak methaemoglobin was 10 ± 9 (SD) hours (median, 8 hours) in these 13 patients; but one patient did not exceed 7 % until 40 hours.
Croatian: Prosječno vrijeme postizanja vršne razine methemoglobina bilo je 10 ± 9 (SD) sati (medijan, 8 sati) u tih 13 bolesnika; jedan bolesnik, međutim, nije premašio vrijednost od 7% do 40 sati.
English: All gas cylinders should be returned to the supplier for disposal.
Croatian: Svi spremnici za plin moraju se vratiti dobavljaču radi zbrinjavanja.
English: The upper limit of exposure (mean exposure) to nitric oxide for personnel defined by worker's legislation is 25 ppm for 8 hours (30 mg/m3) in most countries and the corresponding limit for NO2 is 2-3 ppm (4-6 mg/m3).
Croatian: Gornja granična vrijednost izlaganja (srednja vrijednost izlaganja) dušikovom (II) oksidu na radnom mjestu je definirana zakonom i u većini zemalja iznosi 25 ppm tijekom 8 sati (30 mg/m3), a odgovarajuća granična vrijednost za NO2 iznosi 2-3 ppm (4-6 mg/m3).
English: These include prilocaine (a local anaesthetic used for pain relief in association to minor painful procedures e.g. suturing, and minor surgical or diagnostic procedures) or glyceryl trinitrate (used to treat chest pain).
Croatian: To su prilokain (lokalni anestetik koji se koristi za ublažavanje bolova pri manje bolnim zahvatima, npr. šivanje te manji kirurški ili dijagnostički postupci) ili gliceril trinitrat (koji se koristi za liječenje bolova u prsima).
English: Clinical data supporting the suggested dose in the age range 12-17 years is limited.
Croatian: Postoje ograničeni podaci o doziranju za djecu u dobi od 12 do 17 godina.
English: If you see any signs or symptoms that may be associated to bleeding you should directly inform the doctor.
Croatian: Ako primijetite bilo kakve znakove ili simptome koji mogu biti povezani s krvarenjem,
English: Methaemoglobin levels > 7 % were attained only in patients receiving 80 ppm, where they comprised 35 % of the group.
Croatian: > 7% postignute su samo u bolesnika koji su dobivali dozu od 80 ppm, gdje su činile 35% skupine.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Ensure that the parent or guardian has read and is aware of the indications and cautions presented in the package leaflet prior to administration to their baby.
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Roditelj ili skrbnik mora pročitati Uputu o lijeku i biti svjestan navedenih indikacija i upozorenja prije primjene na djetetu.
English: INOmax contains Nitrogen
Croatian: INOmax sadrži dušik
English: No difference in the incidence of IVH or death was however observed in this study.
Croatian: U tom ispitivanju, međutim, nije bilo razlike u incidenciji IVH ili smrtnih ishoda.
English: INOmax has been safely administered with tolazoline, dopamine, dobutamine, steroids, surfactant, and high-frequency ventilation.
Croatian: INOmax je sigurno primijenjen zajedno s tolazolinom, dopaminom, dobutaminom, steroidima, surfaktantima i visokofrekventnom ventilacijom.
English: Pulmonary hypertension associated with heart surgery INOmax should be used only after conservative support has been optimised.
Croatian: Plućna hipertenzija povezana sa srčanim operacijama INOmax treba primjenjivati tek nakon optimizacije konzervativne potpore.
English: Nitric oxide is absorbed systemically after inhalation.
Croatian: oksid apsorbira se sistemski nakon inhalacije.
English: The doctor will decide when to treat you or your child with INOmax and with other medicines, and will carefully supervise the treatment.
Croatian: Liječnik će odlučiti kada Vi ili Vaše dijete trebate dobivati INOmax i druge lijekove te će pažljivo nadzirati liječenje.
English: INOmax appears to increase the partial pressure of arterial oxygen (PaO2) by dilating pulmonary vessels in better ventilated areas of the lung, redistributing pulmonary blood flow away from lung regions with low ventilation/perfusion (V/Q) ratios toward regions with normal ratios.
Croatian: Čini se da INOmax povećava parcijalni arterijski tlak kisika (PaO2) širenjem plućnih krvnih žila u bolje ventiliranim područjima pluća, redistribucijom plućne cirkulacije iz područja pluća s niskim omjerom ventilacije/perfuzije (V/Q) prema područjima s normalnim omjerima.
English: Regular monitoring of haemostasis and measurement of bleeding time is recommended during the administration of INOmax for more than 24 hours to patients with functional or quantitative platelet anomalies, a low coagulation factor or receiving anticoagulation treatment.
Croatian: Redovito praćenje hemostaze i mjerenje trajanja krvarenja preporučuje se tijekom davanja INOmax-a dulje od 24 sata bolesnicima s funkcionalnim ili kvantitativnim anomalijama trombocita, niskim faktorima zgrušavanja ili bolesnicima na antikoagulacijskoj terapiji.
English: INOmax therapy should only be used and handled by hospital personnel.
Croatian: Lijek INOmax smije primjenjivati i njime rukovati samo bolničko osoblje.
English: The displayed frequency categories use the following convention: 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), not known (cannot be estimated from the available data).
Croatian: vrlo često (≥1/10), često (≥1/100 do <1/10), manje često (≥1/1000 do <1/100), rijetko (≥1/10 000 do <1/1000), vrlo rijetko (<1/10 000), nepoznato (nije moguća procjena iz dostupnih podataka).
English: INOmax is not recommended for use during pregnancy and breastfeeding.
Croatian: INOmax se ne preporučuje tijekom trudnoće i dojenja.
English: Cylinders equipped with a standard valve hand-wheel cannot be used with the INOmax DSIR delivery system.
Croatian: Spremnici sa standardnom ručicom ventila ne mogu se upotrebljavati sa sustavom za dopremu INOmax DSIR.
English: The objective of this double-blind, randomised, placebo controlled trial was to determine whether inhaled nitric oxide would reduce the occurrence of death and/or initiation of extracorporeal membrane oxygenation (ECMO).
Croatian: Cilj ovog randomiziranog dvostruko slijepog, placebom kontroliranog ispitivanja bilo je utvrditi bi li inhalacija dušikovog (II) oksida smanjila incidenciju smrtnih ishoda i/ili uvođenje ekstrakorporalne membranske oksigenacije (ECMO).
English: Persistent Pulmonary Hypertension in the Newborn (PPHN) The maximum recommended dose of INOmax is 20 ppm and this dose should not be exceeded.
Croatian: Perzistentna plućna hipertenzija novorođenčeta (PPHN) Maksimalna preporučena doza INOmax-a iznosi 20 ppm i ne smije se prekoračiti.
English: Before initiation of therapy, during set-up, secure that the device setting is in agreement with the cylinder gas concentration.
Croatian: Prije početka terapije, tijekom faze postavljanja, provjerite je li uređaj podešen u skladu s koncentracijom plina u spremniku za plin.
English: Prilocaine, whether administered as oral, parenteral, or topical formulations may cause methaemoglobinaemia.
Croatian: Prilokain, bez obzira na način primjene: oralnu, parenteralnu ili topikalnu, može prouzročiti methemoglobinemiju.
English: If you have any other questions on the use of this medicine, ask your doctor.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku.
English: The combined incidence of death and/or initiation of ECMO (the prospectively defined primary endpoint) showed a significant advantage for the nitric oxide treated group (46 % vs. 64 %, p=0.006).
Croatian: Ukupna incidencija smrtnih ishoda i/ili uvođenja ECMO (prospektivno definiran primarni krajnji ishod) pokazala je značajnu prednost skupine liječene dušikovim(II) oksidom (46% naspram 64%, p=0,006).