FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Privigen, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Croatian: Djelatna tvar u lijeku Privigen, ljudski normalni imunoglobulin, iznimno je pročišćena bjelančevina dobivena iz ljudske plazme (dijela krvi).
English: Privigen was not compared to other treatments in the studies.
Croatian: U tim ispitivanjima lijek Privigen nije uspoređen s drugim oblicima liječenja.
English: Privigen must not be used in people who are hypersensitive (allergic) to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Croatian: Privigen se ne smije primjenjivati u osoba koje su preosjetljive (alergične) na normalni ljudski imunoglobulin ili bilo koji drugi sastojak, ni u bolesnika koji su alergični na druge vrste imunoglobulina, posebice ako imaju nedostatak (vrlo niske razine) imunoglobulina A (IgA) i ako imaju protutijela protiv IgA.
English: What benefits of Privigen have been shown in studies?
Croatian: Koje su koristi od lijeka Privigen utvrđene u ispitivanjima?
English: How is Privigen used?
Croatian: Kako se Privigen primjenjuje?
English: Some side effects are more likely with a high rate of infusion, in patients with low immunoglobulin levels, or in patients who have not received human normal immunoglobulin before or for a long time.
Croatian: Vjerojatnije je da će pojedine nuspojave nastupiti prilikom primjene infuzije velikom brzinom u bolesnika s niskim razinama imunoglobulina ili u bolesnika koji prethodno ili tijekom dužeg razdoblja nisu primili ljudski normalni imunoglobulin.
English: Privigen must not be used in patients with hyperprolinaemia type I or II (a genetic disorder causing high levels of the amino acid proline in the blood).
Croatian: I ili II (genetski poremećaj koji uzrokuje visoke razine aminokiseline prolina u krvi).
English: Haemolysis (breakdown of red blood cells) is an uncommon side effect in patients given human normal immunoglobulin (occurring with less than 1 dose in 100).
Croatian: U bolesnika koji primaju ljudski normalni imunoglobulin pojavljuje se hemoliza (raspadanje crvenih krvnih stanica) kao manje česta nuspojava (javlja se u manje od 1 na 100 doza).
English: The dose and frequency of infusions (how often it is given) depend on the disease being treated.
Croatian: Doziranje i učestalost infuzija ovise o bolesti koja se liječi.
English: These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections.
Croatian: To mogu biti osobe koje su rođene s nedostatkom protutijela (sindrom primarne imunodeficijencije, PID) ili osobe koje su razvile nedostatak protutijela nakon rođenja (sindrom sekundarne imunodeficijencije, SID), koje imaju niske razine određenih protutijela (naziva IgG) i koje opetovano obolijevaju od ozbiljnih infekcija koje nisu izliječene lijekovima protiv infekcija;
English: For the full list of all side effects with Privigen, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Privigen potražite u uputi o lijeku.
English: O MA (EU) number (Invented) name
Croatian: Broj (EU) odobrenja (Zaštićeno) ime
English: However these data only gave limited safety information.
Croatian: No, ovi su podaci pružili samo ograničene sigurnosne informacije.
English: Overall safety conclusions
Croatian: Cjelokupni sigurnosni zaključci
English: During the period 2002-2012, a total of 210 cases including at least one adverse event after ritodrine treatment were reported.
Croatian: Tijekom razdoblja od 2002. do 2012. prijavljeno je ukupno 210 slučajeva, uključujući i najmanje jednu nuspojavu nakon liječenja ritodrinom.
English: For oral hexoprenaline there are very few safety data.
Croatian: Za oralni heksoprenalin postoji vrlo ograničeni broj sigurnosnih podataka.
English: The timetable for the implementation of the agreement is set out in Annex V.
Croatian: Raspored primjene sporazuma utvrđen je u Dodatku V.
English: c. All marketing authorisation holders should implement risk minimisation measures.
Croatian: c. Svi nositelji odobrenja trebaju primijeniti mjere za smanjivanje rizika.
English: Having reviewed the PRAC recommendation, the CMDh agreed with the overall scientific conclusions and grounds for recommendation.
Croatian: Nakon što je pregledao preporuku PRAC-a, CMDh se suglasio sa svim znanstvenim zaključcima i osnovama za preporuku.
English: Authorised obstetric indications for SABAs differ across Member States.
Croatian: Odobrene opstetrične indikacije za SABA-ove razlikuju se među državama članicama.
English: Approximately 9% of the 425 women in these trials were exposed to the oral formulation and approximately 2% of the reported adverse events were associated with the oral formulation of the drug.
Croatian: Otprilike 9% od 425 žena obuhvaćenih ovim ispitivanjima bilo je izloženo oralnoj formulaciji, a otprilike 2% je prijavilo nuspojave povezane s oralnom formulacijom lijeka.
English: Careful control of the level of hydration is essential to avoid the risk of maternal pulmonary oedema.
Croatian: Pažljiva kontrola razine hidratacije neophodna je za izbjegavanje rizika od pulmonalnog edema u majke.
English: In 10 clinical studies comprising 425 pregnant women, angina pectoris and arrhythmia were reported only in one case each.
Croatian: U 10 kliničkih ispitivanja koja su obuhvatila 425 trudnica, samo u jednom slučaju prijavljene su angina pektoris i aritmija.
English: Hungary considered it was in the interest of the Union to refer the matter to the PRAC and expressed concerns with regards to the posology and warnings reflected in the product information.
Croatian: Mađarska je zaključila da je u interesu Unije da se predmet uputi PRAC-u, te je izrazila svoju zabrinutost u vezi s doziranjem i upozorenjima sadržanima u informacijama o proizvodu.
English: Hibbard (1996) performed a casecontrol study to investigate whether there is an association between long-term oral terbutaline use and peripartum cardiomyopathy.
Croatian: Hibbard (1996.) je proveo ispitivanje slučajeva s kontrolom kako bi istražio postoji li veza između dugotrajne primjene oralnog terbutalina i peripartum kardiomiopatije.
English: With the exception of reports on rhabdomyolysis and SCARs, the cases were mostly in accordance with the known safety profile of ritodrine.
Croatian: Uz iznimku izvještaja o rabdomiolizi i SCAR-ovima, slučajevi su uglavnom u skladu s poznatim sigurnosnim profilom ritodrina.
English: Treatment should be carried out in facilities adequately equipped to perform continuous monitoring of maternal and foetus health status.
Croatian: Liječenje se treba provoditi u institucijama koje su primjereno opremljene za provođenje kontinuiranog nadzora materijala i zdravstvenog statusa fetusa.
English: There are no formulations for inhalation authorised in obstetric indications.
Croatian: Ne postoje formulacije za inhalaciju odobrene u opstetričnim indikacijama.
English: This delay may be used to administer glucocorticoids or to implement other measures known to improve perinatal health.
Croatian: Ovo se odgođeno djelovanje može iskoristiti za primjenu glukokortikoida ili za implementaciju drugih mjera za koje je poznato da poboljšavaju perinatalno zdravlje.
English: CMDh Agreement
Croatian: Sporazum CMDh-a
English: Information on fatal foetal or neonatal conditions was not sufficient to draw any conclusions on the association with intrauterine exposure to terbutaline.
Croatian: Informacije o smrtonosnim fetalnim ili neonatalnim uvjetima nisu bile dovoljne za donošenje bilo kakvih zaključaka o povezanosti intrauterinog izlaganja terbutalinu.
English: Tachycardia, palpitations, and changes of blood pressure accounted for about 2/3 of the adverse events associated with the oral formulation.
Croatian: Tahikardija, palpitacije i promjene u krvnome tlaku odgovorne su za otprilike 2/3 nuspojava povezanih s oralnom formulacijom.
English: Four patients with no pre-existing cardiac pathology developed peripartum cardiomyopathy while on prolonged oral terbutaline for various treatment durations (9.5-53 days).
Croatian: Četiri bolesnika bez prethodno postojeće srčane patologije razvilo je peripartum kardiomiopatiju dok su produženo uzimali oralni terbutalin tijekom različitih duljina liječenja (9,5-53 dana).
English: However, the CMDh considered that a minor change was necessary to the wording proposed in the conditions to the Marketing Authorisations (Annex IV).
Croatian: No, CMDh smatra da su potrebne manje izmjene u tekstu predloženom u uvjetima Odobrenja za stavljanje lijeka u promet (Dodatak IV).
English: Published studies deliver conflicting results and interpretations on the safety of terbutaline (and beta agonists) in tocolysis.
Croatian: Objavljena ispitivanja donose oprečne rezultate i interpretacije o sigurnosti terbutalina (i beta agonista) u tokolizi.
English: Regardless of this, 18 serious cardiovascular cases have been identified in EudraVigilance showing that, not only predisposed, but also otherwise healthy subjects have developed serious cardiovascular complications.
Croatian: Bez obzira na prethodno navedeno, u sustavu EudraVigilance utvrđeno je 18 ozbiljnih kardiovaskularnih slučajeva koji dokazuju da nisu samo predisponirani, nego i inače zdravi subjekti razvili ozbiljne kardiovaskularne komplikacije.
English: Furthermore, premature delivery is an established risk factor of neonatal morbidity and mortality.
Croatian: Nadalje, prijevremeni porod utvrđeni je čimbenik rizika neonatalnog morbiditeta i smrtnosti.
English: Two of the reports of tachycardia developed further and were fatal.
Croatian: U slučaju dvije prijave, tahikardija se dalje razvila i imala je smrtonosan ishod.
English: Scientific conclusions and grounds for revocation or variation as applicable to the terms of the marketing authorisations and detailed explanation for the differences from the PRAC recommendation
Croatian: Znanstveni zaključci i razlozi za ukidanje ili izmjenu primjenjivi na uvjete odobrenja za stavljanje lijeka u promet i detaljno pojašnjenje razlika u odnosu na preporuku PRAC-a
English: Removal of these indications as per the PRAC recommendation will result to the revocation of these marketing authorisations.
Croatian: Uklanjanje ovih indikacija po preporuci PRAC-a rezultirat će povlačenjem ovih odobrenja za stavljanje proizvoda u promet.
English: This should include an adequate assessment of the patient's cardiovascular status with monitoring by electrocardiogram (ECG) throughout treatment in order to identify the early onset of cardiovascular events and further minimise the risk of a serious cardiovascular event.
Croatian: Ovo mora uključivati primjerenu ocjenu kardiovaskularnog statusa bolesnika uz praćenje elektrokardiogramom (EKG-om) tijekom liječenja kako bi se otkrilo rano nastupanje kardiovaskularnih događaja i dodatno umanjio rizik ozbiljnog kardiovaskularnog događaja.
English: The duration of treatment should not exceed 48 hours as data show that the main effect of tocolytic therapy is a delay in delivery of up to 48 hours.
Croatian: Trajanje liječenja ne smije premašiti 48 sati jer podaci ukazuju da je glavno djelovanje tokolitičke terapije odgođeno pri porodu do maksimalno 48 sati.
English: The review of all cardiovascular events for salbutamol showed this medicinal product can induce serious cardiovascular adverse events, which can result in the death of the mother and/or foetus.
Croatian: Pregledom svih kardiovaskularnih događaja za salbutamol utvrđeno je da ovaj lijek može izazvati ozbiljne kardiovaskularne nuspojave, koje mogu rezultirati smrću majke i/ili fetusa.
English: This again highlights the importance of close medical surveillance during therapy, and questions the safety of outpatient tocolysis with terbutaline.
Croatian: Ovo ponovno naglašava važnost pomnog medicinskog nadzora tijekom terapije i pitanja o sigurnosti tokolize s terbutalinom u ambulantnih bolesnika.
English: SABAs should not be used in women with a history of heart disease or in conditions of the mother or foetus in which prolongation of the pregnancy is hazardous.
Croatian: SABA-ovi se ne smiju primjenjivati u žena s anamnezom srčanih bolesti ili u stanjima majke ili fetusa u kojima je produljenje trudnoće opasno.
English: Both formulations of hexoprenaline are also indicated for immobilisation of the uterus pre, during and post cerclage surgery.
Croatian: Obje formulacije heksolrenalina indicirane su također za imobilizaciju maternice prije, tijekom i nakon kirurškog zahvata cerklaže.
English: The PRAC identified serious limitations of the efficacy data for oral and suppository formulations, and noted the available new evidence and/or current medical knowledge on the use of these products for obstetric indications.
Croatian: PRAC je utvrdio ozbiljna ograničenja podataka o djelotvornosti za supozitorne formulacije i istaknuo dostupne nove dokaze i/ili aktualno medicinsko znanje o primjeni ovih proizvoda u opstetričnim indikacijama.
English: Therefore these medicinal products should no longer be indicated in the obstetrics therapeutic indication.
Croatian: Stoga se ovi lijekovi više ne smiju indicirati u opstetričnim terapijskim indikacijama.
English: Having noted the above, the PRAC concluded that the benefit-risk balance is not favourable for the oral formulations and suppositories in view of the overall available safety data, in particular in relation to the risk of serious cardiovascular events, and limited efficacy.
Croatian: Nakon što je istaknuo prethodno navedeno, PRAC je zaključio da omjer koristi i rizika nije povoljan za oralne formulacije i supozitorije s obzirom na sve sigurnosne podatke, posebice u odnosu na rizik od ozbiljnih kardiovaskularnih događaja i ograničene djelotvornosti.
English: As part of the risk minimisation measures the PRAC proposed revised indications for the parenteral formulations taking all the data into account, and making clear the conditions for which these products are indicated.
Croatian: Kao dio mjera za smanjivanje rizika, PRAC je predložio revidirane indikacije za parenteralne formulacije uzimajući u obzir sve podatke i jasno naglašavajući uvjete u kojima su ovi lijekovi indicirani.
English: Some of the products for oral use or suppositories referred in this procedure are authorised only in obstetric indications.
Croatian: Pojedini proizvodi za oralnu primjenu ili supozitoriji navedeni u ovom postupku odobreni su za primjenu samo u opstetričnim indikacijama.
English: These cases of adverse events under ritodrine therapy included both welldocumented case reports from the literature and cases recorded by the MAH from spontaneous reporting from healthcare personnel or Health Authorities.
Croatian: Ovi slučajevi nuspojava pod terapijom ritodrinom uključivali su kako dobro dokumentirane prijave slučajeva iz literature tako i slučajeve koje su registrirali nositelji odobrenja iz spontanih prijava zdravstvenog osoblja i zdravstvenih tijela.
English: The PRAC noted eight infant fatalities, two of which were in association with pulmonary oedema and cardiovascular events.
Croatian: PRAC je zabilježio osam smrti nedonoščadi, od koji su dva smrtna slučaja bila povezana s pulmonalnim edemom i kardiovaskularnim događajima.
English: The PRAC as well recommended that the use of the parental formulations for ECV and emergency is considered favourable where these indications are already authorised.
Croatian: PRAC je također preporučio da se primjena parenteralnih formulacija za ECV i hitne slučajeve smatra povoljnom u slučajevima u kojima su ove indikacije već odobrene.
English: Oral, parenteral and suppositories formulations have been included in this assessment.
Croatian: U ovu ocjenu uključene su oralne, parenteralne i supozitorne formulacije.
English: The seriousness of AEs seems to be directly related to the dose of ritodrine administered to the patient, but also to the treatment duration as most of life-threatening AEs occurred after prolonged ritodrine administration (>72h to months).
Croatian: Čini se da je težina nuspojava izravno povezana s dozom ritodrina koja se primjenjuje u bolesnika, no i s trajanjem liječenja s obzirom da većina nuspojava opasnih po život nastupa nakon produžene primjene ritodrina (>72 sata do mjeseci).
English: The CMDh proposed to shorten the time for recall of the products with only obstetric indications and for which revocation is applicable to ensure that prompt action is taken on products with no marketing authorisation.
Croatian: CMDh je predložio skraćivanje vremena povlačenje za lijekove samo s opstetričnim indikacijama i za koje je opoziv primjenjiv kako bi se osiguralo brzo provođenje radnje za lijekove bez odobrenja za stavljanje lijeka u promet.
English: Having considered the cardiovascular adverse reactions profile associated with the use of these medicinal products in obstetric indications, the PRAC concluded that oral forms and suppositories should no longer be used to supress contractions of the womb.
Croatian: Nakon uzimanja u obzir profila kardiovaskularnih nuspojava povezanog s primjenom ovih medicinskih proizvoda u opstetričnim indikacijama, PRAC je zaključio da se oralni oblici i supozitoriji više ne smiju primjenjivati za suzbijanje kontrakcija maternice.
English: The use of ritodrine is associated with risks of major cardiac and pulmonary dysfunction (rarely myocardial infarction), alteration in glycaemia and blood potassium concentration, gastro-intestinal disorders, tremors, headache and erythema.
Croatian: Primjena ritodrina povezana je s rizicima velike srčane i pulmonalne disfunkcije (rijetko infarktom miokarda), promjenom u glikemiji i koncentraciji kalcija u krvi, gastrointestinalnim poremećajima, tremorima, glavoboljom i eritemom.
English: Even after correction of potentially confounding variables, the relationship remained significant between long-term oral terbutaline therapy for preterm labour and subsequent peripartum cardiomyopathy.
Croatian: Čak i nakon ispravka mogućih zbunjujućih varijabli, zadržala se značajna veza između dugotrajne terapije oralnim terbutalinom za prijevremeni porod i naknadne peripartum kardiomiopatije.
English: A review of safety data for fenoteral showed that the cardiovascular events tachycardia and palpitations were frequently reported in clinical studies and are listed as very common side effects of the drug.
Croatian: Pregledom sigurnosnih podataka za fenoteral utvrđeno je da su kardiovaskularni događaji tahikardije i palpitacije često prijavljivani u kliničkim ispitivanjima, te da su navedeni kao vrlo česta nuspojava lijeka.
English: There is hardly any evidence of maternal death in these studies and very limited data on adverse foetal outcomes (e.g. tachycardia, hyperinsulinaemia).
Croatian: Gotovo da i nema dokaza o smrti majke u ovim ispitivanjima, te su vrlo ograničeni podaci o negativnim ishodima za fetus (primjerice tahikardiji, hiperinzulinemiji).
English: Many of these reports occurred in association with both salbutamol intravenous (i.v.)
Croatian: Mnoge od ovih prijava nastupile su povezane kako s intravenoznim salbutamolom (i.v.) tako i s oralnim salbutamolom.
English: Myocardial infarction or serious arrhythmias were not reported in the clinical trial reports available to the MAH.
Croatian: Infarkt miokarda ili ozbiljne aritmije nisu prijavljene u izvještajima kliničkih ispitivanja dostupnima nositeljima odobrenja.
English: Occurrence of typical adverse effects characteristic of beta receptor stimulation are well documented, and range from mild and transient discomfort to serious cardiovascular side effects requiring prompt medical intervention, e.g. in case of arrhythmias or pulmonary oedema.
Croatian: Nastupanje tipičnih nuspojava karakterističnih za stimulaciju beta receptora dobro je dokumentirano, a raspon nuspojava obuhvaća od blage i prolazne neugode do ozbiljnih kardiovaskularnih nuspojava koje zahtijevaju hitnu medicinsku intervenciju, primjerice u slučaju aritmija ili pulmonalnog edema.
English: In addition specific guidance on the method of administration should be given for these injectable formulations.
Croatian: Nadalje, za ove injekcijske formulacije treba se dati specifična smjernica o metodi primjene.
English: The risk to the mother and foetus could be minimised if active substances are administered by obstetricians/physicians experienced in the use of tocolytic agents.
Croatian: Rizik za majku i fetus može se minimizirati, ako se djelatne tvari primjenjuju od strane opstetričara/liječnika iskusnog u primjeni tokolitičkih sredstava.
English: Fenoterol also contains descriptions of emergency uses in the indications such as dystocias in the dilation and expulsion stages of labour (such as uterine hyperactivity or spasm occurring either spontaneously or as a result of mechanical obstruction or over stimulation by oxytocic agents); intrauterine asphyxia (as indicated by signs such as foetal heart rate decelerations or incipient to moderate foetal acidosis); obstetric emergencies (such as cord prolapse or imminent uterine rupture); uterine relaxation in acute indications such as caesarean section.
Croatian: Fenoterol sadrži također opise primjena u hitnim slučajevima u indikacijama poput otežanih poroda u dilataciji i faza izbacivanja tijekom poroda (poput pojačane aktivnosti maternice ili spazama koji nastupa spontano ili kao rezultat mehaničke opstrukcije ili prekomjerne stimulacije oksitoksičnim sredstvima); intrauterine asfiksije (indicirane znakovima poput usporavanja frekvencije srca fetusa ili početne do umjerene fetalne acidoze); opstetričnih hitnih slučajeva (poput prolapsa pupčane vrpce ili neposredne rupture maternice); opuštanje maternice u akutnim indikacijama poput primjerice carskoga reza.
English: More serious adverse drug reactions have been recorded individually - chest pain, dyspnoea, ileus, loss of consciousness, arrhythmia and also several case reports of pulmonary oedema (four in a publication by Van Iddekinge et al., 1991, one in the EV database, four in the PSUR) have been reported.
Croatian: Ozbiljnije nuspojave zabilježene su u pojedinačnim slučajevima - bol u prsima, dispneja, ileus, gubitak svijesti, aritmija, te je dostavljeno i nekoliko prijava slučaja pulmonalnog edema (četiri u publikaciji objavljenoj od strane Van Iddekinge et al., 1991., jedna u bazi podataka EV, četiri u PSUR-u).
English: For the oral tablet, three serious AEs were reported (loss of consciousness, trismus and a serious skin reaction), and six nonserious AEs for the tablet.
Croatian: U slučaju oralnih tableta, prijavljene su tri ozbiljne nuspojave (gubitak svijesti, trizmus i ozbiljna kožna reakcija) i šest nuspojava koje nisu ozbiljne.
English: There were a number of reports of pulmonary oedema contributing to the events and one case reported pulmonary oedema in association with cardiomegaly, after taking a course of tablets for five weeks, when tocolysis failed.
Croatian: Zabilježen je niz prijava pulmonalnog edema koji doprinosi događajima, a u jednom je slučaju prijavljen pulmonalni edem povezan s kardiomegalijom nakon uzimanja kure tableta tijekom razdoblja od pet tjedana u slučaju kada tokoliza nije bila uspješna.
English: Oral formulations and suppositories are used for the maintenance in tocolysis after the injectable forms have been administered, and considering the cardiovascular safety profile, the PRAC considers that these medicinal products no longer demonstrate a favourable benefit-risk balance.
Croatian: Oralne formulacije i supozitoriji primjenjuju se za održavanje u tokolizi nakon što su primijenjeni injekcijski oblici, a uzimajući u obzir kardiovaskularni sigurnosni profil, PRAC smatra da ovi lijekovi više ne iskazuju povoljan omjer koristi i rizika.