FrancophonIA/ELRC3.0 huggingface dataset:
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse, genotoksilisuse ja kartsinogeensuse mittekliinilised uuringud ei ole näidanud erilist ohtu inimesele.
English: You can also report side effects directly via the following website: www.mhra.gov.uk/yellowcard.
Estonian: Võite kõrvaltoimeid ka ise järgmisel veebisaidil teavitada www.ravimiamet.ee.
English: Hypromellose 2910 (E 464)
Estonian: tärklis, eelželatiniseeritud naatriumkroskarmelloos (E468) hüpromelloos 2910 (E464)
English: White to off-white, film-coated round tablets of 6 mm debossed with ‘LA'
Estonian: Valged või valkjad 6 mm läbimõõduga ümarad õhukese polümeerikattega tabletid, millel on pimetrükk ‘LA'.
English: Tel: + 36 1 336 1614
Estonian: Tel: + 36 1 336 1614 office@angelini.hu
English: • Rhabdomyolysis which is the breakdown of muscle fibres that leads to the release of muscle fibre contents (myoglobin) into the bloodstream, seen as muscle pain, being sick, being confused, an abnormal heart rate and rhythm, and possibly dark urine
Estonian: (müoglobiin) eritumist vereringesse, väljendudes lihasvalude, oksendamise, segasuse, südame ebanormaalse löögisageduse ja rütmihäirete ning võimalik, et ka tumeda uriinina;
English: Co-administration of lurasidone and posaconazole (strong CYP3A4 inhibitor) resulted in an approximate 4-5 fold increase in lurasidone exposure.
Estonian: Lurasidooni samaaegsel manustamisel posakonasooliga (tugev CYP3A4 inhibiitor) suurenes lurasidooni kontsentratsioon ligikaudu 4...5-kordselt.
English: Breast enlargement**** Breast pain**** Galactorrhoea**** Erectile dysfunction**** Amenorrhoea**** Dysmenorrhoea****
Estonian: Närvisüsteemi häired akatiisia somnolentsus parkinsonism** pearinglus düstoonia*** düskineesia letargia düsartria tardiivdüskineesia maliigne neuroleptilin e sündroom krambid****
English: Close supervision of high-risk patients should accompany antipsychotic therapy.
Estonian: Antipsühhootikumravi ajal on vajalik kõrge riskiga patsientide hoolikas jälgimine.
English: Vomiting Dyspepsia Salivary hypersecretion Dry mouth Upper abdominal pain Stomach discomfort
Estonian: Seedetrakti häired iiveldus oksendamine düspepsia ülemäärane süljeeritus suukuivus valu ülakõhus ebamugavustunne maos kõhupuhitus kõhulahtisus**** düsfaagia**** gastriit****
English: Rare cases of glucose related adverse reactions, e.g. increase in blood glucose, have been reported in clinical trials with lurasidone.
Estonian: Lurasidooni kliinilistes uuringutes on harvadel juhtudel esinenud glükoosi ainevahetusega seotud kõrvaltoimeid, nt vere glükoositaseme tõusu.
English: Tel: + 420 546 123 111
Estonian: Tel: + 420 546 123 111 info@angelini.cz
English: Tel: + 43 5 9606 0
Estonian: Tel: + 43 5 9606 0 office@angelini.at
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to18.6 mg lurasidone.
Estonian: Üks õhukese polümeerikattega tablett sisaldab lurasidoonvesinikkloriidi koguses, mis vastab 18,6 mg lurasidoonile.
English: Suicidal behaviour**** Panic attack**** Sleep disorder****
Estonian: Psühhiaatrilised häired unetus erutatus ärevus rahutus hirmuunenäod katatoonia suitsidaalne käitumine**** paanikahoog**** unehäire****
English: • erythromycin (to treat infections)
Estonian: • erütromütsiin (nakkushaiguste raviks);
English: • lack of energy (lethargy)
Estonian: • jõuetus (letargia);
English: Latuda 18.5 mg film-coated tablets
Estonian: Latuda 18,5 mg õhukese polümeerikattega tabletid
English: • slow heart rate
Estonian: • südametegevuse aeglustumine;
English: • seizure (fits)
Estonian: • gaasid (kõhupuhitus);
English: Weight gain has been observed with atypical antipsychotic use.
Estonian: Atüüpiliste antipsühhootikumide kasutamisel on esinenud kehakaalu tõusu.
English: • swelling beneath the skin surface (angioedema)
Estonian: • nahaalune turse (angioödeem).
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 37.2 mg lurasidone.
Estonian: Üks õhukese polümeerikattega tablett sisaldab lurasidoonvesinikkloriidi koguses, mis vastab 37,2 mg lurasidoonile.
English: RO-București 050451 Tel: + 40 21 331 6767
Estonian: Tel: + 40 21 331 6767 office@angelini.ro
English: Latuda film-coated tablets are available in pack sizes containing 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1,
Estonian: Latuda õhukese polümeerikattega tablette turustatakse pakendites, milles on 14 x 1; 28 x 1; 30 x 1; 56 x 1; 60 x 1; 90 x 1 või 98 x 1 õhukese polümeerikattega tabletti perforeeritud üksikannusteks jaotatavates alumiinium- /alumiiniumblistrites.
English: Each film-coated tablet contains lurasidone hydrochloride equivalent to 74.5 mg lurasidone.
Estonian: Üks õhukese polümeerikattega tablett sisaldab lurasidoonvesinikkloriidi koguses, mis vastab 74,5 mg lurasidoonile.
English: Baseline Mean (SD) LS Mean Change (SE) Treatment Difference vs. placebo
Estonian: Ravieelne keskmine (standardhälve, SD) Vähimruutude keskmine muutus (standardviga, SE) Ravi vs platseebo erinevus Hinnang (SE) p-väärtus
English: Mannitol (E 421) Starch, pregelatinised Croscarmellose sodium (E468)
Estonian: Tuum mannitool (E421)
English: Hyperglycaemia
Estonian: Koostoimed greipfruudi mahlaga
English: Ear and labyrinth disorders
Estonian: Kõrva ja labürindi kahjustused vertiigo****
English: Renal impairment No dose adjustment of lurasidone is required in patients with mild renal impairment.
Estonian: Kerge neerukahjustuse korral ei ole lurasidooni annuse kohandamine vajalik.
English: However, an increase in exposure in elderly subjects may be expected for patients if they have impaired renal or hepatic function.
Estonian: Neeru- või maksafunktsiooni kahjustusega eakatel patsientidel seerumikontsentratsioon eeldatavalt suureneb.
English: Study D1050231 N=114 N=118 -
Estonian: N = 114 N = 118
English: • if you have kidney or liver problems.
Estonian: • teie võimalikest maksa- või neeruhäiretest.
English: Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Estonian: Suhkurtõvega ja suhkurtõve tekkimise riskiteguritega patsiente on soovitatav vastavalt kliiniliselt jälgida.
English: Eye disorders
Estonian: Silma kahjustused nägemise ähmastumine
English: Cerebrovascular accident
Estonian: Aju veresoonkonna häire
English: Latuda 74 mg film-coated tablets
Estonian: Latuda 74 mg õhukese polümeerikattega tabletid
English: Limited data are available in elderly people treated with higher doses of lurasidone.
Estonian: Andmed lurasidooni suuremate annuste kasutamise kohta eakatel patsientidel on piiratud.
English: • weight gain
Estonian: • kuumahood;
English: • sleep disorder
Estonian: • nägemise ähmastumine;
English: • slurred speech
Estonian: • segane kõne;
English: Very Common
Estonian: Väga sage Sage
English: Flatulence
Estonian: Krambid
English: Latuda 37 mg film-coated tablets
Estonian: Latuda 37 mg õhukese polümeerikattega tabletid
English: • The other ingredients are mannitol, pregelatinised starch, croscarmellose sodium, hypromellose,
Estonian: − seennakkuste ravimid, näiteks itrakonasool, ketokonasool (välja arvatud šampoonina),
English: 1 x 1 tablet (unit dose)
Estonian: Manustamistee Sisepakendi iseloomustus Pakendi suurus blister (alu/alu) 1 x 1 tablett (üheannuseline)
English: MA (EU) Number Invented name Strength Pharmaceutical form Route of administration Immediate Packaging Package size
Estonian: Tugevus Ravimvorm
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Estonian: Kokkuleppe rakendamine liikmesriikides (müügiloa hoidja esitab muudatuse taotluse):
English: 20 February 2014
Estonian: 20. veebruar 2015
English: Annex V
Estonian: V lisa
English: November 2014 CMDh meeting
Estonian: Koordineerimisrühma 2014. aasta novembri koosolek
English: The procedure started on 20 September 2007.
Estonian: Menetlus algas 20. septembril 2007.
English: The Marketing Authorisation Holder provided supplementary information on 28 January 2008 and 28 April 2008.
Estonian: Müügiloa hoidja esitas täiendava teabe 28. jaanuaril 2008 ja 28. aprillil 2008.
English: Ref. EMEA/CHMP/384879/2008
Estonian: London, 8. oktoober 2008 Viide: EMEA/CHMP/554678/2008
English: Risperdal Consta and associated names is an anti-psychotic, indicated for the maintenance treatment of schizophrenia in patients currently stabilised with oral antipsychotics.
Estonian: Risperdal Consta sarnased nimetused on antipsühhootikum, mis on näidustatud skisofreenia säilitusraviks suukaudsete antipsühhootikumidega hetkel stabiliseeritud patsientidel.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Risperdal Consta and associated names International Non-Proprietary Name (INN): risperidone
Estonian: INIMRAVIMITE KOMITEE ARVAMUS PÄRAST ARTIKLI 30 KOHAST ESILDIST Rispedal Consta ja sarnased nimetused Rahvusvaheline mittekaubanduslik nimetus (INN): risperidoon
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Risperdal Consta and associated names approved across EU Member States, with respect to the indication, the special warnings and precautions for use and the interaction with other medicinal products and other forms of interaction.
Estonian: Esildise aluseks olid Risperdal Consta ja sarnaste nimetuste Euroopa Liidu liikmesriikides heakskiidetud ravimi omaduste kokkuvõtetes esinenud erinevused näidustuses, hoiatustes ja ettevaatusabinõudes kasutamisel ning koostoimetes teiste ravimitega ja muudes koostoimetes.
English: The CHMP gave a positive opinion on 24 July 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Risperdal Consta and associated names.
Estonian: Inimravimite komitee esitas positiivse arvamuse 24. juulil 2008, soovitades ühtlustada Risperdal Consta ja sarnaste nimetuste ravimi omaduste kokkuvõtted, märgistused ja pakendi infolehed.
English: It is available as prolonged release powder and solvent for suspension for intramuscular use.
Estonian: Seda turustatakse lihasesse süstitava toimeainet pikaajaliselt vabastava suspensiooni valmistamiseks pulbri ja lahustina.
English: On 24 July 2007 the European Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Risperdal Consta and associated names.
Estonian: 24. juulil 2007 esitas Euroopa Komisjon Euroopa Ravimiametile muudetud direktiivi 2001/83/EÜ artikli 30 alusel esildise Risperdal Consta ja sarnaste nimetuste liikmesriikides heakskiidetud ravimi omaduste kokkuvõtete, pakendi infolehtede ja märgistuste ühtlustamiseks.
English: The majority of patients were female.
Estonian: Enamik patsiente oli naised.
English: Most of them received only one infusion.
Estonian: Enamikule neist manustati ainult ühte infusiooni.
English: The majority of studies were retrospective.
Estonian: Suurem osa uuringuid olid retrospektiivsed.
English: In about 80% of the cases, the outcome of pregnancy was unknown.
Estonian: Umbes 80% juhtudest pole raseduse tulemus teada.
English: Overall summary of the scientific evaluation of intravenous iron containing medicinal products (see Annex I)
Estonian: Intravenoosset rauda sisaldavate ravimite teaduslike järelduste üldkokkuvõte (vt I lisa)
English: The following analyses were performed on spontaneous or solicited cases, medically confirmed or not, recorded until 15 December 2011.
Estonian: Järgmiste analüüside raames vaadeldi spontaanseid või valitud juhtumeid, mis olid meditsiiniliselt kinnitatud või mitte ning mida oli jälgitud 15. detsembrini 2011.
English: These reactions may be damaging, uncomfortable, or occasionally fatal.
Estonian: Sellised reaktsioonid võivad olla tervistkahjustavad, ebameeldivad või harvem fataalsed.
English: Twenty-two clinical studies were submitted.
Estonian: Esitati 22 kliinilist uuringut.
English: Therefore, no conclusions on safety can be drawn from these studies alone.
Estonian: Seetõttu ei saa nende uuringute põhjal veel ohutust käsitlevaid järeldusi teha.
English: In about one third of the total cases (223/846), the patients recovered after drug withdrawal.
Estonian: Umbes kolmandikul kõigist juhtudest (223/846) taastusid patsiendid pärast ravimi võtmise lõpetamist.
English: The majority of cases were reported as serious (366/587; 62%).
Estonian: Suurem osa teatatud juhtumitest olid rasked (366/587; 62%).
English: Published literature was also provided.
Estonian: Esitati ka avaldatud kirjandus.
English: Among all studies provided, only one life-threatening reaction was reported (Michael, et al 2002).
Estonian: Esitatud uuringute raames anti teada vaid ühest eluohtlikust reaktsioonist (Michael et al, 2002).
English: For some cases (108 out of 168) the time-to-onset of the reaction was reported.
Estonian: Osadel juhtudel (108 juhul 168-st) on teada ka reaktsioonivastuse aeg.
English: The far majority of cases could not be assessed as potential serious allergic reactions.
Estonian: Enamikku juhtumitest ei saanud hinnata potentsiaalselt raskete allergiliste reaktsioonidena.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for intravenous iron containing medicinal products.
Estonian: • Komitee lähtus intravenoosset rauda sisaldavate ravimite käsitlemisel direktiivi 2001/83/EÜ
English: A fatal case was also reported.
Estonian: Teatati ka ühest surmajuhtumist.
English: Of these, 17 were considered serious, of which five within the immune system disorder, as mentioned above.
Estonian: Neist 17 peeti raskeks ning neist viis liigitati immuunsüsteemi häirete alla, nagu eespool mainitud.
English: In approximately 90% of the cases in which the time to onset was reported the reaction occurred within the first 10 minutes of administration, and in about one third it occurred during the test dose.
Estonian: Umbes 90% nendest juhtudest, mille reaktsioonivastuse aeg oli teada, ilmnes reaktsioon esimene 10 minuti jooksul pärast ravimi manustamist, ning umbes kolmandikul juhtudest ilmnes see katseannuse ajal.
English: Within the on-going clinical studies only two serious adverse reactions have been reported.
Estonian: Pooleliolevate kliiniliste uuringute raames on teatatud ainult kahest raskest kõrvaltoimest.
English: This corresponds to a hypersensitivity events frequency rate of 0.060%, which is lower than the frequency rate found in clinical trials.
Estonian: See teeb ülitundlikkuse kõrvalnähtude sagedusmääraks 0,060%, mis on väiksem kui kliiniliste uuringute käigus leitud sagedusmäär.
English: When classifying all cases that were not reported as immune reactions, according to CTCAE approximately 20% were classified as grade III.
Estonian: Kõigi nende juhtumite klassifitseerimisel, millest ei teatatud kui immuunreaktsioonidest, liigitati CTCAE kohaselt umbes 20% III astme juhtumite alla.
English: In conclusion, regarding post-marketing data, 317 cases of hypersensitivity were reported (frequency rate 0.0022%).
Estonian: Kokkuvõtvalt võib öelda, et turustamisjärgsete andmete põhjal anti teada 317 ülitundlikkuse juhtumist (sagedusmäär 0,0022%).
English: Anti-allergic treatment was reported for 94/168 cases.
Estonian: Allergiavastasest ravist teatati 94 juhul 168st.
English: All five patients made full recovery.
Estonian: Kõik viis patsienti taastusid täielikult.
English: A total of 34 grade III (14.4%) and 2 grade IV (0.8%) were reported.
Estonian: Kokku teatati 34-st III astme (14,4%) ja 2-st IV astme (0,8%) juhtumist.
English: It might be of interest to note, that these patients had penicillin allergy and latex allergy, respectively.
Estonian: Vajalik on mainida, et antud patsientidest ühel oli penitsilliini- ja teisel lateksiallergia.
English: One study showed that slow administration of sodium ferric gluconate resulted in less allergic reactions than if this was done during a shorter period of time.
Estonian: Ühest uuringust selgus, et naatrium-raudglükonaadi aeglase manustamisega kaasnes vähem allergilisi reaktsioone kui siis, kui seda tehti lühema aja jooksul.
English: Further, a test-dose might give the prescriber a feeling of false assurance that an allergic reaction is unlikely to happen.
Estonian: Lisaks võib katseannus anda selle määrajale petliku kindlustunde, et allergilise reaktsiooni esinemine on ebatõenäoline.
English: The main safety data which were used in the CHMP assessment and conclusions were post-marketing data for all complexes.
Estonian: Peamised ohutusandmed, millest inimravimite komitee hindamisel ja järelduste tegemisel lähtus, olid kõigi komplekside turustamisjärgsed andmed.
English: In view of the above, on 7 December 2011 France requested the CHMP under Article 31 of Directive 2001/83/EC to assess the above concerns regarding hypersensitivity and its impact on the benefit-risk balance for iron intravenous containing medicinal products, and to give its opinion on measures necessary to ensure the safe and effective use, and on whether the marketing authorisation for these products should be maintained, varied, suspended or withdrawn.
Estonian: Eespool toodut silmas pidades palus Prantsusmaa 7. detsembril 2011 inimravimite komiteel direktiivi 2001/83/EÜ artikli 31 alusel hinnata eespool mainitud huvipunkte, kus käsitleti intravenoosset rauda sisaldavate ravimitega seonduvat ülitundlikkust ja selle mõju kasulikkuse ja riski tasakaalule, ning avaldada arvamust ravimi ohutu ja efektiivse kasutamise tagamiseks vajalike meetmete ning selle kohta, kas kõnealuste ravimite müügiluba tuleks säilitada, muuta, peatada või tühistada.
English: Predisposition to an allergy or known asthma may result in a more severe reaction.
Estonian: Allergia eelsoodumuse või diagnoositud astmaga võib kaasneda raskem reaktsioon.
English: Of these, 3 were classified as anaphylactoid reactions.
Estonian: Neist 3 klassifitseeriti anafülaktoidsete reaktsioonidena.
English: A total of 236 cases of hypersensitivity reactions were reported (mainly grade I and II).
Estonian: Kokku teatati 236 ülitundlikkusreaktsioonide juhtumist (peamiselt I ja II astme juhtumid).
English: In two cases, no symptoms were reported and it was not reported whether treatment of the reaction was provided nor was the time to onset other than the day of the event reported, making it difficult to classify these events.
Estonian: Kahel juhul ei teatatud mingitest sümptomitest ning ei antud teada, kas reaktsiooni raviti; lisaks teatati vaid kõrvalnähu ilmnemise päeval toimunud reaktsioonivastusest, mistõttu osutus nende kõrvalnähtude klassifitseerimine keerukaks.
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations
Estonian: II lisa Euroopa Ravimiameti esitatud teaduslikud järeldused ja müügilubade tingimuste muutmise alused
English: Of note, hypotension, nausea, vomiting and cramps are often symptoms associated with haemodialysis.
Estonian: Siiski ei tohi unustada, et hüpotensioon, iiveldus, oksendamine ja krambid on tihti ka hemodialüüsiga seostatavad sümptomid.
English: For pregnancy specifically, as oral iron may be well tolerated in the first trimester of the pregnancy, the CHMP advised that the intravenous iron complexes are not given to pregnant women in the early stages.
Estonian: Konkreetselt raseduse puhul - kuna suukaudselt manustatavat rauda võidakse raseduse esimesel trimestril hästi taluda - soovitas inimravimite komitee rasedatele intravenoosseid rauakomplekse raseduse varajastes etappides mitte anda.
English: In 8 cases of the total 51 life-threatening cases (15.7%; 8/51 cases, one graded as Grade IV), the patient presented with a history of allergy.
Estonian: 8 juhul kokku 51-st eluohtlikust juhtumist (15,7%; 8/51 juhtumist, üks IV astme juhtum) oli patsiendil ka varem allergiaid esinenud.
English: The CHMP concluded that the information on test dose is not appropriate as it may give false reassurance to the healthcare professionals.
Estonian: Inimravimite komitee jõudis järeldusele, et katseannuse teave pole sobilik, sest see võib tekitada tervishoiutöötajates petliku kindlustunde.
English: Instead caution should be exercised in each iron administration even in the cases of repeated administrations.
Estonian: Selle asemel tuleks igal raua manustamisel olla eriti ettevaatlik (ka korduva manustamise puhul).
English: As the conclusions of this assessment were mainly drawn from the post-marketing data, differentiation between these iron complexes in terms of hypersensitivity reactions could not be identified.
Estonian: Et käesoleva hinnangu järeldused tehti peamiselt turustamisjärgsete andmete põhjal, polnud võimalik antud rauakomplekside ülitundlikkusreaktsioone eristada.
English: The most frequent AEs experienced by patients in all treatment groups were hypotension (48.7%), nausea (31.9%), vomiting (22.1%) and cramps.
Estonian: Kõigi ravirühmade lõikes enim esinenud kõrvalnähtudeks olid hüpotensioon (48,7%), iiveldus (31,9%), oksendamine (22,1%) ja krambid.
English: Over all studies, 36 hypersensitivity events occurring in 35 patients were reported.
Estonian: Kõigi uuringute lõikes teatati 36 ülitundlikkuse kõrvalnähust, mis esinesid kokku 35 patsiendil.
English: One of these cases was an anaphylactoid reaction, and another was a probable serious allergic reaction.
Estonian: Ühel juhul oli tegu anafülaktoidse reaktsiooni ning teisel juhul tõenäoliselt raske allergilise reaktsiooniga.
English: Two of these 3 anaphylactoid reactions occurred in patients with Crohn's disease.
Estonian: Kaks eespool mainitud 3-st anafülaktoidsest reaktsioonist ilmnesid Crohni tõvega patsientidel.
English: Among 20 patients who presented a reaction of grade IV, six (6) patients died.
Estonian: 20 patsiendist, kellel tekkis IV astme reaktsioon, surid kuus (6).
English: As data from the post marketing reporting showed that a successful test dose may give false assurance to the professionals dealing with the product administration, no test dose should be applied.
Estonian: Kuna turustamisjärgse aruandluse andmetest selgus, et edukas katseannus võib anda toote manustamisega tegelevatele tervishoiutöötajatele petliku kindlustunde, ei tohiks katseannust manustada.
English: The test-dose does not seem to prevent the occurrence of severe reactions.
Estonian: Tundub, et katseannus ei hoia ära raskete reaktsioonide esinemist.
English: In later stages of pregnancy the intravenous iron preparations may be given but after careful consideration of the risks involved for the mother and foetus.
Estonian: Raseduse hilisemates etappides võib intravenoosseid rauavalmistisi anda alles pärast emale ja lootele avalduvate riskide põhjalikku kaalumist.
English: The majority of cases were classified as grade III (53%) followed by grade II (32%).
Estonian: Enamik juhtumitest klassifitseeriti III astme (53%) ja II astme (32%) juhtumitena.
English: Analysis on the severity of the hypersensitivity post marketing cases showed 33 cases of the 178 serious cases required hospitalization, 31 cases of the 178 serious cases were of a life-threatening nature, from which 6 patients presented with a history of allergy.
Estonian: Turustamisjärgsete ülitundlikkuse juhtumite analüüsist selgus, et 178 raskest juhtumist 33 juhtumiga kaasnes haiglaravi vajadus ja et 178 raskest juhtumist 31 juhtumit olid eluohtlikku laadi (neist 6 patsiendil oli ka varem allergiaid esinenud).
English: Of these, one was reported as non-serious and four as serious.
Estonian: Üks antud juhtumitest oli kerge ning neli olid rasked.
English: Hypersensitivity (also called allergic reactions) refers to undesirable reactions produced by the normal immune system, including allergies and autoimmunity.
Estonian: Ülitundlikkuse (allergiliste reaktsioonide) all mõeldakse normaalses immuunsüsteemis tekkivaid soovimatuid reaktsioone (sh allergiaid ja autoimmuunsust).
English: In conclusion the post-marketing data are in accordance with the known safety profile of ferric carboxymaltose.
Estonian: Kokkuvõtvalt võib öelda, et turustamisjärgsed andmed vastavad raud-karboksümaltoosi teadaolevale ohutusprofiilile.