natgillin/translations-raw huggingface dataset:
In addition, side effects are reported which are known to occur with controlled ovarian hyperstimulation treatment (e.g. abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (when the embryo develops outside the womb) and miscarriage (see the patient information leaflet of the FSH-containing preparation you are treated with)).
Lisaks on täheldatud kõrvaltoimeid, mis on seotud kontrollitud munasarjade hüperstimulatsiooniga [nt kõhuvalu, munasarjade hüperstimulatsiooni sündroom (OHSS), emakaväline rasedus (kui embrüo areneb väljaspool emakat) ja abort (vaadake teile eelnevalt väljastatud FSH-d sisaldava ravimi pakendi infolehte)].
In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery.
Lisaks on vastsündinutel täheldatud beetablokaadi (nt bradükardia, hüpotensioon, respiratoorne distress ja hüpoglükeemia), kui emale on manustatud beetablokaatoreid kuni sünnitamiseni.
In addition, similar effects were observed on other lung function endpoints e.g. change from baseline in FVC at week 52 and FVC responder analyses providing further substantiation of the effects of nintedanib on slowing disease progression.
Peale selle täheldati sarnaseid toimeid ka teiste kopsufunktsiooni tulemusnäitajate osas – näiteks FVC muutus 52. nädalal võrreldes algväärtusega ja FVC osas reageerijate analüüsid, mis veelgi tõestavad nintedaniibi toimet haiguse progressiooni aeglustamisel.
In addition, skin cancer was reported in around 1% of patients in the placebo controlled clinical trials.
Lisaks raporteeriti platseeboga kontrollitud kliiniliste uuringute käigus ligikaudu 1%-l patsientidest nahavähi esinemist.
In addition, some previous infections may reappear.
Lisaks võivad uuesti tekkida mõned teil varem esinenud infektsioonid.
In addition, some previous infections may reappear. to address the risk that patients using RoActemra may develop complications of diverticulitis which can become serious if not treated. to address the risk of allergic reactions.
Lisaks võivad mõned varem esinenud infektsioonid korduda. et teavitada riskist, et RoActemra’t kasutavatel patsientidel võivad tekkida divertikuliidi komplikatsioonid, mis ilma ravita võivad muutuda tõsisteks. et teavitada allergiliste reaktsioonide riskist
In addition, some side effects are seen in between 1 and 10 patients in 100 following spine surgery itself, including infection after the operation, wound dehiscence (opening of the wound), secretion (seepage) and erythema (redness of the skin).
Lisaks esinevad 1–10 patsiendil 100st kõrvalnähud, mis on seotud lülisambaoperatsiooni endaga, sealhulgas operatsioonijärgne infektsioon, haava lahtitulek, haavaeritis ja nahapunetus.
In addition, statistically significant vaccine efficacy against CIN2+ associated with HPV-16 and HPV-18 individually was demonstrated.
Lisaks tõestati vaktsiini statistiliselt olulist tõhusust individuaalselt HPV-16 ja HPV-18 seotud CIN2+ vastu.
In addition, studies conducted with MedImmune’s 2009 H1N1 pandemic LAIV and seasonal T/LAIV vaccine are also considered supportive because all these vaccines are manufactured using the same process, administered through the same route, and studied primarily in naïve individuals.
Lisaks peetakse toetavateks ka MedImmune’i 2009 H1N1 pandeemilise vaktsiini LAIV ja hooajalise vaktsiini T/LAIV uuringute andmeid, sest kõik need vaktsiinid on toodetud samal viisil, nende manustamistee on sama ning neid on uuritud peamiselt varem vaktsineerimata isikutel.
In addition, studies from the published literature in patients with thalassaemia major were provided to support use of Ferriprox in combination with another iron chelator.
Lisaks esitati raske talasseemiaga patsientide kohta avaldatud kirjandusandmed, et toetada Ferriproxi kasutamist koos teise raua kelaatijaga.
In addition, study I evaluated haemostatic efficacy in the treatment of bleeding episodes; and determined haemostatic efficacy during perioperative management in subjects undergoing major surgical procedures.
Lisaks sellele hinnati uuringus I hemostaatilist efektiivsust veritsusepisoodidel; samuti hinnati hemostaatilist efektiivsust perioperatiivse ravi käigus osalejatel, kellel viidi läbi ulatuslikke kirurgilisi protseduure.
In addition, Study V investigated the safety and efficacy of abatacept or infliximab relative to placebo.
Lisaks selgitati uuringus V abatatsepti või infliksimabi ohutust ja efektiivsust platseeboga võrreldes.
In addition, systemic signs, such as lethargy and a reduction in appetite may also commonly occur, sometimes accompanied by pyrexia and a stiff gait.
Lisaks võivad ilmneda süsteemsed nähud, nagu letargia ja isu vähenemine, millega mõnikord kaasnevad püreksia ja kange kõnnak.
In addition, tenofovir may increase plasma levels of raltegravir, however, the mechanism for this effect is unknown (see Table 1).
Ka tenofoviir võib suurendada raltegraviiri plasmakontsentratsiooni, kuid selle koostoime tekkemehhanism ei ole teada (vt tabel 1).
In addition, tenofovir may increase plasma levels of raltegravir, however, the mechanism for this effect is unknown (see Table 2).
Ka tenofoviir võib suurendada raltegraviiri plasmakontsentratsiooni, kuid selle koostoime tekkemehhanism ei ole teada (vt tabel 2).
In addition, tenofovir may increase plasma levels of raltegravir, however, the mechanism for this effect is unknown (see Table 3).
Ka tenofoviir võib suurendada raltegraviiri plasmakontsentratsiooni, kuid selle koostoime tekkemehhanism ei ole teada (vt tabel 3).
In addition, the 15 mg strength contains indigo carmine (E132) and the 20 mg strength contains iron oxide red (E172)
Lisaks sisaldab 15 mg tugevus indigokarmiini (E132) ja 20 mg tugevus punast raudoksiidi (E172)
In addition, the adverse drug reactions marked with ** were observed in the study with 204 patients receiving Zevalin as consolidation therapy after first-line remission induction where indicated.
Peale selle on ** tähistatud kõrvaltoimed, mida täheldati 204 patsiendil, kes said Zevalin’i konsolideeriva ravina pärast esmast remissiooni induktsiooni.
In addition, the benefits of treatment in terms of the proportion achieving sustained virological response (SVR) compared with placebo were modest in these patients (especially for those with baseline albumin ≤ 35g/L) compared with the group overall.
Lisaks oli nendel patsientidel (eriti neil, kellel algtaseme albumiin oli ≤ 35 g/l) võrreldes rühmaga üldiselt ravis saadav kasu (proportsioon patsientidest, kes saavutasid püsiva viroloogilise ravivastuse [SVR]) võrreldes platseeboga mõõdukas.
In addition, the benefits of treatment in terms of the proportion achieving SVR compared with placebo were modest in these patients (especially for those with baseline albumin ≤ 35 g/L) compared with the group overall.
Lisaks oli nendel patsientidel (eriti neil, kellel algtaseme albumiin oli ≤ 35 g/l) võrreldes rühmaga üldiselt ravist saadav kasu (proportsioon patsientidest, kes saavutasid SVR’i) võrreldes platseeboga mõõdukas (vt lõik 5.1).
In addition, the CHMP noted that the overall benefit of Pradaxa in the treatment and prevention of DVT and PE is comparable to that of warfarin.
Lisaks märkis inimravimite komitee, et Pradaxa üldine kasulikkus süvaveenide tromboosi ja kopsuemboolia ravis ja ennetamisel on võrreldav varfariini kasulikkusega.
In addition, the CHMP recognised that pharmacy preparations of amifampridine are still being used, which further limits the numbers of patients treated with Firdapse.
Peale selle võttis inimravimite komitee arvesse, et endiselt on kasutusel ka amifampridiini apteegipreparaadid, mis vähendab veelgi Firdapsega ravitavate patsientide arvu.
In addition, the CHMP required that an additional study should be carried out to confirm that the current recommended dose is the most appropriate dose.
Komitee nõudis, et lisauuringuga kinnitataks praeguse soovitatava annuse parimat sobivust.
In addition, the clinical response to treatment should be closely monitored in patients receiving Emtricitabine/Tenofovir disoproxil Zentiva at a prolonged dosing interval.
Lisaks tuleb hoolega jälgida kliinilist ravivastust nendel patsientidel, kellele manustatakse Emtricitabine/Tenofovir disoproxil Zentiva’t pikendatud manustamisintervalliga.
In addition, the clinical response to treatment should be closely monitored in patients receiving Truvada at a prolonged dosing interval.
Lisaks tuleb hoolega jälgida kliinilist ravivastust nendel patsientidel, kes saavad Truvada’t pikendatud manustamisintervalliga.
In addition, the Committee concluded that all patients should have their heart closely monitored after the first dose.
Inimravimite komitee järeldas ka, et kõikide patsientide südametegevust peab pärast esimest annust hoolikalt jälgima.
In addition, the company is conducting a five-year observational study to assess the longer-term effects of the medicine as well as a six-year observational study in children who were aged 2 to 5 years at the time of treatment start to assess long-term effects of early treatment.
Lisaks korraldab ettevõte 5-aastase vaatlusuuringu, et hinnata ravimi pikaajalist toimet, ning 6- aastase vaatlusuuringu lastel, kes olid ravi ajal 2–5-aastased, et hinnata varajase ravi pikaajalist toimet.
In addition, the company presented extensive supportive data from large studies and from clinical practice on how well other similar pandemic and seasonal live attenuated influenza A vaccines work in children.
Lisaks esitas ettevõte suurtest uuringutest ja kliinilisest praktikast pärinevad ulatuslikud toetavad andmed selle kohta, kuidas sarnased pandeemilised ja sesoonsed A-gripiviiruse nõrgestatud elusvaktsiinid lastel toimivad.
In addition, the company presented the results of studies looking at the level of protection in adults and in children for up to three years after vaccination with Ixiaro, and at the response to booster doses.
Ettevõte esitas ka nende uuringute tulemused, milles vaadeldi kaitsetaset täiskasvanutel ja lastel kuni 3 aasta jooksul pärast Ixiaroga vaktsineerimist, samuti reaktsiooni korduvannustele.
In addition, the company provided data from several studies comparing the overall survival of patients who had or who had not been previously treated and were given Yervoy at 3 mg per kg bodyweight.
Ettevõte esitas lisaks andmed mitmetest uuringutest, milles võrreldi varem ravitud või ravimata patsientide üldist elulemust, kui neile manustati Yervoyd annuses 3 mg kehamassi kg kohta.
In addition, the company provided data on 40 patients with CD30- positive HL, whose cancer had come back or had not responded to at least two prior therapies and who are not eligible for autologous stem cell transplant or multi-agent chemotherapy.
Peale selle esitas ettevõte andmed CD30-positiivse Hodgkini lümfoomiga 40 patsiendi kohta, kelle vähk oli taastunud või ei reageerinud vähemalt kahele varasemale ravikuurile ja kellel autoloogsete vereloome tüvirakkude siirdamine või keemiaravi mitme ravimiga ei olnud võimalik.
In addition, the company that makes Daliresp will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used.
Dalirespi tootja tagab ka, et ravimit määravad kõigi Euroopa Liidu liikmesriikide meditsiinitöötajad saavad ravimi kõrvalnähtude ja kasutamise teabematerjalid.
In addition, the company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used.
Daxase tootja tagab, et kõik ravimit määravad Euroopa Liidu liikmesriikide meditsiinitöötajad saavad ravimi kõrvalnähtude ja kasutamise teabematerjalid.
In addition, the company that makes Exjade must prepare an education pack for healthcare professionals.
Lisaks peab Exjadet tootev ettevõte koostama tervishoiuspetsialistidele teabepakme.
In addition, the company that makes Gilenya will carry out a study to assess the risk of side effects on the heart and circulation.
Gilenyat tootev ettevõte viib lisaks läbi uuringu, et hinnata kõrvalnähtude riski südamele ja vereringele.
In addition, the company that makes Imnovid will set up a pregnancy-prevention programme in each Member State.
Peale selle algatab Imnovidi tootja kõigis liikmesriikides raseduse vältimise programmi.
In addition, the company that makes Kineret will provide educational material for healthcare providers and for patients or their caregivers.
Kinereti tootja varustab lisaks tervishoiutöötajad, patsiendid või nende hooldajad teabematerjaliga.
In addition, the company that makes Libertek will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine’s side effects and how it should be used.
Dalirespi tootja tagab ka, et ravimit määravad kõigi Euroopa Liidu liikmesriikide meditsiinitöötajad saavad ravimi kõrvalnähtude ja kasutamise teabematerjalid.
In addition, the company that makes Lucentis will provide all clinics where Lucentis is expected to be used with information packs for doctors (including information on the measures needed to minimise the risk of infection associated with injections into the eye) and packs for patients (to help them prepare for Lucentis treatment, recognise serious side effects and know when to seek urgent attention from their doctor).
Lisaks esitab Lucentise tootja kõikidele kliinikutele, kus Lucentist võidakse kasutada, teabepakmed arstidele (mis sisaldavad silma süstimisega kaasneva infektsiooniohu minimeerimise meetmete teavet) ja patsientidele (mis aitavad neil valmistuda raviks Lucentisega, tunda ära raskeid kõrvalnähte ja teada, millal on vaja pöörduda viivitamatult arsti poole).
In addition, the company that makes Nulojix will include an alert card in each medicine’s pack to increase awareness of the benefits and risks with Nulojix.
Nulojixi tootev ettevõte varustab lisaks kõik ravimipakendid hoiatuskaardiga, et parandada teadlikkust Nulojixiga kaasnevatest riskidest ja kasuteguritest.
In addition, the company that makes Ozurdex will ensure that doctors who are expected to use Ozurdex will be provided with an information pack that will include diagrams showing how the injections are given and how to recognise serious side effects.
Samuti varustab Ozurdexi tootja Ozurdexi määravad arstid teabepakmega, mis sisaldab süstimisjuhistega skeeme ning teavet, kuidas tunda ära raskeid kõrvalnähte.
In addition, the company that makes Pradaxa will provide an educational pack for all doctors who are expected to prescribe the medicine, to increase awareness of the risk of bleeding and provide guidance on how to manage it.
Lisaks varustab Pradaxa tootja kõik ravimit määravad arstid teabepakmega, mis sisaldab teavet verejooksuriski ja selle kohta, kuidas selle korral toimida.
In addition, the company that makes Ruconest will ensure that healthcare professionals who are expected to prescribe Ruconest are provided with an educational pack containing information on the proper use of the medicine and warnings about the risk of allergy.
Samuti tagab Ruconesti tootja, et kõikides Euroopa Liidu liikmesriikides saavad kõik Ruconesti-ravi eeldatavasti määravad tervishoiutöötajad teabepakme, milles on ravimi õige kasutamise teave ja allergiariski hoiatus.
In addition, the company that makes Stayveer will provide an educational kit for prescribers and an information booklet for patients in each Member State, explaining the safety of Stayveer (especially its effects on the liver and in pregnancy) and its interactions.
Peale selle koostab Stayveeri tootev ettevõte iga liikmesriigi arstidele teabepakme ja patsientidele teabevoldiku, milles selgitatakse Stayveeri ohutust (eelkõige mõju maksale ja rasedusele) ning koostoimeid.
In addition, the company that makes Thymanax will supply educational material for doctors prescribing Thymanax.
Lisaks saadab Thymanaxi tootja seda ravimit määravatele arstidele teabematerjalid.
In addition, the company that makes Tracleer will provide an educational kit for prescribers and an information booklet for patients in each Member State, explaining the safety of Tracleer (especially its effects on the liver and in pregnancy) and its interactions.
Lisaks koostab Tracleeri tootja iga liikmesriigi arstidele teabepakme ja patsientidele teabevoldiku, milles selgitatakse ravimi ohutust (eelkõige mõju maksale ja rasedusele) ning koostoimeid.
In addition, the company that makes Valdoxan will supply educational material for doctors prescribing Valdoxan.
Lisaks saadab Valdoxani tootja seda ravimit määravatele arstidele teabematerjalid.
In addition, the company that makes Yervoy must ensure that all healthcare professionals expected to prescribe the medicine as well as patients are provided with a brochure with safety information on the medicine including the side effects related to the excessive activity of the immune system.
Yervoy tootja peab lisaks tagama, et nii ravimit tõenäoliselt välja kirjutavad meditsiinitöötajad kui ka patsiendid saavad brošüüri teabega ravimi ohutu kasutamise kohta, sealhulgas immuunsüsteemi ülemäärase aktiivsusega seotud kõrvalnähtude kohta.
In addition, the company that markets Abilify will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Abilify tootja varustab ka patsiendid, nende hooldajad ja arstid teabepakmega, mis selgitab ravimi ohutut kasutamist 13–17-aastastel patsientidel.
In addition, the company that markets Aripiprazole Accord will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Ravimi Aripiprazole Accord tootja varustab ka patsiendid, nende hooldajad ja arstid teabepakmega, mis selgitab ravimi ohutut kasutamist 13–17-aastastel patsientidel.
In addition, the company that markets Aripiprazole Mylan Pharma will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Aripiprazole Mylan Pharmai tootja varustab ka patsiendid, nende hooldajad ja arstid teabepakmega, mis selgitab ravimi ohutut kasutamist 13–17-aastastel patsientidel.
In addition, the company that markets Aripiprazole Zentiva will provide educational materials to be supplied to patients or their caregivers and to doctors to explain the safe use of the medicine in patients between 13 and 17 years.
Aripiprazole Zentiva tootja varustab ka patsiendid, nende hooldajad ja arstid teabepakmega, mis selgitab ravimi ohutut kasutamist 13–17-aastastel patsientidel.
In addition, the company that markets Cerdelga will provide doctors and patients with educational materials to ensure that only patients with type-1 Gaucher disease are treated with Cerdelga and that Cerdelga is not used together with other medicines which can significantly alter its blood levels.
Lisaks annab Cerdelgat turustav ettevõte arstidele ja patsientidele õppematerjalid tagamaks, et Cerdelgaga ravitakse ainult 1. tüüpi Gaucher' tõvega patsiente ja et Cerdelgat ei kasutata koos teiste ravimitega, mis võivad oluliselt muuta selle sisaldust veres.
In addition, the company that markets Cubicin will provide all doctors who are expected to use Cubicin with a dosage card to ensure the safe use of the medicine.
Lisaks tagab Cubicini turustav ettevõte kõigile Cubicini eeldatavasti määravatele arstidele annuste kaardi, et tagada ravimi ohutu kasutamine.
In addition, the company that markets Cyramza will carry out a study on the safety of Cyramza when used on its own for gastric cancer, including at doses higher than the approved dose, and a study to try to further characterise those patients with colorectal cancer who may respond better to Cyramza.
Lisaks korraldab Cyramza turustaja ravimi ohutusuuringu, milles uuritakse Cyramza kasutamist maovähi ainuravimina, sealhulgas heakskiidetust suuremates annustes, ning uuringu, millega püütakse selgitada, millistel kolorektaalvähiga patsientidel on Cyramza-ravi efektiivsem.
In addition, the company that markets Darzalex will provide educational material to all healthcare professionals expected to use the medicine, to inform them that the medicine can affect the result of a blood test (indirect Coombs test) used to determine suitability for blood transfusions.
Peale selle edastab Darzalexi turustav ettevõte kõigile ravimit eeldatavalt kasutavatele tervishoiutöötajatele teabematerjalid, et teavitada neid ravimi mõjust vereülekannete sobivuse määramiseks kasutatava vereanalüüsi (kaudse Coombsi testi) tulemusele.
In addition, the company that markets Deltyba will provide educational material for healthcare professionals, explaining how to use the medicine safely in order to avoid problems such as the development of resistance and side effects on the heart, as well as the risks in pregnancy or women who are breast-feeding.
Lisaks annab Deltyba turustaja teabematerjalid tervishoiutöötajatele, milles selgitatakse ravimi ohutut kasutamist, et vältida selliseid probleeme nagu resistentsuse tekkimine ja südame kõrvalnähud ning rasedus- ja imetamisaegsed riskid.
In addition, the company that markets Eliquis will provide educational material for healthcare professionals expected to prescribe Eliquis that addresses the risk of bleeding during treatment.
Lisaks esitab Eliquist turustav ettevõte tervishoiutöötajatele, kes Eliquist tõenäoliselt määravad, teabematerjalid veritsemise riski kohta ravi ajal.
In addition, the company that markets Esmya will ensure that doctors who are expected to prescribe this medicine receive educational material containing important safety information about Esmya, including recommendations for monitoring and managing endometrial changes that occur with Esmya treatment.
Lisaks tagab Esmya turustaja kõigile ravimit määravatele arstidele teabepakme, mis sisaldab Esmya ohutusteavet, sealhulgas soovitusi ravi ajal tekkivate endomeetriumi muutuste jälgimiseks ja raviks.
In addition, the company that markets Grastofil will carry out studies to confirm the long-term safety of Grastofil.
Lisaks sellele viib Grastofili turustav ettevõte läbi uuringud, et kinnitada Grastofili pikaajalise kasutamise ohutust.
In addition, the company that markets Iclusig will provide educational material for all doctors who are expected to prescribe this medicine highlighting important risks for which monitoring and dose adjustments are recommended.
Lisaks tagab Iclusigi turustav ettevõte kõigile ravimit eeldatavasti määravatele arstidele teabematerjali, mis tutvustab olulisi riske, mille korral jälgimine ja annuste kohandamine on soovitatavad.
In addition, the company that markets Jetrea must ensure that all healthcare professionals who are expected to use Jetrea receive an information pack containing key information on how to use the medicine as well as an information pack to be given to patients.
Lisaks tagab Jetrea tootja kõigile tervishoiutöötajatele, kes Jetreat eeldatavalt kasutavad, teabepakme, mis sisaldab ravimi kasutamise põhiteavet, samuti juhiseid patsientidele.
In addition, the company that markets Lixiana will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.
Lisaks varustab Lixianat turustav ettevõte ravimit määravad arstid teabematerjaliga ja patsiendid hoiatuskaartidega, milles selgitatakse ravimi kasutamisega kaasneva verejooksu riski ja kuidas seda kontrolli all hoida.
In addition, the company that markets Lynparza will carry out studies to further confirm the benefit, including long-term benefit of the medicine in patients with ovarian cancer.
Lisaks peab Lynparzat turustav ettevõte korraldama uuringud, et täiendavalt kinnitada ravimi kasulikkust, sealhulgas pikaajalist kasulikkust munasarjavähiga patsientidele.