FrancophonIA/ELRC3.0 huggingface dataset:
English: Actraphane 30 InnoLet 100 IU/ml Suspension for injection Insulin human
Estonian: Actraphane 30 InnoLet 100 RÜ/ml Süstesuspensioon Insulinum humanum s.c.
English: Actraphane 50 Penfill 100 IU/ml Suspension for injection Insulin human
Estonian: Actraphane 50 Penfill 100 RÜ/ml Süstesuspensioon kolbampullis Insulinum humanum
English: Actraphane 30 FlexPen 100 IU/ml Suspension for injection in pre-filled pen Insulin human
Estonian: Actraphane 30 FlexPen 100 RÜ/ml Süstesuspensioon pen-süstlis Insulinum humanum
English: Package leaflet: Information for the user Actraphane 30 100 IU/ml (international units/ml) suspension for injection in vial human insulin
Estonian: Pakendi infoleht: teave kasutajale Actraphane 30, 100 RÜ/ml (rahvusvahelist ühikut/ml) süstesuspensioon viaalis
English: Use the injection technique shown by your doctor or nurse.
Estonian: Kasutage arsti või diabeediõe poolt soovitatud süstimistehnikat.
English: Actraphane 40 Penfill 100 IU/ml Suspension for injection Insulin human
Estonian: Actraphane 40 Penfill 100 RÜ/ml Süstesuspensioon kolbampullis Insulinum humanum
English: Actraphane 30 InnoLet 100 IU/ml Suspension for injection in pre-filled pen Insulin human
Estonian: Actraphane 30 InnoLet 100 RÜ/ml Süstesuspensioon pen-süstlis Insulinum humanum
English: Actraphane 30 40 IU/ml Suspension for injection Insulin human
Estonian: Actraphane 30 40 RÜ/ml Süstesuspensioon Insulinum humanum
English: Pen cap
Estonian: Paberkleebik
English: Actraphane 30 Penfill 100 IU/ml Suspension for injection Insulin human
Estonian: Actraphane 30 Penfill 100 RÜ/ml Süstesuspensioon kolbampullis Insulinum humanum
English: Package leaflet: Information for the user Actraphane 30 Penfill 100 IU/ml (international units/ml) suspension for injection in cartridge human insulin
Estonian: Pakendi infoleht: teave kasutajale Actraphane 30 Penfill, 100 RÜ/ml (rahvusvahelist ühikut/ml) süstesuspensioon kolbampullis
English: ► After each injection, be sure to remove and discard the needle and store Actraphane without the needle attached.
Estonian: ► Pärast iga süstimist visake nõel ja süstal minema.
English: The needle should be kept under the skin for at least 6 seconds to make sure the entire dose is injected.
Estonian: Et kogu annus saaks kindlasti süstitud, tuleb nõela hoida naha all vähemalt 6 sekundit.
English: Actraphane contains sodium
Estonian: Actraphane sisaldab naatriumi
English: Checking the insulin flow F
Estonian: Insuliini väljavoolu kontrollimine
English: • Complete the other stages of injection without delay.
Estonian: • Pärast segamist sooritage otsekohe kõik järgmised ettevalmistused süstimiseks.
English: Discard the needle and syringe after each injection.
Estonian: Pärast iga süstimist visake nõel ja süstal ära.
English: Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Estonian: Vältimaks hüpoglükeemia kordumist on soovitav teadvuse taastudes manustada suu kaudu süsivesikuid.
English: Dispose of your used InnoLet carefully without the needle attached.
Estonian: Visake kasutatud InnoLet hoolikalt - ilma nõelata - minema.
English: Residual scale
Estonian: Jäägiskaala
English: Always keep the vial in the outer carton when you are not using it, in order to protect from light.
Estonian: Hoidke tagavaraks oleva ravimi viaali alati välispakendis valguse eest kaitstult.
English: Uncommon - Injection site reactions
Estonian: Aeg-ajalt - Süstekoha reaktsioonid
English: Actraphane 30 100 IU/ml Suspension for injection Insulin human
Estonian: Actraphane 30 100 RÜ/ml Süstesuspensioon Insulinum humanum
English: The first infusion lasts 15 minutes.
Estonian: Esimene infusioon kestab 15 minutit.
English: The European Commission granted a marketing authorisation valid throughout the EU for ATryn on 28 July 2006.
Estonian: Euroopa Komisjon andis ATryni müügiloa, mis kehtib kogu Euroopa Liidus, 28. juulil 2006.
English: This means that because the disease is rare, it has not been possible to obtain complete information about ATryn.
Estonian: See tähendab, et kuna haigus on haruldane, ei ole olnud võimalik ATryni kohta saada täielikku teavet.
English: What measures are being taken to ensure the safe and effective use of Atryn?
Estonian: Mis meetmed võetakse, et tagada ATryni ohutu ja efektiivne kasutamine?
English: The full EPAR for ATryn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ATryni kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: However, there was not enough information to identify the most appropriate dose to use during childbirth.
Estonian: Ei olnud siiski piisavalt teavet, et teha kindlaks sünnitusel kasutamiseks
English: However, this has not yet been seen in patients treated with ATryn.
Estonian: ATryniga ravitud patsientidel ei ole seda siiski seni täheldatud.
English: This is followed by a continuous infusion at a lower dose, during which the patients should be continually monitored and the infusion rate adjusted, so that the antithrombin activity is at least 80% of the normal level for the duration of treatment.
Estonian: Seejärel jätkatakse pidevinfusiooniga väiksemas annuses, mille kestel on vaja patsiente pidevalt jälgida ja infusioonikiirust kohandada, et antitrombiini aktiivsus oleks ravi ajal vähemalt 80% normaalsest.
English: This document is a summary of the European Public Assessment Report (EPAR) for ATryn.
Estonian: See on ravimi ATryn Euroopa avaliku hindamisaruande kokkuvõte.
English: What is the risk associated with ATryn?
Estonian: Mis riskid ATryniga kaasnevad?
English: In addition, ATryn was used in five patients who received the medicine during surgery in a ‘compassionate-use programme' (a programme through which doctors can request a medicine for one of their patients before it is authorised).
Estonian: Lisaks kasutati ATryni viiel patsiendil, kellele manustati operatsiooni ajal ravimit eriloaga kasutamise programmi raames (programm, mille kaudu arstid võivad taotleda ravimi kasutamist mõnel patsiendil enne ravimi müügiloa andmist).
English: The Committee decided that ATryn's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et ATryni kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: The company will also put in place, before launch in any European Union (EU) Member State, programmes to ensure that doctors can report information on the patients they treat and monitor the development of antibodies against ATryn.
Estonian: Enne ravimi mis tahes Euroopa Liidu liikmesriigi turule laskmist käivitab tootja ka programmid, millega annab arstidele võimaluse teatada ravitavatest patsientidest ja jälgida ATryni-vastaste antikehade tekkimist.
English: Few patients were treated during the study because congenital antithrombin deficiency is rare - it is estimated that only about one person in 3,000 to 5,000 has the condition.
Estonian: Uuringus osales vähe patsiente, sest antitrombiini kaasasündinud vaegus on haruldane ja esineb hinnanguliselt ühel 3000-5000 inimesest.
English: For more information about treatment with ATryn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ATryniga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: One study of ATryn was carried out in 14 patients aged between 21 and 74 years who had congenital antithrombin deficiency and were at risk of blood clot formation either during surgery (five patients) or during childbirth (nine patients).
Estonian: Üks ATryni uuring viidi läbi 14 patsiendil vanuses 21-74 aastat, kellel oli antitrombiini kaasasündinud vaegus ja tromboosi risk kas operatsioonil (viis patsienti) või sünnitusel (üheksa patsienti).
English: What information is still awaited for ATryn?
Estonian: Milliseid andmeid ATryni kohta veel oodatakse?
English: In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
Estonian: Antitrombiin blokeerib organismis trombiini - aine, millel on vere hüübimises keskne roll.
English: The active substance in ATryn, antithrombin alfa, is a copy of the natural blood protein antithrombin, which is produced by ‘recombinant DNA technology': it is extracted from the milk of goats that have had a gene (DNA) inserted, which makes them able to produce the human protein in their milk.
Estonian: ATryni toimeaine alfa-antitrombiin on loodusliku verevalgu antitrombiini analoog, mida valmistatakse rekombinant-DNA-tehnika abil: seda eraldatakse selliste kitsede piimast, kelle rakkudesse on lisatud geen (DNA), mis võimaldab tekitada nende piimas inimvalku.
English: See the package leaflet for full instructions.
Estonian: Üksikasjalikud juhised on pakendi infolehel.
English: ATryn must not be used in people who may be hypersensitive (allergic) to goat proteins or goat milk.
Estonian: ATryni ei tohi kasutada inimesed, kes on kitsevalkude või kitsepiima suhtes ülitundlikud (allergilised).
English: Because ATryn is a protein given by injection, patients could develop antibodies (proteins produced in response to the medicine), with a risk of an allergic reaction at the time of injection.
Estonian: Et ATryn on süstitav valk, võivad patsientidel tekkida antikehad (ravimile vastureaktsioonina tekkivad valgud), millega kaasneb allergilise reaktsiooni oht süstimisel.
English: For the full list of side effects and restrictions with ATryn, see the package leaflet.
Estonian: ATryni kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi
English: The doctor needs to calculate the doses to use, based both on the patient's weight and on the level of antithrombin activity.
Estonian: Arst peab arvutama kasutatava annuse nii patsiendi kehakaalu kui ka antitrombiini ravieelse aktiivsuse
English: The company that makes ATryn has provided the results of a study looking at the use of ATryn during childbirth in women with congenital antithrombin deficiency to the Agency, and will submit an application with the aim of adding treatment during childbirth to the medicine's marketing authorisation.
Estonian: ATryni tootja saatis ravimiametile sellise uuringu tulemused, milles vaadeldi ATryni kasutamist antitrombiini kaasasündinud vaegusega rasedatel sünnituse ajal, ning ettevõtja esitab taotluse müügiloale näidustuse „ravimi kasutamine sünnitamisel“ lisamiseks.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for ATryn.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: In studies, the most common side effects with ATryn (seen in between 1 and 10 patients in 100) were dizziness, headache, haemorrhage (bleeding, including bleeding at the site of the injection or after surgery), nausea (feeling sick) and wound secretion (discharge from the surgical wound).
Estonian: Uuringutes olid ATryni kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) peapööritus, peavalu, veritsus (sh süstekoha veritsus või operatsioonijärgne veritsus), iiveldus ja operatsioonihaava
English: Patients who have congenital antithrombin deficiency have low blood antithrombin levels and are therefore at increased risk of having blood clots.
Estonian: Antitrombiini kaasasündinud vaegusega patsientidel on antitrombiini sisaldus veres normaalsest väiksem ja sellepärast on neil suurem trombide tekke risk.
English: In the study, among the 13 patients in whom the effectiveness of the treatment could be assessed, two had an episode of DVT, of which only one needed treatment.
Estonian: Uuringu ajal tekkis süvaveenitromboos 2 patsiendil 13st, kelle ravi efektiivsust sai hinnata, ja neist vaid üks vajas ravi.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atryn have been included in the summary of product characteristics and the package leaflet.
Estonian: ATryni omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi ohutu ja tõhusa kasutamise teave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: In the compassionate-use programme, no blood clots were seen in the patients receiving ATryn.
Estonian: Eriloaga kasutamise programmi raames ei täheldatud ATryni saanud patsientidel trombide tekkimist.
English: ATryn has been authorised under ‘exceptional circumstances'.
Estonian: ATryni müügiluba anti erandkorras.
English: ATryn is normally given with heparin (another medicine that helps to prevent blood clots).
Estonian: ATryni manustatakse tavaliselt koos hepariiniga (teine vere
English: How does ATryn work?
Estonian: Kuidas ATryn toimib?
English: The CHMP concluded that the information provided by the company had shown that ATryn can bring the antithrombin activity up to an acceptable level when used at the recommended dose during surgery.
Estonian: Inimravimite komitee järeldas, et ettevõtte esitatud andmed tõendavad, et ATryn, kasutatuna operatsiooni ajal ja vastavalt soovitustele arvutatud annuses, suurendab antitrombiini aktiivsust vastuvõetavale väärtusele.
English: The studies measured how many patients developed deep vein thrombosis (DVT, formation of a blood clot in a deep vein, usually in the leg) during the 30 days after treatment.
Estonian: Uuringutes jälgiti, mitmel patsiendil tekkis kuni 30 päeva jooksul pärast ravi süvaveenitromboos (trombi teke süvaveenis, tavaliselt jalas).
English: Treatment with ATryn should only be started by doctors who are experienced in treating patients with congenital antithrombin deficiency.
Estonian: Ravi ATryniga tohib alustada üksnes antitrombiini kaasasündinud vaeguse ravis kogenud arst.
English: ATryn is a powder that is made up into a solution for infusion (drip) into a vein.
Estonian: ATryn on infusioonilahuse (veeni tilgutatava lahuse) pulber.
English: ATryn is an anticlotting agent.
Estonian: ATryn on hüübimisvastane aine.
English: It is used when the patients are having surgery, to prevent problems due to the formation of blood clots.
Estonian: Atryni kasutatakse patsientide kirurgilise operatsiooni ajal, et ennetada trombidest (soonesisestest verehüüvetest) tulenevaid probleeme.
English: ATryn corrects the antithrombin deficiency, and gives temporary control of the clotting disorder.
Estonian: ATryn korrigeerib antitrombiini vaegust ja kõrvaldab
English: What benefit has ATryn shown during the studies?
Estonian: Milles seisneb uuringute põhjal ATryni kasulikkus?
English: It contains the active substance antithrombin alfa.
Estonian: Ravim sisaldab toimeainena alfa
English: ATryn is used in adults who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Estonian: ATryni kasutatakse antitrombiini (teatud valgu) kaasasündinud vaegusega täiskasvanutel.
English: Taken together, the results support the effectiveness of ATryn in preventing blood clot development in patients having surgery.
Estonian: Kokkuvõttes tõendavad need tulemused ATryni efektiivsust trombide tekke ennetamisel operatsiooni ajal.
English: It contains important information about how to take these two medicines.
Estonian: See sisaldab tähtsat teavet selle kohta, kuidas neid kaht ravimit võtta.
English: Median (min, max)
Estonian: Mediaan (min, max)
English: The other ingredients are:
Estonian: • Teised koostisosad on:
English: Currently available data are described in sections 4.4, 4.8 and 5.1, but no recommendation on a posology can be made.
Estonian: Antud hetkel teadaolevad andmed on esitatud lõikudes 4.4, 4.8 ja 5.1, aga soovitusi annustamise kohta ei ole võimalik anda.
English: Peri- and post-natal development
Estonian: Peri- ja postnataalne areng
English: • Nipple changes or pain
Estonian: • nibude muutused või valu
English: It may be better to avoid using Kalydeco during pregnancy, if possible, and your doctor will help you decide what is best for you and your child.
Estonian: Võib olla parem vältida Kalydeco kasutamist raseduse ajal, kui võimalik, ning teie arst aitab teil otsustada, mis on teile ja teile lapsele kõige parem.
English: Not all pack sizes may be marketed
Estonian: Kõik pakendi suurused ei pruugi olla müügil.
English: The potential relevance of these findings in humans is unknown.
Estonian: Nende leidude võimalik asjakohasus inimese puhul ei ole teada.
English: Kalydeco with food and drink
Estonian: Kalydeco koos toidu ja joogiga
English: As such, a risk to the newborns/infants cannot be excluded.
Estonian: Riski vastsündinutele/imikutele ei saa seega välistada.
English: * Values based on data from a single patient; standard deviation not reported.
Estonian: * Väärtused ühe patsiendi andmete põhjal; standardhälvet ei esitatud.
English: Take the tablets approximately 12 hours apart.
Estonian: Võtke tablette ligikaudu 12-tunniste vahedega.
English: Date of first authorisation: 23 July 2012 Date of latest renewal: 28 April 2017
Estonian: Müügiloa esmase väljastamise kuupäev: 23. juuli 2012 Müügiloa viimase uuendamise kuupäev: 28. aprill 2017
English: Adults (≥ 18 years old) n = 389
Estonian: Täiskasvanud (≥ 18 aastat) n = 389
English: Similar results to part 1 were seen in part 2 of the study.
Estonian: I osaga sarnaseid tulemusi täheldati ka uuringu II osas.
English: Kalydeco dosing recommendations are provided in Table 1.
Estonian: Kalydeco annustamissoovitused on esitatud tabelis 1.
English: Although other risk factors were present in some cases (such as corticosteroid use and exposure to radiation), a possible risk attributable to treatment cannot be excluded.
Estonian: Kuigi mõnel juhul esines ka teisi riskitegureid (näiteks kortikosteroidide kasutamine ja kokkupuude kiirgusega), ei saa raviga kaasnevat võimalikku riski välistada.
English: Each sachet is for single use only.
Estonian: Iga kotike on ainult ühekordseks kasutamiseks.
English: Other medicinal products for which exposure may be increased include glimepiride and glipizide; these medicinal products should be used with caution.
Estonian: Muude ravimite hulka, mille korral võib ekspositsioon suureneda, kuuluvad glimepiriid ja glipisiid; neid ravimeid tuleb kasutada ettevaatusega.
English: For patients who rolled over from study 2 the number of events was, overall, low.
Estonian: 2. uuringust ületoodud patsientidel oli juhtude arv üldjuhul väike.
English: Lift here to open
Estonian: Avamiseks tõstke siit
English: * Treatment occurred during blinded, controlled, 48-week Phase 3 study.
Estonian: * Ravi toimus pimendatud, kontrollitud, 48-nädalase III faasi uuringu käigus.
English: Patients should be instructed to swallow the tablets whole.
Estonian: Patsiente tuleb juhendada, et tabletid tuleb alla neelata tervelt.
English: Pharmacotherapeutic group: Other respiratory system products, ATC code: R07AX02
Estonian: Farmakoterapeutiline rühm: teised hingamissüsteemi toimivad ained, ATC-kood: R07AX02
English: Juvenile animal studies
Estonian: Noorloomade uuringud
English: Study 4: open-label extension study
Estonian: 4. uuring: avatud jätku-uuring
English: Other fat-containing foods are:
Estonian: Teised rasva sisaldavad toidud on:
English: Therefore, liver function tests are recommended for all patients prior to initiating ivacaftor, every 3 months during the first year of treatment and annually thereafter.
Estonian: Seetõttu on soovitatav teha kõikidel patsientidel maksafunktsioonide analüüse enne ivakaftoorravi alustamist, iga 3 kuu järel ravi esimesel aastal ja seejärel kord aastas.
English: Other forms of this medicine (granules in sachet) are more suitable for children under 6 years of age; ask your doctor or pharmacist.
Estonian: Selle ravimi teised vormid (graanulid kotikestes) sobivad paremini kasutamiseks alla 6-aastastel lastel; pidage nõu oma arsti või apteekriga.
English: If this is not possible, give it within the following hour after mixing.
Estonian: Kui see ei ole võimalik, manustage see ühe tunni jooksul pärast segamist.
English: If not immediately consumed, the mixture has been shown to be stable for one hour and therefore should be ingested during this period.
Estonian: Kui segu kohe ei tarbita, püsib see tõestatult stabiilsena ühe tunni jooksul ja tuleb seetõttu selle aja jooksul ära tarbida.
English: Absolute change at week 24
Estonian: Absoluutne muutus 24. nädalaks
English: Morning
Estonian: Hommik
English: Use within one hour after mixing, just before or after a fat-containing meal or snack.
Estonian: Kasutage ühe tunni jooksul pärast segamist, vahetult enne või pärast rasva sisaldava eine või suupiste söömist.
English: An open-label, rollover, 96 week study is on-going to evaluate the long-term safety and efficacy of the combination regimen in both patient populations.
Estonian: Pooleliolevas avatud, 96-nädalases ülemineku-uuringus hinnatakse kombinatsioonravi pikaajalist efektiivsust ja ohutust mõlemas patsientide populatsioonis.
English: Mutation (n)
Estonian: Mutatsioon (n)
English: There were no additional improvements in study 4 (week 48 through week 144).
Estonian: 4. uuringus täiendavat paranemist (48. nädalast 144. nädalani) ei toimunud.
English: Once mixed, the mixture has been shown to be stable for one hour.
Estonian: Pärast segamist püsib segu tõestatult stabiilsena ühe tunni jooksul.
English: 12- to 17-year-olds n = 97
Estonian: 12 kuni 17 aastat n = 97
English: In such cases, the starting dose should be as above recommended, but administered every other day.
Estonian: Sellistel juhtudel peab algannus olema nagu eespool soovitatud, kuid manustamisega üle päeva.
English: Infants aged at least 6 months, toddlers, children, adolescents and adults should be dosed according to Table 1.
Estonian: Annustamisel vähemalt 6 kuu vanustele imikutele, väikelastele, lastele, noorukitele ja täiskasvanutele tuleb järgida tabelit 1.
English: Relative risk of pulmonary exacerbation
Estonian: Pulmonaalse ägenemise suhteline risk
English: For all patients with a history of transaminase elevations, more frequent monitoring of liver function tests should be considered.
Estonian: Kõikidel patsientidel, kellel on esinenud transaminaaside sisalduse suurenemist, tuleb kaaluda maksafunktsiooni analüüside sagedamat jälgimist.
English: The tablets should not be chewed, crushed, or broken before swallowing.
Estonian: Tablette ei tohi enne allaneelamist närida, purustada ega osadeks murda.
English: Treatment of overdose consists of general supportive measures including monitoring of vital signs, liver function tests and observation of the clinical status of the patient.
Estonian: Üleannustamise raviks on üldine toetav ravi, sealhulgas elutähtsate näitude, maksafunktsiooni analüüside ja patsiendi kliinilise seisundi jälgimine.
English: Other medicines and Kalydeco
Estonian: Muud ravimid ja Kalydeco
English: Digoxin and other P-gp substrates
Estonian: Digoksiin ja muud P-gp substraadid
English: 7 tablets
Estonian: 7 tabletti
English: 12- to 17-year-olds
Estonian: 12 kuni 17 aastat
English: In study 5, four patients with the G970R mutation were included.
Estonian: Uuringusse 5 kaasati neli G970R-mutatsiooniga patsienti.
English: Contents of the pack and other information What Kalydeco contains
Estonian: Pakendi sisu ja muu teave Mida Kalydeco sisaldab
English: • Pain or discomfort in the upper right stomach (abdominal) area
Estonian: • valu või ebamugavustunne kõhu parema ülaosa piirkonnas
English: No statistical analysis was conducted for subjects 12 to 17 years of age because only 2 patients were enrolled in this study.
Estonian: Uuringus osalejate kohta vanuses 12 kuni 17 aastat statistilist analüüsi läbi ei viidud, sest sellesse uuringusse kaasati ainult 2 patsienti.
English: Ivacaftor is approximately 99% bound to plasma proteins, primarily to alpha 1-acid glycoprotein and albumin.
Estonian: Ivakaftoor seondub ligikaudu 99% plasmavalkudega, eelkõige alfa-1-happelise glükoproteiini ja albumiiniga.