FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that BeneFIX's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et BeneFIXi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
English: BeneFIX is given by a slow injection into a vein, usually at up to 4 ml per minute and should not be mixed with other infusion solutions or given using a kit other than the one supplied with the medicine.
Estonian: BeneFIXi manustatakse aeglase infusioonina veeni (tavaliselt kuni 4 ml minutis) ja seda ei tohi segada teiste süstelahustega ega manustada muude kui üksnes ravimiga kaasas olnud vahenditega.
English: The dose and the frequency of injection depend on whether BeneFIX is used to treat or prevent bleeding, or to reduce bleeding during surgery, and on the patient's condition.
Estonian: Ravimi annus ja manustamissagedus sõltuvad sellest, kas BeneFIXi kasutatakse verejooksude ravimiseks või ennetamiseks või verejooksu vähendamiseks operatsiooni ajal, samuti patsiendi seisundist.
English: If antibodies develop, BeneFIX will not work effectively, which may result in a loss of bleeding control.
Estonian: Kui tekivad antikehad, ei toimi BeneFIX efektiivselt ega pruugi piirata veritsust.
English: The lack of factor IX causes blood-clotting problems, such as bleeding in the joints, muscles and internal organs.
Estonian: IX hüübimisteguri vaegus põhjustab hüübimishäireid, näiteks verejookse liigestes, lihastes ja siseelundites.
English: For more information about treatment with BeneFIX, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate BeneFIXiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BeneFIX, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati BeneFIXi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: BeneFIX is used to replace the missing factor IX.
Estonian: BeneFIXi kasutatakse puuduva IX hüübimisteguri asendajana.
English: This document is a summary of the European Public Assessment Report (EPAR) for BeneFIX.
Estonian: See on ravimi BeneFIX Euroopa avaliku hindamisaruande kokkuvõte.
English: nonacog alfa
Estonian: alfanonakog
English: Nonacog alfa is not extracted from human blood but produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce human coagulation factor IX.
Estonian: Alfanonakogi ei eraldata inimverest, vaid valmistatakse rekombinant-DNA-tehnika abil: seda tekitavad rakud, millele on lisatud IX inimhüübimisteguri teket võimaldav geen (DNA).
English: The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery.
Estonian: Annust kohandatakse sõltuvalt verejooksu raskusest ja asukohast ning operatsiooni liigist.
English: The studies assessed the number of bleeding episodes that occurred and rated BeneFIX's effectiveness using a scale from ‘no response' to ‘excellent'.
Estonian: Uuringutes hinnati esinenud veritsusjuhtude arvu ja BeneFIXi efektiivsus määrati hinnanguskaalal „ravivastus puudub” kuni „väga hea”.
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 BeneFIX.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: BeneFIX is a medicine that contains the active substance nonacog alfa.
Estonian: BeneFIX on ravim, mis sisaldab toimeainena alfanonakogi.
English: Patients or their carers can give injections of BeneFIX, provided that they have been trained appropriately.
Estonian: Kui patsient või hooldaja on saanud asjakohase väljaõppe, võib ta BeneFIXi süstida ka ise.
English: It corrects the factor IX deficiency and gives temporary control of the bleeding disorder.
Estonian: See korrigeerib IX hüübimisteguri vaegust ning võimaldab hüübimishäiret ajutiselt leevendada.
English: Full details on how to calculate the dose are included in the summary of product characteristics.
Estonian: Üksikasjalik teave annuste arvutamise kohta on ravimi omaduste kokkuvõttes.
English: It has also been studied in patients who have not received any treatment for their haemophilia.
Estonian: Uuriti ka ravimi toimet neile hemofiiliaga patsientidele, kes ei olnud varem ravi saanud.
English: For the full list of all side effects reported with BeneFIX, see the package leaflet.
Estonian: BeneFIXi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Patients with haemophilia B may also develop neutralising antibodies (inhibitors) to factor IX.
Estonian: B-hemofiiliaga patsientidel võivad tekkida ka IX hüübimisfaktori suhtes neutraliseerivad antikehad (inhibiitorid).
English: BeneFIX has been studied in previously treated patients with moderate or severe haemophilia B for prevention or to treat bleeding episodes during and after surgery.
Estonian: BeneFIXi toimet uuriti varem ravitud mõõduka või raske B-hemofiiliaga patsientide ennetusravis või operatsiooniaegsete või -järgsete verejooksude ravis.
English: What is the risk associated with BeneFIX?
Estonian: Mis riskid BeneFIXiga kaasnevad?
English: The active substance in BeneFIX, nonacog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot).
Estonian: BeneFIXi toimeaine alfanonakog on vere hüübimistegurina toimiv valk (aine, mis aitab verel hüübida).
English: It is available as a powder and solvent that are mixed together to form a solution for injection.
Estonian: Seda turustatakse pulbri ja lahustina, millest segatakse kokku süstelahus.
English: BeneFIX must not be used in people who are hypersensitive (allergic) to recombinant coagulation factor IX, to any of the other ingredients, or to hamster proteins.
Estonian: BeneFIXi ei tohi kasutada patsiendid, kes on inimese IX hüübimisteguri, mis tahes muu koostisaine või hamstriproteiinide suhtes ülitundlikud (allergilised).
English: Why has BeneFIX been approved?
Estonian: Miks BeneFIX heaks kiideti?
English: BeneFIX should be started by a doctor who has experience in the treatment of haemophilia.
Estonian: Ravi BeneFIXiga tohib alustada üksnes hemofiilia ravis kogenud arst.
English: Patients with haemophilia B lack a protein called factor IX, which is involved in blood clotting.
Estonian: B-hemofiiliaga patsientidel on vere hüübimises osaleva valgu IX hüübimisteguri vaegus.
English: Hypersensitivity (allergic) reactions have been seen in patients treated with products containing factor IX and may sometimes be severe.
Estonian: IX hüübimisfaktorit sisaldavad ravimid on tekitanud patsientidel ülitundlikkusreaktsioone, mis võivad olla rasked.
English: How is BeneFIX used?
Estonian: Kuidas BeneFIXi kasutatakse?
English: What is BeneFIX used for?
Estonian: Milleks BeneFIXi kasutatakse?
English: BeneFIX is used for the treatment and prevention of bleeding in adults and children with haemophilia B (an inherited bleeding disorder).
Estonian: BeneFIXi kasutatakse B-hemofiiliaga (teatud pärilik hüübimishäire) täiskasvanute ja laste hüübimishäire ravimiseks ja ennetamiseks.
English: How has BeneFIX been studied?
Estonian: Kuidas BeneFIXi uuriti?
English: What benefit has BeneFIX shown during the studies?
Estonian: Milles seisneb uuringute põhjal BeneFIXi kasulikkus?
English: What is BeneFIX?
Estonian: Mis on BeneFIX?
English: 90 (3 x 30) tablets (multipack)
Estonian: 90 (3 x 30) tabletti (hulgipakend)
English: (Invented) name Strength Pharmaceutical Form
Estonian: Tugevus Ravimvorm
English: Inovelon contains the active substance rufinamide and has been authorised since January 2007.
Estonian: Inovelon sisaldab toimeainena rufinamiidi ja sellel on müügiluba alates 2007. aasta jaanuarist.
English: What is Inovelon?
Estonian: Mis on Inovelon?
English: By attaching to these channels, rufinamide prevents them from becoming activated.
Estonian: Kanalitele kinnitudes takistab rufinamiid nende üleminekut aktiivsesse seisundisse.
English: Lennox-Gastaut syndrome is one of the most severe forms of epilepsy in children.
Estonian: Lennoxi-Gastaut' sündroom on üks raskemaid lastel esinevaid epilepsia vorme.
English: More information about Inovelon is available on EMA's website.
Estonian: Lisateave Inoveloni kohta on Euroopa Ravimiameti veebilehel.
English: EMA/848709/2016
Estonian: 16. detsember 2016. a. EMA/848709/2016
English: How does Inovelon work?
Estonian: Kuidas Inovelon toimib?
English: The study investigated the safety of Inovelon and also its impact on the child's behavioural and emotional development assessed by the patient's parent or guardian on a standardised scoring system.
Estonian: Uuringus uuriti Inoveloni ohutust ning selle mõju lapse käitumuslikule ja emotsionaalsele arengule, mida hindas patsiendi vanem või eestkostja standardse hindamissüsteemi alusel.
English: This reduces the likelihood of a seizure occurring.
Estonian: See vähendab epilepsiaepisoodide esinemise tõenäosust.
English: It is currently approved only for children aged 4 years or older.
Estonian: Ravimi kasutamine on praegu heaks kiidetud vaid vähemalt 4aastastel lastel.
English: Its signs and symptoms include multiple types of seizures (fits), abnormal electrical activity in the brain, learning disability and behavioural problems.
Estonian: Selle sümptomite hulka kuuluvad mitut liiki epilepsiaepisoodid, aju elektrilise talitluse häired, õppimishäired ja käitumisprobleemid.
English: What is happening with Inovelon for the treatment of other diseases?
Estonian: Kuidas mõjutab taotluse tagasilükkamine Inoveloni kasutamist teiste haiguste raviks?
English: However, the CHMP considered that including the data obtained in these children in Inovelon's product information could help the healthcare professionals who manage them.
Estonian: Siiski leidis inimravimite komitee, et nende laste kohta saadud andmete lisamine Inoveloni ravimiteabesse võiks aidata tervishoiutöötajatel neid patsiente ravida.
English: The active substance in Inovelon, rufinamide acts by attaching to special channels on the surface of brain cells (sodium channels), which control their electrical activity.
Estonian: Inoveloni toimeaine rufinamiid kinnitub teatud ajurakkude pinnal olevatele kanalitele (naatriumikanalitele), mis reguleerivad rakkude elektrilist talitlust.
English: While the study showed that the safety of Inovelon in patients aged 1 to less than 4 years was consistent with the known safety profile in older children, the CHMP concluded that the study was too small to make conclusions on the medicine's effectiveness.
Estonian: Kuigi uuringust ilmnes, et Inoveloni ohutus 1 kuni alla 4 aasta vanustel patsientidel oli kooskõlas teadaoleva ohutusprofiiliga vanematel lastel, pidas inimravimite komitee uuringut ravimi efektiivsuse kohta järelduste tegemiseks liiga väikesemahuliseks.
English: The company also proposed a way to make predictions on the use of Inovelon in children aged between 1 and 4 years based on existing data in patients aged 4 years and older.
Estonian: Lisaks pakkus ettevõte välja viisi, kuidas prognoosida Inoveloni kasutamist 1-4 aasta vanustel lastel, tuginedes üle 4aasta vanuste laste kohta olemasolevatele andmetele.
English: The company presented data from a study in which 37 children aged between 1 and 4 years with Lennox-Gastaut syndrome received either Inovelon or another epilepsy medicine in addition to their existing treatment.
Estonian: Ettevõte esitas andmed ühest uuringust, kus 37-le Lennoxi-Gastaut' sündroomiga lapsele vanuses 14 aastat manustati lisaks senisele ravile Inoveloni või muud epilepsiaravimit.
English: Regarding the data that the company used to make predictions for use in children aged 1 to less than 4 years, the CHMP considered that further analyses were needed in order to make dosing recommendations in the younger age group.
Estonian: Seoses andmetega, mida ettevõte kasutas 1 kuni alla 4 aasta vanustel lastel kasutamise prognoosimiseks, leidis inimravimite komitee, et nooremas vanuserühmas annustamissoovituste andmiseks on vaja lisaanalüüse.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of the epilepsy medicine Inovelon to children aged 1 to 4 years.
Estonian: Inimravimite komitee vaatas läbi taotluse laiendada epilepsiaravimi Inovelon kasutamist 1-4aastastele lastele.
English: There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Inovelon.
Estonian: Selle taotluse tulemused ei mõjuta praegu või tulevikus Inoveloni kliinilistes uuringutes osalevaid patsiente.
English: and prevents abnormal electrical activity from spreading through the brain.
Estonian: ära elektrilise talitluse häirete levimise üle kogu aju.
English: What was Inovelon expected to be used for?
Estonian: Milleks kavatseti Inoveloni kasutada?
English: Inovelon is used for treating Lennox-Gastaut syndrome, a rare type of epilepsy that usually affects children but can continue into adulthood.
Estonian: See sündroom on harvaesinev epilepsia vorm, millesse haigestuvad tavaliselt lapsed, kuid see võib püsida ka täiskasvanueas.
English: There are no consequences on the use of Inovelon in patients with Lennox-Gastaut syndrome aged 4 years and over.
Estonian: Puudub igasugune mõju Inoveloni kasutamisele üle 4aastaste patsientide Lennoxi-Gastaut' sündroomi raviks.
English: The CHMP therefore concluded that based on the currently available data, Inovelon could not be approved for patients with Lennox-Gastaut syndrome aged less than 4 years.
Estonian: Seega jõudis inimravimite komitee järeldusele, et Inoveloni kasutamist alla 4aastaste patsientide Lennoxi-Gastaut' sündroomi raviks ei ole praeguse teabe põhjal võimalik heaks kiita.
English: Inovelon was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 20 October 2004 for Lennox-Gastaut syndrome.
Estonian: 20. oktoobril 2004 nimetati Inovelon Lennoxi-Gastaut' sündroomi harvikravimiks (ravim, mida kasutatakse harvaesinevate haiguste korral).
English: The company that markets Inovelon applied for it to be used to treat Lennox-Gastaut syndrome in children aged 1 to 4 years.
Estonian: Inoveloni turustav ettevõte taotles ravimi näidustuste laiendamist 1-4aastaste laste Lennoxi-Gastaut' sündroomi raviks.
English: However, the Committee considered that the data could be important for healthcare professionals and recommended their inclusion in Inovelon's product information.
Estonian: Inimravimite komitee leidis, et praegused andmed ei ole selle muudatuse soovitamiseks piisavad, kuid arvas, et need andmed võivad olla tervishoiutöötajatele olulised, ja soovitas need lisada Inoveloni ravimiteabesse.
English: 16 December 2016 EMA/848709/2016 EMEA/H/C/II/0037
Estonian: EMEA/H/C/II/0037
English: This dampens down the activity of the brain cells
Estonian: See muudab ajurakkude talitluse loiuks ja hoiab
English: This will prevent misuse and help to protect the environment.
Estonian: See väldib ravimi väärkasutamist ja aitab kaitsta keskkonda.
English: It is used when the cancer:
Estonian: Seda kasutatakse siis, kui vähk:
English: Similar findings were not observed after a 16 week recovery period.
Estonian: Sarnaseid leide ei täheldatud pärast 16-nädalast taastumisperioodi.
English: The median age for all patients was 72 years.
Estonian: Kõikide patsientide mediaanvanus oli 72 aastat.
English: Key data are summarised in Table 2:
Estonian: Põhiandmete kokkuvõte on toodud tabelis 2:
English: You must also use one barrier method, such as:
Estonian: Samuti peate kasutama ühte barjäärimeetodit, näiteks:
English: Always take Erivedge exactly as your doctor has told you.
Estonian: Võtke Erivedge't alati täpselt nii, nagu arst on teile selgitanud.
English: Date of latest renewal: 26 May 2016
Estonian: Müügiloa viimase uuendamise kuupäev: 26. mai 2016
English: Like all medicines, Erivedge can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka Erivedge põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: Stop using Erivedge and seek medical attention immediately if you notice any of the symptoms described in section 4.
Estonian: Lõpetage Erivedge kasutamine ja otsige kohe arstiabi, kui märkate mis tahes sümptomit, mida on kirjeldatud lõigus 4.
English: Treatment interruptions of up to 4 weeks were allowed based on individual tolerability.
Estonian: Lubatud olid kuni 4-nädalased ravi katkestused individuaalsest taluvusest lähtuvalt.
English: Patients should be instructed never to give this medicinal product to another person.
Estonian: Patsiente tuleb juhendada, et nad ei annaks seda ravimit kunagi ühelegi teisele inimesele.
English: If this happens to you, it is not known if your periods will come back.
Estonian: Kui see juhtub teiega, siis ei ole teada, kas menstruatsioonid algavad uuesti.
English: Pregnancy tests should have a minimum sensitivity of 25 mIU/mL as per local availability.
Estonian: Rasedustesti minimaalne tundlikkus peab olema 25 mIU/ml vastavalt kohalikule kättesaadavusele.
English: Do not stop taking this medicine without talking to your doctor first as this could make your treatment less effective.
Estonian: Ärge lõpetage selle ravimi võtmist ilma kõigepealt arstiga nõu pidamata, sest selle tulemusena võib ravi olla vähem tõhus.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 July 2013
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 12. juuli 2013
English: • within a maximum of 7 days before starting treatment - to make sure that you are not already pregnant
Estonian: • maksimaalselt 7 päeva jooksul enne ravi alustamist - veendumaks, et te ei ole juba rase
English: Amongst these women, amenorrhoea was observed in 3 patients (30 %).
Estonian: Nende naiste seas täheldati amenorröad 3 patsiendil (30 %).
English: This may slow down or stop the growth of the cancer cells, or may kill them.
Estonian: See võib aeglustada või peatada vähirakkude kasvu või rakud surmata.
English: Many of these genes are involved in proliferation, survival, and differentiation.
Estonian: Paljud nendest geenidest osalevad rakkude proliferatsioonis, elulemuses ja diferentseerumises.
English: As a result, your skin cancer may shrink.
Estonian: Selle tulemusena võib nahavähk kahaneda.
English: Although the number of identified cases is limited, the reactions are serious and the association with vismodegib is plausible.
Estonian: Ehkki tuvastatud juhtude arv on piiratud, on tegemist tõsiste reaktsioonidega, ja nende seos vismodegiibi kasutamisega on usutav.
English: • If she becomes pregnant or think for any reason that she may be pregnant,
Estonian: • kui ta rasestub või arvab mis tahes põhjusel, et võib olla rase,
English: The median age of the efficacy evaluable population was 62 years (46 % were at least 65 years old), 61 % male and 100 % White.
Estonian: Keskmine vanus efektiivsuse hindamiseks sobivas populatsioonis oli 62 aastat (46 % olid vähemalt 65-aastased), 61 % olid mehed ja 100 % valge rassi esindajad.
English: Please refer to these documents for further information.
Estonian: Lisateabe saamiseks tutvuge palun nende dokumentidega.
English: • use 2 methods of contraception, one highly effective method and one barrier method (please see the examples below)
Estonian: • kasutage kahte rasestumisvastast meetodit - ühte väga tõhusat meetodit ja ühte barjäärimeetodit (palun vt näited allpool)
English: You must not become pregnant while taking this medicine (see section 2, “Do not take Erivedge” and “Pregnancy, breast-feeding and fertility”).
Estonian: Te ei tohi selle ravimi võtmise ajal rasestuda (vt lõik 2 „Ärge võtke Erivedge't“ ning „Rasedus, imetamine ja viljakus“).
English: Do not take Erivedge
Estonian: Ärge võtke Erivedge't
English: • has menstruated at any time during the previous 12 consecutive months,
Estonian: • kellel on menstruatsioonid esinenud mis tahes ajal eelneva 12 järjestikuse kuu jooksul,
English: This can happen even after stopping Erivedge.
Estonian: See võib tekkida isegi pärast Erivedge-ravi lõpetamist.
English: Objective response was defined as a complete or partial response determined on two consecutive assessments separated by at least 4 weeks.
Estonian: Objektiivset ravivastust defineeriti kui täielikku või osalist ravivastust, määratuna kahel järjestikusel hindamisel vähemalt 4-nädalase vahega.
English: OTHER SPECIAL WARNINGS, IF NECESSARY Risk of severe birth defects
Estonian: TEISED ERIHOIATUSED (VAJADUSEL) Raskete väärarengute risk
English: 3 patients had a best percent change in tumour size of 0; these are represented by minimal positive bars in the figure.
Estonian: Kolmel patsiendil oli kasvaja suuruse parim protsentuaalne muutus 0; seda näitavad väikseimad positiivsed tulbad joonisel.
English: Ex vivo plasma protein binding in human patients is > 99 %.
Estonian: Ex vivo seonduvus plasmavalkudega inimestel on > 99 %.
English: Due to safety concerns (see sections 4.4 and 5.3), this medicinal product should not be used in children and adolescents aged below 18 years.
Estonian: Ohutuskaalutlustel (vt lõigud 4.4 ja 5.3) ei tohi seda ravimit kasutada lastel ja noorukitel vanuses alla 18 aasta.
English: In particular, tell your doctor if you take any of the following medicines:
Estonian: Eriti peab arstile rääkima sellest, kui te võtate mõnda järgmistest ravimitest:
English: • Not to give Erivedge to any other person
Estonian: • Erivedge't ei tohi anda ühelegi teisele inimesele
English: Erivedge can also affect how some other medicines work.
Estonian: Ka Erivedge võib mõjutada mõnede teiste ravimite toimet.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/848/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/13/848/001
English: Four patients were excluded from the figure: 3 patients with stable disease were assessed by non-target lesions only and 1 patient was unevaluable.
Estonian: Neli patsienti arvati jooniselt välja: kolmel stabiilse haigusega patsiendil hinnati ainult mittevalitud haiguskoldeid ja üks patsient ei olnud hinnatav.
English: This interaction is not expected to be clinically significant.
Estonian: See koostoime ei tohiks olla kliiniliselt oluline.
English: Due to the long drug elimination half-life, these events may occur or progress after drug discontinuation.
Estonian: Ravimi pika eliminatsiooni poolväärtusaja tõttu võivad need sündmused tekkida või jätkuda pärast ravimi kasutamise lõpetamist.
English: • surgical sterilisation.
Estonian: • kirurgiline steriliseerimine.
English: • if you are allergic to vismodegib or any of the other ingredients of this medicine (listed in section 6).
Estonian: • kui olete vismodegiibi või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: In vivo interaction data is not available.
Estonian: In vivo koostoimete kohta andmed puuduvad.
English: What Erivedge is and what it is used for What you need to know before you take Erivedge How to take Erivedge
Estonian: Mis ravim on Erivedge ja milleks seda kasutatakse Mida on vaja teada enne Erivedge võtmist Kuidas Erivedge't võtta
English: • A core text as agreed by the Rapporteur
Estonian: • Raportööriga kooskõlastatud teksti põhiosa
English: • if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Erivedge Pregnancy Prevention Programme,
Estonian: • kui te võite rasestuda, kuid ei ole võimeline või ei soovi järgida vajalikke raseduse vältimise meetmeid, mis on loetletud Erivedge raseduse vältimise programmis.
English: • you think your contraception has failed for any reason,
Estonian: • arvate, et rasestumisvastane kaitse ei ole mingil põhjusel olnud tõhus,