FrancophonIA/ELRC3.0 huggingface dataset:
English: Alternatively, intrauterine insemination (IUI) may be performed.
Estonian: Alternatiivselt võib kasutada emakasisest viljastamist.
English: Solvent: 3 mL vials (Type I glass) with a Teflon coated rubber stopper and aluminium flip-off cap. 1 vial of solvent contains 1 mL of water for injections.
Estonian: Lahusti: 3 ml viaalid (I tüüpi klaas), mis on varustatud tefloniga kaetud kummist punnkorgi ja alumiiniumist eemaldatava kattega.
English: There have been reports of ovarian and other reproductive system neoplasms, both benign and malignant, in women who have undergone multiple regimens for infertility treatment.
Estonian: Naistel, kellel kasutatakse viljatuse raviks kombineeritud raviskeemi, on kirjeldatud munasarjade ja teiste paljunemiselundite kasvajaid, nii hea- kui pahaloomulisi.
English: Each Pergoveris (300 IU + 150 IU)/0.48 mL pre-filled pen contains 0.48 mL of solution for injection and can deliver two doses of Pergoveris 150 IU/75 IU.
Estonian: Üks Pergoveris (300 RÜ + 150 RÜ)/0,48 ml pen-süstel sisaldab 0,48 ml süstelahust ja sellest saab manustada kaks Pergoveris 150 RÜ/75 RÜ annust.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris (900 IU + 450 IU)/1.44 mL injection Follitropin alfa/Lutropin alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Pergoveris (900 RÜ + 450 RÜ)/1,44 ml süstevedelik Alfafollitropiin/alfalutropiin
English: • The numbers in the Dose Feedback Window present the number of International Units, or IUs,
Estonian: • Numbrid annuse tagasiside aknas näitavad rahvusvaheliste ühikute (RÜ) arvu ja märgivad alfafollitropiini annust.
English: Contents of the pack and other information What Pergoveris contains
Estonian: Kuidas Pergoveris't säilitada Pakendi sisu ja muu teave
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each multidose pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa* (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa* (r-hLH) in 0.48 mL solution.
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks mitmeannuseline pen-süstel sisaldab 300 RÜ (samaväärne 22 mikrogrammiga) alfafollitropiini* (r-hFSH) ja 150 RÜ (samaväärne 6 mikrogrammiga) alfalutropiini* (r-hLH) 0,48 ml lahuses.
English: Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Estonian: Pergoveris (450 RÜ + 225 RÜ)/0,72 ml süstelahus pen-süstlis Alfafollitropiin/alfalutropiin
English: Pergoveris must be reconstituted with the solvent before use by gentle swirling.
Estonian: Pergoveris'e pulber tuleb enne tarvitamist ettevaatlikult loksutades lahustis lahustada.
English: Pergoveris 150 IU/75 IU powder and solvent for solution for injection Follitropin alfa/Lutropin alfa
Estonian: Pergoveris 150 RÜ/75 RÜ süstelahuse pulber ja lahusti Alfafollitropiin/alfalutropiin
English: This will then release an egg, after an injection of the hormone “human chorionic gonadotropin (hCG)”.
Estonian: Pärast inimese kooriongonadotropiini (hCG) hormooni süstimist vabaneb munarakk ning see aitab naistel rasestuda.
English: Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Estonian: Pergoveris (900 RÜ + 450 RÜ)/1,44 ml süstelahus pen-süstlis Alfafollitropiin/alfalutropiin
English: If you are not sure, talk to your doctor, pharmacist or nurse before using this medicine.
Estonian: Kui te ei ole milleski kindel, pidage nõu oma arsti, apteekri või meditsiiniõega.
English: • Contains 900 IU follitropin alfa and 450 IU lutropin alfa.
Estonian: • Sisaldab 1,44 ml Pergoveris'e lahust • Sisaldab 900 RÜ alfafollitropiini ja 450 RÜ alfalutropiini.
English: Getting the syringe ready for injection
Estonian: Süstla ettevalmistamine süstimiseks
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) One vial contains 150 IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75 IU (equivalent to 3 micrograms) of lutropin alfa (r-hLH).
Estonian: Üks viaal sisaldab 150 RÜ (samaväärne 11 mikrogrammiga) alfafollitropiini (r-hFSH) ja 75 RÜ (samaväärne 3 mikrogrammiga) alfalutropiini (r-hLH).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pergoveris 150 IU/75 IU powder for solution for injection Follitropin alfa/Lutropin alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Pergoveris 150 RÜ/75 RÜ süstelahuse pulber Alfafollitropiin/alfalutropiin s.c.
English: Injecting the dose
Estonian: Annuse seadmise nupp
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) Each pre-filled pen contains 300 IU (equivalent to 22 micrograms) of follitropin alfa (r-hFSH) and 150 IU (equivalent to 6 micrograms) of lutropin alfa (r-hLH) in 0.48 mL.
Estonian: Üks pen-süstel sisaldab 300 RÜ (samaväärne 22 mikrogrammiga) alfafollitropiini (r-hFSH) ja 150 RÜ (samaväärne 6 mikrogrammiga) alfalutropiini (r-hLH) 0,48 ml-s.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris 150 IU/75 IU powder and solvent for solution for injection Follitropin alfa/Lutropin alfa
Estonian: RAVIMPREPARAADI NIMETUS Pergoveris 150 RÜ/75 RÜ süstelahuse pulber ja lahusti Alfafollitropiin/alfalutropiin
English: • Each pre-filled pen of Pergoveris (900 IU + 450 IU)/1.44 mL contains 900 IU (International
Estonian: • Üks Pergoveris (900 RÜ + 450 RÜ)/1,44 ml pen-süstel sisaldab 1,44 ml süstelahuses 900 RÜ
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Estonian: RAVIMPREPARAADI NIMETUS Pergoveris (450 RÜ + 225 RÜ)/0,72 ml süstelahus pen-süstlis Alfafollitropiin/alfalutropiin
English: Breast-feeding
Estonian: Alfalutropiin
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Estonian: RAVIMPREPARAADI NIMETUS Pergoveris (900 RÜ + 450 RÜ)/1,44 ml süstelahus pen-süstlis Alfafollitropiin/alfalutropiin
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen Follitropin alfa/Lutropin alfa
Estonian: RAVIMPREPARAADI NIMETUS Pergoveris (300 RÜ + 150 RÜ)/0,48 ml süstelahus pen-süstlis Alfafollitropiin/alfalutropiin
English: NAME OF THE MEDICINAL PRODUCT Pergoveris 150 IU/75 IU powder and solvent for solution for injection
Estonian: RAVIMPREPARAADI NIMETUS Pergoveris 150 RÜ/75 RÜ süstelahuse pulber ja lahusti
English: • abdominal or pelvic pain
Estonian: • kõhukrambid või kõhupuhitus
English: 3 vials of solvent.
Estonian: 3 lahustiviaali.
English: Management
Estonian: Tegevus
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (450 IU + 225 IU)/0.72 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PERGOVERIS (450 RÜ + 225 RÜ)/0,72 ML SÜSTELAHUS PEN-SÜSTLIS
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (300 IU + 150 IU)/0.48 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PERGOVERIS (300 RÜ + 150 RÜ)/0,48 ML SÜSTELAHUS PEN-SÜSTLIS
English: Caution: Never store the pen with the needle still attached.
Estonian: Ärge säilitage pen-süstlit, nõel küljes.
English: if "0", injectioncomplete if not"0",needsecond injection Injectthisamount.75..usingnewpen
Estonian: kui „0“, süsttäielik kui ei ole„0“,vajate teist süsti Süstige see kogus.75..uuepen-süstliga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING PERGOVERIS (900 IU + 450 IU)/1.44 ML SOLUTION FOR INJECTION IN PRE-FILLED PEN
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED PERGOVERIS (900 RÜ + 450 RÜ)/1,44 ML SÜSTELAHUS PEN-SÜSTLIS
English: Paediatric population There is no relevant use of this medicinal product in the paediatric population.
Estonian: Lapsed Puudub ravimi asjakohane kasutus lastel.
English: Subcutaneous use.
Estonian: 10 lahustiviaali.
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (450 IU + 225 IU)/0.72 mL solution for injection in pre-filled pen
Estonian: RAVIMPREPARAADI NIMETUS Pergoveris (450 RÜ + 225 RÜ)/0,72 ml süstelahus pen-süstlis
English: There have been reports of tumours in the ovaries and other sex organs, both benign and malignant, in women who have undergone multiple regimens for infertility treatment.
Estonian: Kombineeritud raviskeemidel põhinevat viljatusravi saanud naistel on täheldatud munasarjade ning teiste suguorganite hea- ja pahaloomulisi kasvajaid.
English: Getting familiar with the parts of your Pergoveris pre-filled pen
Estonian: Pergoveris'e pen-süstli osadega tutvumine
English: VIAL LABEL
Estonian: Annuse süstimine
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (300 IU + 150 IU)/0.48 mL solution for injection in pre-filled pen
Estonian: RAVIMPREPARAADI NIMETUS Pergoveris (300 RÜ + 150 RÜ)/0,48 ml süstelahus pen-süstlis
English: Prescribed Dose
Estonian: Määratud annus
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/07/396/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/07/396/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/396/006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/07/396/006
English: Powder: 3 mL vials (Type I glass) with a stopper (bromobutyl rubber) and aluminium flip-off cap. 1 vial contains 11 micrograms r-hFSH and 3 micrograms r-hLH.
Estonian: 1 viaal sisaldab 11 mikrogrammi r-hFSH ja 3 mikrogrammi r-hLH.
English: • Inject the solution by pushing gently on the plunger.
Estonian: • Süstige lahust ettevaatlikult süstlakolvile vajutades.
English: 3 Tap the reservoir holder gently (Fig. 6).
Estonian: Koputage ettevaatlikult mahuti hoidikule (joonis 6).
English: NAME OF THE MEDICINAL PRODUCT Pergoveris (900 IU + 450 IU)/1.44 mL solution for injection in pre-filled pen
Estonian: RAVIMPREPARAADI NIMETUS Pergoveris (900 RÜ + 450 RÜ)/1,44 ml süstelahus pen-süstlis
English: Warning: Refer to the Package leaflet for more information on the recommended dose regimen and always follow the dose recommended by your doctor.
Estonian: Lisateavet soovitatud annustamisskeemi kohta leiate pakendi infolehest.
English: • Hold the dose knob down for a minimum of 5
Estonian: • Hoidke annuse seadmise nuppu vähemalt 5 sekundit all tagamaks, et annus on täielikult süstitud (joonis 10).
English: 12/06 19:00 450IU + 225 IU 225IU/ 112.5IU 225
Estonian: 225RÜ/ 112,5RÜ
English: MARKETING AUTHORISATION NUMBERS EU/1/07/396/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/07/396/001
English: • abdominal cramp or bloating.
Estonian: • kõhuvalu või vaagnavalu
English: • Check that the Dose Feedback Window shows
Estonian: Annuse tagasiside aken*
English: 12/06 19:00 450IU + 225 IU
Estonian: 450RÜ + 225RÜ
English: Investigation continuing
Estonian: Uurimine jätkub
English: You can also contact your national medicines authority.
Estonian: Teil on ka võimalus võtta ühendust oma riikliku ravimiametiga.
English: 17 April 2019 EMA/248364/2019 Rev 1
Estonian: 17. aprill 2019 EMA/248364/2019 Rev1
English: • If there is a need for further recalls or other measures, national authorities will inform you of what action to take.
Estonian: • Kui on vaja täiendavaid tagasivõtmisi või muid meetmeid, teavitavad liikmesriikide ametiasutused teid vajalikest meetmetest.
English: 2 International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: M7(R1)
Estonian: 2 Inimravimite tehniliste nõuete rahvusvahelise ühtlustamisnõukogu (ICH) juhised: M7(R1)
English: • If you have any questions about your medicine or any medicine you have taken in the past, speak to your doctor or pharmacist.
Estonian: • Kui teil on küsimusi oma ravimi või muude ravimite kohta, mida olete varem manustanud, pidage nõu oma arsti või apteekriga.
English: Following tests, some medicines have been recalled from pharmacies and are no longer used in the EU.
Estonian: Pärast testimist on mõned ravimid apteekidest tagasi võetud ja neid ELis enam ei kasutata.
English: • Manufacturers must now review their manufacturing processes to avoid the presence of nitrosamines.
Estonian: • Tootjad peavad nüüd läbi vaatama oma tootmisprotsessid, et vältida nitrosamiinide esinemist.
English: The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under Article 31 of Directive 2001/83/EC.
Estonian: Valsartaani sisaldavate ravimite läbivaatamise algatas Euroopa Komisjon 5. juulil 2018. aastal direktiivi 2001/83/EÜ artikli 31 alusel.
English: The estimates have been extrapolated from animal studies and are very low compared with the lifetime risk of cancer in the EU (1 in 2).
Estonian: Hinnangud on ekstrapoleeritud loomkatsetest ja need on väga madalad võrreldes eluaja vähiriskiga ELis (üks kahest).
English: Information for healthcare professionals
Estonian: Tervishoiutöötajatele mõeldud teave
English: • Ever since these impurities were first seen in some sartan medicines, regulatory authorities in the EU have been working to protect patients' health.
Estonian: • Alates sellest, mil kõnealused lisandid esmakordselt mõnedes sartaani sisaldavates ravimites tuvastati, on ELi reguleerivad asutused töötanud patsientide tervise kaitsmise nimel.
English: Information for patients
Estonian: Patsientidele mõeldud teave
English: The CHMP opinion was forwarded to the European Commission, which issued final legally binding decisions for the medicines concerned between 2 April and 17 April 2019 that are applicable in all EU Member States.
Estonian: Inimravimite komitee arvamus edastati Euroopa Komisjonile, kes väljastas ajavahemikul 2. aprillist kuni 17. aprillini 2019 asjaomaste ravimite kohta lõplikud õiguslikult siduvad otsused, mida kohaldatakse kõikides ELi liikmesriikides.
English: EMA's recommendations for NDMA and NDEA were sent to the European Commission, which issued a legally binding decisions.
Estonian: Euroopa Ravimiameti soovitused NDMA ja NDEA kohta saadeti Euroopa Komisjonile, mis väljastas õiguslikult siduva otsuse.
English: Candesartan (32 mg) Irbesartan (300 mg) Losartan (150 mg) Olmesartan (40 mg) Valsartan (320 mg)
Estonian: Kandesartaan (32 mg) Irbesartaan (300 mg) Losartaan (150 mg) Olmesartaan (40 mg) Valsartaan (320 mg)
English: The review estimated the highest possible cancer risk with these impurities.
Estonian: Ülevaates anti hinnang suurimale võimalikule vähiriskile seoses kõnealuste lisanditega.
English: Authorities in the EU will also consider the lessons that can be learned from this review to improve the way impurities in medicines are identified and handled.
Estonian: ELi ametiasutused kaaluvad ka selle ülevaate käigus saadud uut teavet, et tõhustada ravimites esinevate lisandite tuvastamist ja käsitlemist.
English: These medicines are used to treat patients with hypertension (high blood pressure) and those with certain heart or kidney diseases.
Estonian: Neid ravimeid kasutatakse hüpertensiooni (kõrge vererõhk) ja teatud südame- või neeruhaigustega patsientide ravimiseks.
English: The transition period, which will last for 2 years, will allow companies to make the necessary changes to their manufacturing processes and to put in place testing regimes able to detect the smallest amounts of these impurities.
Estonian: Üleminekuperiood, mis kestab 2 aastat, võimaldab ettevõtetel teha vajalikke muudatusi oma tootmisprotsessides ja kehtestada testimisrežiimid, et suuta tuvastada kõnealuste lisandite väikseimad kogused.
English: NDEA in these medicines could lead to 8 extra cases in 100,000 patients taking the medicine at the highest dose every day for 4 years.1
Estonian: Kõnealustes ravimites sisalduv NDEA võib kaasa tuua 8 lisajuhtu 100 000 patsiendi seas, kes võtavad ravimit 4 aasta jooksul iga päev maksimaalse annusena.1
English: Companies must now take measures to avoid the presence of these impurities and carry out rigorous testing of their products.
Estonian: Ettevõtted peavad nüüd võtma meetmed, et vältida kõnealuste lisandite esinemist ja testida oma tooteid rangete põhimõtete alusel.
English: • Nitrosamines are potent carcinogens in animals and probable carcinogens in humans.
Estonian: • Nitrosamiinid on tugevad kantserogeenid loomade jaoks ja tõenäolised kantserogeenid inimeste jaoks.
English: After the transition period, companies must exclude the presence of even lower levels of NDEA or NDMA in their products (< 0.03 parts per million).
Estonian: Pärast üleminekuperioodi peavad ettevõtted oma toodetes välistama isegi NDEA või NDMA väikese sisalduse (< 0,03 miljondikku).
English: For the vast majority of sartan medicines, impurities were either not found or were present at very low levels.
Estonian: Enamiku sartaani sisaldavate ravimite puhul lisandeid ei leitud või leiti väga väikeses koguses.
English: Other medicines of the class which do not have this ring, such as azilsartan, eprosartan and telmisartan, were not included in the review.
Estonian: Muud samasse klassi kuuluvad ravimid, millel puudub selline rõngasstruktuur, nagu asilsartaan, eprosartaan ja telmisartaan, ei olnud läbivaatamisse kaasatud.
English: Companies will have a transition period to make any necessary changes, during which strict temporary limits on levels of these impurities will apply.
Estonian: Ettevõtetele on vajalike muudatuste tegemiseks ette nähtud üleminekuperiood, mille jooksul kohaldatakse asjaomaste lisandite taseme rangeid ajutisi piirmäärasid.
English: It concluded that if 100,000 patients took valsartan from Zhejiang Huahai (where the highest levels of impurities were found) every day for 6 years at the highest dose, there could be 22 extra cases of cancer due to NDMA over the lifetimes of those 100,000 patients.
Estonian: Selles järeldati, et kui 100 000 patsienti manustab Zhejiang Huahai toodetud valsartaani (milles tuvastati suurim lisandite hulk) 6 aasta jooksul iga päev maksimaalse annusena, võib NDMA tõttu esineda nende 100 000 patsiendi eluea jooksul 22 vähi lisajuhtu.
English: Dividing these by the maximum daily dose for each active substance gives the limit in parts per million (see Table 1).
Estonian: Nende jagamisel iga toimeaine suurima ööpäevase annusega saadakse piirmäär miljondikes (vt tabel 1).
English: • You should not stop taking any sartan medicines without speaking to your doctor.
Estonian: • Ärge lõpetage sartaani sisaldavate ravimite manustamist arstiga nõu pidamata.
English: • There is a very low risk that nitrosamine impurities at the levels previously found in some sartan medicines could cause cancer in humans.
Estonian: • On väga väike risk, et nitrosamiini lisandite sisaldus mõnes sartaani sisaldavas ravimis varem leitud tasemel võib põhjustada inimestel vähki.
English: The limits are based on the maximum daily intake for each impurity derived from animal studies: 96.0 nanograms for NDMA and 26.5 nanograms for NDEA.
Estonian: Piirmäärad põhinevad loomkatsete tulemusena saadud mõlema lisandi suurimal ööpäevasel annusel: 96,0 nanogrammi NDMA ja 26,5 nanogrammi NDEA korral.
English: A similar step - involving diethylamine (DEA) - is linked to the presence of NDEA.
Estonian: Sarnane etapp, mis hõlmab dietüülamiini (DEA), on seotud NDEA esinemisega.
English: On 20 September 2018, the review was extended to include medicines containing candesartan, irbesartan, losartan and olmesartan.
Estonian: Läbivaatamist laiendati 20. septembril 2018, et hõlmata kandesartaani, irbesartaani, losartaani ja olmesartaani sisaldavad ravimid.
English: The review was carried out by EMA's Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's opinion.
Estonian: Läbivaatamise korraldas Euroopa Ravimiameti inimravimite komitee (CHMP), mis vastutab inimtervishoius kasutatavate ravimitega seotud küsimuste eest.
English: The review concerns candesartan, irbesartan, losartan, olmesartan and valsartan, which belong to a class of medicines called sartans (also known as angiotensin-II-receptor antagonists).
Estonian: Ülevaade puudutab kandesartaani, irbesartaani, losartaani, olmesartaani ja valsartaani, mis kuuluvad sartaanideks nimetatavate ravimite klassi (tuntud ka kui angiotensiin II retseptori antagonistid).
English: • EMA is now taking further action to prevent these impurities from being present in future batches of sartan medicines.
Estonian: • Euroopa Ravimiamet võtab nüüd täiendavad meetmed, et vältida kõnealuste lisandite esinemist sartaani sisaldavate ravimite tulevastes partiides.
English: On 31 January 2019, EMA recommended that companies making sartan blood pressure medicines (also known as angiotensin II receptor blockers) review their manufacturing processes so that they do not produce nitrosamine impurities.
Estonian: 31. jaanuaril 2019 soovitas Euroopa Ravimiamet, et sartaani sisaldavaid vererõhuravimeid (tuntud ka kui angiotensiin II retseptorite blokaatorid) valmistavad ettevõtted vaataksid läbi oma tootmisprotsessid, veendumaks, et nad ei tooda nitrosamiini lisandeid.
English: After this period, companies will have to demonstrate that their sartan products have no quantifiable levels of these impurities before they can be used in the EU.
Estonian: Pärast kõnealust ajavahemikku peavad ettevõtted tõendama, et nende toodetud sartaani sisaldavates toodetes ei ületa asjaomaste lisandite hulk lubatud taset, enne nende kasutamist ELis.
English: They work by blocking the action of angiotensin II, a hormone that constricts blood vessels and causes blood pressure to rise.
Estonian: Need blokeerivad angiotensiin II ehk hormooni, mis kitsendab veresooni ja põhjustab vererõhu tõusu.
English: Before June 2018, NDMA and NDEA were not among the impurities identified in sartan medicines and were therefore not detected by routine tests.
Estonian: Enne 2018. aasta juunit ei olnud NDMAd ega NDEAd sartaani sisaldavates ravimites tuvastatud lisandite hulgas ja järelikult neid ei leitud tavapäraste testide käigus.
English: • For NDMA, the key step involves dimethylamine (DMA) which forms the impurity in the presence of nitrites, usually under acidic conditions.
Estonian: • NDMA puhul hõlmab põhietapp dimetüülamiini (DMA), mis moodustab tavaliselt happelistes tingimustes nitritite esinemisel lisandi.
English: It is now known that these impurities can form during the production of sartans that contain a specific ring structure known as a tetrazole ring under certain conditions and when certain solvents, reagents, and other raw materials are used.
Estonian: Nüüdseks on teada, et kõnealused lisandid võivad moodustuda nende sartaanide tootmisel, mis sisaldavad teatavat rõngasstruktuuri, mida nimetatakse tetrasoolringiks, ja teatud tingimustel ning teatud lahustite, reaktiivide ja muude toorainete kasutamisel.
English: These sartan medicines have a specific ring structure (tetrazole) whose synthesis could potentially lead to the formation of nitrosamine impurities.
Estonian: Sellistel sartaani sisaldavatel ravimitel on spetsiifiline rõngasstruktuur (tetrasool), mille süntees võib viia nitrosamiini lisandite moodustumiseni.
English: Active substance (max daily dose)
Estonian: Toimeaine (suurim ööpäevane annus)
English: An assessment report with further details about the review has been published on EMA's website.
Estonian: Euroopa Ravimiameti veebisaidil on avaldatud hindamisaruanne koos täiendavate üksikasjadega ülevaate kohta.
English: EMA and national authorities will continue investigating the presence of nitrosamine impurities in medicines, including other impurities such as N-nitrosoethylisopropylamine (EIPNA), Nnitrosodiisopropylamine (DIPNA) and N-nitroso-N-methylamino butyric acid (NMBA).
Estonian: Euroopa Ravimiamet ja riiklikud ametiasutused jätkavad nitrosamiini lisandite esinemise uurimist ravimites, sealhulgas muude lisandite nagu N-nitrosoetüülisopropüülamiini (EIPNA), Nnitrosodiisopropüülamiini (DIPNA) ja N-nitroso-N-metüülamino-butaanhappe (NMBA) uurimist.
English: Temporary limits for NDMA and NDEA impurities
Estonian: NDMA ja NDEA lisandite ajutised piirmäärad
English: In addition, it is possible that impurities were present in some
Estonian: Lisaks on võimalik, et mõnes sartaanis