FrancophonIA/ELRC3.0 huggingface dataset:
English: Nuwiq 500 IU contains approximately 200 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Estonian: Nuwiq 500 RÜ sisaldab pärast lahustamist ligikaudu 200 RÜ/ml inimese VIII hüübimisfaktorit (rDNA) alfasimoktokog.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Estonian: RAVIMPREPARAADI NIMETUS Nuwiq 2500 RÜ süstelahuse pulber ja lahusti alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor)
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 Powder vial contains 1000 IU simoctocog alfa (400 IU/mL after reconstitution).
Estonian: TOIMEAINE(TE) SISALDUS 1 pulbriviaal sisaldab 1000 RÜ alfasimoktokogi (400 RÜ/ml pärast lahustamist).
English: PK parameters for Nuwiq (Dose: 50 IU/kg) in previously treated children aged 2 to 5 years with severe haemophilia A (n = 13)
Estonian: Nuwiq'i farmakokineetilised näitajad (annus: 50 RÜ/kg) eelnevalt ravitud raske A-hemofiiliaga lastel vanuses 2...5 aastat (n = 13) Farmakokineetiline näitaja Kromogeenne uuring Keskmine ± SD Mediaan (vahemik)
English: Nuwiq 1000 IU contains approximately 400 IU/mL of human coagulation factor VIII (rDNA), simoctocog alfa after reconstitution.
Estonian: Nuwiq 1000 RÜ sisaldab pärast lahustamist ligikaudu 400 RÜ/ml inimese VIII hüübimisfaktorit (rDNA) alfasimoktokog.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 2500 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Nuwiq 2500 RÜ süstelahuse pulber alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor) Intravenoosne pärast lahustamist.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 500 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Estonian: RAVIMPREPARAADI NIMETUS Nuwiq 500 RÜ süstelahuse pulber ja lahusti alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 250 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Nuwiq 250 RÜ süstelahuse pulber alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor) Intravenoosne pärast lahustamist.
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 4000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Estonian: RAVIMPREPARAADI NIMETUS Nuwiq 4000 RÜ süstelahuse pulber ja lahusti alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/007
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/936/007
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 2000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Estonian: RAVIMPREPARAADI NIMETUS Nuwiq 2000 RÜ süstelahuse pulber ja lahusti alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 3000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Estonian: RAVIMPREPARAADI NIMETUS Nuwiq 3000 RÜ süstelahuse pulber ja lahusti alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor)
English: NAME OF THE MEDICINAL PRODUCT Nuwiq 1000 IU powder and solvent for solution for injection simoctocog alfa (recombinant human coagulation factor VIII)
Estonian: RAVIMPREPARAADI NIMETUS Nuwiq 1000 RÜ süstelahuse pulber ja lahusti alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor)
English: The solvent is water for injections in a glass pre-filled syringe.
Estonian: Lahustiks on süstevesi klaassüstlis.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/936/005
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 3000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Nuwiq 3000 RÜ süstelahuse pulber alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor) Intravenoosne pärast lahustamist.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 4000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Nuwiq 4000 RÜ süstelahuse pulber alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor) Intravenoosne pärast lahustamist.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 1000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Nuwiq 1000 RÜ süstelahuse pulber alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor) Intravenoosne pärast lahustamist.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 500 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Nuwiq 500 RÜ süstelahuse pulber alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor) Intravenoosne pärast lahustamist.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/936/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/936/006
English: Nuwiq 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Estonian: Iga viaal sisaldab nominaalselt 3000 RÜ inimese VIII hüübimisfaktorit (rDNA) alfasimoktokog.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/936/004
English: Nuwiq 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Estonian: Iga viaal sisaldab nominaalselt 250 RÜ inimese VIII hüübimisfaktorit (rDNA) alfasimoktokog.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Nuwiq 2000 IU powder for solution for injection simoctocog alfa (recombinant human coagulation factor VIII) For intravenous use after reconstitution.
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Nuwiq 2000 RÜ süstelahuse pulber alfasimoktokog (rekombinantne inimese VIII hüübimisfaktor) Intravenoosne pärast lahustamist.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/936/003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/936/003
English: Nuwiq 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Estonian: Iga viaal sisaldab nominaalselt 4000 RÜ inimese VIII hüübimisfaktorit (rDNA) alfasimoktokog.
English: Keep the reconstituted solution at room temperature.
Estonian: Hoidke manustamisvalmis lahust toatemperatuuril.
English: Nuwiq 2500 IU powder and solvent for solution for injection Each vial contains nominally 2500 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Estonian: Iga viaal sisaldab nominaalselt 2500 RÜ inimese VIII hüübimisfaktorit (rDNA) alfasimoktokog.
English: Nuwiq 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), simoctocog alfa.
Estonian: Iga viaal sisaldab nominaalselt 2000 RÜ inimese VIII hüübimisfaktorit (rDNA) alfasimoktokog.
English: What happened during the re-examination?
Estonian: Mis toimus taasläbivaatamise ajal?
English: Opdivo has been authorised since June 2015.
Estonian: Opdivo müügiluba anti 2015. aasta juunis.
English: Yervoy has been authorised since July 2011.
Estonian: Yervoy sai müügiloa juulis 2011.
English: Further information on Opdivo and Yervoy's current uses can be found on the Agency's website.
Estonian: Opdivo ja Yervoy kehtivate näidustuste lisateave on ameti veebilehel.
English: What were the conclusions of the CHMP following the re-examination?
Estonian: Mis olid komitee järeldused taasläbivaatamise järel?
English: The company that applied for the change to the authorisation is Bristol-Myers Squibb Pharma EEIG.
Estonian: Müügiloa muutmist taotles ettevõte Bristol-Myers Squibb Pharma EEIG.
English: It is also used to treat the following other cancers: melanoma (a skin cancer), non-small cell lung cancer, classical Hodgkin lymphoma (a blood cancer), squamous cell cancer of the head and neck, and urothelial (bladder) cancer.
Estonian: Sellega ravitakse ka järgmisi vähivorme: melanoom (nahavähk), mitteväikerakk-kopsuvähk, klassikaline Hodgkini lümfoom (verevähk), pea ja kaela lamerakuline vähk ja uroteeli (kusepõie) vähk.
English: However, the company must conduct a study to determine the precise contribution of Yervoy in the combination and if the risks could be further minimised.
Estonian: Ettevõte peab aga korraldama uuringu, et täpsustada Yervoy kasulikkust kombinatsioonis ja riskide minimeerimise lisameetmeid.
English: At the request of the company, the CHMP re-examined its opinion.
Estonian: Ettevõtte taotlusel vaatas inimravimite komitee oma algse arvamuse uuesti läbi.
English: During the re-examination, the CHMP looked again at all the data and consulted a group of cancer experts and patients with cancer.
Estonian: Taasläbivaatamise ajal vaatas inimravimite komitee kõik andmed uuesti läbi ning konsulteeris vähiekspertidest ja vähipatsientidest koosneva rühmaga.
English: The CHMP was of the opinion that the benefits of the combination largely outweigh its risks and therefore recommended granting the change to the marketing authorisation.
Estonian: Inimravimite komitee oli seepärast arvamusel, et kombinatsiooni kasulikkus on oluliselt suurem kui sellega kaasnevad riskid, ja soovitas seega müügiluba muuta.
English: The CHMP also discussed the possibility to request that further data be collected following the authorisation of the combination.
Estonian: Komitee kaalus ka lisaandmete kogumise võimalust kombinatsiooni heakskiitmise järel.
English: It is used to treat adults with advanced melanoma.
Estonian: Sellega ravitakse täiskasvanutel kaugelearenenud melanoomi.
English: Following the re-examination, the CHMP adopted a final positive opinion on 15 November 2018 recommending that the change to the marketing authorisation be granted for Opdivo and Yervoy, but requested the company to conduct a study to collect further data.
Estonian: Taasläbivaatamise järel võttis inimravimite komitee 15. novembril 2018 vastu lõpliku positiivse arvamuse, soovitades muuta Opdivo ja Yervoy müügiluba, kuid nõudis, et ettevõte korraldaks lisaandmete saamiseks uuringu.
English: Opdivo and Yervoy are cancer medicines.
Estonian: Opdivo ja Yervoy on vähiravimid.
English: The company presented the results of a main study involving 1,096 patients with previously untreated advanced renal cell carcinoma.
Estonian: Ettevõte esitas varem ravimata kaugelearenenud neerurakk-kartsinoomiga 1096 patsiendi põhiuuringu tulemused.
English: Although the precise contribution of Yervoy was not clear, the CHMP reassessed data from other non-clinical and clinical studies, including studies with the combination in relevant other cancer types, and considered that the benefit of Yervoy in the combination has been sufficiently demonstrated.
Estonian: Ehkki Yervoy kasulikkus ei olnud selge, hindas komitee uuesti muudest mittekliinilistest ja kliinilistest uuringutest, sealhulgas muude asjakohaste vähivormide uuringutest saadud kõnealuse kombinatsiooniga ravitud patsientide andmeid ning järeldas, et Yervoy kasulikkus kombinatsioonis on piisavalt tõendatud.
English: On 15 November 2018, the Committee for Medicinal Products for Human Use (CHMP) recommended that a change to the marketing authorisation for the medicinal products Opdivo (nivolumab) and Yervoy (ipilimumab) be granted.
Estonian: 15. novembril 2018 soovitas inimravimite komitee muuta ravimite Opdivo (nivolumaab) ja Yervoy (ipilimumaab) müügiluba.
English: What are Opdivo and Yervoy?
Estonian: Mis on Opdivo ja Yervoy?
English: Although improvements in survival were seen in previously untreated patients given the combination of Opdivo and Yervoy compared with sunitinib, there was no evidence showing if Yervoy contributed to these results and if so, how much.
Estonian: Ehkki Opdivo ja Yervoy kombinatsiooni saanud varem ravimata patsientide elumus paranes võrreldes sunitiniibi saanud patsientidega, puudusid tõendid selle kohta, kas ja kui palju Yervoy neid tulemusi mõjutas.
English: They contain the active substances nivolumab and ipilimumab respectively.
Estonian: Nende toimeained on vastavalt nivolumaab ja ipilimumaab.
English: On 26 July 2018, the CHMP had originally adopted a negative opinion for the use of Opdivo and Yervoy for the treatment of renal cell carcinoma.
Estonian: 26. juulil 2018 oli inimravimite komitee juba vastu võtnud negatiivse arvamuse Opdivo ja Yervoy kasutamise kohta neerurakk-kartsinoomi ravis.
English: Nivolumab attaches to a receptor called PD-1 which is found on certain cells of the immune system called T cells.
Estonian: Nivolumaab seondub retseptoriga PD-1, mida leidub immuunsüsteemi T-rakkudel.
English: The change concerns the use of both medicines together to treat renal cell carcinoma (kidney cancer).
Estonian: Muudatus käsitles nende ravimite koos kasutamist neerurakk-kartsinoomi (neeruvähi) ravis.
English: This means that the CHMP had no way to know if the addition of Yervoy to Opdivo treatment produced additional benefit.
Estonian: Seetõttu polnud inimravimite komiteele selge, kas Yervoy lisamine Opdivole on täiendavalt kasulik.
English: The CHMP considered that the results from the main study comparing Opdivo and Yervoy with sunitinib showed a clinically important increase in patients' survival with the combination, and side effects were considered acceptable.
Estonian: Inimravimite komitee leidis, et Opdivo ja Yervoy kombinatsiooni ja sunitiniibi võrdlusuuring tõendas kombinatsiooni kasutanud patsientide elumuse kliiniliselt olulist pikenemist, ning ravimite kõrvalnähte peeti vastuvõetavaks.
English: At the same time it was clear that combination with Yervoy resulted in more side effects than are seen with Opdivo alone.
Estonian: Samas põhjustas Opdivo ja Yervoy kombinatsioon ilmselgelt rohkem kõrvalnähte kui ainuravimina kasutatav Opdivo.
English: Therefore, at that point in time, the CHMP considered that the combination could not be approved because of the lack of knowledge of the contribution of Yervoy.
Estonian: Seega ei kiitnud inimravimite komitee esialgu kombinatsiooni heaks põhjusel, et Yervoy kasulikkuse kohta puudusid andmed.
English: By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Estonian: Retseptoriga seondudes ei lase nivolumaab valkudel PD-L1 ja PD-L2 T-rakkude aktiivsust välja lülitada ja suurendab nii immuunsüsteemi võimet hävitada vähirakke.
English: Opdivo and Yervoy are to be used together in patients with previously untreated advanced renal cell carcinoma that is considered to be of moderate or high risk of worsening.
Estonian: Opdivot ja Yervoyd kavatsetakse koos kasutada patsientidel, kellel on mõõduka või suure progresseerumise riskiga varem ravimata kaugelearenenud neerurakk-kartsinoom.
English: How do Opdivo and Yervoy work?
Estonian: Kuidas Opdivo ja Yervoy toimivad?
English: The active substance in both medicines, nivolumab and ipilimumab, are monoclonal antibodies, a type of protein that has been designed to recognise and attach to a specific structure.
Estonian: Ravimite toimeained nivolumaab ja ipilimumaab on monoklonaalsed antikehad (teatud valgud), mis tunnevad ära teatud sihtmärgi ja seonduvad sellega.
English: The study looked at the patients' response to treatment and how long patients lived, or lived without their disease getting worse.
Estonian: Selles analüüsiti patsientide ravivastust ja progresseerumiseta elumust.
English: The study compared treatment with Opdivo and Yervoy versus treatment with another cancer medicine, sunitinib.
Estonian: Uuringus võrreldi Opdivot ja Yervoyd teise vähiravimi sunitiniibiga.
English: Cancer cells can produce proteins (PD-L1 and PD-L2) that attach to this receptor and switch off the activity of the T cells, preventing them from attacking the cancer.
Estonian: Vähirakud toodavad valke PD-L1 ja PD-L2, mis kinnituvad sellele retseptorile ja lülitavad välja T-rakkude aktiivsuse, takistades neid vähirakke ründamast.
English: It is known that Opdivo alone produces benefit in previously treated patients with renal cell carcinoma.
Estonian: On teada, et ainuravimina kasutatav Opdivo on varem ravitud neerurakk-kartsinoomiga patsientidele kasulik.
English: What were the CHMP's main concerns that led to the initial negative opinion?
Estonian: Mis olid peamised põhjused, mille tõttu soovitas inimravimite komitee esialgu müügiloa andmisest keelduda?
English: It is already used on its own to treat renal cell carcinoma in patients who have previously been treated with other cancer medicines.
Estonian: Opdivot kasutatakse neerurakk-kartsinoomi ainuravimina patsientidel, keda on varem ravitud muude vähiravimitega.
English: By blocking CTLA-4, ipilimumab causes activation and increase of T cells, which enter into tumours and kill the tumour cells.
Estonian: Valku CTLA-4 blokeerides soodustab ipilimumaab T-rakkude aktiveerumist ja levikut.
English: Ipilimumab attaches to and blocks the activity of CTLA-4, a protein that controls the activity of T cells.
Estonian: Ipilimumab seondub T-rakkude aktiivsust reguleeriva valguga CTLA-4 ning blokeerib selle toime.
English: What are Opdivo and Yervoy to be used for?
Estonian: Milleks kavatsetakse Opdivot ja Yervoyd kasutada?
English: 15, avenue Henry Dunant
Estonian: THERICA 15, avenue Henry Dunant
English: LEK PHARMACEUTICALS d.d.
Estonian: PHARMACEUTICALS d.d.
English: CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule soft capsule
Estonian: CAPERGYL 4,5 mg DOSE QUOTIDIENNE UNIQUE, capsule
English: Hydergin Fas 4,5 mg Filmtabletten
Estonian: Hydergin Fas 4,5 mg FilmTablettten
English: 4.5 mg (1:1:1) film-coated tablet
Estonian: 4.5 mg (1:1:1) Õhukese polümeerikattega tablett
English: Hydergin SRO 6 mg Kapseln modified-release capsule, hard
Estonian: Hydergin SRO 6 mg Kapseln
English: Redergin 1,5 mg tablete 1,5 mg
Estonian: Redergin 1,5 mg Tablette 1,5 mg
English: Verovskova 57, SI-1526 Ljubljana, Slovenia
Estonian: LEK farmacevtska družba d.d., Verovskova 57, SI-1526 Ljubljana, Slovenia
English: Redergin 4,5 mg tablete 4,5 mg
Estonian: Redergin 4,5 mg Tablette 4,5 mg
English: Defiante Farmaceutica sa Rua dos Ferreiros, 260 Funchal MadeiraPortugal
Estonian: Ferreiros, 260 Funchal MadeiraPortugal
English: Belgium Defiante Farmacêutica S.A., Rua dos Ferreiros 260, 9000-082 Funchal, Portugal
Estonian: Defiante Farmacêutica S.A., Rua dos Ferreiros 260, 9000-082 Funchal, Portugal
English: Luxembourg Defiante Farmacêutica, S.A.
Estonian: Defiante Farmaceutica sa
English: Hydergin 1 mg/ml Tropfen 1 mg/ml (1:1:1) oral drops, solution oral use
Estonian: Hydergin 1 mg/ml Tropfen 1 mg/ml
English: Hydergin 3 mg/ml Tropfen 3 mg/ml (1:1:1) oral drops, solution oral use
Estonian: Hydergin 3 mg/ml Tropfen 3 mg/ml
English: The areas harmonised include:
Estonian: Ühtlustatavad valdkonnad on järgmised:
English: What is Septanest?
Estonian: Mis on Septanest?
English: 27 May 2019
Estonian: 27. mai 2019
English: It must also not be given to patients with epilepsy who are not adequately controlled by treatment.
Estonian: Seda ei tohi kasutada ka epilepsiaga patsientidel, kelle haigus ei ole raviga piisavalt reguleeritud.
English: Why was Septanest reviewed?
Estonian: Miks Septanesti ravimiteave uuesti läbi vaadati?
English: The package leaflet has been updated accordingly.
Estonian: Pakendi infolehte uuendati vastavalt.
English: After review of the available data, a number of other contraindications which were only valid in some countries were considered not to be supported by sufficient data or were considered redundant.
Estonian: Pärast kättesaadavate andmete läbivaatamist ei peetud mitmeid teisi vastunäidustusi, mis kehtisid ainult mõnes riigis, piisavate andmetega põhjendatuks või loeti need üleliigseks.
English: Septanest has been authorised in the EU via national procedures.
Estonian: Septanest on saanud Euroopa Liidus müügiloa riiklike menetluste kaudu.
English: Septanest is also available in the EU under other trade names including Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest with Adrenaline, Septanestepi and Septocaine.
Estonian: Septanesti turustatakse ELis ka muude kaubanduslike nimetuste all, näiteks Septanest Forte, Septanest N, Septanest Normal, Septanest SP, Septanest Special, Septanest adrenaliiniga, Septanestepi ja Septocaine.
English: A European Commission decision valid throughout the EU was issued on 27/05/2019.
Estonian: Euroopa Komisjon tegi kogu Euroopa Liidus kehtiva otsuse 27. mail 2019.
English: The maximum recommended dose in all ages is 7 mg of articaine per kg body weight, up to a maximum total dose of 500 mg in adults and 385 mg in children.
Estonian: Igas vanuses patsientide maksimaalne soovitatav annus on 7 mg artikaiini kehamassi kg kohta; maksimaalne koguannus on 500 mg täiskasvanutel ja 385 mg lastel.
English: The review of Septanest was initiated on 29 June 2018 at the request of the marketing authorisation holder, Septodont, under Article 30 of Directive 2001/83/EC.
Estonian: Septanesti läbivaatamine algatati 29. juunil 2018 müügiloa hoidja Septodonti taotlusel vastavalt direktiivi 2001/83/EÜ artiklile 30.
English: In addition, parts of Module 3 of the medicine dossier (which describes how the medicine is produced and its quality controlled) have also been harmonised.
Estonian: Lisaks ühtlustati ka ravimi toimiku moodulit 3 (ravimi tootmine ja kvaliteedikontroll).
English: Other harmonised sections of the SmPC include section 4.4 (special warnings and precautions for use), 4.5 (interactions), 4.6 (fertility, pregnancy and lactation), 4.7 (effects on ability to drive and use machines), 4.8 (side effects), and 4.9 (overdose).
Estonian: Ravimiomaduste kokkuvõttes ühtlustati ka lõigud 4.4 (erihoiatused ja ettevaatusabinõud kasutamisel), 4.5 (koostoimed), 4.6 (fertiilsus, rasedus ja imetamine), 4.7 (autojuhtimise ja masinate käsitsemise võime), 4.8 (kõrvaltoimed) ja 4.9 (üleannustamine).
English: On 28 March 2019, the European Medicines Agency (EMA) completed a review of Septanest (also known by various other names) and recommended changes to the prescribing information in order to harmonise the way the medicine is used in the EU.
Estonian: 28. märtsil 2019 lõpetas Euroopa Ravimiamet (EMA) mitme nimetuse all turustatava Septanesti ravimiteabe läbivaatamise ja soovitas muuta näidustuste teavet, et ühtlustada ravimi kasutamist Euroopa Liidus.
English: Where justified by data, some of the previous contraindications have been included in section 4.4 (special warnings and precautions for use).
Estonian: Andmetega põhjendatud juhtudel lisati mõni varasem vastunäidustus lõiku 4.4 „Erihoiatused ja ettevaatusabinõud kasutamisel“.
English: The recommended dose of Septanest depends on the patient's body weight.
Estonian: Septanesti soovituslik annus sõltub patsiendi vanusest ja kehamassist.
English: After considering the available data on the use of Septanest, the Agency concluded that the SmPC should be harmonised.
Estonian: Pärast Septanesti kasutuse kohta kättesaadavate andmete arvesse võtmist järeldas amet, et ravimi omaduste kokkuvõtet tuleb ühtlustada.