FrancophonIA/ELRC3.0 huggingface dataset:
English: The daily amount of Spectrila needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Estonian: Spectrila patsiendile vajaliku igapäevase koguse võib lahjendada lõpliku mahuga 50-250 ml naatriumkloriidi 9 mg/ml (0,9%) infusioonilahuses.
English: Sinus vein thrombosis can occur.
Estonian: Võib esineda venoossete siinuste tromboos.
English: Common Pain (back pain, joint pain)
Estonian: Sage Valu (seljavalu, liigesevalu)
English: Hyperglycaemic conditions
Estonian: Hüperglükeemilised seisundid
English: Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out accelerated elimination of asparaginase activity.
Estonian: Asparaginaasi aktiivsuse kiirenenud eliminatsiooni välistamiseks võib mõõta asparaginaasi aktiivsuse taset seerumis või plasmas.
English: Fax: +49 4103 8006-100
Estonian: Faks: +49 4103 8006-100
English: • high blood sugar level (hyperglycaemia).
Estonian: • kõrge veresuhkru tase (hüperglükeemia).
English: Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Estonian: Spectrila 10 000 Ü infusioonilahuse kontsentraadi pulber Asparaginaas
English: Measurement of the asparaginase activity level in serum or plasma may be undertaken in order to rule out accelerated reduction of asparaginase activity.
Estonian: Asparaginaasi aktiivsuse kiirenenud vähenemise välistamiseks võib mõõta asparaginaasi aktiivsuse taset seerumis või plasmas.
English: Fax: +49-4103-8006-100
Estonian: Faks: +49-4103-8006-100
English: NAME OF THE MEDICINAL PRODUCT Spectrila 10,000 U powder for concentrate for solution for infusion Asparaginase
Estonian: RAVIMPREPARAADI NIMETUS Spectrila 10 000 Ü infusioonilahuse kontsentraadi pulber Asparaginaas
English: The calculated quantity of asparaginase is dissolved further in 50 to 250 ml of sodium chloride 9 mg/ml (0.9 %) solution for infusion.
Estonian: Väljaarvutatud hulk asparaginaasi lahustatakse veel 50-250 ml naatriumkloriidi 9 mg/ml (0,9%) infusioonilahuses.
English: Sucrose
Estonian: Treemor
English: Common
Estonian: Kogukliirens
English: The daily amount of asparaginase needed per patient can be diluted in a final volume of 50 - 250 ml sodium chloride 9 mg/ml (0.9 %) solution for injection.
Estonian: Asparaginaasi patsiendile vajaliku igapäevase koguse võib lahjendada lõpliku mahuga 50-250 ml naatriumkloriidi 9 mg/ml (0,9%) süstelahuses.
English: • cholestasis (blocked bile flow from the liver)
Estonian: • kolestaas (sapivoolu takistus maksast);
English: LIST OF EXCIPIENTS Excipient: sucrose.
Estonian: ABIAINED Abiaine: sahharoos
English: Hepatic failure with potentially fatal outcome, hepatic necrosis, cholestasis, jaundice
Estonian: Võimaliku surmlõppega maksapuudulikkus, maksanekroos, kolestaas, ikterus
English: • blood clotting disorders (bleeding or formation of blood clots),
Estonian: • verehüübimishäired (veritsus või verehüüvete teke);
English: Common side effects (may affect up to 1 in 10 people):
Estonian: Sagedad kõrvaltoimed (võivad esineda kuni 1 inimesel 10-st):
English: • high blood levels of uric acid (hyperuricaemia)
Estonian: • kõrge kusihappe tase veres (hüperurikeemia);
English: No dose adjustment is necessary in patients with mild to moderate hepatic impairment.
Estonian: Kerge kuni keskmise maksafunktsiooni kahjustusega patsientidel ei ole annuse kohandamine vajalik.
English: Disposal
Estonian: Eritumine
English: Rare (may affect up to 1 in 1,000 people):
Estonian: Harv (võivad esineda kuni 1 inimesel 1000-st):
English: The ready-to-use solution may exhibit a slight opalescence.
Estonian: Manustamiskõlblik lahus võib olla veidi küütlev.
English: • allergic reactions including serious allergic reaction (anaphylactic shock), flushing, rash, low blood pressure, swelling of face and throat, hives, shortness of breath,
Estonian: nahaõhetus, lööve, madal vererõhk, näo ja kõri turse, nõgestõbi, hingeldus;
English: Spectrila 10,000 U powder for concentrate for solution for infusion
Estonian: Spectrila 10 000 Ü infusioonilahuse kontsentraadi pulber
English: The reconstituted solution may exhibit a slight opalescence.
Estonian: Kasutusvalmis lahus võib olla veidi küütlev.
English: • high blood levels of amylase and lipase
Estonian: • kõrge amülaasi ja lipaasi tase veres;
English: Before initiating therapy bilirubin, hepatic transaminases, and coagulation parameters (partial thromboplastin time [PTT], prothrombin time [PT], antithrombin, fibrinogen, and D-dimer) should be determined.
Estonian: Soovituslikud kontrolluuringud ja ohutusalased ettevaatusabinõud Enne ravi alustamist tuleb kindlaks määrata bilirubiini ja maksa transaminaaside tase ning hüübimisparameetrid (osalise tromboplastiini aeg [PTT], protrombiiniaeg [PT], antitrombiin, fibrinogeen ja D-dimeerid).
English: Hyperglycaemia and hypoglycaemia
Estonian: Hüperglükeemia ja hüpoglükeemia
English: Very rare Secondary hypothyroidism, hypoparathyroidism
Estonian: Sekundaarne hüpotüreoidism, hüpoparatüreoidism Ainevahetus- ja toitumishäired Väga sage Hüperglükeemia, hüpoalbumineemia Sage
English: A method other than oral contraceptives should be used in women of childbearing potential (see section 4.4).Men should use effective contraceptive measures and be advised to not father a child while receiving asparaginase.
Estonian: Fertiilses eas naised peavad kasutama suukaudsete rasestumisvastaste vahendite asemel muud meetodit (vt lõik 4.4).
English: PHARMACEUTICAL FORM Powder for concentrate for solution for infusion.
Estonian: Infusioonilahuse kontsentraadi pulber.
English: Posology
Estonian: Ravirühm
English: Unopened vials
Estonian: VIAALI SILT
English: • liver problems,
Estonian: • anafülaksia;
English: Complete asparagine depletion in CSF Yesc
Estonian: Liikvori asparaginaasivarude täielik tühjenemine Jah c
English: A list of all other side effects is set out below according to how common they are: Very common side effects (may affect more than 1 in 10 people):
Estonian: Väga sagedad kõrvaltoimed (võivad esineda enam kui 1 inimesel 10-st):
English: Note:
Estonian: Märkus:
English: Sometimes a single dose of adrenaline may not be sufficient to completely reverse the effects of a serious allergic reaction.
Estonian: Mõnikord ei piisa adrenaliini ühekordsest annusest ägeda allergilise reaktsiooni täielikuks leevendamiseks.
English: For EpiPen/Nepipe and associated names
Estonian: Automaatsüstalde EpiPen/Nepipe ja nendega seotud nimetuste kohta
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Estonian: Liikmesriigi pädevad asutused võivad vastavalt vajadusele muuta ravimi teavet koostöös referentliikmesriigiga ja vastavalt direktiivi 2001/83/EÜ III osa peatükis 4 kirjeldatud protseduuridele.
English: This Summary of Product Characteristics and package leaflet is the outcome of the referral procedure.
Estonian: Käesolev toote omaduste kokkuvõte ja pakendi infoleht on esildismenetluse tulemus.
English: All patients who are prescribed [Invented name] should be thoroughly instructed to understand the indications for the use and the correct method of administration (see section 6.6).
Estonian: Kõiki patsiente, kellele kirjutatakse välja [väljamõeldud nimetus], tuleb üksikasjalikult juhendada näidustuste ja õige manustamisviisi osas (vt lõik 6.6).
English: If your symptoms have not improved or have deteriorated within 5-15 minutes after the first injection, either you or the person with you should give a second injection.
Estonian: Kui teie sümptomid ei leevendu või ei taandu 5...15 minuti jooksul esimesest süstimisest, peate süstima teist korda või laskma seda kellelgi teha.
English: For this reason you should carry more than one [Invented name] with you at all times.
Estonian: Seepärast peaks teil alati kaasas olema rohkem kui üks [ravimi väljamõeldud nimetus].
English: In the absence of clinical improvement or if deterioration occurs, a second injection with an additional [Invented name] may be administered 5-15 minutes after the first injection.
Estonian: Kui ei esine kliinilist paranemist või seisund halveneb, võib 5...15 minutit pärast esimest süstimist teha [ravimi väljamõeldud nimetus] teise süstimise.
English: Section 6 - Contents of the pack and other information
Estonian: - Pakendi sisu ja muu teave
English: It is recommended that your family members, carers or teachers are also instructed in the correct use of [Invented name].
Estonian: Soovitatav on juhendada enda perekonnaliikmeid, hooldajaid või õpetajaid [ravimi väljamõeldud nimetus] õige kasutamise osas.
English: It is strongly advised also to educate the patient's immediate associates (e.g. parents, caregivers, teachers) for the correct usage of the [Invented name] in case support is needed in the emergency situation.
Estonian: Oluline on juhendada [ravimi väljamõeldud nimetus] õige kasutamise osas ka patsiendi lähedasi (nt vanemad, hooldajad, õpetajad) juhuks, kui patsient vajab hädaolukorras abi.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Estonian: III Lisa Ravimi omaduste kokkuvõtte ja pakendi infolehe vastavate osade parandused
English: A. Summary of Products Characteristics
Estonian: A. Ravimi omaduste kokkuvõte
English: [The MAH(s) should submit improved diagram in the instructions for use by increasing the size and ensuring that it clearly shows that the injection should be in the antero-lateral aspect of the thigh]
Estonian: [Müügiloa hoidja(d) peaksid lisama kasutusjuhendile parandatud skeemi, mis on suurem ja näitab selgelt süstimiskoha paiknemist reie esiküljel]
English: Section 6.5 - Nature and contents of container [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Estonian: Lõik 6.5 - Pakendi iseloomustus ja sisu [Sellele lõigule tuleb lisada seadme(te) katmata nõela pikkus ] [Täidetakse riiklikult]
English: Section 4.4 - Special warnings and precautions for use [The section should be amended to reflect the following wording]
Estonian: Lõik 4.4 - Erihoiatused ja ettevaatusabinõud kasutamisel [Sellesse lõiku tuleb sisse viia alljärgnevad parandused]
English: What [Invented name] looks like and contents of the pack [The section should be amended to reflect the exposed needle length of the device(s)] [To be completed nationally]
Estonian: Kuidas X välja näeb ja pakendi sisu [Sellele lõigule tuleb lisada seadme(te) katmata nõela pikkus ] [Täidetakse riiklikult]
English: Section 4.2 - Posology and method of administration [The section should be amended to reflect the following wording]
Estonian: Lõik 4.2 - Annustamine ja manustamisviis [Sellesse lõiku tuleb sisse viia alljärgnevad parandused]
English: Section 3 - How to use [Invented name]
Estonian: Jagu - Kuidas X'i kasutada
English: Section 3 - How to use [Invented name] [The section should be amended to reflect the following wording]
Estonian: - Kuidas X'i kasutada [Sellesse lõiku tuleb sisse viia alljärgnevad parandused]
English: The course of treatment may be repeated but not sooner than 21 days after the start of the first course.
Estonian: Ravikuuri võib korrata, kuid mitte varem kui 21 päeva möödudes esimese ravikuuri alustamisest.
English: Etopophos is marketed in the following EU member States: France, Germany, Sweden and the United Kingdom.
Estonian: Etopophost turustatakse järgmistes Euroopa Liidu liikmesriikides: Prantsusmaa, Saksamaa, Rootsi ja Ühendkuningriik.
English: The recommended dose for adults is 50 to 100 mg per m2 of body surface area for 5 days in a row or 100 to 120 mg/m2 on days 1, 3 and 5.
Estonian: Soovitatav annus täiskasvanutel on 50100 mg kehapindala ruutmeetri kohta 5 järjestikusel päeval või 100-120 mg/m2 1., 3. ja 5. päeval.
English: The company that markets these medicines is Bristol-Myers Squibb.
Estonian: Neid ravimeid turustab ettevõte Bristol-Myers Squibb.
English: What is Etopophos?
Estonian: Mis on Etopophos?
English: Why was Etopophos reviewed?
Estonian: Miks Etopophose ravimiteave uuesti läbi vaadati?
English: Etopophos is given as a slow intravenous infusion.
Estonian: Etopophost manustatakse aeglase intravenoosse infusioonina.
English: On 21 April 2017, the European Medicines Agency completed a review of Etopophos.
Estonian: 21. aprillil 2017 lõpetas Euroopa Ravimiamet (EMA) Etopophose ravimiteabe läbivaatamise.
English: • testicular cancer, including cancer that is resistant to treatment or has come back;
Estonian: • eesnäärmevähk, sealhulgas ravile mittealluv või retsidiveerunud vähk;
English: Etopophos is authorised in the EU via national procedures.
Estonian: Etopophos on Euroopa Liidus saanud müügiloa riiklike menetlustega.
English: • high-risk gestational trophoblastic neoplasia as first- and second-line treatments;
Estonian: • kõrgriskiga rasedusaegne trofoblastiline neoplaasia (esma- ja teise valiku ravina);
English: It is also available in the EU under the trade name Etopofos.
Estonian: Etopophost turustatakse Euroopa Liidus ka kaubandusliku nimetuse Etopofos all.
English: The CHMP recommended that Etopophos should be used in combination with other cancer treatments to treat the following cancers:
Estonian: Inimravimite komitee soovitas Etopophose kasutamist koos teiste vähiravimitega järgmiste vähivormide raviks:
English: On 14 October 2015, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Etopophos in the EU.
Estonian: 14. oktoobril 2015 tegi Euroopa Komisjon inimravimite komiteele esildise Etopophose müügilubade ühtlustamiseks Euroopa Liidus.
English: • Hodgkin's and non-Hodgkin's lymphoma;
Estonian: • Hodgkini ja mitte-Hodgkini lümfoom;
English: For blood cancers (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia), Etopophos is recommended for both adults and children, while its other uses are for adults only.
Estonian: Verevähi vormide korral (Hodgkini ja mitte-Hodgkini lümfoom, äge müeloidleukeemia) soovitatakse Etopophost kasutamiseks nii täiskasvanutel kui ka lastel, kuid teistel näidustustel üksnes täiskasvanutel.
English: Etopophos is a cancer medicine used to treat: testicular cancer, lung cancer, ovarian cancer, gestational trophoblastic neoplasia (a rare tumour of the womb that occurs during pregnancy) and cancers of the blood (Hodgkin's and non-Hodgkin's lymphoma and acute myeloid leukaemia).
Estonian: Etopophos on vähiravim, mida kasutatakse eesnäärme-, kopsu- ja munasarjavähi, rasedusaegse trofoblastilise neoplaasia (harvaesinev emakakasvaja, mis tekib raseduse ajal) ja teatavate verevähi vormide (Hodgkini ja mitte-Hodgkini lümfoom, äge müeloidleukeemia) raviks.
English: In addition, the CHMP recommended Etopophos for treating epithelial ovarian cancer that is resistant to treatments with platinum-containing medicines, with no specification that it should be used in combination with other medicines.
Estonian: Peale selle soovitas inimravimite komitee Etopophost epiteliaalse munasarjavähi raviks, mis ei ole allunud ravile plaatinasisaldusega ravimitega, ilma viiteta sellele, et seda tuleb kasutada kombinatsioonis teiste ravimitega.
English: • acute myeloid leukaemia;
Estonian: • äge müeloidleukeemia;
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Estonian: Seetõttu on ravimi näidustused, ravimi omaduste kokkuvõtted, märgistused ja pakendi infolehed ravimit turustavates liikmesriikides erinevad.
English: Etopophos should not be administered during vaccination with yellow fever or other live vaccines in patients with weakened immune systems and should not be given to breast-feeding women.
Estonian: Etopophost ei tohi kasutada samal ajal vaktsineerimisega kollapalaviku vastu ega muude elusvaktsiinidega nõrgenenud immuunsüsteemiga patsientidel ning seda ei tohi kasutada imetamise ajal.
English: Etopophos contains the active substance etoposide (as etoposide phosphate) and is available as a powder to be made into a solution for infusion into a vein.
Estonian: Etopophos sisaldab toimeainena etoposiidi (etoposiidfosfaadina) ja seda turustatakse infusioonilahuse (veeni tilgutatava lahuse) pulbrina.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Etopophos and associated names in the European Union (EU).
Estonian: EMA inimravimite komitee järeldas, et Etopophose ja sarnaste nimetuste määramise teave tuleb Euroopa Liidus ühtlustada.
English: Etopophos was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühm nimetas Etopophose ühtlustamist vajavaks ravimiks.
English: Laboratorios Dr Esteve, SA Avda.
Estonian: Hispaania Laboratorios Dr Esteve, SA Avda.
English: 3641 RT Mijdrecht Nederland
Estonian: 3641 RT Mijdrecht Holland
English: Bravničarjeva 13 1000 Ljubljana Slovenia
Estonian: Bravničarjeva 13 1000 Ljubljana Sloveenia
English: 1123 Budapest
Estonian: 1123 Budapest Ungari
English: Berkshire RG14 1JA United Kingdom
Estonian: Berkshire RG14 1JA Ühendkuningriik
English: Netherlands Bayer BV Energieweg 1
Estonian: Bayer BV Energieweg 1
English: QUÍMICA FARMACEUTICA BAYER, S. A. Av. Baix Llobregat, 3 y 5
Estonian: Hispaania QUÍMICA FARMACEUTICA BAYER, S. A. Av. Baix Llobregat, 3 y 5
English: Hungary Bayer Hungária Kft Alkotás ut.50
Estonian: Bayer Hungária Kft Alkotás ut.50
English: Via M. Civitali, 1 20148 Milano Italy
Estonian: Via M. Civitali, 1 20148 Milano Itaalia
English: BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX France
Estonian: Prantsusmaa BAYER SANTE 13, rue Jean Jaures 92807 PUTEAUX CEDEX Prantsusmaa
English: Viale Certosa, 130 20156 Milano Italy
Estonian: Viale Certosa, 130 20156 Milano Itaalia
English: 151 25 Marousi - Athens Greece
Estonian: 151 25 Marousi - Athens Kreeka
English: 15125 Maroussi - Athens Greece
Estonian: 15125 Maroussi - Athens Kreeka
English: ANNEX I LIST OF THE PRODUCT NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES AND ICELAND
Estonian: LISA I RAVIMI(TE) NIMETUSTE, RAVIMVORMI(DE), TUGEVUS(T)E, MANUSTAMISVIISI(DE), TAOTLEJA(TE), MÜÜGILOA HOIDJA(TE) LOETELU LIIKMESRIIKIDES
English: Luxembourg Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles
Estonian: Luksemburg Therabel Pharma 110 Rue Egide Van Ochem 1180 Bruxelles
English: United Kingdom
Estonian: Ühendkuningri ik
English: Procter and Gamble Pharmaceuticals Iberia, SL WTC Almeda park, Edif 1, 2º planta 08940 Cornellá de Llobregat Barcelona
Estonian: WTC Almeda park, Edif 1, 2º planta 08940 Cornellá de Llobregat
English: BN22 9AG East Sussex United Kingdom
Estonian: Teva UK Limited Brampton Road BN22 9AG East Sussex Ühendkuningriik
English: Belgium Bayer s.a.-n.v. Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgium
Estonian: Avenue Louise 143 Louizalaan B-1050 Bruxelles Belgia
English: Moxifloxacin Moxifloxacin "Teva"
Estonian: Moxifloxacin "Teva" 400 mg
English: Luxembourg Bayer s.a.-n.v. Avenue Louise 143 Louizalaan 1050 Bruxelles
Estonian: Avenue Louise 143 Louizalaan 1050 Bruxelles
English: 2800 Kongens Lyngby Denmark
Estonian: Teva Denmark A/S, Parallelvej 10, 2800 Kongens Lyngby Taani
English: RECORDATI ESPAÑA, SL Carretera De Zeneta, 149 30588 Beniel (Murcia) Spain
Estonian: 30588 Beniel (Murcia) Hispaania
English: Belgium Therabel Pharma S.A. Rue Egide Van Ophem 108 1180 Bruxelles
Estonian: Rue Egide Van Ophem 108 1180 Bruxelles Belgium
English: Germany Bayer Vital GmbH 51368 Leverkusen Germany
Estonian: Saksamaa Bayer Vital GmbH 51368 Leverkusen Saksamaa
English: Bayer Vital GmbH 51368 Leverkusen Germany
Estonian: Bayer Vital GmbH 51368 Leverkusen Saksamaa
English: Bayer AG 51368 Leverkusen Germany
Estonian: Bayer AG 51368 Leverkusen Saksamaa
English: Bayer Health Care AG 51368 Leverkusen Germany
Estonian: Bayer Health Care AG 51368 Leverkusen Saksamaa
English: Octegra 400 mg tabletten
Estonian: Octegra 400 mg tabletten 400 mg
English: Actira 400 mg film coated tablets400 mg Film-coated tablet
Estonian: Actira 400 mg film coated tablets
English: Avalox 400 mg Filmtabletten 400 mg Film-coated tablet
Estonian: Avalox 400 mg Filmtabletten
English: Avelox 400mg Tablets
Estonian: Avelox 400mg Tablets 400 mg
English: Actimax 400 mg Filmtabletten 400 mg Film-coated tablet
Estonian: Actimax 400 mg Filmtabletten
English: Avelox 400 mg tabletten
Estonian: Avelox 400 mg tabletten 400 mg
English: Actira 400 mg Filmtabletten 400 mg Film-coated tablet
Estonian: Actira 400 mg Filmtabletten
English: Germany Bayer HealthCare AG 51368 Leverkusen
Estonian: Saksamaa Bayer HealthCare AG 51368 Leverkusen
English: Octegra 400 mg Filmtabletten 400 mg Film-coated tablet
Estonian: Octegra 400 mg Filmtabletten
English: Denmark Bayer HealthCare AG 51368 Leverkusen
Estonian: Slovakkia Bayer HealthCare AG 51368 Leverkusen
English: Member State EU/EEA
Estonian: Liikmesriik EL/EMÜ
English: In conclusion, both results were considered to be fully acceptable.
Estonian: Kokkuvõttes peeti mõlemaid tulemusi aktsepteeritavateks.
English: Safety results
Estonian: Ohutuse tulemused
English: The response to the third part (iii) has been provided separately.
Estonian: Vastus punktile iii on esitatud eraldi.
English: Initial Bioequivalence Studies
Estonian: Bioekvivalentsuse esialgsed uuringud
English: The information on the originator product has been clarified to a satisfactory extent.
Estonian: Teave originaalravimi kohta olid selgitatud rahuldaval määral.
English: The change of name was caused by company takeover.
Estonian: Nimetuse muutus oli tingitud firma ülevõtmisest.
English: During the course of the study, 80 adverse events were reported.
Estonian: Selle uuringu käigus teatati 80 kahjulikust kõrvaltoimest.
English: For long-term stability a reduction was seen in pantoprazole content of between 6-8% of the nominal content, which was considered acceptable.
Estonian: Pikaajalise stabiilsuse suhtes täheldati pantoprasooli sisalduse vähenemist 6-8% nominaalsisaldusega võrreldes ja seda peeti aktsepteeritavaks.
English: The CHMP considered that the drug intake after breakfast (30 minutes) was sufficiently short.
Estonian: Inimravimite komitee võttis arvesse, et aeg ravimi manustamiseni pärast hommikusööki (30 minutit) oli piisavalt lühike.
English: There were no deaths, and no serious or other significant adverse events in the course of the study.
Estonian: Surmaga lõppenud juhtumeid ei esinenud ja raskeid või muid olulisi kõrvaltoimeid uuringu käigus ei täheldatud.
English: No extrapolation or imputation has been used in the statistical analysis.
Estonian: Ekstrapoleerimist ega statistilist imputeerimist statistilises analüüsis ei kasutatud.
English: The detailed results of the long-term stability data of human samples were given.
Estonian: Inimproovide pikaajalise stabiilsuse kohta esitati üksikasjalikud tulemused.
English: SE-111 23 Stockholm Sweden
Estonian: SE-111 23 Stockholm Rootsi
English: All but one of them had either been classified as being clinically not significant or been resolved after the follow-up conducted by the Applicant.
Estonian: Kõik peale ühe klassifitseeriti kliiniliselt ebaolulisteks või lahenesid pärast taotleja korraldatud jälgimisuuringut.
English: The reference product patients' leaflet was also provided.
Estonian: Esitati ka võrdlusravimi patsiendi infoleht.
English: All the available data were included without any imputation or extrapolation.
Estonian: Kõik olemasolevad andmed esitati ilma igasuguse statistilise imupteerimise või ekstrapoleerimiseta.
English: The CHMP considered the Applicant's response acceptable.
Estonian: Inimravimite komitee pidas taotleja vastust aktsepteeritavaks.
English: The documentation of the analytical methods comprised an Analytical Report and a Re-validation report.
Estonian: Analüütiliste meetodite dokumentatsioon koosnes analüüsi aruandest ja revalideerimise aruandest.