FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor, pharmacist or nurse before taking Desloratadine Actavis:
Estonian: Enne Desloratadine Actavis võtmist pidage nõu oma arsti, apteekri või meditsiiniõega: - kui teil on neerufunktsiooni häire.
English: In clinical studies with desloratadine, the following side effects were reported as: Common: the following may affect up to 1 in 10 people
Estonian: Sage: järgnevad kõrvaltoimed võivad esineda kuni ühel inimesel 10-st
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOTTLE CARTON
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Tabletipurgi karp
English: • liver inflammation • abnormal liver function tests
Estonian: • kõrvalekalded maksafunktsiooni testide tulemustes
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [Actavis Group PTC ehf.
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS [Actavis Group PTC ehf.
English: Breast-feeding
Estonian: Desloratadinum
English: Desloratadine Actavis 5 mg film-coated tablets desloratadine
Estonian: Desloratadine Actavis 5 mg õhukese polümeerikattega tabletid Desloratadiin
English: - If you get any side effects, talk to your doctor, pharmacist or nurse.
Estonian: - Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti,apteekri või meditsiiniõega.
English: NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis Group PTC ehf.
Estonian: MÜÜGILOA HOIDJA NIMI [Actavis Group PTC ehf.
English: • seizures
Estonian: ● suukuivus
English: NAME OF THE MEDICINAL PRODUCT Desloratadine Actavis 5 mg tablets desloratadine
Estonian: RAVIMPREPARAADI NIMETUS Desloratadine Actavis 5 mg tabletid Desloratadinum
English: Each film-coated tablet (tablet) contains 5 mg desloratadine.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 5 mg desloratadiini.
English: If you stop taking Desloratadine Actavis If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Estonian: Kui teil on lisaküsimusi selle ravimi kasutamise kohta, pidage nõu oma arsti,apteekri või meditsiiniõega.
English: During the marketing of desloratadine, the following side effects were reported as: Very rare: the following may affect up to 1 in 10,000 people
Estonian: Väga harv: järgnevad kõrvaltoimed võivad esineda kuni ühel inimesel 10 000-st • rasked allergilised reaktsioonid • lööve
English: • pounding or irregular heartbeat
Estonian: • südame pekslemine või südame rütmihäired
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: A. TOOTMISLOA HOIDJA, KES VASTUTAB PARTII KASUTAMISEKS VABASTAMISE EEST
English: • change in the way the heart beats • aggression
Estonian: ● ebanormaalne käitumine ● agressiivsus
English: NAME OF THE MEDICINAL PRODUCT Desloratadine Actavis 5 mg film-coated tablets desloratadine
Estonian: RAVIMPREPARAADI NIMETUS Desloratadine Actavis 5 mg õhukese polümeerikattega tabletid Desloratadine
English: Bottles:
Estonian: Blistrid:
English: Other medicines and Desloratadine Actavis There are no known interactions of Desloratadine Actavis with other medicines.
Estonian: Muud ravimid ja Desloratadine Actavis
English: Common Very rare
Estonian: Sage Väga harv
English: • fatigue
Estonian: • unetus
English: NAME OF THE MEDICINAL PRODUCT Desloratadine Actavis 5 mg film-coated tablets
Estonian: RAVIMPREPARAADI NIMETUS Desloratadine Actavis 5 mg õhukese polümeerikattega tabletid.
English: Both active substances have been available in the EU for a number of years.
Estonian: Mõlemat toimeainet on Euroopa Liidus aastaid turustatud.
English: Clopidogrel has been authorised since 1998 as an antiplatelet medicine, and is often used in combination with acetylsalicylic acid.
Estonian: Klopidogreelil on alates 1998. aastast müügiluba antiagregandina ning seda kasutatakse sageli koos atsetüülsalitsüülhappega.
English: The medicine is available as tablets containing 75 mg clopidogrel, either with 75 mg or 100 mg acetylsalicylic acid and can only be obtained with a prescription.
Estonian: Seda turustatakse tablettidena, mis sisaldavad 75 mg klopidogreeli ja kas 75 mg või 100 mg atsetüülsalitsüülhapet.
English: Further information on Clopidogrel/Acetylsalicylic acid Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
Estonian: Lisateave ravimi Clopidogrel/Acetylsalicylic acid Mylan kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/clopidogrel-acetylsalicylic-acid-mylan.
English: The combination of the two active substances reduces the risk of blood clots forming more than either medicine alone.
Estonian: Kahe toimeaine kombinatsioon vähendab trombide tekkeriski rohkem kui kumbki ravim eraldi.
English: • patients who have unstable angina (a severe type of chest pain) or who have had a heart attack with no ‘ST-segment elevation' (an abnormal reading on an electrocardiogram), including those who are having a stent (a short tube) inserted into an artery to prevent it from closing up;
Estonian: • patsiendid, kellel on ebastabiilne stenokardia (teatud tugev rindkerevalu) või kellel on olnud ST-segmendi elevatsioonita (teatud ebanormaalne EKG-näit) südameinfarkt, sealhulgas patsiendid, kellel paigaldatakse arterisse stent (lühike toru, mis takistab soone sulgumist);
English: The European Medicines Agency concluded that, in accordance with EU requirements, Clopidogrel/Acetylsalicylic acid Mylan has been shown to have comparable quality and to be bioequivalent to DuoPlavin.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Clopidogrel/Acetylsalicylic acid Mylan võrreldav kvaliteet ja bioekvivalentsus ravimiga DuoPlavin.
English: The medicine is taken as one tablet once a day instead of the clopidogrel and acetylsalicylic acid tablets that the patient has already been taking separately.
Estonian: Ravimit võetakse üks tablett üks kord ööpäevas seni eraldi võetud klopidogreeli ja atsetüülsalitsüülhappe tablettide asemel.
English: Side effects reported with Clopidogrel/Acetylsalicylic acid Mylan are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ravimi Clopidogrel/Acetylsalicylic acid Mylan kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, DuoPlavin, and do not need to be repeated for Clopidogrel/Acetylsalicylic acid Mylan.
Estonian: Võrdlusravimiga DuoPlavin on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Clopidogrel/Acetylsalicylic acid Mylan korrata.
English: Therefore, the Agency's view was that, as for DuoPlavin, the benefits of Clopidogrel/Acetylsalicylic acid Mylan outweigh the identified risks and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka DuoPlavini korral, ületab ravimi Clopidogrel/Acetylsalicylic acid Mylan kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: This means that Clopidogrel/Acetylsalicylic acid Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called DuoPlavin.
Estonian: See tähendab, et Clopidogrel/Acetylsalicylic acid Mylan sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim DuoPlavin, millel juba on ELis müügiluba.
English: Clopidogrel/Acetylsalicylic acid Mylan is a medicine used to prevent problems caused by blood clots and hardening of the arteries, such as a heart attack, in adults who are already taking both clopidogrel and acetylsalicylic acid as separate tablets.
Estonian: Ravimit Clopidogrel/Acetylsalicylic acid Mylan kasutatakse trombide ehk soonesiseste verehüüvete moodustumisest ja arterite lubjastumisest põhjustatud probleemide, näiteks infarkti ennetamiseks täiskasvanutel, kes juba võtavad nii klopidogreeli kui ka atsetüülsalitsüülhapet eraldi tablettidena.
English: For more information about using Clopidogrel/Acetylsalicylic acid Mylan, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Clopidogrel/Acetylsalicylic acid Mylan kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: What measures are being taken to ensure the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan?
Estonian: Mis meetmed võetakse, et tagada ravimi Clopidogrel/Acetylsalicylic acid Mylan ohutu ja efektiivne kasutamine?
English: Because Clopidogrel/Acetylsalicylic acid Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Clopidogrel/Acetylsalicylic acid Mylan on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Clopidogrel/Acetylsalicylic acid Mylan contains two active substances, clopidogrel and acetylsalicylic acid (also known as aspirin) and is a ‘generic medicine'.
Estonian: Clopidogrel/Acetylsalicylic acid Mylan sisaldab kaht toimeainet - klopidogreeli ja atsetüülsalitsüülhapet (aspiriini) ning see on geneeriline ravim.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Clopidogrel/Acetylsalicylic acid Mylan have been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Clopidogrel/Acetylsalicylic acid Mylan ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: As for all medicines, data on the use of Clopidogrel/Acetylsalicylic acid Mylan are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse ravimi Clopidogrel/Acetylsalicylic acid Mylan kasutamise kohta pidevat järelevalvet.
English: Clopidogrel blocks a substance called ADP from attaching to a receptor (target) on the surface of platelets.
Estonian: Klopidogreel blokeerib adenosiindifosfaadi seondumise retseptoriga (sihtmärgiga) trombotsüütide pinnal.
English: As for every medicine, the company provided studies on the quality of Clopidogrel/Acetylsalicylic acid Mylan.
Estonian: Nagu iga ravimi korral, esitas ettevõte ravimi Clopidogrel/Acetylsalicylic acid Mylan kvaliteedi uuringud.
English: Clopidogrel/Acetylsalicylic acid Mylan (clopidogrel / acetylsalicylic acid)
Estonian: Clopidogrel/Acetylsalicylic acid Mylan (klopidogreel/atsetüülsalitsüülhape)
English: What is Clopidogrel/Acetylsalicylic acid Mylan and what is it used for?
Estonian: Mis on Clopidogrel/Acetylsalicylic acid Mylan ja milleks seda kasutatakse?
English: Why is Clopidogrel/Acetylsalicylic acid Mylan authorised in the EU?
Estonian: Miks Clopidogrel/Acetylsalicylic acid Mylan ELis heaks kiideti?
English: Other information about Clopidogrel/Acetylsalicylic acid Mylan
Estonian: Muu teave ravimi Clopidogrel/Acetylsalicylic acid Mylan kohta
English: An overview of Clopidogrel/Acetylsalicylic acid Mylan and why it is authorised in the EU
Estonian: Ülevaade ravimist Clopidogrel/Acetylsalicylic acid Mylan ja ELis müügiloa väljastamise põhjendus
English: How does Clopidogrel/Acetylsalicylic acid Mylan work?
Estonian: Kuidas Clopidogrel/Acetylsalicylic acid Mylan toimib?
English: How has Clopidogrel/Acetylsalicylic acid Mylan been studied?
Estonian: Kuidas ravimit Clopidogrel/Acetylsalicylic acid Mylan uuriti?
English: Acetylsalicylic acid blocks an enzyme called prostaglandin cyclo-oxygenase.
Estonian: Atsetüülsalitsüülhape blokeerib ensüümi prostaglandiintsüklooksügenaasi.
English: How is Clopidogrel/Acetylsalicylic acid Mylan used?
Estonian: Kuidas ravimit Clopidogrel/Acetylsalicylic acid Mylan kasutatakse?
English: This means that they help to prevent components in the blood called platelets from sticking together and forming clots, thus helping to prevent another heart attack.
Estonian: Ravimi mõlemad toimeained, klopidogreel ja atsetüülsalitsüülhape, on trombotsüütide agregatsiooni vastased ravimid, mis aitavad ennetada trombotsüütide kokkukleepumist ja trombide teket ja hoida ära järgmist südameinfarkti.
English: Single-dose prefilled syringe (glass) without needle
Estonian: Intramuskulaarne Ühekordse annusega eeltäidetud süstal (klaas) ilma nõelata
English: Multi-dose vial (glass)
Estonian: Intramuskulaarne Mitut annust sisaldav viaal (klaas)
English: Ref. EMEA/654674/2009 EMEA/H/C/994
Estonian: London, 22. oktoober 2009 Viide: EMEA/745175/2009 EMEA/H/C/994
English: What is Opaxio?
Estonian: Mis on Opaxio?
English: The application was at day 180 when the company withdrew.
Estonian: Taotluse menetlemine oli kestnud 180 päeva, kui ettevõte võttis taotluse tagasi.
English: The CHMP also had concerns about the side effects of the medicine, especially neuropathy (damage to the nerves) and unexplained deaths.
Estonian: Inimravimite komiteel oli samuti kahtlusi ravimi kõrvalnähtude, eelkõige neuropaatia (närvikahjustuste) ja seletamatute surmajuhtumite suhtes.
English: Paclitaxel is an anticancer medicine which has been available in the European Union since 1993.
Estonian: Paklitakseel on vähiravim, mida on Euroopa Liidus turustatud alates 1993. aastast.
English: The letter from the company notifying the CHMP of the withdrawal of the application is available here
Estonian: Ettevõtte kiri, milles ta teatab inimravimite komiteele taotluse tagasivõtmisest, on avaldatud siin.
English: However, outside the EU, the company is continuing to study Opaxio in several cancers including ovarian, oesophageal and non-small cell lung cancer.
Estonian: Väljaspool Euroopa Liitu aga jätkab ettevõte Opaxio uurimist mitme vähiliigi, sealhulgas munasarjavähi, söögitoruvähi ja mitteväikerakk-kopsuvähi ravis.
English: The company informed the CHMP that the withdrawal has no impact on patients in the European Union (EU) as there are no ongoing clinical trials or compassionate use programmes in the EU.
Estonian: Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmine ei mõjuta patsiente Euroopa Liidus, sest kliinilisi uuringuid ega eriloaga kasutamise programme praegu Euroopa Liidus ei toimu.
English: In addition, the studies did not show that Opaxio was more effective than the two comparators.
Estonian: Peale selle ei näidanud uuringud, et Opaxio on mõlemast võrdlusravimist efektiivsem.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Opaxio?
Estonian: Kuidas mõjutab tagasivõtmine praegu Opaxio kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: In this study, Opaxio was compared with gemcitabine or vinorelbine (two other anticancer medicines).
Estonian: Selles uuringus võrreldi Opaxiot gemtsitabiini või vinorelbiiniga (samuti vähiravimid).
English: The company's view that the study showed that Opaxio was as least as good as the comparators was not accepted by the Committee because it was not clear that the comparators themselves were effective in the type of patients involved in the main study.
Estonian: Komitee ei aktsepteerinud ettevõtte seisukohta, mille järgi uuring näitas, et Opaxio on vähemalt sama efektiivne kui võrdlusravimid, sest ei olnud selge, kas võrdlusravimid ise olid põhiuuringus osalenud patsientide ravis efektiivsed.
English: Questions and answers on the withdrawal of the marketing authorisation application for Opaxio paclitaxel poliglumex
Estonian: Teave müügiloa taotluse tagasivõtmise kohta Opaxio paklitakseel-polüglumeks
English: Opaxio is a powder that is made up into a solution for infusion (drip into a vein).
Estonian: Opaxio on pulber, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: The active substance in Opaxio, paclitaxel poliglumex, is expected to be converted into paclitaxel in the cancer cells.
Estonian: Opaxio toimeaine paklitakseel-polüglumeks eeldatavasti muundub vähirakkudes paklitakseeliks.
English: There were also concerns about impurities in the medicine and about the way paclitaxel is released and distributed in the body when Opaxio is given.
Estonian: Kahtlusi tekitasid ka ravimis sisalduvad lisandid ja Opaxio manustamisele järgneva paklitakseeli vabanemise ning organismis levimise viis.
English: On 21 September 2009, CTI Life Sciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opaxio, for the first-line treatment of patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Estonian: 21. septembril 2009 teatas CTI Life Sciences Ltd ametlikult inimravimite komiteele oma soovist võtta tagasi ravimi Opaxio müügiloa taotlus; ravimit oli kavatsetud kasutada kaugelearenenud mitteväikerakk-kopsuvähiga patsientide raviks, kelle üldseisund ECOG-kriteeriumide järgi on 2.
English: The company presented results of one main study involving 477 patients with advanced non-small cell lung cancer and a performance status of 2.
Estonian: Ettevõte esitas ühe põhiuuringu tulemused, kus osales 477 kaugelearenenud mitteväikerakk-kopsuvähiga patsienti, kelle üldseisund ECOG-kriteeriumide järgi on 2.
English: How is Opaxio expected to work?
Estonian: Milline on Opaxio eeldatav toime?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Opaxio could not have been approved for the first-line treatment of patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Estonian: Tuginedes esitatud andmete analüüsile ja ettevõtte vastustele inimravimite komitee esitatud küsimustele, nägi inimravimite komitee taotluse tagasivõtmise ajal põhjuseid ettevaatlikkuseks ning oli esialgsel seisukohal, et Opaxio kasutamist kaugelearenenud mitteväikerakk-kopsuvähiga patsientide raviks, kelle üldseisund ECOG-kriteeriumide järgi on 2, ei ole võimalik heaks kiita.
English: Paclitaxel works by blocking the ability of cancer cells to break down the internal ‘skeleton' that allows them to divide and multiply.
Estonian: Paklitakseel pärsib vähiraku võimet lagundada enda sisetoest, et rakk saaks jaguneda ja paljuneda.
English: In Opaxio, paclitaxel is attached to poliglumex to make it more soluble.
Estonian: Opaxios on paklitakseel seotud polüglumeksiga, mis muudab selle paremini lahustuvaks.
English: The CHMP noted that the main study did not show that Opaxio was effective in patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Estonian: Inimravimite komitee märkis, et põhiuuring ei näidanud Opaxio efektiivsust nende kaugelearenenud mitteväikerakk-kopsuvähiga patsientide ravis, kelle üldseisund ECOG kriteeriumide järgi on 2.
English: A performance status of 2 means that the patient can take care of him or herself without help but is too ill to do any work.
Estonian: Üldseisund ECOG-kriteeriumide järgi näitab vähipatsiendi seisundit: seisund 2 tähendab, et patsient suudab kõrvalise abita enda eest hoolitseda, kuid on haiguse tõttu töövõimetu.
English: It contains the active substance paclitaxel poliglumex.
Estonian: Ravim sisaldab toimeainena paklitakseel-polüglumeksit.
English: Opaxio was expected to be used in patients with advanced non-small cell lung cancer who have an ECOG performance status of 2.
Estonian: Ravimit Opaxio kavatseti kasutada kaugelearenenud mitteväikerakk-kopsuvähiga patsientide raviks, kelle üldseisund ECOG-kriteeriumide järgi on 2.
English: What was Opaxio expected to be used for?
Estonian: Milleks kavatseti Opaxiot kasutada?
English: The effects of Opaxio were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti ravimi Opaxio toimet muude katsetega.
English: In conclusion, the following harmonised indications were adopted for Femara:
Estonian: Kokkuvõtteks võeti Femara kohta vastu järgmised ühtlustatud näidustused:
English: Femara was first approved in the European Union (EU) in 1996 and is available as a 2.5 mg film-coated tablet.
Estonian: Femara kiideti Euroopa Liidus esmakordselt heaks 1996. aastal ning ravimit turustatakse 2,5 mg õhukese polümeerikattega tabletina.
English: In addition, letrozole is not considered to have a narrow therapeutic index.
Estonian: Lisaks sellele ei ole letrosool kitsa terapeutilise indeksiga.
English: A referral under Article 30(2) of Directive 2001/83/EC, as amended was therefore triggered to resolve these divergences and thus harmonise the product information (PI) across the EU.
Estonian: Seetõttu algatati direktiivi 2001/83/EÜ artikli 30(2) kohane esildis, et kõrvaldada lahknevused ja ühtlustada ravimiteave kogu Euroopa Liidus.
English: Regarding children, invasive breast cancer is extremely rare in children and adolescents but has been reported.
Estonian: Laste kohta tuleb märkida, et invasiivne rinnavähk esineb lastel ja noorukitel väga harva, kuid selle kohta on siiski andmeid.
English: Overall summary of the scientific evaluation of Femara and associated names (see Annex I)
Estonian: Femara ja sarnaste nimetustega ravimite (vt I lisa) teadusliku hindamise üldkokkuvõte
English: The CHMP moved the statement from Section 4.4 to Section 5.1.
Estonian: Inimravimite komitee tõstis selle seisukoha lõigust 4.4 lõiku 5.1.
English: The CHMP therefore considered it justified to qualify the indication with “invasive”.
Estonian: Seetõttu peab inimravimite komitee õigeks kvalifitseerida näidustuseks „invasiivne“.
English: Femara contains letrozole, an aromatase inhibitor which inhibits the conversion of androgens to oestrogens.
Estonian: Femara sisaldab letrosooli, mis on aromataasi inhibiitor ja inhibeerib androgeenide konverteerimist östrogeenideks.
English: The neoadjuvant (pre-operative) treatment indication represented the major deviation across the nationally approved SmPCs, as it was approved in some member states in 2001 but the application was withdrawn in others, primarily because neoadjuvant endocrine treatment was not a validated concept at the time and because the results of the pivotal adjuvant study were not yet available.
Estonian: Neoadjuvantse (operatsioonieelse) ravi näidustus erines riiklikult heakskiidetud ravimi omaduste kokkuvõtetes kõige rohkem, sest mõnedes riikides kiideti see heaks juba 2001. aastal ja teistes lükati taotlus tagasi põhiliselt sellepärast, et neoadjuvantne endokriinravi ei olnud sel ajal veel tunnustatud kontseptsioon ning adjuvantravi kesksete uuringute tulemused ei olnud veel kättesaadavad.
English: The CHMP considered that reviews of clinical databases are poorly suited to assess the risk for interactions or to assess reports of lack of interaction and therefore removed references to these reviews.
Estonian: Inimravimite komitee leidis, et kliiniliste andmebaaside ülevaated ei sobi hästi koostoimete riski hindamiseks või koostoimete puudumise aruannete hindamiseks ning seetõttu eemaldas nende ülevaadete viited.
English: For Section 5.1Pharmacodynamic Properties, the wording was substantially shortened to focus on information relevant to the prescriber for the approved indications.
Estonian: Lõigu 5.1 - Farmakodünaamilised omadused - sõnastust lühendati märkimisväärselt, et keskenduda teabele, mis on oluline ravi määrajale heakskiidetud näidustuste korral.
English: Regarding the pre-operative use of letrozole if receptor status is negative or unknown, the CHMP considered a contraindication to be unnecessary, as this is already sufficiently explained in Section 4.4.
Estonian: Seoses letrosooli operatsioonieelse kasutamisega, kui retseptori staatus on negatiivne või teadmata, pidas inimravimite komitee vastunäidustust mittevajalikuks, sest seda on juba piisavalt selgitatud lõigus 4.4.
English: The CHMP instead included a warning in Section 4.4 stating that safety data in patients with significant organ impairment are lacking.
Estonian: Selle asemel lisas inimravimite komitee hoiatuse lõiku 4.4, väites, et ohutusandmed olulise organikahjustusega patsientide kohta puuduvad.