FrancophonIA/ELRC3.0 huggingface dataset:
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling.
Estonian: Kuumtihendatud karp, milles on 1 blisterpakend 11 x 0,5 mg ja 14 x 1 mg varenikliini õhukese polümeerikattega tabletiga ning 1 blisterpakend 28 või 2 blisterpakendit 14 x 1 mg varenikliini õhukese polümeerikattega tabletiga - sise- ja välismärgistus.
English: Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Estonian: - Ravi alustuspakendis on 2 blisterpakendit: üks läbipaistev blister 11 x CHAMPIX 0,5 mg õhukese polümeerikattega tabletiga ja teine läbipaistev blister 14 x CHAMPIX 1 mg õhukese polümeerikattega tabletiga pappkarbis.
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Estonian: PCTFE/PVC blisterpakendid, mis on suletud alumiiniumfooliumiga, milles on 1 läbipaistev blister 11 x 0,5 mg õhukese polümeerikattega tabletiga ja teine läbipaistev blister 14 x 1 mg õhukese polümeerikattega tabletiga pappkarbis.
English: PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Estonian: PVC blisterpakendid, mis on suletud alumiiniumfooliumiga - pakendis 28 x 1 mg õhukese polümeerikattega tabletti pappkarbis.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Estonian: PCTFE/PVC blisterpakendid, mis on suletud alumiiniumfooliumiga - pakendis 56 x 1 mg õhukese polümeerikattega tabletti teiseses kuumtihendatud karbis.
English: PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Estonian: PCTFE/PVC blisterpakendid, mis on suletud alumiiniumfooliumiga - pakendis 28 x 1 mg õhukese polümeerikattega tabletti teiseses kuumtihendatud karbis.
English: Hepatic impairment
Estonian: Hüperglükeemia
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets, heat sealed card
Estonian: Blisterpakend 11 x 0,5 mg varenikliini õhukese polümeerikattega tabletiga, kuumtihendatud karp
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Estonian: PVC blisterpakendid, mis on suletud alumiiniumfooliumiga, milles on 1 läbipaistev blister 11 x 0,5 mg õhukese polümeerikattega tabletiga ja teine läbipaistev blister 14 x 1 mg õhukese polümeerikattega tabletiga pappkarbis.
English: PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Estonian: PVC blisterpakendid, mis on suletud alumiiniumfooliumiga - pakendis 56 x 1 mg õhukese polümeerikattega tabletti teiseses kuumtihendatud karbis.
English: PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Estonian: PVC blisterpakendid, mis on suletud alumiiniumfooliumiga - pakendis 28 x 1 mg õhukese polümeerikattega tabletti teiseses kuumtihendatud karbis.
English: indigestion, flatulence, dry mouth o Skin rash, itching o Joint ache, muscle ache, back pain o Chest pain, tiredness
Estonian: hambavalu, seedehäire, kõhupuhitus, suukuivus - Nahalööve, sügelemine - Liigesvalu, lihasvalu, seljavalu - Valu rinnus, väsimus
English: Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
Estonian: Üks tablett sisaldab 1 mg varenikliini (tartraadina).
English: PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Estonian: PCTFE/PVC blisterpakendid, mis on suletud alumiiniumfooliumiga, milles on 1 läbipaistev blister 11 x 0,5 mg õhukese polümeerikattega tabletiga ja teine läbipaistev blister 14 x 1 mg õhukese polümeerikattega tabletiga teiseses kuumtihendatud karbis.
English: Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling
Estonian: Kuumtihendatud karp, milles on 1 blisterpakend 11 x 0,5 mg varenikliini õhukese polümeerikattega tabletiga ja 1 blisterpakend 14 x 1 mg varenikliini õhukese polümeerikattega tabletiga ja 1 blisterpakend 28 või 2 blisterpakendit 14 x 1 mg varenikliini õhukese polümeerikattega tabletiga - sise - ja välismärgistus
English: Odds ratio in CAR 9-12 (95% CI) [p-value]
Estonian: Ravivõrdlused: šansisuhe (95% CI), p-väärtus
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets
Estonian: Blisterpakend 11 x 0,5 mg varenikliini õhukese polümeerikattega tabletiga
English: Completed suicideb Composite NPS AE Endpoint of severe intensity n (%)
Estonian: Suitsidaalne käitumine Suitsiidimõtted Täideviidud suitsiid Raskekujuline kombineeritud NPS AE tulemusnäitaja, n (%) AE - kõrvaltoime;
English: SPECIAL STORAGE CONDITIONS Store below 30°C
Estonian: Hoida temperatuuril kuni 30°C.
English: PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Estonian: PVC blisterpakendid, mis on suletud alumiiniumfooliumiga, milles on 1 läbipaistev blister 11 x 0,5 mg õhukese polümeerikattega tabletiga ja teine läbipaistev blister 14 x 1 mg õhukese polümeerikattega tabletiga teiseses kuumtihendatud karbis.
English: SN:
Estonian: EXP:
English: Haematochezia, gastritis, change of bowel habit, eructation, aphthous stomatitis, gingival pain Haematemesis, abnormal faeces, tongue coated Skin and subcutaneous tissue disorders Common Uncommon
Estonian: Veriroe, gastriit, sooletegevuse muutused, röhatised, aftoosne stomatiit, igemevalu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets
Estonian: Suure tihedusega polüetüleenist (HDPE) pudel, milles on 56 x 0,5 mg varenikliini õhukese polümeerikattega tabletti
English: EU/1/06/360/014
Estonian: EU/1/06/360/003 EU/1/06/360/014
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets
Estonian: Suure tihedusega polüetüleenist (HDPE) pudel, milles on 56 x 1 mg varenikliini õhukese polümeerikattega tabletti
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Estonian: Blisterpakend 14 x 1 mg varenikliini õhukese polümeerikattega tabletiga, kuumtihendatud karp
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets
Estonian: Blisterpakend 14 x 1 mg varenikliini õhukese polümeerikattega tabletiga
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg varenicline (as tartrate).
Estonian: Üks tablett sisaldab 0,5 mg varenikliini (tartraadina).
English: The full EPAR and risk management plan summary for Odomzo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Odomzo kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Odomzo is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Odomzo võimalikult ohutu kasutamine.
English: The most common side effects with Odomzo (which may affect more than 1 in 10 people) are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, belly ache, headache, diarrhoea, weight loss, loss of appetite, and itching.
Estonian: Odomzo kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on lihasspasmid, juuste väljalangemine, maitsetundlikkuse häired, väsimus, iiveldus, oksendamine, lihas- ja luuvalu, kõhuvalu, peavalu, kõhulahtisus, kehakaalu langus, isutus ja sügelus.
English: What measures are being taken to ensure the safe and effective use of Odomzo?
Estonian: Mis meetmed võetakse, et tagada Odomzo ohutu ja efektiivne kasutamine?
English: It also considered that the side effects were manageable.
Estonian: Samuti leiti, et kõrvaltoimed on hallatavad.
English: Other information about Odomzo
Estonian: Muu teave Odomzo kohta
English: Odomzo sonidegib
Estonian: Odomzo sonidegiib
English: Odomzo is continued as long as it has a beneficial effect or until it can no longer be taken because of side effects.
Estonian: Odomzo-ravi jätkatakse seni, kuni sellest on kasu või kuni ravimit ei saa kõrvalnähtude tõttu enam võtta.
English: Odomzo is available as capsules (200 mg) and the recommended dose is one capsule taken once a day at least two hours after the last meal and an hour before the next.
Estonian: Odomzot turustatakse kapslitena (200 mg) ning soovitatav annus on üks kapsel ööpäevas vähemalt kaks tundi pärast viimast sööki ja üks tund enne järgmist söögikorda.
English: The main measure of effectiveness was the response to treatment, based on a reduction in tumour size and improvement in other signs of cancer; treatment was considered sufficiently effective if the response rate was at least 30%.
Estonian: Efektiivsuse põhinäitaja oli ravivastus, mille aluseks oli kasvaja suuruse vähenemine ning muude vähisümptomite paranemine; ravi peeti piisavalt tõhusaks, kui ravivastus oli vähemalt 30%.
English: Women who are pregnant or who are breastfeeding must not take Odomzo.
Estonian: Rasedad või imetavad naised ei tohi Odomzot võtta.
English: The company is also required to analyse available tumour material from patients whose cancer worsened despite treatment, in order to determine why the treatment did not work.
Estonian: Samuti peab ettevõte analüüsima nendelt patsientidelt võetud saadaolevat kasvajamaterjali, kelle vähk halvenes ravist hoolimata, et selgitada välja, miks ravi ei toiminud.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Odomzo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Odomzo kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Patients were started on two different doses of Odomzo: 200 or 800 mg once a day.
Estonian: Patsientide ravi alustati kahe erineva Odomzo annusega: 200 või 800 mg üks kord ööpäevas.
English: Furthermore, the company is to supply further analysis from its main study on the effectiveness and safety of Odomzo, including its effectiveness in rapidly growing and slow-growing basal cell carcinoma.
Estonian: Lisaks peab ettevõte esitama põhiuuringul põhineva täiendava analüüsi Odomzo efektiivsuse ja ohutuse kohta, sealhulgas selle efektiivsuse kohta kiiresti kasvava ja aeglaselt kasvava basaalrakulise kartsinoomi ravis.
English: What is Odomzo and what is it used for?
Estonian: Mis on Odomzo ja milleks seda kasutatakse?
English: By attaching to this protein, sonidegib blocks the Hedgehog signalling pathway and thereby reduces the growth and spread of cancer cells.
Estonian: Selle valguga seondumisel blokeerib sonidegiib Hedgehogi signaali ülekanderaja ning vähendab seega vähirakkude kasvu ja levikut.
English: Women who could potentially become pregnant must not take Odomzo unless they comply with the Odomzo pregnancy prevention programme.
Estonian: Viljakas eas naised ei tohi Odomzot võtta, välja arvatud juhul, kui nad nõustuvad järgima Odomzo raseduse vältimise programmi.
English: It will also supply educational material to doctors and to patients, including a reminder card about the risks of the medicine and, in particular, the possibility of serious harm to the unborn baby if Odomzo is taken during pregnancy.
Estonian: Samuti annab ta arstidele ja patsientidele teabematerjale, sealhulgas meeldetuletuskaardi ravimiga seotud riskide ning eelkõige selle kohta, et Odomzo võtmine raseduse ajal võib loodet raskelt kahjustada.
English: Odomzo contains the active substance sonidegib.
Estonian: Odomzo sisaldab toimeainena sonidegiibi.
English: This is a summary of the European public assessment report (EPAR) for Odomzo.
Estonian: See on ravimi Odomzo Euroopa avaliku hindamisaruande kokkuvõte.
English: Why is Odomzo approved?
Estonian: Miks Odomzo heaks kiideti?
English: Of those with locally advanced basal cell carcinoma, around 56% (37 of 66 patients) on the 200-mg dose and 45% (58 of 128 patients) started on the 800-mg dose responded to treatment.
Estonian: Lokaalselt kaugelearenenud basaalrakulise kartsinoomiga patsientidel ilmnes ravivastus 200 mg annuse korral 56%-l patsientidest (37 patsienti 66st) ja 800 mg annusega alustanud patsientidest 45%-l (58 patsienti 128st).
English: Some cancers, including basal cell carcinoma, result from overactivity of a specific set of cell processes called the Hedgehog signalling pathway.
Estonian: Mõned vähiliigid, sealhulgas basaalrakuline kartsinoom, on põhjustatud teatavate rakuprotsesside (nn Hedgehogi signaali ülekanderaja) liigsest aktiivsusest.
English: This pathway normally controls a number of cell activities including cell growth and how cells develop correctly to make up different body organs in unborn babies.
Estonian: See rada reguleerib tavaliselt mitmeid rakutegevusi, sealhulgas raku kasvu ning rakkude normaalset arengut erinevate organite kujunemiseks loodetel.
English: Response rates were less than 20% in patients with metastatic cancer started on either 200 or 800 mg Odomzo and the company withdrew its application for use in metastatic basal cell carcinoma.
Estonian: Metastaatilise vähiga patsientidel, kes alustasid kas 200 või 800 mg Odomzoga, olid ravivastuse määrad alla 20% ning ettevõte võttis tagasi taotluse kasutada ravimit metastaatilise basaalrakulise kartsinoomi korral.
English: It is not intended to provide practical advice on how to use Odomzo.
Estonian: Hindamisaruandes ei anta Odomzo kasutamise praktilisi nõuandeid.
English: The Committee considered that the benefits of Odomzo had been shown for patients with locally advanced disease.
Estonian: Komitee leidis, et Odomzo kasulikkus lokaalselt kaugelearenenud ja metastaatilise haigusega patsientidel on kinnitust leidnud.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Odomzo, including the precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Odomzo omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Odomzo was studied in one main study involving 230 patients with basal cell carcinoma which was either locally advanced or metastatic (spread to other parts of the body).
Estonian: Odomzot uuriti ühes põhiuuringus, milles osales 230 kas lokaalselt kaugelearenenud või metastaatilise (levinud muudesse kehaosadesse) basaalrakulise kartsinoomiga patsienti.
English: In addition, the company will send a letter to doctors when Odomzo is launched.
Estonian: Lisaks saadab ettevõte Odomzo turulelaskmisel arstidele kirja.
English: Odomzo is a cancer medicine used to treat adults with basal cell carcinoma (a type of skin cancer) which is locally advanced (has started to spread nearby) and which cannot be treated either by surgery or by radiotherapy (treatment with radiation).
Estonian: Odomzo on vähiravim, mida kasutatakse lokaalselt kaugelearenenud (kohalikult levima hakanud) basaalrakulise kartsinoomiga (teatud liiki nahavähk), mida ei saa ravida ei kirurgiliselt ega kiiritusraviga, täiskasvanud patsientide raviks.
English: Therefore, women taking Odomzo must take effective measures to prevent pregnancy during treatment and for 20 months after stopping it. Men taking Odomzo must always use condoms for sex with female partners and for 6 months after stopping treatment.
Estonian: Mehed peavad Odomzo-ravi ajal ja 6 kuud pärast ravi lõppu kasutama naispartneritega seksuaalvahekorras alati kondoomi.
English: For practical information about using Odomzo, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Odomzo kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For the full list of all side effects reported with Odomzo, see the package leaflet.
Estonian: Odomzo kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What are the risks associated with Odomzo?
Estonian: Mis riskid Odomzoga kaasnevad?
English: How does Odomzo work?
Estonian: Kuidas Odomzo toimib?
English: Substances that affect the Hedgehog pathway can result in serious harm to an unborn baby.
Estonian: Hedgehogi rada mõjutavad ained võivad loodet tõsiselt kahjustada.
English: It should only be prescribed by a specialist doctor experienced in the treatment of advanced basal cell carcinoma or under the supervision of such a doctor.
Estonian: Seda tohib määrata ainult basaalrakulise kartsinoomi ravikogemusega erialaarst või sellise erialaarsti järelevalve all.
English: For more information about treatment with Odomzo, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Odomzoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What benefits of Odomzo have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Odomzo kasulikkus?
English: Odomzo can only be obtained with a prescription.
Estonian: Odomzo on retseptiravim.
English: Sonidegib, the active substance in Odomzo, attaches to a protein that controls the Hedgehog signalling pathway.
Estonian: Odomzo toimeaine sonidegiib seondub Hedgehogi signaali ülekanderada reguleeriva valguga.
English: How is Odomzo used?
Estonian: Kuidas Odomzot kasutatakse?
English: Cats and dogs
Estonian: Süstelahus Kassid ja koerad
English: Vial (glass)
Estonian: Subkutaanne Viaal (Klaas)
English: 1 bottle + 1 oral syringe + 1 press-in bottle adapter
Estonian: 1 pudel + 1 suukaudne süstal + sissepressitav pudeli adapter
English: 10 mg/ml
Estonian: 10 mg/ml Suukaudse suspensiooni pulber Suukaudne
English: Immediate Packaging
Estonian: Manustamistee Pakendi iseloomustus
English: • Wash and dry your hands.
Estonian: • peske ja kuivatage käed;
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Estonian: {Nimi ja aadress} <{tel}> <{faks}> <{e-mail}>
English: Do not freeze.
Estonian: Mitte külmuda lasta.
English: Therefore, Annex III may not necessarily represent the current text.
Estonian: Seega ei pruugi käesolev Lisa III tingimata kajastada praegust teksti.
English: 59.9% 33% not done
Estonian: 59,9% 33% ei määratud
English: The first report will be provided in 2007 and this requirement will be reevaluated on a regular basis.
Estonian: Esimene aruanne esitatakse 2007. aastal ja see nõue vaadatakse läbi regulaarselt.
English: DATE OF REVISION OF THE TEXT <<Date of revision>>
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV <Teksti läbivaatamise kuupäev>
English: Keep the tube tightly closed.
Estonian: Sulgege tuub tihedalt.
English: Clear or almost clear 1
Estonian: Täielik või peaaegu täielik paranemine 1
English: A Dear Healthcare professional letter should be sent to relevant Healthcare professionals on 3 April
Estonian: Tervishoiutöötajatele mõeldud kirjad tuleb asjassepuutuvatele tervishoiutöötajatele saata 3. aprillil
English: However, you can still wear normal clothing.
Estonian: Ravi ajal võib kanda tavapärast rõivastust.
English: Registry Study (C2311)
Estonian: Registriuuring (C2311)
English: Study C2308
Estonian: Uuring C2308
English: In general, these data are not conclusive and the studies have weaknesses which limit their interpretation.
Estonian: Need andmed ei ole veenvad ja uuringutes on nõrku kohti, mis piiravad nende tulemuste tõlgendamist.
English: Therefore it should not be used in this age group.
Estonian: Seetõttu ei tohi seda kasutada selle vanusegrupi ravis.
English: Independent DSMB
Estonian: Sõltumatu DSMB
English: After the Commission Decision, the Member State competent authorities will update Annex III as required.
Estonian: Peale komisjoni otsust ajakohastavad liikmesriikide pädevad ametivõimud vajadusel Lisa III.
English: Children and adolescents
Estonian: Lapsed ja teismelised
English: This should encompass all age groups including those aged <2 years.
Estonian: See peaks sisaldama kõiki vanuserühmi, sealhulgas alla 2aastased.
English: Apply the cream as follows:
Estonian: Nahale tuleb kreemi kanda järgmiselt:
English: The cream should be applied twice daily, for instance once in the morning and once in the evening.
Estonian: Kreemi kasutatakse kaks korda ööpäevas, näiteks hommikul ja õhtul.
English: Distribution, Metabolism, and Excretion
Estonian: Jaotumine, metabolism ja eritumine
English: In patients with severely inflamed and/or damaged skin, the systemic concentrations may be higher.
Estonian: Tugevalt põletikulise ja/või kahjustatud nahaga patsientidel võib süsteemne kontsentratsioon olla kõrgem.
English: The malignancies reported were very diverse in their origin and location.
Estonian: Kirjeldatud pahaloomulised kasvajad olid oma päritolu ja tekkekoha osas väga erinevad.
English: This will be re-evaluated on a regular basis.
Estonian: See nõue vaadatakse regulaarselt läbi.
English: In accordance with the “Guideline on risk management systems for medicinal products for human use (EMEA/CHMP/96268/2005)”, the MAHs should provide a full Risk Management Plan to the RMS.
Estonian: Vastavalt “Inimtervishoius kasutatavate ravimite riskijuhtimiskava juhendile” (EMEA/inimtervishoius kasutatavate ravimite komitee/96268/2005) peab müügiloa hoidja esitama viiteliikmesriigile täieliku riskijuhtimiskava.
English: National Competent Authorities, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Estonian: Pädevad siseriiklikud asutused, mille tegevust koordineerib viiteliikmesriik, tagab, et müügiloa hoidja täidab järgmised tingimused.
English: Long-term clinical trials were 1 year in duration.
Estonian: Pikemaajalised kliinilised uuringud vältasid 1 aasta.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF MEDICINAL PRODUCTS CONTAINING PIMECROLIMUS (see Annex I)
Estonian: PIMEKROLIIMUST SISALDAVATE RAVIMITE TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE (vt I lisa)
English: The main reasons include too short lengths of exposure, too short durations of follow-up and methodological shortcomings.
Estonian: Peamisteks põhjusteks on liiga lühike kokkupuuteaeg ja jälgimisperiood ning metodoloogilised vead.
English: Bartók-Ház, V. em.
Estonian: BartókHáz, V. em.
English: Always use <Invented Name> exactly as your doctor has instructed.
Estonian: Kasutage { Väljamõeldud nimetus } alati täpselt nii, nagu arst on teile soovitanud.
English: After first opening the container: 12 months.
Estonian: Pärast tuubi esmakordset avamist: 12 kuud.
English: Whitish and homogeneous.
Estonian: Valkjas ja homogeenne.
English: Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AX15
Estonian: Farmakoterapeutiline grupp: Teised dermatoloogias kasutatavad ained, ATC kood: D11AX15
English: Pimecrolimus is exclusively metabolised by CYP 450 3A4.
Estonian: Pimekroliimus metaboliseeritakse CYP 450 3A4 poolt.