FrancophonIA/ELRC3.0 huggingface dataset:
English: Riarify (beclomethasone / formoterol / glycopyrronium bromide)
Estonian: Riarify (beklometasoon/formoterool/glükopürrooniumbromiid)
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system.
Estonian: See toimib sarnaselt looduslike kortikosteroidhormoonidega, vähendades immuunsüsteemi aktiivsust.
English: This medicine is the same as Trimbow, which is already authorised in the EU.
Estonian: See ravim on samane Trimbowiga, millel juba on ELis müügiluba.
English: For more information about using Riarify, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Riarify kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Riarify have been included in the summary of product characteristics and the package leaflet.
Estonian: Riarify ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Patients should be shown how to use the inhaler correctly by a doctor or another healthcare professional, who should also regularly check that the patient's inhalation technique is correct.
Estonian: Arst või muu tervishoiutöötaja peab õpetama patsiendile inhalaatori õiget kasutamist ning korrapäraselt kontrollima, kas patsiendi inhaleerimistehnika on õige.
English: What are the risks associated with Riarify?
Estonian: Mis riskid Riarifyga kaasnevad?
English: No major safety concerns have been reported with Riarify, with side effects being manageable and similar to other COPD medicines.
Estonian: Riarify kohta ei ole teatatud olulistest ohutusprobleemidest ning selle kõrvalnähte peetakse hallatavateks ja sarnaseks teiste KOK-ravimite kõrvalnähtudega.
English: Side effects reported with Riarify are carefully evaluated and any necessary action taken to protect patients.
Estonian: Riarify kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: For the full list of side effects and restrictions with Riarify, see the package leaflet.
Estonian: Riarify kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Beta-2 agonists and muscarinic receptor antagonists help to widen the airways; corticosteroids reduce inflammation in the airways and lungs.
Estonian: Beeta-2-agonistid ja muskariiniretseptori antagonistid laiendavad hingamisteid, kortikosteroidid vähendavad põletikku hingamisteedes ja kopsudes.
English: In the first study lasting a year, after 26 weeks of treatment Riarify improved patients' FEV1 (the maximum volume of air a person can breathe out in one second) by 82 ml before a dose and 261 ml after a dose.
Estonian: Esimeses uuringus, mis kestis ühe aasta, parandas Riarify 26 ravinädala järel patsientidel forsseeritud esimese sekundi ekspiratoorset mahtu (FEV1, suurim õhumaht, mida inimene suudab 1 sekundi jooksul välja hingata) 82 ml võrra enne annust ja 261 ml võrra pärast annust.
English: In this study, Riarify was as effective as tiotropium plus a combination of beclometasone and formoterol at reducing the number of exacerbations.
Estonian: Selles uuringus oli Riarify ägenemiste arvu vähendamisel sama efektiivne kui tiotroopium koos beklometasooni ja formoterooli kombinatsiooniga.
English: Riarify is a medicine used in adults to relieve the symptoms of moderate to severe chronic obstructive pulmonary disease (COPD).
Estonian: Riarify on ravim, mida kasutatakse mõõduka kuni raske kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamiseks täiskasvanutel.
English: What benefits of Riarify have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Riarify kasulikkus?
English: Riarify is used for maintenance (continuing) treatment in patients whose disease is not adequately controlled despite treatment with a combination of two COPD medicines consisting of a long-acting beta-2 agonist plus either an inhaled corticosteroid or a long-acting muscarinic receptor antagonist.
Estonian: Riarifyd kasutatakse säilitusraviks (tavaraviks) patsientidel, kelle haigus ei allu piisavalt ravile vaatamata kombinatsioonravile kahe muu KOK-ravimiga, pikatoimelise beeta-2-agonisti ja kas inhaleeritava kortikosteroidi või pikatoimelise muskariiniretseptori antagonistiga.
English: Riarify contains the active substances beclometasone, formoterol and glycopyrronium bromide.
Estonian: Riarify sisaldab toimeainetena beklometasooni, formoterooli ja glükopürrooniumbromiidi.
English: An overview of Riarify and why it is authorised in the EU
Estonian: Ülevaade ravimist Riarify ja ELis müügiloa väljastamise põhjendus
English: Side effects with Riarify include oral candidiasis (a fungal infection of the mouth caused by a yeast called Candida), muscle spasms and dry mouth.
Estonian: Riarify kõrvalnähud on muu hulgas suuõõne kandidoos (pärmseene Candida põhjustatud seeninfektsioon suuõõnes), lihasespasmid ja suukuivus.
English: In the third study lasting a year, patients treated with Riarify had 15% fewer exacerbations a year than patients treated with a combination of indacaterol (a long-acting beta-2 agonist) and glycopyrronium bromide.
Estonian: Kolmandas uuringus, mis kestis ühe aasta, oli Riarifyd kasutanud patsientidel sümptomite ägenemiste arv aastas 15% väiksem kui patsientidel, kes kasutasid indakaterooli (pikatoimeline beeta-2-agonist) ja glükopürrooniumbromiidi kombinatsiooni.
English: In the second study lasting a year, patients treated with Riarify had 20% fewer exacerbations (flareups of symptoms) per year than patients treated with tiotropium (a long-acting muscarinic receptor antagonist).
Estonian: Teises uuringus, mis kestis ühe aasta, oli Riarifyd kasutanud patsientidel sümptomite ägenemiste arv aastas 20% väiksem kui patsientidel, kes kasutasid tiotroopiumi (pikatoimeline muskariiniretseptori antagonist).
English: Glycopyrronium bromide is a long-acting muscarinic receptor antagonist.
Estonian: Glükopürrooniumbromiid on pikatoimeline muskariiniretseptori antagonist.
English: Riarify is effective at reducing the frequency of exacerbations and improving lung function of patients with COPD.
Estonian: Riarify on efektiivne ägenemiste esinemissageduse vähendamisel ja kopsutalitluse parandamisel KOKiga patsientidel.
English: How is Riarify used?
Estonian: Kuidas Riarifyd kasutatakse?
English: This leads to a reduction in the release of substances involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Estonian: Selle tulemusel väheneb põletikuprotsessis osalevate ainete, näiteks histamiini vabanemine, mis aitab hoida hingamisteid avatuna, võimaldades patsiendil kergemini hingata.
English: Riarify is available as a liquid in a portable inhaler device.
Estonian: Riarifyd turustatakse vedelikuna kaasaskantavas inhalaatoris.
English: It attaches to receptors (targets) known as beta-2 receptors in the muscles of the airways.
Estonian: See seondub hingamisteede lihastes beeta-2retseptoritega (sihtmärgid).
English: Beclometasone belongs to anti-inflammatory medicines known as corticosteroids.
Estonian: Beklometasoon kuulub põletikuvastaste ravimite kortikosteroidide hulka.
English: The three active substances in Riarify work in different ways to reduce inflammation and keep the airways open, allowing the patient to breathe more easily.
Estonian: Riarify kolmel toimeainel on eri toimemehhanismid, mis aitavad vähendada põletikku ja hoida hingamisteed avatuna, võimaldades patsiendil kergemini hingata.
English: Because these receptors help control the contraction of the airway muscles, blocking them causes the muscles to relax, helping to keep the airways open and allowing the patient to breathe more easily.
Estonian: Need retseptorid aitavad reguleerida hingamisteede lihaste kokkutõmbumist, mistõttu lõdvestab nende blokeerimine lihaseid, hoides hingamisteed avatuna ja võimaldades patsiendil kergemini hingata.
English: It opens the airways by blocking muscarinic receptors in muscle cells in the lungs.
Estonian: See blokeerib kopsu lihasrakkudes muskariiniretseptorid, mistõttu hingamisteed avanevad.
English: Riarify has been shown to be effective at relieving symptoms of COPD in three main studies involving over 5,500 patients whose symptoms were not controlled well enough either by combinations of two other COPD medicines or by a muscarinic receptor antagonist alone.
Estonian: Kolmes põhiuuringus, milles osales üle 5500 patsiendi, kelle sümptomid ei allunud piisavalt kas kombinatsioonravile kahe muu KOK-ravimiga või ravile üksnes muskariiniretseptori antagonistiga, tõendati Riarify efektiivsust kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamisel.
English: The medicine can only be obtained with a prescription.
Estonian: Riarify on retseptiravim.
English: How does Riarify work?
Estonian: Kuidas Riarify toimib?
English: Why is Riarify authorised in the EU?
Estonian: ELis Riarifyle väljastatud müügiloa põhjendus
English: By comparison, the FEV1 increased by 1 and 145 ml before and after dosing in patients treated with a medicine containing only 2 of the active substances found in Riarify (beclometasone plus formoterol).
Estonian: Patsientidel, kes said ravimit, mis sisaldas üksnes kaht Riarify toimeainet (beklometasoon ja formoterool), suurenes FEV1 1 ja 145 ml võrra enne ja pärast annust.
English: By attaching to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Estonian: Selle tagajärjel lihased lõõgastuvad, hoides hingamisteed avatuna ja aidates patsiendil kergemini hingata.
English: These usually disappear without any treatment.
Estonian: Tavaliselt kaovad need nähud ilma ravita.
English: People must not handle treated cats for at least eight hours after application of the veterinary medicine.
Estonian: Ravitavat kassi ei tohi puudutada vähemalt kaheksa tundi pärast veterinaarravimi manustamist.
English: Further information on Vectra Felis can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/vectra-felis.
Estonian: Lisateave Vectra Felise kohta on ameti veebilehel: ema.europa.eu/medicines/veterinary/EPAR/vectrafelis.
English: Used applicators should be disposed of immediately and not left within the sight or reach of children.
Estonian: Kasutatud aplikaatorid tuleb otsekohe ära visata ja neid ei tohi jätta lastele nähtavasse või kättesaadavasse kohta.
English: Vectra Felis received a marketing authorisation valid throughout the EU on 6 June 2014.
Estonian: Vectra Felise müügiluba, mis kehtib kogu Euroopa Liidus, anti 6. juunil 2014.
English: Hands should be thoroughly washed immediately after use.
Estonian: Pärast kasutamist tuleb kohe hoolikalt pesta käed.
English: The European Medicines Agency decided that Vectra Felis' benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Vectra Felise kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise saab Euroopa Liidus heaks kiita.
English: Vectra Felis was as effective as the comparator product and reduced flea counts by 91% over the 84 day study period.
Estonian: Vectra Felis oli sama efektiivne kui võrdlusravim ja vähendas kirpude arvu 84-päevase uurimisperioodi jooksul 91% võrra.
English: Treated cats should not be permitted to sleep with their owners, especially children, on the day of treatment.
Estonian: Ravipäeval ei tohi ravitaval kassil lubada omaniku, eriti laste juures magada.
English: The effectiveness of Vectra Felis against fleas was investigated in a large number of laboratory studies and in one field study.
Estonian: Vectra Felise efektiivsust kirpude vastu uuriti arvukates laboriuuringutes ja ühes väliuuringus.
English: The need to re-treat cats and the time interval between treatments requires veterinary assessment.
Estonian: Ravi kordamise vajaduse ja ravikuuride vahelise ajavahemiku määrab veterinaararst.
English: Other information about Vectra Felis
Estonian: Muu teave Vectra Felise kohta
English: People with known hypersensitivity (allergy) to any of the ingredients should avoid contact with the product.
Estonian: Inimesed, kes on ravimi mis tahes koostisainete suhtes ülitundlikud (allergilised), peavad kokkupuudet ravimiga vältima.
English: It also prevents fleas from hatching and developing in the cat's environment.
Estonian: See takistab ka kirpude koorumist ja arenemist kassi ümbruskonnas.
English: Vectra Felis (dinotefuran / pyriproxyfen) EMA/206131/2014
Estonian: Vectra Felis (dinotefuraan/püriproksüfeen) EMA/206131/2014
English: Contact with the skin, eyes or mouth should be avoided.
Estonian: Vältida tuleb ravimi sattumist nahale, silma või suhu.
English: The field study involved 129 cats with flea infestations that were treated once a month for three consecutive months either with Vectra Felis or with another spot-on product containing two different substances, fipronil and (S)-methoprene, that control fleas.
Estonian: Väliuuringus uuriti 129 kirbuinfestatsiooniga kassi, keda raviti kolme järjestikuse kuu jooksul üks kord kuus kas Vectra Felise või teise täpilahusega, mis sisaldas kaht kirbuvastast ainet: fiproniili ja (S)-metopreeni.
English: What are the risks associated with Vectra Felis?
Estonian: Mis riskid Vectra Felisega kaasnevad?
English: Vectra Felis (dinotefuran / pyriproxyfen)
Estonian: Vectra Felis (dinotefuraan/püriproksüfeen)
English: If skin or eye irritation persists, or if the veterinary medicine is accidentally swallowed, immediate medical advice should be sought and the package leaflet or label shown to the doctor.
Estonian: Naha- või silmaärrituse püsimisel või veterinaarravimi juhuslikul allaneelamisel tuleb pöörduda kohe arsti poole ja näidata pakendi infolehte või pakendi etiketti.
English: What is Vectra Felis and what is it used for?
Estonian: Mis on Vectra Felis ja milleks seda kasutatakse?
English: The most common side effects with Vectra Felis (which may affect up to 1 in 1000 cats) are a slight scaling of the skin, temporary redness and itching or temporary hair loss at the application site.
Estonian: Vectra Felise kõige sagedamad kõrvalnähud (võivad esineda kuni 1 kassil 1000st) on kerge ketendus, mööduv punetus ja sügelus või ajutine karvakadu manustamiskohal.
English: After a single treatment, Vectra Felis prevents fleas for one month and blocks the flea life cycle so preventing infestation in the cat's environment for three months.
Estonian: Pärast ühekordset ravi ennetab Vectra Felis kirbuinfestatsiooni ühe kuu jooksul ja blokeerib kirpude elutsükli, hoides ära infestatsiooni kassi ümbruskonnas kolme kuu jooksul.
English: An overview of Vectra Felis and why it is authorised in the EU
Estonian: Vectra Felise ülevaade ja Euroopa Liidus heakskiitmise põhjused
English: Vectra Felis is a veterinary medicine used to treat and prevent flea infestations in cats.
Estonian: Vectra Felis on veterinaarravim, mida kasutatakse kirbuinfestatsioonide raviks ja ennetuseks kassidel.
English: Vectra Felis must not be used in cats or kittens weighing less than 0.6 kg.
Estonian: Ravimit ei tohi kasutada alla 0,6 kg kehamassiga kassidel või kassipoegadel.
English: Dinotefuran is an insecticide which kills insects by acting on receptors (targets) in their nervous system called nicotinic acetylcholine receptors.
Estonian: Dinotefuraan on insektitsiid, mis hävitab putukaid, mõjutades nende närvisüsteemi nikotiinatsetüülkoliini retseptoreid.
English: How does Vectra Felis work?
Estonian: Kuidas Vectra Felis toimib?
English: Pyriproxyfen is an insect growth regulator which stops the flea life cycle by causing production of infertile eggs as well as by blocking the development of immature flea stages into adults.
Estonian: Püriproksüfeen on putukate kasvuregulaator, mis peatab kirpude elutsükli, põhjustades viljatute munade teket ja blokeerides vastsete täiskasvanuks arenemise.
English: In case of accidental spillage onto skin, the area should be washed off immediately with soap and water.
Estonian: Nahale sattumisel tuleb seda kohta pesta vee ja seebiga.
English: If accidental exposure to the eyes occurs, the eyes should be rinsed with water with the eyelids open and for a sufficient length of time.
Estonian: Ravimi sattumisel silma tuleb loputada avatud silmi põhjalikult veega.
English: For a full list of all side-effects reported with Vectra Felis, see the package leaflet.
Estonian: Vectra Felise kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: How is Vectra Felis used?
Estonian: Kuidas Vectra Felist kasutatakse?
English: What benefits of Vectra Felis have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Vectra Felise kasulikkus?
English: Vectra Felis is available as a spot-on solution in an applicator and can be obtained without a prescription.
Estonian: Vectra Felist turustatakse täpilahusena aplikaatoris ja see on retseptiravim.
English: The content of one full Vectra Felis applicator is applied directly to the cat's skin, after parting its fur, at the base of the cat's head.
Estonian: Kassi kuklal tuleb karvad lahku lükata ja kanda kogu ühe Vectra Felise aplikaatori sisu otse kassi kuklanahale.
English: Why is Vectra Felis authorised in the EU?
Estonian: Vectra Felise Euroopa Liidus heakskiitmise põhjused
English: This means that it kills parasites that occur on the skin or in the fur of animals, such as fleas that feed on the animal's skin.
Estonian: Vectra Felis toimib ektoparasititsiidina ehk välisparasiitide vastase ainena, mis hävitab looma nahal või karvades elavaid parasiite, nt kirpe, mis imevad looma verd.
English: 0.5 milligram Al3+
Estonian: 0,5 milligrammi Al3+
English: * adsorbed on aluminium phosphate
Estonian: * adsorbeeritud alumiiniumfosfaadile
English: Suspension for injection Suspension for injection Suspension for injection pre-filled syringe (glass) vial (glass)
Estonian: Intramuskulaarne Intramuskulaarne Intramuskulaarne süstel (klaas) viaal (klaas) viaal (klaas)
English: --1 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1* 1
Estonian: --1 1 annus (0,5 ml) sisaldab: Pneumokokk-polüsahhariidi serotüüpi 1* 1
English: 100 vials (multidose)
Estonian: 100 viaali (mitmeannuselist)
English: Pneumococcal polysaccharide serotype 18C* 2
Estonian: Pneumokokk-polüsahhariidi serotüüpi 18C* 2
English: 50 pre-filled syringes 10 vials (multidose) 100 vials (multidose)
Estonian: 50 süstelit 10 viaali (mitmeannuseline)
English: 1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
Estonian: 1 konjugeeritud proteiin D (saadud mittetüpiseeritavast Haemophilus influenzae'st) kandjavalguga 9...16 mikrogrammi 2 konjugeeritud teetanuse toksoidi kandjavalguga
English: 10 pre-filled syringes + 10 needles
Estonian: 10 süstelit + 10 nõela
English: Pneumococcal polysaccharide serotype 9V* 1
Estonian: Pneumokokk-polüsahhariidi serotüüpi 9V* 1
English: Pneumococcal polysaccharide serotype 6B* 1
Estonian: Pneumokokk-polüsahhariidi serotüüpi 6B* 1
English: 3 conjugated to diphtheria toxoid carrier protein
Estonian: 3 konjugeeritud difteeria toksoidi kandjavalguga
English: Content Pack size
Estonian: Pakendi sisu (kontsentratsioon)
English: The European Commission issued a decision on 13 July 2010.
Estonian: Euroopa Komisjon tegi otsuse 13. juulil 2010.
English: • essential hypertension;
Estonian: • essentsiaalne hüpertensioon;
English: Atacand is authorised in the EU via national procedures.
Estonian: Atacand on Euroopa Liidus heaks kiidetud riiklike menetluste kaudu.
English: Dr Alar Irs (Estonia)
Estonian: Dr Alar Irs (Eesti)
English: Why was Atacand reviewed?
Estonian: Miks Atacandi taotlus uuesti üle vaadati?
English: What is Atacand?
Estonian: Mis on Atacand?
English: Dr Pieter de Graeff (The Netherlands)
Estonian: Dr Pieter de Graeff (Madalmaad)
English: Atacand is also available in the EU under other trade names: Amias, Blopress, Kenzen, Parapres, Racanda and Ratacand.
Estonian: Atacandi turustatakse Euroopa Liidus ka teiste nimetuste all: Amias, Blopress, Kenzen, Parapres, Racanda ja Ratacand.
English: The companies that market these medicines are AstraZeneca and Takeda.
Estonian: Ravimeid turustavad AstraZeneca ja Takeda.
English: There were little differences among Member States in the special warnings section.
Estonian: Erihoiatuste jaotises olid liikmesriikide erinevused väikesed.
English: Some Member States had not approved the 32 mg dose for treating hypertension and there were differences in how heart failure was defined.
Estonian: Mõni liikmesriik ei olnud heaks kiitnud kõrgvererõhutõve raviks 32 mg annust ja südamepuudulikkuse määratluses esines erinevusi.
English: This helps blood pressure to drop, which also makes it easier for the heart to pump out blood.
Estonian: See vähendab vererõhku ja lihtsustab südametalitlust.
English: For heart failure, the starting dose is 4 mg once a day, which can also be increased at intervals of at least two weeks up to a maximum of 32 mg once daily.
Estonian: Südamepuudulikkuse ravis on algannus 4 mg üks kord ööpäevas, mida võib suurendada vähemalt kahenädalaste intervallidega kuni annuseni 32 mg üks kord ööpäevas.
English: On 16 July 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Atacand in the EU.
Estonian: 16. juulil 2009 tegi Euroopa Komisjon inimravimite komiteele esildise, et ühtlustada Atacandi müügiload Euroopa Liidus.
English: Atacand is a medicine used to treat essential hypertension (high blood pressure) in adults.
Estonian: Atacand on ravim, mida kasutatakse essentsiaalse hüpertensiooni (kõrgvererõhutõve) raviks täiskasvanutel.
English: The European Medicines Agency has completed a review of Atacand and associated names.
Estonian: Euroopa Ravimiamet (EMA) on lõpetanud Atacandi ja sarnaste nimetuste kohta tehtud taotluse läbivaatamise.
English: 4.2 Posology and method of administration
Estonian: 4.2 - Annustamine ja manustamisviis
English: The Committee recommend that Atacand must not be used in patients who are hypersensitive (allergic) to candesartan cilexetil or to any of the ingredients.
Estonian: Komitee soovituse kohaselt ei tohi Atacandi kasutada patsiendid, kes on kandesartaantsileksetiili või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: By blocking the receptors to which angiotensin II normally attaches, candesartan cilexetil stops the hormone having an effect, allowing the blood vessels to widen.
Estonian: Blokeerides retseptorid, millega angiotensiin II tavaliselt seondub, peatab kandesartaantsileksetiil hormooni toime ja soodustab veresoonte laienemist.
English: The recommended starting dose for treating hypertension is 8 mg once a day, which can be increased to a maximum of 32 mg once a day, depending on how the patient's blood pressure responds.
Estonian: Soovitatav algannus hüpertensiooni ravis on 8 mg üks kord ööpäevas, mida võib suurendada kuni annuseni 32 mg üks kord ööpäevas, olenevalt vererõhu ravivastusest.
English: The Committee harmonised the warning on hyperkalaemia (high blood potassium levels) across all Member States' SmPCs.
Estonian: Komitee ühtlustas hüperkaleemia (vere liigne kaaliumisisaldus) hoiatuse kogu Euroopa Liidu ravimi omaduste kokkuvõtetes.
English: It must also not be given to women in their second or third trimesters of pregnancy or to patients with severe liver impairment or cholestasis (problems with the elimination of bile).
Estonian: Atacandi ei tohi anda naistele raseduse teisel ja kolmandal trimestril ega ka raskekujulise maksapuudulikkuse või kolestaasiga (sapipais) patsientidele.
English: This has led to divergences among 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: Sel põhjusel ei ühti eri liikmesriikides, kus ravimit turustatakse, ravimi näidustused, mis kajastuvad eri riikide erinevates ravimi omaduste kokkuvõtetes, märgistuses ja pakendi infolehtedes..