FrancophonIA/ELRC3.0 huggingface dataset:
English: NovoRapid FlexTouch is only suitable for subcutaneous injections.
Estonian: NovoRapid FlexTouch on ette nähtud üksnes subkutaanseks süstimiseks.
English: Keep the vial in the outer carton in order to protect it from light.
Estonian: Hoida viaal välispakendis valguse eest kaitstult.
English: Drinking alcohol and taking NovoRapid
Estonian: NovoRapid'i kasutamine koos alkoholiga
English: The 0 must line up with the dose pointer.
Estonian: Number 0 peab olema osutiga ühel joonel ja nõela otsa ilmub insuliini tilk.
English: L Lead the needle tip into the outer needle cap on a flat surface.
Estonian: L Tasasele pinnale asetatuna viige nõela ots suure väliskatte sisse.
English: • NovoRapid PumpCart is ready for use directly in the pump.
Estonian: • NovoRapid PumpCart on eeltäidetud kolbampull, mis on valmis insuliinipumpa asetamiseks.
English: NovoRapid PumpCart is only for use with an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
Estonian: NovoRapid PumpCart on ette nähtud kasutamiseks ainult koos selle kolbampulliga kokkusobiva insuliiniinfusiooni pumbasüsteemiga, näiteks insuliinipumpadega Accu-Chek Insight ja YpsoPump.
English: NAME OF THE MEDICINAL PRODUCT NovoRapid 100 units/ml solution for injection Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS NovoRapid 100 ühikut/ml süstelahus Insulinum aspartum
English: 5 x 3 ml cartridges
Estonian: 5 x 3 ml pen-süstlit
English: Uncommon - Urticaria, rash, eruptions Very rare - Anaphylactic reactions*
Estonian: Aeg-ajalt - Urtikaaria, punetus, lööve Väga harv - Anafülaktilised reaktsioonid* Ainevahetus- ja toitumishäired Väga sage - Hüpoglükeemia* Närvisüsteemi häired
English: NovoRapid FlexPen is a pre-filled pen (colour-coded) designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. FlexPen delivers 1-60 units in increments of 1 unit.
Estonian: NovoRapid FlexPen on pen-süstel (värvikoodiga), mis on ette nähtud kasutamiseks koos kuni 8 mm pikkuste ühekordsete nõeltega NovoFine või NovoTwist.
English: Before opening: NovoRapid FlexPen that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Estonian: Hoidke NovoRapid FlexPen, mida te ei kasuta, külmkapis temperatuuril 2 °C kuni 8 °C, eemal jahutuselemendist.
English: Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark Now turn over for information on how to use your InnoLet.
Estonian: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Taani Lugege lehe pöördelt, kuidas InnoLet'i kasutada.
English: Each pre filled pen contains 300 units of insulin aspart in 3 ml solution for injection.
Estonian: Üks pen-süstel sisaldab 3 ml süstelahust, mis vastab 300 ühikule aspart-insuliinile.
English: c) Effects from diabetes
Estonian: c) Suhkurtõve toimed
English: To see precisely how much insulin is left, use the dose counter:
Estonian: Insuliini koguse täpseks määramiseks pen-süstlis kasutage annuseloendurit:
English: • Insert a NovoRapid PumpCart in the cartridge compartment of the pump.
Estonian: • Sisestage NovoRapid PumpCart insuliinipumba ampullisektsiooni kolvipoolne ots ees.
English: INFORMATION IN BRAILLE NovoRapid
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) NovoRapid
English: Before opening: NovoRapid Penfill that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Estonian: Hoidke NovoRapid Penfill, mida te ei kasuta, külmkapis temperatuuril 2 °C kuni 8 °C, eemal jahutuselemendist.
English: 1 cartridge contains 3 ml equivalent to 300 units.1 ml solution contains 100 units insulin aspart* (equivalent to 3.5 mg).
Estonian: 1 ml lahust sisaldab 100 ühikut aspart-insuliini (Insulinum aspartum)* (vastab 3,5 mg-le).
English: A Pull off the pen cap.
Estonian: A Eemaldage pen-süstli kork.
English: Always keep the pen cap on your FlexTouch when you are not using it in order to protect it from light.
Estonian: Hoidke FlexTouch, mida te ei kasuta, alati suletud korgiga valguse eest kaitstult.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid PumpCart 100 units/ml solution for injection Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) NovoRapid PumpCart 100 ühikut/ml süstelahus Insulinum aspartum s.c.
English: Always protect the cartridge from light during use.
Estonian: Kasutusel olevat kolbampulli tuleb alati kaitsta valguse eest.
English: Administration with FlexTouch
Estonian: MANUSTAMISVIIS FlexTouch
English: NAME OF THE MEDICINAL PRODUCT NovoRapid FlexPen 100 units/ml solution for injection in pre-filled pen Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS NovoRapid FlexPen 100 ühikut/ml süstelahus pen-süstlis Insulinum aspartum
English: Each cartridge contains 160 units of insulin aspart in 1.6 ml solution for injection.
Estonian: Üks kolbampull sisaldab 1,6 ml süstelahust, mis vastab 160 ühikule aspart-insuliinile.
English: Each cartridge contains 300 units of insulin aspart in 3 ml solution for injection.
Estonian: Üks kolbampull sisaldab 3 ml süstelahust, mis vastab 300 ühikule aspart-insuliinile.
English: Your FlexPen is a pre-filled dial-a-dose insulin pen.
Estonian: Teie FlexPen on eeltäidetud dosaatoriga insuliinisüstevahend.
English: METHOD OF ADMINISTRATION FlexPen
Estonian: MANUSTAMISVIIS FlexPen
English: Always keep the pen cap on your InnoLet when you are not using it in order to protect it from light.
Estonian: Kui te InnoLet'i ei kasuta, siis hoidke seda alati suletud korgigaa valguse eest kaitstult.
English: NAME OF THE MEDICINAL PRODUCT NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS NovoRapid InnoLet 100 ühikut/ml süstelahus pen-süstlis Insulinum aspartum
English: Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Estonian: Vältimaks hüpoglükeemia kordumist on soovitatav teadvuse taastudes manustada suu kaudu süsivesikuid.
English: NovoRapid InnoLet 100 units/ml solution for injection in pre-filled pen Insulin aspart
Estonian: NovoRapid InnoLet 100 ühikut/ml süstelahus pen-süstlis Aspart-insuliin (Insulinum aspartum)
English: Thereafter it can be used for up to 7 days below 37°C in an insulin infusion pump system designed to be used with this cartridge, such as the Accu-Chek Insight and YpsoPump insulin pumps.
Estonian: Seejärel võib seda kasutada ainult koos selle kolbampulliga kokkusobivas insuliiniinfusiooni pumbasüsteemis, näiteks insuliinipumpadega Accu-Chek Insight ja YpsoPump maksimaalselt 7 päeva temperatuuril kuni 37 °C.
English: Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark Now turn over for information on how to use your FlexTouch.
Estonian: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Taani Lugege lehe pöördelt, kuidas FlexTouch'i kasutada.
English: NovoRapid FlexPen is only suitable for injecting under the skin.
Estonian: NovoRapid FlexPen on ette nähtud üksnes nahaaluseks süstimiseks.
English: NovoRapid 100 units/ml solution for injection in vial Insulin aspart
Estonian: Pakendi infoleht: teave kasutajale NovoRapid 100 ühikut/ml süstelahus viaalis Aspart-insuliin (Insulinum aspartum)
English: Do not use this medicine after the expiry date which is stated on the FlexTouch label and carton, after ‘EXP'.
Estonian: Ärge kasutage seda ravimit pärast FlexTouch'i etiketil ja pakendil märgitud kõlblikkusaja lõppu.
English: NovoRapid PumpCart is only suitable for CSII in pump systems suitable for insulin infusion.
Estonian: NovoRapid PumpCart on ette nähtud üksnes pidevaks subkutaanseks insuliiniinfusiooniks infusioonipumbas.
English: These usually disappear after a few weeks of taking your insulin.
Estonian: Tavaliselt kaovad need nähud paari nädala jooksul.
English: Misuse of NovoRapid PumpCart
Estonian: NovoRapid PumpCart'i väärkasutus
English: NovoRapid InnoLet is a pre-filled pen designed to be used with NovoFine or NovoTwist disposable needles up to a length of 8 mm. InnoLet delivers 1-50 units in increments of 1 unit.
Estonian: NovoRapid InnoLet on pen-süstel, mis on ette nähtud kasutamiseks koos kuni 8 mm pikkuste ühekordsete nõeltega NovoFine või NovoTwist.
English: If necessary, NovoRapid can be administered intravenously which should be carried out by physicians or other healthcare staff.
Estonian: Vajadusel võib arst või muu meditsiinitöötaja manustada NovoRapid'i veeni.
English: NAME OF THE MEDICINAL PRODUCT NovoRapid FlexTouch 100 units/ml solution for injection in pre-filled pen Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS NovoRapid FlexTouch 100 ühikut/ml süstelahus pen-süstlis Insulinum aspartum
English: Preparing your NovoRapid FlexPen
Estonian: NovoRapid FlexPen'i ettevalmistamine
English: How to take NovoRapid
Estonian: Kuidas NovoRapid'i säilitada
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid InnoLet 100 units/ml solution for injection Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) NovoRapid InnoLet 100 ühikut/ml süstelahus Insulinum aspartum s.c.
English: GENERAL CLASSIFICATION FOR SUPPLY
Estonian: Etikett Annuseloendur
English: NAME OF THE MEDICINAL PRODUCT NovoRapid Penfill 100 units/ml solution for injection in cartridge Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS NovoRapid Penfill 100 ühikut/ml süstelahus kolbampullis Insulinum aspartum
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid FlexPen 100 units/ml solution for injection Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) NovoRapid FlexPen 100 ühikut/ml süstelahus Insulinum aspartum s.c.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid Penfill 100 units/ml solution for injection Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) NovoRapid Penfill 100 ühikut/ml süstelahus Insulinum aspartum s.c.
English: • Follow the instructions in the pump user manual to remove an empty NovoRapid PumpCart cartridge from your pump.
Estonian: • Tühja NovoRapid PumpCart kolbampulli eemaldamisel pumba küljest järgige pumba kasutusjuhendis antud juhiseid.
English: ► Infusion sets (tubing and needle) and NovoRapid PumpCart must not be shared.
Estonian: ► Infusioonikomplekti (voolikut ja nõela) ja NovoRapid PumpCart'i ei tohi anda kasutamiseks teistele.► NovoRapid PumpCart on ette nähtud üksnes nahaaluseks (subkutaanseks) süstimiseks insuliinipumba abil.
English: Before opening: NovoRapid FlexTouch that is not being used is to be stored in the refrigerator at 2°C to 8°C, away from the cooling element.
Estonian: Hoidke NovoRapid InnoLet, mida te ei kasuta, külmkapis temperatuuril 2 °C kuni 8 °C, eemal jahutuselemendist.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTES OF ADMINISTRATION NovoRapid FlexTouch 100 units/ml solution for injection Insulin aspart
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) NovoRapid FlexTouch 100 ühikut/ml süstelahus Insulinum aspartum s.c.
English: Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S, Novo Allé, DK-2880 Bagsværd, Denmark This leaflet was last revised in
Estonian: Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Taani Infoleht on viimati uuendatud
English: Before opening: Store in a refrigerator (2°C to 8°C) During use: Do not refrigerate.
Estonian: Enne avamist: hoida külmkapis (2 °C kuni 8 °C).
English: Push-button Dose selector
Estonian: NovoRapid InnoLet süstelahuse kasutusjuhend.
English: During use or when carried as a spare: The product may be stored for a maximum of 4 weeks.
Estonian: Kasutusel olevat või tagavaraks kaasaskantavat ravimit võib kasutada kuni 4 nädala jooksul.
English: Do not use this medicine after the expiry date which is stated on the InnoLet label and carton, after ‘EXP'.
Estonian: Ärge kasutage seda ravimit pärast kolbampulli etiketil ja pakendil märgitud kõlblikkusaja lõppu.
English: NovoRapid FlexTouch is only suitable for injecting under the skin.
Estonian: NovoRapid FlexTouch on ette nähtud üksnes nahaaluseks süstimiseks.
English: With each injection, change the injection site within the particular area of skin that you use.
Estonian: Iga süstiga vahetage süstekohta ka sama nahapiirkonna ulatuses.
English: Eye disorders
Estonian: Silmakahjustused
English: Invented name Strength Pharmaceutical form Route of administration Packaging Content
Estonian: Müügiloa nr Euroopa Liidus Ravimpreparaadi nimetus Tugevus Ravimvorm Manustamistee Pakendi iseloomustus Pakendi sisu Pakendi suurus EU/1/02/216/001
English: EU Number
Estonian: EU/1/02/216/002
English: The company that applied for authorisation is Centauri Biotech SL.
Estonian: Müügiluba taotles ettevõte Centauri Biotech SL.
English: What is Horse Allo 20?
Estonian: Mis on Horse Allo 20?
English: The CVMP noted that there were problems with the way the main study was designed and carried out, and concluded that the effectiveness of the medicine had not been sufficiently demonstrated.
Estonian: Veterinaarravimite komitee märkis, et põhiuuringu korralduse ja teostamisega oli probleeme, ja järeldas, et ravimi efektiivsus ei ole piisavalt tõendatud.
English: The main measure of effectiveness was a reduction in 1 or more grades of lameness using a scoring system that runs from 1 to 5.
Estonian: Efektiivsuse põhinäitaja oli lonkamise vähenemine 1 või rohkem punkti 1-5punktisel hindamisskaalal.
English: The Committee removed its previous objection that the company did not comply with GMP but all other concerns remained.
Estonian: Komitee võttis tagasi varasema väite, et ettevõte ei vasta headele tootmistavadele, kuid kõik ülejäänud kahtlused jäid püsima.
English: Finally, the Committee had concerns about the way the medicine was manufactured and its quality ensured.
Estonian: Samuti oli komiteel kahtlusi ravimi tootmise viisi ja kvaliteedi tagamise suhtes.
English: The way that mesenchymal stem cells work has not been clearly established but published studies indicate that they have an anti-inflammatory action and may have an effect in regenerating tissue.
Estonian: Mesenhümaalsete tüvirakkude toimemehhanism ei ole täpselt teada, kuid avaldatud uuringud näitavad, et neil on põletikuvastane toime ja need võivad soodustada koe regeneratsiooni.
English: Osteoarthritis is a condition that causes swelling and pain in the joints and which is often associated with lameness.
Estonian: Osteoartriit on liigestes paistetust ja valu põhjustav seisund, mida sageli seostatakse lonkamisega.
English: On 24 January 2019, the CVMP revised part of its opinion but confirmed its recommendation to refuse the marketing authorisation.
Estonian: 24. jaanuaril 2019 vaatas veterinaarravimite komitee oma arvamuse osa üle, kuid kinnitas müügiloa andmisest keeldumise soovituse.
English: The CVMP was therefore of the opinion that the benefits of Horse Allo 20 did not outweigh its risks and recommended that it be refused marketing authorisation.
Estonian: Veterinaarravimite komitee oli seepärast arvamusel, et ravimi Horse Allo 20 kasulikkus ei ületa sellega kaasnevaid riske, ja soovitas müügiloa andmisest keelduda.
English: Horse Allo 20 was developed as a novel therapy medicine containing cells that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Estonian: Horse Allo 20 töötati välja uudse ravimina, mis sisaldab rakke, mida on töödeldud nii, et neid saab kasutada koe parandamiseks, regenereerimiseks või asendamiseks.
English: Following a request from the European Commission, the CVMP revised part of its opinion concerning compliance with Good Manufacturing Practice (GMP).
Estonian: Pärast Euroopa Komisjoni taotlust vaatas veterinaarravimite komitee läbi oma arvamuse seoses vastavusega headele tootmistavadele.
English: The CVMP was also concerned about the high number of side effects reported in the field study.
Estonian: Veterinaarravimite komitee väljendas muret ka seoses väliuuringus teatatud suure arvu kõrvaltoimetega.
English: The applicant presented data from a field study involving horses from 2 years of age with osteoarthritis, where 37 horses were treated with Horse Allo 20 while 33 horses received a dummy treatment.
Estonian: Taotleja esitas andmed väliuuringust, mis hõlmas 2aastaseid ja vanemaid osteoartriidiga hobused, kellest 37 raviti Horse Allo 20ga ja 33 said platseebot (näiv ravi).
English: This was expected to help control the inflammation and joint damage associated with osteoarthritis in horses, and so reduce lameness.
Estonian: Eeldati, et ravim aitab pärssida hobustel osteoartriidiga seostatavat põletikku ja liigesekahjustust ning seega vähendada lonkamist.
English: On 21 June 2018, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Horse Allo 20, intended for the treatment of lameness in adult horses with osteoarthritis.
Estonian: 21. juunil 2018 võttis veterinaarravimite komitee vastu negatiivse arvamuse, soovitades keelduda osteoartriidiga täiskasvanud hobustel lonkamise raviks kasutatava ravimi Horse Allo 20 müügiloa andmisest.
English: Horse Allo 20 is a veterinary medicine that contains allogeneic equine mesenchymal stem cells as active substance.
Estonian: Horse Allo 20 on veterinaarravim, mis sisaldab toimeainena hobuslaste allogeenseid mesenhümaalseid tüvirakke.
English: Horse Allo 20 was expected to be used to treat lameness in adult horses with osteoarthritis.
Estonian: Ravimit Horse Allo 20 kavatseti kasutada osteoartriidiga täiskasvanud hobustel lonkamise raviks.
English: How does Horse Allo 20 work?
Estonian: Kuidas Horse Allo 20 toimib?
English: It was to be available as a suspension for injection into a joint.
Estonian: Ravimit kavatseti turustada lihasesse süstitava süstesuspensioonina.
English: What was Horse Allo 20 expected to be used for?
Estonian: Milleks kavatseti ravimit Horse Allo 20 kasutada?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Betmiga on 20 December 2012.
Estonian: Euroopa Komisjon andis Betmiga müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. detsembril 2012.
English: Betmiga mirabegron
Estonian: Betmiga mirabegroon
English: ‘Prolonged-release' means that mirabegron is released slowly from the tablet over a few hours.
Estonian: „Pikaajaliselt vabastav” tähendab, et mirabegroon vabaneb tabletist aeglaselt mõne tunni jooksul.
English: What measures are being taken to ensure the safe and effective use of Betmiga?
Estonian: Mis meetmed võetakse, et tagada Betmiga ohutu ja efektiivne kasutamine?
English: The potential risk of hypersensitivity (allergic reactions) and effects on the heart has been adequately addressed in the product information.
Estonian: Võimalikku ülitundlikkuse (allergiliste reaktsioonide) riski ja toimeid südamele on ravimiteabes adekvaatselt käsitletud.
English: A risk management plan has been developed to ensure that Betmiga is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Betmiga võimalikult ohutu kasutamine.
English: The full EPAR for Betmiga can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Betmiga kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Betmiga
Estonian: Muu teave Betmiga kohta
English: The main measure of effectiveness was the change in the number of urinations and incontinence episodes per day after 3 months of treatment.
Estonian: Efektiivsuse põhinäitaja oli urineerimiste arvu ja inkontinentsiepisoodide arvu muutus ööpäevas pärast kolmekuulist ravi.
English: Betmiga has been studied in three main studies involving 4,611 patients with overactive bladder syndrome.
Estonian: Betmigat on uuritud kolmes põhiuuringus, milles osales 4611 üliaktiivse põie sündroomiga patsienti.
English: In patients who have reduced kidney or liver function the doctor may need to prescribe a lower dose or avoid the use of Betmiga, especially in patients taking certain other medicines.
Estonian: Patsientidele, kellel on neeru- või maksatalitlushäire, võib arst määrata väiksema annuse või hoiduda Betmiga kasutamisest, eriti kui patsiendid võtavad teatud teisi ravimeid.
English: It is available as prolonged-release tablets (25 mg, 50 mg).
Estonian: Ravimit turustatakse toimeainet pikaajaliselt vabastavate tablettidena (25 mg, 50 mg).
English: Patients received Betmiga (25 mg, 50 mg or 100 mg) or placebo (a dummy treatment) every day for 3 months.
Estonian: Patsiendid said uuringutes iga päev kolme kuu jooksul Betmigat (25 mg, 50 mg või 100 mg) või platseebot (näiv ravim).
English: The recommended dose of Betmiga is 50 mg once a day.
Estonian: Betmiga soovitatav annus on 50 mg üks kord ööpäevas.
English: It is used to treat certain symptoms of the condition: urgency (sudden urge to urinate), increased urinary frequency (the need to urinate frequently) and urge incontinence (involuntary leakage of urine from the bladder when a sudden strong need to urinate is felt).
Estonian: Seda kasutatakse üliaktiivse põie sündroomi mõnede sümptomite raviks, nagu pakiline urineerimisvajadus, suurenenud urineerimissagedus (sage urineerimisvajadus) ja kiire põietühjendamisvajadus (tahtele allumatu uriinileke põiest äkki tekkinud ja tugeva urineerimisvajaduse korral).
English: This is thought to lead to an increase in the capacity of the bladder and changes in the way the bladder contracts, resulting in fewer bladder contractions and thus fewer unwanted urinations.
Estonian: Arvatakse, et see suurendab põie mahtu ja muudab põie kokkutõmbumise moodust, mistõttu esineb vähem põie kokkutõmbeid ning soovimatut urineerimist.
English: This is a summary of the European public assessment report (EPAR) for Betmiga.
Estonian: See on ravimi Betmiga Euroopa avaliku hindamisaruande kokkuvõte.
English: The CHMP therefore decided that Betmiga's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas seetõttu, et Betmiga kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The active substance in Betmiga, mirabegron, is a beta-3-adrenergic-receptor agonist.
Estonian: Betmiga toimeaine mirabegroon on β3-adrenergilise retseptori agonist.
English: For more information about treatment with Betmiga, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Betmigaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Betmiga is a medicine containing the active substance mirabegron.
Estonian: Betmiga on ravim, mis sisaldab toimeainena mirabegrooni.
English: Treatment with 50 mg a day of Betmiga was shown to be effective in reducing the number of urination and incontinence episodes.
Estonian: Uuringud näitasid, et ravi Betmiga annusega 50 mg ööpäevas oli urineerimiste arvu ja inkontinentsiepisoodide arvu vähendamisel efektiivne.
English: Betmiga must not be used in people who have hypertension (high blood pressure) that is severe and uncontrolled.
Estonian: Betmigat ei tohi kasutada patsiendid, kellel on raske ja ravile allumatu hüpertensioon (kõrgvererõhk).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Betmiga, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Betmiga omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.