FrancophonIA/ELRC3.0 huggingface dataset:
English: Because Ziextenzo is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Ziextenzo.
Estonian: Et Ziextenzo on bioloogiliselt sarnane ravim, ei pea Neulastaga tehtud pegfilgrastiimi efektiivsus- ja ohutusuuringuid Ziextenzoga kordama.
English: How does Ziextenzo work?
Estonian: Kuidas Ziextenzo toimib?
English: Ziextenzo is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Estonian: Ziextenzo ei ole ette nähtud patsientidele, kellel on krooniline müeloidleukeemia (teatud verevähk) või müelodüsplastilised sündroomid (haigusseisundid, mille korral tekib patsiendi organismis palju ebanormaalseid vererakke, mille tagajärjel võib välja kujuneda leukeemia).
English: Ziextenzo is a ‘biosimilar medicine'.
Estonian: Ziextenzo on bioloogiliselt sarnane ravim.
English: Ziextenzo can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the treatment of cancer or blood disorders.
Estonian: Ravi peab algama ja toimuma vähi või verehäirete ravis kogenud arsti järelevalve all.
English: In addition, studies in breast cancer patients undergoing chemotherapy have shown that the effectiveness of Ziextenzo is equivalent to that of Neulasta in reducing the duration of neutropenia.
Estonian: Peale selle tõendati keemiaravi saavate rinnavähipatsientide uuringus, et Ziextenzo oli neutropeenia kestuse vähendamisel sama efektiivne kui Neulasta.
English: The reference medicine for Ziextenzo is Neulasta.
Estonian: Ziextenzo võrdlusravim on Neulasta.
English: How is Ziextenzo used?
Estonian: Kuidas Ziextenzot kasutatakse?
English: All these data were considered sufficient to conclude that Ziextenzo will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Estonian: Nende piisavate andmete põhjal järeldati, et Ziextenzo efektiivsus ja ohutus on heakskiidetud näidustustel võrreldav Neulasta efektiivsuse ja ohutusega.
English: For the full list of side effects and restrictions with Ziextenzo, see the package leaflet.
Estonian: Ziextenzo kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Laboratory studies comparing Ziextenzo with Neulasta have shown that the active substance in Ziextenzo is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Estonian: Ziextenzot võrreldi Neulastaga laboriuuringutes, mis tõendasid, et Ziextenzo toimeaine on struktuuri, puhtuse ja bioloogilise toime poolest väga sarnane Neulasta toimeainega.
English: Studies have also shown that giving Ziextenzo produces similar levels of the active substance in the body to giving Neulasta.
Estonian: Uuringud on samuti tõendanud, et Ziextenzo tekitab organismis sarnase toimeainesisalduse kui Neulasta.
English: An overview of Ziextenzo and why it is authorised in the EU
Estonian: Ülevaade ravimist Ziextenzo ja ELis müügiloa väljastamise põhjendus
English: What benefits of Ziextenzo have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Ziextenzo kasulikkus?
English: In Ziextenzo, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Estonian: Ziextenzos on filgrastiim pegüleeritud (seotud keemilise aine polüetüleenglükooliga).
English: Ziextenzo is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Estonian: Neutropeenia (neutrofiilide ehk teatud valgevereliblede vähesus) on vähiravi sage kõrvalnäht ja see võib suurendada patsientide vastuvõtlikkust infektsioonidele (nakkustele).
English: In addition, two studies involving 624 patients who had chemotherapy before or after surgery for breast cancer showed that Ziextenzo was as effective as Neulasta in reducing the duration of neutropenia.
Estonian: Lisaks oli Ziextenzo neutropeenia kestuse vähendamisel sama efektiivne kui Neulasta kahes uuringus, milles osales 624 patsienti, kes said pärast rinnavähi operatsiooni keemiaravi.
English: Kalydeco received a marketing authorisation valid throughout the EU on 23 July 2012.
Estonian: Kalydeco on saanud müügiloa, mis kehtib kogu ELis, 23. juulil 2012.
English: What measures are being taken to ensure the safe and effective use of Kalydeco?
Estonian: Mis meetmed võetakse, et tagada Kalydeco ohutu ja efektiivne kasutamine?
English: The Agency also noted, however, that there were limited data on the longer-term effects of the medicine and that further data should be provided by the company.
Estonian: Amet märkis siiski, et ravimi pikaajalisema mõju kohta ei ole piisavalt andmeid ja ettevõte peab esitama lisaandmeid.
English: The European Medicines Agency therefore decided that the benefits of Kalydeco are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Kalydeco kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: Other information about Kalydeco
Estonian: Muu teave Kalydeco kohta
English: Further information on Kalydeco can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/kalydeco.
Estonian: Lisateave Kalydeco kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/kalydeco.
English: Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu308556.
Estonian: Lisateave harvikravimiks nimetatud ravimi kohta on leitav: ema.europa.eu/en/medicines/human/orphandesignations/eu308556.
English: As for all medicines, data on the use of Kalydeco are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Kalydeco kasutamise kohta pidevat järelevalvet.
English: What is Kalydeco and what is it used for?
Estonian: Mis on Kalydeco ja milleks seda kasutatakse?
English: The company that markets Kalydeco is conducting a study in children who were aged 2 to 5 years at the start of treatment to assess long-term effects of early treatment.
Estonian: Kalydeco turustaja viib läbi uuringu lastel, kes olid ravi alustamisel 2-5-aastased, et hinnata varajase ravi pikaajalist mõju.
English: Why is Kalydeco authorised in the EU?
Estonian: Miks Kalydeco ELis heaks kiideti?
English: Side effects reported with Kalydeco are carefully evaluated and any necessary action taken to protect patients.
Estonian: Kalydeco kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Kalydeco is available as tablets (150 mg) and as granules (25, 50, and 75 mg) in a sachet.
Estonian: Kalydecot turustatakse tablettidena (150 mg) ja kotikeses graanulitena (25, 50 ja 75 mg).
English: Positive results have also been shown with Kalydeco granules in a study involving 19 children aged 1 to 2 years and 11 children aged 6 months to 1 year.
Estonian: Kalydeco graanulitega saadi positiivsed tulemused ka uuringus, milles osales 19 last vanuses 12 aastat ning 11 last vanuses 6 kuud kuni 1 aasta.
English: The most common side effects with Kalydeco (which may affect more than 1 in 10 people) are headache, sore throat, upper respiratory tract infection (nose and throat infection), nasal congestion, abdominal (belly) pain, nasopharyngitis (inflammation of the nose and throat), diarrhoea, dizziness, rash, bacteria in sputum (phlegm) and an increase in certain liver enzymes.
Estonian: Kalydeco kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu, kurguvalu, ülemiste hingamisteede infektsioon (nina-neeluinfektsioon), ninakinnisus, kõhuvalu, nasofarüngiit (nina-neelupõletik), kõhulahtisus, peapööritus, lööve, bakterite esinemine rögas ja teatud maksaensüümide aktiivsuse suurenemine.
English: Kalydeco (ivacaftor)
Estonian: Kalydeco (ivakaftoor)
English: For more information about using Kalydeco, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Kalydeco kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kalydeco have also been included in the summary of product characteristics and the package leaflet.
Estonian: Kalydeco ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The medicine was also shown to have an acceptable safety profile.
Estonian: Ravimil on ka vastuvõetav ohutusprofiil.
English: The tablets are used in adults and children aged 6 years and above and weighing 25 kg or more.
Estonian: Tablette kasutatakse täiskasvanutel ja vähemalt 6-aastastel lastel, kelle kehakaal on vähemalt 25 kg.
English: What are the risks associated with Kalydeco?
Estonian: Mis riskid Kalydecoga kaasnevad?
English: FEV1 is the maximum amount of air a person can breathe out in one second and is a measure of how well the lungs work.
Estonian: Kopsufunktsiooni iseloomustav näitaja FEV1 on suurim õhukogus, mille inimene suudab ühe sekundi jooksul välja hingata.
English: They should be mixed with 5 ml of soft food or liquid to make a suspension to be taken by mouth.
Estonian: Graanulid tuleb segada 5 ml pehme toidu või vedelikuga ja saadud suspensioon alla neelata.
English: The main measure of effectiveness in these studies was based on improvements in patients' FEV1.
Estonian: Efektiivsuse põhinäitaja põhines nendes uuringutes patsientide FEV1 väärtuse paranemisel.
English: For the full list of side effects and restrictions with Kalydeco, see the package leaflet.
Estonian: Kalydeco kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The dose and frequency depends on whether Kalydeco is used alone or together with tezacaftor / ivacaftor.
Estonian: Ravimi annus ja manustamissagedus sõltuvad sellest, kas Kalydecot kasutatakse ainuravimina või koos tesakaftoori/ivakaftooriga.
English: How is Kalydeco used?
Estonian: Kuidas Kalydecot kasutatakse?
English: It should only be prescribed by a doctor with experience in the treatment of cystic fibrosis, and only in patients confirmed to have the mutations mentioned above.
Estonian: Kalydecot tohib määrata üksnes tsüstilise fibroosi ravis kogenud arst ja üksnes patsientidele, kellel on kinnitatud eespool nimetatud mutatsioonid.
English: One of the studies was in patients aged over 12 years, while the other was in patients aged between 6 and 11 years.
Estonian: Ühes uuringus osalesid üle 12-aastased ja teises uuringus 6-11-aastased patsiendid.
English: For infants and children aged 6 months and above and weighing 5 to 25 kg, the granules should be used.
Estonian: Vähemalt 6-kuulistel lastel kehamassiga 5-25 kg tuleb kasutada graanuleid.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Estonian: Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands
English: In the studies, Kalydeco was compared with placebo (a dummy treatment).
Estonian: Uuringutes võrreldi Kalydecot platseeboga (näiv ravim).
English: The two medicines are used in patients who have inherited the F508del mutation from both parents and therefore have the mutation in both copies of the CFTR gene.
Estonian: Neid kaht ravimit kasutatakse patsientidel, kes on saanud mutatsiooni F508del mõlemalt vanemalt ja kellel on see mutatsioon seepärast CFTR-geeni mõlemas koopias.
English: Cystic fibrosis is rare, and Kalydeco was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 July 2008.
Estonian: Tsüstiline fibroos esineb harva ja Kalydeco nimetati 8. juulil 2008 harvikravimiks.
English: The active substance in Kalydeco, ivacaftor, increases the activity of the defective CFTR protein.
Estonian: Kalydeco toimeaine ivakaftoor suurendab defektse CFTR-valgu aktiivsust.
English: Two of the studies involved 219 patients with cystic fibrosis who had the G551D mutation.
Estonian: Kahes nendest uuringutest osales 219 tsüstilise fibroosiga patsienti, kellel oli mutatsioon G551D.
English: Patients who took Kalydeco and tezacaftor / ivacaftor had an average increase in FEV1 of 6.5 percentage points compared with an increase of 4.4 percentage points in patients who took Kalydeco alone and a reduction of 0.3 percentage points in patients who took placebo.
Estonian: Kalydecot ja tesakaftoori/ivakaftoori kasutanud patsientidel suurenes FEV1 väärtus keskmiselt 6,5% võrra, ainult Kalydecot kasutanud patsientidel suurenes see 4,4% võrra ja platseebot kasutanud patsientidel vähenes 0,3% võrra.
English: This makes mucus and digestive juices less thick, thereby helping to relieve symptoms of the disease.
Estonian: See vedeldab lima ja seedemahlu, aidates leevendada haigussümptomeid.
English: The study found that Kalydeco granules resulted in increased bodyweight and a decreased amount of chloride contained in sweat.
Estonian: Uuringust nähtus, et Kalydeco graanulid aitasid suurendada patsientide kehakaalu ja vähendada higi kloriidisisaldust.
English: Serious side effects include abdominal pain and increased liver enzymes.
Estonian: Rasked kõrvalnähud on muu hulgas kõhuvalu ja maksaensüümide aktiivsuse suurenemine.
English: Another study investigated Kalydeco granules in 34 patients aged between 2 and 5 years of age who had cystic fibrosis due to a G551D or S549N mutation.
Estonian: Veel ühes uuringus vaadeldi Kalydeco graanulite kasutamist 34 patsiendil (vanus 2-5 aastat), kelle tsüstiline fibroos oli põhjustatud mutatsioonist G551D või S549N.
English: The first study involved 510 patients with cystic fibrosis who have inherited the F508del mutation from both parents.
Estonian: Esimeses uuringus osales 510 tsüstilise fibroosiga patsienti, kes olid saanud mutatsiooni F508del mõlemalt vanemalt.
English: How does Kalydeco work?
Estonian: Kuidas Kalydeco toimib?
English: The fourth study involved 69 patients aged 6 years and above with cystic fibrosis who had the R117H mutation.
Estonian: Neljandas uuringus osales 69 vähemalt 6-aastast tsüstilise fibroosiga last, kellel oli mutatsioon R117H.
English: Kalydeco contains the active substance ivacaftor.
Estonian: Kalydeco sisaldab toimeainena ivakaftoori.
English: What benefits of Kalydeco have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Kalydeco kasulikkus?
English: The third study involved 39 patients over 6 years of age with cystic fibrosis due to several mutations other than G551D.
Estonian: Kolmandas uuringus osales 39 üle 6-aastast last, kelle tsüstiline fibroos oli põhjustatud muudest mutatsioonidest kui G551D.
English: An overview of Kalydeco and why is it authorised in the EU
Estonian: Ülevaade ravimist Kalydeco ja ELis müügiloa väljastamise põhjendus
English: After 8 weeks of treatment patients who took Kalydeco had an average improvement of 10.7 percentage points more than those who took placebo.
Estonian: Pärast 8 nädalat kestnud ravi oli Kalydecot võtnud patsientide näit paranenud keskmiselt 10,7% võrra rohkem võrreldes platseeborühmaga.
English: Kalydeco can only be obtained with a prescription.
Estonian: Kalydeco on retseptiravim.
English: Kalydeco, taken with tezacaftor / ivacaftor, was compared with Kalydeco taken alone and with placebo.
Estonian: Kalydeco kasutamist koos tesakaftoori/ivakaftooriga võrreldi ainuravimina kasutatava Kalydecoga ja platseeboga.
English: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H mutations
Estonian: Mutatsioonid G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, R117H
English: The doses of Kalydeco may need to be adjusted if the patient is also taking a type of medicine called a ‘moderate or strong CYP3A inhibitor', such as certain antibiotics or medicines for fungal infections.
Estonian: Kui patsient kasutab lisaks mõõdukat või tugevat CYP3A inhibiitorit (teatud tüüpi ravim), näiteks teatud antibiootikume või seeninfektsioonide ravimeid, võib olla vaja Kalydeco annuseid kohandada.
English: Kalydeco is also used on its own to treat patients with cystic fibrosis aged 18 years and above who have the R117H mutation in the CFTR gene.
Estonian: Kalydecot kasutatakse tsüstilise fibroosi ainuravimina ka vähemalt 18-aastastel patsientidel, kellel on CFTR-geeni mutatsioon R117H.
English: Kalydeco is also used together with another cystic fibrosis medicine containing the active substances tezacaftor and ivacaftor to treat patients with cystic fibrosis aged 12 years and above who have a mutation called F508del in the CFTR gene.
Estonian: Samuti kasutatakse Kalydecot koos teise tsüstilise fibroosi ravimiga (mis sisaldab toimeainetena tesakaftoori ja ivakaftoori) tsüstilise fibroosi raviks vähemalt 12-aastastel patsientidel, kellel on CFTRgeeni mutatsioon F508del.
English: No difference was seen between placebo and Kalydeco for children aged 6 years and above.
Estonian: Vähemalt 6-aastastel lastel ei täheldatud platseebo ja Kalydeco kasutamisel erinevust.
English: They are also used in patients who have inherited the F508del mutation from one parent and also have one of the following mutations in CFTR: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G, or 3849+10kbC→T.
Estonian: Neid ravimeid kasutatakse ka patsientidel, kes on saanud mutatsiooni F508del ühelt vanemalt ja kellel on CFTR-geenis lisaks üks järgmistest mutatsioonidest: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G või 3849+10kbC→T.
English: Similar results were seen in patients aged between 6 and 11 years, where Kalydeco treatment led to an improvement of 12.5 percentage points more than with placebo.
Estonian: Sarnased tulemused olid 6-11-aastaste rühmas, kellel Kalydeco parandas FEV1 väärtust 12,5% võrra rohkem kui platseeborühmas.
English: The second study involved 248 patients with cystic fibrosis who have inherited the F508del mutation from one parent and who also have another CFTR mutation.
Estonian: Teises uuringus osales 248 tsüstilise fibroosiga patsienti, kes olid saanud mutatsiooni F508del ühelt vanemalt ja kellel oli lisaks muu geeni CFTR mutatsioon.
English: F508del mutation from both parents or F508del mutation from one parent and P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G or 3849+10kbC→T mutations
Estonian: Mutatsioon F508del mõlemalt vanemalt või mutatsioon F508del ühelt vanemalt ja lisaks mutatsioon P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272 26A→G või 3849+10kbC→T
English: The mutations are: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R (also known as gating mutations).
Estonian: Mutatsioonid on järgmised: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N ja S549R (ioonikanalite talitlust muutvad mutatsioonid).
English: Kalydeco was shown to be effective at improving lung function in 4 main studies involving patients with cystic fibrosis who had various mutations.
Estonian: Kalydeco efektiivsust eri mutatsioonidega tsüstilise fibroosiga patsientide kopsufunktsiooni parandamisel tõendati neljas põhiuuringus.
English: Kalydeco is used on its own to treat cystic fibrosis in patients aged 6 months and above who have one of nine mutations (changes) in the gene for a protein called ‘cystic fibrosis transmembrane conductance regulator' (CFTR).
Estonian: Kalydecot kasutatakse tsüstilise fibroosi ainuravimina vähemalt 6-kuulistel patsientidel, kellel on üks üheksast CFTR-geeni (tsüstilise fibroosi transmembraanse juhtivuse regulaatorvalku määrava geeni) mutatsioonist.
English: Kalydeco used on its own or together with tezacaftor / ivacaftor has been shown to improve lung function in patients with specific mutations.
Estonian: Tõendite kohaselt parandab Kalydeco ainuravimina või koos tesakaftoori/ivakatooriga teatud mutatsioonidega patsientide kopsufunktsiooni.
English: Patients with cystic fibrosis have low bodyweight due to problems with digestion of food and high levels of chloride in sweat due to CFTR not working properly.
Estonian: Kuna CFTRvalgu defektne toimimine põhjustab tsüstilise fibroosiga patsientidel seedehäireid ja higi suurt kloriidisisaldust, on nendel patsientidel väike kehakaal.
English: After 24 weeks of treatment, patients who took the medicines had an average increase in FEV1 of 3.4 percentage points compared with a reduction of 0.6 percentage points in patients who took placebo.
Estonian: 24 ravinädala järel oli FEV1 suurenenud ravimeid kasutanud patsientidel keskmiselt 3,4% võrra ning platseebot kasutanud patsientidel 0,6% võrra.
English: Kalydeco is a medicine used to treat cystic fibrosis, an inherited disease that has severe effects on the lungs, the digestive system and other organs.
Estonian: See on pärilik haigus, mis kahjustab oluliselt kopse, seedesüsteemi ja teisi elundeid.
English: However, when analysing the subset of patients aged 18 years and above alone, an average improvement of around 5.0 percentage points was seen in patients who took Kalydeco compared with patients who took placebo.
Estonian: Samas ilmnes vähemalt 18-aastaste patsientide alarühma tulemuste analüüsimisel, et Kalydecot võtnud patsientide FEV1 väärtus paranes ligikaudu 5,0% võrra rohkem kui platseeborühmas.
English: After 24 weeks of treatment, patients aged 12 years and older who took Kalydeco had an average improvement in FEV1 of 10.6 percentage points more than those who took placebo.
Estonian: Pärast 24 ravinädalat oli vähemalt 12-aastastel Kalydecot kasutanud patsientidel FEV1 väärtus suurenenud keskmiselt 10,6% võrra rohkem kui platseeborühmas.
English: Cystic fibrosis affects the cells that produce mucus and digestive juices.
Estonian: Tsüstiline fibroos kahjustab lima ja seedemahlu tekitavaid rakke, nii et need eritised muutuvad viskoosseks ja põhjustavad ummistusi.
English: Kalydeco, taken with tezacaftor / ivacaftor, was compared with placebo.
Estonian: Kalydecot kasutamist koos tesakaftoori/ivakaftooriga võrreldi platseebo kasutamisega.
English: Kalydeco taken together with tezacaftor / ivacaftor was shown to be effective at improving lung function in two main studies of patients with cystic fibrosis aged 12 years and above with the the F508del mutation.
Estonian: Kahes põhiuuringus, milles osalesid vähemalt 12-aastased tsüstilise fibroosiga patsiendid, kellel esines F508del mutatsioon, oli koos tesakaftoori/ivakaftooriga kasutatud Kalydeco efektiivne kopsufunktsiooni parandamisel.
English: Invented nameStrength Pharmaceutical Form Route of Administration
Estonian: Ravimi väljamõeldud nimetus
English: Page 2 of 2
Estonian: 2 x 5 eeltäidetud süstalt
English: 60 mg Film-coatedtablet Oral use
Estonian: TugevusRavimvorm ManustamisteeSisepakendi iseloomustus
English: Pack size
Estonian: Tugevus Ravimvorm
English: Further information on LysaKare can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/lysakare.
Estonian: Lisateave LysaKare kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/lysakare.
English: What measures are being taken to ensure the safe and effective use of LysaKare?
Estonian: Mis meetmed võetakse, et tagada LysaKare ohutu ja efektiivne kasutamine?
English: Other information about LysaKare
Estonian: Muu teave LysaKare kohta
English: The European Medicines Agency therefore decided that LysaKare's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et LysaKare kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: Side effects with LysaKare are usually mild or moderate.
Estonian: LysaKare kõrvalnähud on tavaliselt kerged või mõõdukad.
English: What is LysaKare and what is it used for?
Estonian: Mis on LysaKare ja milleks seda kasutatakse?
English: Why is LysaKare authorised in the EU?
Estonian: Miks LysaKare ELis heaks kiideti?
English: As for all medicines, data on the use of LysaKare are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse LysaKare kasutamise kohta pidevat järelevalvet.