FrancophonIA/ELRC3.0 huggingface dataset:
English: Although not observed during clinical studies with low dose doxycycline (40 mg/day), the risk for development of resistance in the normal microflora cannot be excluded in patients treated with ORACEA.
Estonian: ORACEA-ravil olevatel patsientidel ei saa välistada resistentsuse teket normaalse mikrofoloora suhtes, kuigi doksütsükliini väikeste annuste (40 mg päevas) kliinilises uuringus ei ole seda täheldatud.
English: • Sinus headache
Estonian: Südame häired: Harv
English: Hypersensitivity reactions including anaphylaxis There have also been reports of: Anaphylactoid purpura
Estonian: Teatatud on ka järgmisest kõrvaltoimest: anafülaktoidne purpur Endokriinsüsteemi häired
English: 40 mg Prolonged-release capsule, hard Oral
Estonian: 40 mg Toimeainet prolongeeritult vabastav kõvakapsel
English: GENERAL CLASSIFICATION FOR SUPPLY [To be completed nationally]
Estonian: RAVIMI VÄLJASTAMISTINGIMUSED [täidetakse riiklikult]
English: General disorders and administration site conditions
Estonian: Üldised häired ja manustamiskoha reaktsioonid Valu Uuringud
English: Low levels of tetracyclines are secreted into the milk of lactating women.
Estonian: Rinnapiima imendub väikeses koguses tetratsükliini.
English: 13 February 2013
Estonian: 13. veebruar 2013
English: They are currently marketed in most EU countries.
Estonian: Neid turustatakse praegu enamikus Euroopa Liidu riikides.
English: Outcome of a procedure under Article 31 of Directive 2001/83/EC
Estonian: Direktiivi 2001/83/EÜ artikli 31 kohase menetluse tulemused
English: These findings were made available to EU national authorities in November 2010.
Estonian: Andmed esitati Euroopa Liidu riiklikele asutustele 2010. aasta novembris.
English: The European Commission issued a decision on 13 February 2013.
Estonian: Euroopa Komisjon tegi otsuse 13. veebruaril 2013.
English: After a re-examination, the Committee confirmed its recommendation on 15 November 2012.
Estonian: Pärast taasläbivaatamist kinnitas komitee soovitused 15. novembril 2012.
English: The full changes made to the information to doctors and patients are detailed here.
Estonian: Kogu muudetud teave arstidele ja patsientidele on siin.
English: − hypercalcaemia caused by cancer.
Estonian: − vähi põhjustatud hüperkaltseemia.
English: What is calcitonin?
Estonian: Mis on kaltsitoniin?
English: Why were calcitonin-containing medicines reviewed?
Estonian: Miks kaltsitoniini sisaldavate ravimite andmed läbi vaadati?
English: The Committee maintained its recommendations after re-examination.
Estonian: Pärast taasläbivaatamist jäi komitee oma soovituste juurde.
English: The CHMP also reviewed post-marketing safety data, randomised controlled studies and experimental cancer studies.
Estonian: Komitee vaatas läbi ka turustamisjärgsed ohutusandmed ning randomiseeritud kontrollitud uuringute ja katseliste vähiuuringute andmed.
English: On 19 July 2012, the European Medicines Agency completed a review of the benefits and risks of calcitonin-containing medicines, concluding that there was evidence of a small increased risk of cancer with long-term use of these medicines.
Estonian: Euroopa Ravimiamet (EMA) lõpetas 19. juulil 2012 kaltsitoniini sisaldavate ravimite kasulikkuse ja riskide läbivaatamise, järeldades, et on olemas tõendavaid andmeid veidi suurenenud vähiriski kohta nende ravimite pikaajalisel kasutamisel.
English: Calcitonin is a hormone that increases the amount of calcium in the bones and lowers the calcium level in the blood.
Estonian: Kaltsitoniin on hormoon, mis suurendab kaltsiumikogust luudes ja vähendab kaltsiumisisaldust veres.
English: Although the cancer rates reported in the studies were low, the increase in cancer rates seen with calcitonin varied between 0.7% in studies with the oral formulation to 2.4% in the studies with the nasal formulation.
Estonian: Kuigi uuringutes teatatud vähi esinemissagedus oli väike, oli vähi esinemissageduse suurenemine 0,7% (kaltsitoniini suukaudse ravimvormi uuringutes) kuni 2,4% (nasaalse ravimvormi uuringutes).
English: It is also used to prevent acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures.
Estonian: Seda kasutatakse ka ootamatu immobilisatsiooni põhjustatud luukoe akuutse hävimise ennetamiseks, näiteks hiljutiste osteoporootiliste luumurdudega patsientidel.
English: Following the receipt of the data from the studies on the unlicensed oral medicine, the UK medicines agency asked the CHMP to carry out a full assessment of the benefit-risk balance of calcitonincontaining medicines and to issue an opinion on whether their marketing authorisations should be maintained, varied, suspended or withdrawn across the EU.
Estonian: Pärast müügiloata suukaudse ravimi uuringute andmete saamist palus Ühendkuningriigi ravimiamet inimravimite komiteel täielikult hinnata kaltsitoniini sisaldavate ravimite kasulikkuse ja riski suhet ning anda arvamus, kas nende ravimite müügiload kogu Euroopa Liidus tuleb säilitada, muuta, peatada või tühistada.
English: The Committee also concluded that the benefits of calcitonin-containing medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.
Estonian: Komitee järeldas ka, et osteoporoosi ravis ei ole kaltsitoniini sisaldavate ravimite kasulikkus suurem kui nende riskid ja neid ei tohi sellel näidustusel enam kasutada.
English: − prevention of acute bone loss due to sudden immobilisation, with a recommended treatment period of two weeks and a maximum treatment period of four weeks;
Estonian: − ootamatu immobilisatsiooni põhjustatud luukoe akuutse hävimise ennetamine; soovitatav raviperiood on kaks nädalat ja pikim raviperiood neli nädalat;
English: Questions and answers on the review of calcitonincontaining medicines
Estonian: Kaltsitoniini sisaldavate ravimite läbivaatamise teave
English: A possible association between calcitonin and prostate cancer was first investigated by the UK medicines regulatory agency in 2004, but a causal association could not be established with the evidence available at the time.
Estonian: Esimest korda uuris kaltsitoniini ja eesnäärmevähi võimalikku seost Ühendkuningriigi ravimiamet 2004. aastal, kuid sel ajal olemas olnud andmete alusel ei suudetud põhjuslikku seost tuvastada.
English: • Patients receiving injectable calcitonin who have any questions should speak to their doctor or pharmacist.
Estonian: • Kaltsitoniini süstitavaid vorme kasutavad patsiendid peavad küsimuste tekkimisel pöörduma oma arsti või apteekri poole.
English: • Calcitonin will only be available as a solution for injection and infusion, and should only be used for:
Estonian: • Kaltsitoniini turustatakse üksnes süste- ja infusioonilahusena ning seda tohib kasutada ainult järgmiste seisundite raviks:
English: • Treatment with calcitonin should be limited to the shortest possible time using the smallest effective dose.
Estonian: • Ravi kaltsitoniiniga peab toimuma nii vähe aega kui võimalik, kasutades vähimat efektiivset annust.
English: − Paget's disease, restricted to patients who do not respond to alternative treatments or for whom such treatments are not suitable, and with treatment normally limited to three months (longer treatment and periodic retreatment may be considered taking into account the benefits and risks);
Estonian: − Pageti tõbi: kasutatakse üksnes patsientidel, kellel ei teki muudele ravimeetoditele ravivastust või kellele need ei sobi; ravi kestus on tavaliselt kuni kolm kuud (kasulikkust ja riske arvestades võib kaaluda ka pikemaajalist ravi ja kordusravi);
English: Calcitonin, manufactured in the laboratory, is used in medicines to treat or prevent conditions that involve the loss of calcium from the bones.
Estonian: Laboris toodetud kaltsitoniini kasutatakse ravimites, millega ravitakse või ennetatakse seisundeid, kus luude kaltsiumisisaldus väheneb.
English: Calcitonin-containing medicines have been available in the EU as solutions for injection or infusion (drip into a vein) since 1973, and as a nasal spray since 1987.
Estonian: Kaltsitoniini sisaldavaid ravimeid on Euroopa Liidus turustatud süste- või infusioonilahustena (veeni tilgutatavate lahustena) alates 1973. aastast ja ninaspreina 1987. aastast.
English: This review was initiated following preliminary findings from two studies of an unlicensed oral calcitonin medicine, which pointed to a possible association with prostate cancer.
Estonian: Läbivaatamine algatati pärast müügiloata suukaudse kaltsitoniini sisaldava ravimi kahe uuringu esialgsete tulemuste selgumist, mis viitasid võimalikule seosele eesnäärmevähiga.
English: • Calcitonin will no longer be used for the treatment of osteoporosis.
Estonian: • Kaltsitoniini ei kasutata enam osteoporoosi raviks.
English: The issue was also investigated in 2009 and 2010 by the EMA's Pharmacovigilance Working Party (PhVWP), but there was insufficient evidence at the time for any regulatory action.
Estonian: 2010. aastal uuris probleemi ka Euroopa Ravimiameti ravimiohutuse järelevalve töörühm, kuid sel ajal puudusid piisavad andmed, et algatada mis tahes regulatiivmeetmeid.
English: Taking into account the limited benefit of calcitonin when used to treat postmenopausal osteoporosis to reduce the risk of vertebral fractures, the CHMP concluded that the benefits of calcitonin did not outweigh the risks in this condition.
Estonian: Arvestades, et kaltsitoniini kasulikkus menopausijärgse osteoporoosi ravis lülisambamurdude riski vähendamiseks on väike, järeldas inimravimite komitee, et sellel näidustusel ei ole kaltsitoniini kasulikkus riskidest suurem.
English: It has been used in the EU for treating osteoporosis (a disease that makes bones fragile), Paget's disease (a bone disease that involves bone remodelling and can cause deformity), and hypercalcaemia (increased blood calcium) caused by cancer.
Estonian: Kaltsitoniini on Euroopa Liidus kasutatud järgmiste haiguste raviks: osteoporoos (luu-urbumus), Pageti tõbi (haigus, millega kaasneb luukoe lagunemine ja taasteke, mis võib põhjustada luudeformatsioone) ja vähi põhjustatud hüperkaltseemia (vere liigne kaltsiumisisaldus).
English: The benefit-risk balance remains positive only for the following uses: treatment of Paget's disease for patients who cannot be treated with alternative treatments, prevention of acute bone loss due to sudden immobilisation such as in patients with recent osteoporotic fractures, and the treatment of hypercalcaemia caused by cancer.
Estonian: Kasulikkuse ja riski suhe jääb positiivseks ainult järgmistel näidustustel: Pageti tõve ravi patsientidel, keda ei saa ravida muude ravimeetoditega, luukoe akuutse hävimise ennetamine ootamatu immobilisatsiooni korral, näiteks hiljutiste osteoporootiliste luumurdudega patsientidel, ja vähi põhjustatud hüperkaltseemia ravi.
English: • Prescribers should note that calcitonin should no longer be used for the treatment of osteoporosis.
Estonian: • Arstid peavad arvestama, et osteoporoosi ravis kaltsitoniini enam kasutada ei tohi.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended that they should only be authorised for short-term use in Paget's disease, acute bone loss due to sudden immobilisation and hypercalcaemia caused by cancer.
Estonian: EMA inimravimite komitee soovitas, et nende ravimite kasutamist tohib heaks kiita üksnes Pageti tõve, ootamatu immobilisatsiooni tõttu toimuva luukoe akuutse hävimise ja vähi põhjustatud hüperkaltseemia lühiajaliseks raviks.
English: However, the CHMP recommended that even for these uses calcitonin treatment should be given for the shortest possible time using the smallest effective dose.
Estonian: Inimravimite komitee soovitas siiski, et isegi nendel näidustustel tuleb kaltsitoniinravi kasutada nii vähe aega ja nii väikeses efektiivses annuses kui võimalik.
English: The CHMP noted that the available data suggest that a higher proportion of patients treated with calcitonin for long periods of time may develop cancer of various types, compared with patients taking placebo.
Estonian: Inimravimite komitee märkis, et olemasolevate andmete alusel võib järeldada, et patsiente, kellel võib tekkida mitmesugust tüüpi vähkkasvajaid, on kaltsitoniiniga ravitute seas rohkem kui platseebot saanute seas.
English: In addition to the two studies of the unlicensed oral calcitonin medicine, the CHMP reviewed available data on the benefits and risks of calcitonin-containing medicines provided by the companies that market these medicines as well as data from the scientific literature and from third parties.
Estonian: Peale müügiloata suukaudse kaltsitoniini sisaldava ravimi kahe uuringu vaatas inimravimite komitee läbi ravimeid turustavatelt ettevõtetelt, kirjandusest ja kolmandatelt isikutelt saadud andmed kaltsitoniini sisaldavate ravimite kasulikkuse ja riskide kohta.
English: Patients being treated for osteoporosis with calcitonin nasal sprays or other formulations are advised to speak to their doctor at a routine appointment, who will recommend suitable alternative treatment.
Estonian: Patsientidel, kes ravivad osteoporoosi kaltsitoniini ninaspreide või muude ravimvormidega, soovitatakse tavavisiidil arsti juurde sellest rääkida.
English: As the nasal spray is only used in osteoporosis, the CHMP recommended that this formulation should no longer be used.
Estonian: Et ninaspreid kasutatakse ainult osteoporoosi korral, soovitas inimravimite komitee selle ravimvormi kasutamise lõpetada.
English: The response was maintained for up to 5 years.
Estonian: Mõju kestis kuni 5 aastat.
English: This summary was last updated in 04-2017.
Estonian: Kokkuvõtte viimane uuendus: 04-2017.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tysabri on 27 June 2006.
Estonian: Euroopa Komisjon andis Tysabri müügiloa, mis kehtib kogu Euroopa Liidus, 27. juunil 2006.
English: What measures are being taken to ensure the safe and effective use of Tysabri?
Estonian: Mis meetmed võetakse, et tagada Tysabri ohutu ja efektiivne kasutamine?
English: The full EPAR for Tysabri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Tysabri kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tysabri natalizumab
Estonian: Tysabri natalisumaab
English: If there is no clear benefit for the patient after six months, the doctor should re-assess the treatment.
Estonian: Kui kuue kuu möödumisel ei ole ilmnenud, et ravim on patsiendile selgelt kasulik, peab arst ravi ümber hindama.
English: About 6% of the patients in studies developed long-lasting antibodies against natalizumab, which reduced the medicine's effectiveness.
Estonian: Ligikaudu 6%-l uuringus osalenud patsientidest kujunesid välja pikaajalised natalisumaabi-vastased antikehad, mis vähendas ravimi efektiivsust.
English: Because the infusion can trigger an allergic reaction, the patient must be monitored during the infusion and for one hour afterwards.
Estonian: Allergilise reaktsiooni ohu tõttu tuleb patsienti infusiooni ajal ja ühe tunni jooksul pärast seda jälgida.
English: Patients should read this card carefully and keep it with them.
Estonian: Patsiendid peavad kaardiga hoolikalt tutvuma ja hoidma seda kättesaadavas kohas.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tysabri's benefits in this restricted population are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Tysabri kasulikkus selles piiratud populatsioonis on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The pack will also include information about other risks of this medicine for patients.
Estonian: Seal on ka ravimi muude riskide teave patsientidele.
English: Other information about Tysabri
Estonian: Muu teave Tysabri kohta
English: Tysabri is given as a one-hour infusion (drip) into a vein once every four weeks.
Estonian: Tysabrit manustatakse üks tund kestva veeniinfusioonina iga 4 nädala järel.
English: A second study showed that adding Tysabri to treatment with another medicine, interferon beta-1a, was more effective than adding placebo, reducing the risk of disability getting worse and the number of relapses.
Estonian: Teine uuring näitas, et Tysabri oli lisamisel ravile ravimiga beeta-1a-interferoon efektiivsem kui platseebo lisamine, vähendades puude süvenemise riski ja relapside arvu.
English: What is Tysabri and what is it used for?
Estonian: Mis on Tysabri ja milleks seda kasutatakse?
English: Finally, a third study, still ongoing, has shown the average number of MS attacks per year falling from 1.99 to 0.22 in Tysabri-treated patients (regardless of which disease-modifying treatment they had previously used),.
Estonian: Kolmas käimasolev uuring on näidanud, et keskmine hulgiskleroosi ägenemiste arv aastas on Tysabriga ravitud patsientidel vähenenud 1,99-lt 0,22-le (sõltumata nende varasemast haigust modifitseerivast ravist).
English: The most common side effects seen in studies with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (itchy rash), headache, dizziness, vomiting, nausea (feeling sick), joint pain, rigors (shaking chills), fever and tiredness.
Estonian: Uuringutes olid Tysabri kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) kuseteede nakkused, nina-neelupõletik, urtikaaria (nõgestõbi), peavalu, peapööritus, oksendamine, iiveldus, liigesevalu, värinad, palavik ja väsimus.
English: PML is a very serious condition that may result in severe disability or death.
Estonian: Progresseeruv multifokaalne leukoentsefalopaatia on väga raske seisund, mis võib põhjustada rasket puuet või surma.
English: This is a summary of the European public assessment report (EPAR) for Tysabri.
Estonian: See on ravimi Tysabri Euroopa avaliku hindamisaruande kokkuvõte.
English: Patients should receive this information when starting Tysabri, when continuing treatment for longer than 2 years, and when stopping treatment, as the risk of PML persists for 6 months after stopping treatment.
Estonian: Patsiendid peavad saama selle teabe enne Tysabri-ravi alustamist, selle jätkamisel kauem kui 2 aastat ning ravi katkestamisel, sest progresseeruva multifokaalse leukoentsefalopaatia risk püsib 6 kuud pärast ravi lõpetamist.
English: Why is Tysabri approved?
Estonian: Miks Tysabri heaks kiideti?
English: The company that markets Tysabri will agree on measures to further enhance the monitoring of patients with each Member State, such as registries and studies of patients receiving Tysabri.
Estonian: Tysabri turustaja lepib igas liikmesriigiga kokku patsientide täiendavad jälgimismeetmed, nagu registrid ja patsiendiuuringud.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tysabri have also been included in the summary of product characteristics and the package leaflet.
Estonian: Tysabri ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: It is not intended to provide practical advice on how to use Tysabri.
Estonian: Hindamisaruandes ei anta Tysabri kasutamise praktilisi nõuandeid.
English: Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells.
Estonian: Hulgiskleroos on närvihaigus, mille korral hävitab põletik närvirakke ümbritseva kaitsekesta.
English: Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine.
Estonian: Tysabrit kasutavale patsiendile tuleb anda ka spetsiaalne hoiatuskaart, millel on ravimi kokkuvõtlik ohutusteave.
English: If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.
Estonian: Kui tekib progresseeruva multifokaalse leukoentsefalopaatia kahtlus, peab arst ravi peatama, kuni on selge, et patsiendil seda nakkust ei ole.
English: In a study comparing Tysabri with placebo (a dummy treatment), the number of MS attacks in Tysabritreated patients fell by about 68% after a year, compared with the patients who received placebo.
Estonian: Uuringus, milles võrreldi Tysabrit platseeboga (näiv ravim), vähenes pärast üht aastat hulgiskleroosi ägenemiste arv platseeboga võrreldes Tysabriga ravitud patsientidel 68% võrra.
English: Tysabri was effective at reducing the number of relapses and the worsening of disability (as measured with the Expanded Disability Status Scale).
Estonian: Tysabri oli efektiivne relapside arvu ja puude süvendamise vähendamisel (mõõdetuna puude kirjeldamise laiendatud skaalal).
English: What are the risks associated with Tysabri?
Estonian: Mis riskid Tysabriga kaasnevad?
English: However, because of its safety risks, it should only be used in patients who have a real need for the medicine either because their disease has failed to respond to at least one other disease-modifying therapy or is rapidly getting worse.
Estonian: Tysabri ohutusriske arvestades tohivad seda kasutada üksnes patsiendid, kes seda tingimata vajavad kas seetõttu, et neil ei tekkinud ravivastust vähemalt ühele haigust modifitseerivale ravimile või kelle haigus süveneb kiiresti.
English: The risk of PML increases the longer a patient has been receiving Tysabri, especially in patients treated for more than two years.
Estonian: Progresseeruva multifokaalse leukoentsefalopaatia risk on seda suurem, mida kauem on patsient saanud Tysabrit, eelkõige kui ravi on kestnud üle kahe aasta.
English: For the full list of all side effects reported with Tysabri, see the package leaflet.
Estonian: Tysabri kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody which targets a protein called ‘α4β1 integrin' found on the surface of white blood cells involved in inflammation.
Estonian: Tysabri toimeaine natalisumaab on monoklonaalne antikeha, mis mõjub põletiku tekitamises osalevate leukotsüütide pinnal leiduvale valgule α4β1-integriinile.
English: By attaching to integrin, natalizumab is thought to stop white blood cells from going from the blood to the brain tissue, thereby reducing inflammation and nerve damage caused by MS.
Estonian: Arvatakse, et integriiniga seondudes takistab natalisumaab leukotsüütide liikumist verest peaaju kudedesse, vähendades seega hulgiskleroosi põhjustatud põletikku ja närvikahjustust.
English: In addition, the risk of disability getting worse was reduced by 42% over two years with Tysabri in comparison with placebo.
Estonian: Kahe aasta jooksul vähenes ka puude süvenemise risk platseeboga võrreldes 42% võrra.
English: For practical information about using Tysabri, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Tysabri kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: This scanner will enable the doctor to check for changes in the brain or spinal cord linked to MS or to the brain infection called progressive multifocal leukoencephalopathy (PML), which has been associated with Tysabri and other MS medicines.
Estonian: Magntresonantstomograafia abil saab arst visualiseerida aju või seljaaju muutusi, mis on tingitud hulgiskleroosist või haruldasest ajunakkusest progresseeruvast multifokaalsest leukoentsefalopaatiast, mida on seostatud Tysabri ja teiste hulgiskleroosi ravimite kasutamisega.
English: Tysabri is a medicine for treating adults with multiple sclerosis (MS) that has failed to respond to another disease-modifying therapy or is rapidly getting worse.
Estonian: Tysabri on ravim, mida kasutatakse hulgikoldekõvastumusega ehk hulgiskleroosiga (sclerosis multiplex) täiskasvanud patsientide raviks, kui ei ole tekkinud ravivastust muule haigust modifitseerivale ravimile või kui haigus süveneb kiiresti.
English: How does Tysabri work?
Estonian: Kuidas Tysabri toimib?