FrancophonIA/ELRC3.0 huggingface dataset:
English: The grounds for the referral were concerns over the type of in vitro (experimental) studies carried out to demonstrate that Mometasone Furoate Sandoz is comparable to Nasonex (that it produces the same levels of the active substance in the nose as Nasonex).
Estonian: Esildise aluseks olid probleemid seoses in vitro (eksperimentaalsete) uuringute tüübiga, mis viidi läbi näitamaks, et Mometasone Furoate Sandoz on võrreldav Nasonexiga (et see tekitab ninas sama toimeainesisalduse nagu Nasonex).
English: What is Mometasone Furoate Sandoz?
Estonian: Mis on Mometasone Furoate Sandoz?
English: Mometasone Furoate Sandoz is a medicine that contains the active substance mometasone furoate.
Estonian: Mometasone Furoate Sandoz on ravim, mis sisaldab toimeainena mometasoonfuroaati.
English: The active substance, mometasone furoate, belongs to the group ‘glucocorticoids'.
Estonian: Toimeaine mometasoonfuroaat kuulub glükokortikoidide rühma.
English: Mometasone Furoate Sandoz is a ‘hybrid medicine'.
Estonian: Mometasone Furoate Sandoz on hübriidravim.
English: The ‘reference medicine' for Mometasone Furoate Sandoz is called Nasonex.
Estonian: Ravimi Mometasone Furoate Sandoz võrdlusravim on Nasonex.
English: Sandoz B.V. submitted an application for Mometasone Furoate Sandoz to the Dutch medicines regulatory agency for a decentralised procedure.
Estonian: esitas Madalmaade ravimiametile taotluse ravimi Mometasone Furoate Sandoz detsentraliseeritud menetluseks.
English: Why was Mometasone Furoate Sandoz reviewed?
Estonian: Miks ravimi Mometasone Furoate Sandoz taotlus uuesti läbi vaadati?
English: Also, data from a clinical study provided additional evidence that Mometasone Furoate Sandoz nasal spray works as well as Nasonex nasal spray in patients.
Estonian: Peale selle pakkusid kliinilise uuringu andmed lisatõestusi selle kohta, et ravimi Mometasone Furoate Sandoz ninasprei toimib patsientidel sama hästi kui Nasonexi ninasprei.
English: In addition, it is used in adults to treat the symptoms of nasal polyps (growths in the lining of the nose).
Estonian: Peale selle kasutatakse ravimit Mometasone Furoate Sandoz täiskasvanutel ninapolüüpide (nina limaskesta vohandid) sümptomite raviks.
English: It can be used in the following situations:
Estonian: Seda tohib kasutada järgmistel juhtudel:
English: Generally one kit is sufficient.
Estonian: Tavaliselt piisab ühest komplektist.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Inductos on 9 September 2002.
Estonian: Euroopa Komisjon andis Inductose müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 9. septembril 2002.
English: Inductos must not be used in the following situations:
Estonian: Inductost ei tohi kasutada järgmistel juhtudel:
English: The full EPAR for Inductos can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Inductose kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: A risk management plan has been developed to ensure that Inductos is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Inductose võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Inductos?
Estonian: Mis meetmed võetakse, et tagada Inductose ohutu ja efektiivne kasutamine?
English: After two years, 57% of the patients treated with Inductos (69 out of 122) had responded to treatment, compared with 59% of the patients treated with a bone graft (78 out of 133).
Estonian: 2 aasta möödumisel tekkis ravivastus 57%-l Inductosega ravitud patsientidest (69 patsienti 122st) ja 59%-l luu siirdamisega ravitud patsientidest (78 patsienti 133st).
English: The matrix is then cut, if needed, to the correct size before use.
Estonian: Enne kasutamist võib vajaduse korral lõigata maatriksi sobivasse suurusesse.
English: In addition, the company that markets Inductos will make sure that educational material is available in all Member States for all healthcare professionals expected to use the medicine.
Estonian: Lisaks annab Inductose turustaja kõigis liikmesriikides teabematerjalid kõigile tervishoiutöötajatele, kes hakkavad eeldatavalt ravimit kasutama.
English: Other information about Inductos
Estonian: Muu teave Inductose kohta
English: Inductos is used in addition to standard treatment and care.
Estonian: Inductost kasutatakse lisaks standardravile ja hooldusele.
English: Inductos is made up into a solution before use, applied to the matrix and left for at least 15 minutes (but no more than two hours).
Estonian: Enne kasutamist valmistatakse Inductosest lahus, mis kantakse maatriksi pinnale ja jäetakse sinna vähemalt 15 minutiks (kuid mitte rohkem kui 2 tunniks).
English: The newly formed bone grows into the matrix, which then degrades.
Estonian: Uus moodustuv luukude kasvab maatriksisse, mis seejärel laguneb.
English: Inductos is used in adults who have been treated for at least six months for back pain due to a damaged disc but have not had an operation.
Estonian: Inductost kasutatakse täiskasvanutel, kellel on kahjustatud lülivahekettast põhjustatud seljavalu ravitud vähemalt 6 kuud, kuid keda ei ole opereeritud;
English: For more information about treatment with Inductos, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Inductosega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Inductos are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Inductose kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Inductos is used together with approved medical devices that correct the position of the spine.
Estonian: Inductost kasutatakse koos heakskiidetud meditsiiniseadmetega, mis korrigeerivad lülisamba asendit.
English: Inductos dibotermin alfa
Estonian: Inductos alfadibotermiin
English: • patients diagnosed with or being treated for cancer;
Estonian: • patsiendid, kellel on diagnoositud vähk või kes saavad vähiravi;
English: The medical devices fix the position of the vertebrae, and Inductos encourages bone to grow between the two vertebrae to join them permanently in the correct position.
Estonian: Meditsiiniseadmed fikseerivad lülide asendi ja Inductos soodustab luukoe tekkimist lülide vahel, et ühendada need püsivalt õigesse asendisse.
English: Patients undergoing treatment with Inductos may be at risk of heterotopic ossification (the growth of bone in abnormal places like soft tissue); this risk is considered to be manageable with the proposed risk minimisation measures.
Estonian: Inductosega ravitavaid patsiente võib ohustada heterotoopne luustumine (luukoe teke mujal, näiteks pehmetes kudedes); riski on võimalik ohjata kavandatavate riskivähendusmeetmetega.
English: For lower back spine fusion, the damaged disc between the vertebrae is removed and replaced with one or more medical devices and Inductos.
Estonian: Nimmelülide fusiooni korral eemaldatakse kahjustatud lülivaheketas, mis asendatakse ühe või mitme meditsiiniseadme ja Inductosega.
English: The most common side effects with Inductos (seen in more than 1 patient in 10) are radiculopathic events (problems occurring at or near the root of the nerve, along the spine, resulting in pain, weakness, numbness, or difficulty controlling specific muscles) when used in spine surgery, and localised infection when used in tibia fracture surgery.
Estonian: Inductose kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on lülisambaoperatsioonil radikulopaatia (lülisambanärvi juures või läheduses esinevad nähud, mis tekitavad valu, nõrkust, tuimust või teatud lihaste juhitavuse raskusi) ja sääreluumurru operatsioonil paikne infektsioon.
English: • patients with an active infection at the surgery site;
Estonian: • patsiendid, kellel on operatsioonikohal aktiivne infektsioon;
English: Inductos should be used by a qualified surgeon.
Estonian: Inductost tohib kasutada üksnes pädev kirurg.
English: The replacement dibotermin alfa acts in same way as BMP-2 produced naturally by the body.
Estonian: Tehislik alfadibotermiin toimib samal viisil kui organismis looduslikult tekkiv BMP-2.
English: This material will include information on the risk of heterotopic ossification and the potential risk of medication errors and incorrect use of Inductos.
Estonian: Materjalis on heterotoopse luustumise riski, ravivigade võimaliku riski ja Inductose väära manustamise teave.
English: Additional studies and analysis of data from the published literature showed that Inductos was more effective than bone graft at inducing fusion of the lower back vertebrae, irrespective of the surgical technique or the type of approved medical device used to hold the bone in position.
Estonian: Täiendavad uuringud ja avaldatud teaduskirjandusandmete analüüs tõendasid, et Inductos oli nimmelülide fusioonlõikusel efektiivsem kui luu siirdamine, olenemata luu õiges asendis hoidmise kirurgilisest meetodist või heakskiidetud meditsiiniseadme liigist.
English: Inductos has been studied in 450 patients with a fractured tibia.
Estonian: Inductose kasutamist uuriti ka 450 sääreluumurruga patsiendil.
English: • patients with an inadequate blood supply at the fracture site;
Estonian: • patsiendid, kellel on luumurru kohal ebapiisav verevarustus;
English: Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Estonian: Alfadibotermiini valmistatakse rekombinant-DNA-tehnika abil: seda toodavad rakud, millesse on viidud alfadibotermiini tekkimist võimaldav geen (DNA).
English: Inductos has been studied in 279 patients having lower back spine fusion.
Estonian: Inductose kasutamist uuriti 279 nimmelülide fusioonlõikusega patsiendil.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Inductos, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Inductose omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Inductos.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This is a summary of the European public assessment report (EPAR) for Inductos.
Estonian: See on ravimi Inductos Euroopa avaliku hindamisaruande kokkuvõte.
English: The main measure of effectiveness was the number of patients who did not need further treatment for their fractured tibia (such as a bone graft or changes to the nail used to fix the bones together) in the year following surgery.
Estonian: Efektiivsuse põhinäitajaks oli nende patsientide arv, kelle sääreluumurdu ei olnud vaja operatsioonijärgsel aastal täiendavalt ravida (näiteks luud siirata või luude fikseerimiseks kasutatud naela korrigeerida).
English: In spinal fusion, Inductos was as effective as bone grafts.
Estonian: Lülisamba fusioonlõikuse korral oli Inductos sama efektiivne kui luu siirdamine.
English: • patients who are still growing;
Estonian: • kasvueas patsiendid;
English: Why has Inductos been approved?
Estonian: Miks Inductos heaks kiideti?
English: What is the risk associated with Inductos?
Estonian: Mis riskid Inductosega kaasnevad?
English: In patients with a fractured tibia, using Inductos in addition to standard care was more effective than standard care alone in reducing the risk of treatment failure.
Estonian: Sääreluumurruga patsientidel vähendas Inductos koos standardraviga ravi ebaõnnestumise riski efektiivsemalt kui üksnes standardravi.
English: Of the patients in the standard care group, 46% needed a further intervention within a year to repair their fracture, while the proportion was 26% for those also receiving Inductos.
Estonian: Standardravi rühmas vajas aasta jooksul lisaravi 46% patsientidest, standardravile lisaks Inductost kasutanud patsientidest vajas lisaravi 26%.
English: What is Inductos?
Estonian: Mis on Inductos?
English: Inductos is a kit for implant.
Estonian: Inductos on implantatsioonikomplekt.
English: The main measure of effectiveness was fusion of the vertebrae confirmed by X-ray, and improvement in the pain and disability reported by the patient, measured two years after surgery.
Estonian: Efektiivsuse põhinäitajad olid lülide fusioon, mida kinnitas röntgenuuring, ning patsiendi hinnang valu ja puude kohta.
English: The CHMP considered that Inductos is effective in single-level lumbar spine fusion as a substitute for autogenous bone graft and for the treatment of acute tibia fractures in adults, as an adjunct to standard care.
Estonian: Inimravimite komitee järeldas, et Inductos on efektiivne nimmelülide ühetasapinnalisel eesmisel fusioonlõikusel, mis asendab autogeenset luusiirdamist, samuti täiskasvanute raskete sääreluumurdude ravis lisaks standardravile.
English: • treating a fracture that is related to a disease such as Paget's disease or cancer.
Estonian: • haigusega seotud (näiteks Pageti tõvest või vähist põhjustatud) luumurdude ravi.
English: Inductos is used to help new bone develop.
Estonian: Inductost kasutatakse uue luukoe tekke soodustamiseks.
English: In this type of surgery, Inductos can be used instead of an autogenous bone graft (bone taken from one part of a person's body and placed in another part of the body).
Estonian: Seda liiki lõikuse korral saab autogeense luusiirdamise (patsiendi organismist võetud luu siirdamine organismis mujale) asemel kasutada Inductost.
English: The kit consists of a powder containing the active substance, dibotermin alfa, a solvent and a matrix (collagen sponge).
Estonian: Komplekt koosneb toimeainet alfadibotermiini sisaldavast pulbrist, lahustist ja maatriksist (kollageenkäsnast).
English: For the full list of restrictions with Inductos, see the package leaflet.
Estonian: Inductose piirangute täielik loetelu on pakendi infolehel.
English: What benefit has Inductos shown during the studies?
Estonian: Milles seisneb uuringute põhjal Inductose kasulikkus?
English: This is a type of surgery used to relieve back pain due to a damaged disc where the disc between two vertebrae (the bones in the spine) is removed and the vertebrae are fused (joined) together.
Estonian: Seda liiki lõikusega leevendatakse seljavalu, mida põhjustab kahjustatud lülivaheketas: lülisamba kahe lüli vaheline ketas eemaldatakse ja lülid ühendatakse.
English: It is only used when the nail to fix the bone does not need ‘reaming' (drilling to make room for nail placement).
Estonian: Seda kasutatakse üksnes juhul, kui luud fikseeriva naela paigaldamiseks ei ole vaja luud täiendavalt puurida.
English: Spinal fusion using Inductos was compared with fusion using a bone graft removed from the hip during surgery.
Estonian: Lülisamba fusioonlõikust Inductose kasutamisega võrreldi fusioonlõikusega, mille käigus siirati puusast võetud luud.
English: The most severe side effect is localised oedema (swelling at the surgery site) when used in upper spine (neck) surgery.
Estonian: Kõige raskem kõrvalnäht on lülisamba ülaosa (kaelapiirkonna) operatsioonil paikne ödeem (operatsioonikoha turse).
English: Inductos was compared with standard care.
Estonian: Inductose kasutamist võrreldi standardraviga.
English: For a fractured tibia, Inductos is placed around the broken bone to aid healing.
Estonian: Sääreluumurru korral paigaldatakse Inductos ümber murdunud luu, et aidata luul paraneda.
English: For the full list of all side effects reported with Inductos, see the package leaflet.
Estonian: Inductose kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The active substance in Inductos, dibotermin alfa, acts on the bone structure.
Estonian: Inductose toimeaine alfadibotermiin mõjutab luukoe struktuuri.
English: It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Estonian: Alfadibotermiin on organismis looduslikult tekkiva uue luukoe moodustamist soodustava aine luu morfogeneetilise valgu 2 (BMP-2) koopia.
English: How is Inductos used?
Estonian: Kuidas Inductost kasutatakse?
English: What is Inductos used for?
Estonian: Milleks Inductost kasutatakse?
English: When implanted, dibotermin alfa stimulates the bone tissue around the matrix to make new bone.
Estonian: Implanteeritud alfadibotermiin soodustab maatriksi ümbruses uue luukoe teket.
English: • lower back spine fusion surgery.
Estonian: • nimmelülide fusioonlõikus.
English: How does Inductos work?
Estonian: Kuidas Inductos toimib?
English: How has Inductos been studied?
Estonian: Kuidas Inductost uuriti?
English: The medicine can only be obtained with a prescription.
Estonian: Inductos on retseptiravim.
English: Doctors will also be given information on the EU registry.
Estonian: Samuti antakse arstidele teavet ELi registri kohta.
English: Scenesse afamelanotide
Estonian: Scenesse afamelanotiid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Scenesse on 22 December 2014.
Estonian: Euroopa Komisjon andis Scenesse müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 22. detsembril 2014.
English: A risk management plan has been developed to ensure that Scenesse is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Scenesse võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Scenesse?
Estonian: Mis meetmed võetakse, et tagada Scenesse ohutu ja efektiivne kasutamine?
English: The Committee also consulted individual patients and experts on their experience with Scenesse.
Estonian: Komitee konsulteeris ka patsientide ja ekspertidega nende kogemuse üle Scenessega.
English: Other information about Scenesse
Estonian: Muu teave Scenesse kohta
English: Scenesse is used to help prevent or reduce these symptoms so that these patients can lead more normal lives.
Estonian: Scenesset kasutatakse nende sümptomite ennetamiseks või vähendamiseks, nii et patsiendid saavad elada tavapärasemat elu.
English: These affected around 1 in 5 patients and were generally mild in severity.
Estonian: Need nähud esinesid umbes 1 patsiendil 5st ja olid üldiselt kerged.
English: What is Scenesse and what is it used for?
Estonian: Mis on Scenesse ja milleks seda kasutatakse?
English: Patients should be observed for allergic reactions for 30 minutes after the injection of each implant.
Estonian: Patsiente tuleb 30 minutit pärast iga implantaadi süstimist allergiliste reaktsioonide suhtes jälgida.
English: Why is Scenesse approved?
Estonian: Miks Scenesse heaks kiideti?
English: This is because it has not been possible to obtain complete information about the benefits of Scenesse, in part due to the rarity of the disease.
Estonian: See tähendab, et osaliselt harvaesineva haiguse tõttu ei olnud võimalik saada Scenesse kasulikkuse kohta täielikku teavet.
English: By stimulating the production of eumelanin in the skin, Scenesse reduces the penetration of light through the skin, thus helping to prevent the painful reactions.
Estonian: Stimuleerides eumelaniini tootmist nahas, vähendab Scenesse valguse tungimist läbi naha, aidates seega ennetada valulikke reaktsioone.
English: Protoporphyrin IX is phototoxic and, when exposed to light, causes the painful reactions seen with this condition.
Estonian: Protoporfüriin IX on fototoksiline ja põhjustab valgusega kokkupuutumisel nimetatud haiguse korral täheldatud valulikke reaktsioone.
English: The most common side effects seen in studies with Scenesse were nausea (feeling sick), headache and reactions at the implant site (such as discoloration, pain and redness).
Estonian: Scenessega läbi viidud uuringutes täheldatud kõige sagedamad kõrvalnähud olid iiveldus, peavalu ja süstekoha reaktsioonid (näiteks värvimuutus, valu ja punetus).
English: The number of implants per year depends on how much protection from the sun is needed.
Estonian: Soovitatav implantaatide arv aastas sõltub sellest, kui pikka toimeaega on vaja.
English: In the study, involving 93 patients with EPP, patients were treated with either Scenesse or a placebo (a dummy treatment) over a six-month period.
Estonian: Uuringus, kus osales 93 EPPga patsienti, raviti neid kuue kuu vältel kas Scenesse või platseeboga (näiv ravim).
English: The full EPAR and risk management plan summary for Scenesse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Scenesse kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Scenesse's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Scenesse kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Scenesse can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Scenesse kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: What information is still awaited for Scenesse?
Estonian: Mis teavet Scenesse kohta veel oodatakse?
English: It is not intended to provide practical advice on how to use Scenesse.
Estonian: Hindamisaruandes ei anta Scenesse kasutamise praktilisi nõuandeid.
English: What are the risks associated with Scenesse?
Estonian: Mis riskid Scenessega kaasnevad?
English: This pigment, known as eumelanin, is produced during exposure to sunlight to block the penetration of light into cells.
Estonian: Seda pigmenti, mida tuntakse eumelaniinina, toodetakse päikesevalgusega kokku puutudes valguse rakkudesse tungimise tõkestamiseks.
English: Daily records of exposure to sunlight between 10 am and 6 pm showed that patients treated with Scenesse spent on average 116 hours in direct sunlight without experiencing pain during the six-month period compared with 61 hours for patients treated with placebo.
Estonian: Kell 10-18 päikesevalguse käes viibimise igapäevane arvestus näitas, et Scenessega ravitud patsiendid veetsid kuue kuu vältel otsese päikesevalguse käes valu tundmata keskmiselt 116 tundi võrreldes 61 tunniga platseebot saanud patsientide puhul.
English: In addition, the company that markets Scenesse will ensure that doctors receive educational material and are trained in how to use the medicine.
Estonian: Lisaks tagab Scenesset turustav ettevõte, et arstid saavad ravimi kasutamise kohta õppematerjalid ja koolituse.
English: In patients with EPP, exposure to light can lead to symptoms such as pain and swelling of the skin, which prevent patients from being able to spend time outdoors or in places with bright light.
Estonian: EPPga patsientidel võib kokkupuude valgusega tekitada selliseid sümptomeid nagu naha valulikkus ja paistetus, mistõttu patsiendid ei saa viibida õues ega ereda valgusega kohtades.
English: Because the number of patients with EPP is low, the disease is considered ‘rare', and Scenesse was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 May 2008.
Estonian: Et EPPga patsientide arv on väike ja see haigus erineb harva, nimetati Scenesse 8. mail 2008 harvikravimiks.