FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that atypical femoral fractures are likely to be a class effect of bisphosphonates but that such fractures occur only rarely and the benefits of bisphosphonatecontaining medicines continue to outweigh their risks.
Estonian: Olemasolevate andmete hindamise ja komiteesisese teadusliku arutelu alusel järeldas inimravimite komitee, et ebatüüpilised reieluumurrud on tõenäoliselt bisfosfonaatide ravimiklassile iseloomulik näht, aga esinevad harva ja bisfosfonaate sisaldavate ravimite kasulikkus on jätkuvalt suurem kui nendega kaasnevad riskid.
English: The CHMP also noted that these fractures had a distinct pattern on X-rays and may be related to bisphosphonate use, especially during long-term use in osteoporosis.
Estonian: Komitee märkis ka, et neid murde saab röntgenipiltidel selgesti eristada ja neid murde võib seostada bisfosfonaatide kasutamisega, eelkõige pikaajalisel kasutamisel osteoporoosi korral.
English: The Committee agreed that this could be related to the mode of action of bisphosphonates, which could lead to a delay in the repair of naturally occurring stress fractures although the exact mechanism is not known.
Estonian: Komitee jõudis ühisele arvamusele, et seda võib seostada bisfosfonaatide toimemehhanismiga, mis võib aeglustada loomulike pingemurdude paranemist, kuigi täpne mehhanism ei ole teada.
English: The CHMP has reviewed all case reports of stress fractures in patients treated with bisphosphonates, relevant data from the published literature and data provided by the companies that make bisphosphonates.
Estonian: Inimravimite komitee vaatas läbi kõik pingemurdude esinemisjuhtude teated bisfosfonaatidega ravitud patsientidel, asjakohased andmed avaldatud kirjandusest ja bisfosfonaatide tootjate esitatud andmed.
English: They have also been available since the mid 1990s for the treatment of osteoporosis (a disease that makes bones fragile) and Paget's disease (a disease involving bone growth that causes bone deformity).
Estonian: Alates 1990. aastate keskelt turustatakse neid ka osteoporoosi (luu-urbumuse) ja Pageti tõve raviks (Pageti tõbi on haigus, millega kaasneb luude lagunemine ja taasteke, mis põhjustab luudeformatsioone).
English: • Patients who are taking bisphosphonate-containing medicines need to be aware of the risk of atypical fracture of the thigh bone.
Estonian: • Bisfosfonaate sisaldavaid ravimeid võtvad patsiendid peavad teadma ebatüüpilise reieluu murru riskist.
English: The European Medicines Agency has completed a review of bisphosphonate-containing medicines at the request of the United Kingdom and the European Commission, following reports of an increased risk of atypical stress fractures of the femur associated with these medicines.
Estonian: Euroopa Ravimiamet on lõpetanud bisfosfonaate sisaldavate ravimite läbivaatamise, mida taotlesid Ühendkuningriik ja Euroopa Komisjon pärast teateid nende ravimitega seostatavate ebatüüpiliste reieluu pingemurdude suurenenud riski kohta.
English: The PhVWP also concluded at the time that it was not possible to rule out the possibility that the effect could be a class effect (an effect common to all bisphosphonates), and decided to keep the issue under close review.
Estonian: Samal ajal jõudis ravimiohutuse järelevalve töörühm järeldusele, et ei saa välistada võimalust et tegu on kogu ravimiklassile (kõigile bisfosfonaatidele) iseloomuliku nähuga, ja otsustas seda küsimust hoolikalt uurida.
English: However, the product information should be amended to add a warning concerning this risk, and, for bisphosphonates used in osteoporosis, to advise doctors to periodically review treatment, in particular after five or more years of treatment.
Estonian: Ravimiteavet tuleb siiski täiendada ja lisada hoiatus kõnealuse riski kohta ning arstidele tuleb soovitada ravi regulaarselt üle vaadata, kui bisfosfonaate kasutatakse osteoporoosi korral, eelkõige kui ravi kestab 5 aastat või kauem.
English: Questions and answers on the review of bisphosphonates and atypical stress fractures
Estonian: Bisfosfonaatide ja luu ebatüüpiliste pingemurdude läbivaatamise teave
English: The centrally authorised bisphosphonate-containing medicines concerned by these referrals are Aclasta and Zometa (zoledronic acid), Bondenza, Bonviva, Bondronat and Ibandronic acid Teva (ibandronic acid), and Adrovance and Fosavance (alendronic acid and vitamin D3).
Estonian: Tsentraliseeritud menetluse teel heaks kiidetud bisfosfonaate sisaldavad ravimid, mida kõnealused esildismenetlused käsitlevad, on järgmised: Aclasta ja Zometa (soledroonhape), Bondenza, Bonviva, Bondronat ja Ibandronic acid Teva (ibandroonhape) ning Adrovance ja Fosavance (alendroonhape ja D3-vitamiin).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of bisphosphonates continue to outweigh their risks but that warnings of the risk of atypical femoral fractures should be added to the prescribing information for all bisphosphonate-containing medicines in the European Union (EU).
Estonian: Ameti inimravimite komitee on jõudnud järeldusele, et bisfosfonaatide kasulikkus on jätkuvalt suurem kui nendega kaasnevad riskid, aga Euroopa Liidus tuleb kõigi bisfosfonaate sisaldavate ravimite määramise teabesse lisada hoiatus ebatüüpiliste reieluumurdude riski kohta.
English: In April 2010, the PhVWP noted that further data from both the published literature and postmarketing reports were now available that suggested that atypical stress fractures of the femur may be a class effect.
Estonian: 2010. aasta aprillis märkis ravimiohutuse järelevalve töörühm, et sel ajal kättesaadavad täiendavad andmed nii avaldatud kirjandusest kui ka turustamisjärgsetest aruannetest viitavad asjaolule, et ebatüüpilised reieluu pingemurrud võivad olla kogu ravimiklassile iseloomulik näht.
English: • Doctors who prescribe bisphosphonate-containing medicines should be aware that atypical fractures may occur rarely in the femur (thigh bone), especially after long term use.
Estonian: • Bisfosfonaate sisaldavaid ravimeid määravad arstid peavad teadma, et harvadel juhtudel võib esineda ebatüüpilisi reieluumurde, eelkõige pikaajalisel kasutamisel.
English: In 2008, the CHMP's Pharmacovigilance Working Party (PhVWP) noted that alendronic acid was associated with an increased risk of atypical fracture of the femur (thigh bone) that developed with low or no trauma.
Estonian: 2008. aastal märkis inimravimite komitee ravimiohutuse järelevalve töörühm, et alendroonhapet seostatakse kerge trauma tagajärjel või traumata tekkinud ebatüüpiliste reieluumurdude suurenenud riskiga.
English: Bisphosphonates include alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid.
Estonian: Bisfosfonaadid on alendroonhape, klodroonhape, etidroonhape, ibandroonhape, neridroonhape, pamidroonhape, risedroonhape, tiludroonhape ja soledroonhape.
English: They work by stopping the action of the osteoclasts, the cells that are involved in breaking the bone down.
Estonian: Bisfosfonaadid pärsivad osteoklastide ehk luukoe lagunemises osalevate rakkude toimet.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Alimta on 20 September 2004.
Estonian: Euroopa Komisjon andis Alimta müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. septembril
English: The full EPAR for Alimta can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Alimta kohta on ameti veebilehel ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It contains the active substance pemetrexed.
Estonian: See sisaldab toimeainena pemetrekseedi.
English: Alimta pemetrexed
Estonian: Alimta pemetrekseed
English: The CHMP concluded that Alimta's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee järeldas, et Alimta kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Other information about Alimta
Estonian: Muu teave Alimta kohta
English: The recommended dose of Alimta is 500 mg per square metre of body surface area (calculated using the patient's height and weight).
Estonian: Alimta soovitatav annus on 500 mg kehapindala ruutmeetri kohta (arvutatakse patsiendi pikkuse ja kehamassi järgi).
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 Alimta.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: For more information about treatment with Alimta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Alimtaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: As a result, the active form of pemetrexed slows down the formation of DNA and RNA and prevents the cells from dividing and multiplying.
Estonian: Selle tulemusena aeglustab pemetrekseedi aktiivne vorm DNA ja RNA moodustumist ja takistab raku pooldumist.
English: The conversion of pemetrexed into its active form occurs more readily in cancer cells than in normal cells, leading to higher levels of the active form of the medicine and a longer duration of action in cancer cells.
Estonian: Pemetrekseedi muundumine aktiivseks vormiks toimub vähirakkudes kergemini kui normaalsetes rakkudes, mistõttu ravimi aktiivse vormi sisaldus vähirakkudes suureneb ja püsib kauem.
English: For the full list of all side effects reported with Alimta, see the package leaflet.
Estonian: Alimta kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: This is a summary of the European public assessment report (EPAR) for Alimta.
Estonian: See on ravimi Alimta Euroopa avaliku hindamisaruande kokkuvõte.
English: Alimta is used to treat two types of lung cancer:
Estonian: Alimtat kasutatakse kopsuvähi kahe vormi ravimiseks:
English: Alimta increased the survival time of patients with malignant pleural mesothelioma.
Estonian: Alimta pikendas pleura pahaloomulise mesotelioomiga patsientide elulemust.
English: What is Alimta?
Estonian: Mis on Alimta?
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos),where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Estonian: • pahaloomuline pleura mesotelioom (kopsukelme vähk, mida tavaliselt põhjustab kokkupuude asbestiga), mille korral Alimtat kasutatakse koos tsisplatiiniga patsientidel, kes varem ei ole saanud keemiaravi ja kelle vähkkasvajat ei saa eemaldada kirurgiliselt;
English: Patients receiving Alimta and cisplatin survived for an average of 12.1 months, compared with 9.3 months in those receiving cisplatin alone.
Estonian: Alimtat ja tsisplatiini kasutanud patsientide keskmine elulemus oli 12,1 kuud ja ainult tsisplatiini kasutanud patsientidel 9,3 kuud.
English: Why has Alimta been approved?
Estonian: Miks Alimta heaks kiideti?
English: How is Alimta used?
Estonian: Kuidas Alimtat kasutatakse?
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Alimta.
Estonian: Kõrvalnähtude vähendamiseks tuleb patsiendil võtta kortikosteroide (põletikuvastane ravim) ja foolhapet (teatud vitamiin) ning talle tuleb Alimta ravi ajal süstida vitamiini B12.
English: Alimta should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Estonian: Alimtat tohib manustada üksnes keemiaravi kasutamises kogenud arsti järelevalve all.
English: Alimta must not be used in people who are hypersensitive (allergic) to pemetrexed or any of the other ingredients.
Estonian: Alimtat ei tohi kasutada patsiendid, kes on pemetrekseedi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Alimta affects fertility, so both men and women who receive it need to be made aware of this.
Estonian: Alimta mõjutab patsiendi viljakust, sellest tuleb teavitada ravimit saavaid mees- ja naispatsiente.
English: Alimta is a powder that is made up into a solution for infusion (drip into a vein).
Estonian: Alimta on pulber, millest valmistatakse infusioonilahus (veeni tilgutatav lahus).
English: It can also be used as a maintenance treatment in patients who have received a platinum-based chemotherapy.
Estonian: Alimtat tohib kasutada ka säilitavaks raviks patsientidel, kes on saanud plaatinaravimitega keemiaravi.
English: When Alimta is given with cisplatin, an ‘anti emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Estonian: Kui Alimtat antakse koos tsisplatiiniga, tuleb enne või pärast tsisplatiini annuse manustamist anda antiemeetikumi (oksendamise ennetamiseks) ja vedelikke (dehüdratsiooni ennetamiseks).
English: The gastrointestinal toxicities seen with Alimta are loss of appetite, nausea (feeling sick), vomiting, diarrhoea, constipation, pharyngitis (sore throat), and mucositis or stomatitis (inflammation of the lining of the digestive system and mouth).
Estonian: Alimta kasutamisel tekkivad gastrointestinaalse toksilisuse nähud on muu hulgas isutus, iiveldus, oksendamine, kõhulahtisus, kõhukinnisus, farüngiit (neelupõletik) ja mukosiit või stomatiit (suu ja seedeelundite limaskesta põletik).
English: In the treatment of non small cell lung cancer, Alimta was as effective as the comparators, with survival times around 10.3 months in patients who had not received chemotherapy in the past, and around 8.1 months in those who had received chemotherapy in the past.
Estonian: Mitteväikerakk-kopsuvähiga patsientide ravis oli Alimta sama efektiivne kui võrdlusravimid: varem keemiaravi mittesaanud patsientide elulemus oli ligikaudu 10,3 kuud ja varem keemiaravi saanud patsientide elulemus ligikaudu 8,1 kuud.
English: The most common side effects with Alimta, used on its own or with other anticancer medicines, are bone marrow suppression (when the bone marrow produces less blood cells than normal) and gastrointestinal toxicities (side effects affecting the stomach and gut).
Estonian: Alimta kõige sagedamad kõrvalnähud, kasutamisel ainsa ravimina või koos teiste vähiravimitega, on luuüdi supressioon (luuüdis tekib normaalsest vähem erütrotsüüte ehk punaseid vereliblesid) ja gastrointestinaalne toksilisus (mao ja soolestikuga seotud kõrvalnähud).
English: What is the risk associated with Alimta?
Estonian: Mis riskid Alimtaga kaasnevad?
English: The main measures of effectiveness were how long the patients survived and how long they lived without their cancer getting worse.
Estonian: Ravi efektiivsuse põhinäitajad olid patsientide elulemus ja aeg vähi progresseerumiseni.
English: For the treatment of malignant pleural mesothelioma, Alimta in combination with cisplatin has been compared with cisplatin alone in one main study in 456 patients who had not received chemotherapy for their disease before.
Estonian: Pleura pahaloomulise mesotelioomi ravis võrreldi Alimta ja tsisplatiini koos kasutamist ainult tsisplatiini kasutamisega ühes põhiuuringus, milles osales 456 patsienti, kes ei olnud varem saanud keemiaravi.
English: Bone marrow suppression causes decreased levels in the blood of white blood cells (the cells that fight infection), platelets (components that help the blood to clot) and haemoglobin (the protein found in red blood cells that carries oxygen around the body).
Estonian: Luuüdi supressioon põhjustab leukotsüütide (valgeliblede ehk nakkusega võitlevate vereliblede), trombotsüütide (vereliistakute ehk vere hüübimises osalevate vererakkude) ja hemoglobiini (erütrotsüütide valk, mis kannab organismis edasi hapnikku) sisalduse vähenemist.
English: How has Alimta been studied?
Estonian: Kuidas Alimtat uuriti?
English: The active substance in Alimta, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Estonian: Alimta toimeaine pemetrekseed on antimetaboliitide rühma kuuluv tsütotoksiline ravim (ravim, mis hävitab poolduvaid rakke, näiteks vähirakke).
English: For maintenance treatment, Alimta was compared with placebo (a dummy treatment) in two main studies involving 1,202 patients whose cancer had not got worse during platinum-based chemotherapy.
Estonian: Säilitusravis võrreldi Alimtat platseeboga (näiv ravim) kahes põhiuuringus, milles osales 1202 patsienti, kelle vähk ei olnud plaatinaravimitega keemiaravi ajal progresseerunud.
English: For the treatment of locally advanced or metastatic non small cell lung cancer, Alimta was compared with gemcitabine (another anticancer medicine), in combination with cisplatin, in a study involving 1,725 patients who had not received chemotherapy before.
Estonian: Lokaalselt kaugelearenenud või metastaatilise mitteväikerakk-kopsuvähi ravis võrreldi Alimta ja tsisplatiini kasutamist gemtsitabiini (samuti vähiravim) ja tsisplatiini kasutamisega uuringus, milles osales 1725 keemiaravi varem mittesaanud patsienti.
English: Improved survival times with Alimta were only seen in patients with non small cell lung cancer of the non-squamous type.
Estonian: Elulemus pikenes Alimta toimel üksnes patsientidel, kelle mitteväikerakulise kopsuvähi vorm oli muu kui lamerakuline.
English: What benefit has Alimta shown during the studies?
Estonian: Milles seisneb uuringute põhjal Alimta kasulikkus?
English: What is Alimta used for?
Estonian: Milleks Alimtat kasutatakse?
English: • advanced ‘non small cell' lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received anticancer treatment.
Estonian: • kaugelearenenud mitteväikerakk-kopsuvähi muu kui lamerakulise vormi ravis, mille korral Alimtat kasutatakse koos tsisplatiiniga patsientidel, keda ei ole varem ravitud, või ainsa ravimina patsientidel, kes on varem saanud keemiaravi.
English: Alimta was also compared with docetaxel (another anticancer medicine) in one study involving 571 patients who had received chemotherapy in the past.
Estonian: Alimtat võrreldi ka dotsetakseeliga (samuti vähiravim) ühes uuringus, milles osales 571 patsienti, kes olid varem keemiaravi saanud.
English: In one maintenance treatment study, patients receiving Alimta lived for a further 4.3 months from the start of maintenance treatment without their cancer getting worse, compared with 2.6 months in those receiving placebo.
Estonian: Ühes säilitusravi uuringus oli aeg ravi algusest kuni vähi progresseerumiseni Alimtat saanud patsientidel 4,3 kuud ja platseebot saanutel 2,6 kuud.
English: Treatment should be delayed or stopped, or the dose reduced, in patients whose blood counts are abnormal or who have certain other side effects.
Estonian: Kui patsiendi vereanalüüsis on kõrvalekaldeid või tal esinevad teatud muud kõrvalnähud, tuleb ravi edasi lükata või peatada või annust vähendada.
English: It must not be used during breast-feeding or at the same time as the vaccine for yellow fever.
Estonian: Alimtat ei tohi kasutada imetavad patsiendid ega patsiendid, keda vaktsineeritakse kollapalaviku vastu.
English: In the second maintenance study, the figures were 4.1 months in the Alimta and 2.8 months in the placebo group.
Estonian: Teises säilitusravi uuringus oli sama aeg Alimtat saanud patsientidel 4,1 kuud ja platseebot saanud patsientidel 2,8 kuud.
English: The medicine can only be obtained with a prescription.
Estonian: Alimta on retseptiravim.
English: How does Alimta work?
Estonian: Kuidas Alimta toimib?
English: 11 February 2015
Estonian: 11. veebruar 2015
English: The final opinion was converted into a Decision by the European Commission on 11 February 2015.
Estonian: Lõplik arvamus vormistati Euroopa Komisjoni otsusena 11. veebruaril 2015.
English: The referral started on 12 March 2014.
Estonian: Esildismenetlus algas 12. märtsil 2014.
English: Written explanations were provided by the applicants and marketing authorisation holders on 16 May 2014 and 4 September 2014.
Estonian: Müügiloa taotlejad ja hoidjad esitasid kirjalikud selgitused 16. mail 2014 ja 4. septembril 2014.
English: The Committee appointed K. Baptiste as rapporteur and C. Muñoz Madero as co-rapporteur.
Estonian: Komitee määras hindajaks K. Baptiste'i ja kaashindajaks C. Muñoz Madero.
English: It is normally used as the sulphate salt.
Estonian: Tavaliselt kasutatakse seda sulfaatsoolana.
English: International non-proprietary name (INN): gentamicin
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): gentamütsiin
English: It is currently included in the list of essential medicines for human use of the World Health Organisation (WHO).
Estonian: Praegu on ravim kantud Maailma Terviseorganisatsiooni (WHO) oluliste inimravimite loetellu.
English: The CVMP was requested to harmonise the indications and dosing regimens of the concerned products, taking into account the available data and in particular with regard to the target animal safety.
Estonian: Veterinaarravimite komiteel paluti ühtlustada asjaomaste ravimite näidustused ja annustamisrežiimid, arvestades olemasolevaid andmeid, eelkõige sihtloomade ohutusandmeid.
English: In veterinary medicine gentamicin is used mainly as a solution for injection for pigs, cattle and horses and as an oral solution for poultry.
Estonian: Veterinaarmeditsiinis kasutatakse gentamütsiini peamiselt sigade, veiste ja hobuste süstelahusena ning kodulindude suukaudse lahusena.
English: Opinion following an Article 350F referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses EMA/106359/2015
Estonian: Arvamus pärast artikli 350F kohast esildist, mis käsitleb gentamütsiini sisaldavaid veterinaarravimeid, mida turustatakse hobuste süstelahustena EMA/106359/2015
English: Therefore, on 6 November 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Estonian: Seetõttu võttis veterinaarravimite komitee 6. novembril 2014 konsensuse alusel vastu positiivse arvamuse, soovitades muuta hobuste süstelahustena turustatavate gentamütsiini sisaldavate veterinaarravimite müügilubade tingimusi.
English: On 14 February 2014, Denmark presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses.
Estonian: Taani tegi 14. veebruaril 2014 Euroopa Ravimiametile direktiivi 2011/82/EÜ artikli 35 kohase esildise gentamütsiini sisaldavate hobustele süstitavate veterinaarravimite kohta.
English: It is also used in human medicine, usually as a solution for injection for intramuscular administration.
Estonian: Gentamütsiini kasutatakse ka inimtervishoius, tavaliselt intramuskulaarse süstelahusena.
English: Opinion following an Article 351 referral for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to horses
Estonian: kohast esildist, mis käsitleb gentamütsiini sisaldavaid veterinaarravimeid, mida turustatakse hobuste süstelahustena
English: Version 10.1, 06/2019
Estonian: Versioon 10.1, 06/2019
English: At the request of the European Medicines Agency;
Estonian: Euroopa Ravimiameti nõudel;
English: < PC {number} [product code]
Estonian: <PC {number} [tootekood]