FrancophonIA/ELRC3.0 huggingface dataset:
English: Skin and subcutaneous tissue disorders Urticaria, rash, pruritus, erythema Musculoskeletal and connective disorders Arthralgia General disorders and administration site conditions Pyrexia, chest pain
Estonian: Lihas-skeleti ja sidekoe kahjustused artralgia Üldised häired ja manustamiskoha reaktsioonid püreksia, valu rindkeres,
English: • Hives, rash, itching, redness of the skin
Estonian: • nõgestõbi, lööve, kihelus, nahapunetus
English: After dilution
Estonian: Ravimi kasutamine lahjendamisjärgselt
English: • Infusion-site swelling, swelling of the extremities, facial swelling
Estonian: • infusioonikoha turse, jäsemete paistetus, näoturse
English: Sodium
Estonian: Naatrium
English: Patients with renal or hepatic impairment There is no clinical experience in patients with renal or hepatic insufficiency.
Estonian: Neeru- või maksakahjustusega patsiendid Neeru- või maksapuudulikkusega patsientidega kliinilised kogemused puuduvad (vt lõik 5.2).
English: Swollen tongue, dyspepsia
Estonian: Idursulfaas Platseebo
English: Adverse reaction (preferred term)
Estonian: Organsüsteem Kõrvaltoime (eelistermin) Väga sage
English: PC:
Estonian: PC SN NN
English: BACKGROUND INFORMATION
Estonian: KLIINILISED ANDMED
English: 1 Article 29(4) of Directive 2001/83/EC, as amended.
Estonian: Lahkarvamused, mis viisid käesoleva esildise läbivaatamiseni direktiivi 2001/83/EÜ artikli 29 lõike 4 põhjal, olid seotud järgmiste teemadega: 1.
English: European Medicines Agency Evaluation of Medicines for Human Use
Estonian: RAVIMPREPARAADI NIMETUS
English: Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, is an opioid analgesic which is indicated in severe chronic pain which can be adequately managed only with opioid analgesics.
Estonian: Fentanyl-ratiopharmi kasutatakse tugeva ja kauakestva valu puhul, mida saab adekvaatselt ravida ainult tugevate valuvaigistitega.
English: London, 23 October 2007 EMEA/338591/2007
Estonian: Avenida de Burgos 16D, 5º Planta, 28036 Madrid, Hispaania
English: This refers to the extension of the indication to non-cancer patients, the choice of conversion tables, whether contraindication for breastfeeding and for interactions with partial agonist opioids should be given inn the product information and the studies needed to demonstrate bioequivalence with the reference medicinal product.
Estonian: Olemasoleva ühekordse annuse uuringu korratavusuuringu biostatistilist hindamist (mis aga näitas bioekvivalentsuse puudumist) võis pidada sobivaks varieerumise hindamiseks samal isikul ja biofarmatseutilise mõju kindlaksmääramiseks seoses ravimi erinevate vabanemismehhanismidega (depoo- või maatriks-tüüpi).
English: Ratiopharm GmbH submitted applications for mutual recognition of Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, transdermal patch on the basis of the marketing authorisation granted by Germany 04 April 2006.
Estonian: Fentanyl ratiopharm 75 µg/uur, pleister voor transdermaal gebruik Ühendkuningriik Telfanyl 75 microgram/hr Transdermal patch
English: Significant difference has been identified with regard to the proposed indication, posology and contraindications in the product information and the demonstration of bioequivalence and this was considered to be of serious public health concern.
Estonian: Toksilisuse nähtudeks on sügav sedatsioon, ataksia, mioos, krambid ja hingamise pärssimine, mis on juhtivaks sümptomiks.
English: During their July 2007 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for Fentanylratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names, that the objections raised by France should not prevent the granting of a Marketing Authorisation and that the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State should be amended.
Estonian: Seoses ravimi omaduste kokkuvõttes esitatud tabeliga suukaudse morfiini annuse teisendamiseks transdermaalse fentanüüli annuseks on inimtervishoius kasutatavate ravimite komitee kättesaadavate andmete põhjal seisukohal, et ravimi omaduste kokkuvõttes tuleks mainida mõlemaid tabeleid (lõik 4.2): Fentanyl-ratiopharmi praeguses ravimi omaduste kokkuvõttes esitatud konservatiivset teisendamistabelit (150:1) patsiendile, kes vajab opioidi rotatsiooni, ja teisendamistabelit 100:1 (Donneri tabel) patsientidele, kes saavad stabiilset ravi opioididega ning taluvad seda hästi.
English: These Member States were not able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the Reference Member State.
Estonian: Erandi võib teha juhul, kui arst on määranud nimeltFentanyl-ratiopharmi.
English: 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2007 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Estonian: Merckle GmbH Ludwig-Merckle-Str. 3 89143 Blaubeuren Saksamaa
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(4)1 REFERRAL FOR Fentanyl-ratiopharm 25/50/75/100 µg/h Matrixpflaster and associated names International Non-Proprietary Name (INN): fentanyl
Estonian: Fentanilo Matrix ratiopharm 25 microgramos/h parches transdérmicos EFG Prantsusmaa Fentanyl ratiopharm 25 µg/h, dispositif transdermique Holland
English: The list of the product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Estonian: Inimtervishoius kasutatavate ravimite komitee soovitab peale selle lisada ravimi omaduste kokkuvõtte lõiku 4.4 järgmise teabe:
English: The final opinion was converted into a Decision by the European Commission on 23 October 2007.
Estonian: Kõlblikkusaeg viitab kuu viimasele päevale.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Revestive on 30 August 2012.
Estonian: Euroopa Komisjon andis Revestive müügiloa, mis kehtib kogu Euroopa Liidus, 30. augustil 2012.
English: The majority of these reactions were mild or moderate.
Estonian: Enamik reaktsioone olid kerged kuni mõõdukad.
English: If a benefit is not observed, treatment should be stopped.
Estonian: Kui ravi kasulikkust ei täheldata, tuleb ravi lõpetada.
English: What measures are being taken to ensure the safe and effective use of Revestive?
Estonian: Mis meetmed võetakse, et tagada Revestive ohutu ja efektiivne kasutamine?
English: Patients or their carers can inject the medicines once they have received adequate training.
Estonian: Patsiendid või nende hooldajad tohivad süstida ravimit ise, kui nad on saanud vastava väljaõppe.
English: Other information about Revestive
Estonian: Muu teave Revestive kohta
English: Revestive teduglutide
Estonian: Revestive teduglutiid
English: What is Revestive and what is it used for?
Estonian: Mis on Revestive ja milleks seda kasutatakse?
English: Why is Revestive approved?
Estonian: Miks Revestive heaks kiideti?
English: The CHMP therefore concluded that Revestive's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu järeldas inimravimite komitee, et Revestive kasulikkus on suurem kui sellega seotud riskid, ja soovitas anda ravimi müügiloa.
English: The company will provide more data about the medicine's safety from a registry of patients.
Estonian: Ettevõte esitab patsientide registrist pärit täiendavaid andmeid ravimi ohutuse kohta.
English: Revestive must not be used in patients who have, or are suspected to have, cancer.
Estonian: Revestivet ei tohi kasutada patsientidel, kellel on vähk või kellel kahtlustatakse vähki.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Revestive have also been included in the summary of product characteristics and the package leaflet.
Estonian: Revestive ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The most commonly reported side effects with Revestive (which may occur in more than 1 in 10 patients) were respiratory tract infections (infections of the throat, sinuses, airways or lungs), headache, belly ache and swollen stomach, nausea, vomiting, and reddening, pain or swelling at the site of the injection.
Estonian: Revestive kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on hingamisteede infektsioonid (kurgu, nina kõrvalurgete, bronhide või kopsude infektsioonid), peavalu, kõhuvalu, kõhu paisumine, iiveldus, oksendamine ning süstekoha punetus, valu või turse.
English: It is not intended to provide practical advice on how to use Revestive.
Estonian: Hindamisaruandes ei anta Revestive kasutamise praktilisi nõuandeid.
English: Furthermore, Revestive showed an acceptable safety profile.
Estonian: Lisaks nähtus Revestive vastuvõetav ohutusprofiil.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Revestive kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The full EPAR for Revestive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Revestive kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Revestive contains the active substance teduglutide.
Estonian: Revestive sisaldab toimeainena teduglutiidi.
English: It must not be used in patients who have had a gastrointestinal cancer (cancer of the stomach, gut or liver) in the last five years.
Estonian: Samuti ei tohi seda kasutada patsientidel, kellel on viimase viie aasta vältel olnud seedetrakti vähk (mao-, soole- või maksavähk).
English: Teduglutide has the advantage of lasting longer than GLP-2 in the body.
Estonian: Teduglutiidi eeliseks on, et selle toime kestab kauem kui GLP-2 toime.
English: What are the risks associated with Revestive?
Estonian: Mis riskid Revestivega kaasnevad?
English: In one study in adults, 63% (27 out of 43) of those who received Revestive had their parenteral nutrition at 20 weeks reduced by at least a fifth and maintained this reduced intake at 24 weeks.
Estonian: Ühes täiskasvanute uuringus vähenes Revestivet saanud patsientidest 63%-l (27 patsienti 43st) parenteraalse toitelahuse kogus 20. nädalal vähemalt viiendiku võrra ja selline koguse vähenemine püsis 24. nädalal.
English: Patients with short bowel syndrome are usually given nutrients as an infusion directly into their veins (parenteral nutrition).
Estonian: Lühikese soole sündroomiga patsientidele antakse tavaliselt toitaineid infusiooni teel otse veeni (parenteraalne toitelahus).
English: This is a summary of the European public assessment report (EPAR) for Revestive.
Estonian: See on ravimi Revestive Euroopa avaliku hindamisaruande kokkuvõte.
English: In a second study in children, 53% (8 out of 15) of those who received Revestive had their parenteral nutrition at 12 weeks reduced by at least a tenth, while none (0 out of 5) of the patients who received a standard treatment achieved the same.
Estonian: Teises uuringus vähenes Revestivet saanud lastest 53%-l (8 last 15st) parenteraalse toitelahuse kogus 12. nädalal vähemalt kümnendiku võrra; standardravile ei tekkinud ühelgi lapsel ravivastust (0 last 5st).
English: Short bowel syndrome is a condition in which nutrients and fluids are not properly absorbed by the gut, usually because a large part of the intestine has been surgically removed.
Estonian: Lühikese soole sündroom on haigusseisund, mille korral toitained ja vedelik ei imendu soolest piisaval määral enamasti seetõttu, et suur osa soolest on kirurgiliselt eemaldatud.
English: The medicine can only be obtained with a prescription, and treatment should be started under the supervision of a doctor with experience in treating short bowel syndrome.
Estonian: Revestive on retseptiravim ning ravi tohib alustada ainult lühikese soole sündroomi ravikogemustega arsti järelevalve all.
English: Studies show that Revestive is beneficial for patients with short bowel syndrome as it significantly reduces the amount of parenteral nutrition they need.
Estonian: Uuringud näitavad, et Revestive on lühikese soole sündroomiga täiskasvanud patsientidele kasulik, sest see vähendab vajatava parenteraalse toitelahuse kogust olulisel määral.
English: Revestive is a medicine for treating short bowel syndrome (or short gut) in adults and children aged 1 year and above.
Estonian: Revestive on ravim, mida kasutatakse lühikese soole sündroomiga täiskasvanute ja vähemalt 1aastaste laste raviks.
English: How is Revestive used?
Estonian: Kuidas Revestivet kasutatakse?
English: Patients who need high volumes of parenteral nutrition may benefit from a significant reduction, whereas patients in need of low amounts may have the chance to be weaned off completely.
Estonian: Parenteraalse toitelahuse suurt kogust vajavatel patsientidel võib lahuse kogust oluliselt vähendada ning lahuse väikest kogust vajavad patsiendid võivad parenteraalsest toitmisest täielikult vabaneda.
English: For practical information about using Revestive, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Revestive kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For more information about treatment with Revestive, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Revestivega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Teduglutide works in a similar way to GLP-2 and increases intestinal absorption by: increasing blood flow to and from the gut, reducing the speed at which food passes through and reducing acid secretions in the stomach which can interfere with absorption in the intestine.
Estonian: Teduglutiid toimib nagu GLP-2, suurendades toitainete imendumist soolest selle verevarustuse parandamise, soole läbimise aja pikendamise ning maohappe sekretsiooni vähendamise teel, mis kõik mõjutavad toitainete imendumist.
English: How does Revestive work?
Estonian: Kuidas Revestive toimib?
English: Because the number of patients with the condition is low, the disease is considered ‘rare', and Revestive was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 December
Estonian: Et lühikese soole sündroomiga patsientide arv on väike ja see haigus esineb harva, nimetati Revestive 11. detsembril 2001 harvikravimiks.
English: In addition, patients with a stoma (an artificial opening at the front of the abdomen to collect faeces or urine) commonly experienced complications, such as swelling of the stoma.
Estonian: Lisaks esines stoomaga (väljaheite ja uriini kogumiseks kirurgiliselt tehtud ava kõhuseinas) patsientidel tavapäraseid tüsistusi, nt stooma turset.
English: What benefits of Revestive have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Revestive kasulikkus?
English: Revestive is given as an injection under the skin of the abdomen.
Estonian: Revestivet manustatakse süstena kõhunaha alla.
English: Revestive has been shown in 2 studies to reduce the amount of parenteral nutrition that patients need.
Estonian: Revestive kahest uuringust nähtus, et see vähendab patsientidele vajaliku parenteraalse toitelahuse kogust.
English: For the full list of all side effects reported with Revestive, see the package leaflet.
Estonian: Revestive kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The recommended dose is 0.05 mg per kilogram body weight once a day, with the daily dose reduced by half in patients with moderate or severely reduced kidney function.
Estonian: Soovitatav annus on 0,05 mg kehamassi kilogrammi kohta üks kord ööpäevas.
English: The active substance in Revestive, teduglutide, is similar to human glucagon-like peptide 2 (GLP-2), a hormone made in the gut that increases absorption of nutrients from the intestine.
Estonian: Revestive toimeaine teduglutiid sarnaneb inimese glükagoonilaadse peptiid-2ga (GLP-2).
English: This compares with 30% (13 out of 43) of those given placebo (a dummy treatment).
Estonian: Platseeborühmas oli sama näitaja 30% (13 patsienti 43st).
English: The protocol shall be submitted to the National Competent Authorities:
Estonian: Protokoll tuleb esitada liikmesriikide pädevatele asutustele:
English: The educational materials should ensure that healthcare professionals and patients/carers are able to successfully administer the product based on the instructions in the product information.
Estonian: Teabematerjal peab tagama, et tervishoiutöötajad ja patsiendid/hooldajad oskavad ravimiteabe juhiste põhjal ravimit õigesti manustada.
English: The final study report shall be submitted to the National Competent Authorities:
Estonian: Viimane uuringuaruanne tuleb esitada liikmesriikide pädevatele asutustele:
English: Each Marketing Authorisation Holder of adrenaline auto-injectors shall perform a PK/PD study to understand the influence of different factors on distribution, exposure and activity of adrenaline when administered via their adrenaline auto-injector device.
Estonian: Iga adrenaliini automaatsüstalde müügiloa hoidja peab tegema farmakokineetika/farmakodünaamika uuringu, et selgitada eri tegurite mõju adrenaliini jaotumisele ja toimele ning kokkupuutele adrenaliiniga, kui adrenaliini manustatakse tema automaatsüstlaga.
English: The Marketing Authorisation Holders of adrenaline auto-injectors shall submit to the National Competent Authorities a Risk Management Plan containing key elements as described in the CHMP assessment report (including educational materials).
Estonian: Adrenaliini automaatsüstalde müügiloa hoidjad peavad esitama liikmesriikide pädevatele asutustele riskijuhtimiskava, mis sisaldab inimravimite komitee hindamisaruandes kirjeldatud põhielemente (sh teabematerjali).
English: National Competent Authorities of Member States or Reference Member State(s), if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Estonian: Liikmesriikide või, kui asjakohane, viiteliikmesriikide pädevad asutused peavad tagama, et müügiloa hoidjad täidavad järgmised tingimused:
English: Austria and Hungary
Estonian: Austria ja Ungari
English: The responses were submitted to the EMEA on 12 September 2006.
Estonian: Vastused esitati Euroopa Ravimiametile 12. septembril 2006.
English: In these cases take immediate contact to a doctor.
Estonian: Sellistel juhtudel pöörduda viivitamatult arsti poole.
English: Not known.
Estonian: Ei ole teada.
English: Belgium, Czech Republic, Denmark, Spain, Finland, Italy, Luxembourg, The Netherlands, Norway, Poland and Slovakia
Estonian: Belgia, Tšehhi Vabariik, Taani, Hispaania, Soome, Itaalia, Luksemburg, Madalmaad, Norra, Poola ja Slovakkia
English: ATCvet code: QM01AE03
Estonian: ATCvet kood: QM01AE03
English: The reason for this was that the national competent authorities of Belgium and Norway considered that this medicinal product could present a potential serious risk to animal health on the ground that the efficacy has not been sufficiently substantiated in the dossier.
Estonian: Põhjuseks oli, et Belgia ja Norra pädevad riigiasutused olid leidnud, et see ravim võib kätkeda endas tõsist ohtu loomade tervisele, sest selle efektiivsust ei olnud toimikus piisavalt põhjendatud.
English: No such studies have been conducted with cattle.
Estonian: Veistel selliseid uuringuid läbi viidud ei ole.
English: Hands should be washed after the administration of the drug.
Estonian: Pärast ravimi manustamist tuleb käsi pesta.
English: 4..6 Adverse reactions (frequency and seriousness)
Estonian: Kõrvaltoimed (sagedus ja tõsidus)
English: The bioavailability after per-oral dosing is about 76 %.
Estonian: Biosaadavus suukaudse manustamise järgselt on ligikaudu 76 %.
English: The variation between individual cows was 1-3 hours.
Estonian: Loomade vaheline interindividuaalne variaabelsus oli 1…3 tundi.
English: In cases of overdose symptomatic therapy should be given.
Estonian: Üleannustamise korral tuleb rakendada sümptomaatilist ravi.
English: Do not use in animals which have completely lost their appetite because this could lead to insufficient absorption of ketoprofen.
Estonian: Mitte kasutada loomadel, kes on täielikult kaotanud söögiisu, sest see võib tingida ketoprofeeni ebapiisava imendumise.
English: The recommended dose and treatment time must not be exceeded.
Estonian: Soovituslikku annust ja ravi kestvusaega ei tohi ületada.
English: For generic applications bioequivalence must be demonstrated.
Estonian: Tuleb tõestada bioekvivalentsust geneeriliseks kasutamiseks.
English: However, a dose confirmation study, submitted with the response, is considered pivotal for the assessment of the efficacy: “Dose confirmation of oral ketoprofen in endotoxin-induced mastitis in cows, Study 06-131-LC, August 7th, 2006”.
Estonian: Kuid peamiseks efektiivsuse hindamise uuringuks loetakse koos vastusega esitatud annust kinnitavat uuringut „Suukaudse ketoprofeeni annuse kinnitamine lehmadel endotoksiinidest põhjustatud mastiidi ravis, uuring 06-131-LC, 7. august 2006“.
English: Reducing of pyrexia or fever and alleviation of inflammation are considered important clinical claims that should be retained as they have been demonstrated clearly enough.
Estonian: Püreksia ehk palaviku vähendamine ja põletiku leevendamine on käsitatavad tähtsate kliiniliste väidetena, mida tuleb kinnitada, sest neid on piisavalt selgelt demonstreeritud.
English: An anti-oedemic effect is usually evaluated over several days, and an NSAID may be considered limited in its efficacy here.
Estonian: Tursevastast toimet hinnatakse tavaliselt mitme päeva jooksul ja NSAID-i efektiivsust võib siin pidada väheseks.
English: The elimination half life after per oral administration was about 4,5 hours.
Estonian: Eliminatsiooni poolväärtusaeg pärast suukaudset manustamist oli ligikaudu 4,5 tundi.
English: However, given that the pharmacokinetic data allowed to optimise the dose (keeping overall exposure comparable between the two products), it is concluded that a bridge exists that allows wellestablished use to apply to Dolovet.
Estonian: Et aga farmakokineetika andmed võimaldasid annust optimeerida (hoides kahe ravimiga üldise kokkupuute võrreldavana), võib järeldada, et on olemas seos, mis võimaldab väljakujunenud kasutusviisi kohaldada Doloveti puhul.
English: In his response the Marketing Authorisation Holder (MAH)did not develop any further the preclinical argument already presented during the mutual recognition procedure.
Estonian: Müügiloa hoidja ei arendanud oma vastuses edasi vastastikuse tunnustamise menetluses juba esitatud prekliinilist arutelu.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OF RESTRICTIONS REGARDING SUPPLY AND USE
Estonian: MÄRGE „AINULT VETERINAARSEKS KASUTAMISEKS” NING TINGIMUSED VÕI PIIRANGUD TARNIMISE JA KASUTAMISE OSAS, kui need on kohaldatavad
English: Somatic cell counts were affected by the challenge, and few differences exist between the groups.
Estonian: Nakatamine kahjustas somaatiliste rakkude arve ja selles suhtes oli rühmade vahel vähe erinevusi.
English: ANNEX II SCIENTIFIC CONCLUSIONS
Estonian: LISA II TEADUSLIKUD JÄRELDUSED
English: The MAH was also requested to substantiate the bridging of pharmacokinetic studies and dose-confirmation studies data to prove efficacy.
Estonian: Müügiloa hoidjal paluti ka põhjendada farmakokineetika uuringute ja annust kinnitavate uuringute andmete seost efektiivsuse tõestamiseks.