FrancophonIA/ELRC3.0 huggingface dataset:
English: The educational material should be agreed with the National Competent Authority and should contain the following:
Estonian: Teabematerjal peab olema riigi pädeva ametiasutusega kooskõlastatud ja sisaldama järgmist:
English: • Enrolment in the PNH and aHUS registries
Estonian: • registreerimine PNH ja aHUS-i registrites
English: • Contact details where a health care practitioner can receive further information
Estonian: • tervishoiutöötaja kontaktandmed lisateabe saamiseks.
English: • The patient safety card and the need to carry it on their person and tell any treating healthcare professional that they are being treated with eculizumab
Estonian: • patsiendi ohutuskaart ja vajadus seda kaasas kanda ja öelda kõikidele tervishoiutöötajatele, et patsient saab ekulisumabravi
English: • Details of the PNH and aHUS registries and how to enter patients
Estonian: • PNH ja aHUS-i registrite ülevaade ja kuidas patsiente neis registreerida.
English: • Patient safety card
Estonian: • patsiendi ohutuskaart.
English: • Patient's/carer's information brochures
Estonian: • patsiendi/hooldaja infobrošüürid
English: The MAH shall agree the details of a controlled drug distribution system and educational material including a patient safety card with each National CompetentAuthority and must implement such programmes nationally to ensure that:
Estonian: Müügiloa hoidja lepib ravimi kontrollitud turustussüsteemi ja teabematerjalide, sealhulgas patsiendi ohutuskaardi üksikasjades kokku iga riigi pädeva ametiasutusega ja rakendab riigis neid programme, et tagada järgmist.
English: All patients being treated with eculizumab receive a patient safety card
Estonian: Kõik ekulisumabiga ravitavad patsiendid saavad patsiendi ohutuskaardi.
English: Breast-feeding should be discontinued during and up to five months after treatment.
Estonian: Imetamine tuleb katkestada ravi ajaks ja kuni viieks kuuks pärast ravi.
English: • The need to explain to and ensure understanding of by patients/carers: o the risks of treatment with eculizumab o the signs and symptoms of sepsis/severe infection and what action to take o the patient's/carer's guides and their contents o the need to carry the patient safety card and to tell any healthcare practitioner that he/she is receiving treatment with eculizumab o the requirement for pre-treatment vaccinations/antibiotic prophylaxis o the enrolment in the registries
Estonian: • vajadus selgitada patsientidele/hooldajatele järgmist ja veenduda, et nad on aru saanud: o ekulisumabraviga kaasnevad riskid o sepsise / raske infektsiooni nähud ja sümptomid ja kuidas nende tekkimisel toimida o patsiendi/hooldaja juhendid ja nende sisu o vajadus kanda kaasas patsiendi ohutuskaarti ja öelda kõikidele tervishoiutöötajatele, et patsient saab ekulisumabravi o ravieelsete vaktsineerimiste / profülaktilise antibiootikumravi nõue o registrites registreerimine
English: • That eculizumab may be teratogenic and the need for effective contraception in women of childbearing potential during and up to five months after treatment, and that breast-feeding should be discontinued during and up to five months after treatment.
Estonian: • et ekulisumab võib olla teratogeenne, ning vajadus kasutada fertiilses eas naistel efektiivseid rasestumisvastaseid vahendeid ravi ajal ja kuni viis kuud pärast ravi, ning et imetamine tuleb katkestada ravi ajaks ja viieks kuuks pärast ravi
English: • The need for patients to be vaccinated against Neisseria meningitidis two weeks prior to receiving eculizumab and/or to receive antibiotic prophylaxis
Estonian: • vajadus vaktsineerida patsiendid Neisseria meningitidis'e vastu ja/või anda profülaktilist antibiootikumravi kaks nädalat enne ekulisumabi saamist
English: • Physician's guides to prescribing
Estonian: • juhised arstile ravimi väljakirjutamiseks
English: • Signs and symptoms of infection and sepsis
Estonian: • infektsiooni ja sepsise nähud ja sümptomid
English: The MAH shall send annually to prescribers and pharmacists who prescribe/dispense eculizumab, a reminder about the need for (re)-vaccination against Neisseria meningitidis for patients on eculizumab.
Estonian: Müügiloa hoidja saadab üks kord aastas ravi määravatele tervishoiutöötajatele ja ravimit väljastavatele apteekritele meeldetuletuse ekulisumabi saavate patsientide Neisseria meningitidis'e vastase (re)vaktsineerimise vajaduse kohta.
English: The patient's/carer's guides should be indication specific and contain the following key messages:
Estonian: Patsiendi/hooldaja juhendid peavad olema esitatud iga näidustuse kohta eraldi ja sisaldama järgmisi põhipunkte:
English: • Summary of product characteristics
Estonian: • ravimi omaduste kokkuvõte
English: • Statement that the patient is receiving eculizumab
Estonian: • märge, et patsient kasutab ekulisumabi
English: The need for effective contraception in women of childbearing potential during and up to five months after treatment.
Estonian: Vajadus kasutada fertiilses eas naistel efektiivseid rasestumisvastaseid vahendeid ravi ajal ja kuni viis kuud pärast ravi.
English: • Treatment with eculizumab increases the risk of severe infection, especially Neisseria meningitidis
Estonian: • ravi ekulisumabiga suurendab raskete, eriti Neisseria meningitidis'est põhjustatud infektsioonide riski
English: The physician's guides to prescribing should be indication specific and contain the following key messages:
Estonian: Juhised arstile ravimi väljakirjutamiseks peavad olema esitatud iga näidustuse kohta eraldi ja sisaldama järgmisi põhipunkte:
English: • Treatment with eculizumab increases the risk of severe infection and sepsis, especially of Neisseria meningitidis
Estonian: • ravi ekulisumabiga suurendab raskete, eriti Neisseria meningitidis'est põhjustatud infektsioonide ja sepsise riski
English: • The risk of infusion reactions including anaphylaxis and advice on post-infusion monitoring
Estonian: • infusiooniga seotud reaktsioonide, sealhulgas anafülaksia tekkimise risk ja nõuanded infusioonijärgseks jälgimiseks
English: • Risk of severe thrombotic microangiopathic complications following eculizumab discontinuation and postponement of administration, its signs, symptoms, monitoring and management (aHUS only)
Estonian: • raskete trombootiliste mikroangiopaatiliste tüsistuste tekkimise risk pärast ekulisumabi kasutamise katkestamist ja manustamise edasilükkamist, selle nähud, sümptomid, jälgimine ja ravi (ainult aHUS-i puhul)
English: • The risk of developing antibodies to eculizumab
Estonian: • ekulisumabivastaste antikehade tekkimise risk
English: • Risk of serious haemolysis following eculizumab discontinuation and postponement of administration, its criteria, the required post-treatment monitoring and its proposed management (PNH only)
Estonian: • tõsise hemolüüsi tekkimise risk pärast ekulisumabi kasutamise katkestamist ning manustamise edasilükkamist, selle kriteeriumid, vajalik ravijärgne jälgimine ja soovitused selle raviks (ainult PNH puhul)
English: • The risk of infusion reactions with eculizumab, including anaphylaxis, and the need for clinical monitoring post-infusion
Estonian: • ekulisumabi infusiooniga seotud reaktsioonide, sealhulgas anafülaksia tekkimise risk ja nõuanded infusioonijärgseks kliiniliseks jälgimiseks
English: • Risk of severe thrombotic microangiopathic complications (in aHUS) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Estonian: • raskete trombootiliste mikroangiopaatiliste tüsistuste tekkimise risk (aHUS-i puhul) pärast ekulisumabravi katkestamist või selle manustamise edasilükkamist, nende nähud ja sümptomid ja soovitus enne ekulisumabravi katkestamist või selle manustamise edasilükkamist pidada nõu ravi määranud tervishoiutöötajaga
English: • The importance of meningococcal vaccination prior to treatment and/or to receive antibiotic prophylaxis
Estonian: • ravieelse meningokokivastase vaktsineerimise ja/või profülaktilise antibiootikumravi nõue
English: • Risk of severe haemolysis (in PNH) following discontinuation/postponement of eculizumab administrations, their signs and symptoms and the recommendation to consult the prescriber before discontinuing/postponing eculizumab administrations
Estonian: • raske hemolüüsi tekkimise risk pärast ekulisumabi kasutamise katkestamist ning manustamise edasilükkamist, selle nähud ja sümptomid ning soovitus enne ekulisumabi kasutamise katkestamist või manustamise edasilükkamist pidada nõu ravi määranud tervishoiutöötajaga
English: 26 April 2012
Estonian: 26. aprill 2012
English: It was to be available as tablets (15, 30 and 45 mg).
Estonian: Ravimit kavatseti turustada tablettidena (15 mg, 30 mg ja 45 mg).
English: The company withdrew before the European Commission had issued a decision on this opinion.
Estonian: Ettevõte võttis taotluse tagasi enne seda, kui Euroopa Komisjon tegi arvamuse kohta otsuse.
English: As a consequence, the blood glucose levels are reduced and this helps to control type 2 diabetes.
Estonian: Selle tulemusel väheneb vere glükoosisisaldus ning see aitab II tüüpi diabeeti reguleerida.
English: What is Pioglitazone ratiopharm?
Estonian: Mis on Pioglitazone ratiopharm?
English: The active substance in Pioglitazone ratiopharm, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Estonian: Ravimi Pioglitazone ratiopharm toimeaine pioglitasoon suurendab rakkude (rasva-, lihas- ja maksarakud) tundlikkust insuliini suhtes, mis tähendab, et organism kasutab paremini enda toodetavat insuliini.
English: On 3 February 2012, ratiopharm GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone ratiopharm, for the treatment of type 2 diabetes.
Estonian: 3. veebruaril 2012 teatas ratiopharm GmbH ametlikult inimravimite komiteele, et soovib tagasi võtta II tüüpi diabeedi raviks ette nähtud ravimi Pioglitazone ratiopharm müügiloa taotluse.
English: Because Pioglitazone ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Estonian: Et Pioglitazone ratiopharm on geneeriline ravim, piirdusid patsiendiuuringud katsetega, milles näidati ravimi bioekvivalentsust võrdlusravimiga Actos.
English: Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone ratiopharm for the treatment of type 2 diabetes.
Estonian: Taotluse tagasivõtmise ajal oli inimravimite komitee andnud seetõttu positiivse arvamuse ning soovitas anda ravimile Pioglitazone ratiopharm II tüüpi diabeedi raviks müügiloa.
English: The CHMP concluded that, in accordance with EU requirements, Pioglitazone ratiopharm had been shown to have comparable quality and to be bioequivalent to Actos.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Pioglitazone ratiopharm võrdväärne kvaliteet ja bioekvivalentsus ravimiga Actos.
English: Pioglitazone ratiopharm is a medicine that contains the active substance pioglitazone.
Estonian: Pioglitazone ratiopharm on ravim, mis sisaldab toimeainena pioglitasooni.
English: This means that Pioglitazone ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
Estonian: See tähendab, et Pioglitazone ratiopharm on sarnane võrdlusravimiga Actos, millel juba on Euroopa Liidus müügiluba.
English: Pioglitazone ratiopharm was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
Estonian: Ravimit Pioglitazone ratiopharm kavatseti kasutada ka koos insuliiniga patsientidel, kellele üksnes insuliini manustamine ei mõju rahuldavalt ja kes ei saa kasutada metformiini.
English: Pioglitazone ratiopharm was developed as a ‘generic medicine'.
Estonian: Pioglitazone ratiopharm töötati välja geneerilise ravimina.
English: Pioglitazone ratiopharm was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Estonian: Ravimit Pioglitazone ratiopharm kavatseti kasutada eelkõige ülekaaluliste täiskasvanud patsientide II tüüpi diabeedi raviks Seda kavatseti kasutada koos dieedi ja füüsilise koormusega.
English: Pioglitazone ratiopharm was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Estonian: Ravimit Pioglitazone ratiopharm kavatseti kasutada ka koos metformiiniga patsientidel, kelle haigus ainult metformiini kasutamisel rahuldavalt ravile ei allu, või koos sulfonüüluurearavimiga (samuti diabeediravim), kui metformiini ei saa kasutada (ravi kahe preparaadiga).
English: How is Pioglitazone ratiopharm expected to work?
Estonian: Milline on ravimi Pioglitazone ratiopharm eeldatav toime?
English: Pioglitazone ratiopharm was also to be used together with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Estonian: Ravimit Pioglitazone ratiopharm kavatseti kasutada koos metformiini ja sulfonüüluurearavimiga patsientidel, kelle haigus ei allu piisavalt suukaudsele ravile kahe preparaadiga (ravi kolme preparaadiga).
English: Pioglitazone ratiopharm was to be used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Estonian: Ravimit Pioglitazone ratiopharm kavatseti kasutada ainsa ravimina patsientidel, kellele ei sobi metformiin (samuti diabeediravim).
English: What was Pioglitazone ratiopharm expected to be used for?
Estonian: Milleks kavatseti ravimit Pioglitazone ratiopharm kasutada?
English: The study lasted for up to 18 months.
Estonian: Uuring kestis kuni 18 kuud.
English: The effect of these antibodies on the safety and effectiveness of Myozyme is not yet clear.
Estonian: Antikehade mõju ravimi ohutusele ja efektiivsusele ei ole veel täiesti selge.
English: Myozyme is given as an infusion of 20 mg per kilogram body weight given once every two weeks.
Estonian: Myozymet manustatakse veeniinfusioonina annuses 20 mg kehakaalu kilogrammi kohta üks kord iga kahe nädala järel.
English: The results were confirmed in the other study, which involved children aged between six months and three and a half years.
Estonian: Tulemusi kinnitas teine uuring, milles osalesid 6 kuu kuni 3,5 aasta vanused lapsed.
English: Myozyme alglucosidase alfa
Estonian: Myozyme alfaalglükosidaas
English: In the first main study, which involved babies less than six months old, all 18 patients treated with Myozyme were alive at 18 months of age, and 15 of these did not need a ventilator to help them breathe.
Estonian: Esimeses põhiuuringus, milles osalesid alla 6 kuu vanused imikud, olid kõik 18 Myozymega ravitud patsienti 18 kuu vanuses elus ja neist 15 suutsid hingata ilma hingamisseadme abita.
English: Almost all of the side effects seen with Myozyme occurred during or just after the infusion and were mild or moderate.
Estonian: Enamik Myozymega kaasnevatest kõrvalnähtudest esinesid infusiooni ajal või vahetult selle järel ning olid nõrgad või mõõdukad.
English: Other information about Myozyme
Estonian: Muu teave Myozyme kohta
English: What measures are being taken to ensure the safe use of Myozyme?
Estonian: Mis meetmeid võetakse, et tagada Myozyme kasutamise ohutus?
English: The infusion should start slowly and then be gradually sped up as long as there are no signs of side effects caused by the infusion.
Estonian: Infusioon peab algama aeglaselt ja seejärel võib infusiooni kiirust vähehaaval suurendada, kui ei esine infusiooniga kaasnevaid kõrvalnähte.
English: The disease can appear at birth (the ‘infantile-onset' form) but also later in life (the ‘late-onset' form).
Estonian: See haigus võib ilmneda kohe pärast sündimist (imikueas ilmnev vorm) või ka hiljem.
English: The CHMP decided that Myozyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Myozyme kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: During the studies in patients with infantile-onset Pompe disease, the most common side effects with Myozyme (seen in more than 1 patient in 10) were tachycardia (rapid heartbeat), flushing (redness), cough, tachypnoea (rapid breathing), vomiting, urticaria (itchy rash), rash, pyrexia (fever) and decreased oxygen saturation (low oxygen levels in the blood).
Estonian: Pompe tõve imikueas algava vormi uuringutel olid Myozyme kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) tahhükardia (südame löögisageduse kiirenemine), õhetus, köha, tahhüpnoe (kiire hingamine), oksendamine, urtikaaria (nõgestõbi), lööve, palavik ja vere hapnikuküllastuse vähenemine (vere väike hapnikusisaldus).
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Myozyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Myozyme kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: The progressive build-up of glycogen causes a wide range of symptoms, including an enlarged heart, breathing difficulties and muscle weakness.
Estonian: Glükogeeni progresseeruv kogunemine põhjustab väga mitmesuguseid sümptomeid, sealhulgas südame laienemist, hingamisraskusi ja lihasnõrkust.
English: In contrast, only one of the 42 patients in the historical comparison group was alive at 18 months of age.
Estonian: Võrdlusrühmas oli 18 kuu vanuses elus seevastu ainult üks patsient 42-st.
English: The full EPAR for Myozyme can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Myozyme kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The company that makes Myozyme is putting a plan in place to ensure that Myozyme is used safely, mainly by monitoring how patients who receive Myozyme develop antibodies, by setting up a register open to all patients with Pompe disease, and by ensuring that doctors know about the reactions that patients may have to the infusion.
Estonian: Myozyme tootja töötab välja ravimi ohutu kasutamise kava, peamiselt jälgides patsiente, kellel tekivad Myozyme suhtes antikehad, koostades Pompe tõvega patsientide registri ja tagades, et arstid teavad võimalikke reaktsioone, mis võivad kaasneda ravimi infusiooniga.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Myozyme to Genzyme Europe B.V. on 29 March 2006.
Estonian: Euroopa Komisjon andis Myozyme müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Genzyme Europe B.V.
English: For more information about treatment with Myozyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Myozymega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: If the enzyme is not present, glycogen builds up in certain tissues, particularly the muscles, including the heart and diaphragm (the main breathing muscle under the lungs).
Estonian: Ensüümi puudumise korral koguneb glükogeen teatud kudedesse, eelkõige südame- ja lihaskoesse (sealhulgas diafragmasse, mis on kopsude all paiknev peamine hingamislihas).
English: The active substance in Myozyme, alglucosidase alfa, is a copy of human alpha-glucosidase, which is produced by a method known as ‘recombinant DNA technology': the enzyme is made by a cell that has received a gene (DNA) that makes it able to produce the enzyme.
Estonian: Myozyme toimeaine alfaalglükosidaas on inimese ensüümi alfaglükosidaasi koopia, mida valmistatakse rekombinant-DNA-tehnika abil: ensüümi toodab rakk, millele on lisatud selle ensüümi teket võimaldav geen (DNA).
English: The main measures of effectiveness were the number of patients who survived and the number who did not need a ventilator to help them breathe.
Estonian: Efektiivsuse põhinäitaja oli ellujäänud patsientide arv ja nende patsientide arv, kes suutsid hingata hingamisseadmeta.
English: This is a summary of the European public assessment report (EPAR) for Myozyme.
Estonian: Käesolev dokument on ravimi Myozyme Euroopa avaliku hindamisaruande kokkuvõte.
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 Myozyme.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Myozyme has been studied in two main studies involving a total of 39 babies and children up to the age of three and a half years with infantile-onset Pompe disease.
Estonian: Myozymet uuriti kahes põhiuuringus, milles osales kokku 39 Pompe tõve imikueas algava vormiga imikut ja kuni 3,5-aastast väikelast.
English: Myozyme must not be used in people who have had a life-threatening anaphylactic (severe allergic) reaction to alglucosidase alfa or any of the other ingredients, which could not be managed by giving the medicine at a slower infusion rate and reduced dose.
Estonian: Myozymet ei tohi kasutada patsiendid, kellel on olnud eluohtlik alfaalglükosidaasi või selle ravimi mis tahes muu koostisaine suhtes anafülaktiline reaktsioon (tugev allergiline reaktsioon), mida ei olnud võimalik ohjeldada ravimit aeglasema infusioonina või väiksemas annuses manustades.
English: Patients who receive Myozyme may develop antibodies (proteins that are produced in response to Myozyme).
Estonian: Myozymet saavatel patsientidel võivad tekkida organismis antikehad (valgud, mis tekivad reaktsioonina Myozymele).
English: Because the number of patients with Pompe disease is low, the disease is considered ‘rare', and Myozyme was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 14 February
Estonian: Et Pompe tõvega patsientide arv on väike ja see haigus esineb harva, nimetati Myozyme 14. veebruaril 2001 harvikravimiks.
English: The replacement enzyme helps to break down glycogen and stops it building up abnormally in the cells.
Estonian: Asendusensüüm aitab lagundada glükogeeni ning peatab selle kogunemise rakkudesse.
English: Myozyme has also been compared with placebo (a dummy treatment) in one main study involving 90 patients with late-onset disease.
Estonian: Myozymet võrreldi ka platseeboga (näiva ravimiga) ühes põhiuuringus, milles osales 90 patsienti, kellel oli haiguse hilise algusega vorm.
English: What is Myozyme?
Estonian: Mis on Myozyme?
English: For the full list of all side effects reported with Myozyme, see the package leaflet.
Estonian: Myozyme kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: This enzyme normally breaks down sugar stored as glycogen into glucose that can be used for energy by the body's cells.
Estonian: Tavaliselt lõhustab see ensüüm organismis glükogeenina (nn loomse tärklisena) sisalduva suhkru glükoosiks, mida saavad organismi rakud energia saamiseks kasutada vahetult.
English: Why has Myozyme been approved?
Estonian: Miks Myozyme heaks kiideti?
English: What is the risk associated with Myozyme?
Estonian: Mis riskid Myozymega kaasnevad?
English: These patients were compared with a ‘historical comparison group' of babies and young children with Pompe disease who had not received treatment and did not take part in the studies.
Estonian: Võrdlusrühmaks olid ülduuringus osalenud imikud ja väikelapsed, kellel oli Pompe tõbi, kuid keda ei ravitud ja kes ei osalenud põhiuuringutes.