FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACEUTICAL FORM AND CONTENTS 10 single doses 0.5 ml pre-filled syringes with 2 separate needles (for each syringe) Suspension for injection in pre-filled syringe
Estonian: RAVIMVORM JA PAKENDI SUURUS 10 üheannuselist 0,5 ml süstelit koos 2 eraldi nõelaga (igale süstlale).
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/009
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/009
English: PHARMACEUTICAL FORM AND CONTENTS 10 single doses 0.5 ml pre-filled syringes with attached needle.
Estonian: RAVIMVORM JA PAKENDI SUURUS 10 üheannuselist 0,5 ml nõelaga süstelit.
English: PHARMACEUTICAL FORM AND CONTENTS 1 single dose 0.5 ml pre-filled syringe with 2 separate needles Suspension for injection in pre-filled syringe
Estonian: RAVIMVORM JA PAKENDI SUURUS 1 üheannuseline 0,5 ml süstel koos 2 eraldi nõelaga.
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/006
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/006
English: HEXAVAC - single dose pre-filled syringe with 1 separate needle - Pack of 10
Estonian: HEXAVAC - üheannuseline süstel koos 1 eraldi nõelaga - 10 tk pakendis
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/010
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/010
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) HEXAVAC
English: PHARMACEUTICAL FORM AND CONTENTS 25 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Estonian: RAVIMVORM JA PAKENDI SUURUS 25 üheannuselist 0,5 ml nõelata süstelit Süstesuspensioon süstelis
English: HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 1
Estonian: HEXAVAC - üheannuseline nõelaga süstel - 1 tk pakendis
English: PHARMACEUTICAL FORM AND CONTENTS 50 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Estonian: RAVIMVORM JA PAKENDI SUURUS 50 üheannuselist 0,5 ml nõelata süstelit Süstesuspensioon süstelis
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/005
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/005
English: HEXAVAC - single dose pre-filled syringe without needle - Pack of 25
Estonian: HEXAVAC - üheannuseline nõelata süstel - 25 tk pakendis
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/003
English: HEXAVAC - single dose pre-filled syringe without needle - Pack of 50
Estonian: HEXAVAC - üheannuseline nõelata süstel - 50 tk pakendis
English: HEXAVAC - single dose pre-filled syringe with attached needle - Pack of 10
Estonian: HEXAVAC - üheannuseline nõelaga süstel - 10 tk pakendis
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/004
English: PHARMACEUTICAL FORM AND CONTENTS 10 single doses 0.5 ml pre-filled syringes without needle Suspension for injection in pre-filled syringe
Estonian: RAVIMVORM JA PAKENDI SUURUS 10 üheannuselist 0,5 ml nõelata süstelit Süstesuspensioon süstelis
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/007
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/007
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/002
English: BEFORE YOU USE HEXAVAC
Estonian: 2. MIDA ON VAJA TEADA ENNE HEXAVAC'i KASUTAMIST
English: PHARMACEUTICAL FORM AND CONTENTS 1 single dose 0.5 ml pre-filled syringe with 1 separate needle Suspension for injection in pre-filled syringe
Estonian: RAVIMVORM JA PAKENDI SUURUS 1 üheannuseline 0,5 ml süstel koos 1 eraldi nõelaga.
English: NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS EU/1/00/147/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/00/147/001
English: What measures are being taken to ensure the safe and effective use of Galafold?
Estonian: Mis meetmed võetakse, et tagada Galafoldi ohutu ja efektiivne kasutamine?
English: The recommended dose of Galafold is one capsule every other day, taken by mouth at least 2 hours before or after food.
Estonian: Galafoldi soovitatav annus on üks kapsel ülepäeviti, võetuna suu kaudu vähemalt 2 tundi enne või pärast sööki.
English: A risk management plan has been developed to ensure that Galafold is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Galafoldi võimalikult ohutu kasutamine.
English: Galafold is available as capsules (123 mg).
Estonian: Galafoldi turustatakse kapslitena (123 mg).
English: Galafold migalastat
Estonian: Galafold migalastaat
English: The Committee noted that Galafold was studied in a limited number of patients, however the available evidence is considered sufficient for such a rare disease.
Estonian: Komitee märkis, et Galafoldi on uuritud piiratud arvul patsientidel, kuid olemasolevaid tõendeid peetakse nii haruldase haiguse kohta piisavaks.
English: Galafold has been investigated in two main studies involving a total of 127 patients with Fabry disease.
Estonian: Galafoldi uuriti kahes põhiuuringus, milles osales kokku 127 Fabry tõvega patsienti.
English: The main measure of effectiveness was the change in patients' kidney function after 18 months of treatment.
Estonian: Efektiivsuse põhinäitaja oli patsientide neerufunktsiooni muutus 18kuulise ravi järel.
English: What is Galafold and what is it used for?
Estonian: Mis on Galafold ja milleks seda kasutatakse?
English: The most common side effect with Galafold (which may affect around 1 in 10 people) is headache.
Estonian: Galafoldi kõige sagedam kõrvalnäht (võib esineda kuni 1 patsiendil 10st) on peavalu.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Galafold can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Galafoldi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Galafold's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Galafoldi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Other information about Galafold
Estonian: Muu teave Galafoldi kohta
English: This allows the enzyme to be transported into areas of the cell where it can break down GL-3.
Estonian: See võimaldab ensüümi transportida rakuosadesse, kus see lagundab rasvainet GL-3.
English: The full EPAR for Galafold can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Galafoldi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Galafold.
Estonian: See on ravimi Galafold Euroopa avaliku hindamisaruande kokkuvõte.
English: It is not intended to provide practical advice on how to use Galafold.
Estonian: Hindamisaruandes ei anta Galafoldi kasutamise praktilisi nõuandeid.
English: What are the risks associated with Galafold?
Estonian: Mis riskid Galafoldiga kaasnevad?
English: Regarding safety, Galafold was well-tolerated.
Estonian: Ohutuse poolest talutakse Galafoldi hästi.
English: For the full list of all side effects and restrictions with Galafold, see the package leaflet.
Estonian: Galafoldi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Galafold contains the active substance migalastat.
Estonian: Galafold sisaldab toimeainena migalastaati.
English: The second study, in 60 patients, compared Galafold with the medicines agalsidase alfa or agalsidase beta, two treatments that replace the missing enzyme.
Estonian: Teises uuringus (60 patsienti) võrreldi Galafoldi alfa-agalsidaasi või beeta-agalsidaasiga, mis mõlemad asendavad puuduvat ensüümi.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Galafold, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Galafoldi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Why is Galafold approved?
Estonian: Miks Galafold heaks kiideti?
English: In this study, Galafold was found to be as effective as enzyme replacement in stabilising patients' kidney function.
Estonian: Uuringus leiti, et Galafold on patsientide neerufunktsiooni stabiliseerimisel sama efektiivne kui ensüümasendusravi.
English: The CHMP also noted that Galafold is taken by mouth and this could be an advantage compared with other authorised treatments such as enzyme replacement which are given by infusion (drip) into a vein.
Estonian: Inimravimite komitee märkis ka, et Galafold on suukaudne ravim, mis võib olla eeliseks võrreldes teiste heaks kiidetud ravimeetoditega, näiteks ensüümasendusraviga, mida manustatakse veeniinfusioonina.
English: Because the number of patients with Fabry disease is low, the disease is considered ‘rare' and Galafold was designated an ‘orphan medicine' (a medicine used in rare diseases) on 22 May 2006.
Estonian: Et Fabry tõvega patsientide arv on väike ja see haigus esineb harva, nimetati Galafold 22. mail 2006 harvikravimiks.
English: The active substance in Galafold, migalastat, attaches to certain unstable forms of alpha-galactosidase A, stabilising the enzyme.
Estonian: Galafoldi toimeaine migalastaat seondub ensüümi alfa-galaktosidaas A teatud ebastabiilsete vormidega, stabiliseerides nii ensüümi.
English: For practical information about using Galafold, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Galafoldi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How does Galafold work?
Estonian: Kuidas Galafold toimib?
English: For more information about treatment with Galafold, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Galafoldiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Galafold is only for use in patients with certain mutations in the alpha-galactosidase A gene.
Estonian: Galafold on ette nähtud kasutamiseks ainult alfa-galaktosidaas A geeni teatud mutatsioonidega patsientidel.
English: What benefits of Galafold have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Galafoldi kasulikkus?
English: Galafold is a medicine used to treat patients aged 16 years or over with Fabry disease.
Estonian: Galafoldi kasutatakse vähemalt 16-aasta vanuste Fabry tõvega patsientide ravimiseks.
English: How is Galafold used?
Estonian: Kuidas Galafoldi kasutatakse?
English: Overall, Galafold was not found to be more effective than placebo at reducing GL-3 deposits; however, additional analyses including only patients with those genetic mutations that can be treated with Galafold showed that patients responded better to Galafold than to placebo after 6 months of treatment.
Estonian: Samas tõendasid täiendavad analüüsid ainult patsientidega, kellel olid Galafoldiga ravitavad geenimutatsioonid, et nad reageerisid 6-kuulise ravi järel paremini Galafoldile kui platseebole.
English: As a result, GL-3 cannot be broken down and it builds up in various cells in the body, including in the heart and kidneys.
Estonian: Fabry tõvega patsientidel ei toimi see ensüüm korralikult, mille tõttu GL-3 ei lagune ja see koguneb organismi mitmesugustesse rakkudesse, näiteks südamesse ja neerudesse.
English: The first study, which compared Galafold with placebo (a dummy treatment) in 67 patients, looked at the proportion of patients who responded to treatment (defined as a reduction of at least 50% in GL-3 deposits in the kidneys).
Estonian: Esimeses uuringus (67 patsienti) võrreldi Galafoldi ja platseebot (näiv ravim) ning jälgiti ravivastusega patsientide protsenti.
English: Galafold can only be obtained with a prescription and treatment should only be started and supervised by a doctor who is experienced in the diagnosis and treatment of Fabry disease.
Estonian: Ravi Galafoldiga peab alustama Fabry tõve diagnoosimises ja ravis kogenud arst ning ravi peab toimuma tema järelevalve all.
English: This is a rare inherited disorder where patients have various mutations (changes) in the gene responsible for the production of an enzyme called alpha-galactosidase A, which normally breaks down a fatty substance called globotriaosylceramide (GL-3).
Estonian: Fabry tõbi on haruldane pärilik haigus, mille korral esineb patsientidel mitmesuguseid mutatsioone (muutusi) geenis, mis juhib ensüümi alfa-galaktosidaas A tekkimist.
English: EU Number
Estonian: Müügiloa nr Euroopa Liidus (Väljamõeldud ) nimetus
English: These amendments should be submitted within a Type IB variation.
Estonian: Need muudatused tuleb esitada IB-tüüpi muudatuste raames.
English: The PRAC also recommended that the treatment duration should be as short as possible.
Estonian: Samuti soovitas ravimiohutuse riskihindamise komitee, et ravi kestus peab olema võimalikult lühike.
English: • The Pharmacovigilance Risk Assessment Committee (PRAC) considered the procedure under Article 31 of Directive 2001/83/EC;
Estonian: • ravimiohutuse riskihindamise komitee võttis menetluse aluseks direktiivi 2001/83/EÜ artikli 31;
English: The wording of Section 3 of the Package Leaflet was amended accordingly.
Estonian: Pakendi infolehe lõigu 3 sõnastuses tehti vastavad muudatused.
English: Hydroxyzine hydrochloride is a first generation antihistamine first authorised in the 1950s and available in 24 EEA member states.
Estonian: Hüdroksüsiin vesinikkloriid on esimese põlvkonna antihistamiin, mis kiideti esmalt heaks 1950. aastatel ja mida turustatakse 24 Euroopa Majanduspiirkonna (EMP) liikmesriigis.
English: The Hungarian competent authority considered it to be in the interest of the Union to refer the matter to the Pharmacovigilance Risk Assessment Committee (PRAC) under Article 31 of Directive 2001/83/EC.
Estonian: Ungari pädev asutus leidis, et liidu huvides on teha ravimiohutuse riskihindamise komiteele direktiivi 2001/83/EÜ artikli 31 kohane esildis.
English: Overall conclusion and grounds for the variation to the Marketing Authorisations
Estonian: Üldised järeldused ja müügilubade muutmise alused
English: In the context of the review, the PRAC consulted the EMA Paediatric Committee (PDCO) and the Geriatric Expert Group (GEG).
Estonian: Läbivaatamise raames konsulteeris ravimiohutuse riskihindamise komitee EMA pediaatriakomitee ja geriaatria eksperdirühmaga.
English: The PRAC was requested to review the benefit-risk balance of hydroxyzinecontaining products, in particular giving consideration to their pro-arrhythmogenic potential in all authorised indications and target populations and to give its recommendation on whether any regulatory measures should be taken on the marketing authorisations.
Estonian: Ravimiohutuse riskihindamise komiteel paluti läbi vaadata hüdroksüsiini sisaldavate ravimite kasulikkuse ja riski tasakaal, kaaludes eelkõige nende proarütmilist potentsiaali kõigil heakskiidetud näidustustel ja sihtpopulatsioonides ning teha soovitus, kas müügilubadega seoses tuleb võtta reguleerivaid meetmeid.
English: This is in line with the concept of the repolarisation reserve, which proposes that the concomitant action of multiple factors is required for the exhaustion of the repolarisation reserve, opening the way to the occurrence of cardiac electrophysiological disturbances.
Estonian: See on kooskõlas repolarisatsiooni reservi kontseptsiooniga, mille kohaselt on repolarisatsiooni reservi ärakasutamiseks vajalik mitme teguri samaaegne toime, mis loob võimaluse südame elektrofüsioloogiliste häirete tekkeks.
English: In addition, further changes to the product information were implemented, including a revision of the posology and a warning that use in the elderly is not recommended due to the anticholinergic effects.
Estonian: Lisaks rakendati ravimiteabe lisamuudatusi, sh annustamise läbivaatamine ja hoiatus, et ravimi antikolinergilise toime tõttu ei soovitata seda manustada eakatele.
English: On 7th March 2014, the Hungarian competent authority was informed of new data on the potential risk for developing QT interval prolongation and/or Torsades de Pointes after exposure to hydroxyzine.
Estonian: 7. märtsil 2014 teatati Ungari pädevale asutusele uutest andmetest QT-intervalli pikenemise ja/või torsades de pointes'i tekke potentsiaalse riski kohta pärast kokkupuudet hüdroksüsiiniga.
English: The risk did not differ between indications and no dose effect could be observed based on postmarketing data, despite pre-clinical data suggesting that hydroxyzine has a dose-dependent hERG inhibitory effect.
Estonian: Risk ei erinenud näidustuste lõikes ja turustamisjärgsete andmete põhjal ei täheldatud annuse toimet, hoolimata sellest, et prekliinilised andmed viitasid, et hüdroksüsiinil on annusest sõltuv hERG-kanalit pärssiv toime.
English: For products with a paediatric formulation (syrup or oral solution), consideration should be given to making available an appropriate measuring device.
Estonian: Lastele mõeldud ravimvormiga (siirup või suukaudne lahus) ravimite puhul tuleb kaaluda asjakohase mõõteseadme lisamist.
English: The products are nationally authorised as prescription-only medicines, for use in a number of indications including the treatment of anxiety disorders, skin conditions (such as pruritus, dermatitis or urticaria) for preoperative sedation and for the treatment of sleep disorders.
Estonian: Ravimid on riiklikult heaks kiidetud retseptiravimitena kasutamiseks mitme näidustuse korral, sh ärevushäirete ja nahahaiguste (nt kihelus, dermatiit või urtikaaria) raviks, operatsioonieelseks sedatsiooniks ja unehäirete raviks.
English: The PRAC considered that the efficacy data did not raise any new concerns.
Estonian: Ravimiohutuse riskihindamise komitee leidis, et efektiivsusandmed ei andnud põhjust ettevaatlikkuseks.
English: The PRAC therefore recommended the variation to the terms of the marketing authorisation for the medicinal products referred to in Annex I and for which the relevant sections of the summary of product characteristics and package leaflet are set out in Annex III of the PRAC recommendation.
Estonian: Seetõttu soovitas ravimiohutuse riskihindamise komitee muuta I lisas osutatud ravimite müügiloa tingimusi; ravimi omaduste kokkuvõtte ja pakendi infolehe vastavad lõigud on ravimiohutuse riskihindamise komitee soovituse III lisas.
English: A maximum daily dose of 100 mg was found to be efficacious and well-tolerated and the PRAC therefore recommended restricting the maximum daily dose to 100 mg per day in adults, with corresponding changes in the paediatric and elderly populations, based on pharmacokinetic data.
Estonian: Efektiivseks ja hästi talutavaks peeti maksimaalset ööpäevast annust 100 mg ning seetõttu soovitas ravimiohutuse riskihindamise komitee määrata täiskasvanutele maksimaalseks ööpäevaseks annuseks 100 mg ja teha farmakokineetiliste andmete põhjal vastavad muudatused laste ja eakate kohta.
English: • The PRAC considered that the available efficacy data did not raise any new concerns;
Estonian: • ravimiohutuse riskihindamise komitee leidis, et olemasolevad efektiivsusandmed ei andnud põhjust ettevaatlikkuseks;
English: Based on the available non-clinical data, the PRAC concluded that hydroxyzine has the potential to block hERG channels and other types of cardiac channels, resulting in a potential risk of QT interval prolongation and cardiac arrhythmia events.
Estonian: Olemasolevate mittekliiniliste andmete põhjal järeldas ravimiohutuse riskihindamise komitee, et hüdroksüsiin võib blokeerida hERG-kanalid ja südame muud tüüpi kanalid, mille tulemus on QT-intervalli pikenemise ja südame rütmihäirete potentsiaalne risk.
English: • The PRAC agreed on measures including a revision of the posology, contraindications in patients with a known acquired or congenital QT interval prolongation and patients with a known risk factor to QT interval prolongation, a warning that use in the elderly is not recommended due to the anticholinergic effect and a request to the MAHs to assess the effectiveness of the risk minimisation measures.
Estonian: • ravimiohutuse riskihindamise komitee leppis kokku meetmetes, mille hulka kuuluvad annustamise läbivaatamine, vastunäidustused patsientidel, kellel on teadaolevalt tekkinud või kaasasündinud QT-intervalli pikenemine, ja teadaoleva QT-intervalli pikenemise riskiteguriga patsientidel, hoiatus, et ravimi antikolinergilise toime tõttu ei soovitata seda manustada eakatele, ja nõue, et müügiloa hoidjad hindaksid riskivähendusmeetmete efektiivsust.
English: This potential risk was confirmed by clinical and post-marketing data, which also identified the at-risk population as consisting of patients with risk factors for QT interval prolongation, such as cardiac medical history, concomitant medications associated with QT interval prolongation and electrolyte imbalance.
Estonian: Seda potentsiaalset riski kinnitasid kliinilised ja turustamisjärgsed andmed, mis näitasid ka seda, et riskirühma kuuluvad patsiendid, kellel on QT-intervalli pikenemise riskitegurid, nagu südamehaiguste anamnees, QT-intervalli pikenemisega seotud ravimite samaaegne manustamine ja elektrolüütide tasakaalu häired.
English: Annex II Scientific conclusions and grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommendation
Estonian: II lisa Teaduslikud järeldused ja müügilubade tingimuste muutmise alused ning ravimiohutuse riskihindamise komitee soovitusest lahknemise teaduslike aluste üksikasjalik selgitus
English: The PRAC considered that the potential risk of QT interval prolongation and Torsades de Pointes can be adequately minimised through appropriate risk minimisation measures targeting the identified risk factors and restricting the use of hydroxyzine, in particular in the atrisk populations.
Estonian: Ravimiohutuse riskihindamise komitee oli seisukohal, et QT-intervalli pikenemise ja torsades de pointes'i potentsiaalset riski on võimalik piisavalt vähendada asjakohaste riskivähendusmeetmetega, mis avaldavad mõju tuvastatud riskiteguritele ja piiravad hüdroksüsiini kasutamist, eelkõige riskirühmades.
English: The CMDh amended the product information accordingly, revising the wording of Section 4.2 of the SmPC as follows: “In adults and children over 40 kg in weight, the maximum daily dose is 100 mg per day” and clarifying the wording of the recommendation in children up to 40 kg in weight.
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm tegi ravimiteabes vastavad muudatused, muutes ravimi omaduste kokkuvõtte lõigu 4.2 sõnastust järgmiselt: „Täiskasvanutel ja üle 40 kg kaaluvatel lastel on maksimaalne ööpäevane annus 100 mg”; ja täpsustades kuni 40 kg kaaluvaid lapsi käsitleva soovituse sõnastust.
English: The PRAC also requested the MAHs to circulate a ‘Direct healthcare professional' communication (DHPC), assess the effectiveness of the risk minimisation measures and continue to monitor the risks of QT interval prolongation, Torsades de Pointes, ventricular arrhythmia, sudden death and cardiac arrest.
Estonian: Samuti palus ravimiohutuse riskihindamise komitee müügiloa hoidjatel levitada tervishoiuspetsialistidele mõeldud otseteatist, hinnata riskivähendusmeetmete efektiivsust ja jätkata QT-intervalli pikenemise, torsades de pointes'i, ventrikulaarse arütmia, äkksurma ja südameseiskumise riskide seiret.