FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Cinryze?
Estonian: Mis meetmed võetakse, et tagada Cinryze ohutu ja efektiivne kasutamine?
English: Two main studies involving children aged 6 to 11 years were also carried out.
Estonian: Kaks põhiuuringut tehti ka lastel vanuses 6-11 aastat.
English: Other information about Cinryze
Estonian: Muu teave Cinryze kohta
English: Supportive data on the effectiveness of Cinryze in children aged 2 to 5 years were also provided.
Estonian: Esitati ka toetavad andmed Cinryze efektiivsuse kohta lastel vanuses 2-5 aastat.
English: Based on the evidence from the studies, the CHMP concluded that Cinryze's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Esitatud uuringuandmete põhjal järeldas inimravimite komitee, et Cinryze kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: What are the risks associated with Cinryze?
Estonian: Mis riskid Cinryzega kaasnevad?
English: This is a summary of the European public assessment report (EPAR) for Cinryze.
Estonian: See on ravimi Cinryze Euroopa avaliku hindamisaruande kokkuvõte.
English: The doctor should review the need for routine prevention on a regular basis and can adjust the frequency of the injections or the dose according to how the patient is responding.
Estonian: Arst peab regulaarselt hindama rutiinse profülaktika vajadust ja tohib patsiendi ravivastuse alusel kohandada süstimise sagedust ja annuse suurust.
English: The patients chosen for the second study were those with frequent attacks, at least two attacks per month on average.
Estonian: Sellesse uuringusse valitud patsientidel esines episoode sageli, keskmiselt vähemalt kaks korda kuus.
English: For more information about treatment with Cinryze, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Cinryzega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: What is Cinryze and what is it used for?
Estonian: Mis on Cinryze ja milleks seda kasutatakse?
English: In addition, the company will maintain a patient registry to provide further data on long-term safety and the way the medicine is used in practice.
Estonian: Lisaks loob tootja patsiendiregistri, et koguda ravimi pikaajalise ohutuse ja praktilise kasutamise kohta lisaandmeid.
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 Cinryze.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Cinryze is used to replace the missing C1 inhibitor, correcting the deficiency and helping to prevent or treat angioedema attacks.
Estonian: Cinryzet kasutatakse puuduva C1-inhibiitori asendamiseks, korrigeerides selle valgu puuduse ja aidates nii ennetada angioödeemiepisoode.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinryze have also been included in the summary of product characteristics and the package leaflet.
Estonian: Cinryze ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Patients with low levels of this protein have excessive activity of these two systems, which leads to the symptoms of angioedema.
Estonian: Patsientidel, kelle veres on C1inhibiitorvalku vähe, on mõlema süsteemi aktiivsus liiga suur, mis põhjustab angioödeemi sümptomite tekke.
English: The second study, involving 24 patients from the first study, looked at the number of attacks over 12week periods when patients were given Cinryze or placebo as prevention.
Estonian: Teises uuringus, milles osales 24 esimese uuringu patsienti, vaadeldi episoodide arvu 12 nädala vältel, kui patsientidele manustati profülaktiliselt Cinryzet või platseebot.
English: Why has Cinryze been approved?
Estonian: Miks Cinryze heaks kiideti?
English: There will also be a training leaflet for patients that should be kept at home.
Estonian: Patsientide teabematerjal sisaldab ka väljaõppe infolehte, mida nad peavad kodus hoidma.
English: Cinryze was effective in preventing attacks triggered by these procedures, with 98% of procedures not triggering an attack within 72 hours.
Estonian: Cinryze oli nende protseduuridega seotud episoodide profülaktikas efektiivne: 98% juhtudest ei täheldatud ravimi kasutamisel 72 tunni vältel turseepisoodi.
English: All the patients were given Cinryze and started having improvements 4 hours into treatment.
Estonian: Kõigile patsientidele manustati Cinryzet ja paranemist täheldati 4 tunni möödudes pärast ravi algust.
English: The only common side effect seen in studies with Cinryze (seen in between 1 and 10 patients in 100) is rash, which is not serious and typically involves the arms, chest, abdomen or the injection site.
Estonian: Uuringutes täheldatud Cinryze ainus sage kõrvalnäht (esinenud 1-10 patsiendil 100st) oli lööve, mis ei olnud raske ja tekkis enamasti käsivartel, rindkerel, kõhul või süstekohas.
English: Cinryze is also used for routine prevention in adults, adolescents and children from 6 years of age who have severe and frequent angioedema attacks for which prevention with oral medicines is not adequate or in patients whose attacks are not adequately treated.
Estonian: Samuti kasutatakse Cinryzet tavaprofülaktikaks täiskasvanutel, noorukitel ja vähemalt 6aastastel lastel, kellel esinevad rasked ja sagedad angioödeemiepisoodid, mida suukaudsete ravimitega ei saa piisavalt ennetada, ja patsientidel, kelle episoode ei ole piisavalt ravitud.
English: The main measure of effectiveness in this study was how long it took for the symptoms to start improving.
Estonian: Efektiivsuse põhinäitaja oli aeg sümptomite leevenemise alguseni.
English: How does Cinryze work?
Estonian: Kuidas Cinryze toimib?
English: The company that makes Cinryze will ensure that healthcare professionals in all Member States who are expected to prescribe Cinryze are provided with an educational pack instructing them to ensure that caregivers and patients who will give the medicine at home are properly trained.
Estonian: Cinryze tootja varustab kõigis liikmesriikides ravimit määravad arstid teabepakmega, milles rõhutatakse, et ravimit kodus manustavad patsiendid ja hooldajad peavad saama asjakohase väljaõppe.
English: Over 50% of patients receiving Cinryze had started having improvements 2 hours into treatment, compared with 33% of patients given placebo.
Estonian: Paranemist täheldati 2 tunni möödudes pärast ravi alustamist Cinryze patsiendirühmas enam kui 50%-l, platseeborühmas aga 33%-l patsientidest.
English: The average number of attacks experienced in patients treated with Cinryze was 6.1 over the 12-week period compared with 12.7 for patients on placebo.
Estonian: Keskmine episoodide arv 12 nädala jooksul oli Cinryzega ravitud patsientidel 6,1 ja platseebot saanud patsientidel 12,7.
English: In children from 6 to 11 years of age the dose is reduced to 500 Units.
Estonian: Lastele vanuses 6-11 aastat manustatakse vähendatud annus 500 ühikut.
English: In the first study, Cinryze or placebo (a dummy treatment) were used to treat angioedema attacks in 71 patients.
Estonian: Esimeses uuringus kasutati Cinryzet või platseebot (näivat ravimit) angioödeemiepisoodide raviks 71 patsiendil.
English: The active substance in Cinryze, human C1 inhibitor, is a protein extracted from human blood.
Estonian: Cinryze toimeaine, inimese C1-inhibiitor, on inimverest eraldatud valk.
English: The average number of attacks during 12 weeks of treatment with Cinryze was reduced compared with the period before Cinryze and the attacks were less severe, did not last as long and required less treatment.
Estonian: Võrreldes ravieelse ajaga vähenes episoodide keskmine arv 12nädalase Cinryze ravi vältel ja episoodid olid kergemad, nende kestus ja ravivajadus vähenes.
English: How is Cinryze used?
Estonian: Kuidas Cinryzet kasutatakse?
English: Patients with hereditary angioedema have attacks of swelling that can occur anywhere in the body, such as in the face or limbs, or around the gut, causing discomfort and pain.
Estonian: Päriliku angioödeemiga patsientidel võivad ebamugavust ja valu tekitavaid turseepisoode esineda kõikjal organismis: näol, jäsemetel, soole ümbruses.
English: Treatment should be started under the supervision of a doctor experienced in treating hereditary angioedema.
Estonian: Ravi tohib alustada üksnes päriliku angioödeemi ravis kogenud arsti järelevalve all.
English: Cinryze is a medicine used to treat angioedema (swelling) attacks in adults, adolescents and children over 2 years with hereditary angioedema.
Estonian: Cinryzet kasutatakse angioödeemi (turse) episoodide raviks päriliku angioödeemiga täiskasvanutel, noorukitel ja üle 2aastastel lastel.
English: Cinryze contains the active substance C1 inhibitor (human).
Estonian: Cinryze sisaldab toimeainena inimese C1-inhibiitorit.
English: The company provided data on the use of Cinryze in 91 adults and children with hereditary angioedema to prevent attacks when undergoing a medical, surgical or dental procedure.
Estonian: Ettevõte esitas samuti andmed 91 päriliku angioödeemiga täiskasvanu ja lapse kohta, kellel Cinryzet kasutati meditsiiniliste, kirurgiliste või hambaravi protseduuridega seotud episoodide profülaktikaks.
English: The C1 inhibitor protein is required to control the ‘complement' and ‘contact' systems, collections of proteins in the blood that fight against infection and cause inflammation.
Estonian: C1-inhibiitorvalk juhib organismis komplemendi- ja kontaktisüsteeme (veres esinevad infektsioonivastased ja põletikku tekitavad valgukogumid).
English: Cinryze can only be obtained with a prescription.
Estonian: Cinryze on retseptiravim.
English: For treatment of angioedema attacks in adults, adolescents and children over 2 years and weighing more than 25 kg, the patient is given 1,000 Units at the first sign of an angioedema attack.
Estonian: Täiskasvanutele, noorukitele ja üle 2aastastele lastele (kehakaaluga üle 25 kg) manustatakse angioödeemiepisoodi raviks episoodi esimeste tunnuste ilmnemisel 1000 ühikut.
English: For prevention before a medical, dental or surgical procedure in adults, adolescents and children over 2 years and weighing more than 25 kg, Cinryze is given as 1,000 Units within the 24 hours before the procedure.
Estonian: Meditsiiniliste, hambaravi või kirurgiliste protseduuride ajal tekkivate angioödeemiepisoodide profülaktikaks manustatakse Cinryzet täiskasvanutele, noorukitele ja üle 2aastastele lastele (kehakaaluga üle 25 kg) 1000 ühikut 24 tundi enne protseduuri.
English: For the full list of all side effects and restrictions with Cinryze, see the package leaflet.
Estonian: Cinryze kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: C1 inhibitor (human)
Estonian: Cinryze inimese C1-inhibiitor
English: What benefits of Cinryze have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Cinryze kasulikkus?
English: It is also used to prevent angioedema attacks that can be triggered by medical, dental or surgical procedures.
Estonian: Cinryzet kasutatakse ka meditsiiniliste, hambaravi või kirurgiliste protseduuride ajal tekkivate angioödeemiepisoodide profülaktikaks.
English: In the first study, Cinryze was used to treat angioedema attacks in 9 children with hereditary angioedema.
Estonian: Esimeses uuringus kasutati Cinryzet angioödeemiepisoodide raviks 9-l päriliku angioödeemiga lapsel.
English: The doctor may decide that the caregivers and patients can carry out the injection provided that they have been adequately trained.
Estonian: Arst võib otsustada, et pärast vastava väljaõppe saamist tohib ravimit süstida patsient ise või tema hooldaja.
English: Cinryze is available as a powder and solvent that are made up into a solution for injection into a vein.
Estonian: Cinryzet turustatakse infusioonilahuse (veeni tilgutatava lahuse) pulbri ja lahustina.
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg.
Estonian: Lastele vanuses 2-11 aastat ja kehakaaluga 10-25 kg manustatakse vähendatud annus 500 ühikut.
English: In the second study, Cinryze was given as prevention to 6 children with hereditary angioedema.
Estonian: Teises uuringus manustati Cinryzet profülaktikaravimina 6-le päriliku angioödeemiga lapsele.
English: A second dose of 1,000 Units may be given if the patient has not responded adequately after one hour, or sooner for attacks in the larynx (voice box) or if the start of the treatment had been delayed.
Estonian: Tunni aja pärast, või kõriturse või hilinenud ravi korral ka varem, tohib manustada teise 1000-ühikulise annuse, kui patsient ei ole esimesele annusele piisavalt reageerinud.
English: Cinryze was more effective than placebo in treating and preventing attacks of angioedema in two main studies involving patients with hereditary angioedema, most of whom were adults.
Estonian: Kahes põhiuuringus, milles osalesid peamiselt täiskasvanud päriliku angioödeemiga patsiendid, oli Cinryze angioödeemiepisoodide ravis ja ennetuses platseebost efektiivsem.
English: The dose is reduced to 500 Units in children aged 2 to 11 years weighing 10 to 25 kg. For routine prevention in adults and adolescents, Cinryze is given as 1,000 Units every 3 or 4 days.
Estonian: Rutiinseks profülaktikaks täiskasvanutel ja noorukitel manustatakse Cinryzet iga 3 kuni 4 päeva järel annuses 1000 ühikut.
English: Therefore, this wording may not necessarily represent the current text.
Estonian: Seega ei pruugi käesolev sõnastus tingimata kajastada praegust teksti.
English: Use in children and adolescents under 18 years of age
Estonian: Kasutamine lastel ja alla 18aastastel noorukitel
English: Following the review of the data available to the national competent authorities, the European Commission triggered an article 31 of Directive 2001/83/EC, as amended, on 17 December 2004.
Estonian: Pärast siseriiklikele pädevatele asutustele kättesaadavate andmete kontrollimist algatas Euroopa Komisjon direktiivi 2001/83/EÜ, viimati muudetud 17. detsembril 2004. aastal, artikli 31 kohase menetluse.
English: If your doctor has prescribed [Invented Name] for a patient under 18 and you want to discuss this, please go back to your doctor.
Estonian: Kui teie arst on [Ravimi nimetus, osastavas käändes] välja kirjutanud alla 18aastasele isikule ning te soovite seetõttu konsultatsiooni, pöörduge uuesti oma arsti poole.
English: As with other psychotropic medication, the possibility of rare, serious psychiatric adverse effects cannot be excluded.
Estonian: Sarnaselt teiste psühhotroopsete ravimite kasutamisega ei saa välistada harvaesinevate või raskete psühhiaatriliste kõrvaltoimete teket.
English: In addition there were some trials with patients suffering from Attention Deficit/Hyperactivity Disorder (ADHD).
Estonian: Lisaks olid mõned uuringud teostatud patsientidel, kes kannatasid tähelepanu defitsiidi ja hüperaktiivsuse sündroomi (ADHD) all.
English: Lithuania Latvian JSC Grindeks, Krustpils ul.
Estonian: Latvian JSC Grindeks, Krustpils ul.
English: Luxembourg Chemische Tempelhof GMBH, Lengedestr.
Estonian: Luksemburg Chemische Tempelhof GMBH, Lengedestr.
English: N.V. Organon Molenstraat 110.
Estonian: Organon Molenstraat 110.
English: You should inform your doctor if any of the symptoms listed above develop or worsen after treatment has begun.
Estonian: Informeerige oma arsti, kui mõni ülalloetletud kõrvaltoimetest tekib või süveneb pärast ravi alustamist.
English: Qualimed 34 rue saint Romain
Estonian: Prantsusmaa Qualimed 34 rue saint Romain
English: KIRON PHARMACEUTICA Groesbeekseweg 11
Estonian: Prantsusmaa KIRON PHARMACEUTICA Groesbeekseweg 11
English: With the preliminary review of the data available to the national competent authorities the CHMP concluded that there were grounds for concerns about increased suicide-related behaviours in paediatric populations.
Estonian: Siseriiklikele pädevatele asutustele kättesaadavate andmete esmase analüüsi põhjal otsustas CHMP, et on alust muretseda suitsiidikäitumise sagenemise pärast pediaatrilistes patsiendigruppides.
English: The EC requested the CHMP to give its opinion on whether the marketing authorisation for medicinal products containing the above mentioned active substances should be maintained, varied, suspended or withdrawn.
Estonian: Euroopa Komisjon palus CHMP-l avaldada oma arvamust selle kohta, kas ülalloetletud toimeaineid sisaldavate ravimite müügiload tuleks senisel kujul säilitada, muuta, ajutiselt peatada või tühistada.
English: TEVA PHARMA 1 COURS DU TRIANGLE Le palatin 1
Estonian: Prantsusmaa TEVA PHARMA 1 COURS DU TRIANGLE Le palatin 1
English: SSRIs are described as 'selective' because they affect only the reuptake pumps responsible for serotonin.
Estonian: SSTIsid kirjeldatakse kui selektiivseid preparaate seetõttu, et nad mõjustavad ainult serotoniini tagasihaarde eest vastutavaid ioonipumpasid.
English: The data reviewed included short-term placebo controlled randomised clinical trials submitted to the competent authorities, randomised clinical trials published in the medical literature, observational studies and ecological studies.
Estonian: Analüüsitud andmete hulka kuulusid pädevatele asutustele esitatud lühiajaliste platseebokontrollitud randomiseeritud kliiniliste katsete, meditsiinikirjanduses avaldatud randomiseeritud kliiniliste katsete, vaatluste ja ökoloogiliste uuringute tulemused.
English: TEVA Classics le palatin1 1, cours du triangle
Estonian: Prantsusmaa TEVA Classics le palatin1 1, cours du triangle
English: Usine Saint Charles 60590 Eragny sur Epte - France
Estonian: Prantsusmaa DISTRIRETI Usine Saint Charles 60590 Eragny sur Epte - France
English: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D. De Luxembourg
Estonian: PHARMACIA ENTERPRISES S.A.6 Circuit de la Foire Internationale L-1347 Luxembourg G.D.
English: This signal was present in all products for which studies were available, and from the available evidence it could not be excluded that this signal would be class related.
Estonian: Suund antud käitumise sagenemisele ilmnes kõigis preparaatide kohta saadavalolevates uuringutes, ning seetõttu ei saa olemasoleva tõendusmaterjali põhjal välistada, et tegemist ei ole ravimklassiga seotud kõrvaltoimega.
English: Solvay Pharma 42 rue Rouget de lisle BP 22
Estonian: Prantsusmaa Solvay Pharma 42 rue Rouget de lisle BP 22
English: Note: This section of the Summary of Product Characteristics is the one that was Annexed to the Commission Decision on this Article 31 referral .
Estonian: Märkus: See toote omaduste kokkuvõtte lõik moodustas vastavalt artiklile 31 esildise kohta tehtud komisjoni otsuse lisa.
English: Note: This section of the Package Leaflet is the one that was Annexed to the Commission Decision on this Article 31 referral .
Estonian: Märkus: See pakendi infolehe lõik moodustas vastavalt artiklile 31 esildise kohta tehtud komisjoni otsuse lisa.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLETS PRESENTED BY THE EMEA
Estonian: II LISA EMEA POOLT ESITATUDTEADUSLIKUD JÄRELDUSED NING RAVIMI OMADUSTE KOKKUVÕTTE JA PAKENDI INFOLEHE MUUTMISE ALUSED
English: The CHMP has recommended the maintenance of the Marketing Authorisations for the medicinal products referred to in Annex I for which the amendments to the relevant sections of the Summary of Product Characteristics and Package Leaflets are set out respectively in Annexes III and IV.
Estonian: soovitab CHMP jätta müügiluba alles I lisas viidatud ravimitele, mille ravimi omaduste kokkuvõtte ning pakendi infolehtede vastavatesse osadesse on sisse viidud III ja IV lisas kirjeldatud parandused.
English: Wyeth pharmaceuticals France Coeur Defense - Tour A La Defense 4
Estonian: Prantsusmaa Wyeth pharmaceuticals France Coeur Defense - Tour A
English: ORGANON ESPAÑOLA, S.A., Ctra.
Estonian: Hispaania ORGANON ESPAÑOLA, S.A., Ctra.
English: Belgium LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
Estonian: LAGEPHA S.A. Avenue Mercator 1 1300 Wavre, Belgium
English: 23 -25 Avenue du Docteur Lannelongue
Estonian: Prantsusmaa BERAL 23 -25 Avenue du Docteur Lannelongue
English: In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.
Estonian: Lisaks ei ole küllaldaselt ohutusalast teavet ravimi kasutamise pikaajalise mõju kohta laste ja noorukite kasvamisele, küpsemisele ja kognitiivsele ning käitumuslikule arengule.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Estonian: Kui kliiniline seisund siiski nõuab ravi alustamist, tuleb patsienti suitsidaalse käitumise sümptomite tekke osas hoolikalt jälgida.
English: Belgium 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
Estonian: 3 DDD PHARMA Diestersteenweg 349, 3510 Kermt, Belgium
English: Netherlands Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
Estonian: Fidia Farmaceutici S.p.A., Via Ponte della Fabbrica, 3/a, I-35031 Albano Terme - Padova
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS
Estonian: RAVIMI OMADUSTE KOKKUVÕTTE MUUTMISE ALUSED
English: Molteni Farmaceutici S.p.A. Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
Estonian: Strada Statale, 76 Loc. Granatieri 50018 Scandicci - Firenze Italy
English: Denmark PSI NV, Kraanlei 27, B-9000 Gent, Belgium
Estonian: PSI NV, Kraanlei 27, B-9000 Gent, Belgium
English: Only some of these products are authorised for the treatment of children and adolescents with obsessive-compulsive disorder and only one of them for the treatment of Attention Deficit/Hyperactivity Disorder.
Estonian: Ainult paari neist võib kasutada laste ja noorukite obsessiiv-kompulsiivse häire raviks ning ühte preparaati tähelepanu defitsiidi ja hüperaktiivsuse sündroomi korral.
English: Synthon Bv Microweg 22
Estonian: Prantsusmaa Synthon Bv Microweg 22
English: ANNEX I LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Estonian: LISA 1 RAVIMITE NIMETUSTE, RAVIMVORMIDE, TUGEVUSTE, MANUSTAMISVIISIDE JA MÜÜGILOA HOIDJATE NIMEKIRI LIIKMESRIIKIDES
English: Luxembourg S.M.B.
Estonian: Luksemburg S.M.B.
English: Netherlands Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
Estonian: Eurobase B.V., Mercuriusweg 8 - 10, NL-3771 NC Barneveld
English: Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
Estonian: Ühendkuningriik Dr Reddy's Laboratories (UK) Limited; 208-214 York Road, London SW11 3SD; UK
English: [Invented Name] should not be used in the treatment of children and adolescents under the age of 18 years <, except for patients with [approved indication]>.
Estonian: [Ravimi nimetus, osastavas käändes] ei tohi kasutada laste ja alla 18aastaste noorukite ravimisel, < välja arvatud [heakskiidetud näidustustega] patsientidel]>.
English: Examination of suicide-related behaviours indicated that no completed suicide was reported in any of the reviewed studies.
Estonian: Suitsiidikäitumise uurimine näitas, et lõpuleviidud enesetapukatseid ei esinenud mitte ainsaski analüüsitud kliinilises katses.
English: Patients beginning treatment for ADHD should be carefully monitored for the appearance or worsening of hostility and emotional lability.
Estonian: Tähelepanu defitsiidi ja hüperaktiivsuse häire tõttu ravi alustanud patsiente tuleb hoolikalt jälgida vaenuliku käitumise tekke või süvenemise ja emotsionaalse labiilsuse kujunemise osas.