FrancophonIA/ELRC3.0 huggingface dataset:
English: Side effects reported with Lorviqua are carefully evaluated and any necessary action taken to protect patients.
Estonian: Lorviqua kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lorviqua have been included in the summary of product characteristics and the package leaflet.
Estonian: Lorviqua ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: There is more evidence to come about the medicine, which the company is required to provide.
Estonian: See tähendab, et ettevõte peab esitama ravimi kohta veel andmeid.
English: For more information about using Lorviqua, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Lorviqua kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Other information about Lorviqua
Estonian: Muu teave Lorviqua kohta
English: Lorviqua received a conditional marketing authorisation valid throughout the EU on 6 May 2019 Further information on Lorviqua can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Lorviqua.
Estonian: Lisateave Lorviqua kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Lorviqua.
English: Treatment with Lorviqua should be started and supervised by a doctor who is experienced in using cancer medicines.
Estonian: Ravi Lorviquaga peab alustama ja jälgima vähiravimite kasutamises kogenud arst.
English: Lorviqua has been given ‘conditional authorisation'.
Estonian: Lorviqua on saanud müügiloa tingimusliku heakskiidu alusel.
English: What information is still awaited for Lorviqua?
Estonian: Mis teavet Lorviqua kohta veel oodatakse?
English: What are the risks associated with Lorviqua?
Estonian: Mis riskid Lorviquaga kaasnevad?
English: Since Lorviqua has been given conditional authorisation, the company that markets Lorviqua will conduct a study with the medicine in patients whose disease has worsened after treatment with alectinib or ceritinib.
Estonian: Et Lorviqua on saanud müügiloa tingimusliku heakskiidu alusel, teeb Lorviqua turustaja ravimiuuringu patsientidel, kellel haigus on süvenenud pärast ravi alektiniibi või tseritiniibiga.
English: For the full list of side effects and restrictions with Lorviqua, see the package leaflet.
Estonian: Lorviqua kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Lorviqua contains the active substance lorlatinib.
Estonian: Lorviqua sisaldab toimeainena lorlatiniibi.
English: In addition, the company will provide the results of an ongoing study comparing Lorviqua with crizotinib in patients with ALK-positive NSCLC who have not been treated before.
Estonian: Lisaks esitab turustaja tulemused toimuvast uuringust, milles võrreldakse Lorviquat krisotiniibiga ALK-positiivsete mitteväikerakk-kopsuvähiga patsientidel, kes ei ole varem ravi saanud.
English: Genetic defects affecting ALK (‘ALK-positive' status) should be confirmed in advance.
Estonian: Eelnevalt peab olema kinnitatud ALK-d mõjutavate geenidefektide esinemine (ALKpositiivsus).
English: How is Lorviqua used?
Estonian: Kuidas Lorviquat kasutatakse?
English: Lorviqua is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC), when the disease is advanced and ‘ALK-positive', which means that the cancer cells have certain changes affecting the gene responsible for a protein called ALK (anaplastic lymphoma kinase).
Estonian: Lorviqua on vähiravim, mida kasutatakse täiskasvanutel mitteväikerakk-kopsuvähi raviks, kui haigus on kaugelearenenud ja ALK-positiivne, mis tähendab, et vähirakkudes on teatud muutused, mis mõjutavad anaplastilise lümfoomi kinaasi (ALK) valku kodeerivat geeni.
English: Response to treatment was assessed using body scans and standardised criteria for assessing solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Estonian: Ravivastust hinnati tomograafiauuringute ja soliidtuumorite standardkriteeriumide alusel ning ravivastus oli täielik, kui patsiendil ei esinenud enam ühtki vähinähtu.
English: Lorviqua was also effective when the cancer had spread to the brain.
Estonian: Samuti oli Lorviqua efektiivne, kui olid tekkinud ajusiirded (vähk oli levinud ajju).
English: The active substance in Lorviqua, lorlatinib, is a tyrosine kinase inhibitor.
Estonian: Lorviqua toimeaine lorlatiniib on türosiinikinaasi inhibiitor.
English: Lorviqua is used on its own when the disease has worsened despite treatment with other medicines of the same class known as ALK tyrosine kinase inhibitors (TKIs), including alectinib, ceritinib and crizotinib.
Estonian: Ravimit Lorviqua kasutatakse ainuravimina, kui haigus on süvenenud vaatamata ravile muude sama klassi ravimitega, mida nimetatakse ALK-türosiinikinaasi inhibiitoriteks (TKI), sealhulgas alektiniibi, tseritiniibi ja krisotiniibiga.
English: In patients with ‘ALK-positive' NSCLC, an abnormal form of ALK is produced that causes the cancer cells to divide and grow in an uncontrolled fashion.
Estonian: ALK-positiivse mitteväikerakk-kopsuvähiga patsientidel tekib organismis ALK ebanormaalne vorm, mis stimuleerib vähirakkude kontrollimatut jagunemist ja kasvu.
English: How does Lorviqua work?
Estonian: Kuidas Lorviqua toimib?
English: Lorviqua was effective at treating ALK-positive NSCLC in one main study which included 139 patients whose disease had worsened despite treatment with either alectinib or ceritinib or with crizotinib and another ALK tyrosine kinase inhibitor.
Estonian: Lorviqua oli efektiivne ALK-positiivse mitteväikerakk-kopsuvähiga patsientide ravis põhiuuringus, milles osales 139 patsienti, kellel haigus oli süvenenud vaatamata ravile alektiniibi või tseritiniibi või krisotiniibi ja muu ALK-türosiinikinaasi inhibiitoriga.
English: Treatment may be stopped altogether if the patient develops severe side effects.
Estonian: Kui patsiendil tekib raskeid kõrvalnähte, võib ravi täiesti lõpetada.
English: Lorviqua was also effective against cancer that had spread to the brain.
Estonian: Samuti oli Lorviqua efektiivne ajusiiretega vähi vastu.
English: Depending on which previous treatment the patients had received, around 67% and 52% of patients treated with Lorviqua had no signs of cancer in the brain or the signs of cancer had reduced.
Estonian: Olenevalt patsiendi varem kasutatud ravist, oli Lorviquaga ravitud patsientide seas patsiente, kellel ei olnud ajus vähileidu või see oli vähenenud, ligikaudu 67% ja 52%.
English: Around 43% of patients who had been previously treated with alectinib or ceritinib were considered by their doctors to have had a complete or partial response to the medicine.
Estonian: Varem alektiniibi või tseritiniibiga ravitud patsientide seas oli patsiente, kellel nende arstide arvates tekkis täielik või osaline ravivastus, ligikaudu 43%.
English: What benefits of Lorviqua have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Lorviqua kasulikkus?
English: An overview of Lorviqua and why it is authorised in the EU
Estonian: Ülevaade ravimist Lorviqua ja ELis müügiloa väljastamise põhjendus
English: Out of patients who had been previously treated with crizotinib and another ALK tyrosine kinase inhibitor, around 40% had a complete or partial response to the medicine.
Estonian: Varem krisotiniibi ja muu ALK-türosiinikinaasi inhibiitoriga ravitud patsientide seas oli patsiente, kellel tekkis täielik või osaline ravivastus, ligikaudu 40%.
English: Very few other treatments are available for patients after ALK tyrosine kinase inhibitors have failed or for those whose cancer has spread to the brain, and the side effects with Lorviqua are manageable.
Estonian: Patsientidel, kellel ravi ALK-türosiinikinaasi inhibiitoritega ei ole toiminud või kellel vähk on levinud ajju, on väga vähe muid ravivõimalusi ning Lorviqua kõrvalnähud on hallatavad.
English: Lorviqua is effective at treating ALK-positive NSCLC that has worsened despite treatment with other ALK tyrosine kinase inhibitors.
Estonian: Lorviqua on efektiivne ALK-positiivse mitteväikerakk-kopsuvähi ravis, kui haigus on süvenenud vaatamata ravile muude ALK-türosiinikinaasi inhibiitoritega.
English: ALK belongs to a family of enzymes called receptor tyrosine kinases, which are involved in the growth of cells and the development of new blood vessels that supply them.
Estonian: See osaleb rakkude kasvus ja neid varustavate uute veresoonte tekkes.
English: Lorviqua can only be obtained with a prescription.
Estonian: Lorviqua on retseptiravim.
English: Pack size blister (PA/Alu/PVC/Alu)
Estonian: Sisepakendi iseloomustus blister (PA/Alu/PVC/Alu) HDPE pudel
English: 224 (4 x 56) capsules
Estonian: 224 (4 x 56) Kapslid 240 Kapslid
English: HDPE bottle
Estonian: Alecensa Alecensa
English: Ref.: EMEA/711149/2009 EMEA/H/C/219
Estonian: Viide: EMEA/703038/2009 EMEA/H/C/219
English: Doc.
Estonian: Ammonaps
English: In contrast, untreated newborns usually die within the first year of life.
Estonian: Seevastu ravimata vastsündinud surevad tavaliselt esimesel eluaastal.
English: The marketing authorisation holder is Swedish Orphan International AB.
Estonian: Müügiloa hoidja on Rootsi Orphan International AB.
English: The marketing authorisation was renewed on 8 December 2004 and on 8 December 2009.
Estonian: Müügiluba pikendati 8. detsembril 2004 ja 8. detsembril 2009.
English: It is available as white oval tablets (500 mg) and as granules (940 mg/g).
Estonian: Seda turustatakse valgete ovaalsete tablettide (500 mg) ja graanulitena (940 mg/g).
English: Ammonaps was not compared with any other treatments.
Estonian: Ammonapsi ei võrreldud teiste ravimitega.
English: The tablets are for adults and children, and the granules are used in babies and in patients who cannot swallow tablets.
Estonian: Tabletid on manustamiseks täiskasvanutele ja lastele ning graanulid imikutele ja patsientidele, kes ei suuda tablette neelata.
English: The Committee recommended that Ammonaps be given marketing authorisation.
Estonian: Komitee soovitas anda Ammonapsile müügiloa.
English: Ammonaps is a long-term treatment and needs to be taken until the patient has a successful liver transplant.
Estonian: Ammonapsi ravi on pikaajaline ja seda tuleb kasutada seni, kuni patsiendile on tehtud edukas maksasiirdamine.
English: Other information about Ammonaps:
Estonian: Muu teave Ammonapsi kohta
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ammonaps on 8 December 1999.
Estonian: Euroopa Komisjon andis Ammonapsi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 8. detsembril 1999.
English: The survival rate was higher in patients who had developed the disease later in life.
Estonian: Elulemus oli suurem nendel patsientidel, kellel haigus avaldus hilisemas elus.
English: The main measure of effectiveness was survival, but the study also looked at the number of hyperammonaemic episodes (periods of very high blood ammonia levels), cognitive development (development of the ability to think, learn and remember), growth, and blood ammonia and glutamine levels.
Estonian: Efektiivsuse põhinäitaja oli elulemus, kuid uuringus vaadeldi ka hüperammoneemiliste episoodide arvu, kognitiivset (intellekti) arengut, kasvamist ning vere ammoniaagi- ja glutamiinisisaldusi.
English: The granules are either mixed into food or drink immediately before being taken, or dissolved in water before being given through a tube leading through the tummy or nose to the stomach.
Estonian: Graanulid kas segatakse toidu või joogi sisse vahetult enne manustamist või lahustatakse vees ja manustatakse seejärel kõhtu või nina läbiva toru kaudu makku.
English: As the company had supplied the additional information requested, the ‘Exceptional Circumstances' ended on 6 July 2004.
Estonian: Et ettevõte esitas vajaliku lisateabe, tühistati müügiloa erandkorras väljastatus 6. juulil 2004.
English: Patients with urea cycle disorders cannot get rid of ammonia from the body, so it can reach high levels, leading to serious problems including disability, brain damage and death.
Estonian: Uureatsükli häirega patsientide organism ei ole võimeline vabanema ammoniaagist, mistõttu selle sisaldus võib muutuda suureks ja tekitada tõsiseid probleeme, sealhulgas invaliidsus, ajukahjustus ja surm.
English: The daily dose of Ammonaps is adjusted for each patient individually and depends on the patient's diet, height and weight.
Estonian: Ammonapsi ööpäevane annus arvutatakse konkreetse patsiendi järgi ja sõltub patsiendi dieedist, pikkusest ja kehakaalust.
English: The most common side effects with Ammonaps (seen in more than 1 patient in 10) are amenorrhoea (absence of periods) and irregular menstruation (irregular periods), but these only occur in fertile female patients.
Estonian: Ammonapsi kõige sagedamad kõrvalnähud (esinenud enam kui ühel patsiendil kümnest) on amenorröa (menstruatsiooni puudumine) ja ebaregulaarne menstruatsioonitsükkel, kuid neid esineb vaid viljakas eas naispatsientidel.
English: • ‘early-onset' disease in babies who show a complete lack of one or more of these enzymes within the first month of life;
Estonian: • varase algusega haigus ühe või enama nimetatud ensüümi täieliku puudulikkusega imikutel esimesel elukuul;
English: Ammonaps was authorised under ‘Exceptional Circumstances', because, as the disease is rare, limited information was available at the time of approval.
Estonian: Ammonapsile anti müügiluba erandkorras, sest kuna see haigus on haruldane, ei olnud ravimi heakskiitmise ajal veel piisavalt teavet.
English: Ammonaps is used in patients who lack one or more of the following enzymes: carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinate synthetase.
Estonian: Ammonapsi kasutatakse patsientidel, kellel esineb ühe või enama järgmise ensüümi puudulikkus: karbamüülfosfaadi süntetaas, ornitiintranskarbamülaas või arginiinsuktsinaadi süntetaas.
English: • ‘late-onset' disease in patients who show a partial lack of an enzyme after the age of one month and have had brain damage caused by high blood ammonia levels.
Estonian: • hilise algusega haigus osalise ensüümpuudulikkusega ühe kuu vanustel patsientidel, kellel on olnud vere kõrgest ammoniaagisisaldusest tingitud ajukahjustus.
English: The overall survival rate was about 80% in newborn babies who received Ammonaps.
Estonian: Ammonapsi saanud vastsündinute korral oli üldine elulemuse määr umbes 80%.
English: Ammonaps sodium phenylbutyrate EPAR summary for the public
Estonian: Naatriumfenüülbutüraat Kokkuvõte üldsusele
English: Therefore, despite the limited information available, the CHMP decided that Ammonaps's benefits are greater than its risks as adjunctive therapy in the chronic management of urea cycle disorders.
Estonian: Inimravimite komitee otsustas seetõttu hoolimata piisava teabe puudumisest, et Ammonapsi kasulikkus on suurem kui sellega kaasnevad riskid adjuvantravimina uureatsükli häirete pikaajalises ravis.
English: For the full list of all side effects reported with Ammonaps, see the Package Leaflet.
Estonian: Ammonapsi kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Early diagnosis and immediate treatment are important to reduce the risk of disability.
Estonian: Puude kujunemise ohu vähendamiseks on oluline varane diagnoosimine ja viivitamatu alustamine raviga.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that urea cycle disorders are a serious disease with few treatments available, and that Ammonaps has been shown to prevent ammonia levels becoming too high.
Estonian: Inimravimite komitee märkis, et uureatsükli häire on väheste ravivõimalustega raske haigus ja et Ammonaps on osutunud efektiivseks ammoniaagisisalduse suurenemise ennetamisel.
English: This allows the levels of nitrogen in the body to decrease, reducing the amount of ammonia produced.
Estonian: See võimaldab lämmastikusisalduse vähenemist organismis, mis vähendab omakorda toodetud ammoniaagi sisaldust.
English: Ammonaps is used as an add-on to other treatments and with a special low-protein diet to reduce the intake of nitrogen.
Estonian: Ammonapsi kasutatakse lisaks muudele ravimitele ning koos madala valgusisaldusega dieediga lämmastiku koguse vähendamiseks.
English: Other common side effects include abnormal kidney function and blood cell counts (red cells, white cells and platelets).
Estonian: Teiste sagedaste kõrvalnähtude hulka kuuluvad ebanormaalne neerutalitlus ja muutused vererakkude (punalibled, valgelibled, vereliistakud) sisalduses.
English: Ammonaps should not be used in people who may be hypersensitive (allergic) to sodium phenylbutyrate or any of the other ingredients.
Estonian: Ammonapsi ei tohi kasutada patsiendid, kes võivad olla naatriumfenüülbutüraadi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Ammonaps has been studied in 82 patients with urea cycle disorders who were treated with Ammonaps and had not received other treatments for their disease before.
Estonian: Ammonapsi on uuritud 82-l uureatsükli häirega patsiendil, kellele manustati Ammonapsi ning kellel ei oldud varem seda haigust ravitud.
English: The dose of Ammonaps should be divided into equal amounts and given with each meal.
Estonian: Ammonapsi ööpäevane annus jagatakse võrdseteks osadeks ja manustatakse söögiaegadel.
English: These patients are not able to get rid of waste nitrogen from the body because they lack some enzymes that are usually found in the liver.
Estonian: Nende patsientide organism ei ole võimeline vabanema jääklämmastikust, kuna neil puuduvad teatud maksaensüümid.
English: In the body, waste nitrogen is in the form of ammonia, which is toxic, especially for the brain.
Estonian: Jääklämmastik on organismis ammoniaagi kujul, mis on eriti mürgine ajule.
English: What is the risk associated with Ammonaps?
Estonian: Mis riskid Ammonapsiga kaasnevad?
English: Ammonaps is used to treat patients who have urea cycle disorders.
Estonian: Ammonapsi kasutatakse patsientidel, kellel on uureatsükli häire.
English: Why has Ammonaps been approved?
Estonian: Miks Ammonaps heaks kiideti?
English: How is Ammonaps used?
Estonian: Kuidas Ammonapsi kasutatakse?
English: The full EPAR for Ammonaps is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Ammonapsi kohta leiate siit.
English: What is Ammonaps used for?
Estonian: Milleks Ammonapsi kasutatakse?
English: What benefit has Ammonaps shown during the studies?
Estonian: Milles seisneb uuringute põhjal Ammonapsi kasulikkus?
English: What is Ammonaps?
Estonian: Mis on Ammonaps?
English: Ammonaps is a medicine that contains the active substance sodium phenylbutyrate.
Estonian: Ammonaps on ravim, mis sisaldab toimeainena naatriumfenüülbutüraati.
English: It must not be used in patients who are pregnant or breast-feeding.
Estonian: Rasedad või imetavad patsiendid Ammonapsi kasutada ei tohi.
English: Ammonaps treatment should be supervised by a doctor who has experience in treating patients with urea cycle disorders.
Estonian: Ravi Ammonapsiga peab toimuma üksnes uureatsükli häiretega patsientide ravis kogenud arsti järelevalve all.
English: How has Ammonaps been studied?
Estonian: Kuidas Ammonapsi uuriti?
English: How does Ammonaps work?
Estonian: Kuidas Ammonaps toimib?
English: The active substance in Ammonaps, sodium phenylbutyrate, is converted into a substance called phenylacetate in the body.
Estonian: Ammonapsi toimeaine naatriumfenüülbutüraat muundatakse organismis fenüülatsetaadiks.
English: Adequate hydration should be maintained.
Estonian: Tuleb tagada adekvaatne hüdratatsioon.
English: Your doctor will tell you how many Levviax tablets to take, at what time and for how long.
Estonian: Teie arst ütleb teile, mitu Levviax'i tabletti võtta, mis ajal ja kui kaua.
English: In children:
Estonian: Lapsed:
English: - while taking other medicines containing any of the following active substances:
Estonian: - kui võtate teisi ravimeid, mis sisaldavad mistahes alljärgnevat toimeainet:
English: -Paediatric patients
Estonian: - pediaatrilised patsiendid
English: The holder of this marketing Authorisation will have to submit PSURs every 6 months.
Estonian: Selle müügiloa hoidja peab esitama perioodilise ohutusaruande iga 6 kuu järel.
English: Antibiotics stop the growth of bacteria which cause infections.
Estonian: Antibiootikumid peatavad infektsioone põhjustavate bakterite kasvu.
English: Interaction studies have only been performed in adults.
Estonian: Koostoimeid on uuritud ainult täiskasvanutel
English: The tablets may be taken with or without food.
Estonian: Tablette võib võtta koos toiduga või ilma.
English: I-67019 Scoppito (L'Aquila), Italy
Estonian: I-67019 Scoppito (L'Aquila), Itaalia
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 July 2001
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Esmase müügiloa väljastamise kuupäev: 09/07/2001
English: If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Estonian: Kui te lõpetate ravimi võtmise enneaegselt, siis võib teil ka välja kujuneda bakteriaalne resistentsus ravimile.
English: If you stop taking the tablets too soon, the infection may return, or your condition may get worse.
Estonian: Kui te lõpetate ravimi võtmise enneaegselt, siis võib infektsioon taastuda või teie seisund halveneda.
English: Levviax should not be used during pregnancy unless clearly necessary.
Estonian: Levviax'it ei tohi kasutada raseduse ajal, kui see ei ole hädavajalik.
English: Levviax is not recommended for use in children below 12 years of age due to lack of data on safety and efficacy (see section 5.2).
Estonian: Levviax'i ei soovitata alla 12-aastaste laste raviks, sest andmed ohutuse ja efektiivsuse kohta puuduvad (vt lõik 5.2).
English: During post-marketing experience, liver failure has been reported (frequency unknown).
Estonian: Turustamisjärgse kasutamise ajal on teatatud maksapuudulikkusest (esinemissagedus teadmata).
English: Furthermore, telithromycin is able to block the formation of the 50S and 30S ribosomal subunits.
Estonian: Lisaks on telitromütsiin võimeline blokeerima ka 50S ja 30S ribosoomi alaühiku moodustamist.
English: Refer also to sections “Do not take Levviax”, “Taking other medicines” and “Driving and using machines”.
Estonian: Lugege lõike „Ärge võtke Levviax'i", „Võtmine koos teiste ravimitega" ja „Autojuhtimine ja masinatega töötamine”.
English: • pimozide (psychiatric problems) - if you have severely impaired renal function and/or severely impaired hepatic function, do not take Levviax while taking other medicines containing any of the following active substances:
Estonian: • pimosiidi (psühhiaatrilised probleemid); - kui teil on tõsiselt kahjustatud neerutalitlus ja/või tõsiselt kahjustatud maksatalitlus, ei või te Levviax'i võtta, kui võtate teisi ravimeid, mis sisaldavad mistahes alljärgnevat toimeainet:
English: If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures and/or specific therapy.
Estonian: Kui kahtlustatakse pseudomembranoosset koliiti, tuleb ravi kohe lõpetada ja alustada toetava ja/või spetsiifilise raviga.
English: Like all medicines Levviax can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka Levviax põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years.
Estonian: Keskkonnatekkese pneumoonia korral on ravimi efektiivsust demonstreeritud piiratud arvu patsientide puhul, kelle riskifaktoriteks olid pneumokokist põhjustatud baktereemia või vanus üle 65 aasta.
English: Hence, Levviax should be used with caution (see also section 4.4 and 5.2).
Estonian: Seetõttu peab Levviax'it kasutama ettevaatlikult (vt ka lõigud 4.4 ja 5.2).
English: Refer also to section “Do not take Levviax”.
Estonian: Lugege lõiku „Ärge võtke Levviax'i".