FrancophonIA/ELRC3.0 huggingface dataset:
English: Diacomit was originally given ‘conditional approval' because there was more evidence to come about the medicine, in particular regarding its short-term and long-term effectiveness and safety.
Estonian: Diacomiti müügiluba anti esialgu tingimuslikult, sest ravimi ja eelkõige selle lühiajalise ja pikaajalise efektiivsuse ja ohutuse kohta oodati täiendavaid andmeid.
English: After starting Diacomit, the dose of clobazam may need to be reduced.
Estonian: Pärast Diacomitiga ravi alustamist võib olla vaja vähendada klobasaami annust.
English: The main measure of effectiveness was the number of patients who ‘responded' to treatment.
Estonian: Efektiivsuse põhinäitaja oli patsientide arv, kelle haigus allus ravile.
English: It is also known to amplify the effects of other anti-epileptic medicines and to slow down the rate at which they are broken down by the liver.
Estonian: On ka teada, et see tugevdab teiste epilepsiaravimite toimet ja aeglustab nende lagunemist maksas.
English: Diacomit should be given at the same time as food, but not with dairy products, carbonated drinks, fruit juice, or food or drinks that contain caffeine or theophylline (a substance found in black and green tea, among other products).
Estonian: Diacomiti tuleb anda koos toiduga, kuid mitte koos piimatoodete, gaseerjookide ega puuviljamahlaga või kofeiini või teofülliini (sisaldub muu hulgas mustas ja rohelises tees) sisaldavate toiduainete või jookidega.
English: The main studies of Diacomit were in children over three years of age.
Estonian: Diacomiti põhiuuringutes osalesid üle 3-aastased lapsed.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Diacomiti kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: It decided that Diacomit's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Komitee otsustas, et Diacomiti kasulikkus ületab sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The full EPAR for Diacomit can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Diacomiti kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Diacomit is an anti-epileptic medicine that contains the active substance stiripentol.
Estonian: Diacomit on epilepsiaravim, mis sisaldab toimeainena stiripentooli.
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 Diacomit.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: The CHMP concluded that Diacomit had shown its effectiveness in SMEI, albeit studies were limited and did not last as long as the Committee expected.
Estonian: Inimravimite komitee järeldas, et Diacomiti efektiivsus lapseea raske müokloonilise epilepsia ravimisel on tõestatud, kuigi uuringud olid piiratud ja nende kestus ei vastanud komitee ootustele.
English: What is the risk associated with Diacomit?
Estonian: Mis riskid Diacomitiga kaasnevad?
English: For more information about treatment with Diacomit, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Diacomitiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Diacomit must not be used in patients who have had psychoses (a serious mental state with a distorted sense of reality) with attacks of delirium (a mental state with confusion, excitement, restlessness and hallucinations).
Estonian: Diacomiti ei tohi kasutada patsiendid, kellel on esinenud psühhoose (raske vaimuseisund, mille korral reaalsuse tunnetus on häiritud), millega on kaasnenud deliirium (vaimuseisund, mida iseloomustavad segasus, ärevus, rahutus ja hallutsinatsioonid).
English: Decisions regarding the use of Diacomit in younger children should be made on a patient-by-patient basis: it can only be given to younger children if the diagnosis of SMEI has been confirmed.
Estonian: Noorematel lastel tuleb Diacomiti kasutamise otsus teha iga patsiendi kohta eraldi: noorematele lastele tohib seda anda ainult siis, kui lapseea raske müokloonilise epilepsia diagnoos on kinnitatud.
English: Similar results were seen in the second study, with 67% responding to Diacomit (8 out of 12) and 9% to placebo (1 out of 9).
Estonian: Teise uuringu tulemused olid sarnased: ravivastusega patsiente oli Diacomiti rühmas 67% (8 patsienti 12st) ja platseeborühmas 9% (1 patsient 9st).
English: This is a summary of the European public assessment report (EPAR) for Diacomit.
Estonian: See on ravimi Diacomit Euroopa avaliku hindamisaruande kokkuvõte.
English: A patient was classified as a ‘responder' if the number of seizures in the second month of treatment was at least 50% lower than the number in the month before treatment was started.
Estonian: Ravivastuseks loeti epilepsiaepisoodide arvu vähenemist patsiendil Diacomitiga ravimise teisel kuul vähemalt 50% võrra võrreldes Diacomitiga ravi alustamisele eelnenud kuuga.
English: The most common side effects with Diacomit (seen in more than 1 in 10 patients) are loss of appetite, weight loss, insomnia (difficulty sleeping), drowsiness, ataxia (inability to co-ordinate muscle movements), hypotonia (low muscle strength) and dystonia (muscle disorders).
Estonian: Diacomiti kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on isutus, kehakaalu vähenemine, unetus, uimasus, ataksia (liigutuste koordinatsioonihäired), hüpotoonia (lihasnõrkus) ja düstoonia (lihastoonuse häired).
English: In the first study, 71% of the patients taking Diacomit responded to treatment (15 out of 21), compared with 5% of the placebo group (1 out of 20).
Estonian: Ravivastusega patsiente oli esimeses uuringus Diacomiti võtnud patsientidest 71% (15 patsienti 21st) ja platseeborühmas 5% (1 patsient 20st).
English: The recommended dose is 50 mg per kilogram bodyweight, divided into two or three doses during the day.
Estonian: Soovitatav annus on 50 mg kehamassi kg kohta (mg/kg) ööpäevas, jagatuna 2 või 3 annuseks.
English: The sachets contain a powder that is used to make up an oral suspension (a liquid with solid particles in it).
Estonian: Kotikesed sisaldavad pulbrit, millest valmistatakse suukaudne suspensioon (tahkeid osakesi sisaldav vedelik).
English: It has been shown in experimental models to increase the levels of a ‘neurotransmitter' called gamma aminobutyric acid (GABA) in the brain.
Estonian: Katsemudelites on tõendatud, et see suurendab neurotransmitteri gammaaminovõihappe (GABA) sisaldust ajus.
English: What is Diacomit?
Estonian: Mis on Diacomit?
English: Why has Diacomit been approved?
Estonian: Miks Diacomit heaks kiideti?
English: The exact way in which stiripentol, the active substance in Diacomit, acts as an anti-epileptic medicine is not fully known.
Estonian: Diacomiti toimeaine stiripentooli täpne toimemehhanism epilepsiaravimina ei ole täielikult teada.
English: See the package leaflet for the full list of restrictions.
Estonian: Piirangute täielik loetelu on pakendi infolehel.
English: For the full list of all side effects reported with Diacomit, see the package leaflet.
Estonian: Diacomiti kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The studies compared Diacomit capsules or sachets with placebo (a dummy treatment), when they were added to the children's existing treatment with clobazam and valproate.
Estonian: Uuringutes võrreldi Diacomiti (kapslid või kotikesed) platseeboga (näiv ravim) nende lisamisel laste senisele ravile klobasaami ja valproaadiga.
English: Because the number of patients with SMEI is low, the disease is considered ‘rare', and Diacomit was designated as an ‘orphan medicine' (a medicine used in rare diseases) on 5 December 2001.
Estonian: Et lapseea raske müokloonilise epilepsiaga patsiente on vähe ja see haigus esineb harva, nimetati Diacomit 5. detsembril 2001 harvikravimiks.
English: Diacomit is used in children with a very rare type of epilepsy called ‘severe myoclonic epilepsy in infancy' (SMEI), also known as Dravet's syndrome.
Estonian: Diacomiti kasutatakse lastel väga harvaesinevat tüüpi epilepsia - lapseea raske müokloonilise epilepsia ehk Dravet' sündroomi raviks.
English: Treatment with Diacomit should only be given under the supervision of a doctor who specialises in the diagnosis and management of epilepsy in children (a paediatrician or paediatric neurologist).
Estonian: Diacomiti tohib anda üksnes laste epilepsia diagnostika ja ravi eriarsti (pediaatri või lasteneuroloogi) järelevalve all.
English: More patients responded to treatment with Diacomit than to placebo.
Estonian: Diacomiti rühmas oli ravivastusega patsiente rohkem kui platseeborühmas.
English: Diacomit is used as an add-on to clobazam and valproate (other anti-epileptic medicines) to treat generalised tonic-clonic seizures (major fits, including loss of consciousness) when these are not adequately controlled with clobazam and valproate.
Estonian: Diacomiti kasutatakse lisaks klobasaamile ja valproaadile (samuti epilepsiaravimid) generaliseerunud toonilis-klooniliste episoodide raviks (rasked epilepsiaepisoodid, millega kaasneb teadvusekaotus), mis piisavalt ei allu ravile klobasaami ja valproaadiga.
English: What benefit has Diacomit shown during the studies?
Estonian: Milles seisneb uuringute põhjal Diacomiti kasulikkus?
English: What is Diacomit used for?
Estonian: Milleks Diacomiti kasutatakse?
English: How has Diacomit been studied?
Estonian: Kuidas Diacomiti uuriti?
English: How does Diacomit work?
Estonian: Kuidas Diacomit toimib?
English: How is Diacomit used?
Estonian: Kuidas Diacomiti kasutatakse?
English: The medicine can only be obtained with a prescription.
Estonian: Diacomit on retseptiravim.
English: 150 (3x50) tablets multipack
Estonian: 150 (3x50) tabletti, multipakend
English: Powder for oral suspension bottle (HDPE)
Estonian: Pudel (kõrgtihe polüetüleen)
English: Do not take a smaller amount.
Estonian: Ärge võtke väiksemat kogust.
English: In particular:
Estonian: Eelkõige:
English: This will usually take about two minutes.
Estonian: Selleks kulub tavaliselt umbes kaks minutit.
English: Subsequent treatment should be symptomatic and supportive.
Estonian: Järgnev ravi peab olema sümptomaatiline ja toetav.
English: However, no systematic data are available.
Estonian: Süsteemseid andmeid ei ole aga saadaval.
English: The relevance of this to man has not been established.
Estonian: Selle tähtsus inimesele ei ole tõestatud.
English: Press it gently against the roof of your mouth with your tongue until it has dissolved completely (this usually takes about two minutes).
Estonian: Suruge see keelega õrnalt suulakke, kuni see täielikult lahustub (selleks kulub tavaliselt umbes kaks minutit).
English: DATE OF REVISION OF THE TEXT {MM/YYYY}
Estonian: TEKSTI LÄBIVAATAMISE KUUPÄEV {KK.AAAA}
English: The effects of these illnesses can be much more severe during treatment with this medicine.
Estonian: Nende haiguste mõju võib selle ravimi võtmise ajal olla palju tõsisem.
English: In case of short-term overdose no emergency medical treatment is required.
Estonian: Lühiajalise üleannustamise korral ei ole erakorraline arstiabi vajalik.
English: − diabetes, or if somebody in your family has diabetes
Estonian: − diabeet, või kui kellelgi teie peres on diabeet;
English: Keep taking your medicine until your doctor tells you to stop, even if you feel better.
Estonian: Jätkake ravimi võtmist, kuni arst palub teil lõpetada, isegi kui tunnete ennast paremini.
English: Other medicines and Jorveza
Estonian: Muud ravimid ja Jorveza
English: The symptoms of some infections can be unusual or less noticeable.
Estonian: Mõne infektsiooni sümptomid võivad olla ebatavalised või vähem märgatavad.
English: This will ensure that your medicine works properly.
Estonian: See tagab ravimi õige toimimise.
English: The antibody response to other vaccines may be diminished.
Estonian: Antikehareaktsioon muudele vaktsiinidele võib väheneda.
English: − high blood pressure
Estonian: − kõrge vererõhk;
English: For information about the observed adverse reactions, see section 4.8.
Estonian: Teave täheldatud kõrvaltoimete kohta vt lõik 4.8.
English: Some of these medicines may increase the effects of Jorveza and your doctor may wish to monitor you carefully if you are taking these medicines.
Estonian: Mõned neist ravimitest võivad Jorveza toimet tugevdada ja teie arst võib soovida teid selliste ravimite kasutamise korral põhjalikumalt jälgida.
English: If you have a kidney problem, your doctor will decide if Jorveza is suitable for you.
Estonian: Kui teil on neeruprobleem, otsustab arst, kas Jorveza on teile sobiv.
English: − if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Estonian: − kui olete budesoniidi või selle ravimi mis tahes koostisosa(de) (loetletud lõigus 6) suhtes allergiline.
English: Do not take this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Estonian: Ärge võtke seda ravimit pärast kõlblikkusaega, mis on märgitud pappkarbil ja blistril pärast „Kõlblik kuni: / EXP“).
English: Very common: may affect more than 1 in 10 people − fungal infections in the gullet (which can cause pain or discomfort when swallowing)
Estonian: Väga sage: võib esineda enam kui ühel inimesel 10-st: − seeninfektsioonid söögitorus (mis võivad põhjustada valu või ebamugavustunne neelamisel)
English: The clinical relevance of these findings to man has not been established (see section 4.6).
Estonian: Nende leidude kliiniline tähtsus inimesele ei ole tõestatud (vt lõik 4.6).
English: Your treatment should last about 6 to 12 weeks.
Estonian: Teie ravi kestab umbes 6...12 nädalat.
English: Speak to your doctor if you want to interrupt or end your treatment early.
Estonian: Rääkige oma arstile, kui soovite ravi katkestada või varem lõpetada.
English: − If you need to be vaccinated please speak to your doctor first.
Estonian: − Kui vajate vaktsineerimist, rääkige kõigepealt oma arstiga.
English: For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks.
Estonian: Patsientidel, kellel ei teki 6 ravinädala jooksul piisavat ravivastust, võib ravi pikendada kuni 12 nädalani.
English: The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been established.
Estonian: Jorveza ohutus ja efektiivsus lastel ja noorukitel vanuses alla 18 aasta ei ole tõestatud.
English: If you have taken too many orodispersible tablets on one occasion, take your next dose as prescribed.
Estonian: Kui olete ühel korral võtnud liiga palju suus dispergeeruvaid tablette, võtke järgmine kord ettenähtud kogus.
English: In case your symptoms do not get better in the first 6 weeks of treatment, you may need to take this medicine for up to 6 more weeks.
Estonian: Kui teie sümptomid esimese 6 ravinädala jooksul ei leevene, võib vajalikuks osutuda selle ravimi võtmine veel kuni 6 nädala jooksul.
English: In patients who have not had these diseases, the vaccination status should be checked, and particular care should be taken to avoid exposure.
Estonian: Neid haigusi varem mittepõdenud patsientide puhul tuleb kontrollida, kas neid on selle haiguse vastu vaktsineeritud, ja kokkupuudet nende haigustega tuleb eriti hoolikalt vältida.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) or not known (cannot be estimated from the available data).
Estonian: Esinemissagedused on määratletud järgmiselt: väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aeg-ajalt (≥ 1/1000 kuni < 1/100), harv (≥ 1/10 000 kuni < 1/1000), väga harv (< 1/10 000) või teadmata (ei saa hinnata olemasolevate andmete alusel).
English: Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).
Estonian: Samaaegset ravi ketokonasooli või muude CYP3A4 inhibiitoritega tuleb vältida (vt lõik 4.5).
English: Please also report your vaccination status to your doctor.
Estonian: Teavitage oma arsti ka oma vaktsineerimistest.
English: EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
Estonian: EU/1/17/1254/001 EU/1/17/1254/002 EU/1/17/1254/003 EU/1/17/1254/004 EU/1/17/1254/005
English: It should be placed on the tip of the tongue and gently pressed against the top of the mouth, where it will dissolve.
Estonian: See tuleb panna keele tippu ja õrnalt suulakke suruda, kus see lahustub.
English: − Tell your doctor if you have not yet had measles and/or if and when you have received your last vaccination for this disease.
Estonian: − Rääkige oma arstile, kui te ei ole veel leetreid põdenud ja/või kas ja millal teid selle haiguse vastu viimati vaktsineeriti.
English: Patients with hepatic impairment should not be treated (see sections 4.4 and 5.2).
Estonian: Maksakahjustusega patsiente ei tohi ravida (vt lõigud 4.4 ja 5.2).
English: − Keep away from people who have chickenpox or herpes zoster (shingles) if you have not had these infections.
Estonian: − Vältige kokkupuudet inimestega, kellel on tuulerõuged või herpes zoster (vöötohatis), kui te ei ole neid nakkushaiguseid kunagi põdenud.
English: The use of this medicine in children younger than 18 years of age has not yet been studied.
Estonian: Alla 18-aastastel lastel ei ole selle ravimi kasutamist veel uuritud.
English: The total number of infections (including those diagnosed by endoscopy and histology without symptoms) was 33, occurring in 27 out of 87 patients (31%).
Estonian: Infektsioonide koguarv (sh need, mis diagnoositi endoskoopiliselt ja histoloogiliselt, ilma sümptomiteta) oli 33, neid esines 27 patsiendil 87-st (31%).
English: Take one orodispersible tablet in the morning and one orodispersible tablet in the evening.
Estonian: Võtke üks suus dispergeeruv tablett hommikul ja üks suus dispergeeruv tablett õhtul.
English: − weakening of the bones (osteoporosis)
Estonian: − luude nõrgenemine (osteoporoos);
English: − decreased amount of the hormone cortisol in your blood.
Estonian: − kortisooli (hormoon) sisalduse vähenemine veres.
English: Jorveza has no or negligible influence on the ability to drive and use machines.
Estonian: Jorveza ei mõjuta või mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
English: − fungal infections in the mouth and throat (symptoms can be white spots)
Estonian: − seeninfektsioonid suus ja kõris (sümptomiteks võivad olla valged laigud);
English: If you have any of the conditions mentioned above you may be at increased risk of side effects.
Estonian: Kui teil esineb ükskõik milline ülal loetletud haigusseisund, võib teil olla suurem risk kõrvaltoimete tekkeks.
English: The co-administration of live vaccines and glucocorticosteroids should be avoided as this is likely to reduce the immune response to vaccines.
Estonian: Elusvaktsiinide ja glükokortikosteroidide koosmanustamist tuleb vältida, kuna see võib vähendada immuunvastust vaktsiinidele.
English: Therefore, concomitant use should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid side effects.
Estonian: Seetõttu tuleb koosmanustamist vältida, välja arvatud juhul, kui kasu ületab süsteemse kortikosteroidi kõrvaltoimete tekkeriski, kuid sel juhul peab patsiente jälgima süsteemse kortikosteroidi kõrvaltoimete suhtes.
English: Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity.
Estonian: Põletikulise reaktsiooni ja immuunsuse pärssimine suurendab vastuvõtlikkust infektsioonide suhtes ja nende raskusastet.
English: − If you know that you are due to have an operation please tell your doctor that you are taking Jorveza.
Estonian: − Kui teate, et teil seisab ees operatsioon, rääkige oma arstile, et võtate Jorvezat.
English: Do not eat, drink, brush your teeth or rinse your mouth for at least 30 minutes after you have taken the orodispersible tablet.
Estonian: Ärge sööge, jooge, peske hambaid ega loputage suud vähemalt 30 minutit pärast suus dispergeeruva tableti võtmist.
English: Take the following precautions during treatment with Jorveza because your immune system may be weakened:
Estonian: Jorveza-ravi ajal tuleb kasutusele võtta järgmised ettevaatusabinõud, kuna teie immuunsüsteem võib olla nõrgenenud.
English: Interference with serological testing
Estonian: Koostoime seroloogiliste analüüsidega
English: Place the orodispersible tablet on the tip of your tongue and close your mouth.
Estonian: Asetage suus dispergeeruv tablett keele tippu ja sulgege suu.
English: Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment.
Estonian: Kuna budesoniid ei eritu neerude kaudu, võib kerge kuni mõõduka kahjustusega patsiente ravida ettevaatusega samade annustega nagu ilma neerukahjustuseta patsiente.
English: White, round, biplane orodispersible tablet, with diameter of 7.1 mm and height of 2.2 mm.
Estonian: Valge ümmargune lame suus dispergeeruv tablett, mille läbimõõt on 7,1 mm ja paksus 2,2 mm.
English: − diuretics (to remove excess fluid from the body).
Estonian: − diureetikumid (kehast liigse vedeliku väljutamiseks).
English: 79108 Freiburg Germany
Estonian: 79108 Freiburg Saksamaa
English: There are currently no data available for patients with renal impairment.
Estonian: Neerukahjustusega patsientide kohta hetkel andmed puuduvad.
English: Your doctor will decide on the appropriate measures and if it is still all right for you to take this medicine.
Estonian: Teie arst otsustab, milliseid meetmeid kasutada ja kas selle ravimi võtmine on teile jätkuvalt sobiv.
English: − tuberculosis
Estonian: − tuberkuloos;
English: Take the carton and this leaflet with you if possible.
Estonian: Võimaluse korral võtke pappkarp ja käesolev infoleht kaasa.
English: Patients with hepatic impairment should therefore not be treated.
Estonian: Maksakahjustusega patsiente ei tohi seetõttu ravida.
English: Pharmacotherapeutic group: Antidiarrheals, intestinal antiinflammatory/antiinfective agents, corticosteroids acting locally, ATC code: A07EA06
Estonian: Farmakoterapeutiline rühm: kõhulahtisuse-, soolepõletiku- ja sooleinfektsioonivastased ained, lokaalselt toimivad kortikosteroidid, ATC-kood: A07EA06
English: However, no systematic study investigating different levels of hepatic impairment is available.
Estonian: Muid maksakahjustuse erinevaid raskusastmeid hindavaid süsteemseid uuringuid ei ole aga saadaval.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from budesonide therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Estonian: Rinnaga toitmise katkestamine või ravi katkestamine/jätkamine budesoniidiga, tuleb otsustada arvestades imetamise kasu lapsele ja ravi kasu naisele.
English: Symptoms of infections can be atypical or masked.
Estonian: Infektsioonide sümptomid võivad olla atüüpilised või varjatud.
English: EU/1/17/1254/001 (20 orodispersible tablets) EU/1/17/1254/002 (30 orodispersible tablets) EU/1/17/1254/003 (60 orodispersible tablets) EU/1/17/1254/004 (90 orodispersible tablets) EU/1/17/1254/005 (100 orodispersible tablets)
Estonian: EU/1/17/1254/001 (20 suus dispergeeruvat tabletti) EU/1/17/1254/002 (30 suus dispergeeruvat tabletti) EU/1/17/1254/003 (60 suus dispergeeruvat tabletti) EU/1/17/1254/004 (90 suus dispergeeruvat tabletti) EU/1/17/1254/005 (100 suus dispergeeruvat tabletti)