FrancophonIA/ELRC3.0 huggingface dataset:
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Estonian: Kehtivad ravimi omaduste kokkuvõte, pakendi märgistus ja pakendi infoleht on koordineerimisgrupiga kokku lepitud lõplikud versioonid.
English: Summary of product characteristics, labelling and package leaflet
Estonian: Ravimi omaduste, kokkuvõte, pakendi märgistus ja infoleht
English: The Mutual Recognition Procedure (UK/V/0145/001/II/007) started on 30 January 2009.
Estonian: Vastastikuse tunnustamise menetlus (UK/V/0145/001/II/007) algas 30. jaanuaril 2009.
English: The application was submitted in the framework of Article 6 of Commission Regulation (EC) No 1084/2003, where the Reference Member State was the United Kingdom and the Concerned Member States were Austria, Belgium, Germany, Greece, Spain, France, Ireland, Italy, Luxembourg, the Netherlands and Portugal.
Estonian: Taotlus esitati komisjoni määruse (EÜ) nr 1084/2003 artikli 6 alusel, viiteliikmesriik oli Ühendkuningriik ning asjaomased liikmesriigid Austria, Belgia, Hispaania, Iirimaa, Itaalia, Kreeka, Luksemburg, Madalmaad, Portugal, Prantsusmaa ja Saksamaa.
English: The referral procedure started on 14 October 2009.
Estonian: Esildismenetlus algas 14. oktoobril 2009.
English: Article 6(12) of Commission Regulation (EC) No 1084/2003.
Estonian: Komisjoni määruse (EÜ) nr 1084/2003 artikli 6 lõige 12.
English: Porcilis PRRS is an immunological veterinary medicinal product containing the Porcine Reproductive and Respiratory Syndrome (PRRS) virus.
Estonian: Porcilis PRRS on immunoloogiline veterinaarravim, mis sisaldab sigade reproduktiiv-respiratoorse sündroomi (PRRS) viirust.
English: PRRS
Estonian: Taustteave
English: On 2 October 2009 the United Kingdom, referred the matter to the Agency under Article 39 of Directive 2001/82/EC as amended by reference to Article 6(12) of Regulation (EC) No 1084/2003 due to concerns raised by Spain relating to the quality and efficacy of the simultaneous administration of Porcilis PRRS with Porcilis M Hyo.
Estonian: 2. oktoobril 2009 tegi Ühendkuningriik Euroopa Ravimiametile muudetud direktiivi 2001/82/EÜ artikli 39 alusel esildise, viidates määruse (EÜ) nr 1084/2003 artikli 6 lõikele 12, sest Hispaania väljendas ravimite Porcilis PRRS ja Porcilis M Hyo samaaegse manustamise kvaliteedi ja efektiivsuse kohta kahtlust.
English: Based on the rapporteurs' assessment of the currently available data, the CVMP adopted, on 19 May 2010, an opinion recommending that the variation application applied for the veterinary medicinal product Porcilis PRRS satisfies the criteria for approval.
Estonian: Praegu kättesaadavatel andmetel põhineva hindajate hinnangu alusel võttis veterinaarravimite komitee 19. mail 2010 vastu arvamuse, milles ta soovitab tunnistada veterinaarravimi Porcilis PRRS müügiloa muutmise taotlus heakskiitmise kriteeriumitele vastavaks.
English: referral for Porcilis
Estonian: kohase esildise kohta seoses ravimiga Porcilis PRRS
English: The product is indicated for use in breeding and finishing pigs from 2 weeks of age.
Estonian: Ravim on näidustatud kasutamiseks vähemalt kahenädalastel aretus- ja nuumsigadel.
English: The marketing authorisation holder Intervet International B.V. submitted an application for a Type II variation subject to Mutual Recognition Procedure for Porcilis PRRS concerning simultaneous administration with Porcilis M Hyo.
Estonian: esitas ravimi Porcilis PRRS kohta selle samaaegseks manustamiseks ravimiga Porcilis M Hyo müügiloa II tüüpi muudatuse taotluse, mille korral nõutakse vastastikuse tunnustamise menetlust.
English: Further information on Steglujan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Steglujani kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Steglujan?
Estonian: Mis meetmed võetakse, et tagada Steglujani ohutu ja efektiivne kasutamine?
English: Regarding safety, this was considered in line with that of other medicines of the same class.
Estonian: Ohutust peeti sama klassi teiste ravimitega võrreldes sarnaseks.
English: What is Steglujan and what is it used for?
Estonian: Mis on Steglujan ja milleks seda kasutatakse?
English: Steglujan (ertugliflozin / sitagliptin)
Estonian: Steglujan (ertugliflosiin/sitagliptiin)
English: At the start of the studies, patients' HbA1c was above 7.0%.
Estonian: Uuringute algul oli patsientide HbA1c sisaldus üle 7,0%.
English: The European Medicines Agency decided that Steglujan's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Steglujani kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise saab Euroopa Liidus heaks kiita.
English: The most common side effects with Steglujan (which may affect more than 1 in 10 people) are fungal infections of the vagina and other infections of the female reproductive system.
Estonian: Steglujani kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on vaginaalne seeninfektsioon ja muud naiste reproduktiivsüsteemi infektsioonid.
English: As for all medicines, data on the use of Steglujan is continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Steglujani kasutamise kohta pidevat järelevalvet.
English: It is used together with diet and exercise in the following patients:
Estonian: Ravimit kasutatakse koos dieedi ja füüsilise koormusega järgmistel patsientidel:
English: Other information about Steglujan
Estonian: Muu teave Steglujani kohta
English: For more information about using Steglujan, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Steglujani kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Steglujan have been included in the summary of product characteristics and the package leaflet.
Estonian: Steglujani ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: • patients whose blood glucose levels are not satisfactorily controlled with the diabetes medicines metformin and/or a sulphonylurea, in combination with either ertugliflozin or sitagliptin;
Estonian: • patsiendid, kelle vere glükoosisisaldust ei saa rahuldavalt reguleerida diabeediravimite metformiini ja/või sulfonüüluurearavimiga, koos ertugliflosiini või sitagliptiiniga;
English: In addition, the results indicated that treatment with Steglujan was associated with a beneficial reduction in body weight.
Estonian: Lisaks näitasid tulemused, et Steglujani raviga kaasneb kehakaalu kasulik langus.
English: Side effects reported with Steglujan are carefully evaluated and any necessary action taken to protect patients.
Estonian: Steglujani kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Type 2 diabetes is a disease in which the body does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Estonian: II tüüpi diabeet on haigus, mille korral organismis ei teki vere glükoosisisalduse reguleerimiseks piisavalt insuliini või organism ei suuda insuliini efektiivselt kasutada.
English: The benefits of Steglujan were lower in patients with kidney problems.
Estonian: Steglujani kasulikkus on väiksem neeruprobleemidega patsientidel.
English: • patients who are already taking ertugliflozin and sitagliptin as separate tablets.
Estonian: • patsiendid, kes juba saavad ertugliflosiini ja sitagliptiini eraldi tablettidena.
English: Three main studies, involving 1,987 patients showed that Steglujan was effective at lowering blood glucose levels in patients with type 2 diabetes, as measured by the decrease in blood levels of HbA1c (a measure of blood glucose) after 6 months of treatment.
Estonian: Kolm põhiuuringut (1987 patsienti) näitasid, et Steglujan on II tüüpi diabeediga patsientidel vere glükoosisisalduse vähendamisel efektiivne; efektiivsust tõendas HbA1c (vere glükoosisisalduse näitaja) sisalduse vähenemine pärast 6 kuud kestnud ravi.
English: In patients whose blood sugar needs further control, the dose can be increased to one 15 mg/100 mg tablet once a day.
Estonian: Patsientidel, kelle vere glükoosisisaldust on vaja täiendavalt reguleerida, tohib annust suurendada ühe 15 mg /100 mg tabletini üks kord ööpäevas.
English: Together, these actions reduce blood glucose levels and help to control type 2 diabetes.
Estonian: Mõlemad toimed koos vähendavad vere glükoosisisaldust ja aitavad II tüüpi diabeeti reguleerida.
English: Steglujan contains the active substances ertugliflozin and sitagliptin.
Estonian: Steglujan sisaldab toimeainena ertugliflosiini ja sitagliptiini.
English: The second study found that adding ertugliflozin to a combination of sitagliptin and metformin was more effective than placebo (a dummy treatment).
Estonian: Teises uuringus leiti, et ertugliflosiini lisamine sitagliptiini ja metformiini kombinatsioonile oli efektiivsem kui platseebo (näiv ravim).
English: How does Steglujan work?
Estonian: Kuidas Steglujan toimib?
English: HbA1c levels fell by between 0.8 and 0.9 points, compared with a fall of 0.1 with placebo.
Estonian: HbA1c sisaldus vähenes 0,8-0,9 protsendipunkti, platseeborühmas 0,1 protsendipunkti.
English: How is Steglujan used?
Estonian: Kuidas Steglujani kasutatakse?
English: For the full list of side effects and restrictions with Steglujan, see the package leaflet.
Estonian: Steglujani kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The third study compared Steglujan with placebo in patients who were not taking other diabetes medicines and in whom diet and exercise were not enough to control their blood sugar levels.
Estonian: Kolmandas uuringus võrreldi Steglujani kasutamist platseeboga patsientidel, kes ei võtnud muid diabeediravimeid ja kelle vere glükoosisisaldus ei olnud ainult dieedi ja füüsilise koormusega reguleeritud.
English: Sitagliptin blocks the breakdown of incretin hormones in the body.
Estonian: Sitagliptiin blokeerib organismis inkretiinhormoonide lagunemise.
English: Sitagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Estonian: Sitagliptiin vähendab ka maksas tekkiva glükoosi kogust, suurendades insuliini ja vähendades glükagooni (teatud hormooni) sisaldust.
English: What are the risks associated with Steglujan?
Estonian: Mis riskid Steglujaniga kaasnevad?
English: Steglujan is available as tablets in 2 strengths of ertugliflozin and sitagliptin (5 mg/100 mg and 15 mg/100 mg) and can only be obtained with a prescription.
Estonian: Steglujan on retseptiravim ja seda turustatakse kahe erineva tugevusega tablettidena: 5 mg ertugliflosiini / 100 mg sitagliptiini ja 15 mg ertugliflosiini / 100 mg sitagliptiini.
English: Prolonging the action of incretin hormones makes the pancreas produce more insulin when blood glucose levels are high.
Estonian: Inkretiinhormoonide toimet pikendades stimuleerib sitagliptiin kõhunääret tootma rohkem insuliini, kui vere glükoosisisaldus on suur.
English: Treatment with the combination of ertugliflozin and sitagliptin lowered HbA1c levels by up to 1.5 percentage points, compared with reductions of up to 1.1 for ertugliflozin and for sitagliptin on their own.
Estonian: Ertugliflosiini ja sitagliptiini kombinatsioonravi vähendas HbA1c sisaldust kuni 1,5 protsendipunkti, ertugliflosiini ja sitagliptiini eraldi manustamine kuni 1,1 protsendipunkti.
English: Steglujan is a medicine used to control blood glucose (sugar) levels in adults with type 2 diabetes.
Estonian: Steglujan on ravim, mida kasutatakse II tüüpi diabeediga täiskasvanutel vere glükoosisisalduse (veresuhkru) reguleerimiseks.
English: This study found that adding Steglujan to diet and exercise was much more effective than placebo, with HbA1c levels falling by between 1.6 and 1.7 points with the combination of ertugliflozin and sitagliptin compared with a fall of 0.4 points with placebo.
Estonian: Uuringus leiti, et Steglujani lisamine dieedile ja füüsilisele koormusele oli platseebost palju efektiivsem ning ertugliflosiini ja sitagliptiini kombinatsioonraviga vähenes HbA1c sisaldus 1,61,7 protsendipunkti, platseeborühmas 0,4 protsendipunkti.
English: Treatment with Steglujan also led to weight loss, which is considered beneficial in patients with diabetes.
Estonian: Ravi Steglujaniga põhjustab ka kaalulangust, mida peetakse diabeedipatsientidele kasulikuks.
English: Steglujan was shown to be effective at controlling blood glucose levels.
Estonian: On tõendatud, et Steglujan reguleerib efektiivselt vere glükoosisisaldust.
English: It does this by blocking a protein in the kidneys (called SGLT2) that normally takes glucose back into the blood from the kidneys.
Estonian: Selleks blokeerib ertugliflosiin neerudes leiduva valgu SGLT2, mis viib tavaliselt neerudes oleva glükoosi tagasi verre.
English: The recommended starting dose is one 5 mg/100 mg tablet taken once a day.
Estonian: Soovitatav algannus on üks tablett (5 mg / 100 mg) üks kord ööpäevas.
English: An overview of Steglujan and why it is authorised in the EU
Estonian: Ülevaade ravimist Steglujan ja ELis müügiloa väljastamise põhjendus
English: The result is a high level of glucose in the blood.
Estonian: See põhjustab vere suure glükoosisisalduse.
English: What benefits of Steglujan have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Steglujani kasulikkus?
English: Ertugliflozin helps to lower blood glucose by making the patient pass out glucose in the urine.
Estonian: Ertugliflosiin aitab vähendada vere glükoosisisaldust, suurendades glükoosi eritumist uriiniga.
English: The first study, in patients who were all taking metformin, compared the combination of ertugliflozin and sitagliptin with ertugliflozin or sitagliptin on their own.
Estonian: Esimeses uuringus võrreldi ertugliflosiini ja sitagliptiini kombinatsiooni ertugliflosiini ja sitagliptiini eraldi manustamisega metformiini saavatel patsientidel.
English: These hormones stimulate the pancreas to produce insulin.
Estonian: Inkretiinhormoonid stimuleerivad insuliini teket kõhunäärmes.
English: The two active substances in Steglujan work in different ways to lower glucose levels:
Estonian: Steglujani toimeained vähendavad vere glükoosisisaldust eri viisil.
English: Why is Steglujan authorised in the EU?
Estonian: ELis Steglujanile väljastatud müügiloa põhjendus
English: Intravenous use vial (glass)
Estonian: Intravenoosne viaal (klaas)
English: 1 g / 0.5 g Powder for concentrate for solution for infusion
Estonian: 1 g / 0.5 g Infusioonilahuse kontsentraadi pulber
English: Appropriate measures should be taken to maintain stable arterial pressure.
Estonian: Stabiilse arteriaalse rõhu säilitamiseks tuleb võtta asjakohased meetmed.
English: Phone: +49 - 89-893 119 22
Estonian: Faks +49 - 89-893 119 20
English: The majority (>90%) of healthcare professionals found Dzuveo easy to use.
Estonian: Enamik (> 90%) tervishoiutöötajaid leidis, et Dzuveot on lihtne kasutada.
English: Increased mortality was noted in all treatment groups.
Estonian: Suremuse suurenemist täheldati kõigis ravirühmades.
English: The frequencies are defined as:
Estonian: Esinemissagedused on määratletud järgmiselt.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first utilisation: 25 June 2018
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 25 juuni 2018
English: Dzuveo should not be used beyond 48 hours.
Estonian: Dzuveot ei tohi kasutada kauem kui 48 tundi.
English: 35, 80339 Munich, Germany.
Estonian: 35, 80339 München, Saksamaa
English: Email: edgar.fenzl@fgk-rs.de
Estonian: E-post: edgar.fenzl@fgk-rs.de
English: You will not give yourself this medicine.
Estonian: Te ei manusta seda ravimit ise.
English: Abuse potential and tolerance
Estonian: Kuritarvitamise risk ja tolerantsus
English: Minimum 1 hour dosing interval.
Estonian: Minimaalne annustamisintervall 1 tund.
English: This does not rule out more direct countermeasures.
Estonian: See ei välista vahetumaid vastumeetmeid.
English: Dzuveo with alcohol
Estonian: Dzuveo koos alkoholiga
English: Other medicines and Dzuveo Tell your doctor if you are taking, have recently taken or might take any other medicines.
Estonian: Muud ravimid ja Dzuveo Teatage oma arstile, kui te võtate või olete hiljuti võtnud või kavatsete võtta mis tahes muid ravimeid.
English: In that case, the opioid antagonist can be administered repeatedly or by infusion.
Estonian: Sel juhul tohib opioidiantagonisti manustada korduvalt või infusiooniga.
English: - this medicine is not used if there are signs of deterioration.
Estonian: - Et seda ravimit ei kasutata, kui esineb märke riknemisest.
English: Signs and symptoms
Estonian: Tunnused ja sümptomid
English: In the case of an excessive dry mouth, patients may be given ice cubes.
Estonian: Liigse suukuivuse korral võib patsientidele anda jääkuubikuid.
English: Hypnotic activity can be demonstrated by EEG alterations.
Estonian: Hüpnootilist toimet tõendab EEG muutumine.
English: Fertility and early embryonic development studies were conducted in male and female rats.
Estonian: Fertiilsuse ja varajase embrüonaalse arengu uuringud tehti isastel ja emastel rottidel.
English: Sufentanil does not induce histamine release.
Estonian: Sufentaniil ei tekita histamiini vabastamist.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web- portal.
Estonian: Nõuded asjaomase ravimi perioodiliste ohutusaruannete esitamiseks on sätestatud direktiivi 2001/83/EÜ artikli 107c punkti 7 kohaselt liidu kontrollpäevade loetelus (EURD loetelu) ja iga hilisem uuendus avaldatakse Euroopa ravimite veebiportaalis.
English: • The method of use of the device;
Estonian: • seadme kasutusjuhend;
English: Children and adolescents Dzuveo should not be used in children and adolescents below 18 years.
Estonian: Lapsed ja noorukid Dzuveot ei tohi kasutada lapsed ega alla 18-aastased noorukid.
English: It can increase the risk of experiencing severe breathing problems.
Estonian: See võib suurendada raskete hingamisprobleemide tekkeriski.
English: Tell the patient to touch their tongue to the roof of their mouth if possible.
Estonian: Paluge patsiendil tõsta keel vastu suulage, kui võimalik.
English: Pharmacotherapeutic group: Anesthetics, opioid anesthetics, ATC Code: N01AH03.
Estonian: Farmakoterapeutiline rühm: anesteetikumid, opioidanesteetikumid, ATC-kood: N01AH03.
English: Reproductive toxicity
Estonian: Reproduktiivtoksilisus
English: All effects of sufentanil can immediately and completely be blocked by administration of a specific antagonist such as naloxone.
Estonian: Kõiki sufentaniili toimeid on võimalik otsekohe ja täielikult blokeerida spetsiifilise antagonisti, nt naloksooni manustamisega.
English: The single-dose applicator (SDA) must be discarded in accordance to the institutional policies and local requirements.
Estonian: Üheannuseline aplikaator tuleb hävitada vastavalt asutusesisesele korrale ja kohalikele nõuetele.
English: 3-4 Ballyboggan Industrial Estate, Ballyboggan Road, Finglas, Dublin 11, Ireland.
Estonian: 3-4 Ballyboggan Industrial Estate, Ballyboggan Road, Finglas, Dublin 11, Iirimaa.
English: • The minimum dosing interval of one sublingual tablet per hour, in order to prevent / minimise the important identified risk of respiratory depression and the important potential risk of overdose;
Estonian: • teave, et iga keelealuse tableti manustamise minimaalne intervall on 1 tund, et ennetada/minimeerida teadaolevat olulist respiratoorse depressiooni riski ja võimalikku olulist üleannustamise riski;
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to special and restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Estonian: B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD Piiratud tingimustel väljastatav retseptiravim ja eriretsepti alusel väljastatav ravim (vt I lisa: Ravimi omaduste kokkuvõte, lõik 4.2).
English: After your treatment the medical staff will dispose of the applicator accordingly.
Estonian: Pärast ravi kõrvaldab meditsiinipersonal aplikaatori kooskõlas nõuetega.
English: Medicines should not be thrown away via wastewater or household waste.
Estonian: Ravimeid ei tohi visata kanalisatsiooni ega olmejäätmete hulka.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1284/001 EU/1/18/1284/002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/18/1284/001 EU/1/18/1284/002
English: Repeat antagonist administration may be required as the duration of respiratory depression may last longer than the duration of the effect of the antagonist (see section 4.9).
Estonian: Vaja võib olla antagonisti korduvmanustamist, sest respiratoorne depressioon võib kesta antagonisti toimest kauem (vt lõik 4.9).
English: After receiving a dose you will not be given another dose for at least one hour.
Estonian: Pärast annuse saamist ei manustata teile teist annust enne ühe tunni möödumist.
English: Neoplasm benign, malignant and unspecified (including cysts and polyps)
Estonian: Hea-, pahaloomulised ja täpsustamata kasvajad (sealhulgas tsüstid ja polüübid)
English: Any change in efficacy/tolerability associated with the increased exposure would be compensated in practice by an increase in the amount of time between doses (see section 4.2).
Estonian: Suurenenud ekspositsiooniga seonduvaid mis tahes muutusi efektiivsuses/talutavuses kompenseeritakse praktikas annustamiskordade intervalli pikendamisega (vt lõik 4.2).
English: The safety and efficacy of sufentanil in children and adolescents below 18 years have not been established.
Estonian: Sufentaniili ohutus ja efektiivsus lastel ning alla 18-aastastel noorukitel ei ole tõendatud.
English: Each pack contains either 5 or 10 pouches.
Estonian: Igas pakendis on kas 5 või 10 kotikest.
English: Administer product immediately after opening pouch.
Estonian: Ravim manustada kohe pärast kotikese avamist.
English: 3-4 Ballyboggan Industrial Estate Ballyboggan Road Finglas Dublin 11 Ireland
Estonian: 3-4 Ballyboggan Industrial Estate Ballyboggan Road Finglas Dublin 11 Iirimaa
English: Sufentanil should not be used in pregnancy, because it crosses the placenta and the foetal respiratory center is sensitive to opiates.
Estonian: Sufentaniili ei tohi kasutada raseduse ajal, sest see läbib platsenta ning loote hingamiskeskus on opiaatide suhtes tundlik.
English: If you are having a blood test ensure your doctor knows you are taking this medicine.
Estonian: Kui teile tehakse vereanalüüs, teatage arstile, et võtate seda ravimit.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Estonian: Loomkatsed on tõendanud reproduktiivtoksilisust (vt lõik 5.3).
English: The maximum daily dose is 720 micrograms (24 tablets per day).
Estonian: Suurim annus on 720 µg ööpäevas (24 tabletti ööpäevas).
English: Do not drink alcohol while using Dzuveo.
Estonian: Ärge kasutage Dzuveo-ravi ajal alkoholi.
English: Of the 221 patients, 147 received active treatment and 74 received placebo.
Estonian: 221 patsiendist kasutasid147 patsienti aktiivravi ja 74 patsienti platseebot.
English: It measures 3 mm in diameter and is enclosed within a single-dose applicator (labelled [sublingual tablet]).
Estonian: Selle läbimõõt on 3 mm ja see paigutatud üheannuselisse aplikaatorisse (märgistusega „[sublingual tablet]“).