FrancophonIA/ELRC3.0 huggingface dataset:
English: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract leading to a prolongation in gastrointestinal transit time, which may be responsible for the constipating effect of fentanyl.
Estonian: Opioidid suurendavad seedetrakti silelihaste toonust ja vähendavad kokkutõmbejõudu, mille tulemusel soolestiku läbimisaeg pikeneb, põhjustades fentanüüliga seonduvat kõhukinnisust.
English: If you think that the dose of Rapinyl that you are using is not controlling your breakthrough pain satisfactorily tell your doctor, as he may need to adjust your dose.
Estonian: Kui teie arvates ei ole Rapinyl'i annus piisav läbilöögivalu leevendamiseks, siis teavitage sellest oma arsti, kes võib vajadusel annust muuta.
English: • runny or blocked nose, dry mouth, sore throat, itching of the skin, skin rash, irritation under the tongue
Estonian: • vesine ja kinnine nina, suu kuivus, kurgu kipitus, naha sügelemine, lööve, ärritus keele all
English: Similarly, the Applicant considered the clinical safety of fentanyl products to be well established and well tolerated in both volunteers and the target population and that the pattern of side effects was consistent with other fentanyl products, including those used for treating BTP.
Estonian: Taotleja arvates on ka fentanüüli preparaatide kliiniline ohutus juba hästi tõestatud ning ravim on vabatahtlikel ja sihtpopulatsioonis tehtud uuringutes olnud hästi talutav ning et kõrvalnähtude muster vastab teiste fentanüülipreparaatide kasutamisel kirjeldatutele, sealhulgas läbimurdevalu raviks.
English: The Applicant was able to provide in the response to the LoOI the interim analyses from 2 ongoing Phase III safety and efficacy clinical studies (EN3267-005 and EN3267-007), performed in the US by Endo.
Estonian: Taotlejal ei õnnestunud kahe praegu Ameerika Ühendriikides ettevõtte Endo poolt läbi viidava käimasoleva III faasi ohutus- ja tõhususuuringu (EN3267-005 ja EN3267-007) vaheanalüüsi alusel aktuaalsete probleemide loetelule vastata.
English: GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Estonian: RAVIMI OMADUSTE KOKKUVÕTTE, MÄRGISTUSE JA PAKENDI INFOLEHE MUUTMISE ALUSED
English: Your doctor will advise you which strength of tablet to use.
Estonian: Teie arst määrab teile sobiva tugevusega tableti.
English: Intravenous fentanyl has been shown to cause bradycardia.
Estonian: Intravenoosne fentanüül võib põhjustada bradükardiat.
English: There should be no noticeable effects on cessation of treatment with Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
Estonian: Rapinyl'i ravi lõppemisel ei tohiks märgatavaid kõrvaltoimeid esineda, siiski on täheldatud võõrutusnähtusid nagu ärevus, treemor, higistamine, kahvatus, iiveldamine ja oksendamine.
English: Due to the low number of patients exposed for a long time, the final results of the studies EN3267-005 and EN3267-007 should be provided as conditions to the Marketing Authorisations.
Estonian: Arvestades pika aja jooksul eksponeeritud patsientide väikest arvu, peab müügiloa tingimusena esitama uuringute EN3267-005 ja EN3267-007 lõplikud tulemused.
English: Patients should be advised not to drive or operate machinery if they become dizzy or drowsy or experience blurred or double vision while taking Rapinyl.
Estonian: Patsiente tuleb juhendada, et autot ei tohi juhtida ega masinatega töötada juhtudel, kui Rapinyl'i kasutamise ajal esineb pearinglust, unisust või nägemishäireid.
English: Adequate body temperature and parenteral fluid intake should be maintained.
Estonian: Tuleb jälgida kehatemperatuuri ja parenteraalselt vedelikke manustada.
English: Rapinyl should be used with caution in patients with bradyarrhythmias.
Estonian: Rapinyl'i tuleb kasutada eelnevalt teadaolevate bradüarütmiatega patsientidel ettevaatusega.
English: Rapinyl is a quick dissolving sublingual tablet formulation.
Estonian: Rapinyl on kiiresti lahustuv sublingvaalne tablett.
English: If you are not sure, talk to your doctor.
Estonian: Kui teil on kahtlusi, pidage nõu oma arstiga.
English: The active substance is fentanyl.
Estonian: Aktiivne toimaine on fentanüül.
English: Undesirable effects typical of opioids are to be expected with Rapinyl; they tend to decrease in intensity with continued use.
Estonian: Rapinyül'i kasutamisel on oodata opioidide tüüpilisi kõrvaltoimeid; sageli need kaovad või nõrgenevad ravimi pideval kasutamisel.
English: Grapefruit juice is also known to inhibit CYP3A4.
Estonian: Greibimahl teatavasti inhibeerib CYP3A4.
English: An extrapolation of the PID at 10 and 15 minutes to responder rates has been provided by the Applicant.
Estonian: Taotleja on esitanud 10. ja 15. minuti PIDtulemuste ülekandmise ravile reageerijate osakaalu hindamiseks.
English: Very common side effects (affects more than 1 user in 10) include: • nausea, headache, sleepiness/tiredness, dizziness.
Estonian: Väga sagedased kõrvaltoimed (tekivad rohkem kui ühel inimesel 10-st): • iiveldus, peavalu, unisus/väsimus, pearinglus.
English: Initial Phase - Finding the most appropriate dose
Estonian: Algfaas - Õige annuse leidmine
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Estonian: II LISA EUROOPA RAVIMIAMETI ESITATUD TEADUSLIKUD JÄRELDUSED NING RAVIMI OMADUSTE KOKKUVÕTTE, MÄRGISTUSE JA PAKENDI INFOLEHE MUUTMISE ALUSED
English: Breakthrough pain is pain which occurs suddenly, even though you have taken or used your usual opioid pain-relieving medicine.
Estonian: Läbilöögivalu on äkkitekkinud lisavalu, mis tekib hoolimata tavaliste opioidsete valuvaigistite kasutamisest.
English: In this situation, endotracheal intubation, assisted ventilation and administration of opioid antagonists as well as muscle relaxants may be requested.
Estonian: Kui selline olukord tekib, tuleb kasutada endotrahheaalset intubatsiooni, hingamise toetamist ja opioidantagoniste, sealhulgas lihasrelaksante.
English: Common: Hallucinations, confusion, anxiety, nervousness, abnormal thinking, abnormal dreams Uncommon: Agitation, depersonalisation, emotional lability
Estonian: Sage: Hallutsinatsioonid, segasus, ärevus, närvilisus, mõtlemishäired, unehäired Aeg-ajalt: Rahutus, depersonalisatio0n, emotsionaalne labiilsus 4.9 Üleannustamine
English: For the treatment of accidental overdose in opioid-naïve individuals, naloxone or other opioid antagonists should be used as clinically indicated and in accordance with their Summary of Product Characteristics.
Estonian: Üleannuse raviks (juhuslik sissevõtmine) opioide varem mittesaanud patsiendil tuleb manustada naloksooni või teisi opioid-antagoniste vastavalt Raviomaduste kokkuvõttes esitatud kliinilistele näidustustele.
English: In such a case, opioids should be used only if absolutely necessary.
Estonian: Sellistel juhtudel tohib opioide kasutada ainult selgel kliinilisel näidustusel.
English: For Rapinyl to work successfully, your doctor will need to identify the most appropriate dose for treating a single episode of breakthrough pain.
Estonian: Rapinyl'i efektiivseks kasutamiseks peab arst teile õige üksikannuse määrama, mis leevendab teie läbilöögivalu episoodi.
English: - the dose range of Rapinyl and the dose proportionalilty between Actiq and Rapinyl was considered as established
Estonian: - ning Rapinyli annusevahemik ning Actiqi ja Rapinyli annuste proportsionaalsus on tõestatud;
English: Patients and their carers must be instructed that Rapinyl contains an active substance in an amount that can be fatal to a child, and therefore to keep all tablets out of the reach and sight of children.
Estonian: 4.4 Hoiatused ja ettevaatusabinõud kasutamisel Patsiente ja nende hooldajaid tuleb teavitada, et Rapinyl sisaldab toimainet koguses, mis võib lapsele olla surmav ning seetõttu tuleb ravimit hoida lastele kättesaamatus kohas.
English: Rapinyl is intended for the treatment of breakthrough pain in patients using opioid therapy for chronic cancer pain.
Estonian: Rapinyl on ette nähtud läbimurdevalu raviks kroonilise pahaloomulise kasvajaga seotud valu tõttu opiaatravi kasutatavatel patsientidel.
English: Rapinyl should only be administered to patients who are considered tolerant to their opioid therapy for persistent cancer pain.
Estonian: Rapinyl'i ei tohi manustada patsientidele, kellel on opioidide ravi tõttu tekkinud oma valuvaigisti suhtes tolerants.
English: Eye disorders Common: Vision abnormal
Estonian: Silma kahjustused Sage: Nägemishäired
English: HOW TO TAKE RAPINYL
Estonian: KUIDAS RAPINYL'I KASUTADA
English: Uncommon: Bradycardia, tachycardia, hypertension Very rare: Arrhythmias
Estonian: Aeg-ajalt: Bradükardia, tahhükardia, hüpertensioon Väga harv: Arütmiad
English: Ask your doctor or pharmacist for advice before taking any medicine when pregnant or breast-feeding.
Estonian: Kui olete rase või toidate last rinnaga, pidage enne ravimi kasutamist nõu oma arsti või apteekriga.
English: In addition, there is solid experience in treating BTP in patients with chronic cancer already receiving a stable dose of background analgesia with strong opioids.
Estonian: Lisaks sellele on olemas kindel kogemus läbimurdevalu ravi kohta selliste krooniliste pahaloomuliste kasvajatega patsientidel, kes kasutavad püsivaks valuvaigistamiseks tugevatoimeliste opiaatide stabiilseid annuseid.
English: 50 microgram sublingual tablet is a white pentagon-shaped tablet 100 microgram sublingual tablet is a white round tablet 200 microgram sublingual tablet is a white oval-shaped tablet 300 microgram sublingual tablet is a white triangle-shaped tablet 400 microgram sublingual tablet is a white diamond-shaped tablet 600 microgram sublingual tablet is a white “D”-shaped tablet 800 microgram sublingual tablet is a white capsule-shaped tablet
Estonian: 50-mikrogrammine sublingvaalne tablett on valge ja viisnurkne tablett 100-mikrogrammine sublingvaalne tablett on valge ja ümar tablett 200-mikrogrammine sublingvaalne tablett on valge ja ovaalne tablett 300-mikrogrammine sublingvaalne tablett on valge ja kolmnurkne tablett 400-mikrogrammine sublingvaalne tablett on valge ja teemandikujuline tablett 600-mikrogrammine sublingvaalne tablett on valge ja “D”-kujuline tablett 800-mikrogrammine sublingvaalne tablett on valge ja kapslikujuline tablett
English: Orally administered fentanyl undergoes pronounced hepatic and intestinal first pass effects.
Estonian: Suukaudu manustatuna läbib fentanüül esmase maksapassaaži ja intestinaalse metabolismi.
English: There should be no noticeable effects if you stop taking Rapinyl, but possible symptoms of withdrawal are anxiety, tremor, sweating, paleness, nausea and vomiting.
Estonian: Rapinyl tablettide kasutamise lõpetamisel ei tohiks ilmneda märgatavaid kõrvaltoimeid, kuid võimalikud on teatud võõrutusnähtud nagu ärevus, treemor, higistamine, kahvatus, iiveldus ja oksendamine.
English: The optimal dose of Rapinyl will be determined by upward titration, on an individual patient basis.
Estonian: Rapinyl'i optimaalne annus tuleb igal patsiendil individuaalselt üles tiitrida.
English: Unused product should be taken, if possible, to your pharmacist.
Estonian: ESITATUD NÕUETELE Kasutamata jäänud ravimid soovitame võimalusel apteeki tagasi viia.
English: Fentanyl is passed on into breast milk and may cause extreme drowsiness and shallow breathing in the breastfed child.
Estonian: Fentanüül eritub rinnapiima ja võib põhjustada rinnaga toidetaval lapsel sedatatsiooni ja respiratoorset depressiooni.
English: Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action.
Estonian: Fentanüül on tõhus µ-opioidne valuvaigisti, mis leevendab kiiresti valu ja mõjub lühikest aega.
English: Opioid-naïve patients because of the risk of life-threatening respiratory depression.
Estonian: Rapinyl on vastunäidustatud opioide säilitusravina mittesaavatel patsientidel, sest neil on suurem risk eluohtliku respiratoorse depressiooni tekkeks.
English: HOW TO STORE RAPINYL
Estonian: KUIDAS RAPINYL'I SAILITADA
English: Discontinuation of therapy:
Estonian: Ravi lõpetamine:
English: Name approval pending
Estonian: Nime kinnitus ootel
English: Sublingual use
Estonian: Sublingvaalne
English: Fentanyl, in common with all µ-opioid receptor agonists, produces dose dependent respiratory depression.
Estonian: Kõik µ-opioidretseptorite agonistid põhjustab annusest sõltuvat respiratoorset depressiooni.
English: It is imperative that any dose re-titration of any analgesic is monitored by a health professional.
Estonian: Valuvaigisti uue annuse tiitrimine peab toimuma kogenud arsti järelvalve all.
English: Tell your doctor before treatment if you have or have recently had any of the following, as your doctor will need to take account of these when prescribing your dose:
Estonian: Kui teil on järgnevalt loetletud probleeme, pidage nõu oma arstiga, sest ta peab annuse määramisel sellega arvestama:
English: Store in the original blister package in order to protect from moisture.
Estonian: Hoida niiskuse eest kaitstult säilitada originaalpakendis.
English: o Analysis of the 30% and 50% responder rates at 10 and 15 minutes for the study EN-3267
Estonian: o uuringu EN3267-005 10. ja 15. minutil 30% ja 50% ulatuses ravile reageerijate analüüs;
English: In addition, the oral cavity was inspected by the clinician or nurse 15-20 minutes after treatment to check for local irritation, no abnormal results were identified and the tablets were well tolerated after both single and repeat doses.
Estonian: Lisaks kontrollis arst või õde suuõõnte seisundit 15…20 minutit pärast ravi paikse ärrituse suhtes.
English: • vomiting, diarrhoea, constipation, stomach ache, bloated feeling, indigestion, loss of appetite
Estonian: • oksendamine, kõhulahtisus, kõhukinnisus, kõhuvalu, tursumine, seedehäired, isutus
English: OTHER SPECIAL WARNING(S), IF NECESSARY This product should ONLY be used as prescribed.
Estonian: TEISED ERIHOIATUSED (VAJADUSEL)
English: SPECIAL STORAGE CONDITIONS Do not store above 25°C.
Estonian: Hoida temperatuuril kuni 25°C
English: Rapinyl 100 microgram sublingual tablets Rapinyl 200 microgram sublingual tablets Rapinyl 300 microgram sublingual tablets Rapinyl 400 microgram sublingual tablets Rapinyl 600 microgram sublingual tablets Rapinyl 800 microgram sublingual tablets
Estonian: Rapinyl 100-mikrogrammised subligvaalsed tabletid Rapinyl 200-mikrogrammised subligvaalsed tabletid Rapinyl 300-mikrogrammised subligvaalsed tabletid Rapinyl 400-mikrogrammised subligvaalsed tabletid Rapinyl 600-mikrogrammised subligvaalsed tabletid Rapinyl 800-mikrogrammised subligvaalsed tabletid
English: Responses to the LoOI and CHMP assessment
Estonian: Vastused aktuaalsete probleemide loetelule ja inimravimite komitee hinnang
English: Not all pack sizes may be marketed 6.6 Special precautions for disposal
Estonian: 6.6 Erihoiatused ravimi hävitamiseks
English: One sublingual tablet contains 50 micrograms fentanyl (as citrate) 100 micrograms fentanyl (as citrate)
Estonian: Üks sublingvaalne tablett sisaldab: 50 mikrogrammi fentanüüli (tsitraadina)
English: You may need to try different strengths of Rapinyl sublingual tablets over a number of episodes of breakthrough pain to find the most appropriate dose.
Estonian: Õige annuse määramiseks tuleb kasutada erineva tugevusega Rapinyl sublingvaalne tablette mitme läbilööguvalu episoodi leevendamiseks.
English: The 100 microgram tablet is a white round tablet The 200 microgram tablet is a white oval-shaped tablet The 300 microgram tablet is a white triangle-shaped tablet The 400 microgram tablet is a white diamond-shaped tablet The 600 microgram tablet is a white “D”-shaped tablet The 800 microgram tablet is a white capsule-shaped tablet
Estonian: 50-mikrogrammine tablett on valge viisnurkne tablett 100-mikrogrammine tablett on valge ja ümmargune tablett 200-mikrogrammine tablett on valge ja ovaalne tablett 300-mikrogrammine tablett on valge ja kolmnurkne tablett 400-mikrogrammine tablett on valge ja teemandikujuline tablett 600-mikrogrammine tablett on valge ja D-kujuline tablett 800-mikrogrammine tablett on valge ja kapslikujuline tablett
English: However, if you are concerned about your pain relief, you should talk to your doctor.
Estonian: Kui teil on valuvaigistite kohta küsimusi, pidage nõu oma arstiga.
English: While opioids generally increase the tone of urinary tract smooth muscle, the net effect tends to be variable, in some cases producing urinary urgency, in others, difficulty in urination.
Estonian: Opioidid tõstavad kuseteede silelihaste toonust, mille tulemusel ilmnevad erinevad sümptomid: osadel patsientidel sageneb urineerimisvajadus, teistel tekivad urineerimisraskused.
English: • depression, difficulty in concentrating, excessive feeling of well being
Estonian: • depressioon, keskendumishäired, eufooria
English: Common: Vomiting, abdominal pain, diarrhoea, constipation, stomach discomfort, dyspepsia, dry mouth
Estonian: Sage: Oksendamine, kõhuvalu, kõhulahtisus, kõhukinnisus, ebamugavustunne kõhus, düspepsia, suukuivus
English: reduced sensitivity to touch, numbness or tingling
Estonian: vähenenud puutetundlikkus, tuimus või kirvendus
English: Skin and subcutaneous tissue disorders Common: Rash, pruritus
Estonian: Naha ja nahaaluskoe kahjustused Sage: Lööve, sügelemine
English: The safety of fentanyl in pregnancy has not been established.
Estonian: Fentanüüli kasutamise kohta raseduse ajal ei ole kliinilisi andmeid.
English: Switching from other fentanyl containing products to Rapinyl must not occur at a 1:1 ratio because of different absorption profiles.
Estonian: Erinevate imendumisprofiilide tõttu ei tohi vahetust teha üks-ühele, kui üleminek Rapinyl'ile toimub teiselt suu kaudu manustatavalt fentanüüli sisaldavalt preparaadilt .
English: Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Estonian: Kasutatakse läbilöögivalu raviks vähihaigetel täiskasvanutel, kes juba kasutavad säilitusravi opioididega kroonilise vähivalu raviks.
English: (Invented) Name Strength
Estonian: Ravimi väljamõeldud nimetus) Nimi
English: Rapinyl 800 µg sublingual tablets
Estonian: Rapinyl 800 µg subligvaalsed tabletid
English: Rapinyl should be used sublingually.
Estonian: Rapinyl on mõeldud oromukosaalseks kasutamiseks.
English: If the long acting opioid or dose of long acting opioid is changed the Rapinyl dose should be re-evaluated and re-titrated as necessary to ensure the patient is on an optimal dose.
Estonian: Kui säilitusravi opioidi või selle annust muudetakse, tuleb optimaalse annuse saavutamiseks Rapinyl'i annusti muuta ja uuesti tiitrida.
English: Common: Gastro-intestinal occlusion, dysphagia, mouth ulcers/stomatitis, tongue disorder Uncommon: Enlarged abdomen, flatulence, thirst Rare: Hiccups
Estonian: Sage: Seedetrakti oklusioon, düsfaagia, suu haavandid/stomatiit, keele häired Aeg-ajalt: Suurenenud kõht, kõhupuhitus, janu
English: The active substance in Rapinyl sublingual tablets is fentanyl.
Estonian: Rapinyl subligvaalsed tabletid toimaine on fentanüül.
English: Taking the medicine
Estonian: VASTAVALT RAVIMPREPARAADILE
English: 800 micrograms fentanyl (as citrate)
Estonian: 800 mikrogrammi fentanüüli (tsitraadina)
English: Rapinyl 400 µg sublingual tablets
Estonian: Rapinyl 400 µg subligvaalsed tabletid
English: Muscle rigidity interfering with respiration has been reported with fentanyl and other opioids.
Estonian: Fentanüüli ja teiste opioidide puhul on täheldatud teatud hingamist takistavat lihasrigiidsust.
English: Take special care with Rapinyl
Estonian: Eriline ettevaatus on vajalik ravimiga Rapinyl
English: General disorders and administration site conditions Uncommon: Malaise
Estonian: Üldised häired ja manustamiskoha reaktsioonid Aeg-ajalt: Halb enesetunne
English: 400 micrograms fentanyl (as citrate)
Estonian: 400 mikrogrammi fentanüüli (tsitraadina)
English: Rapinyl 600 µg sublingual tablets
Estonian: Rapinyl 600 µg subligvaalsed tabletid
English: Rapinyl 300 µg sublingual tablets
Estonian: Rapinyl 300 µg subligvaalsed tabletid
English: 600 micrograms fentanyl (as citrate)
Estonian: 600 mikrogrammi fentanüüli (tsitraadina)
English: Rapinyl 400 microgram sublingual tablets
Estonian: Rapinyl 400-mikrogrammised subligvaalsed tabletid
English: If you feel dizzy, sleepy or have blurred vision when you take Rapinyl, do not drive or use machinery.
Estonian: Ärge juhtige autot ega käsitlege masinaid, kui kasutate Rapinyl'i ja teil on pearinglus, unisus või nägemishäired.
English: Repeated administration of the opioid antagonist may be necessary if the duration of respiratory depression is prolonged.
Estonian: Üleannustamisele järgnev respiratoorne depressioon võib kesta kauem kui opioidantagonisti toime ja seetõttu võib olla vajalik korduv annus.
English: Rapinyl 200 µg sublingual tablets
Estonian: Rapinyl 200 µg subligvaalsed tabletid
English: Renal/hepatic impairment
Estonian: Naha ja nahaaluskoe kahjustused
English: Care should be taken when using naloxone or other opioid antagonists to treat overdose in opioidmaintained patients, due to the risk of precipitating an acute withdrawal syndrome.
Estonian: Naloksooni või teiste opioid-antagonistide mõistlik kasutamine võib olla mõnedel juhtudel näidustatud, kuid see on seotud ägeda võõrutussündroomi provotseerimise riskiga.
English: Your doctor will help you do this and will work with you to find the best strength of tablet to use.
Estonian: Teie arst teeb koostöös teiega kindlaks ravimi vajaliku annuse.
English: Rapinyl 100 µg sublingual tablets
Estonian: Rapinyl 100 µg subligvaalsed tabletid
English: 300 micrograms fentanyl (as citrate)
Estonian: 300 mikrogrammi fentanüüli (tsitraadina)
English: 200 micrograms fentanyl (as citrate)
Estonian: 200 mikrogrammi fentanüüli (tsitraadina)
English: Common: Asthenia, application site irritation
Estonian: Sage: Asteenia, manustamiskoha reaktsioon
English: Rapinyl 800 microgram sublingual tablets
Estonian: Rapinyl 800-mikrogrammised subligvaalsed tabletid
English: In addition, a clinically relevant time-effect profile appropriate for an episode of breakthrough painl and meaningful clinical benefits for the patients were shown; patients could identify an effective dose of Rapinyl and use it successfully to control multiple episodes of breakthrough pain.
Estonian: Lisaks sellel näidati läbimurdevalu korral kliiniliselt olulist aja toime profiili ja ravimiga seotud olulist kliinilist kasu patsientidele.
English: Vascular disorders Common: Vasodilation
Estonian: Sage: Vasodilatsioon
English: Several doses are available for use during the dose titration phase.
Estonian: Annuse tiitrimisfaasis võib erinevaid annuseid kasutada.
English: Common: Myoclonus, insomnia, taste disorders Uncommon: Abnormal gait/coordination, vertigo, amnesia, speech disorders, tremor
Estonian: Aeg-ajalt: Liikumis/koordinatsioonihäired, vertigo, amneesia, kõnehäired, treemor Respiratoorsed, rindkere ja mediastiinumi häired Aeg-ajalt: Hüpoventilatsioon, astma, düspnoe,
English: Applicant
Estonian: ABIAINED
English: Before you start treatment with Rapinyl, you must have been regularly taking or using a prescribed strong pain-relieving medicine, called an opioid, to control your persistent pain.
Estonian: • teil on raskeid hingamisprobleeme te ei ole regulaarselt kasutanud tugevaid valuvaigisteid - opioide püsiva valu raviks to control your persistent painenne Rapinyl'i kasutusele võtmist.
English: Rapinyl 300 microgram sublingual tablets
Estonian: Rapinyl 300-mikrogrammised subligvaalsed tabletid
English: All the above adverse reactions were reported in opioid naïve volunteers administered with Rapinyl.
Estonian: Sage: Depressioon, anoreksia, keskendumisraskused, eufooria Kõiki eespool kirjeldatud kõrvaltoimeid täheldati Rapinyl'i manustamisel opioide varem mittesaanud vabatahtlikel.
English: Conclusion on LoQ
Estonian: Harv: Luksumine
English: Rapinyl 200 microgram sublingual tablets
Estonian: Rapinyl 200-mikrogrammised subligvaalsed tabletid