FrancophonIA/ELRC3.0 huggingface dataset:
English: There have been isolated reports of haemolytic anaemia occurring with concomitant use of hydrochlorothiazide and methyldopa.
Estonian: Hüdroklorotiasiidi ja metüüldopa samaaegsel kasutamisel on üksikjuhtudel kirjeldatud hemolüütilise aneemia teket.
English: EU/1/09/570/041 90 film-coated tablets
Estonian: EU/1/09/570/041 90 õhukese polümeerikattega tabletti
English: EU/1/09/570/018 98 film-coated tablets
Estonian: EU/1/09/570/018 98 õhukese polümeerikattega tabletti
English: Dyspnoea
Estonian: Somnolentsus
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
Estonian: Imprida HCT 10 mg/160 mg/12,5 mg õhukese polümeerikattega tabletid: Iga õhukese polümeerikattega tablett sisaldab 10 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 12,5 mg hüdroklorotiasiidi.
English: Tachycardia
Estonian: Gastriit
English: EU/1/09/570/027 30 film-coated tablets
Estonian: EU/1/09/570/027 30 õhukese polümeerikattega tabletti
English: EU/1/09/570/019 280 film-coated tablets
Estonian: EU/1/09/570/019 280 õhukese polümeerikattega tabletti
English: EU/1/09/570/049 14 film-coated tablets
Estonian: EU/1/09/570/049 14 õhukese polümeerikattega tabletti
English: Ciclosporin
Estonian: Hüpertoonia
English: EU/1/09/570/005 90 film-coated tablets
Estonian: EU/1/09/570/005 90 õhukese polümeerikattega tabletti
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 10 mg amlodipiini (amlodipiinbesülaadina), 320 mg valsartaani ja 25 mg hüdroklorotiasiidi.
English: Myocardial infarction
Estonian: Mittekardiaalne rindkerevalu
English: EU/1/09/570/030 98 film-coated tablets
Estonian: EU/1/09/570/030 98 õhukese polümeerikattega tabletti
English: EU/1/09/570/015 30 film-coated tablets
Estonian: EU/1/09/570/015 30 õhukese polümeerikattega tabletti
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171).
Estonian: Abiained on mikrokristalne tselluloos; krospovidoon; kolloidne veevaba ränidioksiid; magneesiumstearaat; hüpromelloos, makrogool 4000, talk, titaandioksiid (E171).
English: EU/1/09/570/052 56 film-coated tablets
Estonian: EU/1/09/570/052 56 õhukese polümeerikattega tabletti
English: EU/1/09/570/014 28 film-coated tablets
Estonian: EU/1/09/570/014 28 õhukese polümeerikattega tabletti
English: How to store Imprida HCT Further information
Estonian: Kuidas Imprida HCT'd säilitada Lisainfo
English: Dyspepsia
Estonian: Paresteesia
English: Talc
Estonian: Talk
English: EU/1/09/570/053 90 film-coated tablets
Estonian: EU/1/09/570/053 90 õhukese polümeerikattega tabletti
English: • sleepiness
Estonian: • unehäired
English: EU/1/09/570/025 14 film-coated tablets
Estonian: EU/1/09/570/025 14 õhukese polümeerikattega tabletti
English: EU/1/09/570/029 90 film-coated tablets
Estonian: EU/1/09/570/029 90 õhukese polümeerikattega tabletti
English: Imprida HCT 5 mg/160 mg/25 mg film-coated tablets
Estonian: Imprida HCT 5 mg/160 mg/25 mg õhukese polümeerikattega tabletid
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets
Estonian: Imprida HCT 10 mg/160 mg/25 mg õhukese polümeerikattega tabletid
English: EU/1/09/570/037 14 film-coated tablets
Estonian: EU/1/09/570/037 14 õhukese polümeerikattega tabletti
English: Yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VEL” on the other side.
Estonian: Kollased, ovaalsed, kaldu servaga kaksikkumerad tabletid, mille ühele poolele on pressitud „NVR“ ja teisele „VEL“.
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets
Estonian: Imprida HCT 5 mg/160 mg/12,5 mg õhukese polümeerikattega tabletid
English: • inflammation of blood vessels
Estonian: • vere kaaliumisisalduse suurenemine
English: Imprida HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Estonian: Imprida HCT 5 mg/160 mg/25 mg õhukese polümeerikattega tabletid amlodipiin/valsartaan/hüdroklorotiasiid
English: EU/1/09/570/003 30 film-coated tablets
Estonian: EU/1/09/570/003 30 õhukese polümeerikattega tabletti
English: • increase of creatinine in the blood
Estonian: • vere kreatiniinisisalduse suurenemine
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Estonian: Imprida HCT 10 mg/160 mg/25 mg õhukese polümeerikattega tabletid amlodipiin/valsartaan/hüdroklorotiasiid
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse, genotoksilisuse ja kartsinogeensuse prekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: • stomach discomfort
Estonian: • ebamugavustunne kõhus
English: Valsartan and
Estonian: Valsartaanil.
English: EU/1/09/570/039 30 film-coated tablets
Estonian: EU/1/09/570/039 30 õhukese polümeerikattega tabletti
English: • dizziness
Estonian: • sügelus
English: EU/1/09/570/032 56 x 1 film-coated tablet (unit dose) EU/1/09/570/033 98 x 1 film-coated tablet (unit dose) EU/1/09/570/034 280 x 1 film-coated tablet (unit dose)
Estonian: EU/1/09/570/032 56 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/033 98 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/034 280 x 1 õhukese polümeerikattega tablett (üksikannus)
English: EU/1/09/570/051 30 film-coated tablets
Estonian: EU/1/09/570/051 30 õhukese polümeerikattega tabletti
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets
Estonian: Imprida HCT 10 mg/160 mg/12,5 mg õhukese polümeerikattega tabletid
English: EU/1/09/570/044 56 x 1 film-coated tablet (unit dose) EU/1/09/570/045 98 x 1 film-coated tablet (unit dose) EU/1/09/570/046 280 x 1 film-coated tablet (unit dose)
Estonian: EU/1/09/570/044 56 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/045 98 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/046 280 x 1 õhukese polümeerikattega tablett (üksikannus)
English: • diarrhoea
Estonian: • kõhulahtisus
English: • weight decrease
Estonian: • kehakaalu langus
English: EU/1/09/570/002 28 film-coated tablets
Estonian: EU/1/09/570/002 28 õhukese polümeerikattega tabletti
English: EU/1/09/570/008 56 x 1 film-coated tablet (unit dose) EU/1/09/570/009 98 x 1 film-coated tablet (unit dose) EU/1/09/570/010 280 x 1 film-coated tablet (unit dose)
Estonian: EU/1/09/570/008 56 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/009 98 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/010 280 x 1 õhukese polümeerikattega tablett (üksikannus)
English: Thiazides, including hydrochlorothiazide, may increase the risk of adverse reactions caused by amantadine.
Estonian: Tiasiidid (sh hüdroklorotiasiid) võivad suurendada amantadiini kõrvatoimete riski.
English: EU/1/09/570/056 56 x 1 film-coated tablet (unit dose) EU/1/09/570/057 98 x 1 film-coated tablet (unit dose) EU/1/09/570/058 280 x 1 film-coated tablet (unit dose)
Estonian: EU/1/09/570/056 56 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/057 98 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/058 280 x 1 õhukese polümeerikattega tablett (üksikannus)
English: EU/1/09/570/050 28 film-coated tablets
Estonian: EU/1/09/570/050 28 õhukese polümeerikattega tabletti
English: What Imprida HCT looks like and contents of the pack Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Estonian: Kuidas Imprida HCT välja näeb ja pakendi sisu Imprida HCT 10 mg/160 mg/12,5 mg õhukese polümeerikattega tabletid on kahvatukollased, ovaalsed tabletid, mille ühel poolel on kiri „NVR” ja teisel „VDL”.
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Estonian: Imprida HCT 5 mg/160 mg/12,5 mg õhukese polümeerikattega tabletid amlodipiin/valsartaan/hüdroklorotiasiid
English: • facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
Estonian: • näo turse, liigesvalu, lihaskahjustus, palavik (erütematoosne luupus)
English: What Imprida HCT looks like and contents of the pack Imprida HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Estonian: Kuidas Imprida HCT välja näeb ja pakendi sisu Imprida HCT 10 mg/160 mg/25 mg õhukese polümeerikattega tabletid on pruunikaskollased, ovaalsed tabletid, mille ühel poolel on kiri „NVR” ja teisel „VHL”.
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Estonian: Imprida HCT 10 mg/160 mg/12,5 mg õhukese polümeerikattega tabletid amlodipiin/valsartaan/hüdroklorotiasiid
English: EU/1/09/570/017 90 film-coated tablets
Estonian: EU/1/09/570/017 90 õhukese polümeerikattega tabletti
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Estonian: Üks tablett sisaldab 10 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 25 mg hüdroklorotiasiidi.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Estonian: Üks tablett sisaldab 5 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 12,5 mg hüdroklorotiasiidi.
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, yellow iron oxide (E172).
Estonian: Abiained on mikrokristalne tselluloos; krospovidoon; kolloidne veevaba ränidioksiid; magneesiumstearaat; hüpromelloos, makrogool 4000, talk, kollane raudoksiid (E172).
English: Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine or colestipol.
Estonian: Ioonvahetusvaigud Kolestüramiin või kolestipool vähendavad tiasiiddiureetikumide, sh hüdroklorotiasiidi imendumist.
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Estonian: Abiained on mikrokristalne tselluloos; krospovidoon; kolloidne veevaba ränidioksiid; magneesiumstearaat; hüpromelloos, makrogool 4000, talk, titaandioksiid (E171), kollane raudoksiid (E172).
English: EU/1/09/570/020 56 x 1 film-coated tablet (unit dose) EU/1/09/570/021 98 x 1 film-coated tablet (unit dose) EU/1/09/570/022 280 x 1 film-coated tablet (unit dose)
Estonian: EU/1/09/570/020 56 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/021 98 x 1 õhukese polümeerikattega tablett (üksikannus) EU/1/09/570/022 280 x 1 õhukese polümeerikattega tablett (üksikannus)
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Estonian: Üks tablett sisaldab 5 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 25 mg hüdroklorotiasiidi.
English: Phlebitis, thrombophlebitis Uncommon Vasculitis
Estonian: Flebiit, tromboflebiit
English: • rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Estonian: • lööve, sügelus, nõgestõbi, hingamis- või neelamisraskused, pearinglus
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Estonian: Üks tablett sisaldab 10 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 12,5 mg hüdroklorotiasiidi.
English: Serum levels of calcium should be periodically monitored during treatment with thiazides.
Estonian: Kui ravi ajal tekib hüperkaltseemia, tuleb ravi Imprida HCT'ga katkestada.Ravi ajal tiasiiddiureetikumidega tuleb seerumi kaltsiumitaset perioodiliselt jälgida.
English: • runny nose
Estonian: • naha punetus
English: EU/1/09/570/028 56 film-coated tablets
Estonian: EU/1/09/570/028 56 õhukese polümeerikattega tabletti
English: EU/1/09/570/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Estonian: EU/1/09/570/048 280 õhukese polümeerikattega tabletti (hulgipakend, 20 karpi 14 tabletiga) EU/1/09/570/047 280 õhukese polümeerikattega tabletti (hulgipakend, 4 karpi 70 tabletiga)
English: EU/1/09/570/013 14 film-coated tablets
Estonian: EU/1/09/570/013 14 õhukese polümeerikattega tabletti
English: EU/1/09/570/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Estonian: EU/1/09/570/036 280 õhukese polümeerikattega tabletti (hulgipakend, 20 karpi 14 tabletiga) EU/1/09/570/035 280 õhukese polümeerikattega tabletti (hulgipakend, 4 karpi 70 tabletiga)
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VHL” on the other side.
Estonian: Pruunikaskollased, ovaalsed, kaldu servaga kaksikkumerad tabletid, mille ühele poolele on pressitud „NVR“ ja teisele „VHL“.
English: Abdominal discomfort, abdominal pain upper
Estonian: Ebamugavustunne kõhus, ülakõhuvalu
English: EU/1/09/570/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Estonian: EU/1/09/570/060 280 õhukese polümeerikattega tabletti (hulgipakend, 20 karpi 14 tabletiga) EU/1/09/570/059 280 õhukese polümeerikattega tabletti (hulgipakend, 4 karpi 70 tabletiga)
English: • skin reddening
Estonian: • liigesvalu
English: Myalgia
Estonian: Amantadiin
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VFL” on the other side.
Estonian: Pruunikaskollased, ovaalsed, kaldu servaga kaksikkumerad tabletid, mille ühele poolele on pressitud „NVR“ ja teisele „VFL“.
English: • increased muscle stiffness
Estonian: • naha suurenenud valgustundlikkus
English: EU/1/09/570/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Estonian: EU/1/09/570/012 280 õhukese polümeerikattega tabletti (hulgipakend, 20 karpi 14 tabletiga) EU/1/09/570/011 280 õhukese polümeerikattega tabletti (hulgipakend, 4 karpi 70 tabletiga)
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 5 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 25 mg hüdroklorotiasiidi.
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 10 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 12,5 mg hüdroklorotiasiidi.
English: • severe upper stomach ache (inflammation of the pancreas)
Estonian: • verapamiil, diltiaseem (südameravimid);
English: EU/1/09/570/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Estonian: EU/1/09/570/024 280 õhukese polümeerikattega tabletti (hulgipakend, 20 karpi 14 tabletiga) EU/1/09/570/023 280 õhukese polümeerikattega tabletti (hulgipakend, 4 karpi 70 tabletiga)
English: Dry mouth
Estonian: Liigese turse
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 10 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 25 mg hüdroklorotiasiidi.
English: Component of a multipack comprising 20 cartons, each containing 14 tablets.
Estonian: 14 õhukese polümeerikattega tabletti 20 karbist koosneva multipakendi üks osa, igaühes 14 tabletti.
English: Prompt medical or surgical treatment may need to be considered if the intraocular pressure remains uncontrolled.
Estonian: Kui silmasisest rõhku ei saada kontrolli alla, võib olla vaja kohest medikamentoosset või kirurgilist ravi.
English: Pale yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VDL” on the other side.
Estonian: Kahvatukollased, ovaalsed, kaldu servaga kaksikkumerad tabletid, mille ühele poolele on pressitud „NVR“ ja teisele „VDL“.
English: • low level of sodium in the blood
Estonian: • madal naatriumisisaldus veres
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 5 mg amlodipiini (amlodipiinbesülaadina), 160 mg valsartaani ja 12,5 mg hüdroklorotiasiidi.
English: Gynaecomastia
Estonian: Neerukahjustus
English: Very rare Very rare
Estonian: Väga harv Aeg-ajalt
English: • swelling
Estonian: • seljavalu
English: (haemolytic anaemia)
Estonian: (ülitundlikkusreaktsioonid)
English: Cough
Estonian: Harv
English: • liver disorder
Estonian: • lihasspasmid
English: Asthenia
Estonian: Valu
English: Other metabolic disturbances
Estonian: Ekstrapüramidaalne sündroom
English: Common Uncommon Orthostatic hypotension Uncommon
Estonian: Ortostaatiline hüpotensioon Aeg-ajalt
English: This will help protect the environment.
Estonian: Need meetmed aitavad kaitsta keskkonda.
English: CI=95% confidence interval.
Estonian: CI = 95% usaldusvahemik.
English: The following side effects could be very serious:
Estonian: Järgmised kõrvaltoimed võivad olla väga tõsised:
English: c Nominal p-value.
Estonian: c Nominaalne p-väärtus.
English: Sucralose (E955)
Estonian: Sukraloos (E955)
English: Continue to use the medicine as normal.
Estonian: Jätkake ravimi kasutamist nagu tavaliselt.
English: It can be used in adults, adolescents and children of at least 2 years of age.
Estonian: Seda võib kasutada täiskasvanutel, noorukitel ja vähemalt 2 aasta vanustel lastel.
English: You may start on a low dose that your doctor gradually increases over time.
Estonian: Võite alustada väikese annusega, mida teie arst aja jooksul järk-järgult suurendab.
English: Ask your pharmacist about how to throw away any medicine that you no longer use.
Estonian: Küsige oma apteekrilt, kuidas hävitada ravimeid, mida te enam ei kasuta.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1389/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/19/1389/001
English: The medicine may be harmful for those suffering from alcoholism.
Estonian: Ravim võib kahjustada alkoholismi all kannatavaid isikuid.
English: In addition, monitoring of plasma concentrations should be considered.
Estonian: Peale selle tuleb jälgida plasmakontsentratsioone.
English: The Netherlands E-mail: info@gwpharm.com
Estonian: E-post: info@gwpharm.com
English: The interactions are summarised in the table below.
Estonian: Koostoimed on kokkuvõtlikult esitatud allpool tabelis.
English: Take the next dose at your regular time.
Estonian: Järgmine annus võtke tavalisel ajal.
English: The calculated dose should be rounded to the nearest graduated increment.
Estonian: Arvutatud annus tuleb ümardada lähima gradueeritud jaotiseni.
English: One 100 ml bottle
Estonian: Üks 100 ml pudel
English: Dose adjustment may be necessary.
Estonian: Võib osutuda vajalikuks annust kohandada.
English: UGT inhibitors
Estonian: UGT inhibiitorid
English: The mechanism has not been determined.
Estonian: Selle mehhanismi ei ole kindlaks tehtud.
English: Epidyolex must not be given to children under the age of 2 years, since there is no information on use in children below this age.
Estonian: Epidyolexi ei tohi anda alla 2 aasta vanustele lastele, sest kasutamise kohta sellest vanusest noorematel lastel andmed puuduvad.
English: Your doctor and pharmacist will tell you how much (number of ml) Epidyolex to take each day, how many times a day you should take it and which syringe you should use for your dose (1 ml or 5 ml).
Estonian: Teie arst ja apteeker ütlevad teile, kui palju (mitu ml) Epidyolexi iga päev võtta, mitu korda ööpäevas peate seda võtma ja millist süstalt peate oma annuseks kasutama (1 ml või 5 ml).
English: Shake off any water from both parts and allow them to dry in the air until the next use.
Estonian: Raputage mõlemalt osalt vesi maha ja laske neil kuni järgmise kasutuskorrani õhu käes kuivada.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev:
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Estonian: Esinemissagedused on määratletud järgmiselt: väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aeg-ajalt (≥ 1/1000 kuni < 1/100).
English: Intensified Monitoring:
Estonian: Intensiivsem jälgimine
English: The pack contains the following items
Estonian: Pakend sisaldab järgmisi vahendeid:
English: The safety and efficacy of cannabidiol in children aged 6 months to 2 years have not yet been established.
Estonian: Kannabidiooli ohutus ja efektiivsus lastel vanuses 6 kuud kuni 2 aastat ei ole veel tõestatud.
English: If you have any solution left in the bottle more than 8 weeks after it was first opened, you should not use it.
Estonian: Kui teil on jäänud lahust pudelisse rohkem kui 8 nädalaks alates selle esmasest avamisest, ärge seda kasutage.
English: BATCH NUMBER, DONATION AND PRODUCT CODES Lot
Estonian: PARTII NUMBER, ANNETUSE KOODID JA TOOTEKOODID Lot
English: (See also section 3, How to take Epidyolex).
Estonian: (Vt ka lõik 3 „Kuidas Epidyolexi võtta“).
English: In this case, keep careful track of how many times you have filled the syringe (e.g., by marking off each 5 ml dose, respectively) so that you take the right dose.
Estonian: Sel juhul pidage hoolikalt arvestust, mitu korda olete süstalt täitnud (nt märkides ära vastavalt iga 5 ml annuse), et võtaksite õige annuse.
English: Use within 8 weeks after first opening the bottle.
Estonian: Kasutada 8 nädala jooksul pärast pudeli esmast avamist.
English: Your doctor or pharmacist will let you know which syringe to use depending on the dose that has been prescribed.
Estonian: Teie arst või apteeker ütleb teile, millist süstalt kasutada, olenevalt teile määratud annusest.
English: Contact your doctor or go to a hospital straight away.
Estonian: Võtke kohe ühendust oma arstiga või pöörduge haiglasse.
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics; ATC code: N03AX24
Estonian: Farmakoterapeutiline rühm: epilepsiavastased ained, teised epilepsiavastased ained, ATC-kood: N03AX24
English: a average increases of 47% in AUC and 73% in Cmax b based on Cmax and AUC
Estonian: a keskmine suurenemine Cmax ja AUC põhjal 47% AUC ja 73% Cmax b Cmax ja AUC põhjal
English: The elevations typically occur in the first two months of treatment initiation; however, there were cases observed up to 18 months after initiation of treatment, particularly in patients taking concomitant valproate.
Estonian: Neid tõuse tekib tüüpiliselt ravi alustamise esimese kahe kuu jooksul; kuid mõnel juhul täheldati neid ka kuni 18 kuud peale ravi alustamist, eelkõige samaaegselt valproaati kasutavatel patsientidel.
English: Adult population
Estonian: Täiskasvanud populatsioon
English: Epidyolex with food
Estonian: Epidyolex koos toidu
English: In the event of overdose the patient should be observed and appropriate symptomatic treatment given, including monitoring of vital signs.
Estonian: Üleannustamise korral tuleb patsienti jälgida ja anda sobivat sümptomaatilist ravi, sealhulgas jälgida elutähtsaid näitajaid.
English: The doctor will explain how to gradually stop taking Epidyolex.
Estonian: Arst selgitab teile, kuidas Epidyolexi võtmist järk-järgult lõpetada.
English: Epidyolex contains refined sesame oil which may rarely cause severe allergic reactions.
Estonian: Epidyolex sisaldab rafineeritud seesamiõli, mis võib harva põhjustada raskeid allergilisi reaktsioone.