FrancophonIA/ELRC3.0 huggingface dataset:
English: If you use too much insulin, your blood sugar may get too low (hypoglycaemia), see advice in section 4 ‘Too low blood sugar'.
Estonian: Kui te kasutate Tresiba't rohkem kui ette nähtud Kui kasutate liiga palju insuliini, võib veresuhkru tase liiga madalale langeda (hüpoglükeemia) - vt nõuandeid lõigus 4 "Liiga madal veresuhkru tase".
English: The half-life after subcutaneous administration of Tresiba is determined by the rate of absorption from the subcutaneous tissue.
Estonian: Tresiba subkutaansele manustamisele järgneva lõpliku poolväärtusaja määrab ära nahaaluskoest imendumise kiirus.
English: 1 mL solution contains 200 units insulin degludec* (equivalent to 7.32 mg insulin degludec).
Estonian: 1 ml lahust sisaldab 200 ühikut degludek-insuliini* (vastab 7,32 mg degludek-insuliinile).
English: Ratio: 0.86 [0.58; 1.28]
Estonian: Suhe: 0,86 [0,58; 1,28]
English: If it shows less than 160, the number shown is the number of units left in your pen.
Estonian: Kui see näitab vähem kui 160, vastab osutatav arv pen-süstlisse jäänud ühikute arvule.
English: The total glucose-lowering effect is comparable for Tresiba 100 units/mL and 200 units/mL after administration of the same doses of the two products.
Estonian: Kogu glükoositaset langetav toime on võrreldav, kui manustada kahe ravimpreparaadi - Tresiba 100 ühikut/ml ja 200 ühikut/ml - sama annust.
English: HbA1c (%) End of trial Mean change
Estonian: HbA1c(%) Uuringu lõpp Keskmine muutus
English: • Put the pen cap on your pen after each use to protect the insulin from light.
Estonian: • Insuliini valguse eest kaitsmiseks asetage pen-süstlile pärast iga kasutuskorda otsik peale tagasi.
English: Difference: -0.42 [-0.78; -0.06]
Estonian: Erinevus: -0,42 [-0,78; -0,06]
English: Difference: 0.09 [-0.04; 0.22]
Estonian: Erinevus: 0,09 [-0,04; 0,22]
English: It delivers 2-160 units in steps of 2 units.
Estonian: See annustab 2...160 ühikut kahe ühiku kaupa.
English: In the open-label trials the effect of Tresiba was tested in patients with type 1 diabetes mellitus (Table 3), in insulin naïve patients (insulin initiation in type 2 diabetes mellitus, Table 4) and in previous insulin users (insulin intensification in type 2 diabetes mellitus, Table 5) with fixed as well as flexible dosing time (Table 6), and the reduction in HbA1c from baseline to end of trial was confirmed to be non-inferior in all trials against all comparators (insulin detemir and insulin glargine (100 units/mL)).
Estonian: Tresiba toimet testiti avatud uuringutes I tüüpi diabeediga patsientidel (Tabel 3), insuliinnaiivsetel patsientidel (II tüüpi diabeediga insuliinravi alustamine; Tabel 4) ja insuliini varasemalt kasutanud patsientidel (insuliinravi intensiivistamine II tüüpi diabeediga patsientidel; Tabel 5) fikseeritud ja paindliku annustamisajaga (Tabel 6).
English: In children, care should be taken to match insulin doses (especially in basal-bolus regimens) with food intake and physical activities in order to minimise the risk of hypoglycaemia.
Estonian: Laste puhul, eriti kui nad on basaal-boolus režiimil, tuleks hoolikalt jälgida, et insuliini annused vastaksid söödud toidu kogusele ja kehalisele aktiivsusele.
English: INSTRUCTIONS ON USE
Estonian: olevaid juhiseid.
English: This makes sure that the insulin flows.
Estonian: See tagab kogu insuliiniannuse manustamise.
English: Your pen is a pre-filled dial-a-dose insulin pen containing 300 units of insulin.
Estonian: Teie pen-süstel on eeltäidetud valitava annusega insuliini pen-süstel, mis sisaldab 300 ühikut insuliini.
English: Based on your blood sugar level, your doctor may change your dose.
Estonian: Teie arst võib teie veresuhkru tasemest sõltuvalt annust muuta.
English: There is no clinical experience with flexibility in dosing time of Tresiba in children and adolescents.
Estonian: Tresiba manustamisaegade paindlikkuse osas lastel ja noorukitel kliiniline kogemus puudub.
English: Each mL of solution contains 200 units of insulin degludec.
Estonian: Üks ml lahust sisaldab 200 ühikut degludek-insuliini.
English: The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm.
Estonian: Pen-süstel (FlexTouch) on mõeldud kasutamiseks kuni 8 mm pikkuste NovoFine/NovoTwist nõeltega.
English: MARKETING AUTHORISATION NUMBER EU/1/12/807/015 6 pens of 3 mL
Estonian: MÜÜGILOA NUMBER EU/1/12/807/015 6 pen-süstlit 3 ml
English: Maintenance period4
Estonian: Säilitusperiood4
English: • With Tresiba 100 units/mL a dose of 1-80 units per injection, in steps of 1 unit, can be administered.
Estonian: • Tresiba 100 ühikut/ml puhul saab manustada annuse 1...80 ühikut süste kohta ühe ühiku kaupa.
English: - The 100 units/mL pre-filled pen delivers 1-80 units in steps of 1 unit.
Estonian: - 100 ühikut/ml pen-süstel edastab 1...80 ühikut ühe ühiku kaupa.
English: Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen Tresiba comes in a pre-filled pen (FlexTouch) designed to be used with NovoFine or NovoTwist injection needles.
Estonian: Tresiba 100 ühikut/ml ja Tresiba 200 ühikut/ml süstelahus pen-süstlis Tresiba on pen-süstlis (FlexTouch), mis on mõeldud kasutamiseks NovoFine või NovoTwist süstlanõeltega.
English: You can select a maximum of 160 units per dose, in steps of 2 units.
Estonian: Maksimaalne valitav annus on 160 ühikut, annuseid saate valida kahe ühiku kaupa.
English: They may increase or decrease your blood sugar level.
Estonian: Need võivad teie veresuhkru taset nii tõsta kui langetada.
English: Rare (may affect up to 1 in 1,000 people)
Estonian: Harv (võib esineda kuni 1 inimesel 1000-st)
English: Tresiba 200 units/mL solution for injection in pre-filled pen Before first use:
Estonian: Tresiba 200 ühikut/ml süstelahus pen-süstlis Enne esmakordset kasutust:
English: DPP-4 inhibitor 2 Flexible once-daily regimen (intervals of approximately 8-40 hours between doses) + one or two of the following oral antidiabetes agents SU, metformin or DPP-4 inhibitor 3 Once-daily regimen + one or two of the following oral antidiabetes agents: SU, metformin or DPP-4 inhibitor
Estonian: 2 Paindlik kord-päevas-režiim (annustevahelised intervallid ligikaudu 8-40 tundi) + üks või kaks järgmistest suukaudsetest diabeediravimitest: SU, metformiin või
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Estonian: RAVIMVORM JA PAKENDI SUURUS Süstelahus (FlexTouch) Mitmikpakend: 10 (2 x 5) 3 ml pen-süstlit.
English: This was achieved with 30% lower daily doses of Tresiba compared to insulin detemir.
Estonian: Seejuures oli Tresiba annus 30% väiksem kui detemir-insuliini annus.
English: EU/1/12/807/001 1 pen of 3 mL EU/1/12/807/002 1 pen of 3 mL and 7 NovoFine needles EU/1/12/807/003 1 pen of 3 mL and 7 NovoTwist needles EU/1/12/807/004 5 pens of 3 mL
Estonian: EU/1/12/807/001 1 pen-süstel 3 ml EU/1/12/807/002 1 pen-süstel 3 ml ja 7 NovoFine nõela EU/1/12/807/003 1 pen-süstel 3 ml ja 7 NovoTwist nõela EU/1/12/807/004 5 pen-süstlit 3 ml
English: Tresiba 100 units/mL solution for injection in cartridge EU/1/12/807/007
Estonian: Tresiba 100 ühikut/ml süstelahus kolbampullis EU/1/12/807/007
English: If you take a wrong type of insulin, your blood sugar level may get too high or too low.
Estonian: Vale insuliinitüübi kasutamisel võib veresuhkru tase tõusta liiga kõrgele või langeda liiga madalale.
English: Ratio: 0.66 [0.49; 0.88]
Estonian: Suhe: 0,66 [0,49; 0,88]
English: The efficacy and safety of Tresiba have been studied in a 1:1 randomised controlled clinical trial in children and adolescents with type 1 diabetes mellitus for a period of 26 weeks (n=350), followed by a 26-week extension period (n=280).
Estonian: Tresiba efektiivsust ja ohutust uuriti ühes 1:1 randomiseeritud kontrollitud I tüüpi diabeediga laste ja noorukite kliinilises uuringus.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Subcutaneous use
Estonian: MANUSTAMISVIIS JA -TEE Enne ravimi kasutamist lugege pakendi infolehte.
English: Tresiba 100 units/mL solution for injection in pre-filled pen EU/1/12/807/001
Estonian: Tresiba 100 ühikut/ml süstelahus pen-süstlis EU/1/12/807/001
English: Ratio: 0.70 [0.61; 0.80]
Estonian: Suhe: 0,70 [0,61; 0,80]
English: NAME OF THE MEDICINAL PRODUCT Tresiba 100 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 100 units/mL solution for injection in cartridge
Estonian: RAVIMPREPARAADI NIMETUS Tresiba 100 ühikut/ml süstelahus pen-süstlis Tresiba 200 ühikut/ml süstelahus pen-süstlis Tresiba 100 ühikut/ml süstelahus kolbampullis
English: MARKETING AUTHORISATION NUMBER EU/1/12/807/005 10 pens of 3 mL
Estonian: MÜÜGILOA NUMBER EU/1/12/807/005 10 pen-süstlit 3 ml
English: • The dose counter of your pen shows the exact number of insulin units.
Estonian: • Pen-süstli annuse loendur näitab insuliini ühikute täpset arvu.
English: Ratio: 0.64 [0.42; 0.98]
Estonian: Suhe: 0,64 [0,42; 0,98]
English: Do not withdraw solution from the pen
Estonian: Lahust ei tohi pen-süstlist välja tõmmata.
English: Each mL of solution contains 100 units of insulin degludec.
Estonian: Üks ml lahust sisaldab 100 ühikut degludek-insuliini.
English: 1 mL solution contains 100 units insulin degludec* (equivalent to 3.66 mg insulin degludec).
Estonian: 1 ml lahust sisaldab 100 ühikut degludek-insuliini* (vastab 3,66 mg degludek-insuliinile).
English: Tresiba 100 units/mL solution for injection in cartridge One cartridge contains 300 units of insulin degludec in 3 mL solution.
Estonian: Tresiba 100 ühikut/ml süstelahus kolbampullis Üks kolbampull sisaldab 300 ühikut degludek-insuliini 3 ml lahuses.
English: Rate ratio: 0.47 [0.31; 0.73]
Estonian: Esinemissagedus: 0,47 [0,31; 0,73]
English: Table 7 Results from the double-blind, cross-over clinical trials in type 1 and type 2 diabetes mellitus
Estonian: Tabel 7; I ja II tüüpi suhkurtõve topeltpimedate ristuuringute tulemused
English: You can select a maximum of 80 units per dose, in steps of 1 unit.
Estonian: Maksimaalne valitav annus on 80 ühikut, annuseid saate valida ühe ühiku kaupa.
English: Table 1 Day-to-day variability within-patients in glucose-lowering-effect of Tresiba and insulin glargine at steady state in patients with type 1 diabetes mellitus
Estonian: Tabel 1 Tresiba ja glargiin-insuliini (100 ühikut/ml) glükoositaset langetava toime päevadevaheline varieeruvus tasakaaluseisundis I tüüpi suhkurtõvega patsientide puhul
English: Tresiba 100 units/mL solution for injection in pre-filled pen Before first use:
Estonian: Tresiba 100 ühikut/ml süstelahus pen-süstlis Enne esmakordset kasutust:
English: Ratio: 0.98 [0.80; 1.20]
Estonian: Suhe: 0,98 [0,80; 1,20]
English: Ratio: 0.82 [0.69; 0.99]
Estonian: Suhe: 0,82 [0,69; 0,99]
English: Stop using Tresiba and see a doctor straight away if the reactions become serious.
Estonian: Kui reaktsioonid muutuvad tõsiseks, lõpetage Tresiba kasutamine ja võtke viivitamatult ühendust oma arstiga.
English: Always use the dose counter and the dose pointer to see how many units you have selected before injecting the insulin.
Estonian: Enne insuliini süstimist kasutage alati annuse loendurit ja osutit nägemaks, kui palju ühikuid olete valinud.
English: Tresiba 100 units/mL and Tresiba 200 units/mL solution for injection in a pre-filled pen Tresiba is available in two strengths.
Estonian: Tresiba 100 ühikut/ml ja Tresiba 200 ühikut/ml süstelahus pen-süstlis Tresiba on saadaval kahes kontsentratsioonis.
English: Ratio: 0.75 [0.59; 0.96]
Estonian: Suhe: 0,75 [0,59; 0,96]
English: If you select and inject the wrong dose, your blood sugar level may get too high or too low.
Estonian: Kui te valite ja süstite vale annuse, võib see tuua kaasa liiga kõrge või liiga madala veresuhkru taseme.
English: Rate ratio: 0.60 [0.48; 0.76]
Estonian: Esinemissagedus: 0,60 [0,48; 0,76]
English: FPG (mmol/L) End of trial Mean change
Estonian: FPG (mmol/l) Uuringu lõpp Keskmine muutus
English: Pen label Dose counter Dose pointer
Estonian: Annuse loendur Annuse osuti
English: • With Tresiba 200 units/mL a dose of 2-160 units per injection, in steps of 2 units, can be administered.
Estonian: • Tresiba 200 ühikut/ml puhul saab manustada annuse 2...160 ühikut süste kohta kahe ühiku kaupa.
English: In a 104-week clinical trial, 57% of patients with type 2 diabetes treated with Tresiba (insulin degludec) in combination with metformin achieved a target HbA1c <7.0%, and the remaining patients continued in a 26-week open-label trial and were randomised to add liraglutide or a single dose of insulin aspart (with the largest meal).
Estonian: Ühes 104 nädalat kestnud kliinilises uuringus saavutasid HbA1c< 7,0%-lise eesmärkväärtuse 57% II tüüpi diabeediga patsientidest, keda raviti Tresiba (degludek-insuliniini) ja metformiini kombinatsiooniga.
English: Table 4 Results from open-label clinical trials in insulin naïve type 2 diabetes mellitus (insulin initiation)
Estonian: Tabel 4 II tüüpi suhkurtõve avatud kliiniliste uuringute tulemused (insuliinravi alustamine)
English: 5 Blood glucose (BG) confirmed symptomatic hypoglycaemia was defined as episodes confirmed by a plasma glucose value of less than 3.1 mmol/L, with symptoms consistent with hypoglycaemia.
Estonian: 5 Kinnitatud sümptomaatiline hüpoglükeemia oli määratletud kui episoodid, mida kinnitas plasma glükoos < 3,1 mmol/l hüpoglükeemiale vastavate sümptomitega.
English: INFORMATION IN BRAILLE Tresiba pre-filled pen 100 units/mL
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Tresiba pen-süstel 100 ühikut/ml
English: Ratio: 1.10 [0.79; 1.52]
Estonian: Suhe: 1,10 [0,79; 1,52]6
English: MARKETING AUTHORISATION NUMBERS EU/1/12/807/007 5 cartridges of 3 mL EU/1/12/807/008 10 cartridges of 3 mL
Estonian: MÜÜGILOA NUMBRID EU/1/12/807/007 5 kolbampulli 3 ml EU/1/12/807/008 10 kolbampulli 3 ml
English: Ratio: 0.89 [0.85; 0.94]
Estonian: Suhe: 0,89 [0,85; 0,94]
English: Difference: 0.08 [-0.05; 0.21]
Estonian: Erinevus: 0,08 [-0,05; 0,21]
English: Headache; slurred speech; fast heartbeat; cold sweat, cool pale skin; feeling sick, feeling very hungry; tremor or feeling nervous or worried; feeling unusually tired, weak and sleepy; feeling confused, difficulty in concentrating; short-lasting changes in your sight.
Estonian: Liiga madala veresuhkru taseme hoiatavad tunnused - need võivad ilmneda äkki: peavalu, kõnelemisraskused, südamepekslemine, külm higi, jahe ja kahvatu nahk, iiveldus, tugev näljatunne, värisemine, ärevus- või muretunne, ebaharilik väsimus, nõrkus ja unisus, segadustunne, keskendumisraskused, mööduvad nägemishäired.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Tresiba.
Estonian: Enne Tresiba kasutamist rääkige oma arsti, apteekri või meditsiiniõega.
English: What Tresiba looks like and contents of the pack Tresiba is presented as a clear and colourless solution for injection in a pre-filled pen (600 units per 3 mL).
Estonian: Kuidas Tresiba välja näeb ja pakendi sisu Tresiba on selge ja värvitu süstelahus pen-süstlis (600 ühikut 3 ml kohta).
English: Keep cartridges in the outer carton in order to protect from light.
Estonian: Hoida kolbampulle välispakendis valguse eest kaitstult.
English: Ratio: 0.77 [0.44; 1.35]
Estonian: Suhe: 0,77 [0,44; 1,35]
English: Ratio: 0.75 [0.58; 0.99]
Estonian: Suhe: 0,75 [0,58; 0,99]
English: Tresiba 100 units/mL solution for injection in pre-filled pen After first opening or carried as a spare, the medicinal product may be stored for a maximum of 8 weeks.
Estonian: Pärast esmast avamist või tagavaraks kaasaskandmisel võib ravimit säilitada kuni 8 nädalat.
English: Ratio: 0.65 [0.48; 0.89]
Estonian: Suhe: 0,65 [0,48; 0,89]
English: Difference: -0.05 [-0.45; 0.35]
Estonian: Erinevus: -0,05 [-0,45; 0,35]5
English: Tresiba 100 units/mL solution for injection in cartridge The cartridge (Penfill) is designed to be used with Novo Nordisk delivery systems (durable devices for repeated use not included in the pack) and NovoFine/NovoTwist injection needles up to a length of 8 mm.
Estonian: Kolbampull (Penfill) on ette nähtud kasutamiseks koos Novo Nordiski süstevahenditega (vastupidavad korduvaks kasutamiseks mõeldud seadmed, mis ei sisaldu pakendis) ja kuni 8 mm pikkuste nõeltega NovoFine/NovoTwist.
English: INFORMATION IN BRAILLE Tresiba pre-filled pen 200 units/mL
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Tresiba pen-süstel 200 ühikut /ml
English: Dispose of the needle safely after each use.
Estonian: Pärast iga süstimist visake nõel ohutult ära.
English: What Tresiba looks like and contents of the pack Tresiba is presented as a clear and colourless solution for injection in a cartridge (300 units per 3 mL).
Estonian: Kuidas Tresiba välja näeb ja pakendi sisu Tresiba on selge ja värvitu süstelahus kolbampullis (300 ühikut 3 ml kohta).
English: Type 2 diabetes mellitus
Estonian: II tüüpi suhkurtõbi
English: Ratio: 0.64 [0.56; 0.73]
Estonian: Suhe: 0,64 [0,56; 0,73]
English: Nocturnal confirmed3
Estonian: Öine kinnitatud 3
English: Posology
Estonian: Tsinkatsetaat
English: Eye disorder
Estonian: Silmakahjustused
English: There is no clinical experience with Tresiba during breast-feeding.
Estonian: Tresiba kasutamise kohta imetamise ajal puudub kliiniline kogemus.
English: Ratio: 0.58 [0.46; 0.74]
Estonian: Suhe: 0,58 [0,46; 0,74]
English: What Tresiba looks like and contents of the pack Tresiba is presented as a clear and colourless solution for injection in a pre-filled pen (300 units per 3 mL).
Estonian: Kuidas Tresiba välja näeb ja pakendi sisu Tresiba on selge ja värvitu süstelahus pen-süstlis (300 ühikut 3 ml kohta).
English: • Check the name and strength on the label of your pen to make sure that it contains Tresiba 200 units/mL.
Estonian: • Kontrollige pen-süstli etiketil olevat nime ja kontsentratsiooni veendumaks, et see sisaldab Tresiba 200 ühikut/ml.
English: Insulin detemir
Estonian: Detemir-insuliin1
English: Difference: -0.09[-0.23; 0.05]
Estonian: Erinevus: -0,09 [-0,23; 0,05]
English: The dose counter of your pen shows the exact number of insulin units.
Estonian: Pen-süstli annuse loendur näitab insuliini ühikute täpset arvu.
English: • if the pen is damaged or has not been stored correctly (see section 5 ‘How to store Tresiba').
Estonian: • kui Tresiba Penfill on kahjustunud või seda pole nõuetekohaselt säilitatud (vt lõik 5);
English: Odds ratio: 0.73 [0.60; 0.89]
Estonian: Riskisuhe: 0,73 [0,60; 0,89]
English: *Statistically significant a Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose <3.1 mmol/L or by the patient needing third party assistance.
Estonian: *Statistiliselt oluline a Kinnitatud hüpoglükeemia oli määratletud kui episoodid, mida kinnitas plasma glükoos < 3,1 mmol/l või patsiendi vajadus kõrvalise abi järele.
English: Instructions on how to use Tresiba 100 units/mL solution for injection in pre-filled pen (FlexTouch)
Estonian: Juhised Tresiba 100 ühikut/ml süstelahus pen-süstlis kasutamise kohta (FlexTouch)
English: If you do not follow the instructions carefully, you may get too little or too much insulin, which can lead to too high or too low blood sugar level.
Estonian: Kui te ei järgi neid juhiseid hoolikalt, võite saada liiga vähe või liiga palju insuliini.
English: Instructions on how to use Tresiba 200 units/mL solution for injection in pre-filled pen (FlexTouch)
Estonian: Juhised Tresiba 200 ühikut/ml süstelahusega pen-süstli kasutamise kohta (FlexTouch)
English: • Check the name and strength on the label of your pen to make sure that it contains Tresiba 100 units/mL.
Estonian: • Kontrollige pen-süstli etiketil olevat nime ja kontsentratsiooni veendumaks, et see sisaldab Tresiba 100 ühikut/ml.
English: FPG (mmol/L) End of trial Mean change from baseline
Estonian: FPG (mmol/l) Uuringu lõpp Keskmine muutus algväärtusest
English: Keep the cap on the pen in order to protect from light.
Estonian: Hoida pen-süstlit suletud otsikuga valguse eest kaitstult.
English: Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack of 6 (2 x 3) (without needles) pre-filled pens of 3 mL.
Estonian: Pakendi suurused 1 (nõeltega või ilma), 2 (ilma nõelteta), 3 (ilma nõelteta), 5 (ilma nõelteta) ja mitmikpakend 6 (2 x 3) (ilma nõelteta) 3 ml pen-süstlit.
English: Favours Tresiba
Estonian: Tresiba eelised
English: Rate of hypoglycaemia (per patient year of exposure) Severe
Estonian: Hüpoglükeemiad (patsiendiaasta kohta) Raske
English: Can be stored in a refrigerator (2°C - 8°C).
Estonian: Võib hoida külmkapis (2 °C…8 °C).
English: Table 8 Results from DEVOTE
Estonian: Tabel 8 DEVOTE uuringu andmed Tresiba1
English: Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.
Estonian: Kardiaalsete sümptomite halvenemisel tuleb pioglitasooni manustamine lõpetada.
English: The pre-filled pen 100 units/mL can provide a dose of 1-80 units in one injection in steps of 1 unit.
Estonian: Pen-süstel 100 ühikut/ml saab ühe süstiga valida annuse 1...80 ühikut ühe ühiku kaupa.
English: Tresiba 200 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a pre-filled multidose disposable pen made of polypropylene.
Estonian: 3 ml lahust kolvi (halobutüül) ja lamineeritud kummilehega (halobutüül/polüisopreen) kolbampullis (I tüüpi klaas), mis asub mitmeannuselises polüpropüleenist ühekordses pen-süstlis.
English: Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Tresiba.
Estonian: Tresiba'ga ravitud patsientidel esinesid süstekoha reaktsioonid (k.a verevalum süstekohal, valu, verejooks, erüteem, noodulid, turse, värvi muutus, kihelus, soojustunne ja süstekoha massi muutus).
English: Non-clinical data reveal no safety concerns for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse, kartsinogeensuse ja reproduktsioonitoksilisuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: Pack sizes of 1 (with or without needles), 5 (without needles) and multipack of 10 (2 x 5) (without needles) pre-filled pens of 3 mL.
Estonian: Pakendi suurused 1 (nõeltega või ilma), 5 (ilma nõelteta) ja mitmikpakend 10 (2 x 5) (ilma nõelteta) 3 ml pen-süstlit.
English: The dose counter of the pre-filled pen shows the number of units of insulin to be injected.
Estonian: Pen-süstli annuse loendur näitab süstitava insuliini ühikute arvu.
English: • Pull off the pen cap. A
Estonian: • Eemaldage pen-süstli otsik.
English: Tresiba 200 units/mL solution for injection in pre-filled pen Tresiba 200 units/mL packaging and label are dark green with striping with a red box highlighting the formulation strength.
Estonian: Tresiba 200 ühikut/ml pakendil ja etiketil on punased triibud tumerohelisel taustal ning punane raam rõhutab ravimpreparaadi tugevust.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Tresiba 200 units/mL solution for injection insulin degludec
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Tresiba 200 ühikut/ml süstelahus insulinum degludecum
English: Difference: -0.29 [-0.65; 0.06]
Estonian: Erinevus: -0,29 [-0,65; 0,06]
English: However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required:
Estonian: Insuliini spetsiifiline liigannus ei ole määratletav, ent hüpoglükeemia võib areneda järk-järgult, kui manustatakse patsiendi vajadusega võrreldes liiga palju insuliini.
English: Each pre-filled pen contains 600 units of insulin degludec in 3 mL solution.
Estonian: Üks pen süstel sisaldab 600 ühikut degludek-insuliini 3 ml lahuses.
English: Pack sizes of 1 (with or without needles), 2 (without needles), 3 (without needles), 5 (without needles) and multipack containing 6 (2 packs of 3) (without needles) pre-filled pens.
Estonian: Pakendi suurused: 1 (nõeltega või ilma), 2 (ilma nõelteta), 3 (ilma nõelteta), 5 (ilma nõelteta) ja mitmikpakend, mis sisaldab 6 (2 x 3) (ilma nõelteta) pen-süstlit.