FrancophonIA/ELRC3.0 huggingface dataset:
English: • There have been reports of reduction in brain function (encephalopathy) in some patients taking this medicine when they have other conditions.
Estonian: • Mõnedel seda ravimit võtnud patsientidel on täheldatud ajufunktsiooni halvenemist (entsefalopaatia), kui neil on kaasuvana esinenud teatud haigusseisundid.
English: Orange opaque/ Orange opaque, size “1” hard gelatin capsules imprinted with ‘PG' on cap and ‘200' on body.
Estonian: Želatiinist kõvakapsel on oranž läbipaistmatu/oranž läbipaistmatu, suurusega „1”, mille kaanel on märgistus „PG” ja kehal „200”.
English: Pregabalin Accord 150 mg
Estonian: Pregabalin Accord 150 mg kõvakapslid
English: Each hard capsule contains 100 mg of pregabalin.
Estonian: Iga kõvakapsel sisaldab 100 mg pregabaliini.
English: Jaundice
Estonian: Vertiigo
English: • Difficulty breathing, dry nose, nasal congestion.
Estonian: • Hingamisraskused, ninakuivus, kinnine nina.
English: Potassium hydroxide
Estonian: Isutus, hüpoglükeemia
English: 100 mg capsules
Estonian: 100 mg kapslid
English: Skin and subcutaneous tissue disorders
Estonian: Naha ja nahaaluskoe kahjustused Aeg-ajalt
English: Pregabalin Accord 25 mg/ 50 mg/ 75 mg/ 100 mg/ 150 mg/ 200 mg/ 225 mg/ 300 mg hard capsules Printing ink:
Estonian: Pregabalin Accord 25 mg/50 mg/75 mg/100 mg/150 mg/200 mg/225 mg/300 mg kõvakapslid Trükivärv:
English: • Loss of appetite, weight loss, low blood sugar, high blood sugar.
Estonian: • Isutus, kehakaalu vähenemine, madal veresuhkru sisaldus, kõrge veresuhkur.
English: Pregabalin Accord 25 mg hard capsules Each hard capsule contains 25 mg of pregabalin.
Estonian: Pregabalin Accord 25 mg kõvakapslid Iga kõvakapsel sisaldab 25 mg pregabaliini.
English: Each hard capsule contains 75 mg of pregabalin.
Estonian: Iga kõvakapsel sisaldab 75 mg pregabaliini.
English: Pregabalin Accord 200 mg
Estonian: Pregabalin Accord 200 mg kõvakapslid
English: Each hard capsule contains 150 mg of pregabalin.
Estonian: Iga kõvakapsel sisaldab 150 mg pregabaliini.
English: Pregabalin Accord 300 mg
Estonian: Pregabalin Accord 300 mg kõvakapslid
English: Vascular disorders
Estonian: Kaaliumhüdroksiid
English: • Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring.
Estonian: • Ülitundlikkus, näo turse, nahasügelus, nõgeslööve, nohu, ninaverejooks, köha, norskamine.
English: Each hard capsule contains 200 mg of pregabalin.
Estonian: Iga kõvakapsel sisaldab 200 mg pregabaliini.
English: Elevated liver enzymes*
Estonian: Maksaensüümide aktiivsuse tõus*
English: Each hard capsule contains 300 mg of pregabalin.
Estonian: Iga kõvakapsel sisaldab 300 mg pregabaliini.
English: Weight increased
Estonian: Kehakaalu tõus
English: Red opaque/ White opaque, size “0” hard gelatin capsules imprinted with ‘PG' on cap and ‘300' on body.
Estonian: Želatiinist kõvakapsel on punane läbipaistmatu/valge läbipaistmatu, suurusega „0”, mille kaanel on märgistus „PG” ja kehal „300”.
English: Each hard capsule contains 50 mg of pregabalin.
Estonian: Iga kõvakapsel sisaldab 50 mg pregabaliini.
English: Pregabalin Accord 50 mg
Estonian: Pregabalin Accord 50 mg kõvakapslid
English: Pregabalin Accord 100 mg
Estonian: Pregabalin Accord 100 mg kõvakapslid
English: Each hard capsule contains 25 mg of pregabalin.
Estonian: Iga kõvakapsel sisaldab 25 mg pregabaliini.
English: Orange opaque/White opaque, size “1” hard gelatin capsules, imprinted with ‘PG' on cap and ‘225' on body.
Estonian: Želatiinist kõvakapsel on oranž läbipaistmatu/valge läbipaistmatu, suurusega „1”, mille kaanel on märgistus „PG” ja kehal „225”.
English: Investigations
Estonian: Uuringud Sage
English: Renal failure, oliguria, urinary retention
Estonian: Neerupuudulikkus, oliguuria, uriinipeetus Reproduktiivse süsteemi ja rinnanäärme häired Sage
English: Red opaque/White opaque, size “4” hard gelatin capsules, imprinted with ‘PG' on cap and ‘75' on body.
Estonian: Želatiinist kõvakapsel on punane läbipaistmatu/valge läbipaistmatu, suurusega „4”, mille kaanel on märgistus „PG” ja kehal „75”.
English: Pregabalin Accord 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin For the full list of excipients, see section 6.1.
Estonian: Pregabalin Accord 300 mg kõvakapslid Iga kõvakapsel sisaldab 300 mg pregabaliini.
English: Pregabalin Accord 25 mg
Estonian: Pregabalin Accord 25 mg kõvakapslid
English: Pregabalin Accord 200 mg hard capsules pregabalin
Estonian: Pregabalin Accord 200 mg kõvakapslid pregabaliin
English: Pregabalin Accord 25 mg/ 50 mg/ 150 mg hard capsules
Estonian: Pregabalin Accord 25 mg/50 mg/150 mg kõvakapslid Kapsli kest:
English: Pregabalin Accord 100 mg hard capsules pregabalin
Estonian: Pregabalin Accord 100 mg kõvakapslid pregabaliin
English: Pregabalin Accord 225 mg hard capsules pregabalin
Estonian: Pregabalin Accord 225 mg kõvakapslid pregabaliin
English: Red opaque/ Red opaque, size “3” hard gelatin capsules imprinted with ‘PG' on cap and ‘100' on body.
Estonian: Želatiinist kõvakapsel on punane läbipaistmatu/punane läbipaistmatu, suurusega „3”, mille kaanel on märgistus „PG” ja kehal „100”.
English: Vertigo
Estonian: Sugu
English: Pregabalin Accord 50 mg hard capsules Each hard capsule contains50 mg of pregabalin .
Estonian: Pregabalin Accord 50 mg kõvakapslid Iga kõvakapsel sisaldab 50 mg pregabaliini.
English: • Muscle damage.
Estonian: • Vedelik kopsudes
English: • Dilated pupils, cross eyes.
Estonian: • Pupillide laienemine, kõõrdsilmsus
English: Pregabalin Accord 150 mg hard capsules pregabalin
Estonian: Pregabalin Accord 150 mg kõvakapslid pregabaliin
English: Pregabalin Accord 300 mg hard capsules pregabalin
Estonian: Pregabalin Accord 300 mg kõvakapslid pregabaliin
English: White opaque/White opaque, size “3” hard gelatin capsules, imprinted with ‘PG' on cap and ‘50' on body.
Estonian: Želatiinist kõvakapsel on valge läbipaistmatu/valge läbipaistmatu, suurusega „3”, mille kaanel on märgistus „PG” ja kehal „50”.
English: Pregabalin Accord 50 mg hard capsules pregabalin
Estonian: Pregabalin Accord 50 mg kõvakapslid pregabaliin
English: White opaque/White opaque, size “2” hard gelatin capsules, imprinted with ‘PG' on cap and ‘150' on body.
Estonian: Želatiinist kõvakapsel on valge läbipaistmatu/valge läbipaistmatu, suurusega „2”, mille kaanel on märgistus „PG” ja kehal „150”.
English: White opaque/White opaque, size “4” hard gelatin capsules, imprinted with ‘PG' on cap and ‘25' on body.
Estonian: Želatiinist kõvakapsel on valge läbipaistmatu/valge läbipaistmatu, suurusega „4”, mille kaanel on märgistus „PG” ja kehal „25”.
English: Posology The dose range is 150 to 600 mg per day given in either two or three divided doses.
Estonian: Annustamine Annusevahemik on 150...600 mg ööpäevas, mis jagatakse kaheks või kolmeks annuseks.
English: Pregabalin Accord 75 mg hard capsules pregabalin
Estonian: Pregabalin Accord 75 mg kõvakapslid pregabaliin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 150 mg hard capsules}
Estonian: {HDPE pudeli pakendi karp (30, 200) 150 mg kõvakapslite jaoks}
English: If you take more Pregabalin Accord than you should
Estonian: Kui lõpetate Pregabalin Accordi võtmise
English: Pregabalin Accord 25 mg hard capsules pregabalin
Estonian: Pregabalin Accord 25 mg kõvakapslid pregabaliin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 150 mg hard capsules}
Estonian: {HDPE pudeli pakendi etikett (30, 200) 150 mg kõvakapslite jaoks}
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal.
Estonian: • Tähelepanuhäired, kohmakus, mälu halvenemine, mälu kaotus, treemor, kõnehäired,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 75 mg hard capsules}
Estonian: {HDPE pudeli pakendi etikett (30, 200) 75 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 75 mg hard capsules}
Estonian: {HDPE pudeli pakendi karp (30, 200) 75 mg kõvakapslite jaoks}
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 70, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 75 mg hard capsules - PVC/Aluminium}
Estonian: {Blisterpakend (14, 21, 56, 60, 70, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 75 mg kõvakapslite jaoks - PVC/Alumiinium}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 100 mg hard capsules}
Estonian: {HDPE pudeli pakendi karp (30, 200) 100 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 225 mg hard capsules}
Estonian: {HDPE pudeli pakendi karp (30, 200) 225 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 200 mg hard capsules}
Estonian: {HDPE pudeli pakendi karp (30, 200) 200 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 100 mg hard capsules}
Estonian: {HDPE pudeli pakendi etikett (30, 200) 100 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 225 mg hard capsules}
Estonian: {HDPE pudeli pakendi etikett (30, 200) 225 mg kõvakapslite jaoks}
English: You may feel sleepy, confused, agitated, or restless as a result of taking more this medicine than you should.
Estonian: Kui te olete võtnud seda ravimit rohkem kui ette nähtud, võite tunda end unisena, segasena, erutatud või rahutuna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 70, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 75 mg hard capsules.}
Estonian: {Blisterpakendi karp (14, 21, 56, 60, 70, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 75 mg kõvakapslite jaoks.}
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack (14, 21, 56, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 150 mg hard capsules - PVC/Aluminium}
Estonian: {Blisterpakend (14, 21, 56, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 150 mg kõvakapslite jaoks - PVC/Alumiinium}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 200 mg hard capsules}
Estonian: {HDPE pudeli pakendi etikett (30, 200) 200 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 300 mg hard capsules}
Estonian: {HDPE pudeli pakendi karp (30, 200) 300 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 50 mg hard capsules}
Estonian: {HDPE pudeli pakendi etikett (30, 200) 50 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 50 mg hard capsules }
Estonian: {HDPE pudeli pakendi karp (30, 200) 50 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton for HDPE bottle pack (30, 200) for 25 mg hard capsules}
Estonian: {HDPE pudeli pakendi karp (30, 200) 25 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 300 mg hard capsules}
Estonian: {HDPE pudeli pakendi etikett (30, 200) 300 mg kõvakapslite jaoks}
English: 100 hard capsules 112 hard capsules 100 x 1 hard capsules
Estonian: 14 kõvakapslit 21 kõvakapslit 56 kõvakapslit 60 kõvakapslit 84 kõvakapslit 90 kõvakapslit 100 kõvakapslit 112 kõvakapslit 100 x 1 kõvakapslit
English: Renal failure
Estonian: • Maksapuudulikkus
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 150 mg hard capsules.}
Estonian: {Blisterpakendi karp (14, 21, 56, 60, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 150 mg kõvakapslite jaoks.}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Label for HDPE bottle pack (30, 200) for 25 mg hard capsules}
Estonian: {HDPE pudeli pakendi etikett (30, 200) 25 mg kõvakapslite jaoks}
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 100 mg hard capsules- PVC/Aluminium}
Estonian: {Blisterpakend (14, 21, 56, 60, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 100 mg kõvakapslite jaoks - PVC/Alumiinium}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 225 mg hard capsules.}
Estonian: {Blisterpakendi karp (14, 21, 56, 60, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 225 mg kõvakapslite jaoks}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 300 mg hard capsules.}
Estonian: {Blisterpakendi karp (14, 21, 56, 60, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 300 mg kõvakapslite jaoks}
English: • Convulsions.
Estonian: • Kehakaalu suurenemine.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 25 mg hard capsules.}
Estonian: {Blisterpakendi karp (14, 21, 56, 60, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 25 mg kõvakapslite jaoks.}
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 50 mg hard capsules.}
Estonian: {Blisterpakendi karp (14, 21, 56, 60, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 50 mg kõvakapslite jaoks}
English: Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness
Estonian: Lihaskrambid, artralgia, seljavalu, jäsemete valu, kaela spasm Liigeste turse, müalgia, lihastõmblused, kaelavalu, lihaste jäikus
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS {Blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 50 mg hard capsules - PVC/Aluminium}
Estonian: Blisterpakend (14, 21, 56, 60, 84, 90, 100 ja 112) ja ühekordse annusega perforeeritud blisterpakend (100) 50 mg kõvakapslite jaoks - PVC/Alumiinium
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING {Carton of blister pack (14, 21, 56, 60, 84, 90, 100 and 112) and perforated unit dose blister pack (100) for 100 mg hard capsules.}
Estonian: Blisterpakendi karp (14, 21, 56, 60, 84, 90, 100 ja 112) ja perforeeritud ühekordse annusega blisterpakend (100) 100 mg kõvakapslite jaoks
English: 1 pre-filled syringe with safety device
Estonian: 1 süstel ohutusseadisega
English: These findings are not considered relevant to humans.
Estonian: Neid leide ei peeta inimeste jaoks oluliseks.
English: OTHER Week 1, Week 2
Estonian: MUU 1. nädal, 2. nädal
English: More than 170 patients have been investigated in open studies for more than five years and some for up to 10 years.
Estonian: Rohkem kui 170 patsienti uuriti avatud uuringutes rohkem kui viie aasta jooksul ja mõnda neist kuni 10 aasta jooksul.
English: ● This medicine has been prescribed for you only.
Estonian: · Ravim on välja kirjutatud üksnes teile.
English: ● Additional risk minimisation measures
Estonian: · Riski minimeerimise lisameetmed
English: Component of a multipack, can't be sold separately
Estonian: Multipakendi osa, ei saa müüa eraldi
English: If you forget a dose, take it as soon as you remember.
Estonian: Kui te unustate annuse võtmata, võtke see niipea, kui see teil meelde tuleb.
English: Children and adolescents Do not give Esbriet to children and adolescents under the age of 18.
Estonian: Lapsed ja noorukid Esbrieti ei tohi anda alla 18-aastastele lastele ega noorukitele.
English: These medicinal products should be avoided whenever possible.
Estonian: Kui võimalik, tuleb selliste ravimite kasutamist vältida.
English: Statistics
Estonian: Statistika
English: Date of latest renewal: 08 September 2015
Estonian: Müügiloa viimase uuendamise kuupäev: 8. september 2015
English: The safety of Esbriet has been evaluated in clinical studies including 1,650 volunteers and patients.
Estonian: Esbrieti ohutust hinnati kliinilistes uuringutes, kus osales 1650 vabatahtlikku ja patsienti.
English: In some situations, your doctor may advise you to stop taking Esbriet.
Estonian: Teatud olukordades võib arst soovitada, et lõpetaksite Esbrieti võtmise.
English: Other medicines and Esbriet
Estonian: Muud ravimid ja Esbriet
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 February 2011
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 28. veebruar 2011
English: Treatment was administered three times daily for 52 weeks.
Estonian: Ravi manustati kolm korda päevas 52 nädala jooksul.
English: AUC0-∞ (mg•hr/L)
Estonian: AUC0-∞ (mg•h/l)
English: If symptoms continue, patients may be instructed to interrupt treatment for one to two weeks to allow symptoms to resolve.
Estonian: Kui sümptomid jätkuvad, võib patsientidel soovitada ravi üheks kuni kaheks nädalaks katkestada, et sümptomid saaksid leeveneda.
English: A risk to the breastfed infant cannot be excluded.
Estonian: Riski rinnaga toidetavale lapsele ei saa välistada.
English: (sunrise; morning dose)
Estonian: (päikesetõus, hommikune annus)
English: The safety checklist about Esbriet should contain the following key elements related to liver function and photosensitivity:
Estonian: Esbrieti ohutuse kontroll-loend peab sisaldama järgmisi põhielemente maksatalitluse ja fotosensitiivsuse kohta:
English: These are rare side effects.
Estonian: Need on harvaesinevad kõrvaltoimed.
English: No decline (FVC change >0%)
Estonian: Vähenemist ei ole (FVC muutus > 0%)
English: Reversibility was observed after cessation of treatment.
Estonian: Pärast ravi katkestamist täheldati toime pöörduvust.
English: ● Risk Management Plan (RMP)
Estonian: · Riskijuhtimiskava
English: The absolute bioavailability of pirfenidone has not been determined in humans.
Estonian: Pirfenidooni absoluutset biosaadavust inimestel ei ole määratud.
English: The exposure to pirfenidone in smokers was 50% of that observed in non-smokers.
Estonian: Pirfenidooni ekspositsioon oli suitsetajatel 50% mittesuitsetajatel täheldatust.
English: In the event of a suspected overdose, supportive medical care should be provided including monitoring of vital signs and close observation of the clinical status of the patient.
Estonian: Üleannustamise kahtlustuse korral tuleb anda toetavat ravi, sealhulgas jälgida elutähtsaid näitajaid ja hoolikalt jälgida patsiendi kliinilist seisundit.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Estonian: Teatage oma arstile või apteekrile, kui te kasutate, olete hiljuti kasutanud või kavatsete kasutada mis tahes muid ravimeid.
English: In both studies, treatment was administered three times daily for a minimum of 72 weeks.
Estonian: Mõlemas uuringus manustati ravimit kolm korda ööpäevas vähemalt 72 nädala jooksul.
English: 270 capsules
Estonian: 270 kapslit
English: Three of the Phase 3 studies (PIPF-004, PIPF-006, and PIPF-016) were multinational, and one (SP3) was conducted in Japan.
Estonian: Kolm 3. faasi uuringut (PIPF-004, PIPF-006 ja PIPF-016) olid rahvusvahelised ja üks (SP3) toimus Jaapanis.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Estonian: B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD Piiratud tingimustel väljastatav retseptiravim (vt lisa I: Ravimi omaduste kokkuvõte, lõik 4.2).
English: Pharmacotherapeutic group: Immunosuppressants, other immunosuppressants, ATC code: L04AX05 The mechanism of action of pirfenidone has not been fully established.
Estonian: Farmakoterapeutiline rühm: immunosupressandid, teised immunosupressandid, ATC-kood: L04AX05 Pirfenidooni toimemehhanism ei ole lõplikult välja selgitatud.
English: What Esbriet contains
Estonian: Mida Esbriet sisaldab
English: Reports of anaphylactic reactions have also been received.
Estonian: Samuti on teatatud anafülaktilistest reaktsioonidest.
English: It is important that you have these regular blood tests for as long as you are taking Esbriet.
Estonian: On tähtis, et te teeksite vereanalüüse kogu aja jooksul, mil te Esbrieti kasutate.
English: Your medicine is provided in either a 2-week treatment initiation pack, a 4-week treatment pack or in a bottle.
Estonian: Teie ravim on müügil 2-nädalase ravi alustamise pakendina, 4-nädalase ravipakendina või pudelis.
English: As a precautionary measure, it is preferable to avoid the use of Esbriet during pregnancy.
Estonian: Ettevaatusabinõuna on soovitav vältida Esbrieti kasutamist raseduse ajal.
English: Wear sunblock daily and cover your arms, legs and head to reduce exposure to sunlight (see section 4: Possible side effects).
Estonian: Kasutage iga päev päikesekaitsekreemi ja katke käsivarred, jalad ning pea, et vähendada kokkupuudet otsese päikesevalgusega (vt lõik 4 „Võimalikud kõrvaltoimed”).
English: The severity of phototoxic lesions was minimised by application of sunscreen.
Estonian: Fototoksiliste kahjustuste raskust sai minimeerida päiksekaitse kasutamisega.
English: 4 years for bottles.
Estonian: 4 aastat pudelitel.
English: 21 tablets 42 tablets) 90 tablets 180 tablets
Estonian: 21 tabletti 42 tabletti 90 tabletti 180 tabletti
English: Severe photosensitivity reactions are uncommon.
Estonian: Raskeid fotosensitiivsusreaktsioone esineb harva.
English: Adverse reactions were mild, transient, and consistent with the most frequently reported adverse reactions for pirfenidone.
Estonian: Kõrvaltoimed olid kerged, mööduvad ja kooskõlas pirfenidooni kõige sagedamini teatatud kõrvaltoimetega.
English: Dose reduction due to side effects
Estonian: Annuse vähendamine kõrvaltoimete tõttu
English: The capsules contain a white to pale yellow powder.
Estonian: Kapslid sisaldavad valget kuni helekollast pulbrit.
English: Each dose should be separated by at least 3 hours.
Estonian: Kahe annuse vahele peab jääma vähemalt 3 tundi.
English: 3 years for bottles.
Estonian: Pudelitel 3 aastat.
English: You may need to read it again.
Estonian: · Hoidke infoleht alles, et seda vajadusel uuesti lugeda.
English: If symptoms continue, see your doctor.
Estonian: Kui sümptomid püsivad, pöörduge oma arsti poole.
English: This is especially important if you are taking the following medicines, as they may change the effect of Esbriet.
Estonian: Eriti oluline on see järgmisi toimeaineid sisaldavate ravimite korral, mis võivad muuta Esbrieti toimet.
English: AUC0-∞ = area under the concentration-time curve from time zero to infinity.
Estonian: AUC0-∞ = kontsentratsioonikõvera alune pindala aja nullpunktist kuni lõpmatuseni.
English: Each pack contains a total of 63 capsules.
Estonian: Iga pakend sisaldab kokku 63 kapslit.
English: (sun; daytime dose) and (moon; evening dose).
Estonian: (päike; lõunane annus) ja (kuu; õhtune annus).
English: Esbriet is for oral use.
Estonian: Esbriet on suukaudseks kasutamiseks.
English: Decline of less than 10% No decline (FVC change >0%)
Estonian: Vähem kui 10% vähenemine Vähenemist ei ole (FVC muutus > 0%)
English: What Esbriet looks like and contents of the pack
Estonian: Kuidas Esbriet välja näeb ja pakendi sisu
English: Decline of ≥10% or death
Estonian: ≥ 10% vähenemine või surm
English: Following single dose administration of pirfenidone in healthy older adults, the mean apparent terminal elimination half-life was approximately 2.4 hours.
Estonian: Pirfenidooni üksikannuse manustamisel tervetele eakatele täiskasvanutele oli keskmine näiv terminaalse eliminatsiooni poolväärtusaeg ligikaudu 2,4 tundi.