FrancophonIA/ELRC3.0 huggingface dataset:
English: Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Estonian: Toime rinnavähi resistentsusvalgule ( ingl Breast Cancer Resistance Protein, BRCP) ja/või orgaanilisi anioone transportivate polüpeptiidide B1 ja B3 (OATP1B1/B3) substraatidele A771726 korduval manustamisel täheldati rosuvastatiini keskmise Cmax ja AUC tõusu (vastavalt 2,65 ja 2,51 korda).
English: EU/1/09/604/005 30 tablets EU/1/09/604/006 50 tablets EU/1/09/604/007 100 tablets
Estonian: EU/1/09/604/005 30 tabletti EU/1/09/604/006 50 tabletti EU/1/09/604/007 100 tabletti
English: Film-coated tablet.
Estonian: Õhukese polümeerikattega tablett.
English: Rare cases of severe liver injury, including cases with fatal outcome, have been reported during treatment with leflunomide.
Estonian: Leflunomiidravi ajal on esinenud üksikuid tõsiseid maksakahjustusi, sealhulgas surmaga lõppenud juhte.
English: Package leaflet: Information for the user Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Estonian: Pakendi infoleht: teave kasutajale Leflunomide Zentiva 100 mg õhukese polümeerikattega tabletid
English: Rare side effects (may affect up to 1 in 1,000 people)
Estonian: Harva esinevad kõrvaltoimed (võib esineda kuni 1 inimesel 1000-st)
English: 6.6 Special precautions for disposal
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks ja käsitlemiseks
English: agranulocytosis
Estonian: agranulotsütoos
English: Common side effects (may affect up to 1 in 10 people)
Estonian: Sagedased kõrvaltoimed (võib esineda kuni 1 inimesel 10-st)
English: Common:
Estonian: Aeg-ajalt:
English: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin Uncommon: urticaria
Estonian: juuste suurenenud väljalangemine, ekseem, lööve (sh makulopapulaarne lööve), sügelus, kuiv nahk
English: Posology
Estonian: kõõlusrebend
English: Each tablet contains 20 mg leflunomide.
Estonian: Iga tablett sisaldab 20 mg leflunomiidi.
English: • before initiation of leflunomide
Estonian: Leflunomiid (leflunomidum)
English: - if you are male and wish to father a child. As it can not be excluded that Leflunomide Zentiva passes into semen, reliable contraception should be used during treatment with Leflunomide Zentiva.
Estonian: Ei saa välistada Leflunomide Zentiva eritumist seemnevedelikku, ravi ajal Leflunomide Zentiva'ga tuleb kasutada tõhusat rasestumisvastast vahendit.
English: Leflunomide Zentiva 20 mg film-coated tablets leflunomide
Estonian: Leflunomide Zentiva 20 mg õhukese polümeerikattega tabletid Leflunomidum
English: Leflunomide Zentiva 20 mg film-coated tablets
Estonian: Leflunomide Zentiva 20 mg õhukese polümeerikattega tabletid
English: Each tablet contains 10 mg leflunomide.
Estonian: Iga tablett sisaldab 10 mg leflunomiidi.
English: Uncommon side effects (may affect up to 1 in 100 people)
Estonian: Aeg-ajalt esinevad kõrvaltoimed (võib esineda kuni 1 inimesel 100-st)
English: Uncommon: taste disturbances
Estonian: maitsetundlikkuse häired
English: One film-coated tablet contains 20 mg of leflunomide - The other ingredients are: maize starch, povidone (E1201), crospovidone (E1202), silica colloidal anhydrous, magnesium stearate (E470b), and lactose monohydrate in the tablet core, as well as talc (E553b), hypromellose (E464), titanium dioxide (E171), macrogol 8000 and yellow ferric oxide (E172) in the film-coating.
Estonian: - Teised abiained on: maisitärklis, povidoon (E1201), krospovidoon (E1202), veevaba kolloidne räni, magneesiumstearaat (E470b) ja laktoosmonohüdraat tableti sisus; talk (E553b), hüpromelloos (E464), titaandioksiid (E171), makrogool 8000 jakollane raudoksiid (E172) tableti kattes.
English: One film-coated tablet contains 100 mg of leflunomide.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 100 mg leflunomiidi.
English: Leflunomide Zentiva 100 mg film-coated tablets leflunomide
Estonian: Leflunomide Zentiva 100 mg õhukese polümeerikattega tabletid Leflunomidum
English: EU/1/09/604/008 30 tablets EU/1/09/604/009 100 tablets
Estonian: EU/1/09/604/008 30 tabletti EU/1/09/604/009 100 tabletti
English: Renal and urinary disorders Not known:
Estonian: Neerude ja kuseteede häired Teadmata:
English: There have been case reports of increased prothrombin time, when leflunomide and warfarin were co-administered.
Estonian: Leflunomiidi ja varfariini koosmanustamisel on teatatud protrombiini aja pikenemise üksikjuhtudest.
English: Liver reactions
Estonian: Nahareaktsioonid
English: Each tablet contains 100 mg of leflunomide.
Estonian: Iga tablett sisaldab 100 mg leflunomiidi.
English: The risk of their occurrence can be increased in patients with a history of interstitial lung disease.
Estonian: Varasema interstitsiaalse kopsuhaigusega patsientidel võib nende haiguste tekkerisk olla ssuurem.
English: Leflunomide Zentiva 10 mg film-coated tablets leflunomide
Estonian: Leflunomide Zentiva 10 mg õhukese polümeerikattega tabletid Leflunomidum
English: One film-coated tablet contains 10 mg of leflunomide.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 10 mg leflunomiidi.
English: Leflunomide Zentiva 100 mg film-coated tablets
Estonian: Leflunomide Zentiva 100 mg õhukese polümeerikattega tabletid
English: Each film-coated tablet contains 100 mg leflunomide.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 100 mg leflunomiidi.
English: Leflunomide Zentiva 10 mg film-coated tablets
Estonian: Leflunomide Zentiva 10 mg õhukese polümeerikattega tabletid
English: EU/1/09/604/001 30 tablets EU/1/09/604/002 100 tablets
Estonian: EU/1/09/604/001 30 tabletti EU/1/09/604/002 100 tabletti
English: EU/1/09/604/003 30 tablets EU/1/09/604/004 100 tablets
Estonian: EU/1/09/604/003 30 tabletti EU/1/09/604/004 100 tabletti
English: - a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood platelets (thrombocytopenia), - a decrease in the levels of potassium in the blood, - anxiety, - taste disturbances, - urticaria (nettle rash), - tendon rupture, - an increase in the levels of fat in the blood (cholesterol and triglycerides), - a decrease in the levels of phosphate in the blood.
Estonian: (trombotsütopeenia), - vere kaaliumisisalduse langus, - ärevus, - maitsmismeele häired, - urtikaaria (nõgestõbi), - kõõlusrebend, - vere rasvasisalduse (kolesterool ja triglütseriidid) tõus, - fosfaaditaseme langus veres.
English: Binding of A771726 appeared slightly reduced and more variable in plasma from patients with rheumatoid arthritis or chronic renal insufficiency.
Estonian: Reumatoidartriidi või kroonilise neerupuudulikkusega patsientidel on A771726 seondumine valkudega vereplasmas veidi piiratum ja varieeruvam.
English: Each film-coated tablet contains 20 mg leflunomide.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 20 mg leflunomiidi.
English: Therefore, closer monitoring of liver enzymes and haematological parameters is recommended in the initial phase after switching.
Estonian: Seetõttu on vahetult pärast preparaadi vahetust soovitatav hoolikas maksaensüümide ja verenäitajate kontrollimine.
English: hypouricemia Psychiatric disorders Uncommon: anxiety Nervous system disorders Common:
Estonian: hüpourikeemia Psühhiaatrilised häired Aeg-ajalt:
English: Excipients with known effect Each tablet contains 78 mg of lactose monohydrate.
Estonian: Iga tablett sisaldab 78 mg laktoosmonohüdraati.
English: Oral use.
Estonian: Infolehe sisukord
English: Each film-coated tablet contains 10 mg leflunomide.
Estonian: Iga õhukese polümeerikattega tablett sisaldab 10 mg leflunomiidi.
English: - an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the number of white blood cells (leucopenia); decrease in the number of all blood cells
Estonian: - vere punaliblede arvu langus (aneemia) ja vereliistakute (trombotsüütide) arvu langus
English: Excipients with known effect Each tablet contains 72 mg of lactose monohydrate.
Estonian: Iga tablett sisaldab 72 mg laktoosmonohüdraati.
English: Ref.: EMEA/540887/2009 EMEA/H/C/1036
Estonian: Viide: EMEA/540887/2009 EMEA/H/C/1036
English: This summary was last updated in 10-2009.
Estonian: Kokkuvõtte viimane uuendus: 10-2009.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Biopoin to CT Arzneimittel GmbH on 23 October 2009.
Estonian: Euroopa Komisjon andis Biopoin müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele CT Arzneimittel GmbH 23. oktoobril 2009.
English: The Committee recommended that Biopoin be given marketing authorisation.
Estonian: Komitee soovitas anda Biopoinle müügiloa.
English: It is available in pre-filled syringes containing between 1,000 and 30,000 international units (IU) of the active substance, epoetin theta.
Estonian: Seda turustatakse eeltäidetud süstaldes, mis sisaldavad 1000-30 000 rahvusvahelist ühikut (IU) toimeainet teetaepoetiini.
English: Because of the risk of high blood pressure, special care should be taken to monitor and control the patient's blood pressure to avoid complications such as a hypertensive crisis.
Estonian: Kõrge vererõhu riski tõttu tuleb patsiendi vererõhku väga hoolikalt jälgida ja kontrollida, et vältida tüsistusi (nt hüpertensiivne kriis).
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Estonian: Kui soovite lisateavet inimravimite komitee soovituste aluse kohta, lugege palun teadusliku arutelu kokkuvõtet (samuti Euroopa avaliku hindamisaruande osa).
English: The main measure of effectiveness was the average change in haemoglobin levels from 15 to 26 weeks after treatment.
Estonian: Efektiivsuse põhinäitaja oli keskmine hemoglobiinisisalduse muutus 15-26 nädala jooksul pärast ravi.
English: Patients with cancer should continue to receive treatment for up to four weeks after they stop receiving chemotherapy.
Estonian: Vähipatsientidel tuleb ravi jätkata kuni nelja nädala jooksul pärast keemiaravi lõppu.
English: Other information about Biopoin:
Estonian: Muu teave Biopoin kohta
English: There were four main studies in 842 chronic renal failure patients and three main studies in 586 nonmyeloid cancer patients receiving chemotherapy.
Estonian: Toimet uuriti neljas põhiuuringus, milles osales 842 kroonilise neerupuudulikkusega patsienti, ja kolmes põhiuuringus, milles osales 586 keemiaravi saavat mittemüeloidse vähiga patsienti.
English: Patients who receive Biopoin by injection under the skin may inject themselves once they have been trained appropriately.
Estonian: Biopoint nahaaluse süstena saavad patsiendid võivad süstida ravimit endale ise, kui nad on saanud asjakohase väljaõppe.
English: It must not be used in patients with uncontrolled hypertension.
Estonian: Ravimit ei tohi kasutada ravile allumatu hüpertensiooniga patsiendid.
English: The other two studies compared Biopoin with epoetin beta during the maintenance phase.
Estonian: Ülejäänud kahes uuringus võrreldi Biopoint beetaepoetiiniga ravi säilitusfaasi ajal.
English: The most common side effects with Biopoin (seen in between 1 and 10 patients in 100) are shunt thrombosis (clots that can form in blood vessels of patients on dialysis, a blood clearance technique), headache, hypertension (high blood pressure), hypertensive crisis (sudden, dangerously high blood pressure), skin reactions, arthralgia (joint pain) and influenza (flu)-like illness.
Estonian: Biopoin kõige sagedamad kõrvalnähud (esinenud ühel kuni kümnel patsiendil sajast) on šundi tromboos (trombid ehk soonesisesed verehüübed, mis võivad tekkida dialüüsravil (teatud verepuhastusprotseduur)), peavalu, hüpertensioon (kõrge vererõhk), hüpertensiivne kriis (vererõhu äkiline ja ohtlik tõus), nahareaktsioonid, artralgia (liigesevalu) ja gripilaadne haigusseisund.
English: Biopoin should not be used in people who may be hypersensitive (allergic) to epoetin theta, to any other epoetins or substances derived from them, or to any of the other ingredients of Biopoin.
Estonian: Biopoint ei tohi kasutada patsiendid, kes võivad olla teetaepoetiini, teiste epoetiinide või nende derivaatide või Biopoin mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: It is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin theta.
Estonian: Teetaepoetiini valmistatakse rekombinant-DNA-tehnika abil: seda toodab rakk, millele on lisatud teetaepoetiini teket võimaldav geen (DNA).
English: These doses may be doubled after four weeks if the improvement is not enough and may be increased further at monthly intervals by a quarter of the previous dose until the right level of haemoglobin (the protein found in red blood cells that carries oxygen around the body) is achieved.
Estonian: Kui seisund piisavalt ei parane, võib neid annuseid nelja nädala pärast kahekordistada ja neid võib ka edaspidi suurendada iga kuu järel eelmisest annusest 25% võrra, kuni saavutatakse hemoglobiini (vere punaliblede valk, mis kannab organismis edasi hapnikku) vajalik väärtus.
English: The main measure of effectiveness in two of these studies was based on whether increasing the dose of Biopoin from 20 or 40 IU per kg body weight to 120 IU per kg body weight led to improvements in haemoglobin levels during the correction phase.
Estonian: Neist kahes oli efektiivsuse põhinäitaja see, kas Biopoin annuste suurendamine annustelt 20 või 40 IU kehamassi kg kohta annuseni 120 IU kehamassi kg kohta parandab ravi korrektsioonifaasi ajal hemoglobiinisisaldust.
English: For patients with cancer, injections should be given under the skin.
Estonian: Vähipatsientidele tuleb ravimit süstida naha alla.
English: When the anaemia has been corrected, the dose in the ‘maintenance phase' should be adjusted to maintain the right level of haemoglobin.
Estonian: Kui aneemia on ravitud, tuleb säilitusfaasis annust kohandada, et säilitada vajalik hemoglobiinisisaldus.
English: In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Estonian: Keemiaravi saavatel või neeruprobleemidega patsientidel võib aneemiat põhjustada erütropoetiini vähesus või organismi ebapiisav reageerimine organismis sisalduvale looduslikule erütropoetiinile.
English: What is Biopoin?
Estonian: Mis on Biopoin?
English: What is the risk associated with Biopoin?
Estonian: Mis riskid kaasnevad Biopoinga?
English: Biopoin epoetin theta
Estonian: Biopoin teetaepoetiin
English: Why has Biopoin been approved?
Estonian: Miks Biopoin heaks kiideti?
English: In chronic renal failure patients, the correction phase showed that increasing the starting dose of Biopoin leads to improvements in haemoglobin levels.
Estonian: Kroonilise neerupuudulikkusega patsientide uuringutes selgus korrektsioonifaasi kohta, et Biopoin algannuse suurendamine parandab hemoglobiinisisaldust.
English: For full details, see the Package Leaflet.
Estonian: Üksikasjalik teave on pakendi infolehel.
English: This dose may be doubled after four weeks if the haemoglobin has not increased by at least 1 g/dl and can, if needed, be increased further to 60,000 IU after four additional weeks.
Estonian: Kui hemoglobiini sisaldus ei ole neljanädalase ravi järel vähemalt 1 g/dl võrra suurenenud, võib annust kahekordistada ja pärast veel nelja ravinädalat võib annust vajaduse korral suurendada 60 000 IU-ni. Biopoin annus ei tohi ületada annust 60 000 IU nädalas.
English: The initial recommended dose is 20,000 IU once a week for all patients irrespective of their body weight.
Estonian: Soovitatav algannus on kõigile patsientidele olenemata kehamassist 20 000 IU üks kord nädalas.
English: The full EPAR for Biopoin can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Biopoin kohta leiate siit.
English: The weekly dose of Biopoin should not at any time be more than 700 IU per kg body weight.
Estonian: Biopoin suurim annus ei tohi ületada annust 700 IU kehamassi kg kohta nädalas.
English: In the four renal failure studies, patients were given either Biopoin (under the skin or into a vein) or epoetin beta (another erythropoietin-like medicine used for anaemia).
Estonian: Neljas neerupuudulikkusega patsientide uuringus manustati patsientidele Biopoint (nahaaluste või veenisiseste süstetena) või beetaepoetiini (samuti erütropoetiini taoline aneemiaravim).
English: For the full list of all side effects reported with Biopoin, see the Package Leaflet.
Estonian: Biopoin kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: The other two renal failure studies showed that during the maintenance stage the change in haemoglobin levels was similar in patients receiving Biopoin and patients receiving epoetin beta.
Estonian: Ülejäänud kahes neerupuudulikkusega patsientidel tehtud uuringus näidati, et säilitusfaasis oli hemoglobiinisisalduse muutus Biopoint ja beetaepoetiini saanud patsientidel sarnane.
English: It is used in adults with chronic renal failure (long-term, progressive decrease in the ability of the kidneys to work properly) and in adults with non-myeloid cancer (cancer not originating in the bone marrow) who are receiving chemotherapy (medicines to treat cancer).
Estonian: Ravimit kasutatakse kroonilise neerupuudulikkusega (neerutalitluse pikaajaline süvenev halvenemine) täiskasvanutel ja mittemüeloidse vähi (vähk, mis ei lähtu luuüdist) tõttu keemiaravi (vähiravimeid) saavatel täiskasvanutel.
English: Biopoin is used to treat anaemia (low levels of red blood cells or haemoglobin) that is causing symptoms.
Estonian: Biopoint kasutatakse aneemia (vere punaliblede või hemoglobiini vähene sisaldus) raviks.
English: The epoetin theta in Biopoin works in the body in the same way as the natural hormone to stimulate red blood cell production.
Estonian: Biopoins sisalduv teetaepoetiin stimuleerib organismis punaliblede teket samamoodi nagu looduslik hormoon.
English: Average weekly increases in haemoglobin were 0.73 and 0.58 g/dl in patients receiving the higher dose of Biopoin compared with 0.20 and 0.26 g/dl in patients receiving the lower dose of Biopoin.
Estonian: Patsientidel, kes said suuremat Biopoin annust, suurenes hemoglobiinisisaldus nädalas keskmiselt 0,73 ja 0,58 g/dl võrra, Biopoin väiksemat annust saanud patsientidel 0,20 ja 0,26 g/dl võrra.
English: The effects of Biopoin were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Biopoin toimet muude katsetega.
English: Biopoin was effective at treating anaemia in patients with chronic renal failure and patients with nonmyeloid cancer who were receiving chemotherapy.
Estonian: Biopoin oli aneemia ravis efektiivne nii kroonilise neerupuudulikkusega patsientidel kui ka mittemüeloidse vähiga patsientidel, kes said keemiaravi.
English: In the cancer studies, the main measure of effectiveness was the number of patients receiving either Biopoin or placebo (a dummy treatment) with an increase in haemoglobin of 2 g/dl over 12 or 16 weeks.
Estonian: Vähipatsientide uuringutes, kus patsientidele manustati Biopoint või platseebot (näiv ravim), oli efektiivsuse põhinäitaja patsientide arv, kelle hemoglobiinisisaldus suurenes 12 või 16 nädala jooksul 2 g/dl võrra.
English: For patients with kidney failure, in the ‘correction phase', the initial recommended dose, given three times a week, is 20 IU per kilogram body weight for injections under the skin or 40 IU per kg body weight for injections into a vein.
Estonian: Neerupuudulikkusega patsientidele on korrektsioonifaasis soovitatav algannus 20 IU kehamassi kg kohta, manustatuna kolm korda nädalas nahaaluste süstetena, või 40 IU kehamassi kg kohta manustatuna veenisiseste süstetena.
English: In the cancer studies, between 64 and 73% of patients who received Biopoin had an increase in haemoglobin of 2 g/dl compared with between 20 and 26% of patients who were given placebo.
Estonian: Vähipatsientide uuringutes selgus, et patsientide osakaal, kellel hemoglobiinisisaldus suurenes 2 g/dl võrra, oli Biopoint saanud patsientidest 64-73% ja platseebot saanud patsientidest 20-26%.
English: What benefit has Biopoin shown during the studies?
Estonian: Milles seisneb uuringute põhjal Biopoin kasulikkus?
English: How does Biopoin work?
Estonian: Kuidas Biopoin toimib?
English: What is Biopoin used for?
Estonian: Milleks Biopoint kasutatakse?
English: How is Biopoin used?
Estonian: Kuidas Biopoint kasutatakse?
English: How has Biopoin been studied?
Estonian: Kuidas Biopoint uuriti?
English: The active substance in Biopoin, epoetin theta, is a copy of a human hormone called erythropoietin that stimulates the production of red blood cells from the bone marrow.
Estonian: Biopoin toimeaine teetaepoetiin on inimese hormooni erütropoetiini koopia.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Biopoin's benefits are greater than its risks for the treatment of symptomatic anaemia in adults with chronic renal failure and adults with non-myeloid cancers who are receiving chemotherapy.
Estonian: Inimravimite komitee otsustas, et kroonilise neerupuudulikkusega täiskasvanutel ja mittemüeloidse vähi tõttu keemiaravi saavatel patsientidel on Biopoin kasulikkus sümptomaatilise aneemia ravimisel suurem kui kaasnevad riskid.
English: Biopoin treatment should be started by a doctor experienced in treating symptomatic anaemia in patients with chronic renal failure and non-myeloid cancer.
Estonian: Ravi Biopoinga võib alustada üksnes kroonilise neerupuudulikkusega ja mittemüeloidse vähiga patsientide sümptomaatilise aneemia ravikogemusega arst.
English: Erythropoietin is produced by the kidneys.
Estonian: Neerudes tekkiv erütropoetiin stimuleerib luuüdis punaliblede teket.
English: Biopoin is a solution for injection.
Estonian: Biopoin on süstelahus.
English: - The other ingredients are:
Estonian: - Teised koostisosad on:
English: 3 years
Estonian: 3 aastat.
English: OTHER Do not open before use.
Estonian: MUU Enne kasutamist mitte avada.
English: Elderly patients (≥ 65 years)
Estonian: Eakad (≥ 65-aastased)
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Estonian: AINULAADNE IDENTIFIKAATOR - INIMLOETAVAD ANDMED PC:
English: Both patients recovered from these adverse reactions.
Estonian: Mõlemad patsiendid taastusid nendest kõrvaltoimetest.
English: Other medicines and Ofev
Estonian: Muud ravimid ja Ofev
English: Based on this information your doctor may do some blood tests, for example to check your liver function.
Estonian: Sellele infole tuginedes võib arst teha mõned vereproovid, et kontrollida näiteks teie maksafunktsiooni.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 15. jaanuar 2015
English: It is important to take this medicine every day, as long as your doctor prescribes it for you.
Estonian: Oluline on ravimit võtta iga päev seni, kuni arst on seda teile määranud.
English: Date of latest renewal: 23 September 2019
Estonian: Müügiloa viimase uuendamise kuupäev: 23. september 2019
English: No overall differences in safety and efficacy were observed for elderly patients.
Estonian: Eakatel patsientidel ei täheldatud üldisi erinevusi ohutuses ja efektiivsuses.
English: Your doctor will discuss the results of these tests with you and decide whether you may receive Ofev.
Estonian: Teie arst arutab teiega nende analüüside tulemusi ja otsustab, kas teile on võimalik Ofevi määrata.
English: Pruritus, Alopecia
Estonian: Pruritus, alopeetsia
English: It is recommended that you take the capsules with food, i.e. during or immediately before or after a meal.
Estonian: Kapslid on soovitatav võtta koos toiduga, s.t kas söögi ajal või vahetult enne või pärast sööki.
English: A risk to the newborns/infants cannot be excluded.
Estonian: Riski vastsündinutele/imikutele ei saa välistada.
English: Similar results were observed in analyses using a conservative threshold of 10%.
Estonian: Sarnaseid tulemusi täheldati ka analüüsides, milles kasutati konservatiivset, 10%-list läviväärtust.
English: Not all pack-sizes may be marketed.
Estonian: Kõik pakendi suurused ei pruugi olla müügil.