FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP decided that Conbriza's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Conbriza kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The difference was more relevant in the sub-group of women at higher risk of fractures before the study.
Estonian: Erinevus oli olulisem alamrühmas, millesse kuulusid naised, kelle luumurrurisk enne uuringut oli suurem.
English: After two years, the average bone density remained almost unchanged in women who received Conbriza, but in women who received placebo it was reduced by over 1%.
Estonian: Pärast kaht aastat jäi keskmine luutihedus Conbrizat saanud naistel peaaegu muutumatuks, kuid platseebot saanutel vähenes üle 1% võrra.
English: The main measure of effectiveness was the number of new spine fractures over three years.
Estonian: Efektiivsuse põhinäitaja oli uute lülisambamurdude arv kolme aasta jooksul.
English: This is a summary of the European public assessment report (EPAR) for Conbriza.
Estonian: See on ravimi Conbriza Euroopa avaliku hindamisaruande kokkuvõte.
English: For more information about treatment with Conbriza, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Conbrizaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: It must not be used in women with unexplained bleeding from the womb and women with signs or symptoms of endometrial cancer (a cancer of the lining of the womb).
Estonian: Ravimit ei tohi kasutada naised, kellel esineb emaka seletamatut veritsust või endomeetriumivähi (emakalimaskestavähi) tunnuseid või sümptomeid.
English: The most common side effects with Conbriza (seen in more than 1 patient in 10) are hot flushes, muscle spasms and peripheral oedema (swelling, especially of the ankles and feet).
Estonian: Conbriza kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on kuumahood, lihasspasmid ja perifeerne ödeem (eelkõige pahkluude ja jalalabade turse).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Conbriza.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Conbriza, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Conbriza omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Conbriza is a medicine that contains the active substance bazedoxifene.
Estonian: Conbriza on ravim, mis sisaldab toimeainena basedoksifeeni.
English: What is the risk associated with Conbriza?
Estonian: Mis riskid Conbrizaga kaasnevad?
English: Conbriza is only for use in women who have been through the menopause, so it must not be used in women who could become pregnant.
Estonian: Conbrizat tohib kasutada ainult menopausijärgses eas naistel ja seda ei tohi kasutada rasestuda võivatel naistel.
English: Patients should also receive calcium and vitamin D supplements if they do not get enough from their diet.
Estonian: Kui patsient ei saa toidust piisavalt kaltsiumi ja D-vitamiini, tuleb võtta neid täiendavalt sisaldavaid valmistisi.
English: What is Conbriza?
Estonian: Mis on Conbriza?
English: It is used in women who are at risk of fracture (broken bones).
Estonian: Seda kasutatakse naistel, kellel on luumurdude risk.
English: Osteoporosis happens when not enough new bone grows to replace the bone that is naturally broken down.
Estonian: Osteoporoos tekib, kui loomulikul teel laguneva luukoe asemele ei moodustu piisavalt uut luukude.
English: In both main studies the effects of Conbriza were similar to the effects of raloxifene.
Estonian: Mõlemas põhiuuringus oli Conbriza toime sarnane raloksifeeni toimega.
English: Conbriza was also compared with raloxifene and placebo in another main study involving 1,583 postmenopausal women who were considered to be at risk of osteoporosis.
Estonian: Conbrizat võrreldi raloksifeeniga ja platseeboga ka teises põhiuuringus, kus osales 1583 menopausijärgses eas ja osteoporoosiriskiga naist.
English: After three years, 2% of the patients receiving Conbriza (35 out of 1,724) had new fractures compared with 4% of those receiving placebo (59 out of 1,741).
Estonian: Kolme aasta jooksul tekkis uus luumurd 2%-l Conbrizat saanud patsientidest (35 naist 1724-st).
English: Conbriza must not be used in women who have had venous thromboembolism events (problems due to the formation of blood clots in the veins) including deep vein thrombosis (a blood clot in a deep vein, usually in the leg), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Estonian: Conbrizat ei tohi kasutada naised, kellel on veenide trombemboolia (trombidest ehk soonesisestest verehüüvetest põhjustatud veeniprobleemid), sealhulgas süvaveenitromboos (tromb süvaveenis, tavaliselt jalas), kopsuemboolia (trombid kopsudes) või võrkkesta veeni tromboos (tromb silma tagaosas).
English: The active substance in Conbriza, bazedoxifene, is a selective oestrogen receptor modulator (SERM).
Estonian: Conbriza toimeaine basedoksifeen on selektiivne östrogeeni retseptori modulaator (SERM).
English: Why has Conbriza been approved?
Estonian: Miks Conbriza heaks kiideti?
English: For the full list of all side effects reported with Conbriza, see the package leaflet.
Estonian: Conbriza kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Conbriza has been compared with raloxifene (another medicine used to treat osteoporosis) and placebo (a dummy treatment) in one main study involving about 7,500 women with osteoporosis who had been through the menopause.
Estonian: Conbrizat võrreldi raloksifeeniga (samuti osteoporoosiravim) ja platseeboga (näiv ravim) ühes põhiuuringus, kus osales ligikaudu 7500 menopausijärgses eas ja osteoporoosiga naist.
English: What benefit has Conbriza shown during the studies?
Estonian: Milles seisneb uuringute põhjal Conbriza kasulikkus?
English: Conbriza has been shown to significantly reduce fractures in the spine but not in the hip.
Estonian: On tõestatud, et Conbriza vähendab lülisambamurde, kuid mitte puusamurde.
English: Bazedoxifene has the same effect as oestrogen in the bone.
Estonian: Basedoksifeen toimib luudele samamoodi kui östrogeen.
English: How is Conbriza used?
Estonian: Kuidas Conbrizat kasutatakse?
English: The main measure of effectiveness was the change in bone density (a measure of how strong the bones are) in the spine after two years of treatment.
Estonian: Efektiivsuse põhinäitaja oli lülisamba luutugevust näitava luutiheduse muutus kahe raviaasta järel.
English: Conbriza was not shown to be effective at reducing the number of fractures outside the spine.
Estonian: Conbriza ei olnud efektiivne muude luumurdude kui lülisambamurde vähendamisel.
English: What is Conbriza used for?
Estonian: Milleks Conbrizat kasutatakse?
English: In the first study, Conbriza was more effective than placebo at reducing the number of new spine fractures.
Estonian: Esimeses uuringus oli Conbriza uute lülisambamurdude tekkimise riski vähendamisel platseebost efektiivsem.
English: Conbriza is used for the treatment of osteoporosis (a disease that makes bones fragile) in women who have been through the menopause.
Estonian: Conbrizat kasutatakse menopausijärgses eas naistel osteoporoosi (luu-urbnemuse) raviks.
English: Bazedoxifene acts as an ‘agonist' of the oestrogen receptor (a substance that stimulates the receptor for oestrogen) in some tissues in the body.
Estonian: Basedoksifeen toimib teatud kudedes östrogeeniretseptori agonistina ehk ainena, mis stimuleerib seda retseptorit.
English: In the other study, Conbriza was also more effective than placebo at maintaining the bone density of the spine.
Estonian: Teises uuringus oli Conbriza lülisambaluutiheduse säilitamisel platseebost efektiivsem.
English: How has Conbriza been studied?
Estonian: Kuidas Conbrizat uuriti?
English: The medicine can only be obtained with a prescription.
Estonian: Conbriza on retseptiravim.
English: How does Conbriza work?
Estonian: Kuidas Conbriza toimib?
English: This summary was last updated in February 2013.
Estonian: Kokkuvõtte viimane uuendus: veebruar 2013.
English: This will help protect against the disease.
Estonian: See aitab loomi haiguse eest kaitsta.
English: Protection starts 21 days after vaccination and lasts for 105 days.
Estonian: Kaitse algab 21 päeva pärast vaktsineerimist ja kestab 105 päeva.
English: The effectiveness of the vaccine was first studied in a number of laboratory studies in piglets.
Estonian: Vaktsiini efektiivsust põrsastel uuriti kõigepealt mitmes laboratoorses uuringus.
English: Damage to the wall of small blood vessels in the brain results in characteristic nervous signs.
Estonian: Aju väikeste veresoonte seinte kahjustusega kaasnevad iseloomulikud närvisüsteemi nähud.
English: The vaccine is given as a single injection into a muscle, preferably the neck muscle behind the ear.
Estonian: Vaktsiin manustatakse ühe süstina lihasesse, eelistatult kaelalihasesse kõrva taha.
English: Genetically modified recombinant Stx2e antigen
Estonian: Geneetiliselt muundatud rekombinantne Stx2e antigeen
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Ecoporc Shiga on 10 April 2013.
Estonian: Euroopa Komisjon andis Ecoporc Shiga müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 10/04/2013.
English: The laboratory studies showed that the injection had its full effect by 21 days, and that protection lasted for at least 105 days after injection; protection was not affected by antibodies transmitted from the mother.
Estonian: Laboratoorsed uuringud näitasid, et süsti täielik toime tekkis 21. päevaks ja kaitse kestis vähemalt 105 päeva pärast süsti; kaitset ei mõjutanud emalt saadud antikehad.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Ecoporc Shiga exceed the risks for the approved indications and recommended that Ecoporc Shiga be given a marketing authorisation.
Estonian: Veterinaarravimite komitee otsustas, et Ecoporc Shiga kasulikkus on heakskiidetud näidustustel suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The most common side effects after injection of Ecoporc Shiga (which may affect up to 1 in 10 animals) are mild swelling, lasting for up to 7 days, at the injection site and a slight rise in body temperature for up to two days after injection; both resolve without treatment.
Estonian: Ecoporc Shiga kõige sagedamad kõrvalnähud (esinenud enam kui 1 loomal 10st) on kerge turse süstekohas, mis kestab kuni 7 päeva, ja kerge kehatemperatuuri tõus kuni kahe päeva jooksul pärast süsti; kumbki seisund ei vaja ravi.
English: In the future, if the animals are exposed to the bacteria producing the unmodified toxin, the immune system will be able to make antibodies against it more quickly.
Estonian: Kui loomad puutuvad hiljem kokku muundamata toksiini tootvate bakteritega, tekivad antikehad kiiremini.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Estonian: Vaktsiini juhuslikul endale süstimisel pöörduda viivitamatult arsti poole ja näidata pakendi infolehte või pakendi etiketti.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or eggs or milk used for human consumption.
Estonian: Keeluaeg on alates ravimi manustamisest arvestatav aeg, mille jooksul ei tohi looma tappa ega tema liha või piima toiduks tarvitada.
English: The purpose of the studies was to establish how long it took for piglets to be fully protected, the length of time protection lasts against oedema disease as well as the influence of maternal antibodies (transmitted from the mother) on the effectiveness of the vaccine.
Estonian: Uuringute eesmärk oli kindlaks teha, kui ruttu tekib põrsastel täielik kaitse, kui kaua kestab kaitse tursetõve vastu ja milline on emalt saadud antikehade mõju vaktsiini efektiivsusele.
English: The field studies showed that the vaccine reduced the mortality and clinical signs of oedema disease compared with placebo: in all three studies no piglets receiving Ecoporc Shiga died, while up to 11% of piglets receiving placebo died.
Estonian: Väliuuringud näitasid, et vaktsiin vähendas tursetõvest tingitud suremust ja kliinilisi nähte võrreldes platseeboga: kolmes uuringus ei surnud ükski Ecoporc Shigat saanud põrsas, samas kui 11% platseebot saanud põrsastest suri.
English: The modified toxin in the vaccine is produced by a method known as ‘recombinant DNA technology': it is made by bacteria which have received a gene (DNA) that makes them produce the modified toxin.
Estonian: Vaktsiinis sisalduvat muundatud toksiini toodetakse rekombinant-DNA-tehnika abil: seda toodavad bakterid, millele on lisatud toksiini teket võimaldav geen (DNA).
English: The withdrawal period for Ecoporc Shiga is zero days.
Estonian: Ecoporc Shiga keeluaeg on null päeva.
English: Ecoporc Shiga contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Estonian: Ecoporc Shiga sisaldab immuunvastuse tugevdamiseks adjuvanti (alumiiniumhüdroksiid).
English: Three field trials were also performed to assess the effect on mortality and clinical signs of oedema disease in a total of 518 piglets receiving Ecoporc Shiga compared with a similar number of piglets receiving placebo (a dummy injection).
Estonian: Samuti korraldati kolm väliuuringut, et hinnata vaktsiini mõju tursetõvest tingitud suremusele ja kliinilistele nähtudele kokku 518 põrsal, kes said Ecoporc Shigat, võrreldes sama arvu põrsastega, kes said platseebot (näiva ravimi süst).
English: Ecoporc Shiga is used in pigs from the age of 4 days for active immunisation against oedema disease, which leads to fluids accumulating in the tissues of the stomach and gut.
Estonian: Ecoporc Shigat kasutatakse põrsaste aktiivseks immuniseerimiseks alates 4. elupäevast tursetõve vastu, mis põhjustab vedeliku kogunemist mao ja soole kudedesse.
English: For a full list of all side effects reported with Ecoporc Shiga, see the package leaflet.
Estonian: Ecoporc Shiga kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Oedema disease is found worldwide and usually occurs in the first two weeks after weaning of the piglets, and is an acute (short-term) condition which can lead to death within 24 to 48 hours.
Estonian: See on äge (lühiajaline) seisund, mis võib põhjustada surma 24-48 tunni jooksul.
English: It is caused by a bacterial toxin (poison) known as Shiga toxin 2e (Stx2e) that is produced by certain strains of Escherichia coli.
Estonian: Neid põhjustab mõnede Escherichia coli tüvede toodetav bakteriaalne toksiin (mürk), mida nimetatakse Shiga toksiin 2e-ks (Stx2e).
English: Ecoporc Shiga is a vaccine containing the modified toxin Stx2e.
Estonian: Ecoporc Shiga on muundatud toksiini Stx2e sisaldav vaktsiin.
English: When Ecoporc Shiga is given to pigs, the animal's immune system recognises the toxin contained in the vaccine as ‘foreign' and makes antibodies against it.
Estonian: Ecoporc Shiga manustamisel sigadele peab looma immuunsüsteem vaktsiinis sisalduvat toksiini võõraks ja tekitab selle vastu antikehi.
English: What is Ecoporc Shiga?
Estonian: Mis on Ecoporc Shiga?
English: What is the risk associated with Ecoporc Shiga?
Estonian: Mis riskid Ecoporc Shigaga kaasnevad?
English: Other information about Ecoporc Shiga:
Estonian: Muu teave Ecoporc Shiga kohta
English: Why has Ecoporc Shiga been approved?
Estonian: Miks Ecoporc Shiga heaks kiideti?
English: How has Ecoporc Shiga been studied?
Estonian: Kuidas Ecoporc Shigat uuriti?
English: What is Ecoporc Shiga used for?
Estonian: Milleks Ecoporc Shigat kasutatakse?
English: How does Ecoporc Shiga work?
Estonian: Kuidas Ecoporc Shiga toimib?
English: What benefit has Ecoporc Shiga shown during the studies?
Estonian: Milles seisneb uuringute põhjal Ecoporc Shiga kasulikkus?
English: Ecoporc Shiga is a vaccine containing a form of Shiga toxin (Stx2e) that has been modified so that it can no longer cause disease.
Estonian: Ecoporc Shiga on vaktsiin, mis sisaldab Shiga toksiini vormi (Stx2e).
English: [carton only]:
Estonian: [ainult karbil]:
English: wait at least 2 to 3 hours before taking the other.
Estonian: 2 kuni 3 tundi, enne kui võtate teist ravimit.
English: EU/1/11/708/001 30 film-coated tablets EU/1/11/708/002 60 film-coated tablets EU/1/11/708/003 100 film-coated tablets EU/1/11/708/004 175 film-coated tablets
Estonian: EU/1/11/708/001 30 õhukese polümeerikattega tabletti EU/1/11/708/002 60 õhukese polümeerikattega tabletti EU/1/11/708/003 100 õhukese polümeerikattega tabletti EU/1/11/708/004 175 õhukese polümeerikattega tabletti
English: The INR values increased on average by 13% [CI90 6-19%].
Estonian: INR-tase tõusis keskmiselt 13% [CI90 6…19%].
English: The pharmacokinetic properties of entacapone are similar in both young people and elderly.
Estonian: Entakapooni farmakokineetilised omadused on sarnased nii noortel inimestel kui ka eakatel.
English: If this happens, you should not drive or use any tools or machines (see Driving and using machines).
Estonian: Kui see juhtub, ei tohi te juhtida autot või kasutada tööriistu või masinaid (vt lõik „Autojuhtimine ja masinatega töötamine“).
English: Approximately 92 % of the dose is eliminated during ß-phase with a short elimination half-life of 30 minutes.
Estonian: Umbes 92% annusest elimineerub B-faasi ajal lühikese eliminatsiooni poolväärtusajaga 30 minutit.
English: Entacapone can be taken with or without food (see section 5.2).
Estonian: Entakapooni võib manustada kas koos toiduga või ilma (vt lõik 5.2).
English: Pharmacotherapeutic group: other dopaminergic agents, ATC code: N04BX02.
Estonian: Farmakoterapeutiline rühm: teised dopamiinergilised ained, ATC-kood: N04BX02.
English: Daily ON time (Mean ±SD)
Estonian: Igapäevane ON-aeg (Keskmine ±SD)
English: 30 tablets 60 tablets 100 tablets 175 tablets
Estonian: 30 tabletti 60 tabletti 100 tabletti 175 tabletti
English: Patients who are hypersensitive to peanut or soya, should not use this medicinal product.
Estonian: Patsiendid, kes on ülitundlikud maapähklite või soja suhtes, ei tohi seda ravimit kasutada.
English: Therefore, the use of Entacapone Orion in children or adolescents cannot be recommended.
Estonian: Seetõttu ei saa soovitada Entacapone Orion'i kasutamist laste või noorukite puhul.
English: Weight decrease * Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
Estonian: Kehakaalu langus * Kõrvaltoimed on klassifitseeritud sageduse alusel, kõige sagedasem esimesena kasutades järgmist klassifikatsiooni: Väga sage (≥1/10); sage (≥1/100 kuni<1/10); aeg-ajalt (>1/1000 kuni <1/100); harv (≥1/10 000 kuni <1/1000); väga harv (≥1/10 000), teadmata (ei saa hinnata olemasolevate andmete alusel, kuni on olemas andmebaas kliinilistest uuringutest või epidemioloogilistest uuringutest).
English: Date of first authorisation: 18 August 2011 Date of latest renewal: 8 April 2016
Estonian: Müügiloa esmase väljastamise kuupäev: 18/08/2011 Müügiloa viimase uuendamise kuupäev: 08/04/2016
English: To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks.
Estonian: Eemaldage kork ja seejärel vajutage pöidlaga purgisuu kattele, kuni see puruneb.
English: Entacapone showed little or no inhibition of other types of P450 isoenzymes (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A and CYP2C19) (see section
Estonian: Entakapoon näitas vähest või mitte mingit pärssivat toimet teistele P450 tüübi isoensüümidele (CYP1A2, CYP2A6, CYP2D6, CYP2E1, CYP3A ja CYP2C19) (vt lõik 4.5).
English: For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Estonian: Lisaküsimuste tekkimisel selle ravimi kohta pöörduge palun müügiloa hoidja kohaliku esindaja poole:
English: 2D barcode carrying the unique identifier included [carton only]
Estonian: Lisatud on 2D-vöötkood, mis sisaldab ainulaadset identifikaatorit [ainult karbil]
English: Entacapone binds to human albumin binding site II which also binds several other medicinal products, including diazepam and ibuprofen.
Estonian: Entakapoon seostub inimese albumiiniga II asendis, mis seob ka mitmeid teisi ravimeid nagu diasepaam ja ibuprofeen.
English: Data from in vitro studies using human liver microsomal preparations indicate that entacapone inhibits cytochrome P450 2C9 (IC50 4 µM).
Estonian: Andmed in vitro uuringutest, milles kasutati inimese maksa mikrosomaalseid preparaate, näitavad, et entakapoon inhibeerib tsütokroom P450 2C9 (IC50 4 µM).
English: It is estimated that 8090% of the dose is excreted in faeces, although this has not been confirmed in man.
Estonian: Arvatakse, et umbes 80…90% annusest eritub roojaga, kuigi see pole inimese puhul kinnitatud.
English: For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
Estonian: Haigetel, kellel on kujunenud suhteliselt lühikese ajaga progressiivne anoreksia, asteenia ja kaalu langus, peaks tegema üldise meditsiinilise läbivaatuse kaasaarvatud maksafunktsiooni hindamise.
English: COMT inhibition in red blood cells closely follows the plasma concentrations of entacapone, thus clearly indicating the reversible nature of COMT inhibition.
Estonian: COMT inhibeerimine punastes verelibledes järgneb koheselt entakapooni plasmakontsentratsioonile, mis näitab selgelt COMT inhibeerimise pöörduvat iseloomu.
English: Hepatitis with mainly cholestatic features (see section 4.4.)
Estonian: Hepatiit koos peamiselt kolestaatiliste nähtudega (vt lõik 4.4)
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle label.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja purgi sildil.
English: However, in an interaction study with healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-26%].
Estonian: Tervetel vabatahtlikel tehtud, koostoimet käsitlevas uuringus ei mõjutanud entakapoon sellest hoolimata S-varfariini kontsentratsiooni vereplasmas, samas R-varfariini AUC oli keskmiselt 18% kõrgem [CI90 11…26%].
English: The safety of entacapone in infants is unknown.
Estonian: Entakapooni ohutus imikutel on teadmata.
English: See Section 2 Warnings and precautions.
Estonian: Vt lõik „Hoiatused ja ettevaatusabinõud“.
English: This medicinal product does not require any special storage conditions.
Estonian: See ravimpreparaat ei nõua säilitamisel eritingimusi.
English: 10-20% is excreted in urine.
Estonian: Umbes 10...20% eritub uriiniga.
English: However, for patients who are receiving dialysis therapy, a longer dosing interval may be considered (see section 5.2).
Estonian: Siiski tuleb dialüüsi saavatel patsientidel kaaluda pikemaid manustamisintervalle (vt lõik 5.2).
English: Polyvinyl alcohol, partly hydrolysed Talc
Estonian: Polüvinüülalkohol, osaliselt hüdrolüüsitud Talk