FrancophonIA/ELRC3.0 huggingface dataset:
English: Myalepta received a marketing authorisation valid throughout the EU on 30 July 2018.
Estonian: Myalepta nimetati 17. juulil 2012 harvikravimiks.
English: Myalepta can only be obtained with a prescription and treatment should be started and monitored by a doctor experienced in the diagnosis and management of patients with metabolic disorders.
Estonian: Ravi peab alustama ja jälgima ainevahetushäiretega patsientide diagnostikas ja ravis kogenud arst.
English: Myalepta is a medicine used in addition to diet to treat lipodystrophy, where patients have loss of fatty tissue under the skin and build-up of fat elsewhere in the body such as in the liver and muscles.
Estonian: See on seisund, mille korral nahaalune rasvkude väheneb ja rasv ladestub mujal organismis, näiteks maksas ja lihastes.
English: Because the number of patients with the various forms of lipodystrophy is low, the diseases are considered ‘rare', and Myalepta was designated an ‘orphan medicine' (a medicine used in rare diseases) on 17 July 2012.
Estonian: Lipodüstroofia eri vormidega patsientide arv on väike ja neid haigusi esineb harva.
English: It is available as capsules (1.5 mg, 3 mg, 4.5 mg and 6 mg) and as an oral solution (2 mg/ml).
Estonian: Seda turustatakse kapslitena (1,5 mg, 3 mg, 4,5 mg and 6 mg) ja suukaudse lahusena (2 mg/ml).
English: The full EPAR for Rivastigmine 1 A Pharma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Rivastigmine 1 A Pharma kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 1 A Pharma on 11 December 2009.
Estonian: Euroopa Komisjon andis Rivastigmine 1 A Pharma müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 11. detsembril 2009.
English: Rivastigmine 1 A Pharma should be given twice a day, with morning and evening meals.
Estonian: Rivastigmine 1 A Pharmat manustatakse kaks korda ööpäevas, hommiku- ja õhtusöögi ajal.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Rivastigmine 1 A Pharma by the patient.
Estonian: Ravi tohib alustada vaid sel juhul, kui on olemas hooldaja, kes jälgib regulaarselt, kuidas patsient kasutab Rivastigmine 1 A Pharmat.
English: Overall, the most common side effects include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine 1 A Pharma is being increased.
Estonian: Kokkuvõttes on kõige sagedamad kõrvalnähud iiveldus (esinenud 38 patsiendil 100st) ja oksendamine (esinenud 23 patsiendil 100st), eelkõige Rivastigmine 1 A Pharma annuse suurendamise etapil.
English: Therefore, the Committee decided that Rivastigmine 1 A Pharma's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu otsustas inimravimite komitee, et Rivastigmine 1 A Pharma kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: Rivastigmine 1 A Pharma has been studied in three main studies involving 2,126 patients with mild to moderately severe Alzheimer's disease.
Estonian: Rivastigmine 1 A Pharmat uuriti kolmes põhiuuringus, milles osales 2126 kerge kuni mõõdukalt raskekujulise Alzheimeri tõvega patsienti.
English: An additional study in 27 patients was used to show that Rivastigmine 1 A Pharma capsules and oral solution produced similar levels of the active substance in the blood.
Estonian: Täiendava uuringuga, milles osales 27 patsienti, näidati, et Rivastigmine 1 A Pharma kapslite ja suukaudse lahuse kasutamise tulemusena oli toimeaine sisaldus veres sarnane.
English: Rivastigmine 1 A Pharma is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Estonian: Rivastigmine 1 A Pharmat kasutatakse kerge kuni mõõdukalt raskekujulise Alzheimeri dementsusega patsientide raviks; see on progresseeruv ajuhäire, mis kahjustab järk-järgult mälu, vaimseid võimeid ja käitumist.
English: By blocking these enzymes, Rivastigmine 1 A Pharma allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Estonian: Nende ensüümide blokeerimisega võimaldab Rivastigmine 1 A Pharma atsetüülkoliini sisaldusel ajus suureneda, mis aitab vähendada Alzheimeri dementsuse ja Parkinsoni tõvega kaasneva dementsuse sümptomeid.
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine 1 A Pharma's benefits did not outweigh its risks.
Estonian: Inimravimite komitee jõudis algul järeldusele, et Parkinsoni tõvega kaasneva dementsuse ravis ei ole Rivastigmine 1 A Pharma kasulikkus suurem kui sellega kaasnevad riskid.
English: All of the studies lasted six months and compared the effects of Rivastigmine 1 A Pharma with those of placebo (a dummy treatment).
Estonian: Kõikide uuringute kestus oli kuus kuud ja neis võrreldi Rivastigmine 1 A Pharma toimet platseebo (näiv ravim) toimega.
English: For more information about treatment with Rivastigmine 1 A Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Rivastigmine 1 A Pharmaga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In the three studies of Rivastigmine 1 A Pharma in patients with Alzheimer's dementia, patients taking doses of Rivastigmine 1 A Pharma between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Estonian: Kolmes uuringus Rivastigmine 1 A Pharma kasutamise kohta Alzheimeri dementsusega patsientidel paranes Rivastigmine 1 A Pharmat annuses 6-9 mg ööpäevas kasutanud patsientidel kognitiivsete sümptomite punktisumma keskmiselt 0,2 punkti võrra, võrreldes 22,9 punktiga uuringu algul, kusjuures väiksem punktiarv näitab paremaid tulemusi.
English: In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Estonian: Kui patsient seda annust talub, võib annust 1,5 mg kaupa suurendada mitte sagedamini kui kahenädalase intervalliga tavapärase annuseni
English: Other information about Rivastigmine 1 A Pharma
Estonian: Muu teave Rivastigmine 1 A Pharma kohta
English: The CHMP concluded that Rivastigmine 1 A Pharma has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Estonian: Inimravimite komitee järeldas, et Rivastigmine 1 A Pharma efektiivsus Alzheimeri dementsuse sümptomite ravis on olnud tagasihoidlik, kuigi mõnel patsiendil on sellest olnud oluliselt kasu.
English: Rivastigmine 1 A Pharma must not be used in people who are hypersensitive (allergic) to rivastigmine, other carbamate derivatives or any of the other ingredients.
Estonian: Rivastigmine 1 A Pharmat ei tohi kasutada patsiendid, kes on rivastigmiini, karbamaadi derivaatide või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Rivastigmine 1 A Pharma was also studied in 541 patients with dementia due to Parkinson's disease.
Estonian: Rivastigmine 1 A Pharma kasutamist uuriti ka 541 patsiendil, kellel oli Parkinsoni tõvega kaasnev dementsus.
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 Rivastigmine 1 A Pharma.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Rivastigmine 1 A Pharma is a medicine containing the active substance rivastigmine.
Estonian: Rivastigmine 1 A Pharma on ravim, mis sisaldab toimeainena rivastigmiini.
English: Rivastigmine 1 A Pharma is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Estonian: Rivastigmine 1 A Pharmat kasutatakse ka kerge kuni mõõdukalt raskekujulise dementsuse raviks Parkinsoni tõvega patsientidel.
English: This is a summary of the European public assessment report (EPAR) for Rivastigmine 1 A Pharma.
Estonian: See on ravimi Rivastigmine 1 A Pharma Euroopa avaliku hindamisaruande kokkuvõte.
English: For the global score, patients taking Rivastigmine 1 A Pharma had an increase in symptoms of 4.1 points, compared with 4.4 in those taking placebo.
Estonian: Üldiste sümptomite punktisummat silmas pidades paranes Rivastigmine 1 A Pharmat kasutanud patsientidel sümptomite punktisumma 4,1 punkti võrra, võrreldes 4,4 punktiga platseebot kasutanud patsientidel.
English: The types of side effects seen with Rivastigmine 1 A Pharma depend on the type of dementia it is being used to treat.
Estonian: Rivastigmine 1 A Pharma kõrvalnähud sõltuvad dementsuse liigist, mille raviks seda kasutati.
English: For the full list of all side effects reported with Rivastigmine 1 A Pharma, see the package leaflet.
Estonian: Rivastigmine 1 A Pharma kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Rivastigmine 1 A Pharma was more effective than placebo at controlling symptoms.
Estonian: Rivastigmine 1 A Pharma oli sümptomite leevendamisel platseebost efektiivsem.
English: It must also not be used in patients who are suspected to have had in the past an allergic reaction called ‘allergic contact dermatitis' to Exelon patch.
Estonian: Rivastigmine 1 A Pharmat ei tohi kasutada ka patsientidel, kellel võis varem olla Exeloni plaastri suhtes allergiline reaktsioon: allergiline kontaktdermatiit.
English: The patients with dementia due to Parkinson's disease taking Rivastigmine 1 A Pharma capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Estonian: Parkinsoni tõvega kaasneva dementsusega patsientidel, kes kasutasid Rivastigmine 1 A Pharmat, paranesid kognitiivsed sümptomid 2,1 punkti võrra, võrreldes halvenemisega 0,7 punkti võrra platseebot kasutanud patsientidel, kusjuures uuringu alguse tase oli ligikaudu 24 punkti.
English: What is Rivastigmine 1 A Pharma?
Estonian: Mis on Rivastigmine 1 A Pharma?
English: The active substance in Rivastigmine 1 A Pharma, rivastigmine, is an antidementia medicine.
Estonian: Rivastigmine 1 A Pharmas toimeainena sisalduv rivastigmiin on dementsuseravim.
English: Treatment with Rivastigmine 1 A Pharma should be initiated and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease or dementia in patients with Parkinson's disease.
Estonian: Ravi Rivastigmine 1 A Pharmaga tohib alustada üksnes Alzheimeri tõve või Parkinsoni tõvega kaasneva dementsuse diagnoosimises ja ravis kogenud arst ning see peab toimuma tema järelevalve all.
English: The global symptom score also improved more in the patients taking Rivastigmine 1 A Pharma.
Estonian: Rivastigmine 1 A Pharmat kasutanud patsientidel paranes ka üldiste sümptomite punktisumma rohkem.
English: Why has Rivastigmine 1 A Pharma been approved?
Estonian: Miks Rivastigmine 1 A Pharma heaks kiideti?
English: What is the risk associated with Rivastigmine 1 A Pharma?
Estonian: Mis riskid Rivastigmine 1 A Pharmaga kaasnevad?
English: How is Rivastigmine 1 A Pharma used?
Estonian: Kuidas Rivastigmine 1 A Pharmat kasutatakse?
English: How has Rivastigmine 1 A Pharma been studied?
Estonian: Kuidas Rivastigmine 1 A Pharmat uuriti?
English: What is Rivastigmine 1 A Pharma used for?
Estonian: Milleks Rivastigmine 1 A Pharmat kasutatakse?
English: What benefit has Rivastigmine 1 A Pharma shown during the studies?
Estonian: Milles seisneb uuringute põhjal Rivastigmine 1 A Pharma kasulikkus?
English: The amended information to doctors and patients is available here.
Estonian: Arstidele ja patsientidele mõeldud muudetud teave on siin.
English: The European Commission issued a decision on 7 July 2010.
Estonian: Euroopa Komisjon võttis oma otsuse vastu 7. juulil 2010.
English: János Borvendég (Hungary)
Estonian: János Borvendég (Ungari)
English: What is Vascace?
Estonian: Mis on Vascace?
English: It must also not be used in the second and third trimesters (the last six months) of pregnancy.
Estonian: Samuti ei tohi ravimit kasutada raseduse teisel ja kolmandal trimestril (viimase kuue kuu jooksul).
English: Some of the areas harmonised include:
Estonian: Ühtlustamine hõlmab muu hulgas järgmisi osasid.
English: Vascace is authorised in the EU via national procedures.
Estonian: Vascace on ELis heaks kiidetud riiklike menetluste kaudu.
English: The company that markets these medicines is F. Hoffmann - La Roche Ltd.
Estonian: Neid ravimeid turustab ettevõte F. Hoffmann - La Roche Ltd.
English: Vascace should be taken once a day at about the same time each day.
Estonian: Ravimit Vascace tuleks võtta üks kord ööpäevas umbes samal kellaajal.
English: The usual dose is 2.5 to 5 mg per day.
Estonian: Tavapärane annus on 2,5-5 mg ööpäevas.
English: Vascace is also available in the EU under other trade names: Dynorm, Inhibace, Inibace, Justor and Vascase.
Estonian: Ravimit Vascace turustatakse ELis ka teiste nimetuste all: Dynorm, Inhibace, Inibace, Justor ja Vascase.
English: The reduced blood pressure also helps patients with heart failure, because it is easier for the heart to pump out blood if the pressure in the blood vessels is not too high.
Estonian: Vererõhu vähenemine aitab ka südamepuudulikkusega patsiente, kuna südamel on kergem verd pumbata, kui rõhk veresoontes ei ole liiga kõrge.
English: The European Medicines Agency has completed a review of Vascace.
Estonian: Euroopa Ravimiamet on lõpetanud ravimi Vascace läbivaatamise.
English: Other sections such as those on special warnings, interactions and pregnancy and lactation were also harmonised.
Estonian: Samuti ühtlustati ravimi omaduste kokkuvõtte teised jaotised, mis käsitlevad näiteks hoiatusi, koostoimeid ning rasedust ja imetamist.
English: Patients with impairment of kidney function may have to take lower doses.
Estonian: Puuduliku neerutalitlusega patsientidel võib olla vaja võtta väiksemaid annused.
English: Vascace is a medicine that contains the active substance cilazapril.
Estonian: Vascace on ravim, mis sisaldab toimeainena tsilasapriili.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Estonian: See on tekitanud liikmesriikide seas lahknevusi ravimi lubatud kasutamisviisides, mis kajastuvad ravimi omaduste kokkuvõttes, märgistuses ja pakendi infolehes ravimit turustavates riikides.
English: 22 April 2010
Estonian: 22. aprill 2010
English: On 16 September 2009, European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Vascace in the EU.
Estonian: Euroopa Komisjon tegi 16. septembril 2009 inimravimite komiteele esildise, et ühtlustada ravimi Vascace müügiload ELis.
English: The CHMP agreed that Vascace should be used for the treatment of hypertension and chronic heart failure.
Estonian: Inimravimite komitee leppis kokku, et ravimit Vascace tuleks kasutada kõrgvererõhutõve ja kroonilise südamepuudulikkuse raviks.
English: If this dose is well tolerated by the patient, it can be increased to 1 or 2.5 mg once a day.
Estonian: Kui patsient talub seda annust hästi, võib annust suurendada 1 mg-ni või 2,5 mg-ni üks kord ööpäevas.
English: By blocking the production of this hormone, cilazapril allows the blood vessels to widen, reducing the blood pressure.
Estonian: Tsilasapriil laiendab selle hormooni tootmise blokeerimise teel veresooni, vähendades vererõhku.
English: For hypertension, the recommended starting dose is 1 mg per day, which can be adjusted depending on how the patient's blood pressure responds.
Estonian: Kõrgvererõhutõve korral on soovitatav algannus 1 mg ööpäevas; annust võib kohandada vastavalt sellele, kuidas patsiendi vererõhk ravimile reageerib.
English: It is used to treat hypertension and long-term heart failure (inability of the heart to pump enough blood around the body).
Estonian: Ravimit kasutatakse kõrgvererõhutõve ja pikaajalise südamepuudulikkuse (südame võimetus organismi vajalikul määral verd pumbata) raviks.
English: The Committee recommended that Vascace should not be used in patients who are hypersensitive (allergic) to cilazapril or to any other ingredients of the product, or to other ACE inhibitors.
Estonian: Komitee soovitas ravimit Vascace mitte kasutada patsientidel, kes on tsilasapriili või selle ravimi mis tahes muu koostisaine või teiste AKE inhibiitorite suhtes ülitundlikud (allergilised).
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Estonian: Esitatud andmete hindamise ja komitees toimunud teadusliku arutelu põhjal jõudis inimravimite komitee järeldusele, et ravimi omaduste kokkuvõtted, märgistused ja pakendi infolehed tuleks ELis ühtlustada.
English: It must not be used in patients with angioedema (swelling beneath the skin) associated with previous treatment with ACE inhibitor or in patients with hereditary or idiopathic angioedema.
Estonian: Ravimit ei tohi kasutada patsiendid, kellel esineb varasema AKE inhibiitoril põhineva raviga seotud angioödeem (nahaalune turse) või pärilik või idiopaatiline angioödeem.
English: Treatment with diuretics (medicines that help increase the amount of water removed from the body in the urine) should, where possible, be stopped two to three days before starting treatment with Vascace.
Estonian: Võimaluse korral tuleks kaks kuni kolm ööpäeva enne ravi alustamist ravimiga Vascace katkestada ravi diureetikumidega (ravimid, mis aitavad suurendada organismist uriiniga väljutatava vee hulka).
English: A lower starting dose of 0.5 mg is recommended for hypertension in patients with a highly activated ‘renin-angiotensin-aldosterone system' as they may experience an excessive drop in blood pressure.
Estonian: Madalamat algannust 0,5 mg soovitatakse reniini-angiotensiini-aldosterooni süsteemi tugeva aktivatsiooniga kõrgvererõhutõvega patsientidel, kuna neil võib vererõhu langus olla liiga suur.
English: For heart failure, the recommended starting dose is 0.5 mg once a day for one week.
Estonian: Südamepuudulikkuse korral on soovitatav algannus 0,5 mg üks kord ööpäevas ühe nädala vältel.
English: It blocks the action of the enzyme ACE, which is responsible for the production of a hormone in the body called angiotensin II.
Estonian: Tsilasapriil blokeerib organismis hormooni angiotensiin II tootmises osaleva ensüümi AKE toime.
English: The active substance in Vascace, cilazapril, is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Estonian: Ravimi Vascace toimeaine tsilasapriil on angiotensiini konverteeriva ensüümi (AKE) inhibiitor.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Vascace in the European Union (EU).
Estonian: Ameti inimravimite komitee on jõudnud järeldusele, et ravimi Vascace määramise teave tuleb Euroopa Liidus ühtlustada.
English: Why was Vascace reviewed?
Estonian: Mis oli ravimi Vascace läbivaatamise põhjus?
English: Vascace was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühma hinnangul tuleks ravimit Vascace käsitlev teave ühtlustada.
English: Company responses provided on: 28 December 2009, 22 March 2010 Opinion date:
Estonian: 28. detsember 2009, 22. märts 2010
English: • Do not store below 4°C.
Estonian: Mitte hoida alla 4°C.
English: How to store EXTRANEAL
Estonian: Kuidas EXTRANEALI säilitada
English: The expiry date refers to the last day of that month.
Estonian: Kõlblikkusaeg viitab märgitud kuu viimasele päevale.
English: Product configuration
Estonian: Toote konfiguratsioon
English: 6.5 Nature and Contents of Container
Estonian: 6.5 Pakendi iseloomustus ja sisu
English: Flexible PVC container holding 1.5, 2.0 or 2.5 litres.
Estonian: Pehme polüvinüülkloriidist kott mahuga 1,5; 2,0 ja 2,5 liitrit.
English: The Lineo connector contains iodine.
Estonian: Lineo konnektor sisaldab joodi.
English: The shelf life of the product as packaged for sale is 24 months 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).
Estonian: Müügiks pakitud preparaadi kõlblikkusaeg on 24 kuud 12 kuud (vaid preparaadile, mis on toodetud Allistonis, Kanadas ja North Cove`s, USA´s).
English: The lineo connector that may equip the Y transfer line of the twin bag, contains 10.5% of Povidone iodine ointment
Estonian: Lineo-ühendus, mis võib olla ühendatud Y-ülekandeliidesega, sisaldab 10,5% povidoonjodiidsalvi.
English: • Store in the original package.
Estonian: Hoida originaalpakendis.
English: 12 months (for medicinal products manufactured at Alliston, Canada and North Cove, USA only).
Estonian: 12 kuud (vaid preparaadile, mis on toodetud Allistonis, Kanadas ja North Cove`s, USA´s) Väliskilest välja võetud preparaat tuleb koheselt kasutada.
English: Not all configurations may be marketed.
Estonian: Kõiki pakendi suurused ei pruugi olla müügil.
English: Changes are shown as greyed boxed wording
Estonian: Muutused on märgitud halli tekstiga.
English: Number of
Estonian: Maht
English: The date is stated on the carton label and on the bag after the abbreviation Exp. and the symbol .
Estonian: Kõlblikkusaeg on märgitud välispakendile ja kotile pärast märget Exp. Ja sümboliga .
English: DIANEAL PD4 6.3 Shelf life
Estonian: RAVIMI OMADUSTE KOKKUVÕTE DIANEAL PD4
English: The product, once removed from its overpouch should be used immediately.
Estonian: Väliskilest välja võetud preparaat tuleb koheselt kasutada.
English: • Keep out of the reach and sight of children.
Estonian: Hoida laste eest varjatud ja kättesaamatus kohas.
English: Amendments to the relevant sections of the summaries of product characteristics and package leaflets
Estonian: III Lisa Ravimi omaduste kokkuvõtte ja pakendi infolehe tekstide lõike puudutavad muutused
English: units per box
Estonian: Kottide arv karbis
English: Type of connector(s)
Estonian: Konnektori tüüp
English: • Do not use EXTRANEAL after the expiry date.
Estonian: Lahust ei tohi kasutada pärast kõlblikkusaja lõppu.
English: Amendments to be included in the relevant sections of the summary of product characteristics and package leaflets for Dianeal PD4 and Extraneal, as applicable.
Estonian: Dianeali ja Extraneali ravimi omaduste kokkuvõtte ja pakendi infolehe tekstide lõigud sisaldavad vastavaid muutusi.
English: • Dispose EXTRANEAL as you have been trained
Estonian: Kasutamata jäänud EXTRANEAL tuleb hävitada vastavalt saadud koolitusele.
English: Corresponding changes were made to the package leaflets.
Estonian: Pakendi infolehel tehti vastavad muudatused.
English: It was agreed that colistin can be used without age restrictions, but only for the treatment of serious infections.
Estonian: Lepiti kokku, et kolistiini tohib kasutada vanusepiiranguteta, kuid ainult tõsiste infektsioonide raviks.
English: This is possibly because of its limited parenteral use, due to the existence of safer, less neurotoxic and nephrotoxic therapeutic options.
Estonian: See võib tuleneda aine piiratud parenteraalsest kasutamisest, sest on olemas ohutumaid, vähem neuro- ja nefrotoksilisi ravivõimalusi.