FrancophonIA/ELRC3.0 huggingface dataset:
English: The exposure to tafamidis in patients with severe hepatic impairment is unknown.
Estonian: Tafamidise kontsentratsioon raske maksafunktsiooni kahjustusega patsientidel ei ole teada.
English: In the rat peri- and post-natal development study with tafamidis, decreased pup survival and reduced pup weights were noted following maternal treatment during pregnancy and lactation at doses of 15 and 30 mg/kg.
Estonian: Tafamidisega tehtud rottide peri- ja postnataalse arengu uuringus täheldati pärast emase ravimist annustega 15 ja 30 mg/kg tiinuse ning laktatsiooni ajal järglaste elulemuse ja kaalu vähenemist.
English: Treatment should be initiated by and remain under the supervision of a physician knowledgeable in the management of patients with transthyretin amyloid polyneuropathy.
Estonian: Ravi peab alustama ning jälgima arst, kellel on kogemusi transtüretiini amüloidse perifeerse polüneuropaatia ravis.
English: 11 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS
English: Tafamidis meglumine should be added to the standard of care for the treatment of the transthyretin familial amyloid polyneuropathy (TTR-FAP) patient.
Estonian: Tafamidismeglumiin tuleb lisada transtüretiiniga seotud perekondliku amüloidse polüneuropaatiaga (TTR-FAP) patsientide standardravile.
English: How to take Vyndaqel
Estonian: Kuidas Vyndaqeli võtta
English: Dose and time linearity
Estonian: Annuse ja aja võrdelisus
English: SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Estonian: ERIKOHUSTUSED ERANDLIKEL ASJAOLUDEL VÄLJASTATUD MÜÜGILOA JÄRGSETE MEETMETE TÄITMISEKS
English: 4.5 Interaction with other medicinal products and other forms of interaction In a clinical study in healthy volunteers, tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4.
Estonian: Tafamidismeglumiin ei indutseerinud ega inhibeerinud tsütokroom P450 ensüümi CYP3A4 tervete vabatahtlikega tehtud kliinilises uuringus.
English: 4.7 Effects on ability to drive and use machines On the basis of the pharmacodynamic and pharmacokinetic profile, tafamidis meglumine is believed to have no or negligible influence on the ability to drive or use machines.
Estonian: Tafamidismeglumiin ei oma märkimisväärset toimet farmakodünaamilise ja farmakokineetilise profiili alusel autojuhtimise ja masinate käsitsemise võimele.
English: Perforated unit dose blisters of 10 x 20 mg Vyndaqel soft capsules
Estonian: Perforeeritud üksikannuseline blisterpakend 10 x 20 mg Vyndaqeli pehmekapsliga
English: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis meglumine, and for one month after stopping treatment, due to the prolonged half life.
Estonian: Fertiilses eas naised peavad kasutama sobivat rasestumisvastast vahendit tafamidismeglumiini võtmise ajal ja tingituna pikast poolväärtusajast ka ühe kuu jooksul pärast ravi lõpetamist.
English: Pack sizes: a pack of 30 x 1 soft capsules and a multipack containing 90 (3 packs of 30 x 1) soft capsules.
Estonian: Pakendi suurused: pakend 30 x 1 pehmekapslit ja multipakend sisaldab 90 (3 pakki x 30 x 1) pehmekapslit.
English: Pack of 30 x 1 soft capsules - WITH BLUE BOX
Estonian: Pakend 30 x 1 pehmekapslit - KOOS SINISE RAAMIGA
English: • Women that can become pregnant should use birth control while taking Vyndaqel and should continue using birth control for one month after stopping treatment with Vyndaqel.
Estonian: • Fertiilses eas naised peavad Vyndaqeli võtmise ajal kasutama rasestumisvastaseid vahendeid ja jätkama nende kasutamist ühe kuu jooksul pärast ravi lõpetamist.
English: Vyndaqel versus Placebo: NIS-LL and TQOL at Month 18 (Study Fx-005) Placebo
Estonian: kuul (uuring Fx-005) Platseebo
English: Each capsule contains 20 mg tafamidis meglumine equivalent to 12.2 mg tafamidis.
Estonian: Iga kapsel sisaldab 20 mg tafamidismeglumiini, mis vastab 12,2 mg tafamidisele.
English: The capsule may be taken with or without food Instructions for opening the blisters
Estonian: Kapslit võib võtta koos toiduga või ilma.
English: Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, fertility and early embryonic development, genotoxicity and carcinogenic potential.
Estonian: Farmakoloogilise ohutuse, fertiilsuse, varajase embrüonaalse arengu, genotoksilisuse ja kartsinogeensuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: Cmax(ss) and Cmin(ss) was 2.7 and 1.6 µg/ml, respectively.
Estonian: 14 päeva jooksul üks kord ööpäevas 20 mg tafamidismeglumiini manustamisel saadud tulemused näitasid, et püsikontsentratsioon saabus 14. päeval, Cmax(ss) ja Cmin(ss) olid vastavalt 2,7 ning 1,6 µg/ml.
English: Each soft capsule contains 20 mg of micronized tafamidis meglumine equivalent to 12.2 mg tafamidis.
Estonian: Iga pehmekapsel sisaldab 20 mg mikroniseeritud tafamidismeglumiini, mis vastab 12,2 mg tafamidisele.
English: 2 NAME OF THE MARKETING AUTHORISATION HOLDER
Estonian: MÜÜGILOA HOIDJA NIMI
English: If you vomit after taking this medicine and can identify the intact Vyndaqel capsule, then an additional dose of Vyndaqel should be taken in the same day; if you cannot identify the Vyndaqel capsule, then no additional dose of Vyndaqel is necessary, and you can resume taking Vyndaqel the next day as usual.
Estonian: Kui te oksendate pärast ravimi võtmist ja leiate terve Vyndaqeli kapsli, tuleb samal päeval võtta lisaannus Vyndaqeli.
English: Vyndaqel is for oral use.
Estonian: Vyndaqel on ettenähtud suukaudseks manustamiseks.
English: Talk to your doctor, pharmacist or nurse before taking Vyndaqel.
Estonian: Enne Vyndaqeli võtmist pidage nõu oma arsti, apteekri või meditsiiniõega.
English: Following 18 months of treatment, more tafamidis meglumine-treated patients were NIS-LL Responders (change of less than 2 points on NIS-LL) Outcomes for the pre-specified analyses of the primary endpoints are provided in the following table:
Estonian: 18 ravikuu järel oli tafamidismeglumiiniga ravitud patsientide seas rohkem NIS-LL-i järgi ravile vastajad (NIS-LL-i vähem kui 2-punktine muutus).
English: Diarrhoea Upper abdominal pain
Estonian: Kõhulahtisus Valu ülakõhus
English: 4 BATCH NUMBER
Estonian: PARTII NUMBER
English: Vyndaqel 20 mg soft capsules tafamidis meglumine
Estonian: Vyndaqel 20 mg pehmekapslid tafamidismeglumiin
English: 4 PHARMACEUTICAL FORM AND CONTENTS
Estonian: RAVIMVORM JA PAKENDI SUURUS
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 November 2011
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV
English: Macrogol 400 (E1521) Polyvinyl acetate phthalate Propylene glycol (E1520) Carmine (E120)
Estonian: Isopropüülalkohol Puhastatud vesi Makrogool 400 (E1521) Polüvinüülatsetaatftalaat Propüleenglükool (E1520) Karmiin (E120) Briljantsinine FCF (E133)
English: Pack of 30 - for multipack of 90 (3 packs of 30 x 1) soft capsules - WITHOUT BLUE BOX
Estonian: Multipakend 90 pehmekapslit (3 pakki x 30 x 1) - ILMA SINISE RAAMITA
English: Each soft capsule contains 20 mg tafamidis meglumine equivalent to 12.2 mg tafamidis
Estonian: Üks pehmekapsel sisaldab 20 mg tafamidismeglumiini, mis vastab 12,2 mg tafamidisele
English: The dissociation of the transthyretin tetramer to monomers is the rate limiting step in the pathogenesis of TTR amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Estonian: TTR-i amüloidse polüneuropaatia [nimetatakse ka TTR-i perekondlikuks amüloidseks polüneuropaatiaks (TTR-FAP)] patogeneesi kiirust reguleerib transtüretiini tetrameeride dissotsieerumine monomeerideks.
English: Multipack of 90 (3 packs of 30 x 1) soft capsules - WITH BLUE BOX
Estonian: Multipakend 90 pehmekapslit (3 pakki x 30 x 1) - KOOS SINISE RAAMIGA
English: Gastrointestinal disorders
Estonian: Blistrite avamise juhised
English: • Stomach ache or abdominal pain
Estonian: • mao- või ülakõhuvalu
English: • Peel back the paper at the curved arrow to expose the aluminium foil.
Estonian: • Alumiiniumfooliumi avamiseks eemaldage paber kõvera joonega märgitud kohast.
English: How to store Vyndaqel 6.
Estonian: Kuidas Vyndaqeli säilitada
English: Vyndaqel 20 mg soft capsules
Estonian: Vyndaqel 20 mg pehmekapslid
English: 12 MARKETING AUTHORISATION NUMBER(S)
Estonian: MÜÜGILOA NUMBRID
English: What you need to know before you take Vyndaqel Do not take Vyndaqel
Estonian: Mis ravim on Vyndaqel ja milleks seda kasutatakse Mida on vaja teada enne Vyndaqeli võtmist Kuidas Vyndaqeli võtta
English: 8 MARKETING AUTHORISATION NUMBER(S) EU/1/11/717/001
Estonian: EU/1/11/717/001 EU/1/11/717/002
English: 4 CLINICAL PARTICULARS 4.1 Therapeutic indication
Estonian: 4.1 Näidustused
English: Multipack: 90 (3 packs of 30 x 1) soft capsules.
Estonian: Multipakend 90 pehmekapslit (3 pakki x 30 x 1)
English: ANNEX I
Estonian: Partii nr:
English: There is no relevant use of tafamidis in the paediatric population.
Estonian: Lapsed Tafamidise kasutamiseks lastel puudub asjakohane näidustus.
English: 2 STATEMENT OF ACTIVE SUBSTANCES
Estonian: TOIMEAINE(TE) SISALDUS
English: How to store Vyndaqel Keep this medicine out of the sight and reach of children.
Estonian: Võimalikud kõrvaltoimed Kuidas Vyndaqeli säilitada Pakendi sisu ja muu teave
English: Riximyo received a marketing authorisation valid throughout the EU on 15 June 2017.
Estonian: Riximyo on saanud müügiloa, mis kehtib kogu ELis, 15. juunil 2017.
English: What measures are being taken to ensure the safe and effective use of Riximyo?
Estonian: Mis meetmed võetakse, et tagada Riximyo ohutu ja efektiivne kasutamine?
English: Further information on Riximyo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Riximyo.
Estonian: Lisateave Riximyo kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Riximyo.
English: These patients are also to receive an alert card, which they are to carry at all times, instructing them to contact their doctor immediately if they have symptoms of infection.
Estonian: Neile patsientidele antakse ka hoiatuskaart, mida nad peavad kogu aeg kaasas kandma ja milles neil soovitatakse infektsiooni sümptomite ilmnemisel otsekohe arsti poole pöörduda.
English: The cancer improved in just over 87% of those given Riximyo (271 of 311 patients), and in similar numbers of those given MabThera (274 of 313 patients).
Estonian: Ravivastuse saavutas veidi üle 87% Riximyot saanud patsientidest (271 patsienti 311st) ning sarnane osa MabTherat saanud patsientidest (274 patsienti 313st).
English: What is Riximyo and what is it used for?
Estonian: Mis on Riximyo ja milleks seda kasutatakse?
English: This means that Riximyo is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Estonian: See tähendab, et Riximyo on väga sarnane teise bioloogilise ravimiga (võrdlusravimiga), millel juba on ELis müügiluba.
English: Why is Riximyo authorised in the EU?
Estonian: Miks Riximyo ELis heaks kiideti?
English: Riximyo (rituximab)
Estonian: Riximyo (rituksimab)
English: The company marketing Riximyo will provide doctors with additional information about giving the medicine correctly.
Estonian: Riximyo turustaja annab arstidele lisateavet ravimi õige manustamise kohta.
English: As for all medicines, data on the use of Riximyo are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Riximyo kasutamise kohta pidevat järelevalvet.
English: Other information about Riximyo
Estonian: Muu teave Riximyo kohta
English: Side effects reported with Riximyo are carefully evaluated and any necessary action taken to protect patients.
Estonian: Riximyo kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: Therefore, the Agency's view was that, as for MabThera, the benefits of Riximyo outweigh the identified risks and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka MabThera korral, ületab Riximyo kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: Riximyo is a medicine used in adults to treat the following blood cancers and inflammatory conditions:
Estonian: Riximyo on ravim, mida kasutatakse järgmiste verevähkide ja põletikuhaiguste raviks täiskasvanutel:
English: For more information about using Riximyo, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Riximyo kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: The most common side effects with Riximyo are reactions related to the infusion (such as fever, chills and shivering) while most common serious side effects are infusion reactions, infections and heartrelated problems.
Estonian: Riximyo kõige sagedamad kõrvalnähud on infusioonireaktsioonid (nt palavik, külmavärinad ja värisemine); kõige sagedamad rasked kõrvalnähud on infusioonireaktsioonid, infektsioonid ja südameprobleemid.
English: The safety of Riximyo has been evaluated, and on the basis of all the studies carried out, the side effects of the medicine are considered to be comparable to those of the reference medicine MabThera.
Estonian: Riximyo ohutust on hinnatud ja kõigi uuringute põhjal peetakse ravimi kõrvalnähte võrreldavaks võrdlusravimi MabThera kõrvalnähtudega.
English: What are the risks associated with Riximyo?
Estonian: Mis riskid Riximyoga kaasnevad?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Riximyo have also been included in the summary of product characteristics and the package leaflet.
Estonian: Riximyo ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Riximyo has a highly similar structure, purity and biological activity to MabThera and is distributed in the body in the same way.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele bioloogiliselt sarnaste ravimite kohta on Riximyo struktuuri, puhtuse ja bioloogilise toime poolest väga sarnane MabTheraga ning Riximyo jaotub organismis samamoodi.
English: How does Riximyo work?
Estonian: Kuidas Riximyo toimib?
English: Riximyo must not be used in people who are hypersensitive (allergic) to rituximab, mouse proteins or any of the other ingredients or in patients with a severe infection or a severely weakened immune system (the body's defences).
Estonian: Riximyot ei tohi kasutada patsiendid, kes on rituksimabi, hiirevalkude või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised), ega patsiendid, kellel on raske infektsioon või oluliselt nõrgenenud immuunsüsteem (organismi looduslikud kaitsemehhanismid).
English: Depending on the condition it is used to treat, Riximyo may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).
Estonian: Sõltuvalt ravitavast seisundist võib Riximyot manustada ainuravimina, koos keemiaraviga (vähiravimid) või põletikuvastaste ravimitega (metotreksaat või kortikosteroid).
English: It will also provide doctors and patients using the medicine for GPA, MPA or pemphigus with educational material on the risk of infection including that of a rare severe infection, progressive multifocal leukoencephalopathy (PML).
Estonian: Turustaja annab arstidele ja patsientidele, kes kasutavad ravimit granulomatoosse polüangiidi, mikroskoopilise polüangiidi või hariliku villtõve raviks, ka teabematerjali infektsiooniriski, sealhulgas raske harvikinfektsiooni progresseeruva multifokaalse leukoentsefalopaatia riski kohta.
English: The reference medicine for Riximyo is MabThera.
Estonian: Riximyo võrdlusravim on MabThera.
English: In addition, Riximyo was as effective as MabThera in one main study involving 629 patients with advanced, untreated follicular lymphoma, where Riximyo or MabThera were added to other chemotherapy for part of the treatment.
Estonian: Riximyo ja MabThera võrreldavat efektiivsust tõendati ka ühes põhiuuringus, kus osales 629 varem ravimata kaugelearenenud follikulaarlümfoomiga patsienti ning milles muule keemiaravile lisati teatavaks ajaks Riximyo või MabThera.
English: Because Riximyo is a biosimilar medicine, the studies on effectiveness and safety of rituximab carried out with MabThera do not all need to be repeated for Riximyo.
Estonian: Et Riximyo on bioloogiliselt sarnane ravim, ei pea MabTheraga tehtud rituksimabi efektiivsus- ja ohutusuuringuid Riximyoga kordama.
English: Studies have also shown that giving Riximyo produces similar levels of the active substance in the body to giving MabThera.
Estonian: Uuringud on samuti näidanud, et Riximyo põhjustab organismis samasuguse toimeainesisalduse kui MabThera.
English: Patients with GPA, MPA or pemphigus vulgaris must also not receive Riximyo if they have severe heart problems.
Estonian: Granulomatoosse polüangiidi, mikroskoopilise polüangiidi või hariliku villtõvega patsiendid ei tohi kasutada Riximyot raskete südameprobleemide korral.
English: The active substance in Riximyo, rituximab, is a monoclonal antibody designed to attach to a protein called CD20, which is present on B cells.
Estonian: Riximyo toimeaine rituksimab on monoklonaalne antikeha, mis seondub B-lümfotsüütide pinnal oleva valguga CD20.
English: When rituximab attaches to CD20, it causes the B cells to die, which helps in lymphoma and CLL (where B cells have become cancerous) and in pemphigus (where B cells are involved in inflammation).
Estonian: Rituksimabi seondumisel valguga CD20 B-lümfotsüüdid hävivad, mis aitab ravida lümfoomi ja kroonilist lümfotsüütleukeemiat (B-lümfotsüüdid on muutunud pahaloomuliseks) ning villtõbe (B-lümfotsüüdid osalevad põletikuprotsessis).
English: Laboratory studies comparing Riximyo with the reference medicine MabThera have shown that the active substance in Riximyo is highly similar to that in MabThera in terms of structure, purity and biological activity.
Estonian: Riximyot võrreldi võrdlusravimi MabTheraga laboriuuringutes, mis tõendasid, et Riximyo toimeaine on struktuuri, puhtuse ja bioloogilise toime poolest väga sarnane MabThera toimeainega.
English: Riximyo contains the active substance rituximab.
Estonian: Riximyo sisaldab toimeainena rituksimabi.
English: An overview of Riximyo and why it is authorised in the EU
Estonian: Ülevaade ravimist Riximyo ja ELis müügiloa väljastamise põhjendus
English: In addition, a study in patients with follicular lymphoma has shown that the safety and effectiveness of Riximyo are equivalent to those of MabThera.
Estonian: Peale selle näitas follikulaarlümfoomiga patsientide uuring nende ravimite võrreldavat ohutust ja efektiivsust.
English: What benefits of Riximyo have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Riximyo kasulikkus?
English: All these data were considered sufficient to conclude that Riximyo will behave in the same way as MabThera in terms of effectiveness and safety in its authorised uses.
Estonian: Nende piisavate andmete põhjal järeldati, et Riximyo efektiivsus ja ohutus on heakskiidetud näidustustel võrreldavad MabThera efektiivsuse ja ohutusega.
English: How is Riximyo used?
Estonian: Kuidas Riximyot kasutatakse?
English: For the full list of side effects and restrictions of Riximyo, see the package leaflet.
Estonian: Riximyo kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Riximyo is a ‘biosimilar medicine'.
Estonian: Riximyo on bioloogiliselt sarnane ravim.
English: Riximyo can only be obtained with a prescription.
Estonian: Riximyo on retseptiravim.
English: The full EPAR and risk management plan summary for Episalvan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Episalvani kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Episalvan is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Episalvani võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Episalvan?
Estonian: Mis meetmed võetakse, et tagada Episalvani ohutu ja efektiivne kasutamine?
English: With regard to safety, no major issues were identified and side effects were manageable.
Estonian: Mis puutub ohutusse, siis olulisi probleeme ei tuvastatud ja kõrvaltoimed olid kergesti käsitletavad.
English: Other information about Episalvan
Estonian: Muu teave Episalvani kohta
English: The exact way Episalvan works is not fully understood.
Estonian: Episalvani täpne toimemehhanism ei ole täielikult teada.
English: The respective times were 16.0 and 15.1 days respectively in the second study.
Estonian: Teises uuringus olid vastavad ajad 16,0 ja 15,1 päeva.
English: What is Episalvan and what is it used for?
Estonian: Mis on Episalvan ja milleks seda kasutatakse?
English: Although the differences were small they were considered relevant for patients with partial-thickness wounds, which can be difficult to heal and for which treatment options are limited.
Estonian: Kuigi erinevused on väikesed, on need väärtuslikud patsientidele, kellel on pindmised haavad, mille ravimine võib olla keeruline ja ravivõimalused piiratud.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Episalvan's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Episalvani kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: This is a summary of the European public assessment report (EPAR) for Episalvan.
Estonian: See on ravimi Episalvan Euroopa avaliku hindamisaruande kokkuvõte.
English: Why is Episalvan approved?
Estonian: Miks Episalvan heaks kiideti?
English: The gel should be re-applied with every dressing change, until the wound is healed, for up to 4 weeks.
Estonian: Geeli tuleb kuni 4 nädala jooksul igal sideme vahetamisel uuesti haavale kanda, kuni haav paraneb.
English: The most common side effects with Episalvan are wound complications, pain in the skin (both of which may affect more than 3 in 100 people) and pruritus (itching) (which may affect more 1 in 100 people).
Estonian: Episalvani kõige sagedamad kõrvalnähud on haava tüsistused, valu nahas (võivad esineda enam kui 3 patsiendil 100st) ja pruritus (sügelus) (võib esineda enam kui 1 patsiendil 100st).
English: The average time to wound closure was 8.8 days for the wounds treated with standard disinfectant gel and 7.6 days for the wounds treated with Episalvan.
Estonian: Keskmine aeg haava sulgumiseni oli 8,8 päeva haava ravimisel tavapärase desinfitseeriva geeliga ja 7,6 päeva haava ravimisel Episalvaniga.
English: For the full list of all side effects and restrictions reported with Episalvan, see the package leaflet.
Estonian: Episalvani kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Episalvan, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Episalvani omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: What are the risks associated with Episalvan?
Estonian: Mis riskid Episalvaniga kaasnevad?
English: It is not intended to provide practical advice on how to use Episalvan.
Estonian: Hindamisaruandes ei anta Episalvani kasutamise praktilisi nõuandeid.
English: Episalvan was studied in two main studies involving 217 patients with partial-thickness skin wounds in patients who underwent skin graft surgery.
Estonian: Episalvanit uuriti kahes põhiuuringus 217-l pindmiste nahahaavadega patsiendil, kellele siirati nahka.