FrancophonIA/ELRC3.0 huggingface dataset:
English: Transient, mild conjunctival swelling, itching of the eyes, tachypnoea, tremors, diarrhoea, ataxia and uncoordinated movement.
Estonian: Mööduv kergekujuline silma sidekesta turse, silmade sügelus, tahhüpnoe, treemor, kõhulahtisus, ataksia ja koordineerimata liigutused.
English: The safety and efficacy of the product have not been studied in dogs with ocular disease or injury.
Estonian: Preparaadi ohutust ja tõhusust pole hinnatud silmahaiguse või silmavigastusega koertel.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 30 mg/ml ropinirole
Estonian: TOIMEAINE(TE) KOGUS Ropinirool 30 mg/ml
English: Common adverse reactions:
Estonian: Väga sageli esinevad kõrvaltoimed:
English: The veterinary medicinal product should only be administered by a veterinarian or under their close supervision.
Estonian: Veterinaarravimit manustab loomaarst või seda tehakse loomaarsti vahetu järelevalve all.
English: Ropinirole is mainly eliminated by hepatic metabolism.
Estonian: Ropinirool eritub peamiselt maksas toimuva metabolismi kaudu.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s) - common (more than 1 but less than 10 animals in 100 animals treated)
Estonian: Kõrvaltoimete esinemissagedus on defineeritud järgnevalt: - väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast) - aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast)
English: The half-life of elimination (t½) is 4 hours after intravenous administration to dogs.
Estonian: Pärast ravimi intravenoosset manustamist koertele on poolestusaeg (t½) eritumisel 4 tundi.
English: Store the container in the pouch in order to protect from light.
Estonian: Hoidke konteinerit ümbrises valguse eest kaitstult.
English: Open the container by twisting off the tail.
Estonian: Keerake konteineri avamiseks sulgur ära.
English: ROUTE(S) OF ADMINISTRATION Ocular use
Estonian: MANUSTAMISVIIS(ID) Okulaarne
English: Ropinirole is rapidly absorbed into the systemic circulation of dogs after administration as a solution on their eye surface.
Estonian: Ropinirool imendub pärast lahuse koera silmapinnale tilgutamist kiiresti süsteemsesse vereringesse.
English: Ropinirole might reduce the level of prolactin, a hormone that stimulates milk production in pregnant or breast-feeding women.
Estonian: Prolaktiin on hormoon, mis stimuleerib tiinetel või imetavatel emastel loomadel piima produktsiooni.
English: Citric acid monohydrate Sodium citrate Sodium chloride
Estonian: Sidrunhappe monohüdraat Naatriumtsitraat
English: The time to last vomit ranged from 30 to 82 minutes following ocular administration in a pharmacokinetic study in dogs.
Estonian: Farmakokineetika uuringus hinnatud koerte puhul varieerus okulaarsest manustamisest viimase oksendamiskorrani mööduv aeg vahemikus 30 kuni 82 minutit.
English: Be careful not to touch the dropper tip after opening the container in case a second dose is necessary.
Estonian: Pärast konteineri avamist tuleb olla ettevaatlik ja vältida tilguti otsa puudutamist, juhuks kui vajalik on ka teise annuse manustamine.
English: STATEMENT OF ACTIVE SUBSTANCES 30 mg/ml ropinirole
Estonian: TOIMEAINE(TE) SISALDUS Ropinirool 30 mg/ml
English: Very common adverse reactions: Transient mild or moderate hyperaemia of the eye, ocular discharge, protrusion of the 3rd eyelid and blepharospasm.
Estonian: Mööduv kergekujuline või keskmise raskusastmega silma hüpereemia, eritiste väljavool silmast, kolmanda silmalau eendumine ja blefarospasm.
English: Number of eye drops
Estonian: Silmatilkade arv
English: Instructions for use
Estonian: Kasutusjuhised
English: The safety of this veterinary medicinal product has not been established during pregnancy and lactation in the target species.
Estonian: Selle veterinaarravimi ohutus vastava loomaliigi tiinuse ja laktatsiooni perioodil ei ole piisavalt tõestatud.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution for dogs ropinirole
Estonian: VETERINAARRAVIMI NIMETUS Clevor 30 mg/ml, koertele mõeldud silmatilkade lahus ropinirool
English: Ropinirole
Estonian: RAVIMVORM
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation in the target species.
Estonian: Veterinaarravimi ohutus vastava loomaliigi tiinuse ja laktatsiooni perioodil ei ole piisavalt tõestatud.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Estonian: VETERINAARRAVIMI NIMETUS Clevor 30 mg/ml, koertele mõeldud silmatilkade lahus üheannuselises konteineris
English: PACKAGE LEAFLET: Clevor 30 mg/ml eye drops, solution in single-dose container for dogs
Estonian: PAKENDI INFOLEHT Clevor 30 mg/ml, koertele mõeldud silmatilkade lahus üheannuselises konteineris
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops, solution in single-dose container for dogs Ropinirole (ropinirol)
Estonian: Clevor 30 mg/ml, koertele mõeldud silmatilkade lahus üheannuselises konteineris Ropinirool (ropinirol.)
English: (µg/kg)
Estonian: Ropinirool (µg/kg)
English: PHARMACEUTICAL FORM Eye drops solution in single-dose container.
Estonian: Silmatilkade lahus üheannuselises konteineris.
English: Ropinirole (µg/body surface area)
Estonian: Ropinirool (µg/keha pindala)
English: Instructions for administration
Estonian: Manustamisjuhised
English: Ocular use.
Estonian: Okulaarne.
English: Dog bodyweight (kg)
Estonian: Koera kehamass (kg)
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor ropinirole
Estonian: VETERINAARRAVIMI NIMETUS
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Clevor 30 mg/ml eye drops ropinirole
Estonian: Clevor 30 mg/ml, silmatilgad ropinirool
English: STORING THE OPENED CONTAINER:
Estonian: Üheannuselise konteineri silt
English: The safety of the product has not been studied in dogs with hepatic impairment.
Estonian: Preparaadi ohutust pole hinnatud maksapuudulikkusega koertel.
English: Uncommon adverse reactions: Corneal ulceration.
Estonian: Aeg-ajalt esinevad kõrvaltoimed: sarvkesta haavand.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR
Estonian: ERINÕUDED ETTEVAATUSABINÕUDE OSAS KASUTAMATA JÄÄNUD
English: 72 hours.
Estonian: 72 tundi.
English: Human albumin.
Estonian: Inimese albumiin.
English: • These shall contain the following key elements:
Estonian: • Need sisaldavad järgmisi põhielemente.
English: Date of first authorisation: 23 March 2018
Estonian: Müügiloa esmase väljastamise kuupäev: 23. märts 2018
English: Do not give this medicine to children and adolescents (i.e. aged under 18 years) because the potential benefits and risks are unknown.
Estonian: Ärge andke seda ravimit lastele ja noorukitele (st alla 18-aastastele), kuna võimalikud kasud ja riskid ei ole teada.
English: In addition a long term follow-up was conducted up to Week 52.
Estonian: Lisaks viidi läbi pikaajaline järelkontroll kuni 52. nädalani.
English: Justification for not including Braille accepted
Estonian: Põhjendus Braille' mitte lisamiseks on aktsepteeritud
English: In general, these side effects are quite mild and disappear in the days following the fistula procedure.
Estonian: Üldiselt on need kõrvaltoimed üsna kerged ja kaovad fistli protseduurile järgnevatel päevadel.
English: You may have had an initial consultation with the Surgeon 2 to 3 weeks prior to Alofisel administration.
Estonian: Teil võib olla olnud esialgne konsultatsioon kirurgiga 2 kuni 3 nädalat enne Alofiseli manustamist.
English: This should be considered if you are allergic to these antibiotics, as these antibiotics are used in the manufacturing process of this medicine.
Estonian: Sellega tuleb arvestada, kui olete nende antibiootikumide suhtes allergiline, sest neid antibiootikume kasutatakse selle ravimi tootmisprotsessis.
English: eASC were not present in any of the tissues analysed after 3 months or 6 months.
Estonian: eASC-d ei esinenud üheski koes, mida analüüsiti pärast 3 kuud või 6 kuud.
English: Injuring, poisoning and procedural complications
Estonian: Vigastus, mürgistus ja protseduuri tüsistused
English: The safety and efficacy of darvadstrocel in children and adolescents aged 0 to 17 years have not yet been established.
Estonian: Darvadstrotseeli ohutus ja efektiivsus lastel ja noorukitel vanuses 0 kuni 17 aastat ei ole veel tõestatud.
English: As this medicine will be used during surgery, the hospital staff is responsible for the correct storage of the medicine before and during its use, as well as for its correct disposal.
Estonian: Kuna seda ravimit kasutatakse operatsiooni ajal, vastutab haigla personal ravimi õige säilitamise eest enne kasutamist ja selle ajal, samuti selle õige hävitamise eest.
English: The efficacy of Alofisel was assessed in the ADMIRE-CD study.
Estonian: Alofiseli tõhusust hinnati uuringus ADMIRE-CD.
English: The product is checked at different stages during its manufacture to ensure that it is free of infection.
Estonian: Toodet kontrollitakse valmistamise erinevates etappides, et see oleks nakkusvaba.
English: *Conditioning reactions occurring up to seven days after the fistula cleaning for treatment administration.
Estonian: * Reaktsioonid ettevalmistamisele, mis ilmnevad kuni seitsme päeva jooksul pärast fistli puhastamist ravi manustamiseks.
English: Procedural pain*
Estonian: Protseduuriaegne valu*
English: Because the final check takes place just before Alofisel is sent to the hospital, the results of this last check are not known when it is given to you.
Estonian: Kuna viimane kontroll toimub vahetult enne Alofiseli saatmist haiglasse, ei ole viimase kontrolli tulemused veel teada kui teile seda manustatakse.
English: Pharmacotherapeutic group: {not yet assigned}, ATC code: {not yet assigned}.
Estonian: Farmakoterapeutiline rühm: {ei ole veel omistatud}, ATC-kood: {ei ole veel omistatud}.
English: Common side effects (may affect up to 1 to 10 patients):
Estonian: Sagedased kõrvaltoimed (võivad esineda kuni 1 patsiendil 10-st):
English: 6 mL 30 million cells
Estonian: 6 ml 30 miljonit rakku
English: • The educational material for health professionals should contain:
Estonian: • Tervishoiutöötajate teavitusmaterjal peab sisaldama järgmist.
English: If after the procedure you feel ill or have fever, please inform your physician as soon as you can.
Estonian: Kui tunnete end pärast protseduuri halvasti või teil on palavik, teavitage sellest oma arsti esimesel võimalusel.
English: Alofisel is used when the fistulas have not responded sufficiently well to previous treatment.
Estonian: Alofiseli kasutatakse juhul, kui fistlid ei ole varem ravile piisavalt hästi allunud.
English: * Including abscess drainage, seton placement/removal, curettage, suture of internal openings and medical treatments
Estonian: * Kaasa arvatud mädakolde drenaaž, setoni paigaldamine/eemaldamine, küretaaž, sisemiste avade õmblemine ja medikamentoosne ravi
English: Lack of de novo DSA generation was observed between Week 12 and Week 52.
Estonian: De novo DSA tekkimise puudumist täheldati 12. ja 52. nädala vahel.
English: In the unlikely event that the results detected an infection, your treatment team will be informed who will tell you if you need any laboratory tests of treatment for the infection.
Estonian: Ebatõenäolisel juhul, kui nakkus avastatakse, teatatakse sellest teie ravimeeskonnale, kes teavitavad teid, kas teil on vaja mingeid labori uuringuid või nakkuse ravi.
English: The aim of the educational programme is to provide information on how to correctly administer the product in order to minimise the risk of medication errors and to increase awareness about the potential transmission of infectious agents.
Estonian: Teavitusprogrammi eesmärk on anda teavet selle kohta, kuidas toodet õigesti manustada, et vähendada ravivigade ohtu ja suurendada teadlikkust nakkushaiguste võimalikust levikust.
English: Adverse reactions System Organ Class
Estonian: Kõrvaltoimed Organsüsteemi klass
English: No case of overdose has been reported.
Estonian: Ühtegi üleannustamise juhtu ei ole teatatud.
English: b) Identify the location of the internal openings.
Estonian: b) Tuvastage sisemiste avade asukohad.
English: • procedural pain (pain after fistula cleaning)
Estonian: • protseduuriaegne valu (valu pärast fistlite puhastamist)
English: Animal studies are not available with respect to reproductive toxicity (see section 5.3).
Estonian: Reproduktiivtoksilisuse uuringuid loomadel ei ole tehtud (vt lõik 5.3).
English: Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Spain
Estonian: Parque Tecnológico de Madrid 28760 Tres Cantos, Madrid Hispaania
English: C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Spain
Estonian: C/ Marconi, 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, Hispaania
English: As Alofisel is a living stem cell therapy it cannot be sterilised, and therefore could contain potentially infected biological material although the risk is considered to be low and controlled in the manufacturing.
Estonian: Kuna Alofisel sisaldab elusaid tüvirakke, ei saa seda steriliseerida ja seetõttu võib see sisaldada potentsiaalselt nakatunud bioloogilist materjali, kuigi seda ohtu peetakse madalaks ja seda kontrollitakse tootmisel.
English: • Guide for health professionals providing information on potential for microbial information and advice on steps to follow in case a positive culture is identified.
Estonian: • Juhend tervishoiutöötajatele, mis annab teavet potentsiaalsete mikroobide kohta ja annab nõu positiivse kultuuri tuvastamisel vajalike edasiste tegevuste kohta
English: 2.1 General description
Estonian: 2.1 Üldine kirjeldus
English: The efficacy or safety of repeat administration of Alofisel has not been established.
Estonian: Alofiseli korduva manustamise ohutus ja efektiivsus ei ole veel tõestatud.
English: For injection in the fistula tract tissue in a surgical environment under anaesthesia (general or regional (see section 4.4)) as described below.
Estonian: Süstimiseks fistli kanali koesse kirurgilises keskkonnas anesteesia all (üldine või kohalik (vt lõik 4.4)), nagu allpool kirjeldatud.
English: Alofisel group (Alofisel+standard of care*) N= 103
Estonian: Alofiseli rühm (Alofisel + standardravi*) N = 103
English: This medicine contains cells of human origin.
Estonian: See ravimpreparaat sisaldab inimrakke.
English: Do not refrigerate or freeze.
Estonian: Ärge hoidke külmkapis ega laske külmuda.
English: In line with standards for the management of complex perianal fistulas, characterisation of the patient's fistulas is needed prior to treatment.
Estonian: Kooskõlas keerukate perianaalsete fistlite ravimise nõuetega on enne ravi vajalik patsiendi fistlite kirjeldamine.
English: This should be considered in patients with known hypersensitivity to these classes of antibiotics.
Estonian: Sellega tuleb arvestada patsientidel, kellel on nende antibiootikumi rühmade suhtes teada ülitundlikkus.
English: No in vivo interaction studies have been performed.
Estonian: In vivo koostoimeid ei ole uuritud.
English: Alofisel is a living cell therapy and, therefore, the final product cannot be sterilised.
Estonian: Alofisel on elusrakuteraapia ja seetõttu ei saa lõpptoodet steriliseerida.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europe.eu.
Estonian: Täpne teave selle ravimi kohta on Euroopa Ravimiameti kodulehel: http://www.ema.europe.eu.
English: • inject Alofisel.
Estonian: • süstib Alofiseli.
English: The frequency of adverse reactions is defined 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) and not known (cannot be estimated from available data).
Estonian: Kõrvaltoimete esinemissagedus on määratletud järgmiselt: 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) ja teadmata (ei saa hinnata olemasolevate andmete alusel).
English: Therefore, no dose adjustment is required in elderly patients.
Estonian: Seetõttu ei ole eakatel patsientidel vajalik annust kohandada.
English: Patients had draining complex perianal fistulas with an inadequate response to at least one of the following treatments: antibiotics, immunosuppressants or anti-TNFs.
Estonian: Patsientidel olid dreneeritud keerukad perianaalsed fistlid, mis ei olnud piisavalt allunud vähemalt ühele järgmistest raviviisidest: antibiootikumid, immunosupressandid või anti-TNF-id.
English: • massage softly for 20 to 30 seconds the area where the fistula opens on to the skin near your anus.
Estonian: • masseerib kergelt 20 kuni 30 sekundi jooksul piirkonda, kus fistul teie pärakuümbruse nahal avaneb.
English: BATCH NUMBER, DONATION AND PRODUCT CODES
Estonian: PARTII NUMBER, ANNETUSE KOOD JA TOOTEKOOD
English: The nature and intended clinical use of darvadstrocel are such that conventional studies of pharmacokinetics (absorption, distribution, metabolism and elimination) are not applicable.
Estonian: Darvadstrotseeli olemus ja kavandatud kliiniline kasutamine on sellised, et traditsioonilised farmakokineetika uuringud (imendumine, jaotumine, metabolism ja eritumine) ei ole kohaldatavad.
English: Concomitant use of stable doses of immunosuppressants (18% of patients) or anti-TNFs (33%) or both (28%) was allowed during the study.
Estonian: Uuringu ajal oli lubatud samaaegne immunosupressantide (18% patsientidest), anti-TNF-ide (33%) või mõlema (28%) püsiannustes kasutamine.
English: The following listing of adverse reactions is based on the clinical trial experience and is displayed by system organ class.
Estonian: Järgnev kõrvaltoimete loetelu põhineb kliinilistel uuringutel ja see kuvatakse organsüsteemi klasside järgi.
English: • Relevant information on the risk of medication errors and the potential for transmission of infectious agents and details on how to minimise these, including reception, storage and administration instructions (i.e. fistula conditioning, preparation and injection).
Estonian: • Asjakohane teave ravivigade ja nakkusohtlike ainete edasikandumise ohu kohta ning üksikasjalik teave nende minimeerimise kohta, sealhulgas vastuvõtu-, säilitamis- ja manustamisjuhised (st fistlite ettevalmistamine, ravimi ettevalmistamine ja süstimine).
English: The effect of ex vivo expansion on the genetic stability of cells has been assessed in vitro without any indication of carcinogenic potential.
Estonian: Ex vivo kasvatamise mõju rakkude geneetilisele stabiilsusele on hinnatud in vitro ning pole leitud mingeid viiteid kantserogeensele potentsiaalile.
English: Combined remission at Week 24 (% patients) Combined remission at Week 52 (% patients)
Estonian: Kombineeritud paranemine 24. nädalal (% patsientidest) Kombineeritud paranemine 52. nädalal (% patsientidest)
English: The recommended dose is 120 million cells.
Estonian: Soovitatav annus on 120 miljonit rakku.
English: This means that with a dose of 120 million cells it is possible to treat up to three fistula tracts that open to the perianal area.
Estonian: See tähendab, et annusega 120 miljonit rakku on võimalik ravida kuni kolme fistli kanalit, mis avanevad pärakuümbruse piirkonda.
English: Perianal fistulas are described as complex if they have multiple channels and openings, if they penetrate deep inside your body or if they are associated with other complications such as collections of pus (infected liquid also called abscesses).
Estonian: Perianaalseid fistleid nimetatakse keerukateks juhul, kui neil on mitu kanalit ja ava, kui nad tungivad sügavalt kehasse või kui need on seotud teiste tüsistustega, nagu nt mädakogumid (nakatunud vedelik, nimetatakse ka abstsessiks).
English: Do not use this medicine after the expiry date which is stated on the label.
Estonian: Ärge kasutage ravimit pärast kõlblikkusaega, mis on märgitud sildil.
English: Alofisel is supplied on an individual patient basis.
Estonian: Alofiseli tarnitakse patsiendile individuaalselt.
English: Conditioning reactions Conditioning of fistulas has been associated with proctalgia and procedural pain (see section 4.8).
Estonian: Reaktsioonid ettevalmistamisele Fistlite ettevalmistamist on seostatud proktalgia ja protseduuriaegse valuga (vt lõik 4.8).
English: Immediately prior to the administration of Alofisel, the fistula tracts should be conditioned as follows: a) If setons are in place, they must be removed.
Estonian: Vahetult enne Alofiseli manustamist tuleb fistlite kanaleid järgmiselt töödelda: a) Kui paigaldatud on setonid, tuleb need eemaldada.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/surgeon for advice before you are given this medicine.
Estonian: Kui te olete rase, imetate või arvate end olevat rase või kavatsete rasestuda, pidage enne selle ravimi kasutamist nõu oma arsti või kirurgiga.
English: Darvadstrocel has no or negligible influence on the ability to drive and use machines.
Estonian: Darvadstrotseel ei mõjuta või mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
English: Preserve the container away from heat and direct light sources and do not refrigerate or freeze.
Estonian: Säilitage pakendit eemal soojusallikast ja otsesest valgusest ning ärge hoidke seda külmkapis ega laske sel külmuda.
English: For this, injection of a sodium chloride 9 mg/mL (0.9%) solution through the external openings until it gets out through the internal openings is recommended.
Estonian: Selleks on soovitatav süstida naatriumkloriidi 9 mg/ml (0,9%) lahus läbi välimiste avade, kuni see väljub läbi sisemiste avade.
English: Some side effects of Alofisel treatment are related to the process of cleaning your fistulas.
Estonian: Mõned Alofiseli ravi kõrvaltoimed on seotud fistlite puhastamise protsessiga.
English: A total of 212 patients were randomised, and 205 patients received a local injection of either Alofisel 120 million cells or placebo in a 1:1 design.
Estonian: Kokku randomiseeriti 212 patsienti ja 205 patsiendile süstiti paikselt kas 120 miljonit Alofiseli rakku või platseebot suhtes 1 : 1-le.
English: The primary endpoint was the combined remission at Week 24 after study treatment, defined as clinical closure of all treated fistulas (absence of draining despite gentle finger compression) and absence of collection (> 2 cm) confirmed by blinded central MRI.
Estonian: Esmane tulemusnäitaja oli kombineeritud paranemine 24. nädalal pärast uuringuga seotud ravi, mis määratleti kui kõigi ravitud fistlite kliiniline sulgumine (läbilaske puudumine hoolimata õrnast vajutusest sõrmega) ja kogunemise puudumine (> 2 cm), mida kinnitas pime tsentraalne MRT.
English: Women of childbearing age should use effective contraception during treatment with Alofisel.
Estonian: Fertiilses eas naised peavad Alofiseli ravi ajal kasutama tõhusat rasestumisvastast vahendit.
English: Prior to the launch of Alofisel in each Member State, the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Estonian: Enne Alofiseli turule toomist igas liikmesriigis lepib müügiloa hoidja riigi pädeva ametiasutusega kokku teavitusprogrammi sisu ja vormi, sealhulgas teavitamiskanalid, teabe levitamise viisid ja programmi muud aspektid.
English: The following information is related to the day when Alofisel is administered.
Estonian: Järgnev teave on päeva kohta, mil Alofiseli teile manustatakse.
English: What Alofisel contains
Estonian: Mida Alofisel sisaldab
English: Control group (Placebo+standard of care*) N= 102
Estonian: Kontrollrühm (Platseebo + standardravi*) N = 102
English: This leaflet was last revised in <MM/YYYY>
Estonian: Infoleht on viimati uuendatud <KK/AAAA>