FrancophonIA/ELRC3.0 huggingface dataset:
English: No clinically meaningful differences in risankizumab exposure were observed in Chinese or Japanese subjects compared to Caucasian subjects in a clinical pharmacokinetic study.
Estonian: Kliinilise farmakokineetika uuringus ei täheldatud Hiina või Jaapani päritolu patsientidel risankizumabi ekspositsioonis kliiniliselt olulisi erinevusi võrreldes europiidsete patsientidega.
English: Change at Week 52 (SE)
Estonian: PPASI: muutus nädalal (SE)
English: As an IgG1 monoclonal antibody, risankizumab is not expected to be filtered by glomerular filtration in the kidneys or to be excreted as an intact molecule in the urine.
Estonian: Risankizumab kui IgG1 monoklonaalne antikeha, ei läbi eeldatavasti glomerulaarfiltratsiooni neerudes ja ei eritu uriiniga muutumatu molekulina.
English: Subjects randomised to risankizumab received 150 mg of treatment at week 0, week 4 and every 12 weeks thereafter.
Estonian: Risankizumabi rühma randomiseeritud patsientidele manustati 150 mg 0-nädalal, 4. nädalal ja edasi iga 12 nädala järel.
English: How to use Skyrizi
Estonian: Kuidas Skyrizi't kasutada
English: Skyrizi 75 mg injection risankizumab SC
Estonian: Skyrizi 75 mg süstelahus risankizumabum s.c.
English: If you stop using Skyrizi
Estonian: Kui te lõpetate Skyrizi kasutamise
English: • severe itching of the skin, with a red rash or raised bumps
Estonian: • tugev nahasügelus koos punetava lööbe või kupladega.
English: What Skyrizi looks like and contents of the pack Skyrizi is a clear and colourless to slightly yellow liquid in a pre-filled syringe with needle guard.
Estonian: Skyrizi on selge ja värvitu kuni helekollane vedelik nõelakaitsega süstlis.
English: Other side effects Tell your doctor, pharmacist or nurse if you get any of the following side effects
Estonian: Rääkige oma arstile, apteekrile või meditsiiniõele, kui teil tekib ükskõik milline järgmistest kõrvaltoimetest.
English: STEP 5
Estonian: Tabel 5.
English: Among subjects with sPGA of clear or almost clear at week 28 in IMMHANCE, 81.1% (90/111) of subjects re-randomised to continued treatment with risankizumab maintained this response at week 104 compared to 7.1% (16/225) who were re-randomised to withdrawal from risankizumab.
Estonian: Kõigist patsientidest, kellel uuringus IMMHANCE 28. nädalal oli sPGA „puhas“ või „peaaegu puhas“ ja kes uuesti randomiseeriti jätkama ravi risankizumabiga, püsis see ravivastus 104. nädalal 81,1%-l (90/111), võrreldes 7,1%-ga (16/225) neist, kes uuesti randomiseeriti lõpetama ravi risankizumabiga.
English: 2 Injections Required
Estonian: Vajalik on teha 2 süstet
English: Of these subjects, 63.1% (70/111) of subjects re-randomised to continued treatment with risankizumab achieved a sPGA clear response at week 104 compared to 2.2% (5/225) who were re-randomised to withdrawal from risankizumab.
Estonian: Neist patsientidest, kes uuesti randomiseeriti jätkama ravi risankizumabiga, saavutas 104. nädalaks sPGA ravivastuse „puhas“ 63,1% (70/111), võrreldes 2,2%-ga (5/225) patsientidest, kes uuesti randomiseeriti lõpetama ravi risankizumabiga.
English: QR code to be included
Estonian: Lisada QR-kood
English: The mean terminal elimination half-life of risankizumab ranged from 28 to 29 days in Phase 3 studies in subjects with psoriasis.
Estonian: Psoriaasiga patsientide III faasi uuringus oli risankizumabi lõpliku eliminatsiooni keskmine poolväärtusaeg vahemikus 28 kuni 29 päeva.
English: Therapeutic IgG monoclonal antibodies are typically degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgGs.
Estonian: Terapeutilised IgG monoklonaalsed antikehad degradeeritakse tüüpiliselt väikesteks peptiidideks ja aminohapeteks kataboolseid radu pidi samamoodi kui endogeensed IgG-d. Risankizumab ei metaboliseeru eeldatavasti tsütokroom P450 ensüümide vahendusel.
English: • Do not inject into skin that is sore, bruised, red, hard, scarred, or has stretch marks
Estonian: Süstida ei tohi kohta, kus nahk on valulik, verevalumitega, punetav, paksenenud või kus on psoriaasi koldeid.
English: Do not use this medicine if the liquid is cloudy or contains flakes or large particles.
Estonian: Ärge kasutage seda ravimit, kui vedelik on hägune või selles on helbeid või suuri nähtavaid osakesi.
English: Figure 1: Time course of mean percent change from baseline of PASI in ULTIMMA-1 and ULTIMMA-2
Estonian: PASI keskmine protsentuaalne muutus võrreldes ravieelsega ULTIMMA-1 ja ULTIMMA-2 uuringutes ajateljel
English: The liquid should look clear to slightly yellow and may contain tiny white or clear particles
Estonian: Vedelik peab olema selge kuni kergelt kollakas ja võib sisaldada väikseid valgeid või läbipaistvaid osakesi.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Estonian: Kõrvaltoimetest võite ka ise teatada riikliku teavitussüsteemi, (vt V lisa), kaudu.
English: Do not use Skyrizi
Estonian: Skyrizi't ei tohi kasutada
English: The solution is colourless to slightly yellow and clear to slightly opalescent.
Estonian: Värvitu kuni kergelt kollakas ja selge kuni kergelt opalestseeruv lahus.
English: No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of Skyrizi.
Estonian: Spetsiifilisi uuringuid, mis hindaksid maksa- või neerukahjustuse mõju Skyrizi farmakokineetikale, ei ole läbi viidud.
English: This medicine works by stopping a protein in the body called ‘IL-23', which causes inflammation.
Estonian: Selle ravimi toimel blokeeritakse põletikku põhjustava IL-23-nimelise valgu aktiivsus.
English: Improvements were observed in psoriasis involving the scalp, the nails, and the palms and soles at week 16 and week 52 in subjects treated with risankizumab.
Estonian: Risankizumabiga ravi saanud isikutel täheldati 16. ja 52. nädalal psoriaasi paranemist, mis hõlmas peanahka, küüsi, peopesasid ja jalataldu.
English: The pharmacokinetics of risankizumab in paediatric subjects has not been established.
Estonian: Risankizumabi farmakokineetika lastel ei ole teada.
English: The mean (±standard deviation) systemic clearance (CL) of risankizumab was 0.3 (±0.1) L/day in Phase 3 studies in subjects with psoriasis.
Estonian: Psoriaasiga patsientidel läbiviidud III faasi uuringus oli risankizumabi keskmine (±standardhälve) süsteemne kliirens 0,3 (± 0,1) l ööpäevas.
English: • Do not inject if the liquid is cloudy or contains flakes or large particles.
Estonian: • Ärge süstige ravimit, kui vedelik on hägune või sisaldab helbeid või suuri osakesi.
English: Table 3: Mean changes from baseline in NAPSI, PPASI, and PSSI ULTIMMA-1
Estonian: NAPSI, PPASI ja PSSI mediaansed muutused võrreldes ravieelsega ULTIMMA-1
English: It may contain a few translucent to white product-related particles.
Estonian: Selles võib olla veidi väikseid läbipaistvaid kuni valgeid ravimiosakesi.
English: Name and address of the manufacturer(s) of the biological active substance(s)
Estonian: Bioloogilise toimeaine tootjate nimi ja aadress
English: One pre-filled syringe contains 75 mg risankizumab.
Estonian: Üks süstel sisaldab 75 mg risankizumabi.
English: Skyrizi is used to treat adults with moderate to severe plaque psoriasis.
Estonian: Skyrizi't kasutatakse mõõduka kuni raske naastulise psoriaasi raviks täiskasvanutel.
English: Week 16 89 (29.3) Week 52 173 (56.9) All comparisons of risankizumab versus ustekinumab and placebo achieved p<0.001 except for PASI 75 at week 52 in ULTIMMA-2 where p=0.001
Estonian: Kõigis võrdlustes saavutas risankizumab ustekinumabi või platseeboga võrreldes p < 0,001, välja arvatud PASI 75 52. nädalal uuringus ULTIMMA-2, kus p = 0,001
English: Continued on Adalimumab (N=56) n (%)
Estonian: Jätkasid ravi adalimumabiga (N=56) n (%)
English: • PASI 50 to <PASI 90 were re-randomised to either continue adalimumab or switch to risankizumab
Estonian: • PASI 50 kuni < PASI 90 ravivastusega patsiendid randomiseeriti uuesti kas jätkama adalimumabiga või üle minema risankizumabile
English: How to store Skyrizi
Estonian: Kuidas Skyrizi't säilitada
English: 150 mg (two 75 mg injections) 4 weeks after 1
Estonian: 150 mg (kaks 75 mg süstet)
English: You may have slight bleeding from where you injected.
Estonian: Võite märgata kerget veritsust süstekohast.
English: In an integrated analysis of subjects receiving risankizumab in ULTIMMA-1 and ULTIMMA-2 for PASI 100 responders at week 16, 79.8% (206/258) of the subjects who continued on risankizumab maintained the response at week 52.
Estonian: 79,8%-l (206/258) 16. nädalaks PASI 100 ravivastuse saavutanud patsientidest, kes jätkasid ravi risankizumabiga, püsis ravivastus 52. nädalal.
English: Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Estonian: Patsientidel, kellel on eelnevas anamneesis latentne või aktiivne Tb ning ei ole võimalik kinnitada adekvaatse ravikuuri läbimist, tuleb enne ravi alustamist risankizumabiga kaaluda Tb-vastast ravi.
English: Two pre-filled syringes should be injected for the full 150 mg dose.
Estonian: 150 mg koguannuse saamiseks tuleb süstida kaks süstlit.
English: Placebo (N=98) n (%)
Estonian: Platseebo (N=98) n (%)
English: How Skyrizi works
Estonian: Kuidas Skyrizi toimib
English: Tinea infections
Estonian: Tinea infektsioonidb
English: Placebo (N=102) n (%)
Estonian: Platseebo (N=102) n (%)
English: Maintenance of response
Estonian: Ravivastuse säilitamine
English: Body of syringe
Estonian: Süstli korpus
English: For each dose, the injections should be administered at different anatomic locations (such as thighs or abdomen), and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis.
Estonian: Iga annus tuleb süstida erinevasse anatoomilisse piirkonda (nt reide või kõhtu).
English: Special populations
Estonian: Süstimise piirkonnad
English: Check liquid
Estonian: Kontrollige vedelikku
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Estonian: Rääkige oma arstiga enne selle ravimi kasutamist, kui te toidate või kavatsete toita last rinnaga.
English: Skyrizi 75 mg solution for injection in pre-filled syringe
Estonian: Skyrizi 75 mg süstelahus süstlis
English: Skyrizi 75 mg solution for injection in pre-filled syringe risankizumab
Estonian: Skyrizi 75 mg süstelahus süstlis Risankizumab (risankizumabum)
English: It is unknown whether risankizumab is excreted in human milk.
Estonian: Ei ole teada, kas risankizumab eritub inimese rinnapiima.
English: The clearance of risankizumab was not significantly influenced by gender or race in adult subjects with plaque psoriasis.
Estonian: Naastulise psoriaasiga täiskasvanud patsientide sugu või rass ei mõjutanud olulisel määral risankizumabi kliirensit.
English: • difficulty breathing or swallowing
Estonian: • hingamis- või neelamisraskus;
English: Each pre-filled syringe contains 75 mg risankizumab in 0.83 ml.
Estonian: Üks süstel sisaldab 75 mg risankizumabi (risankizumabum) 0,83 ml lahuses.
English: No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of risankizumab.
Estonian: Neeru- või maksakahjustuse mõju risankizumabi farmakokineetikale ei ole spetsiaalselt uuritud.
English: STEP 3
Estonian: Tabel 3.
English: No overall differences in risankizumab exposure were observed between older and younger subjects who received risankizumab.
Estonian: Risankizumabi saanud vanemate ja nooremate patsientide puhul ei täheldatud üldisi erinevusi risankizumabi ekspositsioonis.
English: st dose
Estonian: II LISA
English: • Do not use if the liquid is cloudy or contains flakes or large particles
Estonian: • Ärge kasutage ravimit, kui vedelik on hägune või sisaldab suuri osakesi.
English: • feeling tired
Estonian: • väsimustunne
English: solution for injection 2 pre-filled syringes 2 alcohol pads
Estonian: 2 alkoholiga immutatud lapikest
English: Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination.
Estonian: Risankizumab ei metaboliseeru eeldatavasti maksaensüümide vahendusel ning ei eritu neerude kaudu.
English: ANNEX II
Estonian: 2. annus
English: ANNEX I
Estonian: 1. annus
English: STEP 1
Estonian: Tabel 1.
English: STEP 2
Estonian: 2 süstlit
English: STEP 4
Estonian: Tabel 4.
English: st dose Further doses 150 mg (two 75 mg injections) Every 12 weeks starting after 2
Estonian: Järgmised annused 150 mg (kaks 75 mg süstet)
English: Week 16
Estonian: nädal nädal PASI 75
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Estonian: Kuidas Skyrizi välja näeb ja pakendi sisu
English: • front of right thigh
Estonian: • parema reie esikülg
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants / marketing authorisation holders in the Member States
Estonian: Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, taotlejate loetelu liikmesriikides
English: TruScient has been developed for use in dogs based on the approved use of the InductOs product in humans (EU/1/02/226/001).
Estonian: TruScient on välja töötatud kasutamiseks koertel, tuginedes ravimi InductOs heakskiidetud kasutamisele inimestel (EU/1/02/226/001).
English: TruScient should only be used by a veterinarian.
Estonian: TruScienti tohib kasutada ainult loomaarst.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for TruScient on 14 December 2011.
Estonian: Euroopa Komisjon andis TruScienti müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 14-122011.
English: The main side effects with TruScient (seen in more than 1 dog in 10) were lameness, and firm and soft swelling during the first three weeks after surgery.
Estonian: TruScient põhilised kõrvalnähud (esinenud enam kui 1 koeral 10st) olid lonkamine ning jäik turse ja pehme turse esimese kolme nädala jooksul pärast operatsiooni.
English: TruScient is made up into a solution before use, applied to the collagen sponges and left for at least 15 minutes (but no more than two hours).
Estonian: Enne TruScienti kasutamist valmistatakse selle lahus, mis kantakse kollageenkäsnale ja see jäetakse seisma vähemalt 15 minutiks (aga mitte kauemaks kui kaks tundi).
English: It must not be used in young dogs whose bones are not fully developed, have an active infection at the site of operation, pathological fracture (caused by a disease), or any active malignancy (cancerous growth).
Estonian: Seda ei tohi kasutada noortel koertel, kelle luud ei ole täielikult välja arenenud, ega koertel, kellel on äge infektsioon operatsioonikohal või patoloogiline (haigusest tingitud) luumurd või mis tahes äge pahaloomuline kasvaja (vähkkasvaja).
English: The prepared collagen sponges are then cut, if needed, to the correct size before use.
Estonian: Vajadusel lõigatakse ettevalmistatud kollageenkäsn enne kasutamist õigesse suurusesse.
English: Other information about TruScient:
Estonian: Muu teave TruScienti kohta
English: TruScient was investigated in one main field study in 126 dogs with fractures of the diaphysis.
Estonian: TruScienti uuriti ühes põhilises väliuuringus 126-l diafüüsi murruga koeral.
English: After 18 weeks, the fractures of all the dogs treated with TruScient together with standard surgical care (84) were seen to have healed, compared with 95% of the dogs treated with standard surgical care alone (40 out of 42).
Estonian: 18 nädala pärast olid luumurrud paranenud kõikidel koos TruScienti raviga standardset kirurgilist ravi saanud koertel (84), võrreldes 95% koertest, kes said ainult standardset kirurgilist ravi (40-l 42-st).
English: TruScient dibotermin alfa
Estonian: TruScient alfadibotermiin
English: The kit allows the user to make a solution containing the active substance (0.2 mg/ml) to be applied onto collagen sponges which are implanted during surgery.
Estonian: Komplekt võimaldab valmistada toimeainet sisaldava lahuse (0,2 mg/ml), mis kantakse kollageenkäsnale ja see implanteeritakse operatsiooni käigus.
English: The prepared collagen sponges are implanted during surgery by placing them directly onto the bone fracture and leaving them in place when the surgical wound is stitched up.
Estonian: Ettevalmistatud kollageenkäsnad implanteeritakse operatsiooni käigus, need asetatakse vahetult luumurru kohale ja jäetakse paigale, kui haav kinni õmmeldakse.
English: TruScient is a medicine that contains the active substance dibotermin alfa.
Estonian: TruScient on ravim, mis sisaldab toimeainena alfadibotermiini.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of TruScient exceed the risks for the treatment of diaphyseal bone fractures in dogs and recommended that TruScient be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et TruScienti kasulikkus diafüüsi murdude ravis koertel on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The newly formed bone grows into the collagen sponge, which then dissolves away.
Estonian: Uus luukude kasvab kollageenkäsna sisse, mis seejärel lahustub.
English: Only the amount of prepared sponge needed to cover the affected area of the bone should be used.
Estonian: Kasutada tohib ainult sellist ettevalmistatud kollageenkäsnade kogust, mis on vajalik murrupiirkonna katmiseks.
English: TruScient must not be used in dogs that are hypersensitive (allergic) to dibotermin alfa or any of the other ingredients.
Estonian: TruScienti ei tohi kasutada koertel, kes võivad olla alfadibotermiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: What is TruScient?
Estonian: Mis on TruScient?
English: The replacement dibotermin alfa acts in the same way as BMP-2 produced naturally by the body.
Estonian: Tehislik alfadibotermiin toimib samal viisil kui organismis looduslikult tekkiv BMP-2.
English: The main measure of effectiveness was the time until the fracture was seen to have healed using an X-ray (time to radiographic fracture healing).
Estonian: Efektiivsuse põhinäitaja oli aeg, mis kulub luumurru röntgenipildi abil tuvastatud paranemiseni (radiograafilise uuringuga kinnitatud paranemiseni kuluv aeg).
English: The study assessed TruScient used together with standard surgical care, compared with standard surgical care alone.
Estonian: Uuringus hinnati TruScienti kasutatuna koos standardse kirurgilise raviga ja võrreldi ainult standardse kirurgilise raviga.
English: If TruScient is accidentally spilled onto the skin or eyes, it should be rinsed off immediately.
Estonian: TruScienti juhuslikul sattumisel nahale või silma loputada viivitamatult.
English: Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Estonian: Alfadibotermiini valmistatakse rekombinant-DNA-tehnika abil: ainet toodab rakk, millesse on lisatud alfadibotermiini teket võimaldav geen (DNA).
English: Time to radiographic fracture healing was less when the dogs were treated with TruScient together with standard surgical care.
Estonian: Radiograafilise uuringuga kinnitatud paranemiseni kuluv aeg oli lühem, kui koer sai ravi TruScientiga koos standardse kirurgilise raviga.
English: What is the risk associated with TruScient?
Estonian: Mis riskid TruScientiga kaasnevad?
English: Why has TruScient been approved?
Estonian: Miks TruScient heaks kiideti?
English: For a full list of all side effects reported with TruScient, see the package leaflet.
Estonian: TruScienti kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: TruScient is available as a kit for implant.
Estonian: TruScienti turustatakse implantatsioonikomplektina.
English: When the collagen sponge is implanted into the bone fracture, dibotermin alfa stimulates the bone tissue around the sponge to make new bone.
Estonian: Kui kollageenkäsn on implanteeritud murru kohale, stimuleerib alfadibotermiin käsna ümbruses uue luukoe teket.
English: What is TruScient used for?
Estonian: Milleks TruScienti kasutatakse?
English: What benefit has TruScient shown during the studies?
Estonian: Milles seisneb uuringute põhjal TruScienti kasulikkus?
English: How has TruScient been studied?
Estonian: Kuidas TruScienti uuriti?
English: The active substance in TruScient, dibotermin alfa, acts on the bone structure.
Estonian: TruScienti toimeaine alfadibotermiin avaldab toimet luu struktuurile.
English: It is a copy of a protein called ‘bone morphogenetic protein 2' (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Estonian: Alfadibotermiin on organismis looduslikult tekkiva uue luukoe moodustamist soodustava aine luu morfogeneetilise valgu 2 (BMP-2) koopia.
English: TruScient is used in combination with standard surgical care to treat diaphyseal bone fractures (affecting the diaphysis, the main section of long bone) in dogs.
Estonian: TruScienti kasutatakse kombineerituna standardse kirurgilise raviga diafüüsi murdude (toruluu keskosa murdude) raviks koertel.
English: How does TruScient work?
Estonian: Kuidas TruScient toimib?
English: 1 Article 29(2) of Directive 2001/83/EC, as amended.
Estonian: 1 Art. 29 ust.2 dyrektywy 2001/83/WE, ze zmianami.
English: The Reference Member State was Finland and the Concerned Member States were Austria, Denmark, Germany and Sweden.
Estonian: Võrdlusliikmesriigiks olid Soome ja asjassepuutuvateks liikmesriikideks Austria, Taani, Saksamaa, ja Rootsi.
English: International Non-Proprietary Name (INN): Lansoprazole
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): Lansoprasool
English: A Mutual Recognition Procedure was started on 16 September 2004.
Estonian: Vastastikuse tunnustamise menetlus algatati 16. septembril 2004.
English: The Marketing Authorisation Holder provided written explanations on 13 April 2005.
Estonian: Müügiloa hoidja esitas kirjalikud selgitused 13. aprillil 2005.
English: Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Estonian: Saksamaa esitas lahkarvamuse põhjused EMEAle 15. detsembril 2004.
English: The arbitration procedure started on 20 January 2005.
Estonian: Vahekohtumenetlus algas 20. jaanuaril 2005.
English: The final opinion was converted into a Decision by the European Commission on 15 September 2005.
Estonian: See lõppotsus kinnitati Euroopa Komisjoni otsusena 15. septembril 2005.
English: The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the
Estonian: Asjassepuutuvad liikmesriigid ei jõudnud võrdlusliikmesriigi poolt väljastatud müügiloa vastastikuse tunnustamise taotluse osas kokkuleppele.
English: (CHMP)
Estonian: TAUSTATEAVE
English: The Rapporteur and Co-Rapporteur appointed were Sif Ormarsdottir/Tomas Salmonson, Gottfried Kreutz/Julia Dunne respectively.
Estonian: Ormarsdottir ja Tomas Salmonson ning Gottfried Kreutz ja Julia Dunne.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Estonian: Teaduslikud järeldused on välja toodud II lisas ning toote omaduste kokkuvõte III lisas.
English: During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for
Estonian: Tuginedes kõigile esitatud andmetele ja komitee sisesele arutelule, jõudis inimtervishoius kasutatavate ravimite komitee oma 2005. aasta juuni koosolekul seisukohale, et Lansoprazol Hexali riski ja kasu vahekord on soodne.
English: Significant differences in comparison to the reference product have been identified with regard to the indications' section of the SPCs.
Estonian: Võrreldes võrdluspreparaadiga tuvastati olulised erinevused ravimi omaduste kokkuvõtte näidustuste osa puhul.