FrancophonIA/ELRC3.0 huggingface dataset:
English: In May 2016, an open-label, randomised controlled trial aimed at addressing the incidence of inhibitors between the two classes (pdFVIII vs. rFVIII products) was published in the New England Journal of Medicine1.
Estonian: 2016. aasta mais avaldati ajakirjas New England Journal of Medicine avatud ülesehitusega kontrollrühmaga randomiseeritud uuring, mille eesmärk oli uurida inhibiitorite esinemissagedust kahes ravimiklassis (pdFVIII ja rFVIII).1 Uuringus SIPPET (Survey of Inhibitors in Plasma-Product Exposed Toddlers - inhibiitorite uuring plasmapäritolu ravimitega kokkupuutuvatel väikelastel), hinnati inhibiitorite suhtelist riski pdFVIII-ga ja rFVIII-ga ravitavatel patsientidel.
English: Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII.
Estonian: A-hemofiiliaga patsientidelt, kellel tekkisid VIII faktori inhibiitorid, koguti andmeid immuuntolerantsuse induktsiooni kohta.
English: The findings from the SIPPET study, as well as those from the individual clinical trials and observational studies, are not sufficient to confirm any consistent statistically and clinically meaningful differences in inhibitor risk between the rFVIII and pdFVIII product classes.
Estonian: Uuringu SIPPET ega individuaalsete kliiniliste uuringute ja jälgimisuuringute tulemused ei ole piisavad, et kinnitada rFVIII ja pdFVIII ravimiklasside vahelist inhibiitorite tekkeriski järjepidevat statistiliselt ja kliiniliselt tähenduslikku erinevust.
English: When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation.
Estonian: VIII faktori infusioonil hemofiiliahaigele seondub see haige vereringes vWF-ga.
English: It is important to use the venipuncture set provided with the product for administration as it incorporates an in-line filter.
Estonian: Manustamiseks on oluline kasutada ravimiga kaasasolevat veenipunktsiooni komplekti, sest see sisaldab endas filtrit.
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 3000 IU) water for injections) in the prefilled syringe and the integrated transfer system (Bio-Set).
Estonian: KOGENATE Bayer'i pulbrit tohib lahustada ainult süstlis lisatud lahustiga (2,5 ml süstevesi tugevustele 250 RÜ, 500 RÜ, 1000 RÜ või 5 ml süstevesi tugevustele 2000 RÜ, 3000 RÜ) juurdekuuluva ülekandesüsteemi (Bio-Set) abil.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed with recombinant factor VIII products and may in some cases progress to severe anaphylaxis (including shock).
Estonian: Rekombinantset VIII faktorit sisaldavate ravimite kasutamisel on täheldatud ülitundlikkus- või allergilisi reaktsioone (sh angioödeem, põletus- ja torkimistunne süstekohal, külmavärinad, õhetus, generaliseerunud nõgestõbi, peavalu, lööve, hüpotensioon, letargia, iiveldus, rahutus, tahhükardia, rõhumistunne rinnus, surin, oksendamine, vilistav hingamine).
English: General Disorders and Administratio n Site
Estonian: Üldised häired ja manustamiskoha reaktsioonid
English: • The PRAC noted that the SIPPET study was not designed to evaluate the risk of inhibitor development for individual products, and included a limited number of FVIII products in total.
Estonian: • Ravimiohutuse riskihindamise komitee märkis, et uuringu SIPPET ülesehitus ei võimaldanud hinnata inhibiitorite tekke riski konkreetsete ravimite kasutamisel ning selles uuriti kokku väheseid FVIII-ravimeid.
English: Information submitted by the lead authors of the SIPPET study during the course of the referral was also taken into consideration by PRAC in reaching its conclusion.
Estonian: Ravimiohutuse riskihindamise komitee arvestas järelduste tegemisel ka teavet, mida olid esildismenetluse ajal esitanud uuringu SIPPET juhtivad autorid.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with KOGENATE Bayer.
Estonian: A-hemofiiliaga patsientidel, keda ravitakse VIII hüübimisfaktoriga, sealhulgas KOGENATE Bayer'iga võivad tekkida neutraliseerivad antikehad (inhibiitorid).
English: 250 IU (octocog alfa) (100 IU/mL after reconstitution).
Estonian: 250 RÜ alfaoktokogi (pärast lahustamist 100 RÜ/ml).
English: Hold the pre-filled water for injections syringe upright, grasp the plunger rod as per the diagram and attach the rod by turning it firmly clockwise into the threaded stopper (C).
Estonian: Hoidke süsteveega täidetud süstalt püsti, võtke kätte kolvivars (vt joonist) ja tugevalt päripäeva pöörates, kinnitage vars keermega korgi külge (C).
English: INSTRUCTIONS ON USE Read package leaflet before use.
Estonian: KASUTUSJUHEND Enne ravimi kasutamist lugege pakendi infolehte.
English: 1 pre-filled syringe with 2.5 mL or 5 mL water for injections with separate plunger rod.
Estonian: 1 süstel 2,5 ml või 5 ml süsteveega koos eraldi kolvivarrega 1 viaaliadapter
English: KOGENATE Bayer 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Estonian: KOGENATE Bayer 250 RÜ sisaldab (250 RÜ/2,5 ml) = pärast lahustamist 100 RÜ alfaoktokogi ml kohta.
English: • The SIPPET study was not designed to evaluate the risk of inhibitor development for individual products, and included a limited number of FVIII products.
Estonian: • Uuringu SIPPET ülesehitus ei võimaldanud hinnata inhibiitorite tekke riski konkreetsete ravimite kasutamisel ning selles uuriti väheseid FVIII-ravimeid.
English: • the severity of your haemophilia
Estonian: • hemofiilia raskusastmest;
English: 3000 IU (octocog alfa) (600 IU/mL after reconstitution).
Estonian: 3000 RÜ alfaoktokogi (pärast lahustamist 600 RÜ/ml).
English: The SIPPET study was an open-label, randomized, multi-centre, multi-national trial investigating the incidence of neutralising allo-antibodies in patients with severe congenital haemophilia A (plasma FVIII concentration<1%) with either the use of pdFVIII or rFVIII concentrates.
Estonian: Uuring SIPPET oli avatud ülesehitusega randomiseeritud mitmekeskuseline rahvusvaheline uuring, milles uuriti neutraliseerivate alloantikehade esinemissagedust raske kaasasündinud A-hemofiiliaga
English: KOGENATE Bayer 2000 IU contains (2000 IU / 5 mL) = 400 IU octocog alfa per mL after reconstitution.
Estonian: KOGENATE Bayer 2000 RÜ sisaldab (2000 RÜ/5 ml) = pärast lahustamist 400 RÜ alfaoktokogi ml kohta.
English: Inject the diluent by slowly pushing down on the plunger rod (G).
Estonian: Vajutades aeglaselt kolvivarrele, süstige lahusti viaali (G).
English: KOGENATE Bayer 3000 IU contains (3000 IU / 5 mL) = 600 IU octocog alfa per mL after reconstitution.
Estonian: KOGENATE Bayer 3000 RÜ sisaldab (3000 RÜ/5 ml) = pärast lahustamist 600 RÜ alfaoktokogi ml kohta.
English: KOGENATE Bayer 500 IU contains (500 IU / 2.5 mL) = 200 IU octocog alfa per mL after reconstitution.
Estonian: KOGENATE Bayer 500 RÜ sisaldab (500 RÜ/2,5 ml) = pärast lahustamist 200 RÜ alfaoktokogi ml kohta.
English: Unscrew the syringe to disconnect the vial (I).
Estonian: Keerake süstal viaali küljest lahti (I).
English: As the evidence suggests that all human FVIII products carry a risk of inhibitor development, within the frequency of ‘very common' and ‘uncommon' for PUPs and PTPs respectively, the PRAC recommends that the SmPCs should be aligned with these frequencies unless justified by product specific data.
Estonian: Et tõendite järgi kaasneb kõigi inimese FVIII-ravimitega inhibiitorite tekkerisk, mille esinemissagedus on varem ravimata patsientidel „väga sage“ ja varem ravitud patsientidel „aeg-ajalt“, soovitab ravimiohutuse riskihindamise komitee ravimi omaduste kokkuvõtte andmed nende esinemissageduste järgi ühtlustada, v.a kui ravimiomased andmed ei põhjenda muu sagedusvahemiku kasutamist.
English: The available data supports a frequency of FVIII inhibitor development within the frequency of ‘very common' and ‘uncommon', for PUPs and PTPs respectively, therefore the PRAC recommends that the SmPCs should be aligned with these frequencies unless justified by product specific data.
Estonian: Kättesaadavate andmete järgi on FVIII-inhibiitorite tekke esinemissagedus varem ravimata patsientidel „väga sage“ ja varem ravitud patsientidel „aeg-ajalt“, mistõttu soovitab ravimiohutuse riskihindamise komitee ravimi omaduste kokkuvõtte andmed nende esinemissageduste järgi ühtlustada, v.a kui ravimiomased andmed ei põhjenda muu sagedusvahemiku kasutamist.
English: • The PRAC noted that the efficacy and safety of Factor VIII products as indicated in the treatment and prophylaxis of bleeding in patients with haemophilia A have been established.Based on the available data, the PRAC considered that SmPC updates for the FVIII products are warranted: section 4.4 should be amended to include a warning on the clinical importance of monitoring patients for FVIII inhibitor development.
Estonian: Olemasolevate andmete põhjal oli komitee arvamusel, et tuleb ajakohastada FVIII-ravimite ravimi omaduste kokkuvõtteid: lõiku 4.4 tuleb muuta, et lisada hoiatus patsientide jälgimise kliinilise tähtsuse kohta FVIII inhibiitorite tekke suhtes.
English: KOGENATE Bayer 1000 IU contains (1000 IU / 2.5 mL) = 400 IU octocog alfa per mL after reconstitution.
Estonian: KOGENATE Bayer 1000 RÜ sisaldab (1000 RÜ/2,5 ml) = pärast lahustamist 400 RÜ alfaoktokogi ml kohta.
English: PRAC discussion on grounds for re-examination
Estonian: Taasläbivaatamise aluste arutelu ravimiohutuse riskihindamise komitees
English: Specifically, the findings from the SIPPET study, as well as those from the individual clinical trials and observational studies included in the MAH responses, are not sufficient to confirm any consistent statistically and clinically meaningful differences in inhibitor risk between rFVIII and pdFVIII product classes.
Estonian: Eelkõige ei ole uuringu SIPPET tulemused ega müügiloa hoidjate vastustes sisalduvate üksikute kliiniliste uuringute ja jälgimisuuringute tulemused piisavad, et kinnitada rFVIII- ja pdFVIII-ravimiklasside vahelist inhibiitorite tekkeriski järjepidevat statistiliselt ja kliiniliselt tähenduslikku erinevust.
English: 500 IU (octocog alfa) (200 IU/mL after reconstitution).
Estonian: 500 RÜ alfaoktokogi (pärast lahustamist 200 RÜ/ml).
English: The PRAC considered the views expressed by experts during an ad-hoc meeting.
Estonian: Ravimiohutuse riskihindamise komitee arvestas ajutise eksperdirühma arvamusi.
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously untreated patients
Estonian: PTP = previously treated patients, varem ravitud patsiendid, PUP =
English: 1000 IU (octocog alfa) (400 IU/mL after reconstitution).
Estonian: 1000 RÜ alfaoktokogi (pärast lahustamist 400 RÜ/ml).
English: - Keep this leaflet.
Estonian: Asetage käele žgutt.
English: These therapies should be directed by physicians with experience in the care of patients with haemophilia.
Estonian: Neid ravisid peavad määrama A-hemofiiliaga patsientide ravis kogenud arstid.
English: 2000 IU (octocog alfa) (400 IU/mL after reconstitution).
Estonian: 2000 RÜ alfaoktokogi (pärast lahustamist 400 RÜ/ml).
English: • One mL KOGENATE Bayer 3000 IU contains approximately 600 IU (3000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: • 1 ml KOGENATE Bayer 3000 RÜ sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 600 RÜ (3000 RÜ / 5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN:
English: The RODIN/Pednet study3 also found no evidence of a class difference in inhibitor risk between all pdFVIII vs all rFVIII; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.96 (95% CI 0.62-1.49), and for high titre inhibitors (≥5 BU/ml) was 0.95 (95% CI 0.56-1.61).
Estonian: Kliiniliselt oluliste inhibiitorite korral oli kohandatud ohusuhe 0,96 (95% usaldusvahemik 0,62…1,49) ja kõrges tiitris inhibiitorite korral (≥ 5 BU/ml) 0,95 (95% usaldusvahemik 0,56…1,61).
English: Whether there are significant differences in the risk of inhibitor development between different types of FVIII replacement product remains an area of uncertainty.
Estonian: Seni on ebaselge, kas eri tüüpi FVIII-asendusravimitel on inhibiitorite tekkerisk oluliselt erinev.
English: How to store KOGENATE Bayer
Estonian: Kuidas KOGENATE Bayer'it säilitada
English: • One mL KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: • 1 ml KOGENATE Bayer 250 RÜ sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 100 RÜ (250 RÜ / 2,5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN:
English: KOGENATE Bayer 250 IU powder and solvent for solution for injection KOGENATE Bayer 500 IU powder and solvent for solution for injection KOGENATE Bayer 1000 IU powder and solvent for solution for injection KOGENATE Bayer 2000 IU powder and solvent for solution for injection KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Estonian: KOGENATE Bayer 250 RÜ süstelahuse pulber ja lahusti KOGENATE Bayer 500 RÜ süstelahuse pulber ja lahusti KOGENATE Bayer 1000 RÜ süstelahuse pulber ja lahusti KOGENATE Bayer 2000 RÜ süstelahuse pulber ja lahusti KOGENATE Bayer 3000 RÜ süstelahuse pulber ja lahusti Rekombinantne VIII hüübimisfaktor (alfaoktokog)
English: • One mL KOGENATE Bayer 1000 IU contains approximately 400 IU (1000 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: • 1 ml KOGENATE Bayer 1000 RÜ sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 400 RÜ (1000 RÜ / 2,5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN:
English: Factor VIII products and inhibitor development in severe hemophilia A. N Engl J Med 2013; 368: 231-9.http://www.bloodjournal.org/content/121/20/4046.full.pdf study, the FranceCoag study also found no statistically significant increased risk for any rFVIII products vs Advate when French patients (also in the RODIN/Pednet study) were excluded.
Estonian: Nagu uuringus UKHCDO, ei leitud uuringus FranceCoag inhibiitorite tekke statistiliselt oluliselt suurenenud riski ühegi rFVIII-ravimi ja Advate võrdluses, kui uuringust jäeti välja Prantsusmaa patsiendid (olid kaasatud ka uuringusse RODIN/Pednet).
English: The pre-filled syringe contains water for injections to be used to reconstitute the contents of the vial.
Estonian: Süstlis on süstevesi viaali sisu lahustamiseks.
English: • One mL KOGENATE Bayer 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: • 1 ml KOGENATE Bayer 500 RÜ sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 200 RÜ (500 RÜ / 2,5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN:
English: • One mL KOGENATE Bayer 2000 IU contains approximately 400 IU (2000 IU / 5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Estonian: • 1 ml KOGENATE Bayer 2000 RÜ sisaldab pärast süsteveega manustamiskõlblikuks muutmist ligikaudu 400 RÜ (2000 RÜ / 5 ml) rekombinantset inimese VIII hüübimisfaktorit (INN:
English: Detailed instructions for reconstitution and administration of KOGENATE Bayer using vial with reconstitution cap (Bio-Set System): Wash your hands thoroughly using soap and warm water.
Estonian: Juhised KOGENATE Bayer'i manustamiskõlblikuks muutmiseks ja manustamiseks, kasutades viaali koos manustamiskõlblikuks muutmise Bio-Set süsteemiga.
English: Individual studies have identified a wide range of inhibitor frequency in PUPs across products, and the SIPPET study was not designed to differentiate between individual products in each class.
Estonian: Uuringu SIPPET ülesehitus ei võimaldanud eristada iga ravimiklassi üksikravimeid.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Estonian: KÕLBLIKKUSAEG ANNETUSE KOOD JA TOOTEKOOD
English: Even doses several fold higher than the recommended clinical dose (related to body weight) failed to demonstrate any acute or subacute toxic effects for KOGENATE Bayer in laboratory animals (mouse, rat, rabbit, and dog).
Estonian: Laboriloomadel (hiir, rott, küülik ja koer) ei ilmnenud KOGENATE Bayer'iga ägedat ega alaägedat toksilist toimet isegi soovitatud kliinilisest annusest mitu korda suuremate (kehakaaluga seotud) annuste korral.
English: KOGENATE Bayer 250 IU powder for solution for injection KOGENATE Bayer 500 IU powder for solution for injection KOGENATE Bayer 1000 IU powder for solution for injection KOGENATE Bayer 2000 IU powder for solution for injection KOGENATE Bayer 3000 IU powder for solution for injection
Estonian: KOGENATE Bayer 250 RÜ süstelahuse pulber KOGENATE Bayer 500 RÜ süstelahuse pulber KOGENATE Bayer 1000 RÜ süstelahuse pulber KOGENATE Bayer 2000 RÜ süstelahuse pulber KOGENATE Bayer 3000 RÜ süstelahuse pulber
English: MAH-sponsored studies
Estonian: Müügiloa hoidjate spondeeritud uuringud
English: Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
Estonian: Vajaliku VIII faktori aktiivsuse taseme saavutamiseks arvutab teie arst ravimi vajaliku annuse ja määrab selle kasutamise sageduse.
English: KOGENATE Bayer 250 IU powder and solvent for solution for injection KOGENATE Bayer 500 IU powder and solvent for solution for injection KOGENATE Bayer 1000 IU powder and solvent for solution for injection KOGENATE Bayer 2000 IU powder and solvent for solution for injection KOGENATE Bayer 3000 IU powder and solvent for solution for injection
Estonian: KOGENATE Bayer 250 RÜ, süstelahuse pulber ja lahusti KOGENATE Bayer 500 RÜ, süstelahuse pulber ja lahusti KOGENATE Bayer 1000 RÜ, süstelahuse pulber ja lahusti KOGENATE Bayer 2000 RÜ, süstelahuse pulber ja lahusti KOGENATE Bayer 3000 RÜ, süstelahuse pulber ja lahusti
English: The CANAL study2 found no evidence of a class difference, including pdFVIII products with considerable quantities of von Willebrand factor; for ‘clinically relevant' inhibitors the adjusted hazard ratio was 0.7 (95% CI 0.4-1.1), and for high titre inhibitors (≥5 BU) was 0.8 (95% CI 0.4
Estonian: Kliiniliselt oluliste inhibiitorite korral oli kohandatud ohusuhe 0,7 (95% usaldusvahemik 0,4…1,1) ja kõrges tiitris inhibiitorite korral (≥ 5 BU) 0,8 (95% usaldusvahemik 0,4…1,3).
English: 1 vial adapter
Estonian: 1 süstelahuse pulbriga viaal
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Estonian: Jälgides nõela asendit, süstige lahus 2…5 minuti jooksul veeni.
English: The referral focuses on the risk of inhibitor development in PUPs.
Estonian: Esildis keskendub inhibiitorite tekkeriskile varem ravimata patsientidel.
English: Attach the pre-filled syringe to the threaded vial adapter by turning clockwise (F).
Estonian: Päripäeva keerates kinnitage süstel keermega viaaliadapteri külge (F).
English: The adapter will snap over the vial cap. Do not remove the adapter housing at this point.
Estonian: Ärge adapteri ümbrist veel eemaldage.
English: Place product vial on a firm, non-skid surface.
Estonian: Asetage ravimit sisaldav viaal kindlale mittelibedale pinnale.
English: • syringe plunger rod
Estonian: • süstli kolvivars;
English: Table 3: Frequency of adverse drug reactions MedDRA
Estonian: Kõrvaltoimete esinemissagedused MedDRA standardne organsüsteemi klass
English: 1 vial with powder for solution for injection.
Estonian: VIAAL PULBRIGA SÜSTELAHUSE VALMISTAMISEKS
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE WITH 2.5 mL or 5 mL WATER FOR INJECTIONS
Estonian: 1 Bio-Set süsteemiga süstelahuse pulbrit sisaldav viaal 1 süstel 2,5 ml või 5 ml süsteveega koos eraldi kolvivarrega 1 veenipunktsiooni komplekt
English: initiation pack: 14 tablets + 14 tablets + 14 tablets +14 tablets
Estonian: EU/1/17/1230/025 Lacosamide Accord 50/100/150/200 mg Õhukese polümeerikattega tablett ravi stardipakend: 14 tabletti + 14 tabletti + 14 tabletti +14 tabletti
English: The patient's response to treatment can be assessed approximately eight weeks after treatment.
Estonian: Patsiendi ravivastust saab hinnata ligikaudu 8 nädalat pärast ravi.
English: The full EPAR for Picato can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Picato 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 Picato on 15 November 2012.
Estonian: Euroopa Komisjon andis Picatole müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 15. novembril
English: The exact way Picato works is not fully understood.
Estonian: Picato täpne toimemehhanism ei ole täielikult teada.
English: Other information about Picato
Estonian: Muu teave Picato kohta
English: EPAR summary for the public ingenol mebutate
Estonian: Kokkuvõte üldsusele ingenoolmebutaat
English: There were no major safety concerns with Picato and the side effects seen were mostly local skin reactions which, although they affected most patients, usually resolved within two to four weeks of treatment depending on the location.
Estonian: Picato kasutamisel ei täheldatud olulisi ohutusprobleeme ja kõrvalnähud olid enamikus paiksed nahareaktsioonid, mis möödusid sõltuvalt asukohast tavaliselt 2-4 nädalat pärast ravi, kuigi neid esines enamikul patsientidel.
English: The most frequently reported side effects are skin reactions at the application site of Picato, including erythema (reddening of the skin), flaking or scaling, crusting, swelling, vesiculation or pustulation (blisters), and erosion or ulceration (wearing away of outer skin layer or open sore of the skin).
Estonian: Picato kõige sagedamad kõrvalnähud on manustamiskoha nahareaktsioonid, sealhulgas erüteem (nahapunetus), ketendus, nahakoorikud, turse, villid või mädavillid ning erosioonid (naha pindmise kihi eraldumine) ja haavandumine.
English: For more information about treatment with Picato, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Picatoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
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 Picato.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: What is Picato?
Estonian: Mis on Picato?
English: The CHMP therefore decided that Picato's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas seepärast, et Picato kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: The main measure of effectiveness was the number of patients whose skin was completely cleared of the actinic keratosis eight weeks after treatment.
Estonian: Efektiivsuse põhinäitaja oli patsientide arv, kelle nahk oli 8 nädalat pärast ravi kiirguskeratoosist täielikult paranenud.
English: The content of one tube covers a treatment area of 25 cm2.
Estonian: Ühe tuubiga saab katta kuni 25 cm2 suuruse nahapinna.
English: What benefit has Picato shown during the studies?
Estonian: Milles seisneb uuringute põhjal Picato kasulikkus?