FrancophonIA/ELRC3.0 huggingface dataset:
English: • Peel off one side of the release liner.
Estonian: • Eemaldage eemaldatava kihi üks pool.
English: • Each patch releases 2 mg of rotigotine per 24 hours.
Estonian: • Iga plaaster vabastab 24 tunni vältel 2 mg rotigotiini.
English: • 6 mg/24 h: Each patch releases 6 mg of rotigotine per 24 hours.
Estonian: • 6 mg/24 h: Iga plaaster vabastab 24 tunni vältel 6 mg rotigotiini.
English: Erythema, hyperhidrosis, pruritus
Estonian: Naha ja nahaaluskoe kahjustused erüteem, hüperhidroos, pruuritus,
English: Leganto 1 mg/24 h transdermal patch Each patch releases 1 mg of rotigotine per 24 hours.
Estonian: Leganto 1 mg/24 h transdermaalne plaaster Iga plaaster vabastab 24 tunni vältel 1 mg rotigotiini.
English: Leganto 8 mg/24 h transdermal patch Each patch releases 8 mg of rotigotine per 24 hours.
Estonian: Leganto 8 mg/24 h transdermaalne plaaster Iga plaaster vabastab 24 tunni vältel 8 mg rotigotiini.
English: Leganto 1 mg/24 h transdermal patch EU/1/11/695/001
Estonian: Leganto 1 mg/24 h transdermaalne plaaster EU/1/11/695/001
English: AST, ALT, GGT), weight increased e, heart rate increased e,
Estonian: ASAT, ALAT, GGT), kaalutõus e, kiirenenud pulss e, kreatiniinfosfokinaasi (CPK) taseme tõusd,e (vt
English: Since it ran more or less parallel with a decreased relative total growth of the cells, it may be related to a cytotoxic effect of the compound.
Estonian: In vivo ei kinnitanud seda toimet hiire mikrotuuma test ega roti plaanivälise DNA-sünteesi (UDS) test. Et see toimus enamvähem samaaegselt rakkude suhtelise kasvu üldise vähenemisega, võib seda seostada antud aine tsütotoksilise toimega.
English: • Your starting daily dose will be one 4 mg/24 h patch each day.
Estonian: • Teie päevaseks algannuseks on üks 4 mg/24 h plaaster päevas.
English: The outside is tan-coloured and is imprinted with Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h or 8 mg/24 h.
Estonian: Välimine pool on beež ja sellel on jäljend Leganto 2 mg/24 h, 4 mg/24 h, 6 mg/24 h või 8 mg/24 h.
English: • 3 mg/24 h: Each patch releases 3 mg of rotigotine per 24 hours.
Estonian: • 3 mg/24 h: Iga plaaster vabastab 24 tunni vältel 3 mg rotigotiini.
English: Leganto is available in different strength patches which release the medicine over 24 hours.The strengths are 1 mg/24 h, 2 mg/24 h and 3 mg/24 h for the treatment of Restless Leg Syndrome.
Estonian: Tugevused rahutute jalgade sündroomi raviks on 1 mg/24 h, 2 mg/24 h ja 3 mg/24 h.
English: The outside is tan-coloured and is imprinted with Leganto 2 mg/24 h.
Estonian: Välimine pool on beež ja sellel on jäljend Leganto 2 mg/24 h.
English: • 4 mg/24 h: Each patch releases 4 mg of rotigotine per 24 hours.
Estonian: • 4 mg/24 h: Iga plaaster vabastab 24 tunni vältel 4 mg rotigotiini.
English: Palpitations e,
Estonian: Südame häired palpitatsioonid e,
English: visual impairment e,
Estonian: Silma kahjustused hägune nägemine e,
English: pruritus generalisede, skin irritation e,
Estonian: oksendamine, düspepsia kõhukinnisus e,
English: After 6 months of maintenance treatment in patients with moderate to severe RLS, the baseline IRLS score improved from 30.7 to 20.7 for placebo and from 30.2 to 13.8 for rotigotine.
Estonian: Peale 6-kuulist säilitusravi mõõduka kuni raske rahutute jalgade sündroomiga patsientidel muutus algtaseme IRLS platseebogrupis 30,7-lt 20,7-ni ja rotigotiini-grupis 30,2-lt 13,8-ni. Korrigeeritud keskmine erinevus oli -6,5 punkti (CI 95% -8,7; -4,4, p < 0,0001).
English: Each patch releases 6 mg of rotigotine per 24 hours.
Estonian: Iga plaaster vabastab 24 tunni vältel 6 mg rotigotiini.
English: • delusion
Estonian: • ärevus
English: Component of a multipack, can't be sold separately
Estonian: 28 transdermaalset plaastrit, hulgipakendi osa (ei müüda eraldi).
English: Atrial fibrillation Supraventricular tachycardia
Estonian: Südame häired palpitatsioonid kodade virvendus supraventrikulaarne tahhükardia
English: EU/1/11/695/001 [7 transdermal patches] EU/1/11/695/003 [28 transdermal patches] EU/1/11/695/004 [30 transdermal patches]
Estonian: EU/1/11/695/001 [7 transdermaalset plaastrit] EU/1/11/695/003 [28 transdermaalset plaastrit] EU/1/11/695/004 [30 transdermaalset plaastrit]
English: Hypotension
Estonian: Imendumine
English: Leganto 6 mg/24 h transdermal patch EU/1/11/695/037
Estonian: Leganto 6 mg/24 h transdermaalne plaaster EU/1/11/695/037
English: 1 transdermal patch
Estonian: 1 transdermaalne plaaster
English: Leganto 2 mg/24 h transdermal patch
Estonian: Leganto 2 mg/24 h transdermaalne plaaster
English: Leganto 3 mg/24 h transdermal patch EU/1/11/695/019
Estonian: Leganto 3 mg/24 h transdermaalne plaaster EU/1/11/695/019
English: Leganto 8 mg/24 h transdermal patch rotigotine
Estonian: Leganto 8 mg/24 h transdermaalne plaaster rotigotiin
English: Vascular disorders
Estonian: Transdermaalne plaaster
English: Pruritus
Estonian: Rasedus
English: • To help avoid the skin reactions, you should put the patch on a different area of skin every day,
Estonian: • Nahareaktsioonide vältimiseks peate plaastri asetama iga päev erinevale nahapiirkonnale ning sama piirkonda võib uuesti kasutada alles 14 päeva pärast.
English: EU/1/11/695/007 [84 transdermal patches (3 packs of 28)]
Estonian: EU/1/11/695/007 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
English: EU/1/11/695/019 [7 transdermal patches] EU/1/11/695/021 [28 transdermal patches] EU/1/11/695/022 [30 transdermal patches]
Estonian: EU/1/11/695/019 [7 transdermaalset plaastrit] EU/1/11/695/021 [28 transdermaalset plaastrit] EU/1/11/695/022 [30 transdermaalset plaastrit]
English: Leganto 3 mg/24 h transdermal patch Each patch releases 3 mg of rotigotine per 24 hours.
Estonian: Leganto 3 mg/24 h transdermaalne plaaster Iga plaaster vabastab 24 tunni vältel 3 mg rotigotiini.
English: EU/1/11/695/046 [7 transdermal patches] EU/1/11/695/048 [28 transdermal patches] EU/1/11/695/049 [30 transdermal patches]
Estonian: EU/1/11/695/046 [7 transdermaalset plaastrit] EU/1/11/695/048 [28 transdermaalset plaastrit] EU/1/11/695/049 [30 transdermaalset plaastrit]
English: Dopaminergic adverse reactions
Estonian: Dopamiinergilised kõrvaltoimed
English: Tell your doctor, pharmacist or nurse if you notice any of the side effects listed above.
Estonian: Rääkige oma arstile, apteekrile või meditsiiniõele, kui te märkate mõnda ülaltoodud kõrvaltoimetest.
English: Each patch releases 3 mg of rotigotine per 24 hours.
Estonian: Iga plaaster vabastab 24 tunni vältel 3 mg rotigotiini.
English: Leganto 4 mg/24 h transdermal patch EU/1/11/695/028
Estonian: Leganto 4 mg/24 h transdermaalne plaaster EU/1/11/695/028
English: Each patch releases 2 mg of rotigotine per 24 hours.
Estonian: Iga plaaster vabastab 24 tunni vältel 2 mg rotigotiini.
English: Talk to your doctor or pharmacist if you notice any of the side effects listed above.
Estonian: Rääkige oma arstile või apteekrile, kui te märkate mõnda ülaltoodud kõrvaltoimetest.
English: Leganto 1 mg/24 h transdermal patch rotigotine
Estonian: Leganto 1 mg/24 h transdermaalne plaaster rotigotiin
English: Leganto 4 mg/24 h transdermal patch Each patch releases 4 mg of rotigotine per 24 hours.
Estonian: Leganto 4 mg/24 h transdermaalne plaaster Iga plaaster vabastab 24 tunni vältel 4 mg rotigotiini.
English: Leganto 6 mg/24 h transdermal patch Each patch releases 6 mg of rotigotine per 24 hours.
Estonian: Leganto 6 mg/24 h transdermaalne plaaster Iga plaaster vabastab 24 tunni vältel 6 mg rotigotiini.
English: 7 transdermal patches.
Estonian: 7 PLAASTRIGA KARP- 2.
English: EU/1/11/695/037 [7 transdermal patches] EU/1/11/695/039 [28 transdermal patches] EU/1/11/695/040 [30 transdermal patches]
Estonian: EU/1/11/695/037 [7 transdermaalset plaastrit] EU/1/11/695/039 [28 transdermaalset plaastrit] EU/1/11/695/040 [30 transdermaalset plaastrit]
English: Each patch releases 4 mg of rotigotine per 24 hours.
Estonian: Iga plaaster vabastab 24 tunni vältel 4 mg rotigotiini.
English: EU/1/11/695/010 [7 transdermal patches] EU/1/11/695/012 [28 transdermal patches] EU/1/11/695/013 [30 transdermal patches]
Estonian: EU/1/11/695/010 [7 transdermaalset plaastrit] EU/1/11/695/012 [28 transdermaalset plaastrit] EU/1/11/695/013 [30 transdermaalset plaastrit]
English: Vision blurred e,
Estonian: nägemiskahjustus e,
English: EU/1/11/695/028 [7 transdermal patches] EU/1/11/695/030 [28 transdermal patches] EU/1/11/695/031 [30 transdermal patches]
Estonian: EU/1/11/695/028 [7 transdermaalset plaastrit] EU/1/11/695/030 [28 transdermaalset plaastrit] EU/1/11/695/031 [30 transdermaalset plaastrit]
English: Leganto 6 mg/24 h transdermal patch rotigotine
Estonian: Leganto 6 mg/24 h transdermaalne plaaster rotigotiin
English: • Then put the sticky half of the patch onto your skin.
Estonian: • Kinnitage plaaster kleepuvat pinda pidi nahale.
English: Bayer Vital GmbH Tel: +49-(0)214-30 513 48
Estonian: Deutschland UCB Pharma GmbH Tel: +49-(0) 2173 48 4848
English: Leganto 4 mg/24 h transdermal patch rotigotine
Estonian: Leganto 4 mg/24 h transdermaalne plaaster rotigotiin
English: EU/1/11/695/016 [84 transdermal patches (3 packs of 28)]
Estonian: EU/1/11/695/016 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
English: EU/1/11/695/052 [84 transdermal patches (3 packs of 28)]
Estonian: EU/1/11/695/052 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
English: Leganto 3 mg/24 h transdermal patch rotigotine
Estonian: Leganto 3 mg/24 h transdermaalne plaaster rotigotiin
English: Skin and subcutaneous tissue disorders
Estonian: Kõrva ja labürindi kahjustused peapöörituse
English: EU/1/11/695/025 [84 transdermal patches (3 packs of 28)]
Estonian: EU/1/11/695/025 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
English: EU/1/11/695/043 [84 transdermal patches (3 packs of 28)]
Estonian: EU/1/11/695/043 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
English: Nervous system disorders
Estonian: Seedetrakti häired iiveldus,
English: Leganto 2 mg/24 h transdermal patch Each patch releases 2 mg of rotigotine per 24 hours.
Estonian: Leganto 2 mg/24 h, transdermaalne plaaster Iga plaaster vabastab 24 tunni vältel 2 mg rotigotiini.
English: EU/1/11/695/034 [84 transdermal patches (3 packs of 28)]
Estonian: EU/1/11/695/034 [84 transdermaalset plaastrit (3 karpi á 28 plaastriga)]
English: Hepatic impairment
Estonian: Eemaldatav kiht
English: SACHET LABEL
Estonian: FARMATSEUTILISED ANDMED
English: • Thigh or hip.
Estonian: • Reis või puus.
English: Gastrointestinal disorders
Estonian: Plaastrist tingitud nahareaktsioonid
English: Leganto 2 mg/24 h transdermal patch Rotigotine
Estonian: Leganto 2 mg/24 h transdermaalne plaaster Rotigotiin
English: syncope, syncope vasovagal, loss of consciousness), dyskinesia, dizziness postural, lethargy
Estonian: (k.a sünkoop, vasovagaalne sünkoop, teadvusekaotus), düskineesia, posturaalne pearinglus, letargia krambid langetatud pea sündroom c
English: How to use Leganto
Estonian: Kuidas Legantot säilitada
English: • vomiting, heartburn
Estonian: • oksendamine, kõrvetised
English: • increased heart rate
Estonian: • kiirenenud pulss
English: - Keep this leaflet.
Estonian: Tõmmake kile lahti.
English: Self adhesive matrix layer
Estonian: Isekleepuv maatrikskiht
English: dermatitis contact e, rash generalised e
Estonian: kontaktdermatiit e, üldine lööve
English: Hypersensitivity (allergic reactions) has sometimes been seen.
Estonian: Mõnikord on täheldatud ülitundlikkust (allergilisi reaktsioone).
English: Additionally, any improvement in skin lesions was monitored.
Estonian: Lisaks jälgiti ka nahakahjustuste paranemist.
English: The European Commission granted a marketing authorisation valid throughout the European Union for CEPROTIN to Baxter AG on 16 July 2001.
Estonian: Euroopa Komisjon väljastas CEPROTINi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Baxter AG 16. juulil 2001.
English: It explains how the Committee for Medicinal products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Estonian: Selles selgitatakse, kuidas inimtervishoius kasutatavate ravimite komitee hindas teostatud uuringuid, et koostada soovitused ravimi kasutamise kohta.
English: The marketing authorisation was renewed on 16 July
Estonian: Müügiluba pikendati 16. juulil 2006.
English: The Committee recommended that CEPROTIN be given marketing authorisation.
Estonian: CEPROTINile soovitati anda müügiluba.
English: This summary was last updated in 08-2007.©EMEA 2007
Estonian: Kokkuvõtte viimane uuendus: 08-2007.
English: CEPROTIN is given by intravenous injection (injection into a vein) at a maximum injection rate of 2 ml per minute except for children with a body weight of less than 10 kg, where the injection rate should not exceed 0.2 ml per kilogram body weight per minute.
Estonian: CEPROTINi manustatakse intravenoosse süstina (veenisüstina) suurima süstimiskiirusega 2 ml minutis, välja arvatud alla 10 kg kaaluvatel lastel, kellel ei tohi süstimiskiirus ületada 0,2 ml kehakaalu kilogrammi kohta minutis.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) CEPROTIN EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE CEPROTIN Kokkuvõte üldsusele
English: As the company had supplied the additional information requested, the 'Exceptional Circumstances' ended on 28 July 2006.
Estonian: Et ettevõte esitas vajaliku lisateabe, tühistati müügiloa erandkorras väljastatus 28. juulil 2007.
English: When patients start receiving other anticoagulant medicines, such as warfarin, special care is needed and CEPROTIN treatment must be continued until the warfarin treatment is adjusted.
Estonian: Kui patsiendid hakkavad võtma teisi hüübimisvastase toimega ravimeid, näiteks varfariini, tuleb võtta erilisi ettevaatusmeetmeid ja jätkata CEPROTIN-ravi kuni varfariinravi stabiliseerumiseni.
English: CEPROTIN has been studied in a total of 79 patients, 22 of whom had a diagnosis of the more severe forms of congenital protein C deficiency.
Estonian: CEPROTINi uuriti kokku 79 patsiendil, kellest 22 oli diagnoositud kaasasündinud proteiin C vaeguse mis tahes raskem vorm.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Estonian: Kui soovite inimtervishoius kasutatavate ravimite komitee soovituste aluse kohta lisateavet, lugege palun teadusliku arutelu kokkuvõtet (samuti Euroopa avaliku hindamisaruande osa).
English: CEPROTIN treatment should only be started by a doctor who has experience in this type of therapy and where it is possible to measure protein C activity.
Estonian: Ravi CEPROTINiga võib määrata üksnes sellise ravi kogemustega arst ning juhul, kui on võimalik mõõta proteiin C toimet.
English: The results in the treatment of other types of clotting disorders, and of patients with other protein C deficiencies, were not sufficient to assess completely the use of CEPROTIN in these groups.
Estonian: Muud tüüpi hüübimishäirete ja muude proteiin C vaeguse probleemidega patsientide ravi tulemustest ei piisa, et hinnata CEPROTINi kasutamist neis rühmades.
English: What is CEPROTIN?
Estonian: Mis on CEPROTIN?
English: CEPROTIN should not be used in people who may be hypersensitive (allergic) to human protein C, mouse protein or to heparin, except in life-threatening complications.
Estonian: CEPROTINi ei tohi kasutada inimestel, kes võivad olla ülitundlikud (allergilised) inimese loodusliku proteiin C, hiirevalkude või hepariini suhtes, välja arvatud eluohtlike tüsistuste korral.
English: Why has CEPROTIN been approved?
Estonian: Miks CEPROTIN heaks kiideti?
English: CEPROTIN contains human protein C, extracted and purified from human plasma (the liquid part of the blood).
Estonian: CEPROTIN sisaldab inimese looduslikku proteiin C-d, mis on eraldatud ja puhastatud inimplasmast (vere vedel osa).
English: CEPROTIN was originally authorised under 'Exceptional Circumstances‘, because it was not possible at the time to obtain complete information on the medicine due to the low number of patients diagnosed with this disease.
Estonian: CEPROTINile anti müügiluba esialgu erandkorras, sest kuna seda haigust on diagnoositud vaid väikesel arvul patsientidel, ei olnud ravimi heakskiitmise ajal võimalik koguda ravimi kohta kõikehõlmavat teavet.
English: Protein C slows down the production of thrombin, and therefore slows down further clotting.
Estonian: Proteiin C aeglustab trombiini moodustumist ja seega kogu hüübimist.
English: CEPROTIN is also used for the short-term prevention of clotting in patients with severe congenital protein C deficiency in certain situations when there is an increased risk of clotting, such as surgery or when treatment with a coumarin is not sufficient or possible.
Estonian: Teatud olukordades kasutatakse CEPROTINi ka hüübimise lühiajaliseks pärssimiseks raske proteiin C kaasasündinud vaegusega patsientidel, kui esineb suurenenud hüübimise risk, näiteks operatsiooni ajal või kui ravi kumariiniga ei ole piisav või võimalik.
English: What is the risk associated with CEPROTIN?
Estonian: Millised on CEPROTINiga kaasnevad riskid?
English: CEPROTIN is used in patients with severe congenital (hereditary) protein C deficiency to treat purpura fulminans (extensive clotting of blood within the blood vessels, which causes the death of the tissues just beneath the skin, often leading to organ failure and amputations) and coumarin-induced skin necrosis (a complication of anticoagulant treatment with medicines such as warfarin, causing skin death).
Estonian: CEPROTINi kasutatakse proteiin C raske kaasasündinud (päriliku) vaegusega patsientidel fulminantse purpuri (vere laialdane hüübimine veresoontes, mis põhjustab nahaaluste kudede kärbumist ning sageli elundite talitluse puudulikkust ja amputeerimise vajadust) raviks ja kumariinist põhjustatud nahakärbumist (antikoagulantravi tüsistus, mis tekib ravimite (nt varfariini) kasutamisel ja põhjustab naha kärbumist) raviks.
English: For the full list of all side effects reported with CEPROTIN, see the Package Leaflet.
Estonian: CEPROTINi kohta teatatud kõrvalnähtude täielikku loetelu leiate pakendi infolehelt.
English: Protein C is a natural substance in the blood that controls clotting.
Estonian: Proteiin C on veres sisalduv looduslik aine, mis reguleerib vere hüübimist.
English: It contains the active substance human protein C.
Estonian: Ravim sisaldab toimeainena inimese proteiin C-d.
English: CEPROTINCEPROTINOther information about CEPROTIN:
Estonian: Muu teave CEPROTINi kohta
English: In patients with severe congenital protein C deficiency, CEPROTIN improved all 16 cases of purpura fulminans and all six episodes of coumarin-induced skin necrosis.
Estonian: Proteiin C raske kaasasündinud vaegusega patsientidel leevendas CEPROTIN kõigil 16 juhul fulminantset purpurit ja kõigil kuuel juhul kumariinist põhjustatud nahakärbumist.
English: The Committee for Medicinal products for Human Use (CHMP) decided that CEPROTIN's benefits are greater than its risks for patients with severe congenital protein C deficiency.
Estonian: Inimtervishoius kasutatavate ravimite komitee jõudis otsusele, et CEPROTINi kasulikkus proteiin C raske kaasasündinud vaegusega patsientide ravis on suurem kui sellega kaasnevad riskid.
English: CEPROTIN is a powder and solvent, which are mixed together to form a solution for injection.
Estonian: CEPROTIN koosneb pulbrist ja lahustist, millest segatakse kokku süstelahus.
English: How does CEPROTIN work?
Estonian: Kuidas CEPROTIN toimib?
English: If CEPROTIN is used in patients with severe congenital protein C deficiency, antibodies inhibiting protein C may develop.
Estonian: CEPROTINi kasutamisel proteiin C raske kaasasündinud vaegusega patsientidel võivad tekkida proteiin C toimet vähendavad antikehad.
English: In the body, protein C controls the generation of thrombin, one of the substances (factors) involved in blood clotting.
Estonian: Proteiin C reguleerib organismis trombiini teket, mis on üks verehüübimises osalevatest ainetest (hüübimisteguritest).
English: The main measures of the study were normalisation of protein C levels and other indicators of coagulation (clotting) activation.
Estonian: Ravi toimet mõõdeti põhiliselt proteiin C sisalduse normaliseerumise ja muude hüübimise näitajate järgi.
English: The full EPAR for CEPROTIN is available here.
Estonian: CEPROTINi Euroopa avaliku hindamisaruande täisteksti leiate siit.
English: What benefit has CEPROTIN shown during the studies?
Estonian: Milles seisneb uuringute põhjal CEPROTINi kasulikkus?
English: How has CEPROTIN been studied?
Estonian: Kuidas CEPROTINi uuriti?
English: What is CEPROTIN used for?
Estonian: Milleks CEPROTINi kasutatakse?
English: An injection of CEPROTIN gives an immediate but temporary increase in levels of protein C. Replacement of protein C in protein C deficient patients should control or prevent thrombotic (clotting) problems in these patients.
Estonian: Proteiin C asendamine proteiin C vaegusega patsientidel peaks nendel patsientidel reguleerima või ennetama tromboosist (trombide ehk soonesiseste verehüüvete teke) tingitud probleeme.
English: How is CEPROTIN used?
Estonian: Kuidas CEPROTINi kasutatakse?
English: 23.4 g
Estonian: Alumiiniumtuub 23,4 g
English: 1 tube
Estonian: 1 tuub
English: as well as hybrids of both species (equivalent to 0.5 - 1.0 g birch bark), corresponding to 72-88 mg betulin.
Estonian: 'ilt ning mõlema liigi hübriididelt (ekvivalentne 0,5-1,0 g kasetohuga), mis vastab 72-88 mg betuliinile.
English: Content (concentration)
Estonian: Pakendi sisu (kontsentratsioon
English: 1g of gel contains: 100 mg extract (as dry extract) from birch bark from Betula pendula Roth, Betula pubescens Ehrh.
Estonian: --1 1g geeli sisaldab: 100 mg kasetohuekstrakti (kuivekstraktina), mis pärineb Betula pendula Roth'ilt, Betula pubescens Ehrh.
English: Gel
Estonian: Kutaanne
English: Extraction solvent: n-Heptane
Estonian: Ekstraheerimislahusti: n-heptaan.
English: Further information on Esperoct can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/esperoct.
Estonian: Lisateave Esperocti kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/esperoct.
English: What measures are being taken to ensure the safe and effective use of Esperoct?
Estonian: Mis meetmed võetakse, et tagada Esperocti ohutu ja efektiivne kasutamine?
English: Patients or their carers may be able to inject Esperoct themselves at home once they have been trained appropriately.
Estonian: Patsiendid või nende hooldajad tohivad süstida Esperocti ise kodus, kui nad on saanud asjakohase väljaõppe.
English: Other information about Esperoct
Estonian: Muu teave Esperocti kohta
English: The European Medicines Agency decided that Esperoct's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Esperocti kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: As for all medicines, data on the use of Esperoct are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Esperocti kasutamise kohta pidevat järelevalvet.
English: These include swelling, burning and stinging at the injection site, chills, flushing, itchy rash, headache, hives, low blood pressure, lethargy, nausea and vomiting, restlessness, a rapid heartbeat, tightness of the chest, tingling and wheezing.
Estonian: Need on näiteks turse, põletus- ja torkimistunne süstekohal, külmavärinad, õhetus, sügelev lööve, peavalu, nõgeslööve, madal vererõhk, letargia, iiveldus ja oksendamine, rahutus, kiirenenud südametegevus, rõhumistunne rinnus, kirvendus ja vilistav hingamine.
English: What is Esperoct and what is it used for?
Estonian: Mis on Esperoct ja milleks seda kasutatakse?
English: Since this could potentially cause problems especially in children below 12 years of age, Esperoct is only approved for use in adults and children from 12 years of age.
Estonian: Et see võib tekitada probleeme, eelkõige alla 12-aastastel lastel, on Esperoct heaks kiidetud kasutamiseks üksnes täiskasvanutel ja vähemalt 12-aastastel lastel.