FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Synjardy 5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Estonian: RAVIMPREPARAADI NIMETUS Synjardy 5 mg/1000 mg tabletid empagliflozinum/metformini hydrochloridum
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/850 mg film-coated tablets empagliflozin/metformin hydrochloride
Estonian: RAVIMPREPARAADI NIMETUS Synjardy 12,5 mg/850 mg tabletid empagliflozinum/metformini hydrochloridum
English: Colloidal anhydrous silica
Estonian: Veevaba kolloidne ränidioksiid
English: EU/1/15/1003/001 10 film-coated tablets EU/1/15/1003/002 14 film-coated tablets EU/1/15/1003/003 30 film-coated tablets EU/1/15/1003/004 56 film-coated tablets EU/1/15/1003/005 60 film-coated tablets EU/1/15/1003/037 90 film-coated tablets EU/1/15/1003/006 100 film-coated tablets
Estonian: EU/1/15/1003/001 10 õhukese polümeerikattega tabletti EU/1/15/1003/002 14 õhukese polümeerikattega tabletti EU/1/15/1003/003 30 õhukese polümeerikattega tabletti EU/1/15/1003/004 56 õhukese polümeerikattega tabletti EU/1/15/1003/005 60 õhukese polümeerikattega tabletti EU/1/15/1003/037 90 õhukese polümeerikattega tabletti EU/1/15/1003/006 100 õhukese polümeerikattega tabletti
English: NAME OF THE MEDICINAL PRODUCT Synjardy 12.5 mg/1,000 mg film-coated tablets empagliflozin/metformin hydrochloride
Estonian: RAVIMPREPARAADI NIMETUS Synjardy 12,5 mg/1000 mg tabletid empagliflozinum/metformini hydrochloridum
English: Synjardy 5 mg/1,000 mg film-coated tablets are brownish yellow, oval, biconvex.
Estonian: Synjardy 5 mg/1000 mg õhukese polümeerikattega tabletid on ovaalsed ja pruunikaskollased ja kaksikkumerad.
English: HbA1c (%) at week 18 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Estonian: HbA1c (%) 18. nädalal Algväärtus (keskmine) Muutus võrreldes algväärtusega Erinevus võrreldes platseeboga
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/034 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/035 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/036 200 (2 x 100 x 1) film-coated tablets
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1003/034 120 (2 x 60 x 1) õhukese polümeerikattega tabletti EU/1/15/1003/035 180 (2 x 90 x 1) õhukese polümeerikattega tabletti EU/1/15/1003/036 200 (2 x 100 x 1) õhukese polümeerikattega tabletti
English: HbA1c (%) at week 52 Baseline (mean) Change from baseline Difference from placebo (97.5% CI)
Estonian: HbA1c (%) 52. nädalal Algväärtus (keskmine) Muutus võrreldes algväärtusega Erinevus võrreldes platseeboga
English: EU/1/15/1003/019 10 film-coated tablets EU/1/15/1003/020 14 film-coated tablets EU/1/15/1003/021 30 film-coated tablets EU/1/15/1003/022 56 film-coated tablets EU/1/15/1003/023 60 film-coated tablets EU/1/15/1003/039 90 film-coated tablets EU/1/15/1003/024 100 film-coated tablets
Estonian: EU/1/15/1003/019 10 õhukese polümeerikattega tabletti EU/1/15/1003/020 14 õhukese polümeerikattega tabletti EU/1/15/1003/021 30 õhukese polümeerikattega tabletti EU/1/15/1003/022 56 õhukese polümeerikattega tabletti EU/1/15/1003/023 60 õhukese polümeerikattega tabletti EU/1/15/1003/039 90 õhukese polümeerikattega tabletti EU/1/15/1003/024 100 õhukese polümeerikattega tabletti
English: • difficulty in breathing
Estonian: • kõhuvalu
English: EU/1/15/1003/028 10 film-coated tablets EU/1/15/1003/029 14 film-coated tablets EU/1/15/1003/030 30 film-coated tablets EU/1/15/1003/031 56 film-coated tablets EU/1/15/1003/032 60 film-coated tablets EU/1/15/1003/040 90 film-coated tablets EU/1/15/1003/033 100 film-coated tablets
Estonian: EU/1/15/1003/028 10 õhukese polümeerikattega tabletti EU/1/15/1003/029 14 õhukese polümeerikattega tabletti EU/1/15/1003/030 30 õhukese polümeerikattega tabletti EU/1/15/1003/031 56 õhukese polümeerikattega tabletti EU/1/15/1003/032 60 õhukese polümeerikattega tabletti EU/1/15/1003/040 90 õhukese polümeerikattega tabletti EU/1/15/1003/033 100 õhukese polümeerikattega tabletti
English: EU/1/15/1003/010 10 film-coated tablets EU/1/15/1003/011 14 film-coated tablets EU/1/15/1003/012 30 film-coated tablets EU/1/15/1003/013 56 film-coated tablets EU/1/15/1003/014 60 film-coated tablets EU/1/15/1003/038 90 film-coated tablets EU/1/15/1003/015 100 film-coated tablets
Estonian: EU/1/15/1003/010 10 õhukese polümeerikattega tabletti EU/1/15/1003/011 14 õhukese polümeerikattega tabletti EU/1/15/1003/012 30 õhukese polümeerikattega tabletti EU/1/15/1003/013 56 õhukese polümeerikattega tabletti EU/1/15/1003/014 60 õhukese polümeerikattega tabletti EU/1/15/1003/038 90 õhukese polümeerikattega tabletti EU/1/15/1003/015 100 õhukese polümeerikattega tabletti
English: Full analysis set (FAS) using last observation carried forward (LOCF) prior to glycaemic rescue therapy Subgroup analysis for patients on additional background of metformin (FAS, LOCF) Mean adjusted for baseline value Not evaluated for statistical significance as a part of the sequential confirmatory testing procedure LOCF, values after antihypertensive rescue censored * p-value <0.0001 ** p-value <0.01
Estonian: 1 (97,5% CI) Täisanalüüsiandmestiku (FAS, full analysis set) alarühmade analüüs patsientidel, kes said metformiini - ravi lõpetajad, kasutades viimase teadaoleva tulemuse edasikandmist (LOCF, last observation carried forward) enne vere glükoosisisalduse sümptomaatilist ravi.
English: Foot care
Estonian: Jalgade hooldus
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/025 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/026 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/027 200 (2 x 100 x 1) film-coated tablets
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1003/025 120 (2 x 60 x 1) õhukese polümeerikattega tabletti EU/1/15/1003/026 180 (2 x 90 x 1) õhukese polümeerikattega tabletti EU/1/15/1003/027 200 (2 x 100 x 1) õhukese polümeerikattega tabletti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/016 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/017 180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/018 200 (2 x 100 x 1) film-coated tablets
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1003/016 120 (2 x 60 x 1) õhukese polümeerikattega tabletti EU/1/15/1003/017 180 (2 x 90 x 1) õhukese polümeerikattega tabletti EU/1/15/1003/018 200 (2 x 100 x 1) õhukese polümeerikattega tabletti
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1003/007 120 (2 x 60 x 1) film-coated tablets EU/1/15/1003/008180 (2 x 90 x 1) film-coated tablets EU/1/15/1003/009 200 (2 x 100 x 1) film-coated tablets
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1003/007 120 (2 x 60 x 1) õhukese polümeerikattega tabletti EU/1/15/1003/008 180 (2 x 90 x 1) õhukese polümeerikattega tabletti EU/1/15/1003/009 200 (2 x 100 x 1) õhukese polümeerikattega tabletti
English: Eli Lilly Italia S.p.A. Tel: +39 055 42571
Estonian: Tel: +39 055 42571
English: Table 3: Efficacy results of 24 week placebo-controlled studies Add-on to metformin therapy
Estonian: 24-nädalaste platseebokontrolliga uuringute efektiivsuse tulemused.
English: • changes to the way things taste
Estonian: • maitsemeele muutused
English: What Synjardy looks like and contents of the pack Synjardy 5 mg/850 mg film-coated tablets are yellowish white, oval, biconvex.
Estonian: Synjardy 5 mg/850 mg õhukese polümeerikattega tabletid on ovaalsed, kollakasvalged ja kaksikkumerad.
English: Blood sugar levels, which are too high because of your type 2 diabetes, are thereby reduced.
Estonian: Seeläbi langeb 2. tüüpi suhkurtõve tõttu kõrgenenud veresuhkru sisaldus.
English: 90 (3 x 30) tablets (multipack)
Estonian: 90 (3 × 30) tabletti (mitmikpakend)
English: The application was withdrawn in the Netherlands and United Kingdom.
Estonian: Taotlus võeti tagasi Madalmaades ja Ühendkuningriigis.
English: 1 Article 29(2) of Directive 2001/83/EC, as amended.
Estonian: 1 Direktiivi 2001/83/EÜ artikli 29 lõige 2, koos muudatustega.
English: The Reference Member State was Finland and the Concerned Member States were Austria, Belgium, Denmark, Germany, Italy, Luxembourg, the Netherlands, Portugal, Sweden and United Kingdom.
Estonian: Võrdlusliikmesriigiks oli Soome ja asjassepuutuvateks liikmesriikideks olid Austria, Belgia, Taani, Saksamaa, Itaalia, Luksemburg, Madalmaad, Portugal, Rootsi ja Ühendkuningriik.
English: 21 February 2006 EMEA/CHMP/373061/2005
Estonian: 21. veebruar 2006 EMEA/CHMP/373061/2005
English: Portugal and Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Estonian: Portugal ja Saksamaa esitasid lahkarvamuse põhjused EMEAle 15. detsembril 2004.
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 Reference Member State.
Estonian: Asjassepuutuvad liikmesriigid ei jõudnud võrdlusliikmesriigi poolt väljastatud müügiloa vastastikuse tunnustamise taotluse osas kokkuleppele.
English: The Marketing Authorisation Holder provided written explanations on 20 July 2005.
Estonian: Müügiloa hoidja esitas kirjalikud selgitused 20. juulil 2005.
English: The final opinion was converted into a Decision by the European Commission on 21 February 2006.
Estonian: See lõppotsus kinnitati Euroopa Komisjoni otsusena 21. veebruaril 2006.
English: The Rapporteur and Co-Rapporteur appointed were Sif Ormarsdottir/Tomas Salmonson, Gottfried Kreutz/Julia Dunne respectively.
Estonian: Ettekandjaks ja kaasettekandjaks olid vastavalt Sif Ormarsdottir ja Tomas Salmonson ning Gottfried Kreutz ja Julia Dunne.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol-ratiopharm 15 mg and 30 mg International Non-Proprietary Name (INN): Lansoprazole
Estonian: INIMTERVISHOIUS KASUTATAVATE RAVIMITE KOMITEE ARVAMUS PÄRAST ARTIKLI 29 LÕIKE 21 JÄRGSET ESILDIST Lansoprazol-ratiopharm 15 mg ja 30 mg Rahvusvaheline mittekaubanduslik nimetus (INN): lansoprasooli
English: A Marketing Authorisation for Lansoprazol-ratiopharm (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
Estonian: Ratiopharm GmbH-le AGle väljastati Lansoprazol ratiopharm'i (15 mg ja 30 mg) müügiluba Soomes 7. novembril 2003.
English: The applicant should provide clinical data to support the use of 15 mg capsules for Helicobacter pylori eradication.
Estonian: Taotleja peab esitama kliinilised andmed, mis õigustavad 15 mg kapslite kasutamist Helicobacter pylori eradikatsiooniks.
English: During its September 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 Lansoprazol-ratiopharm.
Estonian: Tuginedes kõigile esitatud andmetele ja komitee sisesele arutelule, jõudis inimtervishoius kasutatavate ravimite komitee oma 2005. aasta septembri koosolekul seisukohale, et Lansoprazol-ratiopharmi riski ja kasu vahekord on soodne.
English: In particular, the data of the bioequivalence of the 2x15 mg capsules and the 30 mg capsules, and the possible need for a reduced dose of lansoprazole in this therapeutic indication.
Estonian: Täpsemalt, andmed 2x15 mg ja 30 mg kapslite bioekvivalentsuse kohta ja võimaliku lansoprasooli vähendatud annuse vajaduse kohta selle näidustuse puhul.
English: Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.
Estonian: “Punktidega, kus tuleb kaaluda Helicobacter pylori eradikatsiooni ravi alast sõnastust valitud ravimi omaduste kokkuvõtte osades”, kiideti inimtervishoius kasutavate ravimite komitee poolt heaks ja positiivne arvamus võeti vastu 15. septembril 2005.
English: For the 15 mg dosage form the therapeutic indication “Helicobacter pylori eradication” is not approved for the reference medicinal product marketed in Portugal.
Estonian: 15 mg annuse puhul ei ole näidustus “Helicobacter pylori eradikatsioon“ Portugalis müüdava võrdluspreparaadi puhul heakskiidetud.
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 ravimi omaduste kokkuvõte III lisas.
English: The SPC of the reference product in Germany contains specific doses and dosing schedules for the combinations of lansoprazole and antibiotics recommended for eradication of Helicobacter pylori.
Estonian: Võrdluspreparaadi ravimi omaduste kokkuvõte Saksamaal sisaldab Helicobacter pylori eradikatsiooniks soovitatud lansoprasooli ja antibiootikumide kombinatsiooni puhul konkreetseid annuseid ja annusegraafikuid.
English: Lansoprazol-ratiopharm (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Estonian: Lansoprasooli kasutatakse kaksiksõrmiksoole ja maohaavandite, refluksösofagiidi, gastroösofageaalse reflukshaiguse raviks, mittesteroidsete põletikuvastaste ravimitega seotud mao- ja kaksteistsõrmikuhaavandite ja Zollinger-Ellisoni sündroomi raviks ja profülaktikaks.
English: Significant differences in comparison to the reference product have been identified with regard to the indication section of the SPCs.
Estonian: Võrreldes võrdluspreparaadiga tuvastati olulised erinevused ravimi omaduste kokkuvõtte näidustuste osa puhul.
English: Changes to the SPC section 4.2 (Posology and Methods of
Estonian: Muutused ravimi omaduste kokkuvõttesse 4.2 (Annustamine ja manustamisviis), mis annavad antibiootikumidele üksikasjalikud annustamissoovitused kooskõlas
English: Significant differences in comparison to the reference product have been identified with regard to the posology section of the SPCs.
Estonian: Võrreldes võrdluspreparaadiga tuvastati olulised erinevused ravimi omaduste kokkuvõtte annustamise osa puhul.
English: The doctor should check the response every four to six weeks and adjust the dose if needed.
Estonian: Arst peab kontrollima ravivastust iga 4-6 nädala järel ja vajaduse korral annust kohandama.
English: Further information on Somavert can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Somavert.
Estonian: Lisateave Somaverti kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/Somavert.
English: What measures are being taken to ensure the safe and effective use of Somavert?
Estonian: Mis meetmed võetakse, et tagada Somaverti ohutu ja efektiivne kasutamine?
English: The effectiveness was measured by comparing the levels of insulin-like growth factor-I (IGF-I) before and at the end of the study.
Estonian: Efektiivsust hinnati, võrreldes insuliinisarnase kasvuteguri I (IGF-I) sisaldust enne uuringut ja uuringu lõpus.
English: The majority of side effects were mild to moderate and of limited duration.
Estonian: Enamik kõrvalnähtudest olid kerged kuni mõõdukad ja lühiajalised.
English: The maximum dose is 30 mg per day.
Estonian: Suurim annus on 30 mg ööpäevas.
English: The European Medicines Agency decided that Somavert's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Somaverti kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: Growth hormone promotes growth during childhood and adolescence.
Estonian: Kasvuhormoon soodustab lapse- ja noorukieas kasvamist.
English: Somavert received a marketing authorisation valid throughout the EU on 13 November 2002.
Estonian: Somaverti müügiluba, mis kehtib kogu Euroopa Liidus, anti 13. novembril 2002.
English: Other information about Somavert
Estonian: Muu teave Somaverti kohta
English: If levels are too high, the doctor may decide not to begin or to stop treatment with Somavert.
Estonian: Kui see on liiga suur, võib arst otsustada Somavertiga ravi mitte alustada või see peatada.
English: As for all medicines, data on the use of Somavert are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Somaverti kasutamise kohta pidevat järelevalvet.
English: The most common side effects of Somavert (seen in more than 1 in 10 people) were headache, diarrhoea and joint pain.
Estonian: Somaverti kõige sagedamad kõrvalnähud (esinenud enam kui 1 inimesel 10st) olid peavalu, kõhulahtisus ja liigesevalu.
English: What is Somavert and what is it used for?
Estonian: Mis on Somavert ja milleks seda kasutatakse?
English: Side effects reported with Somavert are carefully evaluated and any necessary action taken to protect patients.
Estonian: Somaverti kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: IGF-I levels were normal at the end of the study (week 12) in 38.5%, 75% and 82% of patients treated with 10, 15 or 20 mg/day Somavert, respectively, compared with 9.7% of the patients treated with placebo.
Estonian: Patsiente, kellel oli uuringu lõpus (12. nädal) normaalne IGF-I sisaldus, oli ööpäevas Somaverti 10 mg kasutanutest 38,5%, 15 mg kasutanutest 75% ja 20 mg kasutanutest 82% ning platseeborühmas 9,7%.
English: Somavert contains the active substance pegvisomant.
Estonian: Somavert sisaldab toimeainena pegvisomanti.
English: For more information about using Somavert, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Somaverti kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: IGF-I is regulated by human growth hormone and causes growth in the body.
Estonian: IGF-I sisaldust reguleerib inimese kasvuhormoon ja see põhjustab organismi kasvamist.
English: Somavert has been studied in 112 patients with acromegaly in a 12-week study.
Estonian: Somaverti uuriti 12 nädalat kestnud uuringus, milles osales 112 akromegaaliaga patsienti.
English: Afterwards, they received 10, 15 or 20 mg Somavert per day or placebo.
Estonian: Hiljem said nad 10, 15 või 20 mg Somaverti või platseebot ööpäevas.
English: The patient first receives a starting dose of 80 mg under medical supervision.
Estonian: Esmalt saab patsient meditsiinilise järelevalve all algannuse 80 mg.
English: Following this, Somavert is given as an injection of 10 mg once a day.
Estonian: Seejärel süstitakse Somaverti 10 mg üks kord ööpäevas.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Somavert have been included in the summary of product characteristics and the package leaflet.
Estonian: Somaverti ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Somavert lowered IGF-I levels at all of the doses tested.
Estonian: Somavert vähendas IGF-I sisaldust kõigi uuritud annuste korral.
English: What are the risks associated with Somavert?
Estonian: Mis riskid Somavertiga kaasnevad?
English: The active substance in Somavert, pegvisomant, is very similar to human growth hormone, but it has been designed so that it blocks the receptors to which growth hormone normally attaches itself.
Estonian: Somaverti toimeaine pegvisomant on väga sarnane inimese kasvuhormoonile, kuid see on kavandatud blokeerima retseptoreid, millega kasvuhormoon tavaliselt seondub.
English: Somavert is used in patients who did not respond well to surgery and/or radiation therapy, and to treatment with somatostatin analogues (another type of medicine used in acromegaly).
Estonian: Somaverti kasutatakse patsientidel, kellel ei tekkinud piisavat ravivastust kirurgilisele ja/või kiiritusravile ega ravile somatostatiini analoogidega (samuti akromegaaliaravim).
English: How is Somavert used?
Estonian: Kuidas Somaverti kasutatakse?
English: Patients received a starting dose of 80 mg Somavert or placebo (a dummy treatment).
Estonian: Patsiendid said algannuse 80 mg Somaverti või platseebot (näiv ravim).
English: By blocking the receptors, Somavert prevents growth hormone from having an effect, thereby preventing the unwanted growth and other disorders seen in acromegaly.
Estonian: Retseptorite blokeerimisega ennetab Somavert kasvuhormooni toimet ning ühtlasi soovimatut kasvu ja muid akromegaaliaga kaasnevaid häireid.
English: For the full list of side effects and restrictions with Somavert, see the package leaflet.
Estonian: Somaverti kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: Before starting and during treatment with Somavert, the patient should have tests to measure levels of liver enzymes in the blood.
Estonian: Enne Somavertiga toimuva ravi alustamist ja selle ajal tuleb patsiendil määrata maksaensüümide sisaldus veres.
English: Somavert can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of acromegaly.
Estonian: Somavert on retseptiravim ja ravi peab alustama akromegaalia ravis kogenud arst.
English: In adults, rather than gaining height, overproduction of growth hormone leads to acromegaly, with overgrowth of bone, swelling of soft tissue (such as the hands and feet),
Estonian: Täiskasvanutel põhjustab kasvuhormooni ületootmine pikkuse suurenemise asemel akromegaaliagat: tekib luu liigkasv, pehmete kudede turse (nt kätes ja jalalabades), südamehaigused ja muud häired.
English: Somavert is a medicine used to treat adults with acromegaly, a rare hormonal disorder that usually occurs in middle-aged adults and is caused by the pituitary gland producing excess growth hormone.
Estonian: Somaverti kasutatakse akromegaaliaga täiskasvanute raviks (harvaesinev hormonaalne häire, mis avaldub tavaliselt keskealistel täiskasvanutel ja mida põhjustab kasvuhormooni liigne teke ajuripatsis).
English: What benefits of Somavert have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Somaverti kasulikkus?
English: How does Somavert work?
Estonian: Kuidas Somavert toimib?
English: Somavert is available as powder and solvent that are mixed together to make up a solution for injection under the skin.
Estonian: Somaverti turustatakse pulbri ja lahustina, millest segatakse kokku naha alla süstitav süstelahus.
English: The patient or caregiver can inject Somavert after being trained by a doctor or a nurse.
Estonian: Kui patsient või tema hooldaja on saanud arstilt või õelt asjakohase väljaõppe, tohivad nad süstida Somaverti ka ise.
English: Acromegaly occurs when the pituitary gland at the base of the brain makes too much growth hormone, generally because of a benign (non-cancerous) tumour.
Estonian: Akromegaalia tekib, kui ajuripatsis moodustub (tavaliselt healoomulise kasvaja tõttu) liiga palju kasvuhormooni.
English: An overview of Somavert and why it is authorised in the EU
Estonian: Ülevaade ravimist Somavert ja ELis müügiloa väljastamise põhjendus
English: Why is Somavert authorised in the EU?
Estonian: ELis Somavertile väljastatud müügiloa põhjendus
English: ATCvet code: QI04AA02.
Estonian: ATCvet kood: QI04AA02
English: The level of efficacy for other species may differ from that observed in sheep.
Estonian: Efektiivsuse tase teistel liikidel võib erineda sellest, mida on täheldatud lammastel.
English: SPECIAL STORAGE CONDITIONS Store and transport refrigerated .
Estonian: SÄILITAMISE ERITINGIMUSED Hoida ja transportida külmas.
English: 1st injection: from 1.5 months of age.
Estonian: 1. süstimine: alates 1,5 kuu vanusest.