FrancophonIA/ELRC3.0 huggingface dataset:
English: The main measure of effectiveness was the increase in height of patients after one year of treatment.
Estonian: Efektiivsuse põhinäitaja oli patsientide pikkuse suurenemine pärast üheaastast ravi.
English: It is used to treat children aged 2 to 18 years who are failing to grow normally because they do not have enough growth hormone.
Estonian: Seda kasutatakse 2-18aastaste laste raviks, kes ei kasva normaalselt, sest neil ei ole piisavalt kasvuhormooni.
English: The full EPAR for Somatropin Biopartners can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Somatropin Biopartnersi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Estonian: See soodustab kasvu lapse- ja noorukieas ning mõjutab ka viisi, kuidas organism töötleb valke, rasvu ja süsivesikuid.
English: In addition, the company that markets Somatropin Biopartners will provide further long-term data on the effectiveness and safety of the medicine.
Estonian: Lisaks esitab Somatropin Biopartnersit turustav ettevõte edasised pikaajalised andmed ravimi efektiivsuse ja ohutuse kohta.
English: The dose may need to be adjusted, depending on the patient's response to treatment and the side effects the patient experiences.
Estonian: Annust võib olla vaja kohandada sõltuvalt patsiendi ravivastusest ja patsiendil esinevatest kõrvalnähtudest.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Somatropin Biopartners on 05.08.2013.
Estonian: Euroopa Komisjon andis Somatropin Biopartnersi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 05.08.2013.
English: It is also used in adults with a lack of growth hormone who may have either had growth hormone deficiency as children or developed it later during adulthood.
Estonian: Ravimit kasutatakse ka kasvuhormooni puudusega täiskasvanutel, kellel võib olla olnud kasvuhormooni defitsiit lapsena või on see tekkinud hiljem täiskasvanueas.
English: Somatropin Biopartners is injected under the skin once a week.
Estonian: Somatropin Biopartnersit süstitakse naha alla üks kord nädalas.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Somatropin Biopartners' benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Somatropin Biopartnersi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: A risk management plan has been developed to ensure that Somatropin Biopartners is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Somatropin Biopartnersi võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Somatropin Biopartners?
Estonian: Mis meetmed võetakse, et tagada Somatropin Biopartnersi ohutu ja efektiivne kasutamine?
English: The study showed that Somatropin Biopartners was as effective as Genotropin at promoting growth: children receiving Somatropin Biopartners grew around 11.7 cm in one year, compared with 12.0 cm in children receiving Genotropin.
Estonian: Uuring näitas, et Somatropin Biopartners oli kasvu soodustamisel sama efektiivne kui Genotropin: Somatropin Biopartnersit saanud lapsed kasvasid ühe aastaga ligikaudu 11,7 cm ja Genotropini saanud lapsed 12,0 cm.
English: In adults, the recommended dose is 2 mg injected once a week, except for female patients also taking oral oestrogen who should receive 3 mg once a week.
Estonian: Täiskasvanute annus on 2 mg süstituna üks kord nädalas, välja arvatud samal ajal suukaudset östrogeeni võtvad naispatsiendid, kes peavad saama 3 mg üks kord nädalas.
English: Somatropin Biopartners somatropin
Estonian: Somatropin Biopartners somatropiin
English: In adults, the most common side effects (which may affect more than 1 in 10 people) are swelling, mild hyperglycaemia (high blood sugar levels) and headache.
Estonian: Täiskasvanutel on kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) turse, kerge hüperglükeemia (suur veresuhkrusisaldus) ja peavalu.
English: The patient or caregiver can inject Somatropin Biopartners themselves, after training by a doctor or a nurse.
Estonian: Patsient või hooldaja võib süstida Somatropin Biopartnersit ise, kui arst või meditsiiniõde on ta välja õpetanud.
English: Somatropin Biopartners is a medicine that contains human growth hormone (also known as somatropin).
Estonian: Somatropin Biopartners on ravim, mis sisaldab inimese kasvuhormooni (mida nimetatakse ka somatropiiniks).
English: Adults treated with Somatropin Biopartners had an average reduction of body fat of 1 kg while body fat in those treated with placebo increased by 0.5 kg.
Estonian: Somatropin Biopartnersiga ravitud täiskasvanutel vähenes keharasva sisaldus keskmiselt 1 kg võrra, samas kui platseeboga ravitud isikutel keharasva sisaldus suurenes 0,5 kg võrra.
English: This study compared Somatropin Biopartners with placebo (a dummy treatment) and measured the decrease in body fat (which is normally high in adults with growth hormone deficiency) after 6 months of treatment.
Estonian: Uuring võrdles Somatropin Biopartnersit platseeboga (näiv ravim) ja mõõtis keharasva sisalduse (see on kasvuhormooni puudusega täiskasvanutel tavaliselt suur) vähenemist pärast 6-kuulist ravi.
English: Somatropin Biopartners must not be used in patients with an active tumour or an acute lifethreatening illness.
Estonian: Somatropin Biopartnersit ei tohi kasutada aktiivse kasvajaga või ägeda eluohtliku haigusega patsientidel.
English: Somatropin Biopartners has also been studied in one main study involving 151 adults with growth hormone deficiency.
Estonian: Somatropin Biopartnersit on samuti uuritud ühes põhiuuringus, milles osales 151 kasvuhormooni puudusega täiskasvanut.
English: What is Somatropin Biopartners and what is it used for?
Estonian: Mis on Somatropin Biopartners ja milleks seda kasutatakse?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Somatropin Biopartners, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Somatropin Biopartnersi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavate ettevaatusmeetmete teave.
English: This is a summary of the European public assessment report (EPAR) for Somatropin Biopartners.
Estonian: See on ravimi Somatropin Biopartners Euroopa avaliku hindamisaruande kokkuvõte.
English: Other information about Somatropin Biopartners
Estonian: Muu teave Somatropin Biopartnersi kohta
English: The active substance in Somatropin Biopartners, somatropin, is identical to the human growth hormone.
Estonian: Somatropin Biopartnersi toimeaine somatropiin on identne inimese kasvuhormooniga.
English: Somatropin Biopartners has been studied in one main study involving 180 children with a lack of growth hormone.
Estonian: Somatropin Biopartnersit on uuritud ühes põhiuuringus, milles osales 180 kasvuhormooni puudusega last.
English: In children, the most common side effects with Somatropin Biopartners (which may affect more than 1 in 10 people) are injection site swelling and development of antibodies (proteins that are produced in response to Somatropin Biopartners).
Estonian: Lastel on Somatropin Biopartnersi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) süstekoha turse ja antikehade (valgud, mis tekivad vastusena Somatropin Biopartnersile) tekkimine.
English: The study compared Somatropin Biopartners given once a week with another somatropin-containing medicine called Genotropin given once a day.
Estonian: Uuring võrdles üks kord nädalas manustatavat Somatropin Biopartnersit üks kord päevas manustatava teise somatropiini sisaldava ravimiga, Genotropiniga.
English: Regarding its safety, the side effects reported with Somatropin Biopartners were similar to those of other daily somatropin medicines, with the exception of increased injection site reactions in children, which should be balanced against the convenience of weekly injections.
Estonian: Ohutuse seisukohast on Somatropin Biopartnersiga teatatud kõrvalnähud sarnased teiste, iga päev manustatavate somatropiini sisaldavate ravimite omadega, välja arvatud sagenenud süstekoha reaktsioonid lastel, mida tuleb võrrelda üks kord nädalas tehtavate süstide mugavusega.
English: In children, the recommended dose is 0.5 mg per kilogram body weight, injected once a week.
Estonian: Lastel on soovitatav annus 0,5 mg kehamassi kg kohta süstituna üks kord nädalas.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce it. Somatropin Biopartners replaces the natural hormone.
Estonian: Seda toodetakse rekombinant-DNA-tehnika abil: hormooni toodab pärmirakk, millesse on lisatud somatropiini tootmist võimaldav geen (DNA).
English: It is not intended to provide practical advice on how to use Somatropin Biopartners.
Estonian: Hindamisaruandes ei anta Somatropin Biopartnersi kasutamise praktilisi nõuandeid.
English: For practical information about using Somatropin Biopartners, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Somatropin Biopartnersi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Treatment with Somatropin Biopartners should be started and monitored by a doctor experienced in diagnosing and treating patients with growth hormone deficiency.
Estonian: Ravi Somatropin Biopartnersiga peab alustama ja jälgima kasvuhormooni puudusega patsientide diagnoosimises ning ravis kogenud arst.
English: For more information about treatment with Somatropin Biopartners, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Somatropin Biopartnersiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Committee concluded that Somatropin Biopartners is as effective in children who fail to grow normally as other somatropin-containing treatments given daily.
Estonian: Inimravimite komitee järeldas, et Somatropin Biopartners on kasvupeetusega lastel sama efektiivne kui muud iga päev manustatavad somatropiini sisaldavad ravimid.
English: Growth hormone is a substance secreted by the pituitary gland (a gland located at the base of the brain).
Estonian: Kasvuhormoon on aine, mida eritab ajuripats (ajupõhimiku piirkonnas paiknev nääre).
English: In adults who lack growth hormone, Somatropin Biopartners has a modest effect in decreasing body fat.
Estonian: Kasvuhormooni puudusega täiskasvanutel vähendab Somatropin Biopartners mõõdukalt keharasva sisaldust.
English: Why is Somatropin Biopartners approved?
Estonian: Miks Somatropin Biopartners heaks kiideti?
English: For the full list of all side effects reported with Somatropin Biopartners, see the package leaflet.
Estonian: Somatropin Biopartnersi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What are the risks associated with Somatropin Biopartners?
Estonian: Mis riskid Somatropin Biopartnersiga kaasnevad?
English: Somatropin Biopartners is available as a powder and solvent which are made into a suspension for injection.
Estonian: Somatropin Biopartnersit turustatakse pulbri ja lahustina, millest valmistatakse süstesuspensioon.
English: How does Somatropin Biopartners work?
Estonian: Kuidas Somatropin Biopartners toimib?
English: How is Somatropin Biopartners used?
Estonian: Kuidas Somatropin Biopartnersit kasutatakse?
English: What benefits of Somatropin Biopartners have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Somatropin Biopartnersi kasulikkus?
English: Safety and efficacy have not been established in the following:
Estonian: Ohutus ja efektiivsus ei ole kindlaks tehtud järgmistel juhtudel:
English: 95% Exact CI
Estonian: 95% täpne CI
English: Wash your hands before and after applying the ointment.
Estonian: Peske käsi enne ja pärast salvi manustamist.
English: Not all pack sizes may be marketed in your country.
Estonian: Kõik pakendi suurused ei pruugi teie riigis müügil olla.
English: * Activity has been satisfactorily demonstrated in clinical studies
Estonian: * efektiivsust on kliinilistes uuringutes piisavalt demonstreeritud
English: Other medicines and Altargo
Estonian: Muud ravimid ja Altargo
English: CI: confidence interval.
Estonian: CI: usaldusvahemik.
English: If you stop using Altargo too soon, the bacteria may start to grow again and your infection may come back.
Estonian: Kui te lõpetate Altargo kasutamise liiga vara, võivad bakterid uuesti kasvama hakata ning teie infektsioon võib taastuda.
English: Discard open tubes 7 days after opening, even if they are not empty.
Estonian: Avatud tuub tuleb minema visata 7 päeva pärast avamist, isegi kui see pole päris tühi.
English: Currently available data are described in section 5.2, but no recommendation on a
Estonian: Praeguseks saadaolevaid andmeid on kirjeldatud lõigus 5.2, kuid manustamissoovitusi anda ei saa.
English: Consideration should be given to official guidance on the appropriate use of antibacterial medicinal
Estonian: Arvesse tuleb võtta antibakteriaalsete ravimite asjakohase kasutamise ametlikke juhiseid.
English: Confidence interval was not adjusted for multiplicity.
Estonian: Usaldusvahemikku ei kohandatud arvukatele juhtudele.
English: Exact CI is calculated using the F-distribution method.
Estonian: Täpne CI arvutatakse F-jaotusmeetodi abil.
English: Elderly (aged 65 and older)
Estonian: Eakad (65-aastased ja vanemad)
English: However, due to the low systemic plasma levels that have been observed, no safety problems are foreseen.
Estonian: Ent madala süsteemse plasmakontsentratsiooni tõttu ei ole ohutusprobleeme ette näha.
English: Hypersensitivity, including angioedema
Estonian: Ülitundlikkus, sealhulgas angioödeem
English: It must not be put in the eyes, on the mouth or lips, inside the nose or inside the female genital area.
Estonian: Seda ei tohi manustada silma, suhu või huultele, ninna või naistel suguelundite piirkonda.
English: Application site irritation (including burning sensation)
Estonian: Manustamiskoha ärritus (sealhulgas põletustunne)
English: No studies to evaluate effects of retapamulin on pre-/postnatal development were performed.
Estonian: Ei ole läbi viidud uuringuid, et hinnata retapamuliini toimet pre-/postnataalsele arengule.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
Estonian: Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMA) kodulehel http://www.ema.europa.eu/.
English: $: the response rate for MRSA due to PVL+ MRSA was 8/13 (62%)
Estonian: $: MRSA vastane efektiivsus PVL+ MRSA tõttu oli 8/13 (62%)
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable.
Estonian: Vajadusel tuleb konsulteerida spetsialistiga, kui resistentsuse kohalik levimus on selline, et ravimi kasulikkus vähemalt teatud infektsioonivormide korral on küsitav.
English: This might lead to side effects.
Estonian: Selle tagajärjel võivad tekkida kõrvaltoimed.
English: In vitro, three mechanisms have been identified which reduce susceptibility to retapamulin.
Estonian: In vitro on kindlaks tehtud kolm mehhanismi, mis vähendavad tundlikkust retapamuliini suhtes.
English: Keep using Altargo for as long as your doctor advises.
Estonian: Jätkake Altargo kasutamist nii kaua, kui arst on seda soovitanud.
English: S. aureus (all) MRSA
Estonian: S. aureus (kõik) MRSA $
English: Adults (aged 18-65 years), adolescents (aged 12-17 years), infants and children (aged from nine
Estonian: Täiskasvanud (vanuses 18...65 aastat), noorukid (vanuses 12...17 aastat), imikud ja lapsed (vanuses 9
English: • Infected small lacerations, abrasions, or sutured wounds.
Estonian: Infitseerunud väikesed rebendid, abrasioonid või õmmeldud haavad.
English: Neither of these findings is of clinical relevance.
Estonian: Kummalgi leiul ei ole kliinilist tähtsust.
English: Short term treatment of the following superficial skin infections in adults, adolescents, infants and children (aged from nine months) (see section 5.1):
Estonian: Järgmiste pindmiste nahainfektsioonide lühiajaline ravi täiskasvanutel, noorukitel, imikutel ja lastel (alates 9. elukuust) (vt lõik 5.1):
English: The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections.
Estonian: Omandatud resistentsuse levimus võib valitud tüvede puhul varieeruda geograafiliselt ja aja jooksul ning soovitatav on järgida kohalikke resistentsusandmeid, eriti raskekujuliste infektsioonide ravimisel.
English: Date of first authorisation: 24 May 2007 Date of latest renewal: 20 April 2012
Estonian: Müügiloa uuendamise kuupäev: 24.aprill, 2012
English: Patients aged from 2 months to 24 months
Estonian: Patsiendid alates 2. eluaastast
English: Patients not showing a clinical response within two to three days should be re-evaluated and alternative therapy should be considered (see section 4.4).
Estonian: Patsiente, kellel ei ilmne kliinilist ravivastust 2...3 päeva jooksul, tuleb uuesti uurida ja kaaluda alternatiivse ravi kasutamist (vt lõik 4.4).
English: Carefully wipe off the extra ointment.
Estonian: Pühkige liigne salv ettevaatlikult maha.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Altargo should be made taking into account the benefit of breast-feeding to the child and the benefit of Altargo therapy to the
Estonian: Otsuse langetamisel, kas jätkata/katkestada rinnaga toitmine või jätkata/katkestada ravi Altargo'ga, tuleb kaaluda rinnaga toitmisest saadavat kasu lapsele ja Altargo-ravist saadavat kasu naisele.
English: Always use this medicine exactly as your doctor has told you.
Estonian: Kasutage seda ravimit alati täpselt nii, nagu arst või apteeker on teile selgitanud.
English: If super-infection with a non-susceptible organism is suspected, treatment should be guided by clinical and microbiological assessments.
Estonian: Kui kahtlustatakse mittetundlike mikroorganismide poolt tekitatud superinfektsiooni, tuleb ravis juhinduda kliinilistest ja mikrobioloogilistest hinnangutest.
English: Your doctor will decide if this
Estonian: Teie arst otsustab, kas see ravi on teile sobiv.
English: In patients aged less than 18 years the total surface area treated should be no more than 2% of the body surface area.
Estonian: Alla 18-aastastel patsientidel ei tohi ravitav piirkond ületada 2% kehapinnast.
English: It is possible that using Altargo in children who are taking certain medicines (such as some medicines used to treat fungal infections) could result in blood concentrations of Altargo that are higher than usual.
Estonian: On võimalik, et Altargo'ga ravitaval lapsel, kes saab veel teatud teisi ravimeid (näiteks mõned ravimid, mida kasutatakse seennakkuste ravis) tekib veres Altargo suurem kontsentratsioon kui tavaliselt.
English: Due to its distinct mode of action, target specific cross-resistance with other classes of antibacterial agents is rare.
Estonian: Tänu oma erilisele toimemehhanismile on spetsiifilise ristuva resistentsuse teke teiste antibakteriaalsete ainete klassidega harvaesinev.
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Estonian: Kasutamata ravim või jäätmematerjal tuleb hävitada vastavalt kohalikele seadustele.
English: Altargo is not expected to affect your ability to drive or use machines.
Estonian: Eeldatavasti Altargo ei mõjuta teie autojuhtimise või masinate käsitsemise võimet.
English: • contact your doctor or pharmacist immediately.
Estonian: • Võtke otsekohe ühendust oma arstiga.
English: There was no treatment-related effect on embryofetal development.
Estonian: Puudus raviga seotud toime embrüo-loote arengule.
English: If you notice any worsening of the infection or develop increased redness, irritation or other signs and symptoms at the site of application you should stop using Altargo and tell your doctor.
Estonian: Kui te märkate, et nakkus süveneb või tekib tugevam punetus, ärritus või muud nähud manustamiskohal, peate lõpetama Altargo kasutamise ja teavitama sellest oma arsti.
English: Detailed information on this medicine is available on the European Medicines Agency web site:
Estonian: Täpne informatsioon selle ravimi kohta on kättesaadav Euroopa Ravimiameti (EMA) kodulehel
English: Retapamulin is approximately 94% bound to human plasma proteins.
Estonian: Retapamuliini seonduvus inimese plasmavalkudega on ligikaudu 94%.
English: Severe skin reactions or allergies (frequency not known) If you develop a severe skin reaction or an allergy: (e.g. severe itching or severe rash, swelling of the
Estonian: Tõsised nahareaktsioonid või allergia (sagedus teadmata) Kui teil tekivad tõsised nahareaktsioonid või allergia (nt tugev sügelus või tõsine lööve, näo-, huulte
English: • Infected lesions that exceed 10 cm in length or a total surface area >100 cm2.
Estonian: • Infitseeritud kolded, mille pikkus ületab 10 cm või kogupind >100 cm2.
English: Minimal systemic exposure is observed in adults, therefore exposure of the breast-feeding infant is likely to be negligible.
Estonian: Täiskasvanutel täheldatakse minimaalset süsteemset ekspositsiooni, mistõttu on rinnapiimatoidul lapse kokkupuude ravimiga tõenäoliselt ebaoluline.
English: Carton of 12 sachets.
Estonian: Karbis on 12 kotikest.
English: Retapamulin ointment should only be used in pregnancy when topical antibacterial therapy is clearly indicated and the use of retapamulin is considered to be preferable to administration of a systemic antibacterial medicinal product.
Estonian: Retapamuliini salvi tohib raseduse ajal kasutada ainult juhul, kui paikne antibakteriaalne ravi on selgelt näidustatud ja retapamuliini kasutamist loetakse eelistatuks süsteemsele antibakteriaalsele ravile.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached.
Estonian: • kui muudetakse riskijuhtimissüsteemi, eriti kui saadakse uut teavet, mis võib oluliselt mõjutada riski/kasu suhet, või kui saavutatakse oluline (ravimiohutuse või riski
English: Altargo is for adults and children aged nine months and older.
Estonian: Altargo on mõeldud täiskasvanutele ja lastele alates üheksandast elukuust.
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil pärast „Kõlblik kuni“.
English: ITTC- Intent to Treat Clinical Primary Efficacy Population; PPC -Per Protocol Clinical Primary Efficacy population; ITTB- Intent to Treat Bacteriological evaluable, Primary Efficacy Population; PPB - Per Protocol Bacteriologically evaluable, Primary Efficacy Population.
Estonian: ITTC - Ravikavatsusega kliiniline esmase efektiivsuse populatsioon; PPC - protokollile vastav kliiniline esmase efektiivsuse populatsioon; ITTB - ravikavatsusega bakterioloogilise hindamise, primaarse efektiivsuse populatsioon; PPB - vastavalt protokollile bakterioloogilise hindamise, esmase
English: Altargo is used to treat bacterial infections affecting small areas of skin.
Estonian: Altargo't kasutatakse bakteriaalsete nakkuste raviks, mis haaravad väikeseid nahapiirkondi.