FrancophonIA/ELRC3.0 huggingface dataset:
English: Radioactivity was found to cross the placenta following oral administration of labelled doxazosin to pregnant rats.
Estonian: Radioaktiivselt märgistatud doksasosiini suukaudsel manustamisel tiinetele rottidele leiti, et radioaktiivsus läbib platsentat.
English: the CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (see Annex I).
Estonian: soovitab inimtervishoius kasutatavate ravimite komitee anda müügiloa/müügiload Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavatele tablettidele ja sellega seotud nimetustele (vt I lisa), mille ravimiomaduste kokkuvõte, märgistus ja pakendi infoleht on esitatud III lisas.
English: Common: constipation, dyspepsia Uncommon: anorexia, increased appetite, taste disturbances Rare: abdominal discomfort, diarrhoea, vomiting
Estonian: Aeg-ajalt: anoreksia, söögiisu suurenemine, maitsehäired.
English: Uncommon: nightmares, amnesia, emotional instability Rare: depression, agitation
Estonian: Aeg-ajalt: luupainajad, amneesia, emotsionaalne labiilsus.
English: The usual dose of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is one tablet taken as a single dose each day.
Estonian: Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavate tablettide ja seotud nimetuste tavaline annus on üks tablett üks kord päevas.
English: Peak/trough ratio of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets is less than half that of immediate release doxazosin tablets.
Estonian: Doxazosin Winthrop 4 mg prolongeeritult vabastavate tablettide ja seotud nimetuste toimeainet prolongeeritult vabastavate tablettide maksimaalse/minimaalse plasmakontsentratsiooni suhe on vähem kui pool doksasosiini kiiresti vabastavate tablettide omast.
English: Special care should be taken with hypotensive patients or patients with known orthostatic dysregulation taking doxazosin prolonged release tablets to treat benign prostatic hyperplasia (BPH).
Estonian: Erilise ettevaatusega tuleb eesnäärme healoomulist suurenemist ravida doksasosiini prolongeeritult vabastavate tablettidega madala vererõhuga patsientidel ja patsientidel, kellel on teadaolev ortostaatiline düsregulatsioon.
English: In patients with hypertension, the decrease in blood pressure during treatment with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]was similar in both the sitting and standing position.
Estonian: Hüpertensiivsetel patsientidel oli vererõhu langus Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavate tablettidega ja seotud nimetustega ravimisel ühesugune nii istudes kui seistes.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]may be used in benign prostatic hyperplasia (BPH) patients who are either hypertensive or normotensive, as the blood pressure changes in normotensive patients are clinically insignificant.
Estonian: Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavaid tablette ja seotud nimetusi võib kasutada nii hüpertensiivsetel kui ka normotensiivsetel eesnäärme healoomulise suurenemisega patsientidel, sest vererõhu langus normotensiivsetel patsientidel on kliiniliselt ebaoluline.
English: Methacrylic acid copolymer (Eudragir L30 D-55) Macrogol 1300-1600
Estonian: Polüetüleenoksiid, mikrokristalne tselluloos, povidoon, α-tokoferool, butüülhüdroksütolueen (E321), kolloidne veevaba ränidioksiid, naatriumstearüülfumaraat, metakrüülhappe kopolümeer (Eudragir L30 D-55), makrogool 1300-1600, titaandioksiid (E171).
English: The pharmacokinetic properties of doxazosin in Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]prolonged release tablets lead to a minor variation in plasma levels.
Estonian: Doxazosin Winthrop 4 mg prolongeeritult vabastavate tablettide ja seotud nimetuste toimeainet prolongeeritult vabastavate tablettide farmakokineetilised omadused põhjustavad plasmataseme kerge kõikumise.
English: Liver impairment:
Estonian: Seedetraktihäired:
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can be taken with or without food.
Estonian: Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavaid tablette ja seotud nimetusi võib võtta koos söögiga või ilma.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]work by relaxing the muscle around the bladder exit and prostate gland, which allows the urine to pass more easily.
Estonian: Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavad tabletid ja seotud nimetused lõõgastavad põie ja eesnäärme ümber paiknevaid lihaseid, tehes põietühjendamise kergemaks.
English: Throughout the recommended dosage range, Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]has only a minor or no effect on blood pressure in normotensive benign prostatic hyperplasia (BPH) patients.
Estonian: Soovitatud annuse vahemikus on Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavatel tablettidel ja seotud nimetustel eesnäärme healoomulise suurenemisega normotensiivsete patsientide vererõhule vaid minimaalne toime või ei ole seda üldse.
English: Taking Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]with food and drink
Estonian: Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavate tablettide ja seotud nimetuste kasutamine koos toidu ja joogiga
English: NAME OF THE MEDICINAL PRODUCT [See Annex I - To be completed nationally] Doxazosin STATEMENT OF ACTIVE SUBSTANCE(S) Each prolonged-release tablet contains 4 mg of doxazosin (as mesilate).
Estonian: TOIMEAINE(TE) SISALDUS Üks toimeainet prolongeeritult vabastav tablett sisaldab 4 mg doksasosiini (mesülaadina).
English: Musculoskeletal, connective tissue and bone disorders: Uncommon: muscular pain, swelling of joints/arthralgia, muscle weakness
Estonian: Lihas-skeleti ja sidekoe kahjustused: Aeg-ajalt: lihasvalu, liigeste turse, artralgia, lihasnõrkus.
English: Uncommon: arrhythmia, angina pectoris, bradycardia, tachycardia, myocardial infarction
Estonian: Aeg-ajalt: arütmia, stekokardia, bradükardia, tahhükardia, müokardiinfarkt.
English: Hepato-biliary disorders: Rare: icterus, increased liver values
Estonian: Maksa ja sapiteede häired: Harv: kollatõbi, maksafunktsiooni näitajate väärtuste suurenemine.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF Doxazosin “Winthrop” 4 mg prolonged release tablets and associated names (see Annex I)
Estonian: Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavate tablettide ja sarnaste nimetuste (vt i lisa) TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE
English: Do not take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Estonian: Ärge võtke Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavaid tablette ja seotud nimetusi
English: Rare side effects, seen in more than 1 in 10,000 patients but less than 1 out of 1,000, include low blood sugar levels, depression, feeling restless (agitation), pins and needles, blurred vision, stroke (cerebrovascular disturbance), swelling of the voice box, abdominal pain, diarrhoea, vomiting, jaundice, increased liver enzymes in the blood, rash, itching or reddening of the skin, impotence, painful, persistent erection of the penis and low body temperature (especially in the elderly).
Estonian: Harva esinevad kõrvaltoimed, mida on täheldatud rohkem kui 1 patsiendil 10 000-st, kuid vähem kui 1 patsiendil 1000-st, hõlmavad madalat veresuhkru sisaldust, depressiooni, rahutustunnet (agiteeritust), pakitsust ja torkimist, nägemise hägustumist, insulti (peaajuveresoonkonna häired), häälepaelte turset,
English: If you take more Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]than you should:
Estonian: Kui võtate Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavaid tablette ja seotud nimetusi rohkem kui ette nähtud
English: Common: muscle cramps, fatigue, malaise, headache, somnolence Uncommon: tremor, muscular stiffness Rare: paraesthesia
Estonian: Sage: lihaskrambid, väsimus, halb enesetunne, peavalu, unisus.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]can be taken with or after food.
Estonian: Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavaid tablette ja seotud nimetusi võib võtta söögi ajal või pärast sööki.
English: Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Estonian: Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavad tabletid ja seotud nimetused [vt Lisa I] Doksasosiin
English: This is the maximum dose of Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I].
Estonian: See on Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavate tablettide ja seotud nimetuste maksimaalne annus.
English: 3 HOW TO TAKE DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]
Estonian: 3 KUIDAS DOXAZOSIN WINTHROP 4 MG TOIMEAINET PROLONGEERITULT VABASTAVAID TABLETTE JA SEOTUD NIMETUSI VÕTTA
English: General disorders and administration site conditions: Common: asthenia
Estonian: Üldised häired ja manustamiskoha reaktsioonid: Sage: asteenia.
English: Common: palpitations, chest pain
Estonian: Aeg-ajalt: alopeetsia, näoturse, üldine turse.
English: 1 WHAT DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]IS AND WHAT IT IS USED FOR
Estonian: 1 MIS RAVIM ON DOXAZOSIN WINTHROP 4 MG TOIMEAINET PROLONGEERITULT VABASTAVAD TABLETID JA SEOTUD NIMETUSED JA MILLEKS SEDA KASUTATAKSE
English: What Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]is and what it is used for
Estonian: Mis ravim on Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavad tabletid ja seotud nimetused ja milleks seda kasutatakse
English: Before you take Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex
Estonian: Kui te unustate Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavaid tablette ja seotud nimetusi võtta
English: Each prolonged-release tablet contains 4 mg doxazosin (as mesilate).
Estonian: 2 KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks toimeainet prolongeeritult vabastav tablett sisaldab 4 mg doksasosiini (mesülaadina).
English: 2 BEFORE YOU TAKE DOXAZOSIN WINTHROP 4 MG PROLONGED RELEASE TABLETS AND ASSOCIATED NAMES [SEE ANNEX I]
Estonian: 1 RAVIMPREPARAADI NIMETUS Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavad tabletid ja seotud nimetused [vt Lisa I]
English: What Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]looks like and contents of the pack:
Estonian: Kuidas Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavad tabletid ja seotud nimetused välja näevad ja pakendi sisu
English: Ear and labyrinth disorders: Uncommon: tinnitus
Estonian: Kõrva ja labürindi kahjustused: Aeg-ajalt: tinnitus.
English: Uncommon: flushing, fever/shiver, paleness Rare: low body temperature in elderly
Estonian: Aeg-ajalt: nahapunetus, palavik/külmavärinad, nahakahvatus.
English: Take special care with Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]
Estonian: Eriline ettevaatus on vajalik ravimiga Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavad tabletid ja seotud nimetused
English: What Doxazosin Winthrop 4 mg prolonged release tablets and associated names [See Annex I]contains:
Estonian: Mida Doxazosin Winthrop 4 mg toimeainet prolongeeritult vabastavad tabletid ja seotud nimetused sisaldavad - Toimeaine on doksasosiinmesülaat.
English: The procedure started on 18 October 2007.
Estonian: Menetlus algas 18. oktoobril 2007.
English: The Marketing Authorisation Holder provided supplementary information on 28 January 2008.
Estonian: Müügiloa hoidja esitas täiendava teabe 28. jaanuaril 2008.
English: A Decision was issued by the European Commission on 6 October 2008.
Estonian: Euroopa Komisjon tegi otsuse 6. oktoobril 2008.
English: Ref. EMEA/CHMP/541853/2008
Estonian: London, 6. oktoober 2008 Viide: EMEA/CHMP/541622/2008
English: Zyrtec and associated names, 10 mg film coated tablets, 10 mg/ml oral drops, 1 mg/ml oral solution, is an anti-allergic drug indicated for the relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis and for the relief of chronic idiopathic urticaria.
Estonian: Zyrtec ja sarnased nimetused, 10 mg õhukese polümeerkattega tabletid, 10 mg/ml suukaudsed tilgad, 1 mg/ml suukaudne lahus, on allergiaravim, mis on näidustatud hooajalise ja aastaringse allergilise riniidi nina- ja silmasümptomite levendamiseks, samuti kroonilise idiopaatilise nõgestõve leevendamiseks.
English: The basis for referral was that there were divergences in the Summaries of Product Characteristics (SPC) of Zyrtec and associated names approved across EU Member States, in particular with respect to the indications, the posology, the contra-indications and the special warnings.
Estonian: Esildise aluseks olid Zyrteci ja sarnaste nimetuste Euroopa Liidu liikmesriikides heakskiidetud ravimi omaduste kokkuvõtete erinevused, eelkõige seoses näidustuste, annustamise, vastunäidustuste ja erihoiatustega.
English: During its May 2008 meeting, the CHMP, in the light of the overall submitted data and the scientific discussion within the Committee, was of the opinion that the proposal for the harmonisation of the SPC, Labelling and Package Leaflet was acceptable and that they should be amended.
Estonian: 2008. aasta mai koosolekul oli inimravimikomitee, võttes arvesse kõiki esitatud andmeid ja komiteesisest teaduslikku arutelu, arvamusel, et ravimi omaduste kokkuvõtete, märgistuse ja pakendi infolehtede ühtlustamise ettepanek on vastuvõetav ning need dokumendid tuleb muuta.
English: This medicinal product belongs to the 2007 list of products identified for SPC harmonisation.
Estonian: See ravim kuulub 2007. a ravimite loetellu, mille ravimi omaduste kokkuvõtted kuuluvad ühtlustamisele.
English: The CHMP gave a positive opinion on 30 May 2008 recommending the harmonisation of the SPC, Labelling and Package Leaflet for Zyrtec and associated names.
Estonian: Inimravimikomitee esitas positiivse arvamuse 30. mail 2008, soovitades ühtlustada Zyrteci ja sarnaste nimetuste ravimi omaduste kokkuvõtted, märgistused ja pakendi infolehed.
English: On 9 October 2007 the Commission presented to the EMEA a referral under Article 30 of Directive 2001/83/EC, as amended, in order to harmonise the nationally authorised Summaries of Product Characteristics (SPC), Labelling and Package Leaflet of the medicinal product Zyrtec and associated names.
Estonian: 9. oktoobril 2007 esitas komisjon Euroopa Ravimiametile muudetud direktiivi 2001/83/EÜ artikli 30 alusel esildise Zyrteci ja sarnaste nimetuste liikmesriikides heakskiidetud ravimi omaduste kokkuvõtete, pakendi infolehtede ja märgistuste ühtlustamiseks.
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 30 REFERRAL FOR Zyrtec and associated names International Non-Proprietary Name (INN): cetirizine
Estonian: INIMRAVIMITE KOMITEE ARVAMUS PÄRAST ARTIKLI 30 KOHAST ESILDIST Zyrtec ja sarnased nimetused
English: Let stand for 20 minutes.
Estonian: Lasta seista 20 minutit.
English: 04011 Campoverde di Aprilia (LT) Italy
Estonian: 04011 Campoverde di Aprilia (LT) Itaalia
English: Justification for not including Braille accepted.
Estonian: Põhjendus Braille mitte lisamiseks on vastuvõetav.
English: In some cases, fatalities have been reported (see section 4.8).
Estonian: Mõnel korral on teatatud surmajuhtumitest (vt lõik 4.8).
English: No significant findings were observed.
Estonian: Olulisi leide ei täheldatud.
English: On this basis, the absolute risk reduction is 5.8% which means the number needed to treat is 17 to prevent one hospitalisation.
Estonian: Selle põhjal on absoluutne riski vähenemine 5,8%, mis tähendab, et ühe hospitaliseerimise ärahoidmiseks ravi vajavate patsientide arv on 17.
English: Do not use this medicine after the expiry date which is stated on the label after ‘EXP'.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud etiketil pärast „EXP“.
English: However in-use stability has been demonstrated for 3 hours at 20 - 24oC.
Estonian: Siiski on on näidatud stabiilsust kasutamisel 3 tunni jooksul 20...24°C juures.
English: Date of first authorisation: 13 August 1999 Date of latest renewal: 27 July 2009
Estonian: Müügiloa esmase väljastamise kuupäev: 13. august 1999 Müügiloa viimase uuendamise kuupäev: 27.juuli 2009
English: The solution is clear or slightly opalescent.
Estonian: Lahus on selge või kergelt opalestseeruv.
English: Subjects were followed for safety and efficacy for 150 days.
Estonian: Uuritavaid jälgiti preparaadi ohutuse ja efektiivsuse suhtes 150 päeva jooksul.
English: Your child can then go back to the original planned injection.
Estonian: Siis võib teie laps tagasi pöörduda esialgselt plaanitud süsti juurde.
English: Where possible, the first dose should be administered prior to commencement of the RSV season.
Estonian: Võimalusel tuleb esimene annus manustada enne RSV hooaja algust.
English: Store in a refrigerator (2ºC to 8ºC).
Estonian: Hoida külmkapis (2°C...8°C).
English: These doses were 20.25 mg/kg, 21.1 mg/kg and 22.27 mg/kg.
Estonian: Need annused olid 20,25 mg/kg, 21,1 mg/kg ja 22,27 mg/kg.
English: Anaphylaxis, anaphylactic shock (in some cases, fatalities have been reported.)
Estonian: Anafülaksia, anafülaktiline šokk (mõnel korral on teatatud surmajuhtumitest.)
English: For your child's best protection, it is necessary to take the doctor's advice about when to return for additional doses of Synagis.
Estonian: Teie lapse parimaks kaitseks on vajalik kuulata arsti nõuannet selle kohta, millal tema juurde Synagis'e lisaannuste saamiseks tagasi pöörduda.
English: Data on fertility, pregnancy and lactation are not available.
Estonian: Fertiilsuse, raseduse ja imetamise kohta andmed puuduvad.
English: Synagis is not indicated for use in adults.
Estonian: Synagis ei ole näidustatud kasutamiseks täiskasvanutel.
English: After reconstitution, the product should be used immediately.
Estonian: Pärast lahustamist tuleb preparaat koheselt ära kasutada.
English: Groups were equally balanced between cyanotic and acyanotic patients.
Estonian: Gruppides oli võrdselt tsüanootilisi ja tsüanoosita patsiente.
English: AbbVie (as logo)
Estonian: Abbvie (logo)
English: In vitro studies of antiviral activity
Estonian: Viirusevastase toime uuringud in vitro
English: Read all of this leaflet carefully before your child is given this medicine because it contains important information for you and your child.
Estonian: Enne ravimi kasutamist teie lapsel lugege hoolikalt infolehte, kuna see sisaldab teile ja teie lapsele olulist teavet.
English: The majority of clinical RSV isolates tested (n=96) were collected from subjects in the United States.
Estonian: Enamus testitud RSV kliinilistest isolaatidest (n = 96) olid saadud USA-s elavatelt patsientidelt.
English: • Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
Estonian: • alla 2-aastased lapsed, kes on viimase 6 kuu jooksul vajanud bronhopulmonaalse düsplaasia ravi.
English: In clinical studies, three children received an overdose of more than 15 mg/kg.
Estonian: Kliinilistes uuringutes on kolm last saanud 15 mg/kg ületava annuse.
English: Palivizumab solution should stand at room temperature for a minimum of 20 minutes until the solution clarifies.
Estonian: Palivisumabi lahus peab seisma toatemperatuuril vähemalt 20 minutit, kuni lahus selgineb.
English: Keep the vial in the carton in order to protect from light.
Estonian: Hoida viaal karbis, valguse eest kaitstult.
English: For example, for a baby with a body weight of 3 kg, the calculation becomes:
Estonian: Näiteks väikelapsele kehakaaluga 3 kg on võrrand:
English: A total of 222 children were enrolled in two separate studies to examine the safety of palivizumab when it is administered for a second RSV season.
Estonian: Kokku 222 last osales kahes eraldi uuringus, mis hindasid palivisumabi ohutust, kui seda manustati teisel RSV hooajal.
English: This humanised monoclonal antibody is composed of human (95%) and murine (5%) antibody sequences.
Estonian: See inimese monoklonaalne antikeha koosneb inimese (95%) ja närilise (5%) antikehajärjestustest.
English: How often will Synagis be given to my child?
Estonian: Kui sageli Synagis't lapsele manustatakse?
English: In case of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.
Estonian: Üleannustamise korral on soovitatav jälgida patsienti mis tahes kõrvaltoimete nähtude või sümptomite suhtes ja alustada otsekohe asjakohast sümptomaatilist ravi.
English: If your child misses an injection, you should contact your doctor as soon as possible.
Estonian: Kui süst jääb tegemata, kontakteeruge oma arstiga niipea kui võimalik.
English: No medical consequences were identified in these instances.
Estonian: Ühelgi juhul meditsiinilisi tagajärgi ei ilmnenud.
English: Therefore, diagnostic test results, when obtained, should be used in conjunction with clinical findings to guide medical decisions.
Estonian: Seetõttu tuleb otsuste langetamisel diagnostiliste näitajate tulemusi hinnata koos kliiniliste leidudega.
English: If you are not sure about how this product will be given to your child, ask your doctor or pharmacist.
Estonian: Kui te ei ole kindel, kuidas seda ravimit teie lapsele manustatakse, pidage nõu oma arsti või apteekriga.
English: Subjects were stratified by cardiac lesion (cyanotic vs. other) and were followed for safety and efficacy for 150 days.
Estonian: Uuritavad stratifitseeriti südamekahjustuse alusel (tsüanootilised vs. teised) ja jälgiti preparaadi ohutuse ja efektiivsuse suhtes 150 päeva jooksul.
English: What Synagis looks like and contents of the pack
Estonian: Kuidas Synagis välja näeb ja pakendi sisu
English: From the post-marketing experience, overdoses with doses up to 85 mg/kg have been reported and in some cases, adverse reactions were reported which did not differ from those observed with 15 mg/kg dose (see section 4.8).
Estonian: Turuletulekujärgselt on teatatud üleannustamistest annustega kuni 85 mg/kg ning mõnel juhul kirjeldati kõrvaltoimeid, mis ei erinenud 15 mg/kg annuse puhul esinevatest (vt lõik 4.8).
English: This was transient, low titre, resolved despite continued use (first and second season), and could not be detected in 55 of 56 infants during the second season (including 2 with titres during the first season).
Estonian: See oli mööduv, madala tiitriga, lahenes vaatamata ravimi kasutamise jätkamisele (esimene ja teine hooaeg) ning seda ei leitud 55-l lapsel 56st teisel hooajal (sealhulgas 2 lapsel, kellel esinesid antikehad esimesel hooajal).
English: The RSV hospitalisation rate was 9.7% in the placebo group and 5.3% in the Synagis group.
Estonian: RSV tõttu hospitaliseerimise sagedus oli 9,7% platseebogrupis ja 5,3% Synagis'e grupis.
English: Patients with hemodynamically significant congenital heart disease were excluded from enrollment in this study and were studied in a separate study.
Estonian: Hemodünaamiliselt olulise kaasasündinud südamehaigusega patsiendid välistati uuringust kaasamise hetkel ning neid uuriti eraldi teises uuringus.
English: In the first study, all 153 premature infants received both formulations in different sequences.
Estonian: Esimeses uuringus manustati kõigile 153 enneaegsele imikule mõlemat ravimvormi erinevas järjestuses.
English: • Children less than 2 years of age and with haemodynamically significant congenital heart disease.
Estonian: • alla 2-aastased lapsed hemodünaamiliselt olulise kaasasündinud südamehaigusega.
English: Subsequent doses should be administered monthly throughout the RSV season.
Estonian: Järgnevad annused tuleb manustada kord kuus kogu RSV hooaja kestel.