FrancophonIA/ELRC3.0 huggingface dataset:
English: Rotarix can be given at the same time as other vaccines.
Estonian: Rotarixi tohib anda muude vaktsiinidega samal ajal.
English: A further study looked at the safety of Rotarix and its ability to stimulate the production of antibodies in 1,009 babies born up to 13 weeks prematurely.
Estonian: Täiendavas uuringus vaadeldi Rotarixi ohutust ja selle võimet stimuleerida antikehade teket 1009 imikul, kes olid sündinud kuni 13 nädalat enne tähtaega.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rotarix, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Rotarixi omaduste kokkuvõttesse ja pakendi infolehele vaktsiini ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The first dose is given when the baby is older than six weeks.
Estonian: Esimene annus antakse üle 6-nädalasele imikule.
English: If the powder and solvent are used, they should be mixed together just before the vaccine is given, and the resulting suspension given directly into the mouth of the baby using the oral applicator provided.
Estonian: Kui kasutatakse pulbrit ja lahustit, tuleb need segada vahetult enne vaktsiini manustamist ja saadud suspensioon manustatakse lisatud suukaudse aplikaatori abil otse imiku suhu.
English: Rotarix contains small amounts of rotavirus, a virus that causes gastroenteritis.
Estonian: Rotarix sisaldab väheses koguses rotaviirust, sama viirus tekitab gastroenteriiti.
English: Four additional studies were carried out in over 3,000 infants, to confirm that the ready-for-use forms of the vaccine were as safe and as effective as the powder and solvent formulation in stimulating the production of antibodies against rotavirus.
Estonian: Enam kui 3000 imikul toimus neli täiendavat uuringut, et veenduda, kas kasutusvalmis vaktsiinivormid on rotaviiruse vastaste antikehade tekitamisel pulbri ja lahustiga samaväärse ohutuse ja efektiivsusega.
English: The main study compared Rotarix with placebo (a dummy vaccine) in over 63,000 babies who were born at full term (after a pregnancy of at least 36 weeks).
Estonian: Põhiuuringus võrreldi Rotarixi platseeboga (näiv ravim) enam kui 63 000 imikul, kes olid sündinud tähtajal (vähemalt pärast 36. rasedusnädalat).
English: What is Rotarix?
Estonian: Mis on Rotarix?
English: It must also not be given to patients who have disorders that cause severe abnormalities of the immune system called ‘severe combined immunodeficiency', who have had intussusception in the past, or who have problems with their bowel that could put them at risk of intussusception.
Estonian: Vaktsiini ei tohi anda patsientidele, kellel on raske kombineeritud immuunpuudulikkuse (teatud immuunhäire) teket põhjustavad rasked häired, kellel on olnud intussustseptsioon või kellel on soolehäireid, mis võib neid muuta intussustseptsiooni suhtes vastuvõtlikuks.
English: For the full list of all side effects reported with Rotarix, see the package leaflet.
Estonian: Rotarixi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: These results were compared with the findings of a study in babies born at full term who were vaccinated with Rotarix.
Estonian: Tulemusi võrreldi tähtaegselt sündinud ja Rotarixiga vaktsineeritud imikute uuringu tulemustega.
English: Why has Rotarix been approved?
Estonian: Miks Rotarix heaks kiideti?
English: What is the risk associated with Rotarix?
Estonian: Mis riskid Rotarixiga kaasnevad?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rotarix.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: Other information about Rotarix:
Estonian: Muu teave Rotarixi kohta
English: • a powder and solvent that are made up into an oral suspension in an oral applicator;
Estonian: • pulbri ja lahustina, millest valmistatakse suukaudne suspensioon, mida manustatakse suukaudse aplikaatoriga;
English: Rotarix must not be used in babies who are hypersensitive (allergic) to any of the ingredients of the vaccine or those who showed signs of allergy after receiving a dose of rotavirus vaccine in the past.
Estonian: Rotarixi ei tohi kasutada imikutel, kes on toimeaine või vaktsiini mis tahes muu koostisaine suhtes ülitundlikud (allergilised) või kellel on varem tekkinud pärast rotaviirusvaktsiini annust allergianähte.
English: Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines.
Estonian: Väga harva (esinenud vähem kui 1 patsiendil 10 000st) on rotaviirusvaktsiinide kasutamise järel esinenud intussustseptsiooni ehk soole sissetuppumust.
English: Rotarix rotavirus vaccine, live
Estonian: Rotarix rotaviiruse elusvaktsiin
English: The benefit of the vaccine was measured by looking at how many babies developed severe rotavirus gastroenteritis in the months after they had been vaccinated and before they had reached one year of age.
Estonian: Vaktsiini kasulikkust mõõdeti imikute arvu põhjal, kes haigestusid vaktsineerimisjärgsete kuude jooksul ja enne aastaseks saamist raskesse rotaviiruslikku gastroenteriiti.
English: The study in premature babies showed that Rotarix was well tolerated and produced similar levels of antibodies as in infants born at full term.
Estonian: Enneaegsete imikute uuringus selgus, et Rotarixi taluvus oli hea ja vaktsiin tekitas neil antikehade sarnase sisalduse kui tähtaegsetel imikutel.
English: When an infant is given the vaccine, the immune system (the system that fights diseases) recognises the weakened virus as ‘foreign' and makes defences against it. After vaccination, the immune system is able to respond more quickly when it is exposed to the virus again.
Estonian: Kui imikule manustatakse vaktsiini, peab immuunsüsteem (haiguse vastu võitlev süsteem) nõrgestatud viirust võõraks ja tekitab selle vastu kaitse.
English: Rotarix is a vaccine that is given by mouth.
Estonian: Rotarix on suukaudne vaktsiin.
English: • an oral suspension in a prefilled oral applicator;
Estonian: • suukaudne lahus, mida manustatakse eeltäidetud suukaudse aplikaatoriga;
English: What benefit has Rotarix shown during the studies?
Estonian: Milles seisneb uuringute põhjal Rotarixi kasulikkus?
English: How does Rotarix work?
Estonian: Kuidas Rotarix toimib?
English: How has Rotarix been studied?
Estonian: Kuidas Rotarixi uuriti?
English: • an oral suspension in a squeezable tube.
Estonian: • suukaudne lahus, mida manustatakse eeltäidetud tuubist.
English: How is Rotarix used?
Estonian: Kuidas Rotarixi kasutatakse?
English: What is Rotarix used for?
Estonian: Milleks Rotarixi kasutatakse?
English: 14 April 2011
Estonian: 14. aprill 2011
English: What is Octagam?
Estonian: Mis on Octagam?
English: The European Commission issued a decision on this opinion on 30 May 2011.
Estonian: Euroopa Komisjon tegi sellel arvamusel põhineva otsuse 30. mail 2011.
English: • Post-marketing safety studies will be performed.
Estonian: • Toimuvad turustamisjärgsed ohutusuuringud.
English: The current review was initiated in October 2010 at the request of Germany.
Estonian: Käesolev läbivaatamine algatati 2010. aasta oktoobris Saksamaa taotlusel.
English: EMA/293780/2011 rev.1 EMEA/H/A-31/001281
Estonian: EMA/567258/2011 red.1 EMEA/H/A-31/001281
English: The Committee noted that appropriate corrective measures are now in place at the manufacturing sites.
Estonian: Komitee märkis, et ravimi tootmiskohtades võetakse nüüd asjakohaseid parandusmeetmeid.
English: • Patients who have any questions should speak to their doctor or pharmacist.
Estonian: • Küsimuste korral peavad patsiendid pöörduma arsti või apteekri poole.
English: Why was Octagam reviewed?
Estonian: Miks Octagami andmed uuesti läbi vaadati?
English: What are the recommendations for prescribers and patients?
Estonian: Mis on komitee soovitused ravimit määravatele arstidele ja patsientidele?
English: The CHMP noted at the time that the exact cause of the problems could not be identified with certainty.
Estonian: komitee märkis 2010. aasta septembris, et probleemide täpset põhjust ei ole võimalik kindlalt tuvastada.
English: The questions and answers document published in September 2010 can be found here.
Estonian: 2010. aasta septembri teabedokument on avaldatud siin.
English: As with all medicines, doctors are reminded to continue reporting any suspected adverse effects.
Estonian: Nagu kõigi ravimite korral, peavad arstid ka Octagami korral jätkuvalt teatama mis tahes oletatavatest kõrvalnähtudest.
English: • With the new safeguards and improvements to the manufacturing process, doctors are advised that the benefits of the Octagam outweigh its risks and that they can start using the medicine again when it becomes available.
Estonian: • Pidades silmas tootmisprotsessi uusi kaitsemeetmeid ja täiustusi, kinnitatakse arstidele, et Octagami kasulikkus on suurem kui sellega kaasnevad riskid ning et kui ravimi turustamist taasalustatakse, tohib seda taas patsientidele määrata.
English: The Committee also looked at results of batch analyses and independent testing of batches by Member States, as well as information from inspections of two of the manufacturing sites.
Estonian: Komitee vaatas üle ka ravimipartiide analüüside tulemused ja liikmesriikide tehtud sõltumatud partiikatsed, samuti ravimi kahe tootmiskoha kontrollimisel saadud teabe.
English: Immunoglobulins are antibodies (types of protein) normally found in the blood that help the body to fight infections and other diseases.
Estonian: Immunoglobuliinid on normaalses veres sisalduvad antikehad (teatud valgud), mis aitavad organismil võidelda nakkuste ja muude haigustega.
English: The aim of the review was to assess all available data on the safety and quality issues related to the thromboembolic events seen with Octagam.
Estonian: Läbivaatamise eesmärk oli hinnata kõiki Octagami korral teatatud trombemboolianähtudega seotud olemasolevaid ohutus- ja kvaliteediandmeid.
English: The CHMP reviewed investigations that were carried out into the root cause of the problem and proposed corrective measures, including changes to the manufacturing process and tests to be performed during the manufacturing process and on the final products.
Estonian: Inimravimite komitee vaatas läbi probleemi põhjuse väljaselgitamiseks tehtud uuringute tulemused ning pakkus välja parandusmeetmed, sealhulgas tootmisprotsessi muutmise, tootmisprotsessi ajal tehtavad katsed ja lõpptoote katsed.
English: The marketing authorisation holders will also be required to carry out post-marketing safety studies as soon as the medicine is reintroduced into the market in order to confirm the safety of the improved manufacturing process.
Estonian: Müügiloa hoidjad peavad kohe ravimi taasturustamise alguses tegema ka turustamisjärgsed ohutusuuringud, mis kinnitaksid parandatud tootmisprotsessi ohutust.
English: Octagam is used in patients who are at risk of infection because they do not have sufficient antibodies including people with primary immunodeficiency syndrome, or children born with acquired immune deficiency syndrome (AIDS).
Estonian: Octagami kasutatakse patsientidel, keda ohustab infektsioon, sest nende veri ei sisalda piisavalt antikehi, sealhulgas primaarse immuunpuudulikkuse sündroomiga patsientidel ja omandatud immuunpuudulikkuse sündroomiga (AIDS) sündinud lastel.
English: What data has the CHMP reviewed?
Estonian: Mis andmed inimravimite komitee läbi vaatas?
English: using the medicine.
Estonian: Inimravimite
English: It is also used in people with certain immune disorders such as idiopathic thrombocytopenic purpura and in patients who have had a bone marrow transplant.
Estonian: Samuti kasutatakse seda patsientidel, kellel on teatud immuunhäired, näiteks idiopaatiline trombotsütopeeniline purpur, ja patsientidel, kellele on siiratud luuüdi.
English: The European Medicines Agency has completed a review of Octagam and associated names that was triggered by reports of serious thromboembolic events in patients using the medicine.
Estonian: Euroopa Ravimiamet on lõpetanud Octagami ja sarnaste nimetuste kohta tehtud esildise läbivaatamise, mis algatati seoses ravimeid kasutanud patsientidel esinenud raskete trombemboolianähtude teadetega.
English: In addition, critical steps were identified in the manufacturing process that could explain the presence of substances that triggered the thromboembolic events.
Estonian: Peale selle tuvastati tootmisprotsessi kriitilised etapid, milles võis tootesse sattuda trombemboolianähte põhjustanud aineid.
English: In September 2010, the CHMP, following the suspension of the marketing authorisations of Octagam in Germany and Sweden, recommended that all authorisations for the medicine be suspended across the EU.
Estonian: 2010. aasta septembris soovitas inimravimite komitee pärast Octagami müügilubade peatamist Saksamaal ja Rootsis peatada ravimi müügiload ka mujal Euroopa Liidus.
English: Octagam is a solution for infusion (drip into a vein) that contains human normal immunoglobulin extracted from blood as the active substance.
Estonian: Octagam on infusioonilahus (veeni tilgutatav lahus), mis sisaldab toimeainena inimverest eraldatud normaalimmunoglobuliini.
English: The CHMP also agreed on a test to detect factor XIa or other substances that can cause thromboembolic events before batches are released onto the market.
Estonian: Samuti leppis inimravimite komitee kokku XIa hüübimisteguri või muude trombemboolianähte põhjustada võivate ainete tuvastamise katsed, mis tehakse enne ravimipartii turustamist.
English: The CHMP concluded the review with a recommendation that the suspension of the marketing authorisation for Octagam be lifted in the EU on the basis of the safeguards and the change to the medicine's manufacturing process.
Estonian: Inimravimite komitee lõpetas läbivaatamise soovitusega Octagami müügiloa peatamine Euroopa Liidus lõpetada, pidades silmas kaitsemeetmeid ning ravimi tootmise protsessi muutmist.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the EU-wide suspension of the marketing authorisation for Octagam be lifted subject to certain conditions, including a change to the medicine's manufacturing process.
Estonian: Euroopa Ravimiameti inimravimite komitee soovitas Octagami müügiloa kogu Euroopa Liidus kehtinud peatamise teatud tingimustel lõpetada, sealhulgas tingimusel, et muudetakse ravimi tootmise protsessi.
English: Another enzyme, kallikrein, is considered to play a minor role.
Estonian: Samuti võib teatud mõju olla ka teisel ensüümil kallikreiinil.
English: The background to the suspension was an unexpectedly high number of reports of serious thromboembolic events (problems due to the formation of blood clots in the blood vessels) in patients
Estonian: Müügiload peatati seoses ebatavaliselt paljude teadetega rasketest trombemboolianähtudest (trombide ehk soonesiseste verehüüvete tekkest põhjustatud probleemid) ravimit võtvatel patsientidel.
English: The CHMP concluded that the unexpected presence of factor XIa (an enzyme involved in blood clotting) in Octagam was the main cause of the thromboembolic events.
Estonian: Inimravimite komitee järeldas, et trombemboolianähtude peamine põhjus oli teatud ensüümi, XIa hüübimisteguri eeldusvastane sisaldumine Octagamis.
English: These events were thought to be related to problems with the medicine's manufacture, and included stroke, myocardial infarction (heart attack) and pulmonary embolism (clot in a blood vessel supplying the lungs).
Estonian: Neid juhte, sealhulgas insulti, südameinfarkti ja kopsuembooliat, seostati ravimi tootmise probleemidega.
English: The marketing authorisations for Octagam in the EU were suspended by the European Commission, following a review by the CHMP in the September 2010.
Estonian: Inimravimite komitee vaatas küsimuse läbi 2010. aasta septembris ning komitee soovituse alusel peatas Euroopa Komisjon Octagami Euroopa Liidus kehtinud müügiload.1
English: Contains aspartame.
Estonian: Sisaldab aspartaami.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Estonian: Nii nagu kõik ravimid, võib ka see ravim põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Czech Republic
Estonian: City Tower, Hvězdova 1716/2b, 140 78 Praha 4 Tšehhi Vabariik
English: Hertfordshire, WD18 8YA, United Kingdom
Estonian: Hertfordshire, WD18 8YA, Ühendkuningriik
English: Gröbenzell, Germany
Estonian: Gröbenzell, Saksamaa
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Estonian: Teatage oma raviarstile, kui te võtate või olete hiljuti võtnud või kavatsete võtta mis tahes muid ravimeid.
English: - Medicines of this type may cause unusual movements mainly of the face or tongue.
Estonian: • Seda tüüpi ravimid võivad põhjustada peamiselt näo või keele ebaharilikke liigutusi.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Estonian: Enne ravimi võtmist lugege hoolikalt infolehte sest siin on teile vajalikku teavet.
English: - if you have been previously diagnosed with eye problems such as certain kinds of glaucoma (increased pressure in the eye).
Estonian: • Kui teil on diagnoositud probleeme silmadega, nagu nt kindlad glaukoomi vormid (suurenenud surve silmas).
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Estonian: AINULAADNE IDENTIFIKAATOR - INIMLOETAVAD ANDMED
English: Children and adolescents Olanzapine Glenmark is not for patients who are under 18 years.
Estonian: Lapsed ja noorukid OLANZAPINE GLENMARK ei ole mõeldud alla 18-aastastele patsientidele.
English: Mannitol E 421
Estonian: Mannitool E421
English: - Tell your doctor if you or someone else in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.
Estonian: • Öelge oma arstile, kui teil või kellelgi teie perekonnast on esinenud verehüübeid, kuna selliseid ravimeid seostatakse verehüüvete tekkimisega.
English: SN: {number}
Estonian: PC: {number} SN: {number} NN: {number}
English: Activated charcoal reduces the bioavailability of oral olanzapine by 50 to 60 % and should be taken at least 2 hours before or after olanzapine.
Estonian: Aktiveeritud süsi vähendab suukaudse olansapiini biosaadavust 50 kuni 60 % võrra ning seda tuleks manustada vähemalt 2 tundi enne või pärast olansapiini.
English: • unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
Estonian: • Ebatavalised liigutused (sageli esinev kõrvaltoime, mis võib tekkida kuni 1 inimesel 10-st), need on peamiselt näo ja keele liigutused;
English: If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Estonian: Kui te olete rase, imetate või arvate end olevat rase või kavatsete rasestuda, pidage enne selle ravimi kasutamist nõu oma arsti või apteekriga.
English: However, olanzapine (5-20 mg) demonstrated a comparable safety profile in female (n = 467) as in male patients (n = 869).
Estonian: Ometi ilmnes, et olansapiin (5...20 mg) omab nii nais- (n=467) kui meespatsientidel (n=869) võrreldavat ohutusprofiili.
English: Very common: Weight gain 13, elevated triglyceride levels 14, increased appetite.
Estonian: Väga sage: Kaalutõus13, triglütseriidide sisalduse tõus 14, suurenenud söögiisu.
English: Your doctor will tell you how many Olanzapine Glenmark tablets to take and how long you should continue to take them.
Estonian: Arst seletab teile, mitu tabletti Olanzapine Glenmark't võtta ning kui kaua ravi peab jätkuma.
English: Store below 30C.
Estonian: Hoida temperatuuril kuni 30C.
English: • In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position.
Estonian: Ravi varajases staadiumis võivad mõned inimesed tunda pearinglust või minestada (koos südametöö aeglustumisega), eriti kui nad tõusevad üles istuvast või lamavast asendist.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja blistril.
English: • Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.
Estonian: • Mõõdukad kuni rasked maania episoodid, seisund, mille sümptomiks on erutus või eufooria.
English: • If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
Estonian: • Kui te olete teadlik, et teil võib olla organismis soolakadu pikaaegse raske kõhulahtisuse ja oksendamise (halb enesetunne) tagajärjel või diureetikumide (veetabletid) kasutamise tõttu.
English: As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.
Estonian: Tavapärast ettevaatust silmas pidades võib arst teil vererõhku jälgida, kui olete üle 65 aastane.
English: What Olanzapine Glenmark is and what it is used for What you need to know before you take Olanzapine Glenmark How to take Olanzapine Glenmark Possible side effects
Estonian: Mis ravim on Olanzapine Glenmark ja milleks seda kasutatakse Mida on vaja teada enne Olanzapine Glenmark'i võtmist Kuidas Olanzapine Glenmark'i võtta Võimalikud kõrvaltoimed
English: Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16
Estonian: Väga sage: Vähenenud üldbilirubiini tase, suurenenud GGT, prolaktiini sisalduse suurenemine plasmas16.
English: If you forget to take Olanzapine Glenmark Take your tablets as soon as you remember.
Estonian: Kui Te unustate Olanzapine Glenmark't võtta: Võtke tablett niipea, kui see teile meenub.
English: Date of latest renewal: 19 August 2014
Estonian: Müügiloa uuendamise kuupäev: 19 August 2014
English: 12 Adverse event identified from spontaneous post-marketing reporting with frequency estimated at the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database.
Estonian: 12 Kõrvaltoime on identifitseeritud spontaansetest turuletulekujärgsetest teatistest esinemissagedusega hinnanguliselt 95% usaldusvahemiku ülempiiril kasutades olansapiini ühendandmebaasi integreeritud andmebaasi.
English: How to store Olanzapine Glenmark Contents of the pack and other information
Estonian: Kuidas Olanzapine Glenmark'i säilitada Pakendi sisu ja muu teave
English: Discontinuation symptoms7, 12
Estonian: Ravi katkestamise sümptomid7,12
English: Olanzapine Glenmark 2.5 mg tablets Olanzapine Glenmark 5 mg tablets Olanzapine Glenmark 7.5 mg tablets Olanzapine Glenmark 10 mg tablets Olanzapine Glenmark 15 mg tablets Olanzapine Glenmark 20 mg tablets
Estonian: Olanzapine Glenmark 2,5 mg tabletid Olanzapine Glenmark 5 mg tabletid Olanzapine Glenmark 7,5 mg tabletid Olanzapine Glenmark 10 mg tabletid Olanzapine Glenmark 15 mg tabletid Olanzapine Glenmark 20 mg tabletid Olansapiin
English: If you take more Olanzapine Glenmark than you should Patients who have taken more Olanzapine Glenmark than they should have experienced the following symptoms: rapid beating of the heart, agitation/aggressiveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness.
Estonian: Kui Te võtate Olanzapine Glenmark't rohkem kui ette nähtud Patsientidel, kes on võtnud Olanzapine Glenmark't rohkem kui ette nähtud, on esinenud järgmisi sümptomeid: kiired südamelöögid, ärevus/agressiivsus, kõnehäired, ebaharilikud liigutused (eriti näo või keele) ja vähenenud teadlikkuse tase.