FrancophonIA/ELRC3.0 huggingface dataset:
English: Aloxi is used to prevent nausea (feeling sick) and vomiting caused by chemotherapy (medicines to treat cancer).
Estonian: Aloxit kasutatakse, et ennetada iiveldust ja oksendamist, mida põhjustab keemiaravi (vähiravimid).
English: In adults, the solution should be injected into a vein over 30 seconds at a dose of 250 micrograms.
Estonian: Täiskasvanutele süstitakse lahust veeni annuses 250 µg 30 sekundi jooksul.
English: Why has Aloxi been approved?
Estonian: Miks Aloxi heaks kiideti?
English: What is Aloxi?
Estonian: Mis on Aloxi?
English: Aloxi solution for injection has been studied in three main studies involving 1,842 adults receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting.
Estonian: Aloxi süstelahust uuriti kolmes põhiuuringus, kus osales 1842 täiskasvanud patsienti, kes said tugevat või mõõdukat iiveldust ja oksendamist põhjustavat keemiaravi.
English: When it was compared with dolasetron, these values were 63% for Aloxi (119 patients out of 189) and 53% for dolasetron (101 patients out of
Estonian: Võrreldes dolasetrooniga olid vastavad väärtused 63% Aloxi (119 patsienti 189st) ja 53% dolasetrooni kasutamisel (101 patsienti 191st).
English: The full EPAR for Aloxi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Aloxi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports Kui vajate Aloxiga toimuva ravi kohta lisateavet, lugege pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In children, the solution should be given by infusion (drip) into a vein over 15 minutes at a dose of 20 micrograms per kilogram body weight.
Estonian: Lastele manustatakse lahust 15-minutilise veeniinfusioonina annuses 20 µg kehakaalu kilogrammi kohta.
English: What is the risk associated with Aloxi?
Estonian: Mis riskid Aloxiga kaasnevad?
English: With chemotherapy that was a strong trigger of nausea and vomiting, 59% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (132 out of 223), compared with 57% of the patients receiving ondansetron (126 out of 221).
Estonian: Keemiaravi korral, mis põhjustas tugevat iiveldust ja oksendamist, ei oksendanud 24 tunni jooksul pärast keemiaravi 59% Aloxit saanud täiskasvanud patsientidest (132 patsienti 223st) ja 57% ondansetrooni saanud patsientidest (126 patsienti 221st).
English: The capsules are only used in adults for chemotherapy that is a moderate trigger of nausea and vomiting in adults.
Estonian: Kapsleid kasutatakse ainult täiskasvanutel mõõdukat iiveldust ja oksendamist põhjustavate keemiaravi ainete korral.
English: In the study in children receiving chemotherapy that was a strong or moderate trigger of nausea and vomiting, 59% of the children receiving Aloxi solution for injection at a dose of 20 micrograms/kilogram did not vomit in the 24 hours after chemotherapy (98 out of 165), which was the same percentage as seen in patients receiving ondansetron (95 out of 162).
Estonian: Tugevat või mõõdukat iiveldust ja oksendamist põhjustavat keemiaravi saavate laste uuringus ei oksendanud 24 tunni jooksul pärast keemiaravi 59% lastest, kes said Aloxi süstelahust annuses 20 µg kehakaalu kilogrammi kohta (98 last 165st), ning see näitaja oli sama ondansetrooni saanud lastel (95 last 162st).
English: What benefit has Aloxi shown during the studies?
Estonian: Milles seisneb uuringute põhjal Aloxi kasulikkus?
English: With chemotherapy that was a moderate trigger of nausea and vomiting, 81% of the adults receiving Aloxi did not vomit in the 24 hours after chemotherapy (153 out of 189) compared with 69% of those receiving ondansetron (127 out of 185).
Estonian: Keemiaravi korral, mis põhjustas mõõdukat iiveldust ja oksendamist, ei oksendanud 24 tunni jooksul pärast keemiaravi 81% Aloxit saanud täiskasvanud patsientidest (153 patsienti 189st) ja 69% ondansetrooni saanud patsientidest (127 patsienti 185st).
English: Aloxi solution for injection has also been investigated in one study involving 502 children receiving chemotherapy that was a strong or a moderate trigger of nausea and vomiting, where Aloxi was compared with ondansetron.
Estonian: Aloxi süstelahust võrreldi ondansetrooniga ka ühes uuringus, kus osales 502 last, kes said tugevat või mõõdukat iiveldust ja oksendamist põhjustavat keemiaravi.
English: How does Aloxi work?
Estonian: Kuidas Aloxi toimib?
English: What is Aloxi used for?
Estonian: Milleks Aloxit kasutatakse?
English: How has Aloxi been studied?
Estonian: Kuidas Aloxit uuriti?
English: How is Aloxi used?
Estonian: Kuidas Aloxit kasutatakse?
English: With the solution for injection, dizziness, constipation and diarrhoea are also seen in between 1 and 10 adults in 100.
Estonian: Süstelahuse kõrvalnähud (esinenud 1-10 patsiendil 100st) on lisaks peapööritus, kõhukinnisus ja kõhulahtisus.
English: A risk management plan has been developed to ensure that Fluenz is used as safely as possible.
Estonian: Töötati välja riskijuhtimisstrateegia, et tagada Fluenzi võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fluenz on 27 January 2011.
Estonian: Euroopa Komisjon andis Fluenzi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 27. Jaanuaril 2011.
English: What measures are being taken to ensure the safe and effective use of Fluenz?
Estonian: Mis meetmed võetakse, et tagada Fluenzi ohutu ja efektiivne kasutamine?
English: The full EPAR for Fluenz can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Fluenzi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Other information about Fluenz
Estonian: Muu teave Fluenzi kohta
English: It must also not be given to children who are receiving treatment with salicylates (painkillers such as aspirin).
Estonian: Samuti ei tohi seda manustada lastele, kes saavad ravi salitsülaatidega (valuvaigistid, näiteks aspiriin).
English: Children who have not been previously vaccinated against seasonal flu should be given a second dose after at least four weeks.
Estonian: Varem hooajalise gripi vastu vaktsineerimata lastele peab manustama teise annuse vähemalt nelja nädala pärast.
English: Fluenz is used to prevent flu in children and adolescents from 24 months to less than 18 years old.
Estonian: Fluenzit kasutatakse gripi ennetamiseks 24-kuustel kuni alla 18-aastastel lastel ning noorukitel.
English: Fluenz is given as a nasal spray using a single-use nasal applicator (0.1 ml sprayed into each nostril).
Estonian: Fluenzit manustatakse ninapihusena ühekorra-ninaaplikaatoriga (kummassegi ninasõõrmesse pihustatakse 0,1 ml).
English: The main measure of effectiveness was the number of laboratory-confirmed cases of flu caused by the three strains during the given flu season, although one of the studies in adults measured the number of cases of feverish illness (as opposed to confirmed flu cases).
Estonian: Efektiivsuse põhinäitaja oli gripihooajal nende kolme tüve põhjustatud ja laboriuuringuga kinnitatud gripijuhtude arv, ehkki ühes täiskasvanute uuringus hinnati palavikuga kulgevate haigusjuhtude arvu (erinevalt laboriuuringuga kinnitatud gripijuhtudest).
English: The viruses used in Fluenz are grown in hens' eggs.
Estonian: Fluenzis kasutatavad viirused on kasvatatud kanamunades.
English: In the studies in children and adolescents, Fluenz reduced the number of flu cases caused by the three flu strains by between 62% and 100% compared with placebo and by between 35% and 53% compared with the comparator inactivated vaccine.
Estonian: Laste ja noorukite uuringutes vähendas Fluenz kolme gripitüve põhjustatud haigusjuhte platseeboga võrreldes 62-100% ja inaktiveeritud võrdlusvaktsiiniga võrreldes 35-53%.
English: The CHMP therefore decided that Fluenz's benefits are greater than its risks in children and adolescents from 24 months to less than 18 years old and recommended that it be given marketing authorisation in this patient group.
Estonian: Komitee otsustas seetõttu, et Fluenzi kasulikkus 24-kuustel kuni alla 18-aastastel lastel ning noorukitel on suurem kui kaasnevad riskid, ja soovitas anda kasutamiseks sellel patsiendirühmal müügiloa.
English: Fluenz influenza vaccine (live attenuated, nasal)
Estonian: Fluenz gripivaktsiin (nõrgestatud elusvaktsiin, nasaalne)
English: These virus strains need to be included in Fluenz before it can be used.
Estonian: Need viirusetüved peavad sisalduma Fluenzis, enne kui vaktsiini saab kasutada.
English: It contains three live attenuated (weakened) influenza (flu) virus strains: A/California/7/2009 (H1N1)pdm09-like strain; A/Victoria/361/2011 (H3N2)-like strain; and B/Massachusetts/2/2012-like strain.
Estonian: Vaktsiin sisaldab gripiviiruse kolme nõrgestatud elustüve: A/California/7/2009 (H1N1)pdm09-laadne tüvi, A/Victoria/361/2011 (H3N2)-laadne tüvi ja B/Massachusetts/2/2012-laadne tüvi.
English: Nine main studies involving around 24,000 children and adolescents and four studies involving around 11,000 adults compared Fluenz with either placebo (a dummy vaccine) or another injectable flu vaccine containing inactivated (killed) viral material from the same three flu strains.
Estonian: Üheksas põhiuuringus, milles osales kokku ligikaudu 24 000 last ja noorukit, ning neljas põhiuuringus, milles osales ligikaudu 11 000 täiskasvanut, võrreldi Fluenzit platseebo (näiv vaktsiin) või teise inaktiveeritud (hävitatud) viirust sisaldava süstitava vaktsiiniga, mis sisaldas sama kolme gripiviirusetüve viirusematerjali.
English: The flu strains were selected according to the influenza season.
Estonian: Viirusetüved valiti gripihooaja järgi.
English: The most common side effects with Fluenz (seen in more than 1 patient in 10) are reduced appetite, headache, blocked or runny nose and malaise (feeling unwell).
Estonian: Fluenzi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on isutus, peavalu, ninakinnisus või ninavoolus ja halb enesetunne.
English: Fluenz is a vaccine which is available as a nasal spray to protect against influenza A (sub-types H1N1 and H3N2) and influenza B.
Estonian: Fluenz on ninapihusena turustatav vaktsiin, mida kasutatakse kaitseks A-gripi (alatüübid H1N1 ja H3N2) ning B-gripi eest.
English: Fluenz is a vaccine.
Estonian: Fluenz on vaktsiin.
English: Fluenz contains strains of flu virus that have first been weakened so that they do not cause disease.
Estonian: Fluenz sisaldab nõrgestatud gripiviirusetüvesid, mis ei suuda tekitada haigust.
English: It must also not be given to people with weakened immune systems due to conditions such as blood disorders, symptomatic HIV infection and cancer or as a result of certain medical treatments.
Estonian: Fluenzit ei tohi kasutada ka patsiendid, kellel immuunsüsteem on nõrgenenud näiteks verehaiguste, sümptomaatilise HIV-nakkuse ja vähi või teatud ravi tõttu.
English: The studies in adults showed that Fluenz may have some benefits compared with placebo but the results were inconsistent.
Estonian: Täiskasvanute uuringud näitasid, et Fluenzil võib olla platseeboga võrreldes mõningane kasulikkus, kuid tulemused varieerusid.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Fluenz, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Strateegiast lähtudes lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Fluenzi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Some studies also suggested that Fluenz was not as effective as the comparator inactivated vaccine in adults.
Estonian: Mõne uuringu järgi ei olnud Fluenz täiskasvanutel sama efektiivne kui võrdluseks kasutatud inaktiveeritud vaktsiin.
English: For more information about treatment with Fluenz, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Fluenzi kasutamise kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Fluenz.
Estonian: See on vaktsiini Fluenz Euroopa avaliku hindamisaruande kokkuvõte.
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 Fluenz.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: Fluenz must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, to gentamicin (a type of antibiotic), or to eggs or egg proteins.
Estonian: Fluenzit ei tohi kasutada patsiendid, kes on toimeaine või selle vaktsiini mis tahes muu koostisaine, gentamütsiini (teatud antibiootikum), munade või munavalkude suhtes ülitundlikud (allergilised).
English: What is Fluenz?
Estonian: Mis on Fluenz?
English: It must only be used as a nasal spray and must not be injected.
Estonian: Vaktsiini tohib kasutada üksnes ninapihusena; seda süstida ei tohi.
English: Why has Fluenz been approved?
Estonian: Miks Fluenz heaks kiideti?
English: Fluenz will be updated with weakened virus strains type A-H1N1, type A-H3N2 and type B for each season, according to recommendations for the northern hemisphere from the WHO and from the European Union.
Estonian: Fluenzis sisalduvad A-H1N1-, A-H3N2- ja B-gripiviiruse konkreetsed nõrgestatud tüved olenevad WHO soovitustest põhjapoolkerale ja Euroopa Liidu soovitustest.
English: The CHMP noted that the studies showed convincingly that Fluenz was more effective than placebo and the comparator inactivated vaccine in children and adolescents, but not in adults.
Estonian: Inimravimite komitee märkis, et uuringud tõendasid veenvalt, et Fluenz oli lastel ja noorukitel (kuid mitte täiskasvanutel) platseebost ja inaktiveeritud võrdlusvaktsiinist efektiivsem.
English: For the full list of all side effects reported with Fluenz, see the package leaflet.
Estonian: Fluenzi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: What benefit has Fluenz shown during the studies?
Estonian: Milles seisneb uuringute põhjal Fluenzi kasulikkus?
English: What is the risk associated with Fluenz?
Estonian: Mis riskid Fluenziga kaasnevad?
English: How does Fluenz work?
Estonian: Kuidas Fluenz toimib?
English: How has Fluenz been studied?
Estonian: Kuidas Fluenzit uuriti?
English: How is Fluenz used?
Estonian: Kuidas Fluenzit kasutatakse?
English: What is Fluenz used for?
Estonian: Milleks Fluenzit kasutatakse?
English: The physician educational programme should contain the following key elements:
Estonian: Arstide koolitusprogramm peab sisaldama järgmisi võtmeelemente:
English: You may for example take one capsule in the morning and one in the evening.
Estonian: Te võite näiteks võtta ühe kapsli hommikul ja teise õhtul.
English: This way, you will have to take fewer capsules at once.
Estonian: Sellisel juhul peate te võtma korraga vähem kapsleid.
English: Other medicines and Orphacol
Estonian: Muud ravimid ja Orphacol
English: If you take these medicines, take Orphacol at least 5 hours before or at least 5 hours after taking these other medicines.
Estonian: Kui te võtate neid ravimeid, võtke Orphacoli vähemalt 5 tundi enne või 5 tundi pärast nende ravimite võtmist.
English: Pack sizes: 30, 60, 120.
Estonian: Pakendi suurused: 30, 60, 120.
English: Patients should be monitored as follows: 3-monthly during the first year, 6-monthly during the subsequent three years and annually thereafter (see below).
Estonian: Patsientidel tuleb ravivastust hinnata järgmiselt: esimese aasta jooksul iga 3 kuu tagant, järgmise 3 aasta jooksul iga 6 kuu tagant ja seejärel kord aastas (vt allpool).
English: However, absolute numbers of cases are small.
Estonian: Haigusjuhtude koguarv on siiski väike.
English: Due to the rarity of the diseases, the information about the most serious and/or most frequently occurring adverse reactions is limited.
Estonian: Haiguste harulduse tõttu on andmeid kõige raskemate ja/või kõige sagedamini esinevate kõrvaltoimete kohta piiratud hulgal.
English: Tell your doctor or pharmacist if you are taking, have recently taken any or might take other medicines.
Estonian: Teatage oma arstile või apteekrile, kui te kasutate või olete hiljuti kasutanud või kavatsete kasutada mis tahes muid ravimeid.
English: There is no experience in elderly patients.
Estonian: Eakatel patsientidel kasutamise kogemus puudub.
English: Make sure you see your doctor for these regular examinations at least once a year.
Estonian: Te peate nende regulaarsete uuringute tegemiseks kindlasti vähemalt kord aastas arsti juures käima.
English: Please tell your doctor if you are taking ciclosporin.
Estonian: Palun informeerige oma arsti, kui te tsüklosporiini võtate.
English: The dose of cholic acid should be adjusted individually.
Estonian: Koolhappe annust tuleb kohandada individuaalselt.
English: PVC/PVDC-aluminium blister of 10 capsules.
Estonian: PVC/PVDC-alumiiniumblister, mis sisaldab 10 kapslit.
English: At each investigation, the need for dose adjustment should be considered.
Estonian: Iga analüüsi käigus tuleb annuse kohandamise vajadus uuesti läbi vaadata.
English: Oblong, opaque, blue and white capsule.
Estonian: Piklik, läbipaistmatu, sinine ja valge kapsel.
English: The dose should be adjusted accordingly, as described above.
Estonian: Annus tuleb kohandada eespool kirjeldatud viisil.
English: This rarity also made the conduct of controlled clinical studies impossible.
Estonian: Haiguste haruldus ei võimaldanud teha ka kontrolliga kliinilisi uuringuid.
English: No pharmacokinetic study data for Orphacol are available.
Estonian: Farmakokineetiliste uuringute andmeid Orphacoli kohta ei ole.
English: It is very important to continue taking Orphacol during pregnancy.
Estonian: On väga oluline, et te jätkate Orphacoli võtmist raseduse ajal.
English: Date of first authorisation: 12 September 2013 Date of latest renewal: 24 April 2019
Estonian: Müügiloa esmase väljastamise kuupäev: 12. september 2013 Müügiloa viimase uuendamise kuupäev: 24/04/2019
English: If your doctor has prescribed a dose which requires you to take more than one capsule per day, you and your doctor can decide how this will be taken during the day.
Estonian: Kui teie arst on määranud annuse, mis koosneb mitmest kapslist päevas, võite te koos arstiga otsustada, kuidas seda päeva jooksul võtta.
English: If itching and/or diarrhoea last for more than three days, tell your doctor.
Estonian: Kui kihelus ja/või kõhulahtisus kestavad kauem kui kolm päeva, pöörduge arsti poole.
English: Capsules must be swallowed whole with water, without chewing.
Estonian: Kapslid tuleb neelata tervelt koos veega, ilma närimata.
English: In adults, the daily dose should not exceed 500 mg.
Estonian: Täiskasvanutel ei tohi ööpäevane annus ületada 500 mg.
English: The studies have however not been conducted to the same level of detail as for a pharmaceutical agent, as cholic acid is a physiological substance in animals and humans.
Estonian: Uuringuid ei ole aga tehtud sama üksikasjalikult kui ravimitega, sest koolhape on loomade ja inimeste füsioloogias tekkiv aine.
English: Orphacol capsules must be taken with food at approximately the same time each day, in the morning and/or evening.
Estonian: Orphacoli kapsleid tuleb võtta koos toiduga iga päev umbes samal kellaajal, hommikuti ja/või õhtuti.
English: It is extremely important that pregnant women continue their therapy during pregnancy.
Estonian: On äärmiselt oluline, et rasedad jätkaksid raseduse ajal ravi.
English: Episodes of symptomatic overdose have been reported, including accidental overdose.
Estonian: Teatatud on sümptomaatilise üleannustamise episoodidest, sealhulgas juhuslikust üleannustamise juhtumist.
English: Always take Orphacol exactly as your doctor has told you.
Estonian: Võtke seda ravimit alati täpselt nii, nagu arst on teile selgitanud.
English: Capsules must be swallowed whole with water.
Estonian: Kapslid tuleb neelata tervelt koos veega.
English: Take a pregnancy test as soon as you suspect you may be pregnant.
Estonian: Tehke rasedustest niipea, kui kahtlustate rasedust.
English: Contents of the pack and other information What Orphacol contains
Estonian: Pakendi sisu ja muu teave Mida Orphacol sisaldab
English: Patients with hepatic impairment should be monitored closely.
Estonian: Maksakahjustusega patsiente tuleb hoolikalt jälgida.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA KIRJAS BLISTER- VÕI RIBAPAKENDIL BLISTER
English: These reactions abated after dose reduction and are suggestive of overdose.
Estonian: Need reaktsioonid taandusid pärast annuse vähendamist ja viitavad üleannustamisele.
English: If you have taken more Orphacol than you should, contact your doctor as soon as possible.
Estonian: Kui olete võtnud Orphacoli rohkem kui ette nähtud, pöörduge nii kiiresti kui võimalik arsti poole.
English: If you become pregnant during treatment with Orphacol, your doctor will decide which treatment and dose is best in your situation.
Estonian: Kui rasestute Orphacoli võtmise ajal, otsustab teie arst, milline ravi ja kui suur annus on teile sobivaim.
English: Patients that have previously been treated with other bile acids or other cholic acid preparations should be closely monitored in the same manner during the initiation of treatment with Orphacol.
Estonian: Patsiente, keda on varem ravitud teiste sapphapetega või teiste koolhappepreparaatidega, tuleb ravi alustamisel Orphacoliga samamoodi tähelepanelikult jälgida.
English: Your doctor will decide what to do if this happens to you.
Estonian: Sellisel juhul otsustab teie arst, mida teha.
English: What Orphacol is and what it is used for What you need to know before you take Orphacol How to take Orphacol
Estonian: Mis ravim on Orphacol ja milleks seda kasutatakse Mida on vaja teada enne Orphacoli võtmist Kuidas Orphacoli võtta
English: Orphacol capsules are taken by mouth with a meal at approximately the same time each day, in the morning and/or evening.
Estonian: Orphacoli kapsleid võetakse suu kaudu koos toiduga ligikaudu samal kellaajal iga päev, hommikuti ja/või õhtuti.
English: There is a limited amount of data (less than 20 pregnancy outcomes) from the use of cholic acid in pregnant women.
Estonian: Koolhappe kasutamise kohta rasedatel on vähe andmeid (vähem kui 20 rasedusjuhtu).
English: Taking Orphacol at regular times with a meal will help you remember to take this medicine, and may help your body to better take it up.
Estonian: Orphacoli võtmine kindlal kellaajal koos toiduga aitab teil ravimi võtmist meeles pidada ja teie organismil seda paremini omastada.
English: Detailed medium- to long-term data are available for 5 of these patients, of whom 1 has been treated with cholic acid monotherapy.
Estonian: Detailsed keskpikad kuni pikaajalised andmed on olemas neist 5 patsiendi kohta, kellest 1 patsiendile oli määratud koolhappe monoteraapia.
English: The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Estonian: Euroopa Ravimiamet vaatab igal aastal läbi ravimpreparaadi kohta saadud kogu uue teabe ning vajaduse korral ravimi omaduste kokkuvõtet ajakohastatakse.
English: Women of childbearing potential should conduct a pregnancy test as soon as a pregnancy is suspected.
Estonian: Rasestuda võivad naised peavad rasedustesti tegema niipea, kui tekib raseduse kahtlus.