FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency decided that Defitelio's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Defitelio kasulikkus on suurem kui sellega kaasnevad riskid ja ravimi kasutamise võib ELis heaks kiita.
English: Defitelio is used in adults and in children from one month of age.
Estonian: Defiteliot kasutatakse täiskasvanutel ja vähemalt 1 kuu vanustel lastel.
English: Treatment should last for at least 3 weeks and continue until the patient no longer has symptoms.
Estonian: Ravi peab kestma vähemalt 3 nädalat ja jätkuma patsiendi sümptomite taandumiseni.
English: Defitelio (defibrotide)
Estonian: Defitelio (defibrotiid)
English: This overview was last updated in 10-2019.
Estonian: Kokkuvõtte viimane uuendus: 10.2019
English: As for all medicines, data on the use of Defitelio are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Defitelio kasutamise kohta pidevat järelevalvet.
English: The most common side effects with Defitelio are hypotension (low blood pressure) and bleeding.
Estonian: Defitelio kõige sagedamad kõrvalnähud on hüpotensioon (madal vererõhk) ja verejooks.
English: What is Defitelio and what is it used for?
Estonian: Mis on Defitelio ja milleks seda kasutatakse?
English: Further information on Defitelio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Defitelio kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Estonian: Lisateave harvikravimiks nimetatud ravimi kohta on leitav: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: This is because it has not been possible to obtain complete information about Defitelio due to the rarity of the disease.
Estonian: See tähendab, et harvaesineva haiguse tõttu ei olnud võimalik saada Defitelio kohta täielikku teavet.
English: It is given by infusion (drip) into a vein over 2 hours 4 times a day.
Estonian: Ravimit manustatakse 2 tundi kestva veeniinfusioonina 4 korda ööpäevas.
English: Why is Defitelio authorised in the EU?
Estonian: Miks Defitelio ELis heaks kiideti?
English: Benefits of Defitelio were also seen in data from a United States patient registry (information about patients collected in a standard way), where patients with severe VOD after blood stem cell transplantation who received Defitelio plus standard care had better outcomes than those given standard care alone, including a higher 100-day survival rate (39% versus 31%) and a higher proportion of patients whose VOD resolved (51% versus 29%).
Estonian: Defitelio kasulikkus ilmnes ka ühe USA patsiendiregistri andmetest (standardmeetodil kogutud patsiendiandmed): pärast vereloome tüvirakkude siirdamist tekkinud raske veno-oklusiivhaigusega patsientidel, kes said Defiteliot koos standardraviga, olid paremad ravitulemused kui ainult standardravi saanud patsientidel, sealhulgas oli parem 100. päeva elumus (vastavalt 39% vs. 31%) ja taandunud veno-oklusiivhaigusega patsientide osakaal oli suurem (vastavalt 51% vs. 29%).
English: Defitelio lowered the mortality rate to 62% at 100 days after transplantation, and 24% of patients had no symptoms of severe VOD after 100 days.
Estonian: Defitelio kasutamisel vähenes suremus 100. päeval pärast siirdamist 62%-le ning 24%-l patsientidest puudusid 100 päeva pärast raske veno-oklusiivhaiguse sümptomid.
English: For more information about using Defitelio, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Defitelio kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Defitelio have been included in the summary of product characteristics and the package leaflet.
Estonian: Defitelio ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Side effects reported with Defitelio are carefully evaluated and any necessary action taken to protect patients.
Estonian: Defitelio kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: What are the risks associated with Defitelio?
Estonian: Mis riskid Defitelioga kaasnevad?
English: Defitelio has been authorised under ‘exceptional circumstances'.
Estonian: Defitelio on saanud müügiloa erandlikel asjaoludel.
English: Although it was not possible to conduct a study directly comparing Defitelio with placebo (dummy treatment), the company had provided sufficient data to show that patients treated with the medicine had improved chances of survival.
Estonian: Kuigi ei olnud võimalik teha Defitelio ja platseebo (näiv ravim) otsest võrdlusuuringut, esitas ettevõte piisavad andmed, mis tõendasid, et ravim parandas patsientide elumust.
English: In one main study involving 102 patients with severe VOD following blood stem cell transplantation, Defitelio was compared with past records of patients who had received standard supportive care.
Estonian: Ühes põhiuuringus, milles osales 102 patsienti, kellel oli pärast vereloome tüvirakkude siirdamist tekkinud raske venooklusiivhaigus, võrreldi Defitelio andmeid varasemate andmetega patsientidelt, kes olid saanud toetavat standardravi.
English: The company will also analyse data on transplant outcomes in VOD patients who have and have not been treated with Defitelio.
Estonian: Samuti analüüsib turustaja nende venooklusiivhaigusega patsientide siirdamistulemuste andmeid, keda on ja keda ei ole Defitelioga ravitud.
English: Other information about Defitelio
Estonian: Muu teave Defitelio kohta
English: Severe VOD has a high mortality rate of 75% or higher.
Estonian: Raske veno-oklusiivhaiguse korral on suremus suur - 75% või üle selle.
English: Since Defitelio has been authorised under exceptional circumstances, the company that markets the medicine is required to provide results of an ongoing study on safety of the medicine when used for prevention of VOD in adults and children undergoing hematopoietic stem cell transplantation.
Estonian: Et Defitelio on saanud müügiloa erandlikel asjaoludel, peab ravimi turustaja esitama tulemused toimuvast uuringust, milles hinnatakse ravimi ohutust veno-oklusiivhaiguse ennetamisel täiskasvanutel ja lastel, kellele siiratakse vereloome tüvirakke.
English: The dose depends on the patient's bodyweight.
Estonian: Annus sõltub patsiendi kehamassist.
English: Defitelio contains the active substance defibrotide.
Estonian: Defitelio sisaldab toimeainena defibrotiidi.
English: What information is still awaited for Defitelio?
Estonian: Mis teavet Defitelio kohta veel oodatakse?
English: VOD is rare, and Defitelio was designated an ‘orphan medicine' (a medicine used in rare diseases) on 29 July 2004.
Estonian: Veno-oklusiivhaigus esineb harva ja Defitelio nimetati 29. juulil 2004 harvikravimiks.
English: How is Defitelio used?
Estonian: Kuidas Defiteliot kasutatakse?
English: In addition, defibrotide may protect the cells that line blood vessels.
Estonian: Peale selle võib defibrotiid kaitsta veresoonte endoteelirakke.
English: For the full list of side effects of Defitelio, see the package leaflet.
Estonian: Defitelio kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: An overview of Defitelio and why it is authorised in the EU
Estonian: Ülevaade ravimist Defitelio ja ELis müügiloa väljastamise põhjendus
English: How does Defitelio work?
Estonian: Kuidas Defitelio toimib?
English: Defitelio is a medicine used to treat severe veno-occlusive disease (VOD) in patients undergoing haematopoietic (blood) stem cell transplantation.
Estonian: Defitelio on ravim, mida kasutatakse raske veno-oklusiivhaiguse raviks patsientidel, kellele siiratakse hematopoeetilisi (vereloome) tüvirakke.
English: Defitelio must not be used together with other medicines that break down blood clots.
Estonian: Defiteliot ei tohi kasutada koos teiste trombe lagundavate ravimitega.
English: Defitelio can only be obtained with a prescription and it must be prescribed and given by a doctor experienced in the management of complications of blood stem cell transplantation.
Estonian: Defiteliot tohib määrata ja manustada vereloome tüvirakkude siirdamise tüsistuste ravis kogenud arst.
English: What benefits of Defitelio have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Defitelio kasulikkus?
English: Defitelio had been shown to improve survival in patients with severe VOD.
Estonian: Defitelio parandas raske veno-oklusiivhaigusega patsientide elumust.
English: Myeloablative chemotherapy is used to clear the patient's bone marrow of cells before receiving healthy stem cells.
Estonian: Müeloablatiivse keemiaraviga hävitatakse patsiendi luuüdist rakud enne tervete tüvirakkude siirdamist.
English: The medicines used for this treatment can damage the lining of the blood vessels in the liver, leading to the formation of clots and obstruction of the vessels seen in VOD.
Estonian: Selles ravis kasutatavad ravimid võivad kahjustada maksaveresoonte endoteeli, põhjustades veno-oklusiivhaigusele iseloomulikke trombe ja veresoonte ummistumist.
English: VOD is a condition in which the veins in the liver become blocked and stop the liver working properly.
Estonian: Veno-oklusiivhaigus on seisund, mille korral maksaveenid ummistuvad, mis takistab normaalset maksatalitlust.
English: The side effects seen, such as bleeding, were considered manageable and it was not possible to determine with certainty whether they were caused by Defitelio.
Estonian: Ei olnud võimalik kindlalt määrata, kas neid põhjustas Defitelio.
English: VOD is usually a complication resulting from a treatment known as ‘myeloablative chemotherapy' given before blood stem cell transplantation.
Estonian: Veno-oklusiivhaigus tekib tavaliselt enne vereloome tüvirakkude siirdamist tehtava müeloablatiivse keemiaravi tüsistusena.
English: The active substance in Defitelio, defibrotide, works by increasing the breakdown of clots in the blood.
Estonian: Defitelio toimeaine defibrotiid soodustab trombide lagunemist.
English: This helps to protect against the diseases that these bacteria and viruses cause.
Estonian: See aitab kaitsta haiguste eest, mida need bakterid ja viirused põhjustavad.
English: The marketing authorisation was renewed on 7 May 2004.
Estonian: Müügiluba pikendati 7. mail 2004.
English: Their breathing should be monitored for up to three days after vaccination.
Estonian: Nende laste hingamist tuleb jälgida kuni kolme päeva jooksul pärast vaktsineerimist.
English: This summary was last updated in 02-2008.
Estonian: Kokkuvõtte viimane uuendus: 02-2008.
English: This conclusion was confirmed with the results from seven additional studies supplied by the company.
Estonian: Seda järeldust kinnitasid ka ettevõtte esitatud seitsme täiendava uuringu tulemused.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Estonian: Selles selgitatakse, kuidas inimravimikomitee hindas tehtud uuringuid, et koostada ravimi kasutamise soovitused.
English: In both groups, the infants were vaccinated at two, four, and 12 to 15 months of age.
Estonian: Mõlemas rühmas vaktsineeriti lapsi 2, 4 ja 12-15 kuu vanuses.
English: PROCOMVAX has been studied in one main study involving 882 infants.
Estonian: PROCOMVAXi kasutamist uuriti ühes põhiuuringus, milles osales 882 last.
English: The European Commission granted a marketing authorisation valid throughout the EU to Sanofi Pasteur MSD S.N.C.
Estonian: Euroopa Komisjon andis PROCOMVAXi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Sanofi Pasteur MSD S.N.C.
English: However, the company provided further information from other studies to show that three doses of PROCOMVAX produced adequate levels of protection.
Estonian: Ettevõte esitas siiski täiendavaid andmeid teistest uuringutest, mis näitasid, et kolm PROCOMVAXi annust tagasid piisaval tasemel kaitse.
English: for PROCOMVAX on 7 May 1999.
Estonian: 7. mail 1999.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Estonian: Vaktsiinid õpetavad immuunsüsteemi (organismi loomulikke kaitsemehhanisme) ennast haiguse eest kaitsma.
English: Other common side effects are fever, anorexia (loss of appetite), vomiting, diarrhoea, irritability, somnolence (sleepiness), crying (including unusual highpitched crying and prolonged crying) and otitis media (infection of the middle ear).
Estonian: Muud sagedad kõrvalnähud on palavik, anoreksia (isutus), oksendamine, kõhulahtisus, ärrituvus, unisus, nutuhood (tavaliselt kõrgel häälel nutmine ja pikaajaline nutmine) ning keskkõrvapõletik.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Estonian: Kui soovite lisateavet inimravimikomitee soovituste aluse kohta, lugege palun teadusliku arutelu kokkuvõtet (samuti Euroopa avaliku hindamisaruande osa).
English: When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘foreign' and makes antibodies against them.
Estonian: Kui lapsele manustatakse vaktsiini, peab immuunsüsteem bakterite ja viiruste osi võõrasteks ning tekitab nende vastu antikehi.
English: The most common side effects seen with PROCOMVAX are reactions at the injection site, including pain, soreness, erythema (redness) and swelling.
Estonian: PROCOMVAXi kõige sagedamad kõrvalnähud on reaktsioonid süstekohal, sealhulgas valu, valulikkus, erüteem (punetus) ja turse.
English: PROCOMVAX should not be used in infants who may be hypersensitive (allergic) to any of the active substances or any of the other ingredients.
Estonian: PROCOMVAXi ei tohi kasutada lastel, kes võivad olla toimeaine või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: PROCOMVAX contains small amounts of:
Estonian: PROCOMVAX sisaldab vähesel hulgal järgmisi koostisosi:
English: The study compared the effects of PROCOMVAX with those of separate vaccines containing the same active substances.
Estonian: Uuringus võrreldi PROCOMVAXi toimet samu toimeaineid sisaldavate eraldi vaktsiinide toimega.
English: The main study also showed that PROCOMVAX produced adequate levels of protection against hepatitis B virus.
Estonian: Põhiuuring näitas ka, et PROCOMVAX tekitas piisava kaitse B-hepatiidi viiruse vastu.
English: The Committee recommended that PROCOMVAX be given marketing authorisation.
Estonian: Komitee soovitas anda PROCOMVAXile müügiloa.
English: Infants who show signs of hypersensitivity (allergic reaction) after an injection should not receive further injections of the vaccine.
Estonian: Kui lapsel tekivad pärast süsti ülitundlikkusnähud (allergiline reaktsioon), ei tohi talle vaktsiini rohkem süstida.
English: The vaccination schedule is three doses of PROCOMVAX, ideally at two, four, and 12 to 15 months of age.
Estonian: Vaktsineerimisskeem koosneb PROCOMVAXi kolmest annusest, mida on kõige parem manustada 2, 4 ja 12-15 kuu vanuses.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PROCOMVAX
Estonian: EUROOPA AVALIK HINDAMISARUANNE PROCOMVAX Kokkuvõte üldsusele
English: PROCOMVAX is a combination of components that have been available in the European Union (EU) in other vaccines for a number of years.
Estonian: PROCOMVAXi komponente on Euroopa Liidus turustatud mitu aastat muude vaktsiinide koostises.
English: PROCOMVAX is a vaccine.
Estonian: PROCOMVAX on vaktsiin.
English: The vaccine must only be given by injection into a muscle.
Estonian: Vaktsiini võib manustada ainult lihasesisese süstina.
English: In the main study, the responses both to PROCOMVAX and to the separate vaccines were low in terms of levels of antibodies against Hib.
Estonian: Põhiuuringus oli immuunvastus nii PROCOMVAXile kui ka eraldi vaktsiinidele Hib-vastaste antikehade tasemete poolest vähene.
English: As for all vaccines, if PROCOMVAX is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Estonian: Nagu kõikide vaktsiinide korral, tekib PROCOMVAXi kasutamisel väga enneaegsetel lastel apnoe (lühikeste hingamiskatkestuste) oht.
English: Vaccination with PROCOMVAX should be postponed in infants with moderate or severe sudden fever until they have recovered.
Estonian: PROMOVAXiga vaktsineerimine tuleb kuni paranemiseni edasi lükata lastel, kellel on äkki tekkinud mõõdukas või kõrge palavik.
English: These are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Estonian: tehnika abil: neid toodab pärm, millele on lisatud nende valkude teket võimaldav geen (DNA).
English: PROCOMVAX is not recommended for infants younger than six weeks of age, because of a risk of a reduced protective response to Hib.
Estonian: PROCOMVAXi ei soovitata manustada alla 6-nädalastele imikutele, sest neil tekkiv kaitse Hib-bakteri vastu võib olla nõrgem.
English: PROCOMVAX is used to vaccinate infants aged between six weeks and 15 months against ‘invasive' disease caused by Hib (such as bacterial meningitis) and infection with the hepatitis B virus.
Estonian: PROCOMVAXi kasutatakse 6-nädalaste kuni 15-kuuliste laste vaktsineerimiseks Hib-i põhjustatud invasiivse haiguse (näiteks bakteriaalse meningiidi) ja B-hepatiidi viirusega nakatumise vastu.
English: For the full list of all side effects reported with PROCOMVAX, see the Package Leaflet.
Estonian: PROCOMVAXi kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: It contains proteins from Haemophilus influenzae type b (‘Hib', a bacterium that can cause meningitis) and parts of the hepatitis B virus as active substances.
Estonian: See sisaldab toimeainetena meningiiti (ajukelmepõletikku) tekitada võiva bakteri Haemophilus influenzae b-tüübi (Hib) valke ja B-hepatiidi viiruse osi.
English: Other information about PROCOMVAX:
Estonian: Muu teave PROCOMVAXi kohta
English: The main measure of effectiveness whether protective levels of antibodies to Hib and hepatitis B virus had developed at one and two months after vaccination.
Estonian: Efektiivsust mõõdeti põhiliselt selle järgi, kas ühe ja kahe kuu möödumisel vaktsineerimisest olid tekkinud kaitsval tasemel antikehad Hib and B-hepatiidi viiruse vastu.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that PROCOMVAX's benefits are greater than its risks for vaccination against invasive disease caused by Hib and against infection caused by all known subtypes of hepatitis B virus in infants six weeks to 15 months of age.
Estonian: Inimravimikomitee jõudis otsusele, et PROCOMVAXi kasulikkus selle kasutamisel 6-nädalaste kuni 15-kuuliste laste vaktsineerimiseks Hib põhjustatud invasiivse haiguse ja B-hepatiidi viiruse kõikide teadaolevate alatüüpidega nakatumise vastu on suurem kui sellega kaasnevad riskid.
English: PROCOMVAX is a vaccine, which is available as a suspension for injection.
Estonian: PROCOMVAX on vaktsiin, mida turustatakse süstesuspensioonina.
English: The full EPAR for PROCOMVAX can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti PROCOMVAXi kohta leiate siit.
English: • surface antigen (proteins from the surface) of the hepatitis B virus.
Estonian: • B-hepatiidi viiruse pinnaantigeeni (viirusepinna valke).
English: Why has PROCOMVAX been approved?
Estonian: Miks PROCOMVAX heaks kiideti?
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Estonian: Kui immuunsüsteem puutub loomulikul teel viiruste või bakteritega kokku hiljem uuesti, on see võimeline tekitama antikehi kiiremini.
English: Children who receive one dose of a hepatitis B vaccine at or shortly after birth can be given PROCOMVAX.
Estonian: PROCOMVAXi võib manustada lastele, kes saavad B-hepatiidi vaktsiini ühe annuse sündimisel või veidi pärast sündi.
English: • a protein purified from Hib, attached to a carrier (a protein purified from the outer membrane of
Estonian: • Hib-ist eraldatud valku, mis on kinnitatud kandeainele (bakteri Neisseria meningitidis välismembraanist eraldatud valgule);
English: The active substances are ‘adsorbed', meaning that they are fixed onto aluminium compounds, and the vaccine contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Estonian: Vaktsiin sisaldab parema immuunvastuse stimuleerimiseks ka adjuvanti (toimet tugevdavat ainet, teatud alumiiniumiühendit).
English: What is PROCOMVAX?
Estonian: Mis on PROCOMVAX?
English: The additional studies showed that protection against hepatitis B from PROCOMVAX was adequate in infants who had and who had not received hepatitis B vaccination in the past.
Estonian: Täiendavad uuringud näitasid, et PROCOMVAX kaitses B-hepatiidi vastu piisavalt nii varem Bhepatiidiga vaktsineeritud kui ka vaktsineerimata lapsi.
English: What benefit has PROCOMVAX shown during the studies?
Estonian: Milles seisneb uuringute põhjal PROCOMVAXi kasulikkus?
English: What is the risk associated with PROCOMVAX?
Estonian: Mis riskid kaasnevad PROCOMVAXiga?
English: The results of further studies were used to support the use of PROCOMVAX, both in infants who had and who had not received hepatitis B vaccination in the past.
Estonian: PROCOMVAXi kasutamise toetamiseks kasutati ka edasiste, nii varem B-hepatiidiga vaktsineeritud kui ka vaktsineerimata lastega läbiviidud uuringute tulemusi.
English: How has PROCOMVAX been studied?
Estonian: Kuidas PROCOMVAXi uuriti?
English: How is PROCOMVAX used?
Estonian: Kuidas PROCOMVAXi kasutatakse?
English: What is PROCOMVAX used for?
Estonian: Milleks PROCOMVAXi kasutatakse?
English: How does PROCOMVAX work?
Estonian: Kuidas PROCOMVAX toimib?
English: What it is used for
Estonian: Milleks seda kasutatakse
English: Treatment discontinuation may be considered as follows:
Estonian: Ravi katkestamist võib kaaluda järgmiselt:
English: Clinical efficacy and safety:
Estonian: Kliiniline efektiivsus ja ohutus:
English: • If you are over 65 years of age your doctor may monitor your health more closely.
Estonian: • Kui te olete üle 65-aastane, võib teie arst tähelepanelikumalt jälgida teie tervislikku seisundit.
English: • Take care not to infect other people.
Estonian: • Vältige teiste inimeste nakatamist.
English: The tmax was delayed by two hours.
Estonian: tmax pikenes kaks tundi.
English: County Cork, T45 DP77 Ireland
Estonian: County Cork, T45 DP77 Iirimaa
English: Hepsera with food and drink
Estonian: Hepsera koos toidu ja joogiga
English: Some patients have experienced:
Estonian: Mõnel patsiendil on esinenud:
English: Date of first authorisation: 06 March 2003 Date of latest renewal: 06 March 2008
Estonian: Müügiloa esmase väljastamise kuupäev: 6. märts 2003 Müügiloa viimase uuendamise kuupäev: 6. märts 2008
English: Wait and take the next dose at the regular time.
Estonian: Oodake ja võtke järgnev annus tavalisel ajal.
English: If you do get any of them, it is unlikely to be serious, but you need to check.
Estonian: Kui teil mõni selline sümptom ilmneb, ei ole see tõenäoliselt midagi tõsist, kuid teid tuleb kontrollida.
English: The risk of this occurring is increased with long-term use of Hepsera.
Estonian: See risk suureneb Hepsera pikaajalise kasutamisega.
English: Other medicines and Hepsera
Estonian: Muud ravimid ja Hepsera
English: • Tell your doctor immediately if you are pregnant or planning to become pregnant.
Estonian: • Teatage kohe oma arstile, kui olete rase või plaanite rasestuda.
English: The frequency of the following side effects is not known (frequency cannot be estimated from the available data):
Estonian: Järgnevate kõrvaltoimete sagedus pole teada (sagedust ei saa hinnata olemasolevate andmete alusel):
English: 30 tablets.
Estonian: 30 tabletti.