FrancophonIA/ELRC3.0 huggingface dataset:
English: Suspension: 1.5 ml Emulsion: 4.5 ml
Estonian: suspensioon : 1,5 ml emulsioon : 4,5 ml
English: Split Influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)-like strain (NYMC X-179A)
Estonian: Inaktiveeritud purustatud gripiviirus, mille antigeeni* sisaldus on ekvivalentne: A/California/7/2009 (H1N1)-sarnane tüvi (X-179A)
English: 3.8 micrograms HA**
Estonian: 3,8 mikrogrammi HA**
English: 10 vials (suspension)
Estonian: 10 viaali (suspensioon)
English: 10 vials (emulsion)
Estonian: 10 viaali (emulsioon)
English: AF03 adjuvant composed of squalene (12.4 milligrams), sorbitan oleate (1.9 milligrams), polyoxyethylene cetostearyl ether (2.4 milligrams) and mannitol (2.3 milligrams)
Estonian: Adjuvant AF03 sisaldab skvaleeni (12,4 milligrammi), sorbitaanoleaati (1,9 milligrammi), polüoksüetüleentsetostearüüleetrit (2,4 milligrammi) ja mannitooli (2,3 milligrammi).
English: Suspension (H1N1): vial (glass);
Estonian: Suspensioon (H1N1): viaal (klaas)
English: Suspension and emulsion for emulsion for injection
Estonian: Suspensioon ja emulsioon süsteemulsiooni valmistamiseks
English: After mixing, 1 dose (0.5 ml) contains:
Estonian: Pärast segamist sisaldab 1 annus (0,5 ml):
English: Emulsion (adjuvant): vial (glass)
Estonian: Emulsioon (adjuvant): viaal (klaas)
English: * propagated in eggs ** haemagglutinin
Estonian: * kultiveeritud munavalgul ** hemaglutiniin
English: Strength Pharmaceutical Form
Estonian: TugevusRavimvorm Manustamistee Pakendi iseloomustus
English: Packaging
Estonian: Lihasesisene manustamine
English: This summary was last updated in 04-2014.
Estonian: Kokkuvõtte viimane uuendus: 04-2014.
English: The full EPAR and risk management plan summary for BiResp Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte ravimi BiResp Spiromax kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for BiResp Spiromax on 28 April 2014.
Estonian: Euroopa Komisjon andis ravimi BiResp Spiromax müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 28. aprillil 2014.
English: A risk management plan has been developed to ensure that BiResp Spiromax is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada ravimi BiResp Spiromax võimalikult ohutu kasutamine.
English: BiResp Spiromax budesonide / formoterol
Estonian: BiResp Spiromax budesoniid/formoterool
English: It is available as an inhalation powder in a portable inhaler device, and each inhalation provides a fixed dose of the medicine.
Estonian: Seda turustatakse inhalatsioonipulbrina kaasaskantavas inhalaatoris; iga inhalatsioon annab fikseeritud ravimiannuse.
English: What measures are being taken to ensure the safe and effective use of BiResp Spiromax?
Estonian: Mis meetmed võetakse, et tagada ravimi BiResp Spiromax ohutu ja efektiivne kasutamine?
English: It is used for the treatment of asthma in adults for whom a combination product is considered appropriate.
Estonian: Seda kasutatakse astma raviks täiskasvanutel, kes saavad kasutada kombinatsioonravimit.
English: The company initially also applied for a lower strength of BiResp Spiromax, however bioequivalence to the reference product was not demonstrated and the application for this strength was withdrawn.
Estonian: Algselt taotles ettevõte müügiluba ka ravimi BiResp Spiromax väiksemale tugevusele, kuid selle bioekvivalentsust võrdlusravimiga ei tõendatud ning taotlus võeti tagasi.
English: If patients need to take more than 8 inhalations per day, it is recommended they speak to their doctor to have their asthma therapy reconsidered.
Estonian: Kui ööpäevas on vaja üle 8 inhalatsiooni, on patsiendil soovitatav küsida arstilt uut astmaraviskeemi.
English: This leads to a reduction in the release of substances that are involved in the inflammation process, such as histamine, thereby helping to keep the airways clear and allowing the patient to breathe more easily.
Estonian: Selle tulemusel väheneb põletikuprotsessis osalevate ainete, näiteks histamiini eritumine, mis aitab hoida hingamisteid avatuna, nii et patsiendil on kergem hingata.
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Estonian: Ravimit tohib kasutada patsientidel, kellele teised astmaravimid - inhaleeritavad kortikosteroidid ja lühitoimelised beeta-2agonistid - piisavat ei mõju, ja patsientidel, kelle astma allub piisavalt ravile inhaleeritavate kortikosteroidide ja pikatoimeliste beeta-2-agonistidega.
English: BiResp Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Estonian: Ravimit BiResp Spiromax kasutatakse ka raske kroonilise obstruktiivse kopsuhaiguse sümptomite leevendamiseks täiskasvanutel, kellel on regulaarsele ravile vaatamata esinenud haiguse ägenemisi.
English: Budesonide belongs to a group of anti-inflammatory medicines known as corticosteroids.
Estonian: Budesoniid kuulub põletikuvastaste ravimite kortikosteroidide rühma.
English: BiResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
Estonian: BiResp Spiromax on ravim, mis sisaldab toimeainetena budesoniidi ja formoterooli.
English: The Committee recommended that BiResp Spiromax be given marketing authorisation.
Estonian: Komitee soovitas anda ravimi BiResp Spiromaxi müügiloa.
English: Because BiResp Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et BiResp Spiromax on hübriidravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: COPD is a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing.
Estonian: Krooniline obstruktiivne kopsuhaigus on krooniline haigus, mille korral bronhid ja kopsualveoolid kahjustuvad või ummistuvad, mis põhjustab hingamisraskusi.
English: For the regular treatment of asthma, the recommended dose is 1 to 4 inhalations twice a day, depending on the strength being used and the severity of the asthma.
Estonian: Astma regulaarse ravi korral on soovitatav annus 1-4 inhalatsiooni kaks korda ööpäevas olenevalt kasutatava inhalatsioonipulbri tugevusest ja astma raskusest.
English: What is BiResp Spiromax and what is it used for?
Estonian: Mis on BiResp Spiromax ja milleks seda kasutatakse?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for BiResp Spiromax, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi BiResp Spiromax omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: As asthma reliever therapy, patients can take 1 or 2 additional inhalations of BiResp Spiromax 160/4.5 microgram only to relieve their symptoms.
Estonian: Leevendava astmaravimina tohivad patsiendid võtta ööpäevas 1-2 ravimi BiResp Spiromax tugevuse 160/4,5 μg lisaannust üksnes sümptomite leevendamiseks.
English: This is a summary of the European public assessment report (EPAR) for BiResp Spiromax.
Estonian: See on ravimi BiResp Spiromax Euroopa avaliku hindamisaruande kokkuvõte.
English: The higher strength, BiResp Spiromax 320/9 microgram (320 micrograms of budesonide and 9 micrograms of formoterol), can only be used for the regular treatment of asthma and for the treatment of COPD.
Estonian: Ravimi BiResp Spiromax suuremat tugevust 320/9 µg (320 μg budesoniidi ja 9 μg formoterooli) tohib kasutada ainult astma regulaarseks raviks ja kroonilise obstruktiivse kopsuhaiguse raviks.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that BiResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Estonian: Inimravimite komitee järeldas, et on tõendatud ravimi BiResp Spiromax tugevuste 160/4,5 μg ja 320/9 μg võrreldav kvaliteet ja bioekvivalentsus ravimi Symbicort Turbohaleri vastavate tugevustega.
English: Studies in patients have been limited to tests to determine that BiResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Estonian: Patsiendiuuringud piirdusid katsetega, milles näidati ravimi BiResp Spiromax bioekvivalentsust võrdlusravimiga Symbicort Turbohaler.
English: It works by attaching to receptors known as beta-2 receptors found in the muscles of the airways.
Estonian: See kinnitub β2-retseptoritele, mida leidub hingamisteede lihastes.
English: For practical information about using BiResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate ravimi BiResp Spiromax kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: The two active substances in BiResp Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Estonian: Ravimi BiResp Spiromax mõlemat toimeainet on põhjalikult uuritud ning need sisalduvad mitmes ravimis, mida kasutatakse kas eraldi või kombinatsioonis muude ravimitega astma ja kroonilise obstruktiivse kopsuhaiguse ravis.
English: For more information about treatment with BiResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga BiResp Spiromax toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: When it attaches to these receptors, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Estonian: Selle toimel lihased lõõgastuvad, hoides hingamisteid avatuna, nii et patsiendil on kergem hingata.
English: The reference medicine for BiResp Spiromax is Symbicort Turbohaler.
Estonian: Ravimi BiResp Spiromax võrdlusravim on Symbicort Turbohaler.
English: It works in a similar way to naturally occurring corticosteroid hormones, reducing the activity of the immune system by attaching to receptors in various types of immune cell.
Estonian: See toimib samamoodi kui looduslikud kortikosteroidhormoonid: immuunreaktsioonis osalevate mitmesuguste rakkude retseptoritega seondudes vähendab ravim immuunsüsteemi talitlust.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but BiResp Spiromax is given using a different inhaler.
Estonian: See tähendab, et BiResp Spiromax on sarnane võrdlusravimiga, mis sisaldab samu toimeaineid, kuid ravimit BiResp Spiromax manustatakse teiste inhalaatoriga.
English: Other information about BiResp Spiromax
Estonian: Muu teave ravimi BiResp Spiromax kohta
English: It is not intended to provide practical advice on how to use BiResp Spiromax.
Estonian: Hindamisaruandes ei anta ravimi BiResp Spiromax kasutamise praktilisi nõuandeid.
English: 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever.
Estonian: Ravimi BiResp Spiromax tugevust 160/4,5 mikrogrammi (160 μg budesoniidi ja 4,5 μg formoterooli) tohib kasutada regulaarse astmaravimina ja vajaduse korral leevendusravimina.
English: Why is BiResp Spiromax approved?
Estonian: Miks BiResp Spiromax heaks kiideti?
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Estonian: Seetõttu on inimravimite komitee arvamusel, et nagu ka Symbicort Turbohaleri korral, ületab ravimi BiResp Spiromax kasulikkus sellega kaasnevad riskid.
English: BiResp Spiromax is a ‘hybrid medicine'.
Estonian: BiResp Spiromax on hübriidravim.
English: For the treatment of COPD, the recommended dose is 1 or 2 inhalations twice a day, depending on the strength being used.
Estonian: Kroonilise obstruktiivse kopsuhaiguse ravi korral on soovitatav annus 1-2 inhalatsiooni kaks korda ööpäevas olenevalt kasutatava inhalatsioonipulbri tugevusest.
English: It can also be used for the treatment of COPD.
Estonian: Seda tohib kasutada ka kroonilise obstruktiivse kopsuhaiguse raviks.
English: How does BiResp Spiromax work?
Estonian: Kuidas BiResp Spiromax toimib?
English: How has BiResp Spiromax been studied?
Estonian: Kuidas ravimit BiResp Spiromax uuriti?
English: How is BiResp Spiromax used?
Estonian: Kuidas ravimit BiResp Spiromax kasutatakse?
English: What is Synordia?
Estonian: Mis on Synordia?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Estonian: Kui osalete kliinilises uuringus ja vajate ravi kohta lisateavet, võtke ühendust arstiga, kes teile ravi määras.
English: The company presented the results of 2 main studies including 1065 patients.
Estonian: Ettevõte esitas 1065 patsiendiga läbi viidud 2 põhiuuringu tulemused.
English: The application was at day 113 when the company withdrew.
Estonian: Taotluse menetlemine oli 113. päeva seisus, kui ettevõte taotluse tagasi võttis.
English: The tablets contain 80 mg fenofibrate and 500 mg metformin, 80 mg fenofibrate and 850 mg metformin, or 54 mg fenofibrate and 850 mg metformin.
Estonian: Tabletid sisaldavad 80 mg fenofibraati ja 500 mg metformiini, 80 mg fenofibraati ja 850 mg metformiini või 54 mg fenofibraati ja 850 mg metformiini.
English: Around half of the patients in this study had type 2 diabetes.
Estonian: Ligikaudu pooltel selles uuringus osalenud patsientidest oli 2. tüüpi diabeet.
English: Following the CHMP's opinion, it usually takes around 2 months for the European Commission to grant a licence.
Estonian: Pärast inimtervishoius kasutatavate ravimite komitee arvamust kulub Euroopa Komisjonil müügiloa väljastamiseks tavaliselt ligikaudu kaks kuud.
English: International non-proprietary name (INN): fenofibrate/metformin hydrochloride
Estonian: Rahvusvaheline mittekaubanduslik nimetus (INN): fenofibraat/metformiinvesinikkloriid
English: The letter from the company notifying the EMEA of the withdrawal of the application is available here.
Estonian: Ettevõtte taotluse tagasivõtmise kiri, millega ettevõte EMEAt taotluse tagasivõtmisest teavitas, on esitatud siin.
English: Ref. EMEA/490683/2006
Estonian: London, 14. detsember 2006 Dokumendi viide EMEA/490683/2006
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Estonian: Kui ettevõte on saatnud esitatud küsimustele vastused, vaatab inimtervishoius kasutatavate ravimite komitee need läbi ning võib enne oma arvamuse väljendamist esitada ettevõttele veelgi küsimusi (180. päev).
English: It was hoped that this would make it easier for patients to stick to their treatment.
Estonian: Sellega loodeti hõlbustada patsientidel ravijuhiste järgimist.
English: They are combined into one tablet in Synordia in order to reduce the number of tablets the patients need to take every day.
Estonian: Ravimis Synordia on need koondatud ühte tabletti, et vähendada päevas võetavate tablettide arvu.
English: It was intended for use in patients who require both fenofibrate and metformin, and whose condition had already been stabilised by taking these two medicines separately.
Estonian: Seda kavatseti kasutada patsientidel, kes vajavad nii fenofibraati kui ka metformiini ning kelle seisund on neid kaht ravimit eraldi tarvitades juba stabiliseerunud.
English: Fenofibrate can help to correct blood fat levels by activating a receptor within cells called ‘peroxisome proliferator activated receptor (PPAR) alpha'.
Estonian: Fenofibraat võib aidata korrigeerida rasvatasemeid, aktiveerides rakkudes retseptorit, mida nimetatakse peroksisomaalseks proliferaator-aktiveeritud retseptoriks alfa (PPAR).
English: The active substances in Synordia, fenofibrate and metformin, are both well-known medicines: fenofibrate is a serum lipid reducing agent that has been available in the European Union since 1975, and metformin hydrochloride is an anti-diabetic medicine that has been available since 1959.
Estonian: Synordia toimeained fenofibraat ja metformiin on mõlemad tuntud ravimid: fenofibraat on seerumi lipiididetaset vähendav aine, mis on olnud Euroopa Liidus saadaval alates 1975. aastast, ja metformiinvesinikkloriid on diabeediravim, on olnud saadaval alates 1959. aastast.
English: The CHMP was evaluating the initial documentation provided by the company and had not yet made any recommendations.
Estonian: Inimtervishoius kasutatavate ravimite komitee hindas ettevõtte esitatud algseid dokumente ega olnud veel soovitusi andnud.
English: This receptor is normally involved in controlling levels of fat in the body.
Estonian: See retseptor osaleb üldjuhul keha rasvatasemete reguleerimises.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with Synordia?
Estonian: Millised on taotluse tagasivõtmise tagajärjed praegu Synordia kliinilistes uuringutes osalevatele patsientidele?
English: It works mainly by inhibiting glucose production and reducing its absorption in the gut.
Estonian: Selle toime seisneb põhiliselt glükoosi tootmise pärssimises ja selle sooltes imendumise vähendamises.
English: By activating this receptor, the medicine increases levels of HDL cholesterol and decreases levels of triglycerides and other types of fat.
Estonian: Selle retseptori aktiveerimisega tõstab ravim HDLkolesterooli tasemeid ning alandab triglütseriidide ja muud liiki rasvade tasemeid.
English: Patients with type 2 diabetes often have dyslipidaemia (abnormal levels of fat in the blood), such as low levels of high-density lipoprotein (HDL or ‘good') cholesterol and high levels of triglycerides.
Estonian: 2. tüüpi diabeediga patsientidel on sageli düslipideemia (kõrvalekalded vere rasvatasemetes), näiteks kõrge tihedusega lipoproteiini (HDL ehk hea) kolesterooli madal tase ja triglütseriidide kõrge tase.
English: Metformin reduces elevated blood glucose levels.
Estonian: Metformiin alandab vere kõrgenenud glükoositasemeid.
English: As a result of the action of both substances, the blood fat and glucose levels were expected to improve.
Estonian: Mõlema aine toime tulemusena kavatseti parandada vere rasva- ja glükoositasemeid.
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Estonian: Esmaste dokumentide analüüsi tulemuste põhjal koostab inimtervishoius kasutatavate ravimite komitee (120. päeval) küsimuste loetelu, mis saadetakse ettevõttele.
English: Synordia is a medicine containing the active substances fenofibrate and metformin hydrochloride.
Estonian: Synordia on ravim, mille toimeained on fenofibraat ja metformiinvesinikkloriid.
English: The first study included 382 patients with type 2 diabetes and high blood triglyceride levels who were already being treated with metformin.
Estonian: Esimeses uuringus osales 382 patsienti 2. tüüpi diabeediga, kellel oli vere kõrge triglütseriiditase ja keda oli metformiiniga juba ravitud.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood.
Estonian: 2. tüüpi diabeet on haigus, mille puhul kõhunääre ei tooda piisavalt insuliini vere glükoosisisalduse (suhkrusisalduse) reguleerimiseks.
English: Both studies compared the effects of various doses of fenofibrate and metformin taken as separate medicines.
Estonian: Mõlemas uuringus võrreldi fenofibraadi ja metformiini erinevate annuste toimeid nende kasutamisel eraldi ravimitena.
English: The main measure of effectiveness was the change in blood triglyceride levels after 12 weeks.
Estonian: Mõjusust mõõdeti põhiliselt vere triglütseriiditasemetes 12 nädala pärast toimunud muutusega.
English: The doses were the same as the 3 doses available in Synordia tablets.
Estonian: Annused olid samad mis 3 Synordia tablettides sisalduvat annust.
English: On 7 December 2006, Fournier Laboratories Ireland Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that they wish to withdraw their application for a marketing authorisation for Synordia, for the improvement of glycaemic control and dyslipidaemia in patients with type 2 diabetes.
Estonian: 7. detsembril 2006 teatas Fournier Laboratories Ireland Ltd ametlikult inimtervishoius kasutatavate ravimite komiteele oma otsusest võtta tagasi ravimi Synordia müügiloa taotlus.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for SYNORDIA
Estonian: TEAVE MÜÜGILOA TAGASIVÕTMISE KOHTA SYNORDIA
English: What documentation did the company present to support its application to the CHMP?
Estonian: Millised dokumendid esitas ettevõte inimtervishoius kasutatavate ravimite komiteele oma taotluse toetuseks?
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials of Synordia.
Estonian: Ettevõte teatas inimtervishoius kasutatavate ravimite komiteele, et sellel otsusel ei ole Synordia kliinilistes uuringutes osalevatele patsientidele mitte mingeid tagajärgi.
English: The main measure of effectiveness was the proportion of patients whose blood glucose and fat levels had returned to within the normal range after 12 weeks of treatment.
Estonian: Mõjusust mõõdeti põhiliselt patsientide osakaaluga, kellel olid vere normaalsed glükoosi- ja rasvatasemed pärast 12 nädalat kestnud ravi taastunud.
English: The second study examined the effects of a combination of the 2 active substances in 683 patients with abnormal levels of glucose or fat in the blood.
Estonian: Teises uuringus vaadeldi 2 toimeaine kombineerimise toimet 683 patsiendil, kellel esines vere glükoosi- ja rasvatasemetes kõrvalekaldeid.
English: The CHMP was evaluating the initial documentation provided by the company.
Estonian: Inimtervishoius kasutatavate ravimite komitee hindas ettevõtte esitatud algseid dokumente.
English: How is Synordia expected to work?
Estonian: Milline on Synordia eeldatav toime?
English: It examined the effect of adding fenofibrate to the patients'
Estonian: Selles uuriti fenofibraadi toimet selle lisamisel patsiendi olemasolevale ravile.
English: Synordia was to be used to improve levels of sugar and fat in the blood of patients with type 2 diabetes, along with changes to diet and exercise.
Estonian: Synordiat kavatseti kasutada 2. tüüpi diabeediga patsientide vere suhkru- ja rasvatasemete parandamiseks koos dieedi ja harjutustega.
English: What was Synordia expected to be used for?
Estonian: Milleks kavatseti Synordiat kasutada?
English: Other medicines and SIFROL
Estonian: Muud ravimid ja SIFROL
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 14 October 1997
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 14. oktoober 1997
English: Date of latest renewal: 14 October 2007
Estonian: Müügiloa viimase uuendamise kuupäev: 14. oktoober 2007
English: The use of SIFROL tablets should be considered.
Estonian: Tuleks kaaluda SIFROL tablettide kasutamisvõimalust.
English: SIFROL should not be used during pregnancy unless clearly necessary, i.e. if the potential benefit justifies the potential risk to the foetus.
Estonian: SIFROL'i ei tohi kasutada raseduse ajal välja arvatud juhul, kui see on äärmiselt vajalik, s.t kui oodatav kasu õigustab võimaliku ohu lootele.