FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tobi Podhaler, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Tobi Podhaleri omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: This is a summary of the European public assessment report (EPAR) for Tobi Podhaler.
Estonian: Käesolev dokument on ravimi Tobi Podhaler Euroopa avaliku hindamisaruande kokkuvõte.
English: It works by disrupting the production of proteins that P. aeruginosa needs to build its cell walls.
Estonian: See pärsib P. aeruginosa rakumembraani moodustamiseks vajalike valkude teket.
English: The applicant presented data on an existing nebuliser solution containing tobramycin called Tobi.
Estonian: Müügiloa taotleja esitas andmed juba olemasoleva tobramütsiini sisaldava nebuleeritava lahuse Tobi kohta.
English: The CHMP decided that Tobi Podhaler's benefits are greater than its risks, since it is effective at treating lung infection in cystic fibrosis patients and given its added convenience for patients.
Estonian: Inimravimite komitee otsustas, et Tobi Podhaleri kasulikkus on suurem kui sellega kaasnevad riskid, sest see on efektiivne kopsuinfektsiooni ravis tsüstilise fibroosiga patsientidel ja seda on mugav kasutada.
English: Tobi Podhaler must not be used in people who are hypersensitive (allergic) to tobramycin, any aminoglycoside or any of the other ingredients.
Estonian: Tobi Podhalerit ei tohi kasutada patsiendid, kes on tobramütsiini, mis tahes aminoglükosiidide või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Other information about Tobi Podhaler
Estonian: Muu teave Tobi Podhaleri kohta
English: Tobi Podhaler is a medicine that contains the active substance tobramycin.
Estonian: Tobi Podhaler on ravim, mis sisaldab toimeainena tobramütsiini.
English: Tobi Podhaler is used to suppress chronic lung infection caused by bacteria called Pseudomonas aeruginosa in adults and children aged 6 years and over who have cystic fibrosis.
Estonian: Tobi Podhalerit kasutatakse bakteri Pseudomonas aeruginosa põhjustatud kroonilise kopsuinfektsiooni pärssimiseks tsüstilise fibroosiga täiskasvanutel ja vähemalt 6-aastastel lastel.
English: For the full list of all side effects reported with Tobi Podhaler, see the package leaflet.
Estonian: Tobi Podhaleri kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The active substance in Tobi Podhaler, tobramycin, is an antibiotic that belongs to the group ‘aminoglycosides'.
Estonian: Tobi Podhaleri toimeaine tobramütsiin on aminoglükosiidide rühma kuuluv antibiootikum.
English: Tobi Podhaler was studied in two main trials in patients who had cystic fibrosis with P. aeruginosa lung infection.
Estonian: Ravimit Tobi Podhaler uuriti kahes põhiuuringus tsüstilise fibroosi ja P. aeruginosa põhjustatud bakteriaalse kopsuinfektsiooniga patsientidel.
English: Tobi Podhaler was more effective than placebo in treating P. aeruginosa infection in patients with cystic fibrosis.
Estonian: Tobi Podhaler oli P. aeruginosa infektsiooni ravis tsüstilise fibroosiga patsientidel efektiivsem kui platseebo.
English: What is the risk associated with Tobi Podhaler?
Estonian: Mis riskid Tobi Podhaleriga kaasnevad?
English: What is Tobi Podhaler?
Estonian: Mis on Tobi Podhaler?
English: Tobi Podhaler is inhaled using a hand-held device called Podhaler.
Estonian: Tobi Podhalerit inhaleeritakse käeshoitava seadme Podhaleri abil.
English: The patient should continue with a cycle of four weeks ‘on' treatment followed by four weeks ‘off'
Estonian: Patsient jätkab nelja ravinädala ja nelja ravivaba nädala tsüklit seni, kuni see on arsti arvates kasulik.
English: Why has Tobi Podhaler been approved?
Estonian: Miks Tobi Podhaler heaks kiideti?
English: The effect of Tobi Podhaler was similar to that of Tobi after three cycles of treatment.
Estonian: Kolme ravitsükli järel oli Tobi Podhaleri toime sarnane Tobi toimega.
English: Tobi Podhaler is intended to increase the convenience of taking tobramycin for patients.
Estonian: Tobi Podhaleriga on patsiendil mugavam tobramütsiini manustada.
English: How has Tobi Podhaler been studied?
Estonian: Kuidas Tobi Podhalerit uuriti?
English: How is Tobi Podhaler used?
Estonian: Kuidas Tobi Podhalerit kasutatakse?
English: What benefit has Tobi Podhaler shown during the studies?
Estonian: Milles seisneb uuringute põhjal Tobi Podhaleri kasulikkus?
English: Tobramycin is a well-known antibiotic that has been used to treat lung infection in cystic fibrosis patients, available in the form of a solution used with a nebuliser (a machine that changes a solution into an aerosol that the patient can breathe in).
Estonian: Tobramütsiin on tsüstilise fibroosiga patsientidel kopsuinfektsiooni raviks kasutatav tuntud antibiootikum.
English: What is Tobi Podhaler used for?
Estonian: Milleks Tobi Podhalerit kasutatakse?
English: The medicine can only be obtained with a prescription.
Estonian: Ravimi kasutamise üksikasjalik teave on pakendi infolehel.
English: Emtricitabine/Tenofovir disoproxil Mylan received a marketing authorisation valid throughout the EU on 16 December 2016.
Estonian: Emtricitabine/Tenofovir disoproxil Mylan on saanud müügiloa, mis kehtib kogu ELis, 16. detsembril
English: Further information on Emtricitabine/Tenofovir disoproxil Mylan can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-mylan.
Estonian: Lisateave ravimi Emtricitabine/Tenofovir disoproxil Mylan kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/emtricitabinetenofovir-disoproxil-mylan.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Emtricitabine/Tenofovir disoproxil Mylan has been shown to have comparable quality and to be bioequivalent to Truvada.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Emtricitabine/Tenofovir disoproxil Mylan võrreldav kvaliteet ja bioekvivalentsus ravimiga Truvada.
English: Side effects reported with Emtricitabine/Tenofovir disoproxil Mylan are carefully evaluated and any necessary action taken to protect patients.
Estonian: Ravimi Emtricitabine/Tenofovir disoproxil Mylan kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: Studies on the benefits and risks of the active substances in the authorised uses have already been carried out with the reference medicine, Truvada, and do not need to be repeated for Emtricitabine/Tenofovir disoproxil Mylan.
Estonian: Võrdlusravimiga Truvada on juba tehtud toimeaine heakskiidetud kasutamisviiside kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Emtricitabine/Tenofovir disoproxil Mylan korrata.
English: Emtricitabine/Tenofovir disoproxil Mylan does not cure HIV infection or AIDS, but it holds off damage to the immune system and the development of infections and diseases associated with AIDS.
Estonian: Emtricitabine/Tenofovir disoproxil Mylan ei tervenda HIV-infektsioonist ega AIDSist, kuid võib immuunsüsteemi kahjustumist ning AIDSiga kaasnevate infektsioonide ja haiguste teket edasi lükata.
English: Therefore, the Agency's view was that, as for Truvada, the benefit of Emtricitabine/Tenofovir disoproxil Mylan outweighs the identified risk and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Truvada korral, ületab ravimi Emtricitabine/Tenofovir disoproxil Mylan kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: Because Emtricitabine/Tenofovir disoproxil Mylan is a generic 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 Emtricitabine/Tenofovir disoproxil Mylan on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: What measures are being taken to ensure the safe and effective use of Emtricitabine/Tenofovir disoproxil Mylan?
Estonian: Mis meetmed võetakse, et tagada ravimi Emtricitabine/Tenofovir disoproxil Mylan ohutu ja efektiivne kasutamine?
English: Emtricitabine/Tenofovir disoproxil Mylan is available as tablets (200 mg emtricitabine and 245 mg tenofovir disoproxil).
Estonian: Ravimit Emtricitabine/Tenofovir disoproxil Mylan turustatakse tablettidena (200 mg emtritsitabiini ja 245 mg tenofoviirdisoproksiili).
English: For more information about using Emtricitabine/Tenofovir disoproxil Mylan, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Emtricitabine/Tenofovir disoproxil Mylan kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Emtricitabine/Tenofovir disoproxil Mylan is an HIV medicine that is used in combination with at least one other HIV medicine to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Estonian: Emtricitabine/Tenofovir disoproxil Mylan on HIV-ravim, mida kasutatakse koos vähemalt ühe muu HIVravimiga, et ravida omandatud immuunpuudulikkuse sündroomi (AIDS) põhjustava inimese 1. tüüpi immuunpuudulikkuse viirusega (HIV-1) nakatunud täiskasvanuid.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emtricitabine/Tenofovir disoproxil Mylan have also been included in the summary of product characteristics and the package leaflet.
Estonian: Ravimi Emtricitabine/Tenofovir disoproxil Mylan ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Emtricitabine/Tenofovir disoproxil Mylan can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Estonian: Emtricitabine/Tenofovir disoproxil Mylan on retseptiravim ja ravi peab alustama HIV-infektsiooni ravis kogenud arst.
English: As for all medicines, data on the use of Emtricitabine/Tenofovir disoproxil Mylan are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse ravimi Emtricitabine/Tenofovir disoproxil Mylan kasutamise kohta pidevat järelevalvet.
English: Emtricitabine/Tenofovir disoproxil Mylan (emtricitabine / tenofovir disoproxil)
Estonian: Emtricitabine/Tenofovir disoproxil Mylan (emtritsitabiin/tenofoviirdisoproksiil)
English: For pre-exposure prophylaxis of HIV-1 infection, it is expected that Emtricitabine/Tenofovir disoproxil Mylan in the blood will stop the virus from multiplying and spreading from the site of infection in case the individual is exposed to the virus.
Estonian: HIV-1 infektsiooni kokkupuute-eelse ennetamise korral eeldatakse, et viirusega kokkupuutel peatab veres sisalduv Emtricitabine/Tenofovir disoproxil Mylan viiruse paljunemise ja levimise infektsioonikohast kaugemale.
English: What is Emtricitabine/Tenofovir disoproxil Mylan and what is it used for?
Estonian: Mis on Emtricitabine/Tenofovir disoproxil Mylan ja milleks seda kasutatakse?
English: This means that it contains the same active substances and works in the same way as a ‘reference medicine' already authorised in the EU called Truvada.
Estonian: See tähendab, et Emtricitabine/Tenofovir disoproxil Mylan sisaldab sama toimeainet ja toimib samamoodi nagu võrdlusravim Truvada, millel juba on Euroopa Liidus müügiluba.
English: Emtricitabine/Tenofovir disoproxil Mylan is also used to help prevent sexually transmitted HIV-1 infection in adults and adolescents who are at high risk of being infected (pre-exposure prophylaxis or PrEP).
Estonian: Ravimit Emtricitabine/Tenofovir disoproxil Mylan kasutatakse ka sugulisel teel leviva HIV-1 infektsiooni ennetamiseks suure infektsiooniriskiga täiskasvanutel ja noorukitel (kokkupuute-eelne profülaktika).
English: The company that markets Emtricitabine/Tenofovir disoproxil Mylan will provide an information pack to doctors which covers the potential harmful effects of Emtricitabine/Tenofovir disoproxil Mylan on kidney function and information about use for pre-exposure prophylaxis.
Estonian: Ravimi Emtricitabine/Tenofovir disoproxil Mylan turustaja varustab arstid teabepakmega, mis selgitab ravimi võimalikku kahjulikku toimet neerutalitlusele ja selle kasutamist kokkupuute-eelseks profülaktikaks.
English: For the treatment of HIV-infection, Emtricitabine/Tenofovir disoproxil Mylan, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Estonian: Vähemalt ühe muu viirusravimiga koos manustatav Emtricitabine/Tenofovir disoproxil Mylan vähendab HIVi kogust veres ja hoiab selle sisalduse väikese.
English: Other information about Emtricitabine/Tenofovir disoproxil Mylan
Estonian: Muu teave ravimi Emtricitabine/Tenofovir disoproxil Mylan kohta
English: As for every medicine, the company provided studies on the quality of Emtricitabine/Tenofovir disoproxil Mylan.
Estonian: Nagu iga ravimi korral, esitas ettevõte ravimi Emtricitabine/Tenofovir disoproxil Mylan kvaliteedi uuringud.
English: Emtricitabine/Tenofovir disoproxil Mylan contains two active substances: emtricitabine, which is a nucleoside reverse transcriptase inhibitor; and tenofovir disoproxil, which is a ‘prodrug' of tenofovir.
Estonian: Emtricitabine/Tenofovir disoproxil Mylan sisaldab kahte toimeainet: nukleosiidset pöördtranskriptaasi inhibiitorit emtritsitabiini ja tenofoviiri eelravimit tenofoviirdisoproksiili.
English: An overview of Emtricitabine/Tenofovir disoproxil Mylan and why it is authorised in the EU
Estonian: Ülevaade ravimist Emtricitabine/Tenofovir disoproxil Mylan ja ELis müügiloa väljastamise põhjendus
English: Both emtricitabine and tenofovir work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to reproduce itself in the cells it has infected.
Estonian: Pöördtranskriptaas on HIVi toodetav ensüüm, mis võimaldab viirusel nakatunud rakkudes paljuneda.
English: How has Emtricitabine/Tenofovir disoproxil Mylan been studied?
Estonian: Kuidas ravimit Emtricitabine/Tenofovir disoproxil Mylan uuriti?
English: How is Emtricitabine/Tenofovir disoproxil Mylan used?
Estonian: Kuidas Emtricitabine/Tenofovir disoproxil Mylan toimib?
English: Iscover with food and drink
Estonian: Iscover koos toidu ja joogiga
English: Other medicines and Iscover
Estonian: Muud ravimid ja Iscover
English: Some other medicines may influence the use of Iscover or vice versa.
Estonian: Mõned teised ravimid võivad mõjutada Iscover'i toimet ja vastupidi.
English: 6 Contents of the pack and other information What Iscover contains
Estonian: Pakendi sisu ja muu teave Mida Iscover sisaldab
English: Posology • Adults and elderly
Estonian: Annustamine • Täiskasvanud ja eakad.
English: What Iscover is and what it is used for
Estonian: Mis ravim on Iscover ja milleks seda kasutatakse
English: Strada Statale 17, Km 22 67019 Scoppito (AQ) - Italy
Estonian: Strada Statale 17, Km 22 67019 Scoppito (AQ) - Itaalia
English: Iscover is unlikely to affect your ability to drive or to use machines.
Estonian: Iscover ei tohiks avaldada mõju teie autojuhtimise või masinate käsitsemise võimele.
English: What Iscover is and what it is used for What you need to know before you take Iscover How to take Iscover
Estonian: Mis ravim on Iscover ja milleks seda kasutatakse Mida on vaja teada enne Iscover'i võtmist Kuidas Iscover'i võtta
English: Your doctor should have prescribed Iscover plus acetylsalicylic acid if you cannot take ‘oral anticoagulants' and you do not have a risk of major bleeding.
Estonian: Teie arst peab olema teile määranud Iscover'i koos atseüülsalitsüülhappega, kui te ei saa võtta suukaudseid antikoagulante ning teil ei ole suure verejooksu ohtu.
English: If you forget to take Iscover
Estonian: Kui te unustate Iscover'i võtta
English: Approximately 88% of patients received concomitant ASA (range of 1 to 23 mg/kg/day).
Estonian: Ligikaudu 88% patsientidest said samaaegselt ASH (vahemikus 1...23 mg/kg/ööpäev).
English: You should take Iscover for as long as your doctor continues to prescribe it.
Estonian: Iscover'i tuleb võtta nii kaua, kui arst teile seda välja kirjutab.
English: As a precautionary measure, breast-feeding should not be continued during treatment with Iscover.
Estonian: Ettevaatusabinõuna ei tohi Iscover'iga ravi ajal rinnapiimaga toitmist jätkata.
English: If you think any of these apply to you, or if you are in any doubt at all, consult your doctor before taking Iscover.
Estonian: Kui te arvate, et mõni nendest kehtib teie kohta või kui teil tekib mingeid kahtlusi, konsulteerige enne Iscover'i võtmist arstiga.
English: The most common side effect reported with Iscover is bleeding.
Estonian: Kõige sagedamini täheldatud kõrvaltoime Iscover'i kasutamisel on verejooks.
English: What Iscover looks like and contents of the pack
Estonian: Kuidas Iscover välja näeb ja pakendi sisu
English: Platelets are very small structures in the blood which clump together during blood clotting.
Estonian: Trombotsüüdid on väga väikesed vere vormelemendid, , mis vere hüübimise käigus kokku kleepuvad.
English: Iscover may be taken with or without food.
Estonian: Iscover'i võib võtta koos toiduga või ilma.
English: Serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)*, insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)*
Estonian: Seerumtõbi, anafülaktoidsed reaktsioonid, ravimi ristreaktiivne ülitundlikkus tienopüridiinide vahel (nt tiklopidiin, prasugreel; vt lõik 4.4)*, autoimmuunne insuliinisündroom, mis võib põhjustada rasket hüpoglükeemiat, eriti HLA DRA4 alamtüübiga patsientidel (sagedasem Jaapani populatsioonis)*
English: Very rare side effects (may affect up to 1 in 10,000 people):
Estonian: Väga harva esinevad kõrvaltoimed (võivad esineda kuni 1 inimesel 10000-st):
English: What you need to know before you take Iscover Do not take Iscover
Estonian: Mida on vaja teada enne Iscover'i võtmist Ärge võtke Iscover'i
English: The recommended dose, including for patients with a condition called ‘atrial fibrillation' (an irregular heartbeat), is one 75 mg tablet of Iscover per day to be taken orally with or without food, and at the same time each day.
Estonian: Soovitatav annus, sh patsientidele, kellel on seisund, mida nimetatakse kodade virvenduseks (ebaregulaarsed südamelöögid), on üks Iscover 75 mg tablett ööpäevas suukaudselt koos toiduga või ilma ja iga päev samal kellaajal.
English: How to take Iscover
Estonian: Kuidas Iscover'i võtta
English: If you take more Iscover than you should
Estonian: Kui te võtate Iscover'i rohkem kui ette nähtud
English: The dose of 0.2 mg/kg achieved the mean percent inhibition of 49.3% (5 µM ADP-induced platelet aggregation) which was comparable to that of adults taking Iscover 75 mg/day.
Estonian: 0,2 mg/kg annuse puhul saadi keskmiseks inhibeerimise protsendiks 49,3% (5 µMADP-indutseeritud trombotsüütide agregatsioon), mis oli võrreldav Iscover 75 mg/kg täiskasvanutel.
English: If you forget to take a dose of Iscover, but remember within 12 hours of your usual time, take your tablet straightaway and then take your next tablet at the usual time.
Estonian: Kui te unustate Iscover'i annuse võtmata, kuid see meenub teile lähema 12 tunni jooksul, võtke tablett kohe sisse ning järgmine annus võtke tavapärasel ajal.
English: Iscover contains lactose.
Estonian: Iscover sisaldab laktoosi.
English: Iscover is supplied in cardboard cartons containing: 7, 14, 28, 30, 84, 90 and 100 tablets in PVC/PVDC/Aluminium blisters or in all aluminium blisters 50x1 tablets in PVC/PVDC/Aluminium blisters or in all aluminium perforated unit-dose blisters.
Estonian: Iscover on kartongkarpides, mis sisaldavad: - 7, 14, 28, 30, 84, 90 ja 100 PVC/PVDC/alumiiniumblistris või täisalumiiniumblistris; - 50x1 tabletti PVC/PVDC/alumiiniumblistris või täisalumiinium üheannuselises perforeeritavas blistris.
English: Then, the recommended dose is one 75 mg tablet of Iscover per day as described above.
Estonian: Seejärel on soovitatav annus üks 75 mg Iscover'i tablett ööpäevas vastavalt ülevalpool kirjeldatule.
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking Iscover:
Estonian: Kui teil esineb mõni allpool nimetatud seisund, peate sellest enne Iscover´i kasutamist arstile rääkima:
English: You should have been told that ‘oral anticoagulants' are more effective than acetylsalicylic acid or the combined use of Iscover and acetylsalicylic acid for this condition.
Estonian: Teile peab olema öeldud, et selle seisundi korral on suukaudsed antikoagulandid tõhusamad kui atsetüülsalitsüülhape või kombineeritud ravi atsetüülsalitsüülhappe ja Iscover'iga.
English: If you stop taking Iscover Do not stop the treatment unless your doctor tells you so.
Estonian: Ärge lõpetage ravi, kui arst ei ole seda öelnud.
English: If you experience prolonged bleeding when taking Iscover
Estonian: Kui märkate Iscover'i võtmise ajal veritsusaja pikenemist
English: If you become pregnant while taking Iscover, consult your doctor immediately as it is recommended not to take clopidogrel while you are pregnant.
Estonian: Kui jääte rasedaks Iscover'i kasutamise ajal, konsulteerige viivitamatult arstiga, kuna klopidogreeli võtmine raseduse ajal ei ole soovitatav.
English: For the 7, 14, 28 and 84 tablets pack sizes, you can check the day on which you last took a tablet of Iscover by referring to the calendar printed on the blister.
Estonian: Päeva, millal te viimati tableti võtsite, saate 7-, 14-, 28- ja 84-tabletiste pakendite puhul kontrollida blisterpakendile trükitud kalendri abil.
English: 5 How to store Iscover Contents of the pack and other information
Estonian: Võimalikud kõrvaltoimed 5 Kuidas Iscover'i säilitada Pakendi sisu ja muu teave
English: Each film-coated tablet contains 12 mg of lactose and 13.2 mg of hydrogenated castor oil.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 12 mg laktoosi ja 13,2 mg hüdrogeenitud riitsinusõli.
English: If Iscover is supplied in all aluminium blisters, it does not require any special storage conditions.
Estonian: Kui Iscover on pakendatud alumiiniumist blistrisse, siis see ravimpreparaat ei vaja säilitamisel eritingimusi.
English: Marketing Authorisation Holder: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris
Estonian: Müügiloa hoidja: sanofi-aventis groupe 54, rue La Boétie F-75008 Paris Prantsusmaa
English: Each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil.
Estonian: Üks õhukese polümeerikattega tablett sisaldab 3 mg laktoosi ja 3,3 mg hüdrogeenitud riitsinusõli.
English: You have been prescribed Iscover to help prevent blood clots and reduce the risk of these severe events because: - You have a condition of hardening of arteries (also known as atherosclerosis), and - You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease, or - You have experienced a severe type of chest pain known as ‘unstable angina' or ‘myocardial infarction' (heart attack).
Estonian: Teile on määratud Iscover, aitamaks ära hoida verehüübeid ja vähendamaks selliste raskete kahjustuste tekkeriski, sest: - teil on arterite seinte jäigastumine (tuntud kui ateroskleroos) ja - teil on eelnevalt olnud südameatakk, insult või perifeersete arterite haigus, või - te olete tundnud tõsist valu rindkeres, mida nimetatakse “ebastabiilne stenokardia” või "südamelihase infarkt" (südameatakk).
English: Iscover contains clopidogrel and belongs to a group of medicines called antiplatelet medicinal products.
Estonian: Iscover sisaldab klopidogreeli ja kuulub trombotsüütide agregatsiooni pärssivate ravimite rühma.
English: If Iscover is supplied in PVC/PVDC/aluminium blisters, store below 30°C.
Estonian: Kui Iscover on pakendatud PVC/PVDC/alumiinium blistrisse, siis hoida temperatuuril kuni 30°C.