FrancophonIA/ELRC3.0 huggingface dataset:
English: Desirudin is contraindicated in patients: - with hypersensitivity to the active substance or to any of the excipients - with active bleeding and/or irreversible coagulation disorders - with severe renal and hepatic impairment
Estonian: Desirudiin on vastunäidustatud patsientidel: - ülitundlikkuse korral toimeaine või ravimi ükskõik millise abiaine suhtes; - ägeda verejooksu ja/või taaspöördumatu hüübimissüsteemi haiguse esinemise korral; - raske neeru- ja maksapuudulikkuse esinemise korral; - raseduse ajal (vt lõik 4.6); - raske kontrollimatu hüpertoonia ja alaägeda bakteriaalse endokardiidi esinemise korral.
English: Usual dosage
Estonian: Tavaline annustamine
English: The other ingredients in the powder are magnesium chloride and sodium hydroxide.
Estonian: Abiained on magneesiumkloriid, naatriumhüdroksiid pulbris ning mannitool ja süstevesi lahustis.
English: A slower terminal elimination phase follows with a dose-independent mean terminal elimination half life of 2 to 3 h. The mean residence times are 1.7-2 h and 6-7 h after IV and SC administration, respectively.
Estonian: Keskmine organismis püsimise aeg on intravenoosse manustamise järgselt 1,7…2 tundi ja 6…7 tundi subkutaanse manustamise järgselt.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential.
Estonian: Farmakoloogilise ohutuse, kroonilise toksilisuse, genotoksilisuse ja kartsinogeensuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: General disorders and administration site conditions Fever, injection site mass, haematomas, oedema in legs Pain in legs, pain, abdominal and chest pain
Estonian: palavik, sõlme teke süstekohas, hematoomid, tursed jalgadel
English: Prevention of deep venous thrombosis in patients undergoing elective hip or knee replacement
Estonian: Süvaveenide tromboosi profülaktika patsientidel, kes lähevad puusa- või põlveliigese asendusoperatsioonile (endoproteesimine).
English: White powder and clear, colourless solvent for solution for injection
Estonian: RAVIMVORM Süstelahuse valge pulber ja selge värvitu lahusti.
English: Anti-hirudin antibodies have been detected upon re-exposure to desirudin in
Estonian: hirudiinivastaseid antikehi on kliinilistes uuringutes leitud desirudiini korduva manustamise järgselt.
English: As these reactions are immune-mediated, patients with previous exposure to hirudin or hirudin analogue may be at an increased risk.
Estonian: Eelnevalt hirudiini või hirudiini analooge saanud patsiendid kuuluvad riskigruppi, kuna kõik need reaktsioonid on vahendatud immuunsüsteemi poolt.
English: Skin and subcutaneous tissue disorders
Estonian: hüpotensioon, süvaveenide põletik
English: After reconstitution one vial contains 15 mg** desirudin* per 0.5 ml Desirudin consists in a single chain polypeptide of 65 amino acid residues and 3 disulphide bridges.
Estonian: Desirudiin on 65 aminohappe jäägist ja kolmest disulfiidsillast koosnev üheahelaline polüpeptiid.
English: Name and address of the manufacturer of the biological active substance
Estonian: Bioloogilis(t)e toimeaine(te) tootja(te) nimi ja aadress
English: You should not be given Revasc if you are pregnant.
Estonian: Raseduse ajal ei tohi Revasc'i kasutada.
English: A mean peak aPTT prolongation of around 1.4 times baseline value is observed following a subcutaneous (SC) b.i.d.
Estonian: Pärast 15 mg desirudiini subkutaanset manustamist kaks korda päevas on täheldatud keskmise kõrgeima aPTT väärtuse pikenemist umbes 1,4 kordselt võrreldes algväärtusega.
English: - if you have an uncontrolled high blood pressure
Estonian: - kui teil esineb sageli veritsusi või on teil mõni tõsine veritsushaigus (nt hemofiilia) - kui teil on raske neeru- või maksahaigus - kui teil on südame infektsioon - kui teil on kontrollimatult kõrge vererõhk - kui te olete rase
English: Currently, there is no clinical experience to support the use of Revasc
Estonian: Käesoleva ajani puuduvad kliinilised kogemused desirudiini kasutamise kohta üle 12 päeva.
English: EXPIRY DATE
Estonian: KLIINILISED ANDMED
English: injection of 15mg desirudin.
Estonian: Revasc 15 mg/0,5 ml Süstelahuse pulber Desirudiin Subkutaanne
English: EU/1/19/1382/001 Azacitidine Celgene 25 mg/ml
Estonian: EU/1/19/1382/001 Asatsitidiin Celgene 25 mg/ml
English: Subcutaneous use vial (glass) 100 mg
Estonian: Subkutaanne Viaal (klaas) 100 mg
English: Powder for suspension for injection
Estonian: Süstesuspensiooni pulber
English: 24 July 2013
Estonian: 24. juuli 2013
English: 01 October 2013
Estonian: 1. oktoober 2013
English: Implementation of the agreement by the Member States (submission of the variation by the Marketing Authorisation Holder):
Estonian: Kokkuleppe rakendamine liikmesriikides (müügiloa hoidja poolne muudatuste esitamine):
English: June 2013 CMDh meeting
Estonian: Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühma koosolek juunis 2013
English: The European Commission issued a decision on 20 January 2012.
Estonian: Euroopa Komisjon tegi otsuse 20. jaanuaril 2012.
English: The company wanted the authorisation to be recognised in Belgium, Bulgaria, Cyprus, Czech, Denmark, Estonia, Greece, France, Hungary, Ireland, Iceland, Lithuania, Luxembourg, Latvia, Malta, Netherlands, Norway, Poland, Romania, Slovenia, Slovakia and the United Kingdom (the ‘concerned Member States').
Estonian: Ettevõte soovis, et müügiluba tunnustaksid ka Belgia, Bulgaaria, Küpros, Tšehhi Vabariik, Taani, Eesti, Kreeka, Prantsusmaa, Ungari, Iirimaa, Island, Leedu, Luksemburg, Läti, Malta, Madalmaad, Norra, Poola, Rumeenia, Sloveenia, Slovakkia ja Ühendkuningriik (asjaomased liikmesriigid).
English: Why was Priligy reviewed?
Estonian: Miks Priligy üle vaadati?
English: Priligy is a medicine used to treat premature ejaculation in men aged 18 to 64 years old.
Estonian: Priligy on ravim, mida kasutatakse enneaegse ejakulatsiooni raviks 18-64-aastastel meestel.
English: What is Priligy?
Estonian: Mis on Priligy?
English: Priligy is believed to increase the time it takes to ejaculate by increasing the amount of a neurotransmitter between the nerve cells.
Estonian: Arvatakse, et Priligy pikendab aega ejakulatsiooni tekkeni sellega, et suurendab teatud neurotransmitteri sisaldust närvirakkude vahel.
English: The CHMP also concluded that the potential increased risk for syncope has been proven to be manageable.
Estonian: Samuti järeldas inimravimite komitee, et sünkoobi võimalik suurenenud risk on talutav.
English: However, the Member States were not able to reach an agreement and the Swedish medicines regulatory agency referred the matter to the CHMP for arbitration on 24 February 2011.
Estonian: Liikmesriigid ei jõudnud aga kokkuleppele ning 24. veebruaril 2011 tegi Rootsi ravimiamet inimravimite komiteele selles küsimuses esildise vahekohtumenetluse algatamiseks.
English: Patients should not start treatment with 60 mg tablets, and may only be switched to 60 mg if they have not responded sufficiently to the 30 mg tablets and have not experienced moderate or severe adverse reactions or symptoms suggestive of syncope.
Estonian: Patsiendid ei tohi alustada ravi 60 mg tablettidega ja annuse tohib 60 mg-ks suurendada üksnes juhul, kui patsiendid ei ole piisavalt reageerinud 30 mg tablettidele ja neil ei ole esinenud mõõdukaid või raskeid kõrvaltoimeid ega sümptomeid, mis võiksid viidata sünkoobile.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of Priligy tablets.
Estonian: Euroopa Ravimiamet on lõpetanud vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele Priligy tablettide heakskiitmises.
English: The company that markets Priligy in Sweden, Janssen-Cilag AB, submitted an application to market Priligy (30 mg and 60 mg tablets) through the mutual recognition procedure based on the initial authorisation granted by Sweden on 6 February 2009.
Estonian: Priligyd Rootsis turustav ettevõte Janssen-Cilag AB esitas Priligy (30 mg ja 60 mg tablettide) turustamise taotluse vastastikuse tunnustamise menetluse kaudu, võttes aluseks Rootsis 6. veebruaril 2009 antud esialgse müügiloa.
English: The active substance, dapoxetine, is a selective serotonin re-uptake inhibitor (SSRI) and it works by preventing the neurotransmitter 5-hydroxytryptamine (also called serotonin) from being taken back up into nerve cells in the brain and spinal cord, thereby increasing the amount of serotonin between nerve cells.
Estonian: Ravimi toimeaine dapoksetiin on selektiivne serotoniini tagasihaarde inhibiitor (SSTI), mis pärsib peaja seljaajus neurotransmitteri 5-hüdroksütrüptamiini (serotoniini) tagasihaaret närvirakkidesse, suurendades nii serotoniini sisaldust närvirakkude vahel.
English: Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets)
Estonian: Priligy teave (dapoksetiin, 30 mg ja 60 mg tabletid)
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Priligy 60 mg outweigh its risks, and that therefore the marketing authorisation for Priligy (30 mg and 60 mg) should be granted in all concerned Member States.
Estonian: Tuginedes olemasolevate andmete hindamisele ja komiteesisesele teaduslikule arutelule, järeldas inimravimite komitee, et Priligy 60 mg tablettide kasulikkus on suurem kui nendega kaasnevad riskid ning seega tuleb kõigis asjaomastes liikmesriikides anda Priligy 30 mg ja 60 mg tablettide müügiload.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of the 60 mg tablet (over which there was disagreement) do outweigh its risks and that the marketing authorisation for Priligy granted in Sweden can be recognised in other Member States of the EU.
Estonian: Ravimiameti inimravimite komitee järeldas, et lahkarvamuse põhjustanud Priligy 60 mg tablettide kasulikkus on suurem kui nendega kaasnevad riskid ja Rootsis antud Priligy müügiluba saab tunnustada ka Euroopa Liidu teistes liikmesriikides.
English: The grounds for the referral were concerns over the benefit-risk balance of the 60 mg tablet by some Member States, who considered its additional benefit compared with the 30 mg tablet to be too modest when weighed against the increased risk of severe cases of syncope (fainting) seen in studies with the medicine.
Estonian: Esildise põhjuseks oli mõne liikmesriigi ettevaatlikkus Priligy 60 mg tablettide kasulikkuse ja riski suhte pärast, sest nende arvates oli 60 mg tablettide täiendav kasulikkus võrreldes 30 mg tablettidega liiga väike, võrreldes ravimiuuringutel täheldatud raske sünkoobi (minestuse) suurema riskiga.
English: Questions and answers on Priligy (dapoxetine, 30 mg and 60 mg tablets) EMA/59013/2012
Estonian: Priligy teave (dapoksetiin, 30 mg ja 60 mg tabletid) EMA/106792/20122
English: The marketing authorisation was renewed on 3 May 2001 and on 3 May 2006.
Estonian: Müügiluba pikendati 3. mail 2001 ja 3. mail 2006.
English: The marketing authorisation holder is N.V. Organon.
Estonian: Müügiloa hoidja on N.V.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Puregon on 3 May 1996.
Estonian: Euroopa Komisjon andis Puregonile müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 3. mail 1996.
English: Puregon was as effective as the comparator in all of the studies.
Estonian: Puregon oli kõikides uuringutes sama efektiivne kui võrdlusaine.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREGON EPAR summary for the public
Estonian: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) PUREGON Kokkuvõte üldsusele
English: The Committee recommended that Puregon be given marketing authorisation.
Estonian: Komitee soovitas anda Puregonile müügiloa.
English: Puregon's use in women undergoing fertility treatment has been studied in 981 patients.
Estonian: Puregoni kasutamist viljatusravi saavatel naistel on uuritud 981 patsiendil.
English: The dose and frequency of administration of Puregon depend on its use (see above) and the patient's response to treatment.
Estonian: Puregoni annus ja manustamissagedus sõltub kasutuseesmärgist (vt eespool) ning patsiendi ravivastusest.
English: Puregon is used to treat infertility in women in the following situations:
Estonian: Puregoni kasutatakse naiste infertiilsuse raviks järgmistel juhtudel:
English: Puregon can only be obtained with a prescription.
Estonian: Puregoni saab üksnes retsepti alusel.
English: The powder should be mixed with the solvent provided just before use.
Estonian: Pulber tuleb kaasasoleva lahustiga segada vahetult enne kasutamist.
English: In all of the studies, Puregon was compared to the natural FSH hormone that was extracted from urine.
Estonian: Kõikides uuringutes võrreldi Puregoni loodusliku FSH-ga, mis oli eraldatud uriinist.
English: Puregon can also be used to stimulate sperm production in men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Estonian: Puregoni võib kasutada ka sperma tekke stimuleerimiseks meestel, kellel on hüpogonadotroopne hüpogonadism (hormoonpuudulikkusest tingitud haruldane haigus).
English: Treatment with Puregon should be carried out by a doctor who has experience in the treatment of fertility problems.
Estonian: Ravi Puregoniga peab tegema viljastumisprobleemide ravi kogemusega arst.
English: In the body, FSH regulates the reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles.
Estonian: Organismis reguleerib FSH reproduktiivfunktsiooni: naistel stimuleerib FSH munasarjades munarakkude eraldumist ja meestel munandites sperma teket.
English: The most common side effects reported are a reaction and pain at the injection site.
Estonian: Puregoni kõige sagedamad teatatud kõrvalnähud on süstekoha reaktsioon ja valu.
English: In 4 % of the women treated with Puregon in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain, and diarrhoea) have been reported.
Estonian: 4 %-l kliinilistes uuringutes Puregoniga ravitud naistest ilmnesid munasarja hüperstimulatsiooni sündroomi sümptomid (nt iiveldus, kaalutõus, kõhulahtisus).
English: Puregon should only be administered by people who have been trained by the doctor and have access to expert advice.
Estonian: Puregoni tohib määrata vaid patsientidele, kes on saanud arstilt asjakohase väljaõppe ning kelle on võimalus saada vajaduse korral asjatundja nõuandeid.
English: The patient or their partner may carry out the injections.
Estonian: Süstida võib kas patsient ise või tema pereliige.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Puregon's benefits are greater than its risks in the female for the treatment of infertility, and in the male for deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Estonian: Inimravimite komitee otsustas, et Puregoni kasulikkus on suurem kui riskid naiste infertiilsuse ja meeste puudulikku spermatekke ravis, kui need seisundid on tekkinud hüpogonadotroofilise hüpogonadismi tõttu.
English: Puregon was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate.
Estonian: Puregoni uuriti 172 anovulatoorsel naisel, uuringus loendati ovulatsiooni tekkeks vajalikke ravitsükleid.
English: It is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Estonian: Seda toodab rakk, millesse on lisatud inimese FSH teket võimaldav geen (DNA).
English: Previously, the FSH used as a medicine was extracted from urine.
Estonian: Varem eraldati ravimina kasutatav FSH uriinist.
English: In women, it must not be used when there is ovarian failure, ovarian enlargement or the presence of cysts that are not due to polycystic ovarian disease, or vaginal bleeding.
Estonian: Naised ei tohi ravimit kasutada munasarjade puudulikkuse, laienenud munasarjade või sellise tsüsti korral, mis ei ole tingitud munasarjade polütsüstilisest haigusest, ega tupeverejooksu korral.
English: Puregon should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients.
Estonian: Puregoni ei tohi kasutada patsiendid, kes võivad olla beetafollitropiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: The follitropin beta in Puregon is produced by a method known as ‘recombinant DNA technology'.
Estonian: Puregonis sisalduvat beetafollitropiini toodetakse rekombinant-DNA-tehnika abil.
English: • women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation).
Estonian: • anovulatoorsed naised (kellel ei teki munarakke), kelle ravi klomifeentsitraadiga (samuti ovulatsiooni stimuleeriv ravim) ei ole andnud tulemusi;
English: Puregon is given as a ‘subcutaneous' injection (under the skin) or into a muscle.
Estonian: Puregoni manustatakse üks kord nädalas subkutaanse (nahaaluse) süstina või süstina lihasesse.
English: Why has Puregon been approved?
Estonian: Miks Puregon heaks kiideti?
English: Puregon must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus.
Estonian: Puregoni ei tohi kasutada patsiendid, kellel on munasarja-, rinnanäärme-, emaka-, munandi-, hüpofüüsi- (ajuripatsi-) või hüpotalamusekasvaja.
English: What is Puregon?
Estonian: Mis on Puregon?
English: Puregon was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.
Estonian: Puregon oli viljatusravis, ovulatsiooni esilekutsumisel ja spermatekke stimuleerimisel sama efektiivne kui uriinist eraldatud FSH.
English: In men, Puregon was studied to see its effect on sperm production in 49 patients.
Estonian: Puregoni toimet meeste spermaproduktsoonile uuriti 49 patsiendil.
English: It is also available as a solution for injection in a vial or a cartridge.
Estonian: See on saadaval ka süstelahusena viaalis või kolbampullis.
English: Puregon is administered to stimulate the ovaries to produce more than one egg at a time
Estonian: Puregoni manustatakse munasarjade stimuleerimiseks, et neis tekiks korraga mitu munarakku.
English: Other information about Puregon:
Estonian: Muu teave Puregoni kohta
English: Puregon is a powder and solvent to be made up into a solution for injection.
Estonian: Puregon on pulber ja lahusti süstelahuse valmistamiseks.
English: The active substance in Puregon, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH).
Estonian: Puregoni toimeaine beetafollitropiin on loodusliku follitropiini ehk folliikuleid stimuleeriva hormooni (FSH) tehisteisend.
English: What is the risk associated with Puregon?
Estonian: Mis riskid kaasnevad Puregoniga?
English: Puregon contains the active substance follitropin beta.
Estonian: Puregoni toimeaine on follitropiin beeta.
English: What benefit has Puregon shown during the studies?
Estonian: Milles seisneb uuringute põhjal Puregoni kasulikkus?
English: How has Puregon been studied?
Estonian: Kuidas Puregoni uuriti?
English: How is Puregon used?
Estonian: Kuidas Puregoni kasutatakse?
English: What is Puregon used for?
Estonian: Milleks Puregoni kasutatakse?
English: The full EPAR for Puregon is available here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Puregoni kohta leiate siit.
English: For a full list of all side effects reported with Puregon, see the Package Leaflet.
Estonian: Puregoni kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: How does Puregon work?
Estonian: Kuidas Puregon toimib?
English: For a full description of the doses, please see the Package Leaflet.
Estonian: Annuste täieliku kirjelduse leiate pakendi infolehelt.
English: Oral use blister (OPA/aluminium/PVC/ aluminium)
Estonian: Suukaudne blister (OPA/alumiinium/PVC /alumiinium)
English: Immediate Packaging
Estonian: Sisepakend
English: Cats and dogs
Estonian: Süstesuspensioon Koer
English: Before you begin
Estonian: Enne kui alustate
English: Combined studies 1 & 2
Estonian: Kombineeritud uuringud 1 & 2
English: Adult and children (1 to 17 years):
Estonian: Täiskasvanud ja lapsed (1…17-aastased):
English: Ask your pharmacist how to throw away medicines you no longer use.
Estonian: Küsige apteekrilt, kuidas visata ära ravimeid, mida te enam ei kasuta.
English: Do not try to inject yourself if you have not been trained.
Estonian: Ärge üritage ise endale süstida, kui teid ei ole koolitatud.
English: • Do dissolve slowly and carefully.
Estonian: • Lahustage aeglaselt ja hoolikalt.
English: • Do check your dose before starting this step.
Estonian: • Kontrollige oma annust enne selle sammu alustamist.
English: If the expiry date has passed, do not use.
Estonian: Kui kõlblikkusaeg on möödas, ärge seda kasutage.
English: One Amgen Center Drive Thousand Oaks, CA 91320 USA
Estonian: One Amgen Center Drive Thousand Oaks, CA 91320 Ameerika Ühendriigid
English: Date of first authorisation: 4 February 2009 Date of latest renewal: 20 December 2013
Estonian: Müügiloa esmase väljastamise kuupäev: 4. veebruar 2009 Müügiloa viimase uuendamise kuupäev: 20. detsember 2013
English: This section is divided into the following subsections:
Estonian: See lõik on jaotatud järgnevateks alalõikudeks:
English: Push slowly and gently
Estonian: Suruge aeglaselt ja õrnalt
English: As with all therapeutic proteins, there is a potential for immunogenicity.
Estonian: Nagu kõigi terapeutiliste valkudega, on immunogeensus võimalik.
English: Always use Nplate exactly as your doctor has told you.
Estonian: Kasutage Nplate'i alati täpselt nii nagu arst on teile selgitanud.
English: A risk to the newborns/infants cannot be excluded.
Estonian: Ohtu vastsündinutele ja imikutele ei saa välistada.
English: Do the following:
Estonian: Tehke järgnevat:
English: Before you begin Step 3 please note the following:
Estonian: Enne 3. sammu alustamist pange palun tähele järgnevat:
English: > 150 for two consecutive weeks
Estonian: > 150 kaks nädalat järjest
English: Component of a multipack, not to be sold separately.
Estonian: Osa hulgipakendist, mitte müüa eraldi.
English: Both studies were similarly designed.
Estonian: Mõlemad uuringud olid ülesehituselt sarnased.
English: Before you begin Step 4 please note the following:
Estonian: Enne 4. sammu alustamist pange palun tähele järgnevat:
English: Other medicines and Nplate
Estonian: Muud ravimid ja Nplate
English: Do not use Nplate:
Estonian: Ärge kasutage Nplate'i:
English: IMMEDIATELY continue to step 7.
Estonian: Jätkake OTSEKOHE sammuga 7.
English: The overall safety profile was similar to that seen in adults.
Estonian: Üldine ohutusprofiil oli sarnane täiskasvanutel nähtuga.
English: Before continuing:
Estonian: Enne jätkamist:
English: No other diluents have been tested.
Estonian: Ühtegi teist lahjendit ei ole testitud.
English: No overall differences in safety or efficacy have been observed in patients < 65 and ≥ 65 years of age (see section 5.1).
Estonian: Üldiseid ohutuse ja efektiivsuse erinevusi < 65- ja ≥ 65-aastastel patsientidel ei ole täheldatud (vt lõik 5.1).
English: Read all instructions for use thoroughly.
Estonian: Lugege kõiki kasutusjuhiseid tähelepanelikult.
English: • Wash your hands with soap and warm water.
Estonian: • Peske käed seebi ja sooja veega.
English: ITP is a disease in which your body's immune system destroys its own platelets.
Estonian: ITP on haigus, mille puhul organismi oma immuunsüsteem hävitab omaenda vereliistakuid.
English: • if you are allergic to romiplostim or any of the other ingredients of this medicine (listed in section 6).
Estonian: • kui olete romiplostiimi või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: • Do not pull plunger back to more than 1 mL.
Estonian: • Ärge tõmmake kolbi tagasi üle 1 ml.
English: Your doctor will tell you how much you must take.
Estonian: Arst ütleb teile, kui palju peab manustama.
English: The median duration of exposure was 65.4 weeks.
Estonian: Ravimiga kokkupuute mediaanne kestus oli 65,4 nädalat.