FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/009
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/009
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Estonian: Sisu: 1 viaal 1000 RÜ oktokog alfat ja 1 viaal 2 ml steriilse süsteveega, eelnevalt kokku pandud BAXJECT III süsteemis.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/010
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/010
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/013
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/013
English: Each vial contains nominally 500 IU human coagulation factor VIII (rDNA), octocog alfa.
Estonian: Igas viaalis on 500 RÜ oktokog alfat, rekombinantset inimese VIII (rDNA) hüübimisfaktorit.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Estonian: Sisu: 1 viaal 1500 RÜ oktokog alfat, 1 viaal 2 ml steriilse süsteveega, 1BAXJECT II süsteem.
English: ADVATE contains approximately 50 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 50 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/019
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/019
English: ADVATE contains approximately 500 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 500 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: ADVATE contains approximately 200 IU per ml of human coagulation factor VIII (rDNA), octocog alfa after reconstitution.
Estonian: ADVATE sisaldab pärast lahustamist ligikaudu 200 RÜ ml kohta inimese VIII (rDNA) hüübimisfaktorit, oktokog alfat.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Estonian: Sisu: 1 viaal 1500 RÜ oktokog alfat ja 1 viaal 2 ml steriilse süsteveega, eelnevalt kokku pandud BAXJECT III süsteemis.
English: Prevention of bleeding
Estonian: Protseduurijärgne verejooks
English: Chills
Estonian: Iiveldus
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1500 IU powder and solvent for solution for injection Octocog alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 1500 IU süstelahuse pulber.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 3000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Estonian: Sisu: 1 viaal 3000 RÜ oktokog alfat ja 1 viaal 5 ml steriilse süsteveega, eelnevalt kokku pandud BAXJECT III süsteemis.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1500
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 1500
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/004
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 2000 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Estonian: Sisu: 1 viaal 2000 RÜ oktokog alfat ja 1 viaal 5 ml steriilse süsteveega, eelnevalt kokku pandud BAXJECT III süsteemis.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 2000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Estonian: Sisu: 1 viaal 2000 RÜ oktokog alfat, 1 viaal 5 ml steriilse süsteveega, 1 BAXJECT II süsteem.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Estonian: Sisu: 1 viaal 1000 RÜ oktokog alfat, 1 viaal 2 ml steriilse süsteveega, 1 BAXJECT II süsteem.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Estonian: Sisu: 1 viaal 250 RÜ oktokog alfat ja 1 viaal 2 ml steriilse süsteveega, eelnevalt kokku pandud BAXJECT III süsteemis.
English: Each vial contains nominally 250 IU human coagulation factor VIII (rDNA), octocog alfa.
Estonian: Igas viaalis on 250 RÜ oktokog alfat, rekombinantset inimese VIII (rDNA) hüübimisfaktorit.
English: Each vial contains nominally 2000 IU human coagulation factor VIII (rDNA), octocog alfa.
Estonian: Igas viaalis on 2000 RÜ oktokog alfat, rekombinantset inimese VIII (rDNA) hüübimisfaktorit.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Estonian: Sisu: 1 viaal 250 RÜ oktokog alfat, 1 viaal 5 ml steriilse süsteveega, 1 BAXJECT II süsteem.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa and 1 vial with 5 ml sterilised water for injections preassembled in BAXJECT III system.
Estonian: Sisu: 1 viaal 500 RÜ oktokog alfat ja 1 viaal 5 ml steriilse süsteveega, eelnevalt kokku pandud BAXJECT III süsteemis.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 500 IU powder and solvent for solution for injection Octocog alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 500 IU süstelahuse pulber.
English: NAME OF THE MEDICINAL PRODUCT ADVATE 3000 IU powder and solvent for solution for injection Octocog alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 3000 IU süstelahuse pulber.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/007
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/003
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/003
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 250 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Estonian: Sisu: 1 viaal 250 RÜ oktokog alfat, 1 viaal 2 ml steriilse süsteveega, 1 BAXJECT II süsteem.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa and 1 vial with 2 ml sterilised water for injections preassembled in BAXJECT III system.
Estonian: Sisu: 1 viaal 500 RÜ oktokog alfat ja 1 viaal 2 ml steriilse süsteveega, eelnevalt kokku pandud BAXJECT III süsteemis.
English: Solvent Sterilised water for injections
Estonian: Lahusti: steriilne süstevesi.
English: IV use
Estonian: IV
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 250 IU powder for solution for injection Octocog alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 250 IU süstelahuse pulber.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Estonian: Sisu: 1 viaal 500 RÜ oktokog alfat, 1 viaal 5 ml steriilse süsteveega, 1 BAXJECT II süsteem.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 1000
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 1000
English: NAME OF THE MEDICINAL PRODUCT ADVATE 1000 IU powder and solvent for solution for injection Octocog alfa
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 1000 IU süstelahuse pulber.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 1000 IU octocog alfa, 1 vial with 5 ml sterilised water for injections, 1 BAXJECT II device.
Estonian: Sisu: 1 viaal 1000 RÜ oktokog alfat, 1 viaal 5 ml steriilse süsteveega, 1 BAXJECT II seade.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 vial with 500 IU octocog alfa, 1 vial with 2 ml sterilised water for injections, 1 BAXJECT II device.
Estonian: Sisu: 1 viaal 500 RÜ oktokog alfat, 1 viaal 2 ml steriilse süsteveega, 1 BAXJECT II süsteem.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/002
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/271/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/03/271/001
English: Peripheral oedema
Estonian: Perifeersed tursed
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION ADVATE 3000
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE ADVATE 3000
English: Implementation of the agreement by the Member States: - suspension of the marketing authorisations of methadone oral solutions containing povidone of high molecular weight (K90)
Estonian: Seisukoha rakendamine liikmesriikides: - suure molekulmassiga povidooni (K90) sisaldavate suukaudsete metadoonilahuste müügilubade peatamine
English: Within 3 months after adoption of CMDh agreement
Estonian: Kolme kuu jooksul pärast koordineerimisrühma seisukoha vastuvõtmist
English: - submission of the variation by the Marketing Authorisation Holders of methadone tablets containing povidone of low molecular weight (K25 or K30)
Estonian: - väikese molekulmassiga povidooni (K25 või K30) sisaldavate metadoonitablettide müügiloa hoidjad taotlevad müügiloa muutmist
English: July 2014 CMDh meeting
Estonian: Koordineerimisrühma juuli 2014 koosolek
English: Transmission to National Competent Authorities of the translations of the annexes to the agreement:
Estonian: Seisukoha lisade tõlgete edastamine riikide ravimiametitele
English: Adoption of CMDh agreement:
Estonian: Koordineerimisrühma seisukoha vastuvõtmine
English: Annex V
Estonian: V lisa Inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste koordineerimisrühma seisukoha rakendamise ajakava
English: The powder should dissolve in less than 60 minutes.
Estonian: Pulber peab lahustuma vähem kui 60 minuti jooksul.
English: Date of first authorisation: 22 May 2014 Date of latest renewal: 2 April 2019
Estonian: Müügiloa esmase väljastamise kuupäev: 22. mai 2014 Müügiloa viimase uuendamise kuupäev: 2 aprillil 2019
English: 70 days
Estonian: 70 päeva
English: 206 days
Estonian: 206 päeva
English: Not reached
Estonian: Ei saabunud
English: • It will be given slowly over a period of 1 hour.
Estonian: • Ravimit manustatakse aeglaselt 1 tunni jooksul.
English: • cyclosporin, used during and after organ transplants
Estonian: • tsüklosporiin, mida kasutatakse organsiirdamise ajal ja järel
English: You should use effective methods of contraception during this time.
Estonian: Sel ajal peate kasutama tõhusaid rasestumisvastaseid vahendeid.
English: Other medicines and SYLVANT
Estonian: Muud ravimid ja SYLVANT
English: Protocol:
Estonian: Protokoll:
English: • SYLVANT is available in packs containing 1 vial.
Estonian: • SYLVANT on saadaval pakendites, mis sisaldavad 1 viaali.
English: As this medicine will be given to you by your doctor or nurse, it is unlikely that you will be given too much.
Estonian: Et seda ravimit manustab teile arst või õde, siis ei ole tõenäoline, et seda manustatakse teile liiga palju.
English: Dose reduction is not recommended.
Estonian: Annuste vähendamine ei ole soovitatav.
English: Do not remove contents until all of the powder has been completely dissolved.
Estonian: Ärge tõmmake viaali sisu süstlasse enne kui kogu pulber on täielikult lahustunud.
English: SYLVANT is not likely to affect your ability to drive, cycle, or use any tools or machines.
Estonian: SYLVANT ei mõjuta tõenäoliselt teie võimet juhtida autot või sõita rattaga või kasutada mis tahes tööriistu või masinaid.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud sildil pärast „EXP“.
English: None of these patients had neutralising antibodies.
Estonian: Ühelgi neist patsientidest ei esinenud neutraliseerivaid antikehasid.
English: No dose adjustment is required (see section 5.2).
Estonian: Annuste kohandamine ei ole vajalik (vt lõik 5.2).
English: This medicinal product is for single use only.
Estonian: See ravimpreparaat on ette nähtud ainult ühekordseks kasutamiseks.
English: 30/11/2015 (aligned with expected PSUR cycle)
Estonian: 30/11/2015 (kooskõlas eeldatava perioodilise ohutusaruande tsükliga)
English: You should not stop using SYLVANT without discussing with your doctor first.
Estonian: Ärge lõpetage SYLVANT'i kasutamist ilma kõigepealt arstiga nõu pidamata.
English: • You will receive treatment until you and your doctor agree that you will no longer benefit from the treatment.
Estonian: • Teie ravi jätkatakse senikaua, kuni nii arsti kui ka teie enda hinnangul see ravi ei ole enam teile kasulik.
English: Contents of the pack and other information What SYLVANT contains
Estonian: Pakendi sisu ja muu teave Mida SYLVANT sisaldab
English: All tumour responses were durable for > 18 weeks.
Estonian: Kõik tuumori ravivastused püsisid > 18 nädalat.
English: Common (may affect up to 1 in 10 people): • high level of cholesterol in the blood
Estonian: Sage (võib esineda kuni 1 inimesel 10-st): • kolesterooli kõrge tase veres.
English: The registry should be continued for the either 100 patients, or 5 years, whichever is greater.
Estonian: Registrit tuleb pidada kas kuni 100 patsiendi või 5 aasta täitumiseni, vastavalt kumb saabub enne.
English: • SYLVANT is not recommended for use during pregnancy.
Estonian: • SYLVANT'i ei ole soovitatav kasutada raseduse ajal.
English: As with all therapeutic proteins, there is potential for the generation of anti-medicine antibodies (immunogenicity).
Estonian: Sarnaselt kõigile terapeutilistele proteiinidele on võimalik ravimivastaste antikehade tekkimine (immunogeensus).
English: Chemical and physical in-use stability has been demonstrated for up to 8 hours at room temperature (see section 6.6).
Estonian: Ravimi kasutusaegne keemilis-füüsikaline stabiilsus on tõestatud kuni 8 tunni jooksul toatemperatuuril (vt lõik 6.6).
English: • oral contraceptives, used to prevent pregnancy.
Estonian: • suukaudsed rasestumisvastased pillid, mida kasutatakse raseduse vältimiseks.
English: Tell your doctor straight away if you have a severe allergic reaction during or after the infusion.
Estonian: Teatage otsekohe oma arstile, kui teil tekib infusiooni ajal või järel raske allergiline reaktsioon.
English: Immunomodulatory medicinal products may increase the risk of malignancy.
Estonian: Immunomoduleerivad ravimid võivad suurendada maliigsete protsesside arenemise riski.
English: Pharmacotherapeutic group: Immunosuppresants, interleukin inhibitors, ATC code: L04AC11.
Estonian: Farmakoterapeutiline rühm: immunosupressandid, interleukiini inhibiitorid, ATC-kood: L04AC11.
English: These infections may be serious, such as pneumonia or blood poisoning (also called “sepsis”).
Estonian: Need infektsioonid võivad olla tõsised, nt kopsupõletik või veremürgistus (mida nimetatakse ka sepsiseks).
English: It is not known if SYLVANT may affect the baby or a pregnant or breast-feeding woman.
Estonian: Ei ole teada, kas SYLVANT võib mõjutada sündivat last, rasedat või imetavat ema.
English: The safety and efficacy of siltuximab in children aged 17 years and younger have not been established.
Estonian: Siltuksimabi ohutus ja efektiivsus lastel vanuses 17 aastat või nooremad ei ole tõestatud.
English: After a median of 6 years of follow-up, none of the 60 patients had died and maintenance of disease control was demonstrated in 58 of 60 patients.
Estonian: Pärast jälgimisperioodi, mille kestuse mediaan oli 6 aastat, ei olnud surnud ükski patsient 60-st ning haigus allus jätkuvalt ravile 58 patsiendil 60-st.
English: Intravenous infusion after reconstitution and dilution.
Estonian: Intravenoosne infusioon pärast lahustamist ja lahjendamist.
English: In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Estonian: Et parandada bioloogiliste ravimpreparaatide jälgitavust, tuleb selgelt dokumenteerida manustatud ravimpreparaadi kaubanduslik nimetus ja partii number.
English: Therefore, an increased susceptibility to specific tumours cannot be entirely ruled out.
Estonian: Seega ei saa täielikult välistada suurenenud kalduvust teatud kasvajate tekkeks.
English: • In some cases, if you are pregnant and need treatment for MCD, your doctor may advise that the benefit of taking SYLVANT for your health outweighs the possible risks to your unborn baby, including increased risk of infection and use of certain vaccines in babies born to mothers exposed to SYLVANT while pregnant.
Estonian: • Kui olete rase ning vajate MCD ravi, siis mõnikord võib teie arst leida, et SYLVANT-ravist saadav kasu kaalub üles võimaliku riski teie sündimata lapsele, kaasa arvatud suurenenud infektsioonirisk ja teatud vaktsiinide kasutamine lastel, kelle emad said raseduse ajal ravi SYLVANT'iga.
English: SYLVANT will be given to you by your doctor or nurse, in a hospital or clinic only.
Estonian: SYLVANT'i manustab teile arst või õde ainult haiglas või kliinikus.
English: • you have an infection at the moment - this is because SYLVANT may lower your ability to feel or fight infections, and infections may get worse.
Estonian: • kui teil on praegusel hetkel mõni infektsioon, sest SYLVANT võib vähendada teie vastupanuvõimet nakkuste suhtes ning infektsioonid võivad halveneda.
English: The results showed no significant difference in the PK of siltuximab in patients older than 65 years compared to patients age 65 years or younger.
Estonian: Tulemused ei näidanud erilisi muutusi siltuksimabi farmakokineetikas üle 65-aastastel patsientidel võrreldes patsientidega, kes olid 65-aastased või nooremad.
English: It is not known if SYLVANT is safe and effective in this population, therefore SYLVANT should not be given to children and adolescents.
Estonian: Ei ole teada, kas SYLVANT'i kasutamine selles vanuserühmas on ohutu ja efektiivne, seetõttu ei tohi SYLVANT'i manustada lastele ja noorukitele.
English: Siltuximab should be given to a pregnant woman only if the benefit clearly outweighs the risk.
Estonian: Siltuksimabi tohib rasedatele manustada üksnes juhul kui kasu kaalub selgelt üles riskid.
English: Your doctor may prescribe medicines to correct this.
Estonian: Teie arst võib teile kirjutada ravimeid, mis aitavad seda kontrolli all hoida.
English: NL-2333 CB Leiden The Netherlands
Estonian: NL-2333 CB Leiden
English: Name and address of the manufacturers of the biological active substances
Estonian: Bioloogilise toimeaine tootjate nimed ja aadressid
English: Infections, including localised infections, should be treated prior to administration of SYLVANT.
Estonian: Kõik infektsioonid, sh lokaliseerunud infektsioonid, peavad olema välja ravitud enne SYLVANT'i manustamist.
English: What SYLVANT looks like and contents of the pack
Estonian: Kuidas SYLVANT välja näeb ja pakendi sisu
English: • You must not become pregnant while you are being treated with SYLVANT and for 3 months after your treatment has finished.
Estonian: • Te ei tohi rasestuda SYLVANT-ravi ajal ja 3 kuu jooksul pärast ravi lõpetamist.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Estonian: Enne kui teile manustatakse seda ravimit, lugege hoolikalt infolehte, sest siin on teile vajalikku teavet.
English: Subgroup analyses
Estonian: Alarühmade analüüsid
English: After reconstitution and dilution
Estonian: Pärast lahustamist ja lahjendamist
English: Requirements before first SYLVANT administration
Estonian: Nõutav väärtus enne SYLVANT'i esmakordset manustamist
English: This helps reduce the size of the affected lymph nodes, which reduces the symptoms of the illness and should help you carry out your normal daily tasks.
Estonian: See võimaldab vähendada haigusest haaratud lümfisõlmede mõõtmeid, mille tagajärjel vähenevad haigussümptomid ja te saate taas hakkama oma igapäevaste ülesannetega.
English: Treatment was continued until treatment failure (defined as disease progression based on increase in symptoms, radiologic progression or deterioration in performance status) or unacceptable toxicity.
Estonian: Ravi jätkati kuni ravivastuse kadumiseni (defineeriti haiguse progresseerumisena, mis avaldus sümptomite tugevnemise, radioloogilise progresseerumise või sooritusvõime halvenemisena) või kuni talumatu toksilise toime avaldumiseni.
English: Time to treatment failure
Estonian: Aeg ravivastuse kadumiseni
English: Tell your doctor straight away if you notice the following side effects, as he or she may need to stop your treatment:
Estonian: Rääkige otsekohe oma arstile, kui te märkate järgmisi kõrvaltoimeid, sest on võimalik, et arst peab teie ravi katkestama:
English: Use aseptic technique.
Estonian: Rakendage aseptilist tehnikat.
English: SYLVANT does not contain preservatives; therefore do not store any unused portion of the infusion solution for re-use.
Estonian: SYLVANT ei sisalda säilitusaineid; seetõttu ei tohi allesjäänud infusioonilahust säilitada korduva kasutamise eesmärgil.
English: If you think you have been given too much SYLVANT, tell your doctor or nurse straight away.
Estonian: Kui teile tundub, et teile manustati SYLVANT'i liiga palju, teavitage otsekohe oma arsti või meditsiiniõde.
English: The following factors had no clinical effect on the clearance of siltuximab: gender, age, and ethnicity.
Estonian: Järgmised tegurid ei avaldanud siltuksimabi kliirensile kliinilist mõju: sugu, vanus ja rahvus.
English: • you have liver disease or changes that show up in blood tests of the liver.
Estonian: • kui teil on maksahaigus või muutused vereanalüüsides, mis näitavad maksa tööd.
English: Therefore, prescribers should diligently monitor patients receiving treatment in order to detect serious infections.
Estonian: Seetõttu peab raviarst väga hoolikalt jälgima ravitava patsiendi seisundit, et avastada võimalikud tõsised infektsioonid.
English: This medicinal product should be administered by qualified healthcare professionals and under appropriate medical supervision.
Estonian: Seda ravimit tohib manustada vastava väljaõppega meditsiinitöötaja asjakohase arstliku järelevalve all.
English: Siltuximab must be administered as an intravenous infusion.
Estonian: Siltuksimabi peab manustama intravenoosse infusioonina.
English: Biomarkers
Estonian: Biomarkerid
English: There are no data from the use of siltuximab in pregnant women.
Estonian: Puuduvad andmed siltuksimabi kasutamise kohta rasedatel naistel.
English: MCD-related signs and symptoms were prospectively collected.
Estonian: Andmed MCD-ga seotud nähtude ja sümptomite kohta koguti prospektiivselt.
English: Your doctor will monitor you and your liver function.
Estonian: Arst jälgib teie seisundit ja maksafunktsiooni.
English: The following side effects may happen with this medicine.
Estonian: Selle ravimi kasutamisel võib esineda järgmisi kõrvaltoimeid.
English: The dose of the concomitant medicinal products should be adjusted as needed.
Estonian: Vastavalt vajadusele peab kohandama samaaegsete ravimpreparaatide annust.
English: • joint pain, arm or leg pain
Estonian: • liigesevalu, käe või jala valu
English: A registry should be conducted to collect information on patients with Castleman's disease, who are candidates to receive Sylvant or are currently receiving treatment with Sylvant.
Estonian: Luua register kogumaks andmeid Castlemani tõvega patsientide kohta, kes on Sylvant'i ravi kandidaadid või saavad hetkel ravi Sylvant'iga.
English: Your doctor may stop your treatment with SYLVANT straight away.
Estonian: Võimalik, et arst lõpetab otsekohe teie ravi SYLVANT'iga.