FrancophonIA/ELRC3.0 huggingface dataset:
English: Aluminium perforated unit dose blisters in cartons of 14 × 1, 28 × 1, 49 × 1 tablets.
Estonian: Üheannuseline perforeeritav alumiiniumblister pakend, karbis on 14 × 1, 28 × 1, 49 × 1 tabletti.
English: ABILIFY 10 mg orodispersible tablets Red iron oxide (E 172)
Estonian: ABILIFY 10 mg suus dispergeeruvad tabletid Punane raudoksiid (E 172)
English: ABILIFY 10 mg tablets
Estonian: ABILIFY 10 mg tabletid
English: Only take other medicines while you are on ABILIFY if your doctor tells you that you can.
Estonian: ABILIFY kasutades võtke teisi ravimeid ainult siis, kui arst on määranud.
English: The administration of lorazepam solution for injection had no effect on the pharmacokinetics of ABILIFY solution for injection when administered concomitantly.
Estonian: Samaaegselt manustatud lorasepaami süstelahus ei omanud mõju ABILIFY süstelahuse farmakokineetikale.
English: ABILIFY 15 mg orodispersible tablets Each orodispersible tablet contains 15 mg of aripiprazole.
Estonian: ABILIFY 15 mg suus dispergeeruvad tabletid Üks suus dispergeeruv tablett sisaldab 15 mg aripiprasooli.
English: Stiffness
Estonian: Suukuivus
English: ABILIFY 30 mg orodispersible tablets Each orodispersible tablet contains 30 mg of aripiprazole.
Estonian: ABILIFY 30 mg suus dispergeeruvad tabletid Üks suus dispergeeruv tablett sisaldab 30 mg aripiprasooli.
English: • dry mouth.
Estonian: • suukuivus.
English: ABILIFY 10 mg orodispersible tablets ABILIFY 15 mg orodispersible tablets ABILIFY 30 mg orodispersible tablets
Estonian: ABILIFY 5 mg tabletid ABILIFY 10 mg tabletid ABILIFY 15 mg tabletid ABILIFY 30 mg tabletid
English: Headache Sedation Somnolence Dizziness
Estonian: Treemor Peavalu Sedatsioon Unisus Pearinglus
English: ABILIFY 15 mg orodispersible tablets 15 mg: Round and yellow, marked with "A" over "641" on one side and "15" on the other.
Estonian: ABILIFY 15 mg suus dispergeeruvad tabletid Ümmargune ja kollane, ühele küljele on pressitud "A" ja "641" ja teisele küljele"15".
English: Hyperprolactinaemia Diabetic hyperosmolar coma
Estonian: Hüperprolaktineemia Hüperosmolaarne diabeetiline
English: • feeling anxious,
Estonian: • erutuvus,
English: • baldness,
Estonian: • unisus,
English: ABILIFY 10 mg orodispersible tablets Each orodispersible tablet contains 10 mg of aripiprazole.
Estonian: ABILIFY 10 mg suus dispergeeruvad tabletid Üks suus dispergeeruv tablett sisaldab 10 mg aripiprasooli.
English: ABILIFY 15 mg orodispersible tablets are round and yellow, marked with ‘"A" over "641"' on one side and ‘15' on the other.
Estonian: ABILIFY 15 mg suus dispergeeruvad tabletid on ümarad ja kollased ning selle ühele küljele on pressitud "A" ja "641"" ja teisele "15".
English: Each tablet contains 30 mg of aripiprazole.
Estonian: Iga tablett sisaldab 30 mg aripiprasooli.
English: ABILIFY 1 mg/mL oral solution aripiprazole
Estonian: ABILIFY 1 mg/ml suukaudne lahus aripiprasool
English: ABILIFY 5 mg tablets:
Estonian: ABILIFY 5 mg tabletid:
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotics, including aripiprazole, must be discontinued.
Estonian: Kõikide antipsühhootikumide, sealhulgas aripiprasooli manustamine tuleb lõpetada, kui patsiendil ilmnevad võimalikud MNS-i tunnused või sümptomid või täiendavate MNS-i kliiniliste tunnusteta ebaselge etioloogiaga kõrge palavik.
English: ABILIFY 15 mg tablets:
Estonian: ABILIFY 15 mg tabletid:
English: ABILIFY 15 mg tablets
Estonian: ABILIFY 15 mg tabletid
English: ABILIFY 5 mg tablets
Estonian: ABILIFY 5 mg tabletid
English: EU/1/04/276/016 (30 mg, 14 × 1 tablets) EU/1/04/276/017 (30 mg, 28 × 1 tablets) EU/1/04/276/018 (30 mg, 49 × 1 tablets) EU/1/04/276/019 (30 mg, 56 × 1 tablets) EU/1/04/276/020 (30 mg, 98 × 1 tablets)
Estonian: EU/1/04/276/016 (30 mg, 14 × 1 tablett) EU/1/04/276/017 (30 mg, 28 × 1 tablett) EU/1/04/276/018 (30 mg, 49 × 1 tablett) EU/1/04/276/019 (30 mg, 56 × 1 tablett) EU/1/04/276/020 (30 mg, 98 × 1 tablett)
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Estonian: Tel: +31 (0) 20 85 46 555
English: ABILIFY 10 mg orodispersible tablets 10 mg: Round and pink, marked with "A" over "640" on one side and "10" on the other.
Estonian: ABILIFY 10 mg suus dispergeeruvad tabletid Ümmargune ja roosa, ühele küljele on pressitud "A" ja "640" ja teisele küljele "10".
English: Each tablet contains 5 mg of aripiprazole.
Estonian: Iga tablett sisaldab 5 mg aripiprasooli.
English: Sulfobutylether β-cyclodextrin (SBECD) Tartaric acid
Estonian: Sulfobutüüleeterbeetatsüklodekstriin (SBECD) Viinhape
English: In the paediatric bipolar population (10 to 17 years) with exposure up to 30 weeks, incidence of low serum prolactin levels in females (< 3 ng/mL) and males (< 2 ng/mL) was 28.0 % and 53.3 %, respectively.
Estonian: Bipolaarse meeleoluhäirega lastel (10- kuni 17-aastased) ekspositsiooniga üle 30 nädala oli madala prolaktiinitaseme esinemine seerumis neidudel (< 3 ng/ml) ja noormeestel (< 2 ng/ml) vastavalt 28,0 % ja 53,3 %.
English: ABILIFY 30 mg orodispersible tablets 30 mg: Round and pink, marked with "A" over "643" on one side and "30" on the other.
Estonian: ABILIFY 30 mg suus dispergeeruvad tabletid Ümmargune ja roosa, ühele küljele on pressitud "A" ja "643" ja teisele küljele"30".
English: Each tablet contains 10 mg of aripiprazole.
Estonian: Iga tablett sisaldab 10 mg aripiprasooli.
English: ABILIFY 1 mg/mL oral solution
Estonian: ABILIFY 1 mg/ml suukaudne lahus
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Estonian: Ravim sisaldab vähem kui 1 mmol (23 mg) naatriumi annustamisühikus, mis tähendab põhimõtteliselt “naatriumivaba”.
English: The administration of ABILIFY solution for injection had no effect on the pharmacokinetics of lorazepam solution for injection when administered concomitantly.
Estonian: Samaaegselt manustatud ABILIFY süstelahus ei omanud mõju lorasepaami süstelahuse farmakokineetikale.
English: Each tablet contains 15 mg of aripiprazole.
Estonian: Iga tablett sisaldab 15 mg aripiprasooli.
English: ABILIFY 30 mg tablets aripiprazole
Estonian: ABILIFY 30 mg tabletid aripiprasool
English: OUTER CARTON AND BOTTLE LABEL
Estonian: VÄLISPAKENDIL JA SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISKARP JA PUDELI ETIKETT
English: Xylitol
Estonian: Ksülitool
English: EU/1/04/276/006 (10 mg, 14 × 1 tablets) EU/1/04/276/007 (10 mg, 28 × 1 tablets) EU/1/04/276/008 (10 mg, 49 × 1 tablets) EU/1/04/276/009 (10 mg, 56 × 1 tablets) EU/1/04/276/010 (10 mg, 98 × 1 tablets)
Estonian: EU/1/04/276/006 (10 mg, 14 × 1 tablett) EU/1/04/276/007 (10 mg, 28 × 1 tablett) EU/1/04/276/008 (10 mg, 49 × 1 tablett) EU/1/04/276/009 (10 mg, 56 × 1 tablett) EU/1/04/276/010 (10 mg, 98 × 1 tablett)
English: EU/1/04/276/030 (30 mg, 14 × 1 orodispersible tablets) EU/1/04/276/031 (30 mg, 28 × 1 orodispersible tablets) EU/1/04/276/032 (30 mg, 49 × 1 orodispersible tablets)
Estonian: EU/1/04/276/030 (30 mg, 14 × 1 suus dispergeeruvat tabletti) EU/1/04/276/031 (30 mg, 28 × 1 suus dispergeeruvat tabletti) EU/1/04/276/032 (30 mg, 49 × 1 suus dispergeeruvat tabletti)
English: Non-clinical data reveal no special hazard for humans based on conventional oral aripiprazole studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction and development.
Estonian: Farmakoloogilise ohutuse, korduvtoksilisuse, genotoksilisuse, kartsinogeensuse, reproduktsiooni- ja arengutoksilisuse mittekliinilised uuringud ei ole näidanud suukaudse aripiprasooli kahjulikku toimet inimesele.
English: EU/1/04/276/011 (15 mg, 14 × 1 tablets) EU/1/04/276/012 (15 mg, 28 × 1 tablets) EU/1/04/276/013 (15 mg, 49 × 1 tablets) EU/1/04/276/014 (15 mg, 56 × 1 tablets) EU/1/04/276/015 (15 mg, 98 × 1 tablets)
Estonian: EU/1/04/276/011 (15 mg, 14 × 1 tablett) EU/1/04/276/012 (15 mg, 28 × 1 tablett) EU/1/04/276/013 (15 mg, 49 × 1 tablett) EU/1/04/276/014 (15 mg, 56 × 1 tablett) EU/1/04/276/015 (15 mg, 98 × 1 tablett)
English: The safety profile of a long-term, double-blind, placebo-controlled trial was also similar except for the following reactions that were reported more frequently than paediatric patients taking placebo: weight decreased, blood insulin increased, arrhythmia, and leukopenia were reported commonly (≥ 1/100,
Estonian: Sarnane oli ka pikaajalise topeltpimeda platseebokontrolliga uuringu ohutusprofiil, kui välja arvata järgnevad kõrvaltoimed, mis esinesid sagedamini kui platseebot saanud noorukitel: kehakaalu langus,
English: EU/1/04/276/001 (5 mg, 14 × 1 tablets) EU/1/04/276/002 (5 mg, 28 × 1 tablets) EU/1/04/276/003 (5 mg, 49 × 1 tablets) EU/1/04/276/004 (5 mg, 56 × 1 tablets) EU/1/04/276/005 (5 mg, 98 × 1 tablets)
Estonian: EU/1/04/276/001 (5 mg, 14 × 1 tablett) EU/1/04/276/002 (5 mg, 28 × 1 tablett) EU/1/04/276/003 (5 mg, 49 × 1 tablett) EU/1/04/276/004 (5 mg, 56 × 1 tablett) EU/1/04/276/005 (5 mg, 98 × 1 tablett)
English: ABILIFY 30 mg orodispersible tablets are round and pink, marked with ‘"A" over "643"' on one side and ‘30' on the other.
Estonian: ABILIFY 30 mg suus dispergeeruvad tabletid on ümarad ja roosad ning selle ühele küljele on pressitud ""A" ja "643"" ja teisele "30".
English: • decreased number of or difficulty making bowel movements,
Estonian: • Kõht käib harvem läbi või on sellega raskusi,
English: Each orodispersible tablet contains 15 mg of aripiprazole.
Estonian: Iga suus dispergeeruv tablett sisaldab 15 mg aripiprasooli.
English: Seizure
Estonian: Süstevesi
English: ABILIFY 10 mg orodispersible tablets are round and pink, marked with ‘"A" over "640"' on one side and ‘10' on the other.
Estonian: ABILIFY 10 mg suus dispergeeruvad tabletid on ümarad ja roosad ning selle ühele küljele on pressitud ""A" ja "640"" ja teisele "10".
English: ABILIFY orodispersible tablets contain lactose.
Estonian: ABILIFY suus dispergeeruvad tabletid sisaldavad laktoosi.
English: ABILIFY 10 mg tablets aripiprazole
Estonian: ABILIFY 10 mg tabletid aripiprasool
English: Each orodispersible tablet contains 10 mg of aripiprazole.
Estonian: Iga suus dispergeeruv tablett sisaldab 10 mg aripiprasooli.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VÄLISPAKEND
English: Each orodispersible tablet contains 30 mg of aripiprazole.
Estonian: Iga suus dispergeeruv tablett sisaldab 30 mg aripiprasooli.
English: ABILIFY 5 mg tablets aripiprazole
Estonian: ABILIFY 5 mg tabletid aripiprasool
English: EU/1/04/276/024 (10 mg, 14 × 1 orodispersible tablets) EU/1/04/276/025 (10 mg, 28 × 1 orodispersible tablets) EU/1/04/276/026 (10 mg, 49 × 1 orodispersible tablets)
Estonian: EU/1/04/276/024 (10 mg, 14 × 1 suus dispergeeruvat tablett) EU/1/04/276/025 (10 mg, 28 × 1 suus dispergeeruvat tablett) EU/1/04/276/026 (10 mg, 49 × 1 suus dispergeeruvat tablett)
English: EU/1/04/276/027 (15 mg, 14 × 1 orodispersible tablets) EU/1/04/276/028 (15 mg, 28 × 1 orodispersible tablets) EU/1/04/276/029 (15 mg, 49 × 1 orodispersible tablets)
Estonian: EU/1/04/276/027 (15 mg, 14 × 1 suus dispergeeruvat tablett) EU/1/04/276/028 (15 mg, 28 × 1 suus dispergeeruvat tablett) EU/1/04/276/029 (15 mg, 49 × 1 suus dispergeeruvat tablett)
English: Alkaline phosphatase increased QT prolonged
Estonian: QT-aja pikenemine Vere glükoosisisalduse suurenemine
English: ABILIFY 15 mg orodispersible tablets aripiprazole
Estonian: ABILIFY 15 mg suus dispergeeruvad tabletid aripiprasool
English: If you miss an injection of ABILIFY
Estonian: Kui te unustate ABILIFY süstimise
English: ABILIFY 30 mg orodispersible tablets:
Estonian: ABILIFY 30 mg suus dispergeeruvad tabletid:
English: ABILIFY 15 mg tablets aripiprazole
Estonian: ABILIFY 15 mg tabletid aripiprasool
English: ABILIFY 30 mg orodispersible tablets aripiprazole
Estonian: ABILIFY 30 mg suus dispergeeruvad tabletid aripiprasool
English: Rhabdomyolysis Myalgia
Estonian: Kaaliumatsesulfaam
English: Tardive dyskinesia
Estonian: Teadmata häired
English: - a tendency to wander away.
Estonian: - tung kindla sihita hulkuda.
English: ABILIFY 5 mg tablets ABILIFY 10 mg tablets ABILIFY 15 mg tablets ABILIFY 30 mg tablets aripiprazole
Estonian: ABILIFY 5 mg tabletid ABILIFY 10 mg tabletid ABILIFY 15 mg tabletid ABILIFY 30 mg tabletid aripiprasool
English: ABILIFY 10 mg orodispersible tablets aripiprazole
Estonian: ABILIFY 10 mg suus dispergeeruvad tabletid aripiprasool
English: The recommended dose is 9.75 mg (1.3 mL) for the first injection.
Estonian: Tavaliselt on esimese süste annus 9,75 mg (1,3 ml).
English: • trembling,
Estonian: • lihasvalu,
English: Suicide attempt, suicidal ideation and completed suicide (see section 4.4)
Estonian: Suitsiidikatse, suitsidaalsed mõtted, täideviidud suitsiid (vt lõik 4.4) Patoloogiline mängurlus Impulsi kontrolli häire Liigsöömine
English: Orodispersible tablets
Estonian: Leukopeenia Neutropeenia
English: In addition, cases of stroke or "mini" stroke have been reported.
Estonian: Lisaks on esinenud ajurabandust või aju mikrorabandust.
English: Package leaflet: Information for the user ABILIFY 10 mg orodispersible tablets ABILIFY 15 mg orodispersible tablets ABILIFY 30 mg orodispersible tablets aripiprazole
Estonian: ABILIFY 10 mg suus dispergeeruvad tabletid ABILIFY 15 mg suus dispergeeruvad tabletid ABILIFY 30 mg suus dispergeeruvad tabletid
English: ABILIFY 15 mg orodispersible tablets
Estonian: ABILIFY 15 mg suus dispergeeruvad tabletid
English: Aspartate Aminotransferase increased
Estonian: Aspartaataminotransferaasi aktiivsuse suurenemine Gammaglutamüültransferaasi aktiivsuse suurenemine Aluselise fosfataasi aktiivsuse suurenemine
English: ABILIFY 10 mg orodispersible tablets:
Estonian: ABILIFY 10 mg suus dispergeeruvad tabletid:
English: • heart attack,
Estonian: • kiire südame löögisagedus,
English: ABILIFY 15 mg orodispersible tablets:
Estonian: ABILIFY 15 mg suus dispergeeruvad tabletid:
English: ABILIFY 10 mg orodispersible tablets
Estonian: ABILIFY 10 mg suus dispergeeruvad tabletid
English: Glycerin
Estonian: Pearinglus
English: The oral solution contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Estonian: Suukaudne lahus sisaldab metüülparahüdroksübensoaati ja propüülparahüdroksübensoaati.
English: Dysphagia
Estonian: Ülitundlikkus
English: Aripiprazole is well absorbed when administered orally as the solution.
Estonian: Suukaudse lahusena manustatult imendub aripiprasool hästi.
English: Hepatitis Jaundice
Estonian: Düspepsia Iiveldus
English: ABILIFY orodispersible tablets contain sodium.
Estonian: ABILIFY suus dispergeeruvad tabletid sisaldavad naatriumi.
English: Sucrose
Estonian: Minestus
English: Sodium
Estonian: Piimhape
English: Your doctor will discuss this with you.
Estonian: Teie arst arutab seda teiega.
English: This can lead to symptoms such as:
Estonian: Selle tagajärjel võivad ilmneda sellised sümptomid nagu:
English: Children and adolescents Ogivri is not recommended for anyone under the age of 18 years.
Estonian: Lapsed ja noorukid Ogivri't ei soovitata kasutada ühelgi alla 18-aastasel isikul.
English: TTP = time to progression; "ne" indicates that it could not be estimated or it was not yet reached.
Estonian: AP - aeg progresseerumiseni; „ne“ näitab, et tulemust ei saa hinnata või on veel määramata.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 12 December 2018
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV Müügiloa esmase väljastamise kuupäev: 12. detsember 2018
English: This medicinal product must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Estonian: Seda ravimpreparaati ei tohi segada ega lahjendada teiste ravimitega, välja arvatud nendega, mis on loetletud lõigus 6.6.
English: Therefore, your doctor may decide to continue to check your heart functions, even after you finish treatment.
Estonian: Seetõttu võib arst otsustada, et jätkab teie südametegevuse kontrollimist isegi pärast ravi lõppu.
English: In other situations, the decision on the need for additional cytotoxic chemotherapy is determined based on individual factors.
Estonian: Teistes olukordades tehakse otsus täiendava tsütotoksilise keemiaravi vajaduse kohta individuaalsete tegurite alusel.
English: It is not known whether trastuzumab can affect reproductive capacity.
Estonian: Ei ole teada, kas trastuzumabi võib mõjutada reproduktiivsust.
English: Median follow-up 8 years**
Estonian: Mediaanne järelkontroll 8 aastat**
English: 117 allée des Parcs 69800 Saint-Priest France
Estonian: 117 allée des Parcs 69800 Saint-Priest Prantsusmaa
English: The bioactivity of D7D and the clinical impact of the elevation of this metabolite were unclear.
Estonian: D7D bioaktiivsus ja selle metaboliidi sisalduse tõusu kliiniline mõju olid ebaselged.
English: Side effects of not known frequency: frequency cannot be estimated from the available data
Estonian: Teadmata esinemissagedusega kõrvaltoimed: sagedust ei saa olemasolevate andmete põhjal hinnata)
English: 12 weeks.
Estonian: 12 nädala jooksul;
English: The t1/2 decreases with decreasing concentrations within a dosing interval (see Table 16).
Estonian: t1/2 väheneb kontsentratsioonide vähendamisega annustamisintervalli jooksul (vt tabel 16).
English: If diluted aseptically, it may be stored for 24 hours (do not store above 30°C).
Estonian: Aseptiliselt lahjendatuna võib seda säilitada kuni 24 tundi (mitte üle 30°C).
English: Details of risk minimisation measures that are consistent with the EU Risk Management Plan are presented in (section 4.4) Warnings and Precautions.
Estonian: Üksikasjalikud andmed riski minimeerimise meetmete kohta, mis on kooskõlas EL riskijuhtimiskavaga, on toodud lõigus 4.4 „Hoiatused ja ettevaatusabinõud kasutamisel“.
English: Other medicines and Ogivri
Estonian: Muud ravimid ja Ogivri
English: Do not stop using this medicine without talking to your doctor first.
Estonian: Ärge lõpetage selle ravimi kasutamist ilma arstiga nõu pidamata.
English: Some of these symptoms can be serious and some patients have died (see section 2 under “Warnings and precautions”).
Estonian: Mõned nendest sümptomitest võivad olla tõsised ning esinenud on ka surmajuhtumeid (vt lõik 2 „Hoiatused ja ettevaatusabinõud“).
English: Ogivri should only be given by a doctor or nurse.
Estonian: Ogivri't tohib manustada ainult arst või meditsiiniõde.
English: Glucose solutions must not be used for dilution since these cause aggregation of the protein.
Estonian: Glükoosi ei tohi kasutada lahjendamiseks, kuna need põhjustavad proteiini agregatsiooni.
English: If you develop any signs of heart failure (inadequate pumping of blood by the heart), your heart function may be checked more frequently (every six to eight weeks), you may receive treatment for heart failure or you may have to stop Ogivri treatment.
Estonian: Kui teil tekivad mis tahes südamepuudulikkuse (süda ei pumpa verd piisavalt) sümptomid, kontrollitakse teie südametegevust sagedamini (iga kuue kuni kaheksa nädala järel), te võite saada südamepuudulikkuse ravi või osutub vajalikuks Ogivri'ga ravi lõpetamine.
English: Trastuzumab 1 Year N = 1702***
Estonian: Trastuzumab 1 aasta N=1702***
English: The product is not intended to be stored after reconstitution and dilution unless this has taken place under controlled and validated aseptic conditions.
Estonian: Ravimit pole ettenähtud pärast manustamiskõlblikuks muutmist ja lahjendamist säilitada välja arvatud juhul, kui see on toimunud kontrollitud ja valideeritud aseptilistes tingimustes.
English: The results of these simulations indicate that at least 95 % of patients will reach concentrations that are < 1 mcg/mL (approximately 3 % of the population predicted Cmin,ss, or about 97 % washout) by 7 months.
Estonian: Nende simulatsioonide tulemused näitavad, et vähemalt 95% patsientidest saavutavad kontsentratsioonid alla 1 mcg/ml (ligikaudu 3% populatsiooni prognoositud Cmin,ss väärtusest või ligikaudu 97% väljaviimisel organismist) 7 kuuga.
English: Trastuzumab loading dose should be administered as a 90-minute intravenous infusion.
Estonian: Trastuzumabi küllastusannus tuleb manustada 90-minutilise intravenoosse infusioonina.
English: • Your doctor will advise you of the risks and benefits of taking Ogivri during pregnancy.
Estonian: • Teie arst teavitab teid Ogivri rasedusaegse kasutamisega kaasnevatest ohtudest ja oodatavast kasust.
English: In this section, the following categories of frequency have been used: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Estonian: Selles lõigus on kasutatud järgmisi esinemissageduse kategooriaid: väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aeg-ajalt (≥ 1/1000 kuni < 1/100), harv (≥ 1/10 000 kuni < 1/1000), väga harv (< 1/10 000), teadmata (ei saa hinnata olemasolevate andmete alusel).
English: * defined as absence of any invasive cancer both in the breast and axillary nodes
Estonian: * defineeriti kui igasuguse invasiivse vähi puudumist nii rinnanäärmes kui ka kaenlaalustes lümfisõlmedes
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Estonian: Et parandada bioloogiliste ravimite jälgitavust, peab manustatud ravim nimetus ja partii number olema selgelt märgitud.
English: Observation N = 1697***
Estonian: Vaatlus N=1697***
English: See section 5.1 for chemotherapy combination dosing.
Estonian: Vt lõik 5.1 keemiaraviga kombineeritud annustamine.
English: These medicines (or any other anthracyclines) can damage heart muscle and increase the risk of heart problems with Ogivri.
Estonian: Need ravimid (või ükskõik millised teised antratsükliinid) võivad kahjustada südamelihast ja suurendada südameprobleemide tekkeriski Ogivri'ga ravi ajal.
English: Chemo + Trastuzumab (n = 115)
Estonian: Keemiaravi + trastuzumab (n = 115)
English: Treatment with Ogivri alone or with a taxane may affect the heart, especially if you have ever used an anthracycline (taxanes and anthracyclines are two other kinds of medicine used to treat cancer).
Estonian: Ravi ainult Ogivri'ga või koos taksaanidega võib mõjutada südant, eriti kui te olete kunagi kasutanud antratsükliine (taksaanid ja antratsükliinid on kaks teist tüüpi ravimit, mida kasutatakse vähiravis).
English: Heart problems can sometimes occur during treatment and occasionally after treatment has stopped and can be serious.
Estonian: Mõnikord võivad ravi ajal ja aeg-ajalt pärast ravi lõppu tekkida südameprobleemid, mis võivad olla tõsised.
English: If you experience any of the above symptoms when your treatment with Ogivri has finished, you should see your doctor and tell them that you have previously been treated with Ogivri.
Estonian: Kui teil tekib mõni ülalloetletud sümptomitest pärast Ogivri'ga ravi lõppu, pöörduge oma arsti poole ja öelge talle, et olete enne saanud ravi Ogivri'ga.
English: Once the infusion is prepared it should be administered immediately.
Estonian: Kui infusioon on ettevalmistatud, tuleb see koheselt manustada.
English: - The active substance is trastuzumab.
Estonian: - Toimeaine on trastuzumab.
English: Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.
Estonian: Patsiente tuleb teavitada nende reaktsioonide hilise tekke võimalusest ning juhendada, et nende sümptomitetekkimisel tuleb ühendust võtta oma arstiga.
English: If during treatment you experience symptoms, such as chills or fever, you should not drive or use machines until these symptoms disappear.
Estonian: Kui teil tekivad ravi ajal kõrvalnähud, nagu külmavärinad või palavik, peate hoiduma autojuhtimisest või masinate käsitsemisest seni, kuni need nähud on kadunud.
English: Ogivri is a biosimilar medicinal product.
Estonian: Ogivri on bioloogiliselt sarnane ravimpreparaat.
English: Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments
Estonian: Hormoonretseptor-positiivsetel patsientidel peab olema ebaõnnestunud ka hormoonravi, välja arvatud juhul, kui patsientidele on see raviviis sobimatu.