FrancophonIA/ELRC3.0 huggingface dataset:
English: • stomach upsets including feeling sick (nausea), being sick (vomiting), diarrhoea or constipation
Estonian: • maoärritus, sh iiveldus, oksendamine, kõhulahtisus või kõhukinnisus;
English: • high blood sugar
Estonian: • kõrge veresuhkur;
English: Each vial of 1.5 ml (nominal volume) of concentrate contains 60 mg cabazitaxel.
Estonian: Iga viaal 1,5 ml (nominaalmaht) kontsentraadiga sisaldab 60 mg kabasitakseeli (cabazitaxelum).
English: Cardiac failure events were more common on cabazitaxel, the event term being reported for 2 patients (0.5%).
Estonian: Südamepuudulikkust esines kabasitakseeliga sagedamini, juhuterminist teatati 2 patsiendil (0,5%).
English: The concentrate solution and the solvent should be clear.
Estonian: Kontsentraadilahus peab olema läbipaistev.
English: Cabazitaxel is active in docetaxel-sensitive tumours.
Estonian: Kabasitakseel toimib dotsetakseel-tundlikele kasvajatele.
English: • JEVTANA must be prepared (diluted) before it is given.
Estonian: • Enne manustamist tuleb JEVTANA lahjendada.
English: Grade ≥ 3 adverse reactionsb (%)
Estonian: ≥ 3 raskusastme kõrvaltoimedb (%)
English: JEVTANA should not be used during breast-feeding.
Estonian: Imetamise ajal ei tohi JEVTANA't kasutada.
English: • alteration in sense of taste
Estonian: • maitsetundlikkuse muutused;
English: Cabazitaxel crossed the placenta barrier in rats.
Estonian: Kabasitakseel läbis rottidel platsentaarbarjääri.
English: Delay treatment until improvement, then reduce cabazitaxel dose from 25 mg/m2 to 20 mg/m2.
Estonian: Ravi edasilükkamine kuni paranemiseni; seejärel vähendada kabasitakseeli annust tasemelt 25 mg/m2 tasemele 20 mg/m2.
English: The following adverse reactions reported at rates 5% higher in patients 65 years of age or greater compared to younger patients were fatigue (40.4% versus 29.8%), clinical neutropenia (24.2% versus 17.6%), asthenia (23.8% versus 14.5%), pyrexia (14.6% versus 7.6%), dizziness (10.0% versus 4.6%), urinary tract infection (9.6% versus 3.1%) and dehydration (6.7% versus 1.5%), respectively.
Estonian: Kõrvaltoimed, millest teatati 65-aastastel ja vanematel patsientidel ≥5% sagedamini kui noorematel patsientidel, olid väsimus (40,4% versus 29,8%), kliiniline neutropeenia (24,2% versus 17,6%), asteenia (23,8% versus 14,5%), püreksia (14,6% versus 7,6%), pearinglus (10,0% versus 4,6%), kuseteede infektsioon (9,6% versus 3,1%) ja dehüdratsioon (6,7% versus 1,5%).
English: What JEVTANA looks like and contents of the pack JEVTANA is a concentrate and solvent for solution for infusion (sterile concentrate).
Estonian: JEVTANA on infusioonilahuse kontsentraat ja lahusti (steriilne kontsentraat).
English: Table 5 - Summary of safety data for cabazitaxel 25 mg/m2 arm versus cabazitaxel 20 mg/m2 arm in EFC11785 study
Estonian: Ohutusandmete kokkuvõte kabasitakseeli annusega 25 mg/m2, võrreldes annusega 20 mg/m2, uuringus EFC11785.
English: The safety of JEVTANA in combination with prednisone or prednisolone was evaluated in 371 patients with metastatic castration resistant prostate cancer who were treated with 25 mg/m2
Estonian: JEVTANA ohutust kombinatsioonis prednisooni või prednisolooniga hinnati 371 patsiendil metastaatilise kastratsioonresistentse eesnäärmevähiga, keda raviti kabasitakseeliga annuses 25 mg/m2 üks kord iga kolme nädala järel randomiseeritud avatud kontrollitud III faasi uuringus.
English: Renal colic Haematuria Pollakiuria Hydronephrosis Urinary retention Urinary incontinence Ureteric obstruction
Estonian: Neerukoolika Hematuuria Pollakisuuria Hüdronefroos Kusepeetus Kusepidamatus Kuseteede obstruktsioon
English: Haemoglobin and haematocrit should be checked before treatment with cabazitaxel and if patients exhibit signs or symptoms of anaemia or blood loss.
Estonian: Enne ravi alustamist kabasitakseeliga ning kui patsiendil on aneemia või verekaotuse nähud või sümptomid, peab kontrollima hemoglobiini ja hematokritti.
English: A sub-group of 59 patients received prior cumulative dose of docetaxel <225 mg/m² (29 patients in JEVTANA arm, 30 patients in mitoxantrone arm).
Estonian: 59 patsiendist koosnevale alarühmale (29 patsienti JEVTANA haaras, 30 patsienti mitoksantrooni haaras) manustati eelnevalt dotsetakseeli kumulatiivne annus <225 mg/m2.
English: Exposures in animals were lower than those seen in humans receiving clinically relevant doses of cabazitaxel.
Estonian: Süsteemne saadavus loomadel oli madalam, kui inimestel kabasitakseeli kliiniliste annuste manustamisel.
English: This overfill ensures that after initial dilution with the ENTIRE content of the solvent vial, the concentration of cabazitaxel is 10 mg/ml.
Estonian: See ületäide tagab, et pärast esmast lahjendamist lahusti viaali KOGU sisuga, on kabasitakseeli kontsentratsioon lahuses 10 mg/ml.
English: The most commonly (≥5%) occurring grade ≥3 adverse reactions in the cabazitaxel group were neutropenia (81.7%), leukopenia (68.2%), anaemia (10.5%), febrile neutropenia (7.5%), diarrhoea
Estonian: raskusastmega kõrvaltoimed kabasitakseeli rühmas olid neutropeenia (81,7%), leukopeenia (68,2%), aneemia (10,5%), febriilne neutropeenia (7,5%), diarröa (6,2%).
English: In addition, patients should also refrain from taking St. John's Wort.
Estonian: Lisaks peavad patsiendid hoiduma naistepuna ürdi kasutamisest.
English: Step 2.3
Estonian: Aste 2.3
English: After initial dilution with the entire solvent, each ml of solution contains 10 mg cabazitaxel.
Estonian: Pärast esmast lahustamist kogu lahustiga sisaldab lahuse iga ml 10 mg kabasitakseeli.
English: • JEVTANA will be given to you by a doctor or a nurse.
Estonian: • Arst või meditsiiniõde manustab teile JEVTANA't.
English: Contents of the pack and other information
Estonian: Kuidas JEVTANA't säilitada Pakendi sisu ja muu teave
English: Step 2.4
Estonian: Aste 2.4
English: The PSA response was 39.2% in patients on JEVTANA arm (95%CI: 33.9-44.5) versus 17.8% of patients on mitoxantrone (95%CI: 13.7-22.0), p=0.0002.
Estonian: PSA ravivastuse määr oli JEVTANA haara patsientidel 39,2% (95%CI: 33,9...44,5) versus 17,8% mitoksantrooni haara patsientidel (95% CI: 13,7...22,0), p=0,0002.
English: Step 1.5
Estonian: Aste 1.5
English: If it should come into contact with mucous membranes, wash immediately and thoroughly with water.
Estonian: Limaskestadele sattudes peske kohe ja põhjalikult veega.
English: • Severe hepatic impairment (total bilirubin >3 x ULN).
Estonian: • Raske maksakahjustus (üldbilirubiin ≥3 x normväärtuse ülapiir.
English: This can occur if you have severe or long-lasting diarrhoea, or fever, or if you are being sick
Estonian: See võib tekkida tõsise või kauakestva kõhulahtisuse või oksendamise korral.
English: Neuropathy peripheral Peripheral sensory neuropathy Dizziness Headache Paraesthesia Lethargy
Estonian: Perifeerne neuropaatia Perifeerne sensoorne neuropaatia Pööritustunne Peavalu
English: One ml of concentrate contains 40 mg cabazitaxel.
Estonian: Üks ml kontsentraati sisaldab 40 mg kabasitakseeli (cabazitaxelum).
English: • low blood potassium
Estonian: • madal kaaliumisisaldus veres;
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 March 2011
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV
English: Oropharyngeal pain Pneumonia
Estonian: Suu ja neelupiirkonna valu Pneumoonia
English: • painful or frequent urination
Estonian: • valulik või sage urineerimine;
English: Neutropenia was the most common adverse reaction leading to medicinal product discontinuation
Estonian: Neutropeenia oli kõige sagedasem kõrvaltoime, mis viis ravi katkestamiseni (2,4%).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4.5 ml (ethanol 96% and water for injections).
Estonian: 4,5 ml (96% etanool ja süstevesi)
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.Your doctor will discuss these with you and will explain the potential risks and benefits of your treatment.
Estonian: Arst räägib teiega sellest ning selgitab teile ravi võimalikku riski ja kasu.
English: • feeling anxious
Estonian: • ärevustunne;
English: Treatment with JEVTANA is contraindicated in patients with severe hepatic impairment (total bilirubin > 3 x ULN) (See sections 4.3 and 5.2).
Estonian: Ravi JEVTANA'ga on vastunäidustatud raske maksakahjustusega patsientidel (üldbilirubiin seerumis >3 x normväärtuse ülapiir; vt lõigud 4.2 ja 4.3).
English: Grade>3 n (%)
Estonian: raskusaste n (%)
English: There was a median PSA progression of 6.4 months (95%CI: 5.1-7.3) for patients in JEVTANA arm, compared to 3.1 months (95%CI: 2.2-4.4) in the mitoxantrone arm, HR 0.75 months (95%CI: 0.63-0.90), p=0.0010.
Estonian: Aja mediaan PSA progressioonini oli JEVTANA haaras 6,4 kuud (95%CI: 5,1...7,3), võrreldes 3,1 kuuga (95%CI: 2,2...4,4) mitoksantrooni haaras; HR 0,75 (95%CI: 0,63...0,90), p=0,0010.
English: Cabazitaxel demonstrated a broad spectrum of antitumour activity against advanced human tumours xenografted in mice.
Estonian: Kabasitakseelil oli laiaspektriline kasvajavastane aktiivsus inimese kaugelearenenud kasvajakoe siirikutesse hiirtel.
English: Step 2.2
Estonian: Aste 2.2
English: Cabazitaxel should not be given to patients with severe hepatic impairment (total bilirubin >3 x ULN) (see sections 4.3, 4.4 and 5.2).
Estonian: Kabasitakseeli ei tohi manustada raske maksakahjustusega patsientidele (üldbilirubiin seerumis ≥3 x normväärtuse ülapiir (vt lõigud 4.3, 4.4 ja 5.2).
English: Patients with mild hepatic impairment (total bilirubin >1 to ≤1.5 x Upper Limit of Normal (ULN) or AST >1.5 x ULN), should have cabazitaxel dose reduced to 20 mg/m2.
Estonian: Kerge maksakahjustusega patsientidel (üldbilirubiin seerumis >1...<1,5 x normväärtuse ülapiir või ASAT >1,5 x normväärtuse ülapiir) tuleb kabasitakseeli annust vähendada tasemele 20 mg/m2.
English: In addition, cabazitaxel demonstrated activity in tumour models insensitive to chemotherapy including docetaxel.
Estonian: Lisaks toimis kabasitakseel kasvajamudelitele, mis olid resistentsed keemiaravile, k.a dotsetakseel.
English: After initial dilution of the concentrate with the solvent Chemical and physical in-use stability has been demonstrated for 1 hour at ambient temperature (15°C-30°C).
Estonian: Keemilist ja füüsikalist stabiilsust on tõestatud 1 tunni jooksul ümbritseval temperatuuril (15°C...30°C).
English: Hypoaesthesia Sciatica
Estonian: Hüpesteesia Ishias
English: Dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 x ULN or AST >1.5 x ULN), hepatic impairment (see sections 4.2 and 5.2).
Estonian: Kerge maksakahjustusega patsientidel (üldbilirubiin seerumis >1…≤1,5 x normväärtuse ülapiir või ASAT >1,5 x normväärtuse ülapiir) tuleb vähendada annust (vt lõigud 4.2 ja 5.2).
English: What you need to know before you are given JEVTANA
Estonian: Mida on vaja teada enne JEVTANA kasutamist Ärge kasutage JEVTANA't:
English: Psychiatric disorders Anxiety Confusional state Nervous system Dysgeusia
Estonian: Psühhiaatrilised häired Ärevus Segasusseisund
English: One patient in the cabazitaxel group died from cardiac failure.
Estonian: Kabasitakseeli rühmas suri üks patsient südamepuudulikkuse tõttu.
English: Step 1.4
Estonian: Aste 1.4
English: • muscle discomfort, aches or pain
Estonian: • ebamugavustunne lihastes, valulikkus või valu;
English: Very common (may affect more than 1 in 10 people):
Estonian: Väga sage (võib esineda enam kui inimesel 10-st):
English: Around 20 metabolites of cabazitaxel are excreted into human urine and faeces.
Estonian: Inimese uriini ja roojaga eritub ligikaudu 20 kabasitakseeli metaboliiti.
English: One single use clear glass vial, closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap with a colourless plastic flip-off cover, containing 4.5 ml (nominal volume) solvent.
Estonian: • Üks ühekordselt kasutatav läbipaistvast klaasist viaal, suletud halli kloorbutüül-kummikorgiga, mis on kaetud kuldset värvi alumiiniumkattega ning värvitu äratõmmatava plastkaanega; sisaldab 4,5 ml lahustit (nominaalmaht).
English: Cardiac disorders and arrhythmias
Estonian: Südame häired ja arütmiad
English: 1 ml concentrate contains 40 mg cabazitaxel.
Estonian: 1 ml kontsentraati sisaldab 40 mg kabasitakseeli.
English: Anaemia has been observed in patients receiving cabazitaxel (see section 4.8).
Estonian: Kabasitakseeliga ravitavatel patsientidel on täheldatud aneemiat (vt lõik 4.8).
English: The dose of cabazitaxel should be reduced from 25 mg/m2 to 20 mg/m2 for persistent grade >2 peripheral neuropathy (see section 4.2).
Estonian: Püsiva ≥2 raskusastmega perifeerse neuropaatia korral peab kabasitakseeli annust vähendama tasemelt 25 mg/m2 tasemele 20 mg/m2 (vt lõik 4.2).
English: Step 1.2
Estonian: Aste 1.2
English: Talk to your doctor before getting vaccinations while you are receiving JEVTANA.
Estonian: Enne vaktsineerimist JEVTANA-ravi ajal pidage nõu oma arstiga.
English: Your doctor may need to treat you.
Estonian: Vajadusel arst määrab ravi.
English: PVC infusion containers or polyurethane infusion sets should not be used for the preparation and administration of the infusion solution.
Estonian: Infusioonilahuse valmistamisel ja manustamisel ei tohi kasutada PVC-st infusioonimahuteid või polüuretaanist infusioonikomplekte.
English: Paediatric population See section 4.2
Estonian: Lapsed (vt lõik 4.2)
English: Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm3, then reduce cabazitaxel dose from 25 mg/m2 to
Estonian: Ravi edasilükkamine kuni paranemise või taandumiseni ja kuni neutrofiilide üldarv on >1500 rakku/mm3 ; seejärel vähendada kabasitakseeli annust tasemelt 25 mg/m2 tasemele 20 mg/m2.
English: No major deviation to the dose proportionality was observed from 10 to 30 mg/m² in patients with advanced solid tumours (n=126).
Estonian: Kaugelearenenud soliidtuumoritega patsientidel (n=126) ei täheldatud annusvahemikus 10...30 mg/m2 annuse proportsionaalsuses suuremaid kõrvalekaldeid.
English: Step 1.3
Estonian: Aste 1.3
English: • skin feeling hot or flushed
Estonian: • kuuma- või õhetustunne nahal;
English: Adverse reactions
Estonian: Ülitundlikkusreaktsioonid
English: Co-administration with strong CYP3A inhibitors should be avoided since they may increase the plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Estonian: Peab vältima koosmanustamist tugevatoimeliste CYP3A inhibiitoritega, sest need võivad suurendada kabasitakseeli kontsentratsiooni vereplasmas (vt lõigud 4.2 ja 4.5).
English: Inspect the concentrate vial and the supplied solvent.
Estonian: Kontrollige kontsentraadi viaali ja kaasasolevat lahustit.
English: • haemorrhoids
Estonian: • kõhuvalu;
English: One single useclear glass vial, closed with a grey chlorobutyl rubber closure sealed by an aluminium cap with a light green plastic flip-off cover, containing 1.5 ml (nominal volume) concentrate.
Estonian: • Üks ühekordselt kasutatav läbipaistvast klaasist viaal, suletud halli kloorbutüül-kummikorgiga, mis on kaetud alumiiniumkattega ning helerohelise äratõmmatava plastkaanega; sisaldab 1,5 ml kontsentraati (nominaalmaht).
English: You should not be given JEVTANA if any of the above apply to you.
Estonian: Kui ülalnimetatu kehtib teie kohta, ei tohi teile JEVTANA't manustada.
English: Concomitant medicinal products use
Estonian: Kaasuvad ravimid
English: This overfill ensures that after dilution with the ENTIRE contents of the accompanying solvent, there is solution containing 10 mg/ml cabazitaxel.
Estonian: See ületäide tagab, et pärast lahjendamist kaasasoleva lahusti viaali KOGU sisuga sisaldab lahus kabasitakseeli 10 mg/ml.
English: Co-administration with strong CYP3A inducers should be avoided since they may decrease plasma concentrations of cabazitaxel (see sections 4.2 and 4.5).
Estonian: Peab vältima koosmanustamist tugevatoimeliste CYP3A indutseerijatega, sest need võivad vähendada kabasitakseeli kontsentratsiooni vereplasmas (vt lõigud 4.2 ja 4.5).
English: Cabazitaxel is eliminated primarily via liver metabolism.
Estonian: Kabasitakseel eemaldatakse peamiselt biotransformatsiooni teel maksas.
English: Concentrate and solvent for solution for infusion (sterile concentrate).
Estonian: Infusiooonilahuse kontsentraat ja lahusti (steriilne kontsentraat).
English: Peripheral oedema Mucosal inflammation Pain
Estonian: Perifeerne ödeem Limaskestapõletik Valu
English: Solution for IV infusion after final dilution (see package leaflet).
Estonian: infusioonilahus (vt pakendi infoleht).
English: • Solvent: 4.5 ml of solvent in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by a gold colour aluminium cap covered with a colourless plastic flip-off cap. Each vial contains 4.5 ml nominal volume (fill volume: 5.67 ml).
Estonian: • Lahusti: 4,5 ml lahustit 15 ml läbipaistvast klaasist viaalis (I tüüp), suletuna halli kloorbutüülkummikorgiga, mis on kaetud kuldset värvi alumiiniumkattega ning värvitu äratõmmatava plastkaanega.
English: Step 1.1
Estonian: Aste 1.1
English: Risk of neutropenia
Estonian: Neutropeeniaoht
English: There was a significant higher rate of tumour response of 14.4% (95%CI: 9.6-19.3) in patients in the JEVTANA arm compared to 4.4% (95%CI: 1.6-7.2) for patients in the mitoxantrone arm, p=0.0005.
Estonian: Kasvaja ravivastuse määr oli JEVTANA ravihaaras oluliselt kõrgem kui mitoksantrooni haaras: vastavalt 14,4% (95%CI: 9,6...19,3) ja 4,4% (95%CI: 1,6...7,2), p=0,0005.
English: Concentrate vial: polysorbate 80 and citric acid; Solvent vial: ethanol 96% and water for injections.
Estonian: Viaal lahustiga: 96% etanool ja süstevesi.
English: Solvent vial
Estonian: Lahusti viaal
English: The incidence of atrial fibrillation was 1.1% in the cabazitaxel group.
Estonian: Kodade virvenduse esinemissagedus kabasitakseeli rühmas oli 1,1%.
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion cabazitaxel
Estonian: JEVTANA 60 mg infusioonilahuse kontsentraat ja lahusti cabazitaxelum
English: Abdominal pain upper
Estonian: QT-intervalli pikenemine
English: These medicines include the following: - ketoconazole, rifampicin (for infections); - carbamazepine, phenobarbital or phenytoin (for seizures); - St John's Wort (Hypericum perforatum) (herbal remedy for depression and other conditions); - statins (such as simvastatin, lovastatin, atorvastatin, rosuvastatin, or pravastatin) (for reducing the cholesterol in your blood); - valsartan (for hypertension); - repaglinide (for diabetes).
Estonian: • statiinid (nt simvastatiin, lovastatiin, atorvastatiin, rosuvastatiin või pravastatiin) - kolesterooli vähendamiseks teie veres;
English: Patients received a median duration of 6 cycles of cabazitaxel.
Estonian: Ravi kestuse mediaan kabasitakseeliga oli 6 tsüklit.
English: Gastrointestinal (GI) hemorrhage and perforation, ileus, colitis, including fatal outcome, have been reported in patients treated with cabazitaxel (see section 4.8).
Estonian: Kabasitakseeliga ravitud patsientidel on teatatud seedetrakti verejooksust ja perforatsioonist, iileusest, koliidist, k.a surmaga lõppenud juhud (vt lõik 4.8).
English: METHOD OF ADMINISTRATION Dilute with the ENTIRE supplied solvent.
Estonian: Lahjendada kaasasoleva lahusti KOGU sisuga.
English: Each 1.5 ml vial of concentrate contains 60 mg cabazitaxel.
Estonian: Igas 1,5 ml kontsentraati sisaldavas viaalis on 60 mg kabasitakseeli.
English: • If you get any side effects talk to your doctor, pharmacist or nurse.
Estonian: • Kui teil tekib ükskõik milline kõrvaltoime, pidage nõu oma arsti, apteekri või meditsiiniõega.
English: EXP Read the leaflet for the shelf life of the diluted solution.
Estonian: EXP Lahjendatud lahuse säilitamistingimusi vt infolehest.
English: Preparation and administration precautions
Estonian: Erihoiatused valmistamiseks ja manustamiseks
English: Risk of cardiac arrhythmias
Estonian: Hüperglükeemia Hüpokaleemia
English: Delay treatment until improvement or resolution, then reduce cabazitaxel dose from 25 mg/m2 to
Estonian: Ravi edasilükkamine kuni paranemise või taandumiseni; seejärel vähendada kabasitakseeli annust tasemelt 25 mg/m2 tasemele 20 mg/m2.
English: MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Estonian: A. RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV(AD) TOOTJA(D)
English: • Concentrate: 1.5 ml of concentrate in a 15 ml clear glass vial (type I) closed with a grey chlorobutyl rubber closure sealed by an aluminium cap covered with a light green plastic flip-off cap. Each vial contains 60 mg cabazitaxel per 1.5 ml nominal volume (fill volume: 73.2 mg of cabazitaxel/1.83 ml).
Estonian: • Kontsentraat: 1,5 ml kontsentraati 15 ml läbipaistvast klaasist viaalis ( tüüp), suletuna halli kloorbutüül-kummikorgiga, mis on kaetud alumiiniumkattega ning helerohelise äratõmmatava plastkaanega.
English: There is no known antidote to cabazitaxel.
Estonian: Kabasitakseelile ei ole teadaolevat antidooti.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION JEVTANA 60 mg sterile concentrate cabazitaxel
Estonian: JEVTANA 60 mg steriilne kontsentraat cabazitaxelum
English: • urinary tract infection
Estonian: • kuseteede infektsioon;
English: Influenza Cystitis
Estonian: TSÜTOTOKSILINE
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturers responsible for batch release
Estonian: Ravimipartii kasutamiseks vabastamise eest vastutavate tootjate nimi ja aadress
English: • muscle spasm
Estonian: • lihasvalu;
English: NAME OF THE MEDICINAL PRODUCT JEVTANA 60 mg concentrate and solvent for solution for infusion.
Estonian: JEVTANA 60 mg infusioonilahuse kontsentraat ja lahusti.
English: Cabazitaxel is minimally excreted through the kidney.
Estonian: Kabasitakseel eritub neerude kaudu minimaalselt.
English: What JEVTANA contains
Estonian: Kuidas JEVTANA välja näeb ja pakendi sisu
English: Grade ≥ 3 anaemia
Estonian: Neutropeeniaa* Aneemiaa
English: Instructions for use
Estonian: Manustamisviis
English: • dizziness
Estonian: • hingeldus;
English: The MTD of cabazitaxel in patients with severe hepatic impairment was not established.
Estonian: Raske maksakahjustusega patsientidel ei ole kabasitakseeli maksimaalne talutav annus kindlaks tehtud.
English: However, in-use storage time can be longer under specific conditions mentioned in section Shelf life and special precautions for storage above.
Estonian: „Säilitamistingimused ja erihoiatused säilitamiseks“, võib kasutusaeg pikem olla.
English: Cystitis due to radiation recall phenomenon, including haemorrhagic cystitis, were reported uncommonly.
Estonian: Neerude ja kusteede häired Aeg-ajalt on teatatud tsüstiidist, k.a hemorraagilisest tsüstiidist kiiritusravi järelreaktsioonina.
English: Concentratesolvent mixture 10 mg/ml
Estonian: Lahjendamise järgselt sisaldab lahus kabasitakseeli 10 mg/ml.
English: Each vial of concentrate contains 60 mg cabazitaxel.
Estonian: Iga kontsentraadi viaal sisaldab 60 mg kabasitakseeli.
English: Cardiac disorders* Atrial fibrillation Tachycardia
Estonian: Südame häired* Kodade virvendus Tahhükardia
English: Risk of renal failure
Estonian: Neerupuudulikkuse oht
English: Vomiting
Estonian: Artralgia
English: Abdominal distension
Estonian: Paresteesia Letargia
English: Acute renal failure Renal failure Dysuria
Estonian: Äge neerupuudulikkus Neerupuudulikkus Düsuuria
English: • mental confusion
Estonian: • pööritustunne;
English: Gastroesophageal reflux disease
Estonian: Düspepsia Ülakõhuvalu Hemorroidid Gastroösofageaalne reflukshaigus Päraku hemorraagia Suukuivus Kõhupuhitus
English: Posology and method of administration, and/or 4.4.
Estonian: „Annustamine ja manustamisviis“ ja/või 4.4.