FrancophonIA/ELRC3.0 huggingface dataset:
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should normally not be longer than 24 hours at 2C - 8C followed by up to 24 hours at room temperature (23C27C) during administration.
Estonian: Vastasel korral vastutab säilitamise aja ja tingimuste eest kasutaja ning see ei tohiks temperatuuril 2 C - 8 C ületada 24 tundi ja sellejärgselt toatemperatuuril (23 C - 27 C) manustamise ajal kuni 24 tundi.
English: The recommended dose regimen for galsulfase is 1 mg/kg body weight administered once every week as an intravenous infusion over 4 hours.
Estonian: Soovitatav annusevahemik on 1 mg galsulfaasi kg kehakaalu kohta, mida manustatakse üks kord nädalas intravenoosse neljatunnise infusiooni teel.
English: There have been post-marketing reports of patients treated with Naglazyme who experienced the onset or worsening of SCC requiring decompression surgery.
Estonian: Turuletulekujärgselt on esinenud Naglazymega ravitud patsientidel selja-/peaaju kompressiooni tekkimise või süvenemise juhtumeid, mis vajasid dekompressioonioperatsiooni.
English: Naglazyme treatment should be supervised by a physician experienced in the management of patients with MPS VI or other inherited metabolic diseases.
Estonian: Naglazyme-ravi peab toimuma MPS VI või teiste pärilike ainevahetushaiguste ravi kogemusega arsti järelvalve all.
English: Before dilution, each vial is to be inspected for particulate matter and discolouration.
Estonian: Enne lahjendamist tuleb kõiki viaale kontrollida võõrosakeste ja värvimuutuse suhtes.
English: The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles.
Estonian: Selge kuni kergelt opaliseeruv ja värvitu kuni helekollane lahus ei tohi sisaldada nähtavaid osakesi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution contains 1 mg galsulfase.
Estonian: TOIMEAINE(TE) SISALDUS Iga ml lahust sisaldab 1 mg galsulfaasi.
English: If you experience any reaction like this, please tell your doctor immediately.
Estonian: Mõne nimetatud reaktsiooni tekkimisel öelge seda kohe arstile.
English: • Low blood-oxygen
Estonian: • vere madal hapnikutase
English: People with MPS VI disease have either a low level, or no level, of an enzyme called N-acetylgalactosamine 4-sulfatase, which breaks down specific substances (glycosaminoglycans) in the body.
Estonian: VI tüüpi mukopolüsahharidoosiga inimestel on ensüümi N-atsetüülgalaktosamiini 4-sulfataasi tase madal või see ensüüm puudub; see ensüüm lagundab organismis teatavaid aineid (glükoosaminoglükaane).
English: Your doctor or nurse will administer Naglazyme to you.
Estonian: Naglazyme't manustab teile arst või õde.
English: Abdominal pain1, umbilical hernia1, vomiting, nausea
Estonian: Kõhuvalu1, nabasong1, oksendamine, iiveldus
English: Caution must be exercised in the management and treatment of patients with compromised airways by limitation or careful monitoring of antihistamine and other sedative medicinal product use.
Estonian: Neil juhtudel tuleb ravi antihistamiinide ja teiste sedatiivsete ravimitega piirata või patsiente hoolikalt jälgida.
English: How this medicine works
Estonian: Kuidas see ravim toimib
English: This medicinal product has been authorised under "Exceptional Circumstances".
Estonian: Ravimpreparaat on saanud müügiloa erandlikel asjaoludel.
English: A volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion is to be withdrawn and discarded from a 250 ml infusion bag equal to the total volume of Naglazyme to be added.
Estonian: 9 mg/ml (0,9%) naatriumkloriidi infusioonilahuse 250 ml kotist tuleb eemaldada lisatava Naglazyme'i mahu võrra lahust ja see ära visata.
English: • When new information is received that may impact on the current Safety
Estonian: • Kui on laekunud uus informatsioon, mis võib avaldada mõju kehtivale ohutuse spetsifikatsioonile, ravimiohutuse plaanile või riski minimeerimise tegevustele.
English: • Increased heart rate
Estonian: • südametegevuse kiirenemine
English: Diluted solutions: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C).
Estonian: Lahjendatud lahused: keemiliste ja füüsikaliste omaduste püsivus on toatemperatuuril (23 C - 27 C) tõestatud kuni 4 päeva.
English: The volume of Naglazyme is to be slowly added to the sodium chloride 9 mg/ml (0.9%) solution for infusion.
Estonian: Naglazyme'i vajalik kogus tuleb aeglaselt lisada 9 mg/ml (0,9%) naatriumkloriidi infusioonilahusesse.
English: Samples from those subjects who have a consistent increase in urinary GAG values together with high antibody levels will have their antibody samples assessed for evidence of neutralizing activities.
Estonian: Püsivalt suurte uriini-GAG väärtuste ja samaaegselt ka kõrgete antikehatasemetega uuritavatelt kogutud proovidest tehakse antikehade analüüse, et hinnata võimalikku neutraliseerivat toimet.
English: The solution is to be mixed gently before infusion.
Estonian: Enne infusiooni tuleb lahust õrnalt segada.
English: Table 1: Frequency of adverse drug reactions with Naglazyme
Estonian: Tabel 1: Naglazyme'i kõrvaltoimete esinemissagedus MedDRA Organsüsteemi klass
English: Pharyngitis1, gastroenteritis1
Estonian: Infektsioonid ja infestatsioonid Farüngiit1,gastroenteriit1
English: Dyspnoea1, nasal congestion1
Estonian: Düspnoe1, ninakinnisus1
English: Laryngeal oedema, hypoxia, tachypnoea
Estonian: Kõriturse, hüpoksia, tahhüpnoe
English: Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture.
Estonian: Galsulfaas on inimese N-atsetüülgalaktosamiini 4-sulfataasi rekombinantne vorm, mis on valmistatud hiina hamstri munasarja rakukultuuri DNA rekombinatsioonil.
English: Galsulfase is recombinant human N-acetylgalactosamine 4-sulfatase produced by genetically engineered Chinese Hamster Ovary (CHO) cells.
Estonian: Galsulfaas on inimese N-atsetüülgalaktosamiini 4-sulfataasi rekombinantne vorm, mis on valmistatud hiina hamstri munasarja rakkude geneetilisel töötlusel.
English: Higher antibody levels (≥ 65610 Dilution Fraction) will be compared with the subject's urinary GAG values with a view to assess potential impacts on efficacy.
Estonian: Et hinnata võimalikku mõju efektiivsusele, uuritakse seoseid kõrgemate antikehatasemete (≥ 65610 lahjendusfraktsioon) ja uriini-GAG (glükoosaminoglükaanide) sisalduse vahel.
English: The concentrate for solution for infusion has to be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion using aseptic technique.
Estonian: Infusioonilahuse kontsentraat tuleb lahjendada 9 mg/ml (0,9%) naatriumkloriidi infusioonilahusega, järgides aseptika nõudeid.
English: The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature.
Estonian: Naglazyme infusiooni ettevalmistus (järgida aseptika nõudeid) Ravitava patsiendi kehakaalu arvestades tuleb kindlaks teha lahjendatavate viaalide arv ja võtta need külmkapist välja ligikaudu 20 minutit enne, et lasta neil toatemperatuurini soojeneda.
English: • Nasal congestion
Estonian: • naba väljavõlvumine
English: Serious adverse reactions included laryngeal edema, apnoea, pyrexia, urticaria, respiratory distress, angioedema, asthma and anaphylactoid reaction.
Estonian: Tõsised kõrvaltoimed olid kõriturse, apnoe, palavik, nõgestõbi, respiratoorne distress, angioödeem, astma ja anafülaksialaadne reaktsioon.
English: PSURs The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP.
Estonian: Müügiloa hoidja jätkab iga-aastaste perioodiliste ohutusaruannete esitamist, kui inimravimite komitee ei ole teisiti otsustanud.
English: The secondary efficacy endpoints were the rate of stairs climbed in three minutes and the urinary glycosaminoglycan excretion of treated patients compared to placebo at Week 24.
Estonian: Sekundaarne tulemusnäitaja oli kolme minuti jooksul astutud trepiastmete arv ja uriini eritunud glükoosaminoglükaani hulk.
English: It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Estonian: Pole teada, kas galsulfaas imendub rinnapiima.
English: A brief update will be submitted as part of the Annual Reassessments.
Estonian: Lühike ülevaade uuendustest edastatakse igaaastase hindamisaruandega
English: The solution is to be visually inspected for particulate matter prior to use.
Estonian: Enne kasutust tuleb lahust silmaga kontrollida võõrosakeste suhtes.
English: Ear pain1, hearing impaired1
Estonian: Kõrva ja labürindi kahjustused Kõrvavalu1, kuulmise halvenemine1
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Estonian: MANUSTAMISVIIS JA -TEE Enne ravimi kasutamist lugege pakendi infolehte Intravenoosne
English: Naglazyme is supplied as a concentrate for solution for infusion.
Estonian: Naglazyme on saadaval infusioonilahuse kontsentraadina.
English: In case of a mild or moderate IAR, treatment with antihistamines and paracetamol should be considered and/or a reduction in the infusion rate to half the rate at which the reaction occurred.
Estonian: Kergete kuni keskmise raskusega infusiooniga seotud reaktsioonide korral tuleks kaaluda ravi antihistamiinide ja paratsetamooliga ja/või reaktsiooniaegse infusiooni manustamise kiiruse aeglustamist kaks korda.
English: - This medicine has not been tested in patients with kidney or liver problems.
Estonian: - Neeru- ja maksahäiretega patsientidel ei ole selle ravimi kasutamist uuritud.
English: The following information is intended for medical or healthcare professionals only: Naglazyme should not be mixed with other medicinal products in the same infusion, except for those mentioned below.
Estonian: Naglazyme'i ei tohi segada teiste ravimitega samasse infusioonikotti.
English: • Wheezing • Skin redness
Estonian: • vilistav hingamine • nahapunetus
English: Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD. Galsulfase is comprised of 495 amino acids after cleavage of the N-terminus.
Estonian: Puhastatud galsulfaas on ligikaudu 56 kD molekulkaaluga glükoproteiin, inimese Natsetüülgalaktosamiini 4-sulfataasi rekombinantne vorm.
English: Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Estonian: Mukopolüsahhariidide ladestumishaigused on põhjustatud spetsiifiliste lüsosomaalsete ensüümide puudusest organismis.
English: MPS VI is a heterogeneous and multisystemic disorder characterized by the deficiency of N-acetylgalactoasamine 4-sulfatase, a lysosomal hydrolase which catalyses the hydrolysis of sulfate moiety of the glycosaminoglycan, dermatan sulfate.
Estonian: MPS VI on heterogeenne ja multisüsteemne haigus, mida iseloomustab N-atsetüülgalaktosamiini 4sulfataasi puudus.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Naglazyme, 1 mg/ml infusioonilahuse kontsentraat Galsulfaas
English: Sodium phosphate dibasic, heptahydrate
Estonian: Kahealuseline naatriumfosfaatheptahüdraat
English: Interim results will be provided in the CSP Annual Reports.
Estonian: Vahetulemused esitatakse kliinilise järelevalveprogrammi aastaaruannetes
English: Institution of positive-airway pressure during sleep as well as potential tracheostomy in clinically appropriate situations should also be considered.
Estonian: Kui kliiniline seisund nõuab, tuleks kaaluda positiivse rõhuga mehhaanilise ventilatsiooni rakendamist une ajal ja trahheostoomia rajamist.
English: NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion
Estonian: RAVIMPREPARAADI NIMETUS Naglazyme 1 mg/ml infusioonilahuse kontsentraat
English: There is no evidence for special considerations when Naglazyme is administered to the paediatric population.
Estonian: Puuduvad tõendid erikaalutluste arvessevõtmiseks Naglazyme manustamisel lastele.
English: The most common adverse reactions were pyrexia, rash, pruritus, urticaria, chills/rigors, nausea, headache, abdominal pain, vomiting and dypsnoea.
Estonian: Kõige sagedamad kõrvaltoimed olid palavik, lööve, kihelus, nõgestõbi, külmavärinad/vappekülm, iiveldus, peavalu, kõhuvalu, oksendamine ja düspnoe.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Clear type 1, 5 ml VIAL
Estonian: MINIMAALSED NÕUDED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
English: BioMarin Pharmaceutical Inc.
Estonian: Infusioonilahuse kontsentraat.
English: Angioeodema1, rash1, urticaria, pruritus Very Common Erythema
Estonian: Angioödeem1, lööve1, nõgestõbi, kihelus
English: Spinal/cervical cord compression (SCC) with resultant myelopathy is a known and serious complication that can be due to MPS VI.
Estonian: VI tüüpi mukopolüsahharidoosi teadaolev ja tõsine võimalik tüsistus on selja-/peaaju kompressioon koos sellest tuleneva müelopaatiaga.
English: • Decreased heart rate
Estonian: • südametegevuse aeglustumine
English: Due Date
Estonian: Tähtaeg
English: The solution must be diluted further before it can be infused.
Estonian: Enne infusiooni teel manustamist tuleb lahust lahjendada.
English: Concentrate for solution for infusion.
Estonian: See vähendab võimalust infusiooniga seotud reaktsioonide tekkeks.
English: Spinal or cervical cord compression
Estonian: Selja- või peaaju kompressioon
English: • Malaise
Estonian: • hingeldus
English: Pallor
Estonian: Süstevesi
English: • Tremor
Estonian: • treemor
English: In the Naglazyme clinical trials, IARs were usually manageable by interrupting or slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol), thus enabling the patient to continue treatment.
Estonian: Samuti kui patsient sai (eel-) ravi antihistamiinide ja/või palavikuvastaste ravimitega (paratsetamool).
English: NAME OF THE MEDICINAL PRODUCT Naglazyme 1 mg/ml concentrate for solution for infusion Galsulfase
Estonian: Naglazyme 1 mg/ml infusioonilahuse kontsentraat Galsulfaas
English: Sodium phosphate monobasic, monohydrate
Estonian: Ühealuseline naatriumfosfaatmonohüdraat
English: • Skin paleness
Estonian: • ninakinnisus
English: • Itching
Estonian: • kipitus
English: • non-small-cell lung cancer.
Estonian: Mitteväikerakk-kopsuvähk
English: • breast cancer.
Estonian: Rinnanäärmevähk
English: Taxespira docetaxel
Estonian: Docetaxelum
English: The full EPAR and risk management plan summary for Taxespira can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Täpne teave selle ravimi kohta on Euroopa Ravimiameti kodulehel http://www.ema.europa.eu/.
English: What is Taxespira and what is it used for?
Estonian: Mis ravim on Taxespira ja milleks seda kasutatakse
English: EMA/13030/2016 EMEA/H/C/003925
Estonian: EU/1/15/1017/001 EU/1/15/1017/002 EU/1/15/1017/003
English: This summary was last updated in 01-2016.
Estonian: Infoleht on viimati uuendatud <{KK/AAAA}> <{kuu AAAA}>.
English: Previously known as Docetaxel Hospira UK Limited.
Estonian: Hospira UK Limited Horizon,
English: Taxespira is used with cisplatin and 5-fluorouracil.
Estonian: Kombinatsioon tsisplatiini ja 5-fluorouratsiiliga
English: How is Taxespira used?
Estonian: Kuidas Taxespira'i kasutada
English: What measures are being taken to ensure the safe and effective use of Taxespira?
Estonian: RAVIMPREPARAADI OHUTU JA EFEKTIIVSE KASUTAMISE TINGIMUSED JA
English: Taxespira is available as a concentrate for solution for infusion (drip) into a vein and is given as a onehour infusion every three weeks.
Estonian: Dotsetakseeli manustatakse ühetunnilise infusioonina iga kolme nädala järel.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Estonian: SL6 6RJ United Kingdom
English: The active substance docetaxel, belongs to the group of anticancer medicines known as the taxanes.
Estonian: Dotsetakseel kuulub taksoidideks nimetatavate kasvajavastaste ravimite gruppi.
English: For practical information about using Taxespira, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui teil on lisaküsimusi selle ravimi kasutamise kohta, pidage nõu oma arsti või haiglaapteekriga.
English: EPAR summary for the public
Estonian: Üldised juhised
English: Further information can be found in the summary of the risk management plan.
Estonian: Ajakohastatud riskijuhtimiskava tuleb esitada:
English: By keeping the skeleton intact the cells cannot divide and they eventually die.
Estonian: Kristallide esinemisel ei tohi lahust enam kasutada ning see tuleb ära visata.
English: It is not intended to provide practical advice on how to use Taxespira.
Estonian: Mida on vaja teada enne Taxespira'i kasutamist Ärge kasutage Taxespira'i
English: The name of the medicine was changed to Taxespira on 12 October 2015.
Estonian: Selle ravimi nimi on Taxespira.
English: Taxespira is used with prednisone or prednisolone (anti-inflammatory medicines);
Estonian: - Eesnäärmevähi ravis manustatakse Taxespira'i kombinatsioonis prednisooni või prednisolooniga.
English: It can also be used with other cancer medicines (doxorubicin, cyclophosphamide, trastuzumab or capecitabine) in patients who have not yet received any treatment for their cancer or after other treatments have failed, depending on the type and stage of the breast cancer being treated;
Estonian: Teie arst määras teile Taxespira'i rinnanäärme vähi, kopsuvähi erivormi (mitteväikerakk-kopsuvähk), eesnäärmevähi, maovähi või pea ja kaelapiirkonna vähi raviks: - Kaugelearenenud rinnanäärmevähi raviks võib Taxespira'i manustada kas üksinda, kombinatsioonis doksorubitsiiniga, kombinatsioonis trastuzumabiga või kombinatsioonis kapetsitabiiniga.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Docetaxel Hospira UK Limited on 28 August 2015.
Estonian: Patsiendile vajaliku annuse manustamiseks võib olla vaja rohkem kui ühte Doxetaxel Hospira UK Limited'i infusioonilahuse kontsentraadi viaali.
English: Taxespira is only used when the neutrophil count (the level of a type of white blood cell in the blood) is normal (at least 1,500 cells/mm3).
Estonian: Järgnevates tsüklites ei tohi dotsetakseeli manustada, kuni neutrofiilide arv 75 mg/m on taastunud tasemele > 1500 rakku/mm ja trombotsüütide arv > 100 000 rakku/mm 3.
English: Taxespira is used in wards specialising in chemotherapy (using medicines to treat cancer) under the supervision of a doctor who is qualified in the use of chemotherapy.
Estonian: Vajalik on G-CSF profülaktiline manustamine vähendamaks hematoloogilise toksilisuse tekke ohtu (vt Annuse korrigeerimine ravi käigus).
English: • gastric adenocarcinoma (a type of stomach cancer) in patients who have not yet received any treatment for their cancer.
Estonian: gastroösofageaalliidese adenokartsinoomi raviks patsientidel, kes ei ole varem saanud keemiaravi metastaatilise haiguse raviks.
English: The dose, duration of treatment and the medicines it is used with depend on the type of cancer being treated.
Estonian: Kontratseptsioon meestel ja naistel Ravi ajal peab kasutama efektiivset kontratseptsiooni meetodit.
English: Taxespira is used with cisplatin and 5-fluorouracil (other cancer medicines);
Estonian: Taxespira kombinatsioonis tsisplatiini ja 5-fluorouratsiiliga on näidustatud mao metastaatilise adenokartsinoomi, k.a.
English: An antiinflammatory medicine such as dexamethasone should also be given to the patient, starting on the day before the Taxespira infusion.
Estonian: Olulise tähtsusega kliinilises uuringus manustati dotsetakseeli esimene infusioon järgmisel päeval pärast trastuzumabi esimese annuse manustamist.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Taxespira has been shown to be comparable to Taxotere.
Estonian: WHO sooritusseisundi esimese halvenemiseni kulunud aja mediaan oli oluliselt pikem TPF haaras, võrreldes PF-ga.
English: The company also showed that Taxespira solution for infusion has comparable quality to that of Taxotere.
Estonian: Uuringus ei suudetud tõestada dotsetakseeli ja karboplatiini kombinatsiooni efektiivsuse samasust ega vähemust võrreldes Vcis standardraviga.
English: How does Taxespira work?
Estonian: Kuidas Taxespira'i säilitada
English: Docetaxel blocks a stage of cell division, whereby the internal ‘skeleton' is dismantled to allow the cell to divide.
Estonian: In vitro on näidatud, et dotsetakseel katkestab mikrotubulaarse võrgustiku rakkudes, mis on eluliselt vajalikud raku mitootiliste ja interfaasi funktsioonide jaoks.
English: For more information about treatment with Taxespira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: - Kui teil on lisaküsimusi, pidage nõu oma arsti, haiglaapteekri või meditsiiniõega.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Taxespira, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Sellega tuleb arvestada raseduse ja imetamise ajal, lastel ja kõrgriskirühma kuuluvatel patsientidel, nt maksahaiguse või epilepsia korral.
English: Because Taxespira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Taxespira on kasvajatevastane aine, mille käsitsemisel ning Taxespira lahuste valmistamisel tuleb sarnaselt teiste potentsiaalselt toksiliste ainetega olla ettevaatlik.
English: For more information on generic medicines, see the question-and-answer document here.
Estonian: Trastuzumabi annuse kohandamise kohta informatsiooni saamiseks lugege trastuzumabi ravimi omaduste kokkuvõtet.
English: No additional studies in humans were needed as Taxespira is a generic medicine that is given by infusion and contains the same active substance as Taxotere.
Estonian: In vivo on dotsetakseel rakutsüklist sõltumatu ja teda iseloomustab lai eksperimentaalse kasvajavastase aktiivsuse spekter hiire ja inimese kaugelearenenud siirdatud kasvajate suhtes.
English: For more information, see the summary of product characteristics.
Estonian: Täpsemat informatsiooni saab trastuzumabi ravimi omaduste kokkuvõttest.
English: Docetaxel also affects non-cancer cells such as blood cells, which can cause side effects
Estonian: Dotsetakseeli infusioonilahus on üleküllastunud, mistõttu selles võib aja jooksul tekkida kristalliseerumine.
English: Taxespira contains the active substance docetaxel and is a ‘generic medicine'.
Estonian: Üks ml kontsentraati sisaldab 20 mg dotsetakseeli (trihüdraadina).
English: Other information about Taxespira
Estonian: Taxespira kombinatsioonis trastuzumabiga
English: What are the benefits and risks of Taxespira?
Estonian: Üldiselt näitavad uuringutulemused TAC-i kasu/riski suhte positiivsust FAC suhtes.
English: The company provided data from the published literature on docetaxel.
Estonian: Prednisoonil puudus dotsetakseeli farmakokineetikale statistiliselt oluline toime.
English: CI - confidence interval.
Estonian: CI, confidence interval - usaldusintervall.
English: - if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives).
Estonian: - kui teil on kunagi tekkinud allergiline reaktsioon sarnast tüüpi ravimi suhtes (karbamiidi derivaadid).
English: Date of first authorisation: 04 December 1998 Date of latest renewal: 21 May 2008
Estonian: Müügiloa esmase väljastamise kuupäev: 04. detsember 1998 Müügiloa viimase uuendamise kuupäev: 21. mai 2008
English: Not known (frequency cannot be estimated from the available data)
Estonian: Teadmata (ei saa hinnata olemasolevate andmete alusel)
English: Source: Study D2340-Table 11-6 and Table 11-7
Estonian: Allikas: Uuring D2340-Tabel 11-6 ja Tabel 11-7