FrancophonIA/ELRC3.0 huggingface dataset:
English: Suomi/Finland VIRBAC
Estonian: Suomi/Finland
English: WITHDRAWAL PERIOD(S) Withdrawal periods: Meat and offal: 13 days.
Estonian: Keeluaeg: lihale ja söödavatele kudedele: 13 päeva.
English: 4) Turn the ring, in order to select the weight of the calf to be treated.
Estonian: 4) Keerake rõngast ravitava vasika kehamassi valimiseks.
English: 1) Choose the dip tube designed for the height of the bottle (the shorter one for the 490 ml bottle and the longer one for the 980 ml bottle) and insert it into the free hole located in the base of the pump cap. 2) Remove the cap of the bottle and screw the pump on.
Estonian: 1) Valige toru, mis sobib pudeli kõrgusega (lühem 490 ml pudelile ja pikem 980 ml pudelile), ja sisestage see tühja auku, mis paikneb pumba korgi all.
English: Active substance: halofuginone (as lactate salt)
Estonian: Toimeaine halofuginoon (laktaatsoolana)
English: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Estonian: Õige annuse tagamiseks on vajalik kasutada süstalt või sobivat vahendit suukaudseks manustamiseks.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Väliskarp
English: - Wear protective gloves while handling the product.
Estonian: - Veterinaarravimi käsitsemisel tuleb kanda kaitsekindaid.
English: Boxes with a metering pump:
Estonian: Mõõtepumbaga karbid:
English: STATEMENT OF ACTIVE SUBSTANCES Each ml contains:
Estonian: Üks ml sisaldab:
English: 5) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
Estonian: 5) Pumba täitmiseks vajutage õrnalt päästikule, kuni otsaku tippu tekib tilk.
English: [Bottle with a 4 to 12 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Estonian: [4 ml kuni 12 ml pumbaga pudel:] Õige annuse tagamiseks tuleb valida kõige sobivam mõõtepump sõltuvalt ravitavate loomade kehamassist.
English: 4) Prime the pump by pressing the trigger gently, until a drop appears at the tip of the nozzle.
Estonian: 4) Pumba täitmiseks vajutage õrnalt päästikule, kuni otsaku tippu tekib tilk.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains:
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer responsible for batch release VIRBAC
Estonian: Ravimipartii vabastamise eest vastutava tootja nimi ja aadress VIRBAC
English: Bottle without a pump: To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Estonian: Ilma pumbata pudel: õige annuse tagamiseks on vajalik kasutada süstalt või sobivat vahendit suukaudseks manustamiseks.
English: Bottle with a pump: To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Estonian: Pumbaga pudel: õige annuse tagamiseks tuleb valida kõige sobivam mõõtepump sõltuvalt ravitavate loomade kehamassist.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves halofuginone
Estonian: Kriptazen 0,5 mg/ml suukaudne lahus vasikatele halofuginonum
English: Cardboard box containing one 500 ml bottle (high-density polyethylene) containing 490 ml of solution or one 1000 ml bottle containing 980 ml of solution, sealed with a high density polyethylene cap, with or without a metering pump, with two different lengths dip tubes (22 and 24 cm) made of ethylenevinyl acetate.
Estonian: Pappkarp, milles on üks 500 ml pudel (suure tihedusega polüetüleen), mis sisaldab 490 ml lahust, või üks 1000 ml pudel, mis sisaldab 980 ml lahust, suletud suure tihedusega polüetüleenist korgiga, koos mõõtepumbaga või ilma selleta, etüleen-vinüülatsetaadist valmistatud toruga.
English: [Bottle without a pump:] To ensure a correct dosage, the use of either a syringe or any appropriate device for oral administration is necessary.
Estonian: [Ilma pumbata pudel:] Õige annuse tagamiseks on vajalik kasutada süstalt või sobivat vahendit suukaudseks manustamiseks.
English: 5) Restrain the calf and insert the nozzle of the metering pump into its mouth 6) Pull the trigger of the metering pump completely for release of a dose that equals 4 ml of solution.
Estonian: 6) Vajutage lõpuni mõõtepumba päästikule, et vabastada 4 ml lahusega võrdne annus.
English: Package with a metering pump:
Estonian: Mõõtepumbaga pakend:
English: DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION Date of first authorisation: 08/02/2019
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE / MÜÜGILOA UUENDAMISE KUUPÄEV
English: Marker residue Animal species MRLs
Estonian: Farmakoloogilise toimega aine Markerjääk Loomaliigid Jääkide piirnormid Sihtkoed Muud sätted Terapeutiline klassifikatsioon
English: [Bottle with a 4 ml pump:] To ensure a correct dosage, the most appropriate metering pump should be selected, depending on the weight of the animals to be treated.
Estonian: [4 ml pumbaga pudel:] Õige annuse tagamiseks tuleb valida kõige sobivam mõõtepump sõltuvalt ravitavate loomade kehamassist.
English: PACKAGE LEAFLET: Kriptazen 0.5 mg/ml oral solution for calves NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC 1ère avenue - 2065 m - LID 06516 Carros France
Estonian: PAKENDI INFOLEHT Kriptazen 0,5 mg/ml suukaudne lahus vasikatele MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMIPARTII VABASTAMISE EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
English: Unchanged halofuginone is the major component in the tissues.
Estonian: Kudedes on peamine komponent muutumatu halofuginoon.
English: 9) Always replace the cap on the tip of the nozzle after use.
Estonian: 9) Pange pärast kasutamist alati kork tagasi otsaku tipu peale.
English: 8) Always replace the cap on the tip of the nozzle after use.
Estonian: 8) Pange pärast kasutamist alati kork tagasi otsaku tipu peale.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER VIRBAC
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS
English: Specific pharmacovigilance requirements:
Estonian: Ravimohutuse järelevalve nõuded
English: Cattle (new born calves): - Prevention of diarrhoea due to diagnosed Cryptosporidium parvum, in farms with history of
Estonian: Veised (vastsündinud vasikad) - Diagnoositud Cryptosporidium parvum'i põhjustatud kõhulahtisuse ennetamine farmides, kus on Manustamine peab algama esimese 24 kuni 48 elutunni jooksul.
English: Withdrawal period(s)
Estonian: Keeluaeg (-ajad)
English: METHOD AND ROUTE(S) OF ADMINISTRATION For oral use.
Estonian: MANUSTAMISVIIS JA -TEE(D)
English: MARKETING AUTHORISATION HOLDER VIRBAC
Estonian: MÜÜGILOA HOIDJA
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kriptazen 0.5 mg/ml oral solution for calves.
Estonian: Kriptazen 0,5 mg/ml suukaudne lahus vasikatele.
English: (as lactate salt) Excipients:
Estonian: (laktaatsoolana)
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION For oral use in calves after feeding.
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISVIIS(ID) JA -MEETOD
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Estonian: B. TARNIMIS- JA KASUTAMISTINGIMUSED VÕI PIIRANGUD
English: Therapeutic classification
Estonian: VETERINAARRAVIMI NIMETUS
English: AUTHORISATION
Estonian: Toimeaine
English: PHARMACEUTICAL FORM Oral solution.
Estonian: Retseptiravim.
English: EU/1/15/1024/002 Keytruda 25 mg/ml
Estonian: 50 mg Infusioonilahuse kontsentraadi pulber mg/ml
English: Concentrate for solution for infusion
Estonian: Infusioonilahuse kontsentraat
English: The exact cause is not known.
Estonian: Selle täpne põhjus ei ole teada.
English: The estimated 1-year survival rate was 41%.
Estonian: Hinnanguline 1-aasta elulemuse määr oli 41%.
English: After opening
Estonian: Pärast avamist
English: OTHER SPECIAL WARNING(S), IF NECESSARY For single use only.
Estonian: TEISED ERIHOIATUSED (VAJADUSEL) Ainult ühekordseks kasutuseks.
English: ATC code: L01XC17.
Estonian: ATC-kood: L01XC17.
English: Patients were enrolled regardless of their PD-L1 status.
Estonian: Patsiente kaasati sõltumata nende PD-L1 staatusest.
English: Efficacy results are shown in Table 3.
Estonian: Efektiivsuse tulemused on toodud Tabelis 3.
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Estonian: Teie arst räägib nendest teiega ning selgitab teie raviga seotud võimalikke ohte ja hüvesid.
English: However, the role of this biomarker (PD-L1 expression) has not been fully elucidated.
Estonian: Sellele vaatamata ei ole selle biomarkeri (PD-L1 ekspressioon) osatähtsus välja selgitatud.
English: The PFS was measured by RECIST version 1.1.
Estonian: PFS mõõdeti vastavalt RECIST versioonile 1.1.
English: The majority of patients were white (93%) and male (76%).
Estonian: Enamik patsientidest olid valged (93%) ja meessoost (76%).
English: Before treatment, your doctor will check your general health.
Estonian: Enne ravi algust kontrollib arst teie üldist tervislikku seisundit.
English: This helps increase their activity against the lung cancer cells.
Estonian: See suurendab nende aktiivsust vähirakkude vastu.
English: It is important that you keep this Alert Card and show it to your partner or caregivers.
Estonian: Kandke seda kaarti kogu aeg endaga kaasas ning näidake seda oma partnerile või hooldajale.
English: The primary efficacy outcome measure was overall survival (OS).
Estonian: Esmane efektiivsuse tulemusnäitaja oli üldine elulemus (overall survival, OS).
English: No overall differences in safety or efficacy were reported between elderly ( ≥ 65 years) and younger patients (< 65 years).
Estonian: Ei ole teateid efektiivsuse või ohutuse erinevustest eakatel (≥ 65 aastat) ja noorematel patsientidel (< 65 aasta).
English: Please note that these signs and symptoms are sometimes delayed, and may develop weeks or months after your last dose.
Estonian: Palun pange tähele, et need nähud ja sümptomid tekivad mõnikord hiljem ja võivad tekkida nädalaid või kuid pärast viimase annuse manustamist.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1026/001 40 mg vial EU/1/15/1026/002 100 mg vial
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/15/1026/001 40 mg viaal EU/1/15/1026/002 100 mg viaal
English: Tell your doctor if you are taking or have recently taken any other medicines.
Estonian: Palun informeerige oma arsti, kui te kasutate või olete hiljuti kasutanud mingeid muid ravimeid.
English: The updated data should be submitted by 31st December
Estonian: Täiendatud andmed tuleb esitada 31.
English: Talk to your doctor if you are not
Estonian: Rääkige oma arstiga kui te ei ole selles kindel.
English: Stopping your treatment may stop the effect of the medicine.
Estonian: Ravi lõpetamine võib ravimi mõju lõpetada.
English: Because of the small sample size, no definitive conclusions can be drawn from these data.
Estonian: Valimi väiksuse tõttu ei saa nende andmete põhjal teha lõplikke järeldusi.
English: Dose escalation or reduction is not recommended.
Estonian: Annust ei soovitata suurendada ega vähendada.
English: The average EQ-VAS increased over time for both treatment groups, indicating better overall health status for patients remaining on treatment.
Estonian: Keskmine EQ-VAS suurenes aja jooksul mõlemas ravirühmas, mis viitas ravi jätkavate patsientide paremale üldisele tervislikule seisundile.
English: • Details on how to minimise the safety concern through appropriate monitoring and management
Estonian: • Juhised ohutusega seotud asjaolude vähendamiseks asjakohase jälgimise ning tegevuse kaudu
English: Very common (may affect more than 1 in 10 people) Decreased appetite
Estonian: Väga sage (võib tekkida rohkem kui 1 inimesel 10-st) Söögiisu vähenemine
English: Safety and efficacy in elderly patients
Estonian: Ohutus ja efektiivsus eakatel
English: Nivolumab is produced in Chinese hamster ovary cells by recombinant DNA technology.
Estonian: Nivolumab on toodetud hiina hamstri munasarja rakkudes rekombinantse DNA tehnoloogia abil.
English: Nivolumab BMS may cause changes in the results of tests carried out by your doctor.
Estonian: Nivolumab BMS võib põhjustada muutusi teie arsti poolt tehtavate analüüside tulemustes.
English: You will also find this information in the Patient Alert Card you have been given by your doctor.
Estonian: Selle teabe leiate ka oma arstilt saadud hoiatuskaardilt.
English: September 2015
Estonian: Sept. 2015
English: Children and adolescents Nivolumab BMS should not be used in children and adolescents below 18 years of age.
Estonian: Lapsed ja noorukid Nivolumab BMS'i ei tohi kasutada alla 18-aastastel lastel ja noorukitel.
English: Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of nivolumab (see “Description of selected adverse reactions” below).
Estonian: Enamus neist, sealhulgas rasked reaktsioonid, lahenesid pärast asjakohase ravi alustamist või nivolumabi manustamise katkestamist (vt allpool esitatud “Valitud kõrvaltoimete kirjeldus”).
English: The physician educational material should contain:
Estonian: Arsti õppematerjal peab sisaldama:
English: Only 4 (0.8%) patients were persistent positive.
Estonian: Ainult 4 patsiendil (0,8%) olid need analüüsid püsivalt positiivsed.
English: These reactions are presented by system organ class and by frequency.
Estonian: Need kõrvaltoimed on esitatud organsüsteemi klasside ja esinemissageduste kaupa.
English: Because many medicinal products, including antibodies, can be secreted in human milk, a risk to the newborns/infants cannot be excluded.
Estonian: Kuna paljud ravimid, sealhulgas antikehad, võivad imenduda inimese rinnapiima, ei saa välistada riski vastsündinutele/imikutele.
English: • Physician educational material • Patient alert card
Estonian: • Arsti õppematerjal • Patsiendi hoiatuskaart
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Estonian: • kui muudetakse riskijuhtimissüsteemi, eriti kui saadakse uut teavet, mis võib oluliselt mõjutada riski/kasu suhet, või kui saavutatakse oluline (ravimiohutuse või riski minimeerimise)
English: docetaxel (n = 137)
Estonian: dotsetakseel (n = 137)
English: The Adverse Reaction Management Guide shall contain the following key elements:
Estonian: Kõrvaltoimete käsitsemise juhend peab sisaldama järgmisi põhielemente:
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Estonian: Igas esinemissageduse grupis on kõrvaltoimed esitatud tõsiduse vähenemise järjekorras.
English: The solution has a pH of approximately 6.0 and an osmolality of approximately 340 mOsm/kg.
Estonian: Lahuse pH on ligikaudu 6,0 ja osmolaalsus ligikaudu 340 mOsm/kg.
English: Tell your doctor immediately if you have any of these signs or symptoms or if they get worse.
Estonian: Rääkige otsekohe oma arstiga kui teil tekib mõni nimetatud sümptomitest või kui need süvenevad.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Estonian: TEAVE BRAILLE' KIRJAS (PUNKTKIRJAS) Põhjendus Braille mitte lisamiseks on heaks kiidetud.
English: Baseline characteristics were generally balanced between the two groups.
Estonian: Ravieelsed näitajad olid kahes ravirühmas üldiselt tasakaalus.
English: Feeling tired or weak
Estonian: Väsimus- või nõrkustunne
English: The safety and efficacy of Nivolumab BMS in children below 18 years of age have not been established.
Estonian: Nivolumab BMS'i ohutus ja efektiivsus lastel vanuses alla 18 aastat ei ole tõestatud.
English: Do not try to treat your symptoms with other medicines on your own.
Estonian: Ärge üritage ise oma sümptomeid ravida ravimitega, mis teil olemas on.
English: A risk to the breast-fed infant cannot be excluded.
Estonian: Riski imikule ei saa välistada.
English: Do not shake the vial.
Estonian: Ärge raputage viaali.
English: Studies in animals have shown embryofoetal toxicity (see section 5.3).
Estonian: Loomkatsed on näidanud embrüofetaalset toksilisust (vt lõik 5.3).
English: Tumour assessments, according to the Response Evaluation Criteria in Solid Tumours (RECIST), version 1.1, were conducted 9 weeks after randomisation and continued every 6 weeks thereafter.
Estonian: Kasvaja hindamisi tehti vastavalt RECIST (Response Evaluation Criteria in Solid Tumours) versioonile 1.1 9 nädalat pärast randomiseerimist ja seejärel iga 6 nädala järel.
English: Key secondary efficacy outcome measures were investigator-assessed objective response rate (ORR) and progression-free survival (PFS).
Estonian: Olulisimad teisesed tulemusnäitajad olid uurija poolt hinnatavad objektiivne ravivastuse määr (objective response rate, ORR) ja progressioonivaba elulemus (progression free survival, PFS).
English: Treatment modification
Estonian: Ravi modifitseerimine
English: In the absence of data, nivolumab should be used with caution in these populations after careful consideration of the potential risk-benefit on an individual basis.
Estonian: Kuna andmed puuduvad, tuleb sellel populatsioonil nivolumabi kasutada ettevaatusega pärast võimaliku kasu ja riski suhte individuaalset hindamist.
English: Be aware of important symptoms of inflammation.
Estonian: Teadke põletiku olulisi sümptomeid.
English: If you have any further questions about your treatment or on the use of this medicine, ask your doctor.
Estonian: Kui teil on lisaküsimusi oma ravi kohta või selle ravimi kasutamise kohta, pidage nõu oma arstiga.
English: The effects of Nivolumab BMS in pregnant women are not known, but it is possible that the active substance, nivolumab, could harm an unborn baby.
Estonian: Nivolumab BMS'i toimed rasedatele naistele ei ole teada, aga on võimalik, et toimeaine nivolumab võib kahjustada sündimata last.
English: Median (95% CI) (months)
Estonian: Mediaan (95% CI) kuud
English: Nivolumab BMS infusion must be completed within 24 hours of preparation.
Estonian: Nivolumab BMS'i infusiooni peab läbi viima 24 tunni jooksul alates ettevalmistamisest.
English: You will also have blood tests during your treatment.
Estonian: Teile tehakse ravi ajal vereanalüüse.
English: Results for growth indices, as well as teratogenic, neurobehavioral, immunological, and clinical pathology parameters throughout the 6-month postnatal period were comparable to the control group.
Estonian: Kasvuga seotud näitajad, samuti teratogeensed, neuroloogilis-käitumuslikud, immunoloogilised ja kliinilise patoloogia näitajad olid 6kuulise postnataalse perioodi jooksul võrreldavad kontrollgrupiga.
English: Prior to launch of Nivolumab BMS in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Estonian: Enne Nivolumab BMS turustamise algust peab müügiloa hoidja iga liikmesriigi pädeva asutusega kokku leppima koolitusprogrammi sisu ning vormi, sealhulgas kommunikatsioonivahendid, jaotamise meetodid ning programmi muud aspektid.
English: The value of biomarkers to predict the efficacy of nivolumab should be further explored, specifically:
Estonian: Täiendavalt tuleb uurida biomarkereid, mis annaks võimaluse ennustada nivolumabi efektiivsust, sealhulgas:
English: Do not take any other medicines during your treatment without talking to your doctor first.
Estonian: Ärge võtke ravi ajal mingeid muid ravimeid ilma eelnevalt oma arstiga nõu pidamata.
English: Frequencies are defined as: 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).
Estonian: Esinemissagedused on määratletud järgmiselt: väga sage (≥ 1/10), sage (≥ 1/100 kuni < 1/10), aegajalt (≥ 1/1000 kuni < 1/100), harva (≥ 1/10 000 kuni < 1/1000), väga harva (< 1/10 000).
English: Do not stop treatment with Nivolumab BMS unless you have discussed this with your doctor.
Estonian: Ärge lõpetage ravi Nivolumab BMS'ga, välja arvatud juhul, kui olete seda arutanud oma arstiga.
English: Rapid tapering may lead to worsening of the adverse reaction.
Estonian: Kiire annuse vähendamine võib põhjustada kõrvaltoime süvenemist.
English: Probability of Survival
Estonian: Elulemuse tõenäosus
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in
Estonian: Tervishoiutöötajatel palutakse teavitada kõigist võimalikest kõrvaltoimetest riikliku teavitamissüsteemi kaudu, mis on loetletud
English: Nivolumab BMS acts on your immune system and may cause inflammation in parts of your body.
Estonian: Nivolumab BMS avaldab toimet teie immuunsüsteemile ja võib põhjustada põletikku organismi erinevates osades.
English: The metabolic pathway of nivolumab has not been characterised.
Estonian: Nivolumabi metaboolset rada ei ole iseloomustatud.
English: Inflammation or problems with your kidneys.
Estonian: Neerupõletikku või probleeme neerudega.
English: As with all therapeutic proteins, there is a potential for an immune response to nivolumab.
Estonian: Sarnaselt teistele terapeutilistele proteiinidele on ka nivolumabi suhtes võimalik immuunreaktsiooni teke.
English: Nivolumab BMS should not be frozen.
Estonian: Nivolumab BMS'il ei tohi lasta külmuda.
English: Guidelines for permanent discontinuation or withholding of doses are described in Table 1.
Estonian: Ravi püsiva või ajutise katkestamise juhised on esitatud Tabelis 1.
English: Take care to ensure aseptic handling when you prepare the infusion.
Estonian: Veenduge, et rakendate infusiooni ettevalmistamisel aseptilise käitlemise reegleid.
English: The vials must be kept in the original package in order to protect from light.
Estonian: Viaale tuleb hoida originaalpakendis, et kaitsta neid valguse eest.
English: For storage conditions after preparation of the infusion, see section 6.3.
Estonian: Säilitamistingimused pärast infusiooni ettevalmistamist vt lõik 6.3.
English: Frequencies reflect the proportion of patients who experienced a worsening from baseline in laboratory measurements.
Estonian: Esinemissagedused viitavad patsientide osakaalule, kellel ilmnes laboratoorsete näitajate halvenemine võrreldes lähteväärtusega.
English: • Signs or symptoms of the safety concern and when to seek attention from a HCP
Estonian: • Ohutusega seotud nähud ja sümptomid ning soovitused millal pöörduda tervishoiutöötaja poole.
English: Use a separate infusion line for the infusion.
Estonian: Kasutage infusiooni jaoks eraldi infusioonisüsteemi.
English: Nivolumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Estonian: Eeldatakse, et nivolumab laguneb kataboolsete radade kaudu väikesteks peptiidideks ja aminohapeteks samal viisil nagu endogeensed IgG-d.
English: Patients should be monitored continuously (at least up to 5 months after the last dose) as an adverse reaction with nivolumab may occur at any time during or after discontinuation of nivolumab therapy.
Estonian: Patsiente tuleb pidevalt jälgida (vähemalt 5 kuud pärast viimase annuse manustamist), sest nivolumabi kõrvaltoimed võivad ilmneda mis tahes hetkel nivolumab-ravi ajal või pärast selle katkestamist.
English: Although hyperparathyroidism was not reported in CA209017, immune-related hyperparathyroidism might be considered especially if associated with hypophosphataemia (reported in 6 hypercalcemic patients in this study).
Estonian: Kuigi uuringus CA209017 hüperparatüreoosi ei teatatud, võib oletada immuunsüsteemiga seotud hüperparatüreoosi, eriti kui see on seotud hüpofosfataeemiaga (selles uuringus teatatud 6 hüperkaltseemia patsiendil).