FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Estonian: Kliiniliselt olulisteks CTC toksilisusteks, mida registreeriti ≥ 1 %-l ja ≤ 5 %-l patsientidest, kes olid randomiseeritult määratud tsisplatiini ja pemetrekseedi gruppi, olid: neerupuudulikkus, infektsioon, palavik, neutropeenia palavikuga, ASAT, ALAT ja GGT tõus, urtikaaria ja valu rinnus.
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Estonian: Pemetrexed Sandoz 500 mg infusioonilahuse kontsentraadi pulber Üks viaal sisaldab 500 mg pemetrekseedi (dinaatriumpemetrekseedina).
English: • Low white blood cells
Estonian: • Valgete vererakkude arvu langus
English: Pemetrexed Sandoz 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Estonian: Pemetrexed Sandoz 100 mg: Iga viaal sisaldab 100 milligrammi pemetrekseedi (dinaatriumpemetrekseedina).
English: Pemetrexed Sandoz 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Estonian: Pemetrexed Sandoz 500 mg: Iga viaal sisaldab 500 milligrammi pemetrekseedi (dinaatriumpemetrekseedina).
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Estonian: Kui induktsioonfaas kaasa arvata, oli muu kui prevaleeruvalt lamerakulise histoloogiaga mitteväikerakk-kopsuvähiga patsientidel üldise elulemuse mwdiaan 18,6 kuud pemetrekseedi-rühmas ja 13,6 kuud platseeborühmas (riskisuhe = 0,71, 95 % CI = 0,56…0,88, p = 0,002).
English: From the start of pemetrexed plus cisplatin first-line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio= 0.78, 95% CI= 0.64-0.96).
Estonian: Alates pemetrekseed/tsisplatiin esimese rea induktsioonravist oli OS mediaan pemetrekseedi grupis 16,9 kuud ja platseebogrupis 14,0 kuud (riskisuhe = 0,78, 95% CI= 0,64...0,96).
English: Clinically relevant toxicity that was reported in < 1 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: GGT increase, chest pain, arrhythmia, and motor neuropathy.
Estonian: Kliiniliselt oluliste toksilisuse juhtudena, mida täheldati sagedusega < 1 % patsientidest, kes olid randomiseeritud tsisplatiini ja pemetrekseedi rühma, olid GGT tõus, rindkerevalu, arütmia ja motoorne neuropaatia.
English: Uncommon (may affect up to 1 in 100 people)
Estonian: Aeg-ajalt (võib esineda kuni 1-l inimesel 100st)
English: Clinically relevant toxicity that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Estonian: Kliiniliselt oluliste toksilisuse juhtumitena, mida täheldati sagedusega ≥ 1 % ja ≤ 5 % patsientidest, kes olid randomiseeritud tsisplatiini ja pemetrekseedi rühma, olid ASAT tõus, ALAT tõus, infektsioon, febriilne neutropeenia, neerupuudulikkus, palavik, dehüdratsioon, konjunktiviit ja kreatiniini kliirensi vähenemine.
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (N = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Estonian: Muu kui prevaleeruvalt lamerakulise histoloogiaga mitteväikerakk-kopsuvähiga patsientidel (N = 481) oli üldise elulemuse mediaan 15,5 kuud pemetrekseedi-rühmas ja 10,3 kuud platseeborühmas (riskisuhe = 0,70, 95 % CI = 0,56…0,88, p = 0,002).
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Estonian: Pemetrexed Sandoz 1000 mg infusioonilahuse kontsentraadi pulber Üks viaal sisaldab ligikaudu 1000 mg pemetrekseedi (dinaatriumpemetrekseedina).
English: Excipient with known effect Each vial contains approximately 11 mg sodium.
Estonian: Iga viaal sisaldab ligikaudu 11 mg naatriumi.
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Estonian: Lahustage 100 mg viaali sisu 4,2 ml naatriumkloriidi 9 mg/ml (0,9 %) süstelahusega, mis ei sisalda säilitusainet, mille tulemusena saate lahuse, mis sisaldab pemetrekseedi 25 mg/ml.
English: • Low platelet count
Estonian: • Madal trombotsüütide arv
English: • Non-inferiority p-value (HR)
Estonian: Mittehalvemuse p-väärtus (HR) Progressioonivaba elulemus (kuud) Mediaan
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Estonian: Lahustage 500 mg viaali sisu 20 ml naatriumkloriidi 9 mg/ml (0,9 %) süstelahusega, mis ei sisalda säilitusainet, mille tulemusena saate lahuse, mis sisaldab pemetrekseedi 25 mg/ml.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Estonian: RAVIMPREPARAADI NIMETUS Pemetrexed Sandoz 1000 mg infusioonilahuse kontsentraadi pulber pemetrekseed
English: Progression-free survival (months)
Estonian: Progressioonivaba elulemus
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Estonian: Iga viaal sisaldab 1000 mg pemetrekseedi (dinaatriumpemetrekseedina).
English: • If you have pain, redness, swelling or sores in your mouth (very common).
Estonian: ▪ Kui teil tekivad valu, punetus, turse või haavandid suus (väga sage).
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1,500 cells/mm3 and platelets should be ≥ 100,000 cells/mm3.
Estonian: Enne keemiaravi iga tsükli algust peab patsient vastama järgmistele kriteeriumidele: neutrofiilide absoluutarv peab olema
English: Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Estonian: Lahustage 1000 mg viaali sisu 40 ml naatriumkloriidi 9 mg/ml (0,9 %) süstelahusega, mis ei sisalda säilitusainet, mille tulemusena saate lahuse, mis sisaldab pemetrekseedi 25 mg/ml.
English: Pemetrexed Sandoz.
Estonian: Sandoz'ga.
English: Pemetrexed Sandoz is a powder for concentrate for solution for infusion in a glass vial.
Estonian: Kuidas Pemetrexed Sandoz välja näeb ja pakendi sisu Pemetrexed Sandoz on klaasviaalis infusioonilahuse kontsentraadi pulber.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Pemetrexed Sandoz 1000 mg infusioonilahuse kontsentraadi pulber pemetrekseed
English: Excipient with known effect Each vial contains approximately 108 mg sodium.
Estonian: Üks viaal sisaldab ligikaudu 108 mg naatriumi.
English: Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Estonian: Domaniewska 50C 02-672 Warszawa Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Estonian: RAVIMPREPARAADI NIMETUS Pemetrexed Sandoz 500 mg infusioonilahuse kontsentraadi pulber pemetrekseed
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Estonian: RAVIMPREPARAADI NIMETUS Pemetrexed Sandoz 100 mg infusioonilahuse kontsentraadi pulber pemetrekseed
English: Table 1.
Estonian: Partii nr:
English: • Fatigue (tiredness)
Estonian: • Hepatiit (maksapõletik)
English: Pemetrexed Sandoz as single agent In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of pemetrexed is 500 mg/m2 BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Estonian: Pemetrexed Sandoze soovituslikuks annuseks 500 mg/m2 KP, mida manustatakse veenisisese infusioonina 10 minuti jooksul 21-päevase tsükli esimesel päeval.
English: Excipient with known effect Each vial contains approximately 54 mg sodium.
Estonian: Üks viaal sisaldab ligikaudu 54 mg naatriumi.
English: Manufacturer Ebewe Pharma Ges.m.b.H Nfg.KG
Estonian: Ebewe Pharma Ges.m.b.H Nfg.KG Mondseestrasse 11, 4866 Unterach
English: Cisplatin (N = 222)
Estonian: (N = 222)
English: • 95% CI for median
Estonian: Elulemus (kuud) mediaan (k.) 95% CI mediaan
English: Therefore, caution should be made when administering higher doses of NSAIDs or acetylsalicylic acid, concurrently with pemetrexed to patients with normal function (creatinine clearance ≥ 80 ml/min).
Estonian: Normaalse neerufunktsiooniga patsientidel (kreatiniini kliirens ≥ 80 ml/min), kellele manustatakse pemetrekseedi, tuleb ettevaatusega kasutada MSPVR-eid või atsetüülsalitsüülhappe suuremates annustes.
English: Common Taste disturbance Eye disorders Common Conjunctivitis Diarrhoea
Estonian: Konjunktiviit Kõhulahtisus Oksendamine Stomatiit/ Farüngiit Iiveldus Anoreksia
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Pemetrexed Sandoz 100 mg infusioonilahuse kontsentraadi pulber pemetrekseed
English: Granulocytes decreased
Estonian: Neerude häired
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Pemetrexed Sandoz 500 mg infusioonilahuse kontsentraadi pulber pemetrekseed
English: Serious cardiovascular and cerebrovascular events, including myocardial infarction, angina pectoris, cerebrovascular accident, and transient ischaemic attack, have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Estonian: Aeg-ajalt registreeriti pemetrekseedi kliiniliste uuringute ajal, tavaliselt teise tsütotoksilise ainega koosmanustamise korral, raskeid kardiovaskulaarseid ja tserebrovaskulaarseid atakke, sh müokardiinfarkti, stenokardiat, ajuinsulti ja transitoorset ajuisheemiat.
English: • Blood clots in the lung blood vessels (pulmonary embolism)
Estonian: • Verehüübed kopsuveresoontes (kopsu trombemboolia)
English: Driving and using machines Pemetrexed Sandoz may make you feel tired.
Estonian: Ometi on täheldatud, et pemetrekseed võib põhjustada väsimust.
English: Pregnancy
Estonian: Patsiendid
English: Cisplatin (N = 163)
Estonian: (N = 163)
English: Oedema
Estonian: Turse
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Estonian: - kui te toidate last rinnaga, siis peate Pemetrexed Sandoz-ravi ajaks imetamise katkestama.
English: Docetaxel
Estonian: Tsisplatiin
English: Fatigue Pain
Estonian: Isutus Oksendamine
English: • Dehydration
Estonian: • Neerupuudulikkus
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Clear, colorless 10 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 100 mg of pemetrexed.
Estonian: Selge, värvitu 10 ml I tüüpi klaasist ja klorobutüül kummikorgiga ning alumiiniumist äratõmmatava korgiga suletud viaal sisaldab 100 mg pemetrekseedi.
English: The pharmacokinetic properties of pemetrexed following single-agent administration have been evaluated in
Estonian: Pemetrekseedi farmakokineetilisi omadusi pärast tema manustamist monoteraapiana on hinnatud 426-l erinevate soliidtuumoritega vähipatsiendil, kellele manustati 10-minutilise infusioonina
English: Gastrointestinal disorders
Estonian: Suurerakuline kartsinoom
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004.
Estonian: Euroopa Komisjon andis Novemi müügiloa, mis kehtib kogu Euroopa Liidus, 2. märtsil 2004.
English: The full EPAR for Novem can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Novemi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: What is Novem and what is it used for?
Estonian: Mis on Novem ja milleks seda kasutatakse?
English: This document is a summary of the European Public Assessment Report.
Estonian: See on ravimi Novem Euroopa avaliku hindamisaruande kokkuvõte.
English: Novem meloxicam
Estonian: Novem meloksikaam
English: Other information about Novem:
Estonian: Muu teave Novemi kohta
English: The withdrawal period for meat is five days.
Estonian: Liha keeluaeg on 5 päeva.
English: What are the risks associated with Novem?
Estonian: Mis riskid Novemiga kaasnevad?
English: Why is Novem approved?
Estonian: Miks Novem heaks kiideti?
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Novem's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et Novemi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: In very rare cases anaphylactoid (allergic) reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Estonian: Väga harva võib esineda anafülaktilisi (allergilisi) reaktsioone (sh surmavaid), mida tuleb ravida sümptomaatiliselt.
English: As prostaglandins are substances that trigger inflammation, pain, exudation (fluid that leaks out of blood vessels during an inflammation) and fever, meloxicam reduces these signs of disease.
Estonian: Et prostaglandiinid tekitavad põletikku, valu, eksudatsiooni (põletiku korral vedeliku imbumine veresoontest välja) ja palavikku, vähendab meloksikaam neid haigussümptomeid.
English: Cattle
Estonian: Veised
English: The studies showed that the addition of Novem to antibiotic therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone.
Estonian: Uuringud tõendasid, et võrreldes üksnes antibiootikumraviga parandas antibiootikumravile Novemi lisamine oluliselt kliinilisi parameetreid ja vähendas palavikku.
English: In cattle and pigs both subcutaneous and intramuscular administration are well tolerated; only a slight temporary swelling at the injection site following subcutaneous administration was observed in less than 10% of the cattle treated in clinical studies.
Estonian: Veised ja sead taluvad subkutaanset ja intramuskulaarset manustamist hästi; subkutaanse manustamise järel täheldati ainult kerget mööduvat süstekoha turset vähem kui 10%-l kliinilistes uuringutes osalenud veistest.
English: The withdrawal period is 15 days for meat and five days for milk.
Estonian: Liha keeluaeg on 15 päeva ja piima keeluaeg 5 päeva.
English: If the product is accidentally self-injected, the advice of a doctor should be sought immediately.
Estonian: Juhusliku enesesüstimise korral tuleb pöörduda kohe arsti poole.
English: How is Novem used?
Estonian: Kuidas Novemit kasutatakse?
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Estonian: Keeluaeg on alates ravimi manustamisest arvestatav aeg, mille jooksul ei tohi looma tappa ega tema liha inimtoiduks tarvitada.
English: Novem is an anti-inflammatory medicine used in cattle and pigs.
Estonian: Novem on põletikuvastane ravim, mida kasutatakse veistel ja sigadel.
English: For more information about treatment with Novem, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad Novemi kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: How does Novem work?
Estonian: Kuidas Novem toimib?
English: Novem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Estonian: Novem sisaldab meloksikaami, mis kuulub mittesteroidsete põletikuvastaste ravimite klassi.
English: • pain following minor soft tissue surgery such as castration
Estonian: • valu vähendamine pehmete kudede väikeste operatsioonide, näiteks kastreerimise järel;
English: What benefits of Novem have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Novemi kasulikkus?
English: The dose to use depends on the animal and its bodyweight.
Estonian: Kasutatav annus sõltub loomaliigist ja looma kehamassist.
English: Meloxicam acts by blocking an enzyme called cyclooxygenase which is involved in the production of prostaglandins.
Estonian: Novem blokeerib prostaglandiinide tekkes osaleva ensüümi tsüklooksügenaasi.
English: Similarly, treatment combining rehydration solution and Novem was shown to be superior to rehydration solution alone.
Estonian: Samuti oli rehüdratsioonilahuse ja Novemi kombineeritud ravi efektiivsem kui üksnes rehüdratsioonilahuse kasutamine.
English: • acute respiratory infection (infection of the lungs and airways) together with antibiotics
Estonian: • ägeda respiratoorse infektsiooni (kopsude ja hingamisteede nakkuse) ravi koos
English: Appropriate studies have been carried out in various target animals to show that Novem is effective and safe in its approved uses.
Estonian: Novemise efektiivsuse ja ohutuse tõendamiseks heakskiidetud näidustustel on sihtloomaliikidel tehtud asjakohased uuringud.
English: (mastitis-metritis-agalactia syndrome) together with the main treatment with antibiotics.
Estonian: • ägeda mastiidi (udarapõletiku) ravi koos põhiravina kasutatavate antibiootikumidega.
English: Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Estonian: Selles selgitatakse, kuidas amet hindas veterinaarravimit, et soovitada müügiloa andmist Euroopa Liidus ja kasutustingimusi.
English: In pigs, Novem is used to treat:
Estonian: Sigadel kasutatakse Novemit järgmistel näidustustel:
English: • lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move)
Estonian: • lonkamise ja põletikusümptomite vähendamine mittenakkuslike lokomotoorsete häirete
English: Injections are given under the skin for cattle and into the muscles for pigs.
Estonian: Veistele manustatakse Novemit nahaaluste süstetena ja sigadele lihasesiseste süstetena.
English: • diarrhoea in calves of over one week of age and young, non-lactating cattle together with oral re hydration therapy (medicines given by mouth to restore water levels in the body)
Estonian: • üle 1-nädalastel vasikatel ja mullikatel kõhulahtisuse ravi koos suukaudse rehüdreeriva raviga
English: • infections that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia
Estonian: • poegimisjärgsete haiguste, näiteks puerperaalse sepsise (poegimisjärgse veremürgistuse) ja tokseemia (mastiidi-metriidi-agalaktia sündroomi) toetav ravi koos põhiravina kasutatavate
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Novem.
Estonian: Kokkupuudet Novemiga peavad vältima isikud, kes on mittesteroidsete põletikuvastaste ravimite suhtes ülitundlikud (allergilised).
English: • pain following dehorning in calves
Estonian: • nudistamisjärgse valu ravi vasikatel;
English: Annex III Condition for lifting the suspension of the marketing authorisations
Estonian: III lisa Müügilubade peatamise lõpetamise tingimused
English: The MAH should reformulate the product, to include a level of magnesium which is justified based on the most recent knowledge in the area.
Estonian: Müügiloa hoidja peab muutma toote koostist, nii et selle magneesiumisisaldus põhineks kõige uuematel antud valdkonna teadmistel.
English: Condition for lifting the suspension of the marketing authorisations for Numeta G13%E and associated names
Estonian: Numeta G13%E ja sarnaste nimetuste müügilubade peatamise lõpetamise tingimus
English: The MAH should liaise with the Reference Member State to agree on the appropriate procedure to be used for the fulfilment of this condition.
Estonian: Müügiloa hoidja peab koos viiteliikmesriigiga kokku leppima sobiva menetluse, mida müügilubade peatamise lõpetamise tingimuse täitmiseks kasutada.
English: For the suspension of the marketing authorisations of Numeta G13%E to be lifted, the National competent authorities of Member States shall verify that the following conditions are fulfilled by the MAH:
Estonian: Müügiloa peatamise lõpetamiseks peavad pädevad asutused veenduma, et müügiloa hoidja on täitnud järgmise tingimuse.
English: --1 Hydrocortisone aceponate: 1.11 mg/ml; Miconazole (as nitrate form): 15.1 mg/ml; Gentamicin (as sulphate form): 1,505 IU/ml.
Estonian: --1 Üks ml sisaldab 1,11 mg hüdrokortisoonatseponaati, 15,1 mg mikonasooli (nitraadina) ja 1505 TÜ gentamütsiini (sulfaadina).
English: 1 container
Estonian: 1 konteiner Ei rakendata
English: Auricular use Multi-dose container (PP)
Estonian: Konteiner (pumbaga mitmeannuselin)
English: Content Package size Withdrawal period
Estonian: Pakendi suurus
English: EMA/CHMP/761027/2012 EMEA/H/C/002506
Estonian: 13. detsember 2012 EMA/130131/2013EMEA/H/C/002506
English: What is Solumarv?
Estonian: Mis on Solumarv?
English: The application was a joint application from Marvel LifeSciences for Solumarv and two other medicines (Isomarv medium and Combimarv, also developed as biosimilar medicines).
Estonian: Ettevõtte Marvel LifeSciences esitas ühistaotluse ravimi Solumarv ja veel kahe teise ravimi kohta (Isomarv medium ja Combimarv, mis on samuti välja töötatud bioloogiliselt sarnaste ravimitena).
English: The reference medicine for Solumarv in this application was Humulin S.
Estonian: Solumarvi võrdlusravim oli kõnealuse taotluse korral Humulin S.
English: Withdrawal of the marketing authorisation application for Solumarv (human insulin)
Estonian: Müügiloa taotluse tagasivõtmise teave Solumarv (iniminsuliin)
English: Solumarv is a medicine that contains the active substance human insulin.
Estonian: Solumarv on ravim, mis sisaldab toimeainena iniminsuliini.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Solumarv in clinical trials.
Estonian: Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmise ajal ei saanud ravimit Solumarv kliinilistes uuringutes mitte ükski patsient.
English: For more information on biosimilar medicines, see the questions-and-answers document here.
Estonian: Lisateave bioloogiliselt sarnaste ravimite kohta on teabedokumendis siin
English: The insulin in Solumarv is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Estonian: Ravimis Solumarv sisalduvat insuliini valmistatakse rekombinant-DNA-tehnoloogia abil: insuliini toodab bakter, millele on lisatud selle teket võimaldav geen (DNA).
English: The initial concerns related mainly to the manufacture of the medicine and whether Solumarv was sufficiently similar to its reference medicine.
Estonian: Ettevaatlikkuse peamised põhjused olid seotud ravimi tootmisega, samuti kaheldi, kas Solumarv on võrdlusravimiga piisavalt sarnane.
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Estonian: See tähendab, et Solumarv pidi sarnanema bioloogilise võrdlusravimiga, millel juba on Euroopa Liidus müügiluba.