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.
Lithuanian: Le tossicità CTC clinicamente rilevanti riportate in una percentuale ≥ 1 % e < 5 % dei pazienti che sono stati assegnati in maniera randomizzata a ricevere cisplatino e pemetrexed, comprendono: insufficienza renale, infezione, piressia, neutropenia febbrile, aumento dei valori di AST, ALT e GGT, orticaria e dolore toracico.
English: Pemetrexed Sandoz 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium).
Lithuanian: Pemetrexed Sandoz 1000 mg: Ogni flaconcino contiene 1000 milligrammi di pemetrexed (come pemetrexed disodico)
English: Pemetrexed Sandoz 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Lithuanian: Pemetrexed Sandoz 500 mg: Ogni flaconcino contiene 500 milligrammi di pemetrexed (come pemetrexed disodico)
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Lithuanian: Pemetrexed Sandoz 500 mg polvere per concentrato per soluzione per infusione Ogni flaconcino contiene 500 mg di pemetrexed (come pemetrexed disodico).
English: Blood and lymphatic system disorders
Lithuanian: Patologie del sistema emolinfopoietico
English: Rare cases of hepatitis, potentially serious, have been reported during clinical studies with pemetrexed.
Lithuanian: Durante gli studi clinici con pemetrexed sono stati riportati rari casi di epatite, potenzialmente grave.
English: • Bullous conditions (blistering skin diseases)-including Stevens-Johnson syndrome and Toxic epidermal necrolysis
Lithuanian: • Formazione di bolle (malattie della cute che causano vescicole) - che includono la sindrome di
English: Concomitant administration of substances that are also tubularly secreted (e.g., probenecid, penicillin) could potentially result in delayed clearance of pemetrexed.
Lithuanian: probenecid, penicillina) potrebbero potenzialmente determinare una clearance ritardata del pemetrexed.
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Lithuanian: Pemetrexed Sandoz 100 mg polvere per concentrato per soluzione per infusione Ogni flaconcino contiene 100 mg di pemetrexed (come pemetrexed disodico).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1037/003
Lithuanian: NUMERO DELL'AUTORIZZAZIONE ALL'IMMISSIONE IN COMMERCIO EU/1/15/1037/003
English: Pemetrexed Sandoz 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Lithuanian: Pemetrexed Sandoz 100 mg: Ogni flaconcino contiene 100 milligrammi di pemetrexed (come pemetrexed disodico)
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups
Lithuanian: gemcitabina + cisplatino come trattamento di prima linea del carcinoma polmonare non a piccole cellule - Popolazione ITT e sottogruppi istologici Sopravvivenza globale media in mesi (95 % CI)
English: SGOT (AST) elevation 6.8
Lithuanian: Aumento della SGOT (AST)
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.
Lithuanian: Ricostituire ogni flaconcino da 500 mg con 20 ml di soluzione di cloruro di sodio 9 mg/ml (0,9 %) per preparazioni iniettabili (senza conservanti), per ottenere una soluzione contenente 25 mg/ml di pemetrexed.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Lithuanian: DENOMINAZIONE DEL MEDICINALE Pemetrexed Sandoz 1000 mg polvere per concentrato per soluzione per infusione pemetrexed
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.
Lithuanian: Ricostituire i flaconcini da 100 mg con 4,2 ml di soluzione di cloruro di sodio 9 mg/ml (0,9 %) per preparazioni iniettabili (senza conservanti), per ottenere una soluzione contenente 25 mg/ml di pemetrexed.
English: VIAL LABEL
Lithuanian: FOGLIO ILLUSTRATIVO
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Clear, colorless 100 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 1000 mg of pemetrexed.
Lithuanian: Pemetrexed Sandoz 500 mg polvere per concentrato per soluzione per infusione Flaconcino tipo I di vetro trasparente, incolore da 100 ml con tappo in gomma clorobutilica e ghiera in alluminio con cappuccio a strappo, contenente 1000 mg di pemetrexed.
English: • Lower limb swelling with pain and redness
Lithuanian: ● Rigonfiamento con dolore e arrossamento agli arti inferiori
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.
Lithuanian: Ricostituire ogni flaconcino da 1000 mg con 40 ml di soluzione di cloruro di sodio 9 mg/ml (0,9 %) per preparazioni iniettabili (senza conservanti), per ottenere una soluzione contenente 25 mg/ml di pemetrexed.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Lithuanian: DENOMINAZIONE DEL MEDICINALE Pemetrexed Sandoz 500 mg polvere per concentrato per soluzione per infusione pemetrexed
English: • Chest pain
Lithuanian: • Dolore al torace
English: Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Lithuanian: Domaniewska 50C 02-672 Warszawa Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Lithuanian: DENOMINAZIONE DEL MEDICINALE Pemetrexed Sandoz 100 mg polvere per concentrato per soluzione per infusione pemetrexed
English: Special precautions for disposal and other handling
Lithuanian: Istruzioni per lo smaltimento e la manipolazione
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Lithuanian: DENOMINAZIONE DEL MEDICINALE E VIA(E) DI SOMMINISTRAZIONE Pemetrexed Sandoz 1000 mg polvere per concentrato per soluzione per infusione pemetrexed
English: Posology
Lithuanian: Posologia
English: Frequency* Event**
Lithuanian: Evento**
English: • Constipation
Lithuanian: • Costipazione
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Lithuanian: DENOMINAZIONE DEL MEDICINALE E VIA(E) DI SOMMINISTRAZIONE Pemetrexed Sandoz 500 mg polvere per concentrato per soluzione per infusione pemetrexed
English: Constipation
Lithuanian: Allattamento
English: Less toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities, such as neutropenia, febrile neutropenia, and infection with Grade 3/4 neutropenia, were reported when pretreatment with folic acid and vitamin B12 was administered.
Lithuanian: Quando è stato somministrato un pretrattamento con acido folico e vitamina B12 sono state riportate una tossicità inferiore e una riduzione delle tossicità non-ematologica ed ematologica di grado 3/4,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Lithuanian: COMPOSIZIONE QUALITATIVA E QUANTITATIVA IN TERMINI DI PRINCIPIO(I) ATTIVO(I) Ogni flaconcino contiene 1000 mg di pemetrexed (come pemetrexed disodico).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Lithuanian: DENOMINAZIONE DEL MEDICINALE E VIA(E) DI SOMMINISTRAZIONE Pemetrexed Sandoz 100 mg polvere per concentrato per soluzione per infusione pemetrexed
English: Common Taste disturbance Eye disorders Common Conjunctivitis Diarrhoea
Lithuanian: Comune Dispepsia Eruzione cutanea
English: • Kidney failure
Lithuanian: • Insufficienza renale
English: - if you are breast-feeding; you must discontinue breast-feeding during treatment with
Lithuanian: - se sta allattando al seno; deve interrompere l'allattamento durante il trattamento con Pemetrexed Sandoz.
English: Neutrophils/Granulocyte s decreased
Lithuanian: Riduzione dei neutrofili/ granulociti Riduzione dei leucociti Riduzione dell'emoglobina
English: Taste disturbance Nausea
Lithuanian: Comune Alterazione del gusto
English: 6.3 Shelf life
Lithuanian: 6.3 Periodo di validità
English: Progression-free survival (months)
Lithuanian: Sopravvivenza libera da progressione
English: * Refer to National Cancer Institute CTC version 2 for each grade of toxicity except the term “creatinine clearance decreased”.
Lithuanian: *Con riferimento alla versione 2 del National Cancer Institute CTC per ogni grado di tossicità eccetto che per il termine “riduzione della clearance della creatinina” ** derivato dal termine “renale/genitourinario - altro”. ***In accordo con i National Cancer Institute CTC (v2.0; NCI 1998), l'alterazione del gusto e l'alopecia devono essere riportate esclusivamente come Grado 1 o 2.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Lithuanian: COMPOSIZIONE QUALITATIVA E QUANTITATIVA IN TERMINI DI PRINCIPIO(I) ATTIVO(I) Ogni flaconcino contiene 100 mg di pemetrexed (come pemetrexed disodico).
English: • 95% CI for median
Lithuanian: Sopravvivenza (mesi) Mediana (m) 95% CI per mediana
English: • Non-inferiority p-value (HR)
Lithuanian: 95 % CI per HR p-value (HR) di non-inferiorità Sopravvivenza libera da progressione (mesi) Mediana
English: Stomatitis/ Pharyngitis 14.7 1.1 17.4 1.1 Nausea
Lithuanian: Comune Neuropatia-sensitiva 7,4 0,6 5,0 0,2 Nausea
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Lithuanian: COMPOSIZIONE QUALITATIVA E QUANTITATIVA IN TERMINI DI PRINCIPIO(I) ATTIVO(I) Ogni flaconcino contiene 500 mg di pemetrexed (come pemetrexed disodico).
English: - If you get any side effects, talk to your doctor or pharmacist.
Lithuanian: - Se si manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si rivolga al medico o al farmacista.
English: Pemetrexed Sandoz.
Lithuanian: Cosa contiene Pemetrexed Sandoz
English: Common Dyspepsia Rash
Lithuanian: Comune Dispepsia/ Pirosi
English: 6 A. LABELLING
Lithuanian: ETICHETTATURA
English: Creatinine elevation 10.1* 0.8
Lithuanian: Mucosite/stomatite 6,8 0,8 1,7 0,0 Aumento di ALT (SGPT)
English: EXP
Lithuanian: Stipsi
English: If you get any side effects, talk to your doctor or pharmacist.
Lithuanian: Se manifesta un qualsiasi effetto indesiderato, compresi quelli non elencati in questo foglio, si rivolga al medico o al farmacista.
English: Other information about Novem:
Lithuanian: Kita informacija apie Novem:
English: Novem meloxicam
Lithuanian: Novem meloksikamas
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.
Lithuanian: Išsamų Novem EPAR rasite Agentūros interneto svetainėje adresu: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports.
English: Why is Novem approved?
Lithuanian: Kodėl Novem buvo patvirtintas?
English: What is Novem and what is it used for?
Lithuanian: Kas yra Novem ir kam jis naudojamas?
English: What benefits of Novem have been shown in studies?
Lithuanian: Kokia Novem nauda nustatyta tyrimuose?
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.
Lithuanian: Agentūros Veterinarinių vaistų komitetas (CVMP) padarė išvadą, kad Novem nauda yra didesnė už jo keliamą riziką, ir rekomendavo leisti naudoti šį vaistą ES.
English: What are the risks associated with Novem?
Lithuanian: Kokia rizika siejama su Novem naudojimu?
English: Appropriate studies have been carried out in various target animals to show that Novem is effective and safe in its approved uses.
Lithuanian: Su įvairiais paskirties gyvūnais buvo atlikti tokie tyrimai, kuriais siekta įrodyti, kad pagal patvirtintas indikacijas naudojamas Novem yra veiksmingas ir saugus.
English: In very rare cases anaphylactoid (allergic) reactions which may be serious (including fatal) may occur and should be treated symptomatically.
Lithuanian: Labai retais atvejais gali pasireikšti anafilaktoidinės (alerginės) reakcijos, kurios gali būti sunkios (taip pat mirtinos) ir kurias reikia gydyti simptomiškai.
English: The dose to use depends on the animal and its bodyweight.
Lithuanian: Naudojama vaisto dozė priklauso nuo gyvūno ir jo kūno svorio.
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.
Lithuanian: Kadangi prostaglandinai yra medžiagos, sukeliančios uždegimą, skausmą, eksudaciją (skysčio išsiskyrimą iš kraujagyslių esant uždegimui) ir karščiavimą, meloksikamas slopina šiuos ligos simptomus.
English: Novem is available as a solution for injection and can only be obtained with a prescription.
Lithuanian: Novem tiekiamas injekcinio tirpalo forma ir jo galima įsigyti tik pateikus receptą.
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.
Lithuanian: Galvijams ir kiaulėms tiek po oda, tiek į raumenis leidžiamas vaistas toleruojamas gerai; tik mažiau nei 10 proc. galvijų, kuriems klinikinių tyrimų metu buvo atlikta injekcija po oda, injekcijos vieta šiek tiek laikinai patino.
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.
Lithuanian: Išlauka - tai laikas, kurį, sušvirkštus vaistą, negalima skersti gyvūno ir jo mėsos arba pieno vartoti žmonių maistui.
English: • lameness and inflammation in non-infectious locomotor disorders (diseases that affect the ability to move)
Lithuanian: • neinfekcinių lokomotorinių sutrikimų (poveikį gebėjimui judėti turinčių sutrikimų) sukeliamam raišumui ir uždegimui gydyti;
English: How does Novem work?
Lithuanian: Kaip veikia Novem?
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004.
Lithuanian: suteikė visoje Europos Sąjungoje galiojantį Novem registracijos pažymėjimą.
English: People who are hypersensitive (allergic) to NSAIDs should avoid contact with Novem.
Lithuanian: Žmonės, kurie yra itin jautrūs (alergiški) nesteroidiniams vaistams nuo uždegimo, turi vengti sąlyčio su Novem.
English: The studies showed that the addition of Novem to antibiotic therapy significantly improved clinical parameters and reduced fever compared to antibiotics alone.
Lithuanian: Šie tyrimai parodė, kad kartu su antibiotikais naudojant Novem, klinikiniai rodikliai buvo geresni ir karščiavimo atvejų buvo mažiau, nei naudojant vienus antibiotikus.
English: (mastitis-metritis-agalactia syndrome) together with the main treatment with antibiotics.
Lithuanian: (mastito, metrito ir agalaktijos sindromui) gydyti, kartu taikant pagrindinį gydymą antibiotikais.
English: For more information about treatment with Novem, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Lithuanian: Daugiau informacijos apie gydymą Novem gyvūnų savininkai arba laikytojai turėtų ieškoti informaciniame lapelyje arba kreiptis į veterinarijos gydytoją ar vaistininką.
English: If the product is accidentally self-injected, the advice of a doctor should be sought immediately.
Lithuanian: Atsitiktinai susišvirkštus vaisto, reikia nedelsiant kreiptis į gydytoją.
English: • infections that occur after farrowing (giving birth) such as puerperal septicaemia and toxaemia
Lithuanian: • infekcijoms, kurios išsivysto apsiparšiavus, kaip antai pogimdyminei septicemijai ir toksemijai
English: The withdrawal period is 15 days for meat and five days for milk.
Lithuanian: Išlauka skerdienai - 15 parų, pienui - 5 paros.
English: Novem contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Lithuanian: Novem sudėtyje yra meloksikamo, kuris priskiriamas prie vadinamųjų nesteroidinių vaistų nuo uždegimo (NVNU).
English: Injections are given under the skin for cattle and into the muscles for pigs.
Lithuanian: Vaistas švirkščiamas galvijams po oda, o kiaulėms - į raumenis.
English: Novem is an anti-inflammatory medicine used in cattle and pigs.
Lithuanian: Novem - tai galvijams ir kiaulėms naudojamas vaistas nuo uždegimo.
English: • pain following minor soft tissue surgery such as castration
Lithuanian: • skausmui po nedidelių minkštųjų audinių operacijų, pvz.
English: Similarly, treatment combining rehydration solution and Novem was shown to be superior to rehydration solution alone.
Lithuanian: Be to, gydymas rehidratuojančio tirpalo ir Novem deriniu buvo veiksmingesnis už gydymą vienu rehidratuojančiu tirpalu.
English: • acute respiratory infection (infection of the lungs and airways) together with antibiotics
Lithuanian: • kartu su antibiotikais ūmioms kvėpavimo sistemos (plaučių ir kvėpavimo takų) infekcijoms gydyti;
English: • acute mastitis (inflammation of the udder) together with the main treatment with antibiotics.
Lithuanian: • ūminiam mastitui (tešmens uždegimui) gydyti, kartu taikant pagrindinį gydymą antibiotikais.
English: How is Novem used?
Lithuanian: Kaip naudoti Novem?
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)
Lithuanian: • kartu su geriamaisiais rehidratuojančiais vaistais (geriamaisiais vaistais reikiamam vandens kiekiui organizme atkurti) veršelių nuo vienos savaitės ir jaunų nelaktuojančių galvijų viduriavimui gydyti;
English: The withdrawal period for meat is five days.
Lithuanian: Išlauka skerdienai - 5 paros.
English: In pigs, Novem is used to treat:
Lithuanian: Kiaulėms Novem skiriamas:
English: • pain following dehorning in calves
Lithuanian: • po nuraginimo galvijų juntamam skausmui malšinti;
English: Annex III Condition for lifting the suspension of the marketing authorisations
Lithuanian: Sustabdyto rinkodaros leidimų galiojimo atnaujinimo sąlyga
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:
Lithuanian: Kad būtų galima atnaujinti sustabdytą Numeta G13%E rinkodaros leidimų galiojimą, valstybių narių nacionalinės kompetentingos institucijos privalo patikrinti ir patvirtinti, kad rinkodaros leidimo turėtojas įvykdė toliau nurodytas sąlygas:
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.
Lithuanian: Rinkodaros leidimo turėtojas turi pakoreguoti preparato formulę, kad jo sudėtyje esantis magnio kiekis būtų pagrįstas naujausiomis šios srities žiniomis.
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.
Lithuanian: Rinkodaros leidimo turėtojas turi susisiekti su referencine valstybe nare, kad jie galėtų su susitarti dėl atitinkamos procedūros, kuria bus vadovaujamasi siekiant įvykdyti šią sustabdyto rinkodaros leidimo galiojimo atnaujinimo sąlygą.
English: Condition for lifting the suspension of the marketing authorisations for Numeta G13%E and associated names
Lithuanian: Sustabdyto Numeta G13%E ir susijusių pavadinimų rinkodaros leidimų galiojimo atnaujinimo sąlyga
English: --1 Hydrocortisone aceponate: 1.11 mg/ml; Miconazole (as nitrate form): 15.1 mg/ml; Gentamicin (as sulphate form): 1,505 IU/ml.
Lithuanian: --1 Hidrokortizono aceponato - 1,11 mg/ml; mikonazolo (nitrato) - 15,1 mg/ml; gentamicino (sulfato) - 1 505 TV/ml.
English: Invented name
Lithuanian: EU numeris Sugalvotas pavadinimas
English: Strength
Lithuanian: Netaikytina
English: 10 ml
Lithuanian: Buteliukas (PP) 10 ml
English: EU number
Lithuanian: Kiekis
English: 1 container
Lithuanian: 1 buteliukas Netaikytina
English: Pharmaceutical form
Lithuanian: Stiprumas Vaisto forma
English: EMA/CHMP/761027/2012 EMEA/H/C/002506
Lithuanian: EMEA/H/C/002506
English: For more information on biosimilar medicines, see the questions-and-answers document here.
Lithuanian: Daugiau informacijos apie biologiškai panašius vaistinius preparatus rasite klausimų ir atsakymų dokumente čia.
English: What is Solumarv?
Lithuanian: Kas yra Solumarv?
English: The reference medicine for Solumarv in this application was Humulin S.
Lithuanian: Šioje paraiškoje nurodytas referencinis Solumarv vaistinis preparatas buvo Humulin S.
English: The company presented the results of studies designed to show that Solumarv is similar to its reference medicine Humulin S in terms of its structure, biological activity and clinical performance.
Lithuanian: Bendrovė pateikė rezultatus, gautus atlikus tyrimus, kuriais siekta įrodyti, kad Solumarv panašus į referencinį vaistą Humulin S savo struktūra, biologiniu aktyvumu ir klinikiniu veiksmingumu.
English: Withdrawal of the marketing authorisation application for Solumarv (human insulin)
Lithuanian: Paraiškos gauti Solumarv (žmogaus insulino) rinkodaros teisę atsiėmimas
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Solumarv could not have been approved.
Lithuanian: Po pirminio vertinimo CHMP turėjo didelių abejonių ir buvo priėmęs negalutinę nuomonę, kad Solumarv negali būti registruotas.
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Solumarv in clinical trials.
Lithuanian: Bendrovė pranešė CHMP, kad paraiškos atsiėmimo metu Solumarv nevartojo nė vienas klinikiniuose tyrimuose dalyvaujantis pacientas.
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).
Lithuanian: Paraiška dėl Solumarv buvo bendra bendrovės „Marvel LifeSciences“ pateikta paraiška gauti Solumarv ir dar dviejų vaistų (Isomarv medium ir Combimarv; jie taip pat kurti kaip biologiškai panašūs vaistai) rinkodaros teises.
English: Among these were results from studies that looked at how the body handles Solumarv compared with Humulin S and how these insulins affect blood sugar levels.
Lithuanian: Tarp jų pateikti rezultatai, gauti atlikus tyrimus, kurių metu analizuota, kaip organizmas reaguoja į Solumarv, palyginti su Humulin S, ir kaip šie insulinai veikia cukraus kiekį kraujyje.
English: The initial concerns related mainly to the manufacture of the medicine and whether Solumarv was sufficiently similar to its reference medicine.
Lithuanian: Pirminės abejonės buvo susijusios daugiausia su vaisto gamyba ir galimu nepakankamu Solumarv panašumu į referencinį vaistą.
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.
Lithuanian: Solumarv sudėtyje esantis insulinas gaminamas vadinamuoju rekombinantinės DNR technologijos būdu: ją gamina bakterijos, kurioms buvo implantuotas insulino gamybą užtikrinantis genas (DNR).