FrancophonIA/ELRC3.0 huggingface dataset:
English: Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles.
Lithuanian: Dėžutė, kurioje yra 2 x 1 buteliukas, 2 x 10 buteliukų ir 2 x 50 buteliukų.
English: This vaccine is specifically indicated during pregnancy.
Lithuanian: Ši vakcina specialiai skirta naudoti šuningumo metu.
English: 10 doses: powder (10 bottles) + solvent (10 bottles) 50 doses: powder (50 bottles) + solvent (50 bottles)
Lithuanian: 10 dozių: milteliai (10 buteliukų) + skiediklis (10 buteliukų) 50 dozių: milteliai (50 buteliukų) + skiediklis (50 buteliukų)
English: In order for immunity to be conferred to the puppies, sufficient intake of colostrum is required.
Lithuanian: Kad šuniukų organizme susidarytų imunitetas, būtina užtikrinti pakankamą krekenų suvartojimą.
English: The vaccine may commonly cause transient oedema at the site of injection.
Lithuanian: Dažnai vakcina gali sukelti trumpalaikės edemos atsiradimą injekcijos vietoje.
English: These are rare and appropriate symptomatic treatment should be administered.
Lithuanian: Tuo atveju būtina gydyti simptomiškai.
English: - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Lithuanian: - nedažna (daugiau nei 1, bet mažiau nei 10 iš 1 000 gyvūnų), - reta (daugiau nei 1, bet mažiau nei 10 iš 10 000 gyvūnų),
English: B. CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Lithuanian: SĄLYGOS AR APRIBOJIMAI DĖL TIEKIMO IR NAUDOJIMO
English: Special precautions for use in animals: Vaccinate only healthy animals.
Lithuanian: Specialios naudojimo atsargumo priemonės Specialios atsargumo priemonės, naudojant vaistą gyvūnams Vakcinuoti galima tik sveikus gyvūnus.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Lithuanian: BIOLOGIŠKAI VEIKLIOS (-IŲ) MEDŽIAGOS (-Ų) GAMINTOJAS IR GAMINTOJAS, ATSAKINGAS UŽ VAISTO SERIJOS IŠLEIDIMĄ
English: Purified subunit vaccine for the active immunisation of pregnant bitches to induce passive immunity in puppies against herpesvirus-induced fatal neonatal disease.
Lithuanian: Tai išgryninta vakcina, skirta šuningoms kalėms aktyviai imunizuoti, kad šuniukams susidarytų pasyvus imunitetas herpes viruso sukeliamai mirtinai naujagimių ligai.
English: Polyoxyethylene fatty acids Ether of fatty alcohols and of polyols Triethanolamine
Lithuanian: polioksietileno riebalų rūgštys, riebalų alkoholių ir poliolių eteriai,
English: The reconstituted content shall be a milky emulsion.
Lithuanian: Paruošta vakcina turi būti pieniška emulsija.
English: Shelf life of the veterinary medicinal product as packaged for sale: 24 months.
Lithuanian: Veterinarinio vaisto tinkamumo laikas, nepažeidus originalios pakuotės, - 24 mėn.
English: Vaccinate only healthy animals.
Lithuanian: Specialios atsargumo priemonės, naudojant vaistą gyvūnams Vakcinuoti galima tik sveikus gyvūnus.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 2 x 1 bottle, 2 x 10 bottles and 2 x 50 bottles
Lithuanian: DUOMENYS, KURIE TURI BŪTI ANT ANTRINĖS PAKUOTĖS Dėžutė, kurioje yra 2 x 1 buteliukas, 2 x 10 buteliukų ir 2 x 50 buteliukų
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports).
Lithuanian: Nepalankių reakcijų dažnumas nustatytas vadovaujantis tokia konvencija: - labai dažna (vieno gydymo metu nepalankios reakcijos pasireiškė daugiau nei 1 iš 10 gyvūnų), - dažna (daugiau nei 1, bet mažiau nei 10 iš 100 gyvūnų),
English: No undesirable effects other than those mentioned in the “Adverse reactions” section have been observed after the administration of several doses.
Lithuanian: Sušvirkštus kelias vakcinos dozes, jokio nepalankaus poveikio, išskyrus aprašytą punkte „Nepalankios reakcijos“, nepastebėta.
English: Date of first authorisation: 26.03.2001 Date of last renewal: 18.04.2006
Lithuanian: Rinkodaros teisė paskutinį kartą atnaujinta 2006-04-18.
English: Active immunisation of bitches to prevent mortality, clinical signs and lesions in puppies resulting from canine herpes virus infections acquired in the first few days of life through passive immunity.
Lithuanian: Kalėms aktyviai imunizuoti, norint per pasyvų imunitetą apsaugoti šuniukus nuo gaišimo, klinikinių požymių ir pažeidimų, kuriuos sukelia pirmosiomis gyvenimo dienomis įvykęs užsikrėtimas šunų herpes virusu.
English: Aseptically reconstitute the contents of the powder with the solvent supplied with this vaccine.
Lithuanian: Reikia aseptiškai atskiesti vakcinos miltelius skiedikliu, pridėtu prie šio veterinarinio vaisto.
English: EXP {month/year} Once reconstituted use immediately.
Lithuanian: Tinka iki {mėnuo/metai} Atskiedus būtina sunaudoti nedelsiant.
English: Eurican Herpes 205 solvent
Lithuanian: Eurican Herpes 205, skiediklis
English: EU/2/01/029/001 10 doses: powder (10 bottles) + solvent (10 bottles) EU/2/01/029/002 50 doses: powder (50 bottles) + solvent (50 bottles) EU/2/01/029/003 1 dose: powder (1 bottle) + solvent (1 bottle)
Lithuanian: EU/2/01/029/002 50 dozių: milteliai (50 buteliukų) + skiediklis (50 buteliukų)
English: Pregnancy: This vaccine is specifically indicated during pregnancy.
Lithuanian: Vaikingumas Ši vakcina specialiai skirta naudoti šuningumo metu.
English: Powder and solvent for emulsion for injection.
Lithuanian: Milteliai ir skiediklis injekcinei emulsijai ruošti.
English: Casein hydrolysate Collagen hydrolysate Salts
Lithuanian: sorbitolis, dekstranas 40, kazeino hidrolizatas, kolageno hidrolizatas, druskos,
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Lithuanian: - labai dažna (vieno gydymo metu nepalankios reakcijos pasireiškė daugiau nei 1 iš 10 gyvūnų),
English: Eurican Herpes 205 powder for injection
Lithuanian: Eurican Herpes 205, injekciniai milteliai
English: Second injection: 1 to 2 weeks before the expected date of whelping.
Lithuanian: antrą kartą: likus 1-2 sav.
English: Pharmacotherapeutic group : Inactivated viral vaccines ATCvet code: QI07AA06
Lithuanian: IMUNOLOGINĖS SAVYBĖS Farmakoterapinė grupė: inaktyvintos virusinės vakcinos.
English: Light paraffin oil ......................................................................................................... 224.8 to 244.1 mg For the full list of excipients, see section 6.1.
Lithuanian: 224,8-244,1 mg.
English: Shelf life after reconstitution: use immediately
Lithuanian: Tinkamumo laikas, atskiedus pagal nurodymus, - sunaudoti nedelsiant.
English: Veterinary medicinal product subject to prescription
Lithuanian: Buteliukas VETERINARINIO VAISTO PAVADINIMAS
English: Eurican Herpes 205 powder and solvent for emulsion for injection
Lithuanian: Eurican Herpes 205, liofilizatas ir skiediklis injekcinei emulsijai ruošti
English: Sorbitol
Lithuanian: trietanolaminas.
English: Powder and solvent for emulsion for injection Lyophilisate : white pellet.
Lithuanian: Liofilizatas: balti milteliai.
English: Eurican Herpes 205 powder and solvent for emulsion for injection.
Lithuanian: Eurican Herpes 205, milteliai ir skiediklis injekcinei emulsijai ruošti
English: Subcutaneous use.
Lithuanian: iki numatomo šuniavimosi.
English: Abortion and premature parturition can occur as a result of CHV infection in bitches, the protection of the bitch against infection has not been studied for this vaccine.
Lithuanian: Užsikrėtusioms CHV (šunų herpes virusu) kalėms gali įvykti abortas arba priešlaikinis atsivedimas.
English: Per 1-ml dose: Canine herpesvirus (F205 strain) antigens ............................................... 0.3 to 1.75 µg* *expressed in µg of gB glycoproteins
Lithuanian: Vienoje 1 ml dozėje yra F205 padermės šunų herpes viruso antigenų.......................
English: PACKAGE LEAFLET FOR: Eurican Herpes 205 powder and solvent for emulsion for injection
Lithuanian: INFORMACINIS LAPELIS Eurican Herpes 205, milteliai ir skiediklis injekcinei emulsijai ruošti
English: 4.11 Withdrawal period(s)
Lithuanian: NAUDOJIMO BŪDAS (-AI)
English: Overdose:
Lithuanian: Veiklioji medžiaga:
English: EU Number
Lithuanian: Burnos
English: The Committee recommended that Enviage be given marketing authorisation.
Lithuanian: Komitetas rekomendavo suteikti preparato Enviage rinkodaros teisę.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) ENVIAGE EPAR summary for the public
Lithuanian: EUROPOS VIEŠAS VERTINIMO PROTOKOLAS (EPAR) ENVIAGE EPAR santrauka plačiajai visuomenei
English: The full EPAR for Enviage can be found here.
Lithuanian: Išsamų Enviage EPAR galima rasti čia.
English: What benefit has Enviage shown during the studies?
Lithuanian: Kokia Enviage nauda atsiskleidė tyrimų metu?
English: Enviage is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Lithuanian: Enviage nerekomenduojama vartoti pacientams iki 18 metų, kadangi nepakanka duomenų apie vaisto saugumą ir veiksmingumą šios grupės pacientams.
English: Other information about Enviage:
Lithuanian: Kita informacija apie Enviage
English: Enviage was studied in 14 main studies involving over 10,000 patients with essential hypertension.
Lithuanian: Enviage buvo tiriamas 14 pagrindinių tyrimų, kuriuose dalyvavo daugiau nei 10 000 pirmine hipertenzija sergančių pacientų.
English: The most common side effect with Enviage (seen in between 1 and 10 patients in 100) is diarrhoea.
Lithuanian: Dažniausias šalutinis reiškinys, pastebėtas gydant Enviage (pasireiškęs 1-10 pacientų iš 100), yra viduriavimas.
English: The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Lithuanian: Kraujo spaudimas buvo matuojamas gyvsidabrio milimetrais (mmHg).
English: The effects of Enviage were first tested in experimental models before being studied in humans.
Lithuanian: Enviage poveikis pirmą kartą buvo išbandytas su eksperimentiniais modeliais ir tik paskui buvo tiriamas jo poveikis žmonėms.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Enviage are greater than its risks for the treatment of essential hypertension.
Lithuanian: Žmonėms skirtų vaistinių preparatų komitetas (CHMP) nusprendė, kad Enviage nauda yra didesnė už riziką, kai juo gydomi pirmine hipertenzija sergantys pacientai.
English: It should be taken with a light meal preferably at the same time each day, but grapefruit juice should not be taken together with Enviage.
Lithuanian: Enviage rekomenduojama vartoti užvalgius, geriau kasdien tuo pačiu paros metu, tačiau vaisto negalima užgerti greipfrutų sultimis.
English: By blocking the production of angiotensin I, levels of both angiotensin I and angiotensin II fall.
Lithuanian: Slopinant angiotenzino I gamybą sumažėja angiotenzino I ir angiotenzino II kiekis.
English: The recommended dose of Enviage is 150 mg once a day, either taken alone or in combination with other medicines for hypertension.
Lithuanian: Rekomenduojama Enviage dozė yra 150 mg vieną kartą per parą; vaistas gali būti skiriamas vienas arba kartu su kitais vaistais nuo hipertenzijos.
English: The medicine's effects were maintained for up to a year in two of the studies.
Lithuanian: Du tyrimai parodė, kad vaisto poveikis išliko iki vienerių metų.
English: Its use during the first three months of pregnancy and in women planning to become pregnant is not recommended.
Lithuanian: Preparato nerekomenduojama vartoti pirmąjį nėštumo trimestrą arba planuojant nėštumą.
English: The studies lasted between six and 52 weeks and the main measure of effectiveness was the change in blood pressure during either the resting phase of the heartbeat (‘diastolic') or when the chambers of the heart were contracting (‘systolic').
Lithuanian: Tyrimai truko 6-52 savaites; pagrindinis veiksmingumo rodiklis buvo kraujospūdžio pokyčiai širdies atsipalaidavimo fazėje (diastolinis kraujospūdis) arba širdies kamerų susitraukimo fazėje (sistolinis kraujospūdis).
English: Enviage is used to treat essential hypertension (high blood pressure).
Lithuanian: Enviage skirtas pirminei hipertenzijai (padidėjusiam kraujo spaudimui) gydyti.
English: What is the risk associated with Enviage?
Lithuanian: Kokia rizika siejama su Enviage vartojimu?
English: Enviage should not be used by people who may be hypersensitive (allergic) to aliskiren or any of the other ingredients.
Lithuanian: Enviage negalima skirti žmonėms, kurie gali būti itin jautrūs (alergiški) aliskirenui arba bet kuriai sudėtinei Enviage medžiagai.
English: For the full list of all side effects reported with Enviage, see the Package Leaflet.
Lithuanian: Išsamų visų šalutinių reiškinių, apie kuriuos pranešta gydant Enviage, sąrašą galima rasti pakuotės lapelyje.
English: Enviage also reduced blood pressure in patients with diabetes and patients who were overweight.
Lithuanian: Enviage taip pat sumažino cukriniu diabetu sergančių pacientų ir antsvorį turinčių pacientų kraujospūdį.
English: Why has Enviage been approved?
Lithuanian: Kodėl Enviage buvo patvirtintas?
English: Enviage is a medicine that contains the active substance aliskiren.
Lithuanian: Enviage -tai vaistinis preparatas, kurio sudėtyje yra veikliosios medžiagos aliskireno.
English: This causes vasodilation (widening of the blood vessels), so that the blood pressure drops.
Lithuanian: Tai sukelia vazodilataciją (kraujagyslių išsiplėtimą) ir dėl to nukrenta kraujospūdis.
English: Enviage must also not be taken with ciclosporin (a medicine that reduces the activity of the immune system), quinidine (used to correct irregular heartbeat) or verapamil (used to treat heart problems).
Lithuanian: Enviage taip pat negalima vartoti kartu su ciklosporinu (imuninės sistemos aktyvumą mažinančiu preparatu), kinidinu (sutrikusį širdies ritmą atstatančiu preparatu) arba verapamiliu (skiriamu esant širdies veiklos sutrikimams).
English: Combination studies looked at Enviage used with an angiotensin converting enzyme inhibitor (ramipril), an angiotensin receptor blocker (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Lithuanian: Buvo atlikti vaistų derinių tyrimai Enviage skiriant kartu su angiotenziną konvertuojančio fermento inhibitorimi ramipriliu, angiotenzino receptorių blokatoriumi valsartanu, betablokatoriumi atenololiu, kalcio kanalų blokatoriumi amlodipinu ir diuretiku hidrochlorotiazidu.
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Lithuanian: Angiotenzinas I virsta hormonu angiotenzinu II, kuris yra stiprus vazokonstriktorius (kraujagysles siaurinanti medžiaga).
English: The studies also showed that Enviage, when taken in combination with other medicines (especially hydrochlorothiazide), can produce additional decreases in blood pressure compared with the decreases produced by these medicines when they are taken without Enviage.
Lithuanian: Be to, tyrimai parodė, kad Enviage ir kitų vaistų (ypač hidrochlorotiazido) derinys gali dar labiau sumažinti kraujospūdį nei vaistai, vartojami be Enviage.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Enviage to Novartis Europharm Limited on 22 August 2007.
Lithuanian: bendrovei „Novartis Europharm Limited“ suteikė visoje Europos Sąjungoje galiojančią preparato Enviage rinkodaros teisę.
English: What is Enviage?
Lithuanian: Kas yra Enviage?
English: Enviage, taken alone or in combination with other medicines, was also compared with other medicines for hypertension.
Lithuanian: Be to, Enviage, skiriamas vienas arba kartu su kitais vaistais, buvo lyginamas su kitais spaudimą mažinančiais vaistais.
English: Thirteen of the studies included patients with mild to moderate hypertension, and one included patients with severe hypertension.
Lithuanian: Trylikoje iš jų dalyvavo pacientai, sergantys lengva arba vidutinio sunkumo hipertenzija, o viename - pacientai, sergantys sunkia hipertenzija.
English: This may reduce the risks associated with high blood pressure, such as having a stroke.
Lithuanian: Taip sumažėja aukšto kraujo spaudimo keliama (pvz., insulto) rizika.
English: It must not be used in patients who have had angioedema (swelling under the skin) with aliskiren or in women who are more than three months pregnant.
Lithuanian: Preparato negalima skirti pacientams, kuriems aliskirenas sukėlė angioedemą (tinimą po oda), arba moterims nuo ketvirtojo nėštumo mėnesio.
English: When the results of the five studies comparing Enviage taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Enviage, from an average of 99.4 mmHg at the start of the study.
Lithuanian: pacientų, aštuonias savaites vartojusių 150 mg Enviage paros dozę, diastolinis kraujospūdis vidutiniškai sumažėjo 9,0 mmHg (tyrimo pradžioje vidutinis diastolinis kraujospūdis buvo 99,4 mmHg).
English: This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients taking placebo.
Lithuanian: Pacientų, kuriems buvo skirtas placebas, kraujospūdis sumažėjo 5,8 mmHg (tyrimo pradžioje buvo 99,3 mmHg).
English: It is available as tablets (pink and round: 150 mg; red and oval: 300 mg).
Lithuanian: Jis tiekiamas tabletėmis (rožinės spalvos apvalioje tabletėje yra 150 mg veikliosios medžiagos, o raudonos spalvos ovalioje tabletėje - 300 mg veikliosios medžiagos)
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Enviage.
Lithuanian: arba vyresniems pacientams ir pacientams, vartojusiems didesnes Enviage dozes.
English: In five of the studies, the effects of Enviage taken alone were compared with those of placebo (a dummy treatment).
Lithuanian: Enviage, skiriamas vienas, buvo lyginamas su placebu (gydomojo poveikio neturinčiu preparatu).
English: Enviage on its own was more effective than placebo and as effective as comparator treatments in reducing blood pressure.
Lithuanian: Tyrimų metu nustatyta, kad Enviage geriau nei placebas mažina kraujospūdį ir yra toks pat veiksmingas kaip lyginamieji vaistai nuo hipertenzijos.
English: How is Enviage used?
Lithuanian: Kaip vartoti Enviage?
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Lithuanian: Veiklioji Enviage medžiaga aliskirenas yra renino inhibitorius. Jis slopina žmogaus fermento renino, kuris dalyvauja angiotenzino I gamyboje, aktyvumą.
English: How has Enviage been studied?
Lithuanian: Kaip buvo tiriamas Enviage?
English: What is Enviage used for?
Lithuanian: Kam vartojamas Enviage?
English: The dose of Enviage may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Lithuanian: Jei kraujospūdis pacientui sumažėja nepakankamai, dozę galima padidinti iki 300 mg vieną kartą per parą.
English: How does Enviage work?
Lithuanian: Kaip veikia Enviage?
English: Further information can be found here:
Lithuanian: Išsamesnę informaciją galima rasti čia:
English: The CHMP also had some concerns regarding some aspects of the manufacture and quality control of the medicine.
Lithuanian: CHMP taip pat turėjo tam tikrų abejonių dėl kai kurių vaisto gamybos ir kokybės kontrolės aspektų.
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Lithuanian: Per 15 dienų nuo pranešimo apie šią neigiamą nuomonę gavimo dienos bendrovė gali pareikalauti pakartotinai apsvarstyti priimtą nuomonę.
English: The company provided data in experimental models from the scientific literature.
Lithuanian: Pareiškėjas pateikė duomenis apie eksperimentinius modelius, remdamasis moksline literatūra.
English: What is Lympreva?
Lithuanian: Kas yra Lympreva?
English: The main measure of effectiveness was based on how long the patients lived without their cancer symptoms reappearing or until death.
Lithuanian: Pagrindinis veiksmingumo rodiklis buvo paciento išgyvenimo trukmė iki avėžio simptomų atsinaujinimo ar mirties.
English: Page 2/2
Lithuanian: balandžio 24 d.
English: What consequences does this refusal have for patients in clinical trials or compassionate use programmes?
Lithuanian: Kokių pasekmių atsisakymas suteikti rinkodaros leidimą turės pacientams, dalyvaujantiems klinikiniuose tyrimuose arba labdaringo vartojimo programose?
English: In addition, the effectiveness of Lympreva following induction treatment with the current standard of care (the so-called ‘anti-CD20' therapies) has not been demonstrated.
Lithuanian: Be to, Lympreva veiksmingumas po indukcinio gydymo etapo, taikant šiuo metu standartine laikomą terapiją (gydymą vadinamaisiais anti-CD20 vaistais), neįrodytas.
English: The company that applied for authorisation is Biovest Europe Ltd.
Lithuanian: Paraišką dėl rinkodaros leidimo suteikimo pateikė bendrovė „Biovest Europe Ltd“.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom24 April 2015
Lithuanian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: The company also presented the results of one main study involving a total of 177 adults with follicular lymphoma who had responded to induction treatment with an established therapy known as PACE (prednisone, doxyrubicin, cyclophosphamide, and etoposide) and who had no sign of their disease.
Lithuanian: Bendrovė taip pat pateikė vieno pagrindinio tyrimo su 177 folikuline limfoma sergančiais suaugusiesiais, kuriems buvo nustatytas atsakas į indukcinį gydymą taikant plačiai pripažįstamą terapiją, vadinamą PACE (gydymą prednizonu, doksirubicinu, ciklofosfamidu ir etopozidu), ir kuriems nepasireiškė jokių ligos požymių, rezultatus.
English: It was expected to be used in combination with another medicine called granulocyte macrophage colony-stimulating factor (GM-CSF).
Lithuanian: Šį vaistą buvo numatyta vartoti kartu su kitu vaistu, vadinamu granulocitų makrofagų kolonijas stimuliuojančiu faktoriumi (GM-KSF).
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Lympreva did not outweigh its risks and recommended that it be refused marketing authorisation.
Lithuanian: Todėl tuo metu CHMP laikėsi nuomonės, kad Lympreva nauda nėra didesnė už jo keliamą riziką, ir rekomendavo nesuteikti šio vaistinio preparato rinkodaros leidimo.
English: Refusal of the marketing authorisation for Lympreva (dasiprotimut-T) EMA/249530/2015
Lithuanian: Atsisakymas suteikti Lympreva (dasiprotimuto-T) rinkodaros leidimą EMA/372517/2015
English: The CHMP considered that the way the main study was designed and carried out was inadequate to allow the Committee to establish the medicine's benefit.
Lithuanian: CHMP laikėsi nuomonės, kad pagrindinis Lympreva tyrimas buvo suplanuotas ir atliktas netinkamai, todėl komitetas negali patvirtinti šio vaisto naudos.
English: Lympreva was expected to be given to patients whose signs of disease had disappeared following an ‘induction' treatment, to maintain the complete disappearance of symptoms of cancer.
Lithuanian: Lympreva buvo numatyta skirti pacientams, kurių ligos požymiai išnyko po vadinamojo indukcinio gydymo etapo, siekiant, kad vėžio simptomai išliktų visiškai išnykę.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Lympreva.
Lithuanian: Bendrovė pranešė CHMP, kad šiuo metu Lympreva klinikiniai tyrimai ir labdaringo vartojimo programos nevykdomos.