FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 Article 31 of Directive 2001/83/EC as amended, referral under Community interest.
Lithuanian: Iš dalies pakeistos Direktyvos 2001/83/EB 31 straipsnis, Bendrijos interesais pradta kreipimosi procedra.
English: What are the recommendations for patients and prescribers?
Lithuanian: Kokios yra rekomendacijos pacientams ir vaistus skiriantiems gydytojams?
English: • a reduction of the maximum recommended dose to 3 mg per day;
Lithuanian: • apriboti didžiausi rekomenduojam doz iki 3 mg per dien ;
English: When it affects the heart valves, it can lead to problems with the flow of blood around the heart and, eventually, heart failure (an inability of the heart to pump enough blood around the body).
Lithuanian: Kai ji pažeidžia širdies vožtuvus, tai gali sukelti kraujotakos aplink šird problem ir galiausiai - širdies nepakankamum (širdis nesugeba užtikrinti efektyvios kraujotakos).
English: Which data has the CHMP reviewed?
Lithuanian: Kuriuos duomenis CHMP perži r jo?
English: There was not enough information available to allow the Committee to recommend a similar contraindication for lisuride.
Lithuanian: Netur damas pakankamai informacijos, Komitetas negal jo rekomenduoti panašios kontraindikacijos lizuridui.
English: • Patients or their carers who have any questions or concerns should speak to their doctor or pharmacist.
Lithuanian: • Turint klausim ar abejoni , pacientams arba juos priži rintiems asmenims reikia kreiptis gydytoj arba vaistinink.
English: This suggested that cardiac fibrosis may be more common that previously thought.
Lithuanian: Tai leidžia daryti prielaid , kad širdies fibroz gali b ti dažnesn nei manyta.
English: This review was carried out under an ‘Article 31' referral1.
Lithuanian: Perži ra atlikta pagal 31 straipsnyje numatyt kreipimosi proced r
English: The Committee noted that there is a plausible mechanism for how these medicines may cause fibrosis, through activation of ‘5-HT2B receptors', leading to cell division and formation of fibrous tissue, although other mechanisms might be involved.
Lithuanian: Komitetas pasteb jo, kad yra tik tinas mechanizmas, kaip šie vaistai sukelia fibroz : tai yra „5-HT2B receptori “ aktyvacija, sukelianti l steli dalijim si ir skaidulinio audinio susidarym , nors galimi ir kiti mechanizmai.
English: • a warning stating that patients must be monitored for signs of fibrosis with echocardiography before treatment is started and regularly during treatment;
Lithuanian: • traukti sp jim , kad pacientai turi b ti stebimi d l fibroz s požymi naudojant echokardiografij prieš pradedant gydym ir reguliariai gydymo metu;
English: • Doctors should prescribe ergot-derived dopamine agonists according to the updated prescribing information.
Lithuanian: • Gydytojai turi skirti skalsi kilm s dopamino agonistus pagal atnaujint skyrimo informacij .
English: Ergot-derived dopamine agonists are a group of medicines consisting of bromocriptine, cabergoline, dihydroergocryptine, lisuride and pergolide.
Lithuanian: Skalsi kilm s dopamino agonistai yra vaist grup , kuriai priklauso bromokriptinas, kabergolinas, dihidroergokriptinas, lizuridas ir pergolidas.
English: The CHMP also recommended that companies that make these two medicines should conduct studies to look at how closely doctors follow the updated prescribing information and the impact that these changes have on the incidence of fibrosis of the heart valves.
Lithuanian: CHMP taip pat rekomendavo, kad šiuos du vaistus gaminan ios bendrov s atlikt tyrimus, siekiant vertinti, kaip gydytojai laikosi atnaujintoje skyrimo informacijoje pateikt nurodym , ir koki tak šie pakeitimai turi širdies vožtuv fibroz s dažniui.
English: Among the ergot-derived dopamine agonists, cabergoline and pergolide activate these receptors most strongly, possibly explaining the greater risk of fibrosis seen with these medicines.
Lithuanian: Iš skalsi kilm s dopamino agonist kabergolinas ir pergolidas stipriausiai stimuliuoja šiuos receptorius, o tai gali paaiškinti didesn fibroz s rizik vartojant šiuos vaistus.
English: Based on the information available, the CHMP has concluded that the marketing authorisations for the ergot-derived dopamine agonists should be maintained, but changes to the prescribing information for the medicines should be introduced to reduce the risk of fibrosis.
Lithuanian: Remdamasis turima informacija, CHMP padar išvad , kad skalsi kilm s dopamino agonist rinkodaros teises reikia palikti galioti, bet traukti pakeitimus vaist skyrimo informacij , kad b t sumažinta fibroz s rizika.
English: The absence of fibrosis in the heart should be verified before treatment is started.
Lithuanian: Prieš pradedant gydym , reikia pasitikrinti, ar nesergama širdies fibroze.
English: The CHMP reviewed all of the available information on the risk of fibrosis and valve problems from clinical trials, observational studies (studies looking at the effects of medicines as they are used by patients) and ‘spontaneous reports' of side effects made by patients or doctors to the companies that make the medicines or to health authorities.
Lithuanian: CHMP perži r jo vis turim informacij apie fibroz s rizik ir širdies vožtuv sutrikimus, gaut iš klinikini tyrim , steb jimo tyrim (tyrimai, per kuriuos stebimas vaist poveikis pacientams ši vaist vartojimo metu) ir pacient ar gydytoj pateikt „spontanišk pranešim “ apie šalutinius poveikius vaistus gaminanioms bendrovms arba sveikatos priežiros tarnyboms.
English: • Patients should be monitored for the signs of fibrosis in the heart and elsewhere in the body throughout treatment, using blood tests or chest X-rays as appropriate.
Lithuanian: • Pacientai turi b ti stebimi d l širdies ar kito k no organo ar audinio fibroz s požymi viso gydymo metu, atliekant, jei reikia, kraujo tyrimus arba kr tin s rentgenogramas.
English: • ‘cardiac fibrosis' as a ‘very common' side effect (seen in more than 1 patient in 10 taking either medicine).
Lithuanian: • nurodyti „širdies fibroz “ kaip „labai dažn “ šalutin poveik (pasireiškiant daugiau nei 1
English: Dopamine agonists work by stimulating brain and nerve cells in a similar way to dopamine, a messenger substance in the nervous system.
Lithuanian: Dopamino agonistai veikia stimuliuodami smegen ir nerv l steles panašiai kaip dopaminas, nerv sistemos pernešan ioji medžiaga.
English: The European Medicines Agency (EMEA) has completed a review of the safety of the ergot-derived dopamine agonists, a group of medicines that are mainly used to treat Parkinson's disease.
Lithuanian: Europos vaist agent ra (EMEA) užbaig skalsi kilm s dopamino agonist , vaist grup s, kuri daugiausia vartojama Parkinsono ligai gydyti, saugumo perži r .
English: This group of dopamine agonists are called ‘ergotderived', because they were first produced from a type of fungus called ergot.
Lithuanian: Ši dopamino agonist grup vadinama „skalsi kilm s“ dopamino agonistais, nes jie pirmiausia buvo išskirti iš grybo, vadinamo paprast ja skalse.
English: • Ergot-derived dopamine agonists should not be taken by patients who have had fibrosis in the heart, lungs or abdomen.
Lithuanian: • Skalsi kilm s dopamino agonist negalima vartoti pacientams, sergantiems širdies, plau i ar pilvo fibroze.
English: QUESTIONS AND ANSWERS ON THE REVIEW OF ERGOT-DERIVED DOPAMINE AGONISTS
Lithuanian: KLAUSIMAI IR ATSAKYMAI D L SKALSI KILM S DOPAMINO AGONIST PERŽI ROS
English: What are ergot-derived dopamine agonists?
Lithuanian: Kas yra skalsi kilm s dopamino agonistai?
English: Therefore, the CHMP recommended that the prescribing information for these two medicines should be updated to include:
Lithuanian: Tod l CHMP rekomendavo ši dviej vaist skyrimo informacij pakeisti taip:
English: Fibrosis can affect a number of body structures such as the heart, the lungs or the abdomen.
Lithuanian: Fibroz gali pažeisti daugel k no strukt r , pvz., šird , plau ius ar pilv .
English: The CHMP also concluded that the risk of fibrosis, including fibrosis of the heart valves, does not appear to be the same for all five medicines in the class.
Lithuanian: CHMP taip pat padar išvad , kad fibroz s, skaitant širdies vožtuv fibroz , rizika kiekvieno iš penki min tai klasei priklausan i vaist vartojimo atveju n ra vienoda.
English: In contrast, there is not enough evidence to determine whether there is an increased risk of fibrosis of the heart valves in patients taking bromocriptine, dihydroergocryptine or lisuride.
Lithuanian: Priešingai nei pirm j dviej vaist atveju, nepakanka rodym nustatyti, ar pacientams, vartojantiems bromokriptin , dihidroergokriptin ar lizurid , rizika susirgti širdies vožtuv fibroze yra didesn .
English: They are also used to treat conditions including hyperprolactinaemia (high levels of the hormone prolactin in the blood) and prolactinoma (a non-cancerous tumour of the pituitary gland at the base of the brain), and to prevent lactation (production of breast milk) and migraine.
Lithuanian: Jie tiekiami rink jau daug met , ir daugiausia vartojami Parkinsono ligai gydyti vartojant tik šiuos vaistus arba juos skiriant su kitais vaistais. Jie taip pat vartojami hiperprolaktinemijai (didelis hormono prolaktino kiekis kraujyje) ir prolaktinomai (ne v žio kilm s hipofiz s auglys smegen pagrinde) gydyti bei laktacijos (pieno gamyba kr tyse) ir migrenos profilaktikai.
English: For cabergoline and pergolide, the Committee noted that the risk of fibrosis of the heart valves is well established, that the prescribing information for both products already includes contraindications stating that patients with evidence of heart valve problems should not take them, and that the medicines should only be used for Parkinson's disease in patients who have already taken or cannot take other treatments.
Lithuanian: abiej preparat skyrimo informacij jau yra trauktos kontraindikacijos, sp jan ios, kad pacientams, turintiems širdies vožtuv veiklos sutrikim požymi , j vartoti negalima, ir kad šiuos vaistus galima vartoti tik gydant Parkinsono liga sergan ius pacientus, kurie jau yra išband arba kuriems negali b ti taikomos kitos gydymo alternatyvos.
English: However, since such a risk cannot completely be excluded, the Committee recommended that warnings on the possible risk of fibrosis in patients taking these medicines at high doses for long periods should be included in their prescribing information.
Lithuanian: Ta iau, kadangi tokios rizikos negalima visiškai atmesti, Komitetas rekomendavo ši vaist skyrimo informacij traukti sp jimus d l galimos fibroz s rizikos pacientams, vartojantiems juos didel mis doz mis ilg laik . Bromokriptino doz irgi turi b ti apribota iki 30 mg per par .
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the marketing authorisations for these medicines should be maintained.
Lithuanian: Agent ros Žmon ms skirt vaistini preparat komitetas (CHMP) padar išvad , kad ši vaist rinkodaros teis s turi b ti paliktos galioti.
English: In addition, the CHMP recommended that a contraindication for patients with pre-existing valve problems should be included in the prescribing information for bromocriptine and dihydroergocryptine-containing medicines.
Lithuanian: Be to, CHMP rekomendavo vaistini preparat , kuri sud tyje yra bromokriptino ir dihidroergokriptino, skyrimo informacij traukti kontraindikacij širdies vožtuv sutrikim turintiems pacientams.
English: All five medicines are authorised by regulatory authorities in Member States.
Lithuanian: Valstybi nari vaist kontrol s tarnybos yra suteikusios vis penki preparat rinkodaros teises.
English: The review focused on the risk of fibrosis (the formation of fibrous tissue in some body structures) in patients taking these medicines for long periods, particularly cardiac fibrosis (abnormal thickening of the heart valves).
Lithuanian: Perži ra atlikta siekiant vertinti fibroz s (skaidulinio audinio susidarymas kai kuriose k no strukt rose), ypa širdies fibroz s (patologinis širdies vožtuv sustor jimas), rizik ilgai vartojantiems šiuos vaistus pacientams.
English: However, restrictions on the way these medicines are used should be introduced, to reduce the risk of fibrosis developing.
Lithuanian: Ta iau, siekiant sumažinti fibroz s vystymosi rizik , turi b ti vesti ši vaist vartojimo apribojimai.
English: • To reduce the risk of cardiac fibrosis, patients should be prescribed a daily maximum of 3 mg pergolide or cabergoline, or 30 mg bromocriptine.
Lithuanian: 3 mg pergolido ar kabergolino arba 30 mg bromokriptino.
English: Why have ergot-derived dopamine agonists been reviewed?
Lithuanian: Kod l skalsi kilm s dopamino agonistai buvo perži r ti?
English: However, two studies published in scientific journals using echocardiography (ultrasound scans of the heart) have shown that fibrosis of the heart valves can begin to develop well before symptoms start to appear.
Lithuanian: Fibroz s simptom atsiradimas kaip skalsi kilm s dopamino agonist šalutinis poveikis, ypa vartojant šiuos vaistus ilg laik , žinomas daugel met . Ta iau dviej moksliniuose žurnaluose paskelbt tyrim metu, naudojant echokardiografij (širdies tyrimas ultragarsu), buvo rodyta, kad širdies vožtuv fibroz gali prasid ti gerokai prieš pasirodant simptomams.
English: Consequently, the United Kingdom's medicines regulatory authority asked the CHMP to review the risk of fibrosis, including cardiac fibrosis, associated with the use of ergot-derived dopamine agonists.
Lithuanian: Tod l Jungtin s Karalyst s vaist kontrol s tarnyba papraš CHMP perži r ti su skalsi kilm s dopamino agonist vartojimu susijusi fibroz s, skaitant širdies fibroz , rizik .
English: --1 ≥ 394AU/ml (Antigenic units determined by ELISA) (1400 AU corresponding to ≥ 492 AU in the potency test)
Lithuanian: --1 ≥ 394AV/ml (ELISA metodu nustatyti antigeno vienetai) (1400 AV atitinka ≥ 492 AV pagal stiprumo tyrimą)
English: Vial (type I glass) closed with a rubber stopper secured with aluminium cap
Lithuanian: Buteliukas (I tipo stiklo), užkimštas gumos kamšteliu ir apgaubtas aliumininiu gaubteliu
English: 10 vials Zero days
Lithuanian: 10 buteliukų 0 parų
English: It was to be available as 10 mg tablets.
Lithuanian: Jį buvo numatyta tiekti 10 mg tabletėmis.
English: This complex then blocks mTOR.
Lithuanian: Šis kompleksas blokuoja mTOR.
English: 14 December 2012 EMA/807998/2012 EMEA/H/C/2259
Lithuanian: EMEA/H/C/2259
English: What is Jenzyl?
Lithuanian: Kas yra Jenzyl?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Lithuanian: Jeigu dalyvaujate klinikiniame tyrime ir pageidaujate gauti daugiau informacijos apie Jums taikomą gydymą, kreipkitės į Jus gydantį gydytoją
English: Withdrawal of the marketing authorisation application for Jenzyl (ridaforolimus)
Lithuanian: Paraiškos gauti Jenzyl (ridaforolimuzo) rinkodaros leidimą atsiėmimas
English: This is expected to slow down the growth and proliferation of cancer cells.
Lithuanian: Dėl tokio poveikio vėžio ląstelių augimas ir proliferacija turėtų sulėtėti.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated a list of questions.
Lithuanian: Paraiška atsiimta, kai CHMP buvo įvertinęs bendrovės pateiktus pirminius dokumentus ir parengęs klausimų sąrašą.
English: Since mTOR is involved in the control of cell division and the growth of blood vessels, ridaforolimus prevents the division of tumour cells and reduces their blood supply.
Lithuanian: Kadangi mTOR dalyvauja kontroliuojant ląstelių dalijimąsi ir kraujagyslių augimą, ridaforolimuzas neleidžia naviko ląstelėms dalytis ir slopina jų aprūpinimą krauju.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Jenzyl can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation (soft tissue sarcoma and primary malignant bone tumours).
Lithuanian: Retųjų vaistinių preparatų komiteto nuomonės dėl Jenzyl santrauką galima rasti Agentūros interneto svetainėje ema.europa.eu/Find medicine/Human medicines/Rare disease designation (dėl minkštųjų audinių sarkomos ir dėl pirminių piktybinių kaulų navikų).
English: The company had not yet responded to the last round of questions at the time of the withdrawal.
Lithuanian: Paraiškos atsiėmimo metu bendrovė dar nebuvo atsakiusi į paskutinį kartą pateiktus klausimus.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Jenzyl did not outweigh its risks.
Lithuanian: Todėl paraiškos atsiėmimo metu CHMP laikėsi nuomonės, kad Jenzyl teikiama nauda nėra didesnė už jo keliamą riziką.
English: Jenzyl is a medicine that contains the active substance ridaforolimus.
Lithuanian: Jenzyl - tai vaistas, kurio sudėtyje yra veikliosios medžiagos ridaforolimuzo.
English: The CHMP considered this benefit to be modest, when taking into account that patients usually survived for a long time after their disease had progressed.
Lithuanian: CHMP laikėsi nuomonės, kad ši nauda yra labai nedidelė, atsižvelgiant į tai, kad paprastai, kai liga pradeda progresuoti, pacientai išgyvena dar ilgą laiką.
English: It was expected to be used as maintenance therapy in patients who have already received two or three regimens of chemotherapy.
Lithuanian: Jį buvo numatyta skirti kaip palaikomąjį gydymą pacientams, kuriems jau taikyti du ar trys chemoterapijos kursai.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Jenzyl.
Lithuanian: Bendrovė pranešė CHMP, kad paraiškos atsiėmimas neturės jokių pasekmių pacientams, šiuo metu dalyvaujantiems Jenzyl vartojimo klinikiniuose tyrimuose.
English: In terms of safety, the CHMP was concerned by the high frequency of side effects interfering with the patient's wellbeing as well as some uncommon but potentially lifethreatening side effects.
Lithuanian: Dėl saugumo, CHMP rūpestį kėlė didelis šalutinių reiškinių, kurie neigiamai veikia paciento savijautą, dažnis, taip pat nedažni šalutiniai reiškiniai, kurie gali kelti pavojų gyvybei.
English: The study compared Jenzyl with placebo (a dummy treatment).
Lithuanian: Atliekant tyrimą Jenzyl buvo lyginamas su placebu (gydomojo poveikio neturinčiu preparatu).
English: The CHMP also considered that the somewhat larger effect seen in patients who had received two or three previous regimens of chemotherapy compared with those who received one or more regimens might not reflect the medicine's true effect size, as the reason the medicine would work better at later stages of the disease was unclear.
Lithuanian: Taip pat CHMP laikėsi nuomonės, jog šiek tiek stipresnis vaisto poveikis pacientams, kuriems anksčiau taikyti du ar trys chemoterapijos kursai, palyginti su pacientais, kuriems anksčiau skirta vienas ar daugiau chemoterapijos kursų, gali neatitikti tikrojo vaisto poveikio dydžio, nes neaišku, kodėl vėlesnėse ligos stadijose šis vaistas veiktų geriau.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that it decided to withdraw the application since the CHMP considered that the data provided did not allow the Committee to conclude on a positive benefit-risk balance.
Lithuanian: Savo laiške, kuriuo agentūra informuota apie paraiškos atsiėmimą, bendrovė nurodė nusprendusi atsiimti paraišką todėl, kad CHMP laikėsi nuomonės, jog remdamasis pateiktais duomenimis komitetas negali padaryti išvados, kad šio preparato naudos ir rizikos santykis yra teigiamas.
English: How is Jenzyl expected to work?
Lithuanian: Kokio tikimasi Jenzyl veikimo?
English: In the body, ridaforolimus first attaches to a protein called FKBP-12 that is found inside cells to make a ‘complex'.
Lithuanian: Patekęs į organizmą, ridaforolimuzas pirma jungiasi prie ląstelių viduje esančio baltymo, vadinamo FKBP-12,
English: On 27 November 2012, Merck Sharp & Dohme Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Jenzyl, for the maintenance treatment of patients with metastatic soft tissue sarcoma or bone sarcoma previously treated with chemotherapy.
Lithuanian: bendrovė „Merck Sharp & Dohme Limited“ oficialiai pranešė Žmonėms skirtų vaistinių preparatų komitetui (CHMP) apie savo pageidavimą atsiimti paraišką gauti Jenzyl, skirto metastazavusia minkštųjų audinių sarkoma arba kaulų sarkoma sergančių pacientų, kuriems anksčiau taikyta chemoterapija, palaikomajam gydymui, rinkodaros leidimą.
English: The company presented the results of one main study involving 711 patients with metastatic soft tissue sarcoma or bone sarcoma who have received up to four cycles of one, two or three alternative chemotherapy regimens.
Lithuanian: Bendrovė pateikė vieno pagrindinio tyrimo, kuriame dalyvavo 711 metastazavusia minkštųjų audinių sarkoma ar kaulų sarkoma sergančių pacientų, kuriems taikyta iki keturių gydymo vieno, dviem arba trim chemoterapiniais vaistais kursų, rezultatus.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Jenzyl could not have been approved for the treatment of patients with metastatic soft tissue sarcoma or bone sarcoma as maintenance therapy.
Lithuanian: Remdamasis peržiūrėtais duomenimis ir bendrovės atsakymais į CHMP parengto sąrašo klausimus, paraiškos atsiėmimo metu CHMP dar turėjo abejonių ir buvo priėmęs negalutinę nuomonę, kad Jenzyl negali būti registruotas palaikomajam metastazavusia minkštųjų audinių sarkoma arba kaulų sarkoma sergančių pacientų gydymui.
English: The main measure of effectiveness was the time patients lived until their disease got worse.
Lithuanian: Pagrindinis veiksmingumo rodiklis buvo pacientų išgyvenimo ligai neprogresavus trukmė.
English: The CHMP was concerned that taking Jenzyl only led to a small increase in the time patients lived until their disease got worse compared with placebo (18 versus 15 weeks in patients who had one or more regimens of previous chemotherapy, and 16 versus 10 weeks in patients who had received two or three previous regimens of chemotherapy).
Lithuanian: CHMP nerimą kėlė tai, kad vartojant Jenzyl, pacientų išgyvenimo ligai neprogresavus trukmė buvo tik šiek tiek ilgesnė, nei vartojant placebą (pacientų, kuriems anksčiau skirta vienas ar daugiau chemoterapijos kursų, grupėje - atitinkamai 18 ir 15 savaičių, o pacientų, kuriems anksčiau taikyti du arba trys chemoterapijos kursai, grupėje - atitinkamai 16 ir 10 savaičių).
English: What was Jenzyl expected to be used for?
Lithuanian: Kokiais atvejais buvo numatyta vartoti Jenzyl?
English: Jenzyl was expected to be used for the treatment of adults with soft tissue sarcoma (a type of cancer that affects the soft, supporting tissues of the body) or bone sarcoma (bone cancer) that are metastatic (have spread to other parts of the body).
Lithuanian: Jenzyl buvo numatyta gydyti metastazavusia (į kitas kūno dalis išplitusia) minkštųjų audinių sarkoma (vėžiu, kuris pažeidžia minkštuosius ir pagalbinius kūno audinius) arba kaulų sarkoma (kaulų vėžiu) sergančius suaugusiuosius.
English: The active substance in Jenzyl, ridaforolimus, blocks the action of an enzyme called ‘mammalian target of rapamycin' (mTOR), which regulates the growth and division of cells in the body and which has increased activity in patients with sarcoma.
Lithuanian: mammalian target of rapamycin, mTOR), kuris kontroliuoja ląstelių augimą ir dalijimąsi organizme; sarkoma sergančių pacientų organizme šis fermentas yra aktyvesnis, nei įprastai.
English: Jenzyl was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 26 August 2005 and 28 October 2005 for the treatment of soft tissue sarcoma and primary malignant bone tumours.
Lithuanian: rugpjūčio 26 d. Jenzyl priskirtas retųjų vaistų (retoms ligoms gydyti skirtų vaistų) kategorijai, o 2005 m.
English: 5 x 2 tablets
Lithuanian: 5 x 2 tabletės
English: Package sizes perforated unit dose blister (PVC/Alu)
Lithuanian: Perforuota vienadozė PVC/Al lizdinė plokštelė
English: Strength Pharmaceutical Form
Lithuanian: Stiprumas Farmacinė forma Vartojimo būdas Vidinė Pakuotė