FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP noted that the studies supported the use of Aptivus capsules in adults.
Maltese: Is-CHMP innota li l-istudji sostnew l-użu ta' kapsuli Aptivus fl-adulti.
English: It blocks an enzyme called protease that is involved in the reproduction of HIV.
Maltese: Din timblokka enzima li tissejjaħ proteażi li hija involuta fir-riproduzzjoni tal-HIV.
English: Aptivus is used in combination with low-dose ritonavir (another HIV-medicine) and other HIV-medicines.
Maltese: Aptivus jintuża flimkien ma' doża baxxa ta' ritonavir (mediċina oħra kontra l-HIV) u mediċini oħra kontra l-HIV.
English: Ritonavir is another protease inhibitor that is used as a ‘booster'.
Maltese: Ritonavir hija inibitur tal-proteażi ieħor li jintuża bħala ‘booster'.
English: Why has Aptivus been approved?
Maltese: Għaliex ġie aprovat Aptivus?
English: In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules) twice a day.
Maltese: Fil-pazjenti ta' età minn 12-il sena 'l fuq, id-doża rakkomandata ta' Aptivus hija ta' 500 mg (żewġ kapsuli) darbtejn kuljum.
English: Aptivus capsules have been studied in two main studies involving a total of 1,483 adults who had received many different HIV-medicines in the past, and were not responding to their current treatment combination including a protease inhibitor.
Maltese: Il-kapsuli ta' Aptivus ġew studjati f'żewġ studji ewlenin li kienu jinvolvu 1,483 adult li kienu rċevew ħafna mediċini differenti kontra l-HIV fil-passat, u li ma kinux qed jirrispondu għall-kombinazzjoni talkura attwali tagħhom inkluż l-inibitur tal-proteażi.
English: Therefore, the CHMP decided that the benefits of Aptivus capsules are greater than their risks for the treatment of adults and adolescents 12 years of age or older.
Maltese: Għalhekk, is-CHMP iddeċieda li l-benefiċċji tal-kapsuli Aptivus huma akbar mirriskji għall-kura ta' adulti u adoloxxenti ta' 12-il sena jew aktar.
English: • medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high levels in the blood.
Maltese: • mediċini li jitkissru bl-istess mod ta' Aptivus jew ritonavir u li jagħmlu l-ħsara meta l-livelli tagħhom fid-demm ikunu għolja.
English: How has Aptivus been studied?
Maltese: Kif ġie studjat Aptivus?
English: A risk management plan has been developed to ensure that Aptivus is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Aptivus jintuża bl-aktar mod sigur possibbli.
English: The Committee also decided that the benefits of Aptivus oral solution are greater than its risks for children from two to 12 years of age.
Maltese: Il-Kumitat iddeċieda wkoll li lbenefiċċji ta' Aptivus bħala soluzzjoni orali huma akbar mir-riskji tiegħu fi tfal ta' età minn sentejn sa 12-il sena.
English: This allows a lower dose of tipranavir to be used for the same antiviral effect.
Maltese: Dan jippermetti li tintuża doża iżgħar tat-tipranavir għall-istess effett antivirali.
English: In adults, the most common side effects when taking Aptivus with ritonavir (seen in more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
Maltese: Fl-adulti, l-effetti sekondarji l-aktar komuni meta Aptivus jittieħed mar-ritonavir (li dehru f'aktar minn pazjent 1 minn 10) huma dijarrea u nawżja (dardir).
English: Aptivus capsules, taken in combination with ritonavir, were more effective than the comparator medicines in patients with few remaining options for successful HIV treatment.
Maltese: Il-kapsuli ta' Aptivus, meħudin f'kombinazzjoni ma' ritonavir, irriżultaw aktar effikaċi mill-mediċini tattqabbil f'pazjenti li kien fadalilhom ftit alternattivi għall-kura b'suċċess kontra l-HIV.
English: What is Aptivus?
Maltese: X'inhu Aptivus?
English: What is the risk associated with Aptivus?
Maltese: X'inhu r-riskju assoċjat ma' Aptivus?
English: It is used in patients who have already been treated with other antiviral medicines for HIV infection, and in whom many other medicines in the same class as Aptivus (protease inhibitors) do not work.
Maltese: Jintuża minn pazjenti li jkunu diġà ġew ikkurati b'mediċini antivirali oħra għall-infezzjoni mill-HIV, u li fuqhom ħafna mediċini oħra fl-istess klassi ta' Aptivus (inibituri tal-proteażi) ma jkunux ħadmu.
English: Aptivus with ritonavir must not be used with colchicine (a medicine used to treat gout) in patients with kidney or liver impairment.
Maltese: Aptivus ma' ritonavir m'għandux jintuża ma' colchicine (mediċina użata għall-kura tal-gotta) f'pazjenti b'indeboliment tal-kliewi jew tal-fwied.
English: Treatment with Aptivus should be started by a doctor who has experience in the treatment of HIV-1 infection.
Maltese: Il-kura b'Aptivus għandha tinbeda minn tabib li għandu esperjenza fil-kura tal-infezzjoni HIV-1.
English: Aptivus does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Aptivus ma jfejjaqx infezzjoni mill-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lissistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: Aptivus, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Aptivus, meħud flimkien ma' mediċini oħra kontra l-HIV, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: For the full list of all side effects reported with Aptivus, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Aptivus, ara l-fuljett ta' tagħrif.
English: The dose of the oral solution depends on body surface area (calculated using the child's height and weight).
Maltese: Iddoża tas-soluzzjoni orali tiddependi miż-żona tal-wiċċ tal-ġisem (ikkalkolata skont it-tul u l-piż tattifel/tifla).
English: When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.
Maltese: Meta l-enzima tiġi imblukkata, il-virus ma jirriproduċix ruħu bħas-soltu, u dan inaqqas il-firxa tal-infezzjoni.
English: EMA/CHMP/800910/2012 EMEA/H/C/002610
Maltese: EMA/130421/2013 EMEA/H/C/002610
English: EMA/CHMP/800910/2012
Maltese: EMA/130421/2013
English: Isomarv medium is a medicine that contains the active substance human insulin.
Maltese: Isomarv medium huwa mediċina li fiha s-sustanza attiva insulina umana.
English: What is Isomarv medium?
Maltese: Isomarv medium?
English: The insulin in Isomarv medium 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.
Maltese: L-insulina f'Isomarv medium issir b'metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': hija magħmula minn batterji li jkunu rċievew ġene (DNA) li jagħmel lill-batterji kapaċi jipproduċu l-insulina.
English: The application was a joint application from Marvel LifeSciences for Isomarv medium and two other medicines (Solumarv and Combimarv, also developed as biosimilar medicines).
Maltese: L-applikazzjoni kienet applikazzjoni konġunta minn Marvel LifeSciences għal Isomarv medium u żewġ mediċini oħrajn (Solumarv u Combimarv, żviluppati wkoll bħala mediċini bijosimili).
English: Isomarv medium was intended as a replacement insulin that is similar to the insulin made by the body.
Maltese: Isomarv medium kien maħsub bħala insulina ta' sostituzzjoni li hija simili għall-insulina magħmula mill-ġisem.
English: The CHMP also noted problems with the study data provided by the company, including statistical errors and missing information.
Maltese: Is-CHMP innota wkoll problemi fid-dejta tal-istudju mibgħuta mill-kumpanija, inkluż żbalji statistiċi u informazzjoni nieqsa.
English: The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
Maltese: L-applikazzjoni ġiet irtirata wara li s-CHMP evalwa d-dokumentazzjoni inizjali li mibgħuta millkumpanija u fassal list ta' mistoqsijiet.
English: On 15 November 2012, Marvel LifeSciences Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Isomarv medium, intended for the treatment of patients with diabetes who require insulin to control their blood glucose.
Maltese: Fil-15 ta' Novembru 2012, Marvel LifeSciences Ltd għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li bil-ħsieb li tirtira l-applikazzjoni tagħha għal bidla talawtorizzazzjoni għat-tqegħid fis-suq għal Isomarv medium, li huwa prodott medċinali li jintuża fil-kura ta' pazjenti bid-dijabete li jeħtieġu l-insulina biex jikkontrollaw il-livell tal-glukożju fid-demm.
English: Isomarv medium was developed as a biosimilar medicine.
Maltese: Isomarv medium tfassal bħala mediċina bijosimili.
English: In addition, the company presented the results from a main study in 432 patients with diabetes comparing the safety and effectiveness of the three medicines from Marvel LifeSciences with their respective reference medicines.
Maltese: Barra dan, il-kumpanija ppreżentat ir-riżultati minn studju ewlieni li sar fuq 432 pazjent bid-dijabete li qabbel is-sigurtà u l-effikaċja tat-tliet mediċini minn Marvel LifeSciences mal-mediċini ta' referenza rispettivi tagħhom.
English: In its letter notifying the Agency of the withdrawal of application, the company stated that they decided to withdraw the applications in order to repeat the studies at a validated contract research organisation and to submit additional data.
Maltese: Fl-ittra tagħha li tinnotifika lill-Aġenzija bl-irtirar tal-applikazzjoni, il-kumpanija ddikjarat li ddeċidiet li tirtira l-applikazzjonijiet ħalli tirrepeti l-istudji f'organizzazzjoni ta' riċerka ta' kuntratt validata u li tissottometti dejta addizzjonali.
English: The concerns over the data led the CHMP to request an inspection of Bombay Bioresearch Centre (BBRC) in India, where studies were carried out for Marvel LifeSciences (the sponsor of the studies), and also of Marvel LifeSciences's UK site.
Maltese: It-tħassib fuq id-dejta wassal biex is-CHMP jitlob li ssir spezzjoni ta' Bombay Bioresearch Centre (BBRC) fl-Indja fejn kienu saru l-istudji għal Marvel LifeSciences (l-isponsor talistudji), kif ukoll tas-sit tar-Renju Unit ta' Marvel LifeSciences.
English: The reference medicine for Isomarv medium in this application was Humulin I. For more information on biosimilar medicines, see the questions-and-answers document here.
Maltese: Ilmediċina ta' referenza għal Isomarv medium f'din l-applikazzjoni kienet Humulin I.
English: After its initial assessment, the CHMP had significant concerns and was of the provisional opinion that Isomarv medium could not have been approved.
Maltese: Wara l-valutazzjoni inizjali tiegħu, is-CHMP kellu tħassib sinifikanti u kien tal-opinjoni proviżorja li Isomarv medium ma setax jiġi approvat.
English: The company presented the results of studies designed to show that Isomarv medium is similar to its reference medicine Humulin I in terms of its structure, biological activity and clinical performance.
Maltese: Il-kumpanija ppreżentat ir-riżultati tal-istudji mfassla biex juru li Isomarv medium huwa simili għallmediċina ta' referenza tiegħu Humulin I f'termini tal-istruttura tiegħu, tal-attività bijoloġika tiegħu u talprestazzjoni klinika tiegħu.
English: Isomarv medium was expected to be used to treat patients with diabetes who require insulin to control their blood glucose (sugar).
Maltese: Isomarv medium kien mistenni jintuża biex jikkura pazjenti bid-dijabete li għandhom bżonn l-insulina ħalli jikkontrollaw il-glukożju (zokkor) fid-demm.
English: What was Isomarv medium expected to be used for?
Maltese: Kif kien mistenni li jaħdem Isomarv medium?
English: The initial concerns related mainly to the manufacture of the medicine and whether Isomarv medium was sufficiently similar to its reference medicine.
Maltese: It-tħassib inizjali kellu x'jaqsam prinċipalment mal-manifattura tal-mediċina u mal-kwistjoni dwar jekk Isomarv medium kienx simili biżżejjed mal-mediċina ta' referenza tiegħu.
English: Co. Galway IRELAND
Maltese: Galway L-IRLANDA
English: Grade ≥ 3 n (%)
Maltese: Grad ≥3 n (%)
English: 117 Allée des Parcs 69800 Saint-Priest FRANCE
Maltese: 117 Allée des Parcs 69800 SAINT-PRIEST FRANZA
English: Pharmacotherapeutic group: Endocrine therapy, anti-estrogens, ATC code: L02BA03
Maltese: Terapija endokrinali, anti-estroġeni, Kodiċi ATC: L02BA03
English: Manufacturer MYLAN TEORANTA Inverin
Maltese: Manifattur MYLAN TEORANTA Inverin
English: Fulvestrant Mylan contains 10% w/v ethanol (alcohol)
Maltese: Fulvestrant Mylan fih 10% w/v ethanol (alkoħol)
English: Benzyl benzoate Benzyl alcohol Ethanol, anhydrous Castor oil, refined
Maltese: Benzyl benzoate Benzyl alcohol Ethanol, anhydrous Castor oil, raffinat
English: Fulvestrant is indicated:
Maltese: Fulvestrant huwa indikat:
English: Very common Elevated hepatic enzymes (ALT, AST, ALP) a
Maltese: Enzimi epatiċi għoljin (ALT, AST, ALP)a
English: CBR [% (95% CI)]
Maltese: CBR [% (CI ta' 95%)]
English: What Fulvestrant Mylan contains - The active substance is fulvestrant.
Maltese: Mylan - Is-sustanza attiva hi fulvestrant.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 08 january 2018
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 08 jannar 2018
English: Identified metabolites (includes 17-ketone, sulphone, 3-sulphate, 3- and 17-glucuronide metabolites) are either less active or exhibit similar activity to fulvestrant in anti-estrogen models.
Maltese: Il-metaboliti identifikati (jinkludu metaboliti ta' 17-ketone, sulphone, 3-sulphate, 3 u 17-glucuronide) huma jew inqas attivi jew juru attivitajiet simili għal fulvestrant f'mudelli ta' antiestroġenu.
English: Fulvestrant is contraindicated in pregnancy (see section 4.3).
Maltese: Fulvestrant huwa kontra-indikat waqt it-tqala (ara sezzjoni 4.3).
English: Adult females (including elderly)
Maltese: Nisa adulti (inkluż l-anzjani)
English: Dermatitis, Dermatitis acneiform, Toxic skin eruption.
Maltese: Dermatite, Dermatite akneiforma, Eruzzjoni tossika tal-ġilda.
English: Fulvestrant Mylan contains benzyl alcohol
Maltese: Fulvestrant Mylan fih benzyl alcohol
English: BPG Products SRL Tel: + 40 372 579 000
Maltese: BGP Products SRL Tel: + 40 372 579 000
English: One dose contains 500 mg benzyl alcohol, and up to 1000 mg ethanol anhydrous.
Maltese: Doża waħda fiha 500 mg ta' benzyl alcohol, u sa 1000 mg ethanol anhydrous.
English: Secondary endpoints included OR, CBR, OS, safety, and time-to-deterioration (TTD) in pain endpoint.
Maltese: L-end-points sekondarji inkludew OR, CBR, OS, is-sigurtà, u ż-żmien għad-deterjorazzjoni (TTD, time-to-deterioration) fl-end-point tal-uġigħ.
English: PFS:Progression-free survival; ORR:Objective response rate; OR:Objective response; CBR:Clinical benefit rate; CB:Clinical benefit; OS:Overall survival; K-M:Kaplan-Meier; CI:Confidence interval; AI:Aromatase inhibitor; AE:Anti-estrogen.
Maltese: PFS: Sopravivenza mingħajr il-marda; ORR Rata oġġettiva tar-ripons; OR: Rata tar-ripons; CBR: Rata ta' benefiċċju kliniku; CB: Benefiċċju kliniku; OS: Soppravivenza totali; K-M: Kaplan-Meier; CI: Intervall ta' fiduċja;
English: The geometric mean (standard deviation) steady state trough concentration (Cmin,ss) and AUCss was 4.2 (0.9) ng/mL and 3680 (1020) ng*hr/mL, respectively.
Maltese: Ilkonċentrazzjoni minima fi stat fiss tal-medja ġeometrika (standard deviation) (Cmin,ss) u l-AUCss kienet 4.2 (0.9) ng/mL u 3680 (1020) ng.hr/mL, rispettivament.
English: Hepatic failurec,f, hepatitis f, elevated gamma-GT f
Maltese: Insuffiċjenza epatikac,f, epatitef, gamma-GT għoli
English: 1 pre-filled syringe (5 ml) 1 safety needle
Maltese: 1 siringa mimlija għal-lest (5 mL) 1 labra tas-sigurtà
English: In table 1, the following frequency categories for adverse drug reactions (ADRs) were calculated based on the fulvestrant 500 mg treatment group in pooled safety analyses of studies that compared fulvestrant 500 mg with fulvestrant 250 mg [CONFIRM (Study D6997C00002), FINDER 1 (Study D6997C00004), FINDER 2 (Study D6997C00006), and NEWEST (Study D6997C00003) studies], or from FALCON (Study D699BC00001) alone that compared fulvestrant 500 mg with anastrozole 1 mg. Where frequencies differ between the pooled safety analysis and FALCON, the highest frequency is presented.
Maltese: F'tabella 1, il-kategoriji ta' frekwenzi li jmiss għar-reazzjonijiet avversi tal-mediċina ġew ikkalkolati fuq grupp ta' trattament ta' fulvestrant 500 mg miġbura f'analiżi ta' sigurtà ta' studji li qabblu fulvestrant 500 mg ma' fulvestrant 250 mg [CONFIRM (Studju D6997C00002), FINDER 1 (Studju D6997C00004), FINDER 2 (Studju D6997C00006), u NEWEST (Studju D6997C00003)].
English: Secondary end points* OR [% (95% CI)] OR (measurable disease) [% (95% CI)]
Maltese: End-points sekondarji* OR [% (CI ta' 95%)] OR (marda li titkejjel) [% (CI ta' 95%)]
English: -AE subgroup (n=423)
Maltese: - Sotto grupp ta' AE (n=423)
English: OS is presented for the final survival analyses at 75 % maturity.
Maltese: b OS hija ppreżentata għall-analiżi tas-sopravivenza finali f'maturità ta' 75%.
English: Frequency groupings are defined according to the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100).
Maltese: Komuni ħafna (≥1/10), Komuni (≥1/100, <1/10), Mhux komuni (≥1/1000, <1/100).
English: Women with severe hepatic impairment (Child-Pugh class C) were not evaluated.
Maltese: Individwi b'indeboliment epatiku qawwi (Child-Pugh klassi C) ma ġewx evalwati.
English: -AI subgroup (n=313)a
Maltese: - Sotto grupp ta' AI (n=313)a
English: Castor oil, refined
Maltese: anhydrous, castor oil, raffinat.
English: System Organ Class Frequency Preferred Terma
Maltese: Sistema ta' klassifika ta' l-organi Frekwenza
English: Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain, Stomatitis.
Maltese: Infjamazzjoni mukuża, Uġigħ orali, Skumdità orofarinġeali, Uġigħ orofarinġeali, Stomatite.
English: In the FALCON study, the number of patients who reported an adverse reaction of joint and musculoskeletal pain was 65 (31.2%) and 48 (24.1%) for fulvestrant and anastrozole arms, respectively.
Maltese: Fl-istudju FALCON, in-numru ta' pazjenti li rrappurtaw reazzjoni avversa ta' uġigħ fil-ġogi u muskolu-skeletriku kien ta' 65 (31.2%) u 48 (24.1%) għal fergħat ta' fulvestrant u anastrozole, rispettivament.
English: Fifty-five percent (55.0%) of patients had visceral metastasis at baseline.
Maltese: Ħamsa u ħamsin filmija (55.0%) talpazjenti kellhom metastażi vixxerali fil-linja bażi.
English: A more mature update of efficacy data is reported in Table 5.
Maltese: Aġġornament aktar matur tad-dejta tal-effikaċja huwa rrappurtat f'Tabella 5.
English: Fulvestrant Mylan contains 10% w/v ethanol (alcohol) i.e. up to 1000 mg per dose, equivalent to 20 ml beer or 8 ml wine per dose.
Maltese: Fulvestrant Mylan fih 10% w/v ethanol (alcohol), jiġifieri sa 1000 mg kull doża, ekwivalenti għal 20 mL birra jew 8 mL inbid f'kull doża.
English: -AE subgroup (n=423) -AI subgroup (n=313)a a
Maltese: - Sotto grupp ta' AE (n=423) - Sotto grupp ta' AI (n=313)a
English: The hazard ratio of fulvestrant 250 mg to anastrozole for time to death was 1.01 (95% CI 0.86 to 1.19).
Maltese: Il-proporzjon ta' periklu ta' fulvestrant 250 mg għal anastrozole għaż-żmien sal-mewt kien ta' 1.01 (95% CI 0.86 sa 1.19).
English: No data are available regarding endometrial morphology.
Maltese: M'hemmx dejta rigward il-morfoloġija tal-endometriju.
English: An open-label phase 2 study investigated the safety, efficacy and pharmacokinetics of fulvestrant in 30 girls aged 1 to 8 years with Progressive Precocious Puberty associated with McCune Albright Syndrome (MAS).
Maltese: Studju ta' Fażi 2 open label investiga s-sigurtà, l-effikaċja u l-farmakokinetika ta' fulvestrant fi 30 tifla ta' età minn 1 sa 8 snin b'Pubertà Prekoċi Progressiva assoċjata mas-sindrome ta' McCune Albright (MAS).
English: Anorexiaa
Maltese: Anoressijaa
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Maltese: Data disponibbli hija deskritta fis-sezzjonijiet 5.1 u 5.2, iżda ma tista' ssir dwar pożoloġija.
English: Febrile neutropenia has been reported in 0.9% patients receiving fulvestrant in combination with palbociclib.
Maltese: Ġiet irrappurtata newtropenja bid-deni f'0.9% pazjenti li kienu qed jirċievu fulvestrant flimkien ma' palbociclib.
English: g Stomatitis includes the following PTs: Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration,
Maltese: Stomatite tal-ħalq, Kejlite, Glossite, Glossodinja, Ulċerazzjoni fil-ħalq,
English: The objective response rate for Fulvestrant 250 mg was 19.2% compared with 16.5% for anastrozole.
Maltese: Ir-rata ta' rispons oġġettiv għal fulvestrant 250 mg kienet ta' 19.2% meta mqabbla ma' 16.5% għal anastrozole.
English: Comparison between groups (Fulvestrant 500 mg/ Fulvestrant 250 mg) Hazard ratio
Maltese: Tqabbil bejn gruppi (Fulvestrant 500 mg/ Fulvestrant 250 mg) Proporzjon ta' periklu
English: Fulvestrant plus palbociclib (N=206)
Maltese: Fulvestrant u palbociclib (N=206)
English: The pharmacokinetics of fulvestrant has been evaluated in a clinical study conducted in 30 girls with Progressive Precocious Puberty associated with McCune Albright Syndrome (see section 5.1).
Maltese: Il-farmakokinetiċi ta' fulvestrant ġew evalwati fi prova klinika mwettqa fuq 30 tifla b'Pubertà Prekoċi Progressiva assoċċjata mas-Sindromu ta' McCune Albright (ara sezzjoni 5.1).
English: N=number of patients; CI=confidence interval; NE=not estimable; OR=objective response; CBR=clinical benefit response; DOR=duration of response
Maltese: N=numru ta' pazjenti; CI=intervall ta' kunfidenza; NE=ma tistax tittieħed stima; OR=rispons oġġettiv; CBR=rispons ta' benefiċċju kliniku;
English: Infections and infestations Very common Infectionsb Blood and lymphatic system disorders Very common Neutropeniac Leukopeniad Anaemiae Thrombocytopeniaf Uncommon Febrile neutropenia Metabolism and nutrition disorders Very common Decreased appetite Nervous system disorders Common Dysgeusia Eye disorders Common Lacrimation increased Vision blurred Dry eye Respiratory, thoracic and mediastinal disorders Common Epistaxis Gastrointestinal disorders Very common Nausea
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna Infezzjonijietb Disturbi tad-demm u tas-sistema limfatika Komuni ħafna Newtropenjac Lewkopenijad Anemijae Tromboċitopenijaf Mhux komuni Newtropenja bid-deni Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni ħafna Nuqqas ta' aptit Disturbi fis-sistema nervuża Komuni Disturbi fit-togħma Disturbi fl-għajnejn Komuni Żieda fil-lakrimazzjoni Vista mċajpra Għajn xotta Disturbi respiratorji, toraċiċi u medjastinali Komuni Epistassi Disturbi gastro-intestinali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1253/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/17/1253/001
English: Children and adolescents Fulvestrant Mylan is not indicated in children and adolescents under 18 years.
Maltese: Mylan mhux indikat għal tfal u adolexxenti ta' taħt it-18-il sena.
English: 0.95 (95% CI 0.82 to 1.10).
Maltese: 82 għal 1.10).
English: -AE subgroup (n=296) -AI subgroup (n=205)a CBRe
Maltese: % ta' pazjenti b'OR; differenza assoluta f'% Il-pazjenti kollha - Sotto grupp ta' AE (n=296) - Sotto grupp ta' AI (n=205)a CBRe
English: Thromboembolic events are commonly observed in women with advanced breast cancer and have been observed in clinical studies with fulvestrant (see section 4.8).
Maltese: Avvenimenti tromboemboliċi huma osservati ta' spiss f'nisa b'kanċer tas-sider avvanzat u ġew osservati fi provi kliniċi b'fulvestrant (ara sezzjoni 4.8).
English: In a population pharmacokinetic analysis of data from phase 3 studies, no difference in fulvestrant's pharmacokinetic profile was detected with regard to age (range 33 to 89 years), weight (40-127 kg) or race.
Maltese: F'analiżi farmakokinetika tal-popolazzjoni ta' dejta minn studji ta' Fażi 3, ma rriżultat ebda differenza fil-profil farmakokinetiku ta' fulvestrant fir-rigward tal-età (fil-medda ta' bejn 33 sa 89 sena), tal-piż (40 - 127 kg) jew tar-razza.