FrancophonIA/ELRC3.0 huggingface dataset:
English: Further dilution with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection is required, to obtain a final concentration of between 25 and 50 micrograms/ml prior to administration to the patient.
Maltese: Hu meħtieġ li għal konċentrazzjoni finali li tingħata lil pazjent tkun ta' bejn 25 u 50 mikrogramm/ml għas-soluzzjoni għall-infużjoni il-volum xieraq tas-soluzzjoni rikostitwita jiġi dilwit jew b'9 mg/ml (0.9 %) ta' soluzzjoni ta' sodium chloride għall-injezzjoni jew b'50 mg/ml (5 %) soluzzjoni ta' glucose għall-injezzjoni.
English: Median survival (weeks) (95% CI)
Maltese: Medjan (95 % C.I.) Proporzjon ta' periklu (95 % C.I.)
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count ˂ 0.5 x 10
Maltese: Jekk it-tnaqqis fid-doża jiġi magħżul għal pazjenti li jġarrbu newtropenja qawwija (l-għadd tannewtrofili ˂ 0.5 x 10
English: • Itchy rash (or hives).
Maltese: • Ġilda safra (suffejra)
English: Initial dose The recommended dose of topotecan is 1.5 mg/m2 body surface area perday administered by intravenous infusion over 30 minutes daily for five consecutive days with a three-week interval between the start of each course.
Maltese: Id-doża rakkomandata ta' topotecan hi ta' 1.5 mg/m2/jum tal-erja superfiċjali korporali/jum, b'infużjoni ġol-vina fuq 30 minuta għal 5 ijiem konsekuttivi b'intervall ta' tliet ġimgħat bejn il-bidu ta' kull kors.
English: Median time to progression was similar in the two groups (13.3 weeks and 12.3 weeks, respectively).
Maltese: Iż-żmien medjan għallprogressjoni kien jixtiebaħ fiż-żewġ gruppi (13.3 ġimgħat u 12.3 ġimgħat, rispettivament).
English: Topotecan should only be administered under the supervision of a physician experienced in the use of chemotherapy (see section 6.6).
Maltese: Topotecan għandu jiġi rikostitwit u dilwit aktar qabel l-użu (ara sezzjoni 6.6).
English: • Severe stomach pain, nausea, vomiting of blood, black or bloody stools (possible symptoms of gastrointestinal perforation).
Maltese: • Uġigħ qawwi fl-istonku, dardir, rimettar tad-demm, ippurgar iswed jew imdemmi (sintomi possibbli ta' perforazzjoni gastrointestinali).
English: Patients with prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Maltese: Meta tikkura kanċer taċ-ċerviċi, Topotecan Hospira jingħata ma' mediċina oħra, imsejħa cisplatin.
English: Patient self-reports of symptoms using an unblinded assessment showed a consistent trend for symptom benefit for oral topotecan plus BSC.
Maltese: Rapporti miġbura mill-pazjenti stess ta' assessjar unblinded urew benefiċċju konsistenti fuq sintomi b'topotecan mill-ħalq flimkien ma' BSC.
English: In association with severe neutropenia, fever or infection occurred in 16 % of patients during course 1 and overall in 23 % of patients (6 % of courses).
Maltese: Flimkien ma' newtropenja qawwija, kien hemm inċidenza ta' deni jew infezzjoni seħħet f'16 % tal-pazjenti waqt l-ewwel kors u b'kollox f'23 % talpazjenti (6 % tal-korsijiet).
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin
Maltese: M'hemmx biżżejjed esperjenza dwar l-użu ta' topotecan f'pazjenti li għandhom indeboliment serju talkliewi (tneħħija ta' kreatinina < 20 ml/min) jew li jbatu minn indeboliment serju tal-fwied (bilirubin fis-serum ≥ 10 mg/dl) minħabba ċirrosi.
English: Patients without prior cisplatin chemoradiotherapy Cisplatin Topotecan/Cisplatin
Maltese: Topotecan/Cisplatin
English: Each 4 ml vial of concentrate contains 4 mg topotecan (as hydrochloride).
Maltese: Kull kunjett ta' 4 ml ta' konċentrat fih 4 mg topotecan (bħala hydrochloride)
English: The response rate to topotecan in the combined small cell lung cancer programme (n = 480) for patients with relapsed disease sensitive to first-line therapy was 20.2 %.
Maltese: Ir-rata ta' rispons ta' topotecan fil-programm ikkombinat tal-kanċer taċ-ċelluli ż-żgħar tal-pulmun (n = 480) għal pazjenti fejn reġgħet feġġet il-marda li kienet sensittiva għat-terapija ewlenija, kien ta' 20.2 %.
English: Pfizer SA/NV Tél/Tel: +32 2 554 62 11
Maltese: Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 00
English: Patients with prior exposure to cisplatin require a sustained treatment-free interval to justify treatment with the combination (see section 5.1).
Maltese: Pazjenti li qabel kellhom esponiment għal cisplatin jinħtieġu intervall sostnut mingħajr trattament biex jiġġustifika trattament biż-żewġ mediċini flimkien (ara section 5.1).
English: Resulting from its mechanism of action, topotecan is genotoxic to mammalian cells (mouse lymphoma cells and human lymphocytes) in vitro and mouse bone marrow cells in vivo.
Maltese: Minħabba l-mekkaniżmu tal-azzjoni tiegħu, topotecan hu ġenotossiku għal ċelluli mammiferi (ċelluli tal-limfoma tal-ġurdien u limfoċiti tal-bniedem) in vitro u ċelluli tal-mudullun tal-ġurdien in vivo.
English: − Severe hypersensitivity to the active substance or to any of the excipients.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux elenkata.
English: Topotecan Hospira is provided as a sterile concentrate containing 4 mg topotecan in 4 ml solution (1 mg/ml).
Maltese: Topotecan Hospira jiġi bħala konċentrat sterili li fih 4 mg topotecan f'4 ml soluzzjoni.
English: The carcinogenic potential of topotecan has not been studied.
Maltese: Il-potenzjal karċinoġeniku ta' topotecan ma ġiex studjat.
English: Gastrointestinal disorders Very common
Maltese: Perforazzjoni gastrointestinali Disturbi fil-fwied u fil-marrara Komuni
English: Hyperbilirubinaemia
Maltese: Kif jingħata Topotecan Hospira
English: 9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Maltese: 9/l, u livell ta' emoglobina ta' ≥ 9 g/dl (jekk hemm bżonn wara trasfużjoni).
English: Topotecan Hospira 4 mg/4 ml is supplied in Type I clear glass vials, each sealed with a chlorobutyl rubber stopper, aluminium seal and plastic flip-off closure.
Maltese: Topotecan Hospira 4 mg/4ml jiġi f'kunjetti ċari mingħajr kulur, tal-ħġieġ Tip I li jkunu ssiġillati b'tapp tal-lastku tal-chlorobutyl, b'siġill tal-aluminju u b'għatu li jinqala' bis-saba'.
English: • Keep this leaflet.
Maltese: • Telf ta' xagħar.
English: Median survival in patients treated with oral topotecan plus BSC was 25.9 weeks (95 % C.I.
Maltese: Is-sopravivenza medjana f'pazjenti trattati b'topotecan orali flimkien ma' BSC kienet ta' 25.
English: In vitro data using human liver microsomes indicate the formation of small amounts of Ndemethylated topotecan.
Maltese: Tagħrif in vitro fejn intużaw l-mikrosomi tal-fwied uman jindika l-formazzjoni ta' ammonti żgħar ta' N-demethylated topotecan.
English: Standard oncology practice for the management of neutropenia is either to administer topotecan with other medicinal products (e.g. G-CSF) or to reduce the dose to maintain neutrophil counts.
Maltese: Il-prattika ta' onkoloġija standard għall-immaniġġar ta' newtropenija hija jew li tagħti topotecan ma' prodotti mediċinali oħra (eż. G-CSF) jew li tnaqqas id-doża biex iżżomm il-livelli ta' newtrofili.
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Maltese: Infjammazzjoni tal-mukuża Imwiet minħabba sepsis kienu rrappurtati f'pazjenti kkurati b'topotecan (ara sezzjoni 4.4).
English: Topotecan inhibits topoisomerase-I by stabilising the covalent complex of enzyme and strand-cleaved DNA which is an intermediate of the catalytic mechanism.
Maltese: Reazzjonijiet avversi huma elenkati hawn taħt, ikklassifikati skont is-sistema tal-ġisem u l-frekwenza assoluta (il-ġrajjiet kollha rappurtati).
English: How topotecan is given A doctor or nurse will administer topotecan as an infusion into your arm lasting about 30 minutes.
Maltese: Tabib jew infermier se jagħtik Topotecan Hospira bħala infużjoni ġo dirgħajk għal perjodu ta' madwar 30 minuta.
English: Document Name: Document Title:
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Patients with renal impairment
Maltese: Pazjenti bi kliewi indeboliti
English: 9/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/m 2/day for subsequent courses (or subsequently down to 0.45 mg/m 2/day if necessary).
Maltese: 9/l) għal sebat ijiem jew aktar, jew newtropenja qawwija assoċjata ma' deni jew infezzjoni, jew li t-trattament kien ittardjat minħabba newtropenja, id-doża għandha titnaqqsilhom b'20 % għal 0.60 mg/m 2/ġurnata għall-korsijiet sussegwenti (jew sussegwentement titnaqqas għal
English: As would be expected, patients with poor performance status (PS>1) have a lower response rate and an increased incidence of complications such as fever, infection and sepsis (see section 4.8).
Maltese: Kif inhu mistenni, pazjenti li għandhom stat ta' saħħa ħażina (PS>1) għandhom rata ta' rispons aktar baxxa u inċidenza ogħla ta' kumplikazzjonijiet bħal deni, infezzjoni u sepsis (ara sezzjoni 4.8).
English: A clear yellow to yellow-green solution.
Maltese: • Żomm dan il-fuljett.
English: If you are being treated for cervical cancer, you may get side effects from the othermedicine (cisplatin)that you willbe given along with Topotecan Hospira.
Maltese: Jekk inti qed tiġi kkurat għal kanċer taċ-ċerviċi, , inti jista' jkun ikollok effetti sekondarji millmediċina l-oħra (cisplatin) li inti se tingħata flimkien ma' Topotecan Hospira.
English: Preclinical studies indicate plasma protein binding of topotecan is low (35%) and distribution between blood cells and plasma was fairly homogeneous.
Maltese: Studji ta' qabel l-użu kliniku jindikaw li r-rabta ta' topotecan malproteini fil-plażma hi baxxa (35 %) u d-distribuzzjoni bejn iċ-ċelluli tad-demm u l-plażma hi pjuttost omoġenja.
English: Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion
Maltese: Topotecan Hospira 4 mg/4 ml konċentrat għal soluzzjoni għall-infużjoni.
English: A supplementary retrospective analysis was conducted on data from 523 patients with relapsed ovarian cancer.
Maltese: Saret analiżi supplementari retrospettiva f'523 pazjent li kellhom karċinoma tal-ovarji li reġa' feġġ.
English: Initial dose The recommended dose of topotecan is 0.75 mg/m2/day administered as a 30-minute intravenous infusion on days 1, 2 and 3.
Maltese: Id-doża rakkomandata ta' topotecan hi ta' 0.75 mg/m2/kuljum li tingħata għal nofs siegħa b'infużjoni ġol-vina kuljum f'jum 1, 2 u 3. Cisplatin jiġi mogħti bħala infużjoni intravenuża f'jum 1 f'doża ta' 50 mg/m2/kuljum u wara tingħata d-doża ta' topotecan.
English: • Staff handling this medicinal product should wear adequate protective clothing including mask, goggles and gloves.
Maltese: • Personal li jimmanipula dan il-prodott mediċinali għandu jilbes indumenti protettivi li jinkludu maskla, gogils u ingwanti.
English: A reduction in topotecan clearance was observed.
Maltese: Tnaqqis fit-tneħħija ta' topotecan ġiet osservata.
English: orange: 4 mg; red-brown: 8 mg).
Maltese: Huwa disponibbli bħala pilloli (roża: 2 mg; oranġjo: 4 mg; ħomor fil-kannella: 8 mg).
English: This document is a summary of the European Public Assessment Report (EPAR) for Avandia.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) Avandia.
English: Other information about Avandia:
Maltese: Informazzjoni oħra dwar Avandia:
English: Avandia is a medicine that contains the active substance rosiglitazone.
Maltese: Avandia huwa mediċina li fih s-sustanza attiva rosiglitazone.
English: The most common side effects with Avandia (low red blood cell counts) and oedema (swelling), as well as hypercholesterolaemi cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type o hyperlipaemia (high blood fat levels), weight increase, increased appetite, cardia oxygen supply to the heart muscle), constipation, bone fractures (broken bon (low blood glu side effects may occur.
Maltese: L-effetti sekondarji l-aktar komuni b'Avandia (li dehru f'bejn pazjent wieħed u għaxra minn kull mija) huma l-anemija (ammont baxx ta' ċelloli ħomor fid-demm), u edema (nefħa), kif ukoll iperkolesterolemija (livelli għolja ta' kolesterol fid-demm), ipertrigliċeridemija (livelli għolja ta' trigliċeridi, tip ta' xaħam), iperlipemija (livelli għolja ta' xaħam fid-demm), żieda fit-toqol, żieda fl-aptit, iskemija kardjolopika (tnaqqis ta' ossiġnu għall-muskolu tal-qalb), stitikezza, ksur tal-għadam u ipogliċemija (livell baxx ta' glukożju fid-demm).
English: Avandia to SmithKline Beecham Ltd. on 11 July 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha għal Avandia lil SmithKline Beecham Ltd. fil-11 ta' Lulju 2000.
English: What is Avandia?
Maltese: X'inhu AVANDIA?
English: What is the risk associated with Avandia?
Maltese: X'inhu r-riskju assoċjat ma' Avandia?
English: Avandia
Maltese: Avandia rosiglitazone
English: Avandia can also be used with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Maltese: Avandia jista' jintuża' wkoll kemm ma' metaformina kif ukoll ma' sulfonilurea f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti minkejja terapija doppja mill-ħalq (‘terapija tripla').
English: rosiglitazone how the Committe use for Avandia.
Maltese: Għaliex ġie approvat Avandia?
English: It must not be used in patients who have heart failure, problems with their liver, an ‘acute coronary syndrome' such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, or complications of diabetes (diabetic ketoacidosis or diabetic precoma).
Maltese: M'għandux jintuża f'pazjenti li jkollhom insuffiċjenza kardijaka, problemi bil-fwied, 'sindromu koronarju akut' bħal anġina instabbli (tip gravi ta' wġigħ fis-sider li l-intensità tiegħu tinbidel) jew ċerti tipi ta' attakk tal-qalb, jew kumplikazzjonijiet ta' diabete (detoaċidożi diabetika jew prekoma diabetika).
English: Avandia, used on its own, has been compared with placebo (a dummy treatment), metformin and patients who were already using es measured the level of an indication of how ontrolled.
Maltese: Avandia, użat waħdu, tqabbel ma' plaċebo (trattament finta), metformina u glibenblamide (tip ta' sulfonilurea).
English: How has Avandia been studied?
Maltese: Kif ġie studjat Avandia?
English: If Avandia is used in combination with other antidiabetes medicines, other this can lead to heart und the body).
Maltese: Jekk avandia jintuża flimkien ma' mediċini antidiabetiċi oħra, jista' jkun hemm effetti sekondarji oħra.
English: The recommended starting dose of Avandia is 4 mg per day, given as a single do doses.
Maltese: Id-doża inizjali rakkomandata ta' Avandia hi 4 mg kuljum, mogħtija bħala doża waħda, jew f'żewġ dożi ta' 2 mg.
English: It has also been studied in metformin, a sulphonylurea, or both metformin and a sulphonylurea.
Maltese: Ġie studjat ukoll f'pazjenti li kienu diġà qed jużaw metformina, tip ta' sulfonilurea, jew kemm metformina kif ukoll tip ta' sulfonilurea.
English: For the full list of all side effects reported with Avandia, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurtati b'Avandia, ara lFuljett ta' Tagħrif.
English: Com antidiabetes medicines led to further decreases in the level of HbA1c, ind levels had been further reduced.
Maltese: Il-kombinazzjoni ma' mediċini antidiabetiċi oħra wassal għal aktar tnaqqis fil-livell ta' HbA1c, li juri li l-livelli tal-glukożju fiddemm kienu tnaqqsu aktar.
English: The studi a substance in the blood called glycosylated haemoglobin (HbA1c), which gives well the blood glucose is c
Maltese: L-istudji kejlu l-livell ta' sustanza fid-demm magħrufa bħala emoglobina glikosilata (HbA1c), li tagħti indikazzjoni ta' kemm hu kkontrollat tajjeb il-glukożju fid-demm.
English: Avandia taken alone was more effective than placebo in reducing HbA1c.
Maltese: Avandia meħud waħdu kien aktar effettiv minn plaċebo biex titnaqqas HbA1c.
English: Ref.: EMEA/717671/2009 EMEA/H/C/1093
Maltese: EMEA/711414/2009 EMEA/H/C/1093
English: It is available as white tablets (75, 150 and 300 mg).
Maltese: Huwa disponibbli f'pilloli bojod (75, 150 u 300 mg).
English: Irbesartan Teva is a medicine that contains the active substance irbesartan.
Maltese: Irbesartan Teva huwa mediċina li fiha s-sustanza attiva irbesartan.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Teva to Teva Pharma B.V. on 30 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Irbesartan Teva lil Teva Pharma B.V. fi 30 ta' Ottubru 2009.
English: The usual recommended dose is 150 mg once a day.
Maltese: Id-doża normalment rakkomandata hija ta' 150 mg darba kuljum.
English: What are the benefit and risk of Irbesartan Teva?
Maltese: X'inhu l-benefiċċju u r-riskju ta' Irbesartan Teva?
English: Because Irbesartan Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel.
Maltese: Billi Irbesartan Teva huwa mediċina ġenerika, l-istudji ġew limitati għal testitjiet biex jiddeterminaw il-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Aprovel.
English: Why has Irbesartan Teva been approved?
Maltese: Għaliex ġie approvat Irbesartan Teva?
English: This means that Irbesartan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Maltese: Irbesartan Teva huwa ‘mediċina ġenerika' li jfisser li Irbesartan Teva hija simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Aprovel.
English: Because Irbesartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Maltese: Billi Irbesartan Teva huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċji u r-riskji jitqiesu li kienu l-istess bħal dawk tal-mediċina ta' referenza.
English: Irbesartan Teva is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Maltese: Irbesartan Teva jintuża wkoll għat-trattament tal-mard tal-kliewi f'pazjenti b'ipertensjoni u b'dijabete tat-tip 2 (dijabete li mhix dipendenti fuq l-insulina).
English: If the blood pressure is not sufficiently controlled, the dose can be increased to 300 mg a day or other medicines for hypertension can be added, such as hydrochlorothiazide.
Maltese: Jekk il-pressjoni tad-demm ma tkunx ikkontrollata kif xieraq, id-doża tista' tiżdied għal 300 mg kuljum jew inkella jistgħu jingħataw mediċini antipertensivi oħra, bħal hydrochlorothiazide.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Irbesartan Teva has been shown to have comparable quality and to be bioequivalent to Aprovel.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda li, b'mod konformi mar-rekwiżiti tal-UE, intwera li Irbesartan Teva għandu kwalità komparabbli ma' u li huwa bijoekwivalenti għal Aprovel.
English: Irbesartan Teva 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.
Maltese: Irbesartan Teva mhux rakkomandat sabiex jintuża fi tfal tħat it-18-il sena, minħabba nuqqas ta' tagħrif fuq is-sigurtà u l-effikaċja f'dan il-grupp tal-età.
English: The active substance in Irbesartan Teva, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Irbesartan Teva, irbesartan, hija tip ta' 'antagonist tar-riċetturi tal-anġjotensina
English: What is Irbesartan Teva?
Maltese: X'inhu Irbesartan Teva?
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għall-aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument mistoqsija-u-tweġiba hawn.
English: This allows the blood pressure to drop, reducing the risks associated with high blood pressure, such as having a stroke.
Maltese: Dan iwassal għal tnaqqis fil-pressjoni tad-demm, u b'hekk inaqqas ir-riskji assoċjati minn pressjoni għolja tad-demm, fosthom il-puplesija.
English: Other information about Irbesartan Teva:
Maltese: Aktar tagħrif ieħor dwar Irbesartan Teva:
English: How is Irbesartan Teva used?
Maltese: Kif tintuża Irbesartan Teva?
English: In patients with hypertension and type 2 diabetes, Irbesartan Teva is added to other treatments for hypertension.
Maltese: Fil-pazjenti b'ipertensjoni u b'dijabete tat-tip 2, Irbesartan Teva jiżdied ma' trattamenti oħra għallipertensjoni.
English: How does Irbesartan Teva work?
Maltese: Għal xiex jintuża Irbesartan Teva?
English: How has Irbesartan Teva been studied?
Maltese: Kif ġie studjat Irbesartan Teva?
English: The full EPAR for Fablyn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Fablyn lasofoxifene
Maltese: Fablyn lasofoksifina
English: This summary was last updated in 06-2012.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'06-2012.
English: The active substance in Fablyn, lasofoxifene, is a selective oestrogen receptor modulator (SERM).
Maltese: Is-sustanza attiva f'Fablyn, il-lasofoksifina, hija modulatur selettiv tar-riċettur tal-estroġenu (SERM).
English: Over five years, 6% of the women taking Fablyn 500 micrograms had a new spine fracture (155 out of 2,748), compared with 9% of those taking placebo (255 out of 2,744).
Maltese: Fuq 5 snin, 6% tan-nisa li kienu fuq Fablyn tal-500 mikrogramma kellhom ksur tax-xewka tad-dahar ġdida (155 minn 2,748), imqabbla ma' 9% ta' dawk li jieħdu l-plaċebo (255 minn 2,744).
English: Fablyn is a medicine that contains the active substance lasofoxifene.
Maltese: Fablyn huwa mediċina li fih is-sustanza attiva lasofoksifina.
English: Two doses of Fablyn (250 and 500 micrograms once a day) have been compared with placebo (a dummy treatment) in one main study involving almost 9,000 postmenopausal women with osteoporosis aged 60 to 80 years.
Maltese: Żewġ dożi ta' Fablyn (250 u 500 mikrogrammi darba kuljum) ġew imqabbla ma' plaċebo (trattament finta) fi studju prinċipali li jinvolvi madwar 9,000 mara wara l-menopawża bl-osteoporożi ta' etajiet minn 60 sa 80 sena.
English: This is a summary of the European public assessment report (EPAR) for Fablyn.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Fablyn.
English: It must not be used in patients who have had problems with venous thromboembolism including deep vein thrombosis (DVT), pulmonary embolism (a blood clot in the lungs) and retinal vein thrombosis (a blood clot at the back of the eye).
Maltese: Ma għandhux jintuża f'pazjenti li kellhom problemi b'tromboemboliżmu tal-vini inkluż trombożi tal-vini l-fondi (DVT), emboliżmu pulmonari (embolu fil-pulmun) u trombożi tal-vini tar-retina (embolu fuq in-naħa ta' wara tal-għajn).
English: Also, results with the 250-microgram dose were pointing to 500 micrograms being more effective.
Maltese: Riżultati tad-doża tal-250 mikrogramma wrew ukoll illi dik tal-500 mikrogramma kienet aktar effettiva.
English: Why has Fablyn been approved?
Maltese: Għaliex ġie approvat Fablyn?
English: What is Fablyn?
Maltese: X'inhu Fablyn?
English: How has Fablyn been studied?
Maltese: Kif ġie studjat Fablyn?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fablyn on 24 February 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Fablyn valida fl-Unjoni Ewropea kollha fl-24 ta' Frar 2009.
English: Fablyn was more effective than placebo at reducing the number of new fractures.
Maltese: Fablyn kien aktar effettiv minn plaċebo fit-tnaqqis tan-numru ta' ksur ġodda.