FrancophonIA/ELRC3.0 huggingface dataset:
English: In a longitudinal study, 232 patients clinically diagnosed with amnestic mild cognitive impairment (aMCI), underwent baseline flutemetamol (18F) PET scans, and were followed for 36 months to evaluate the relationship between flutemetamol (18F) imaging and changes in diagnostic status.
Maltese: Fi studju lonġitudinali, 232 pazjent klinikament dijanjostikati b'indeboliment konoxxittiv ta' amnesija ħafifa (aMCI), sarulhom skans PET bi flutemetamol (18F) fil-linja bażi, u kienu segwiti għal 36 xahar biex tiġi evalwata r-relazzjoni bejn immaġini bi flutemetamol (18F) u bidliet fl-istat dijanjostiku.
English: Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.
Maltese: Qabel it-tnedija f'kull Stat Membru id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jiftiehem dwar il-programm edukattiv finali mal-Awtorità Kompetenti Nazzjonali.
English: The negative images show a tapered intensity to the periphery of the tissue.
Maltese: L-immaġini negattivi juru intensità li tonqos gradwalment lejn il-periferija tat-tessut.
English: A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan, see sections 4.4 and 5.1.
Maltese: Għal-limitazzjonijiet fl-interpretazzjoni ta' sken pożittiv, ara sezzjonijiet 4.4 u 5.1.
English: Talk to your nuclear medicine doctor before you are given VIZAMYL if you: have kidney problems have liver problems are pregnant or think you may be pregnant are breast-feeding
Maltese: Kellem lit-tabib tal-mediċina nukleari qabel tingħata VIZAMYL jekk inti: għandek problemi tal-kliewi għandek problemi tal-fwied tqila jew taħseb li inti tqila qed tredda'
English: Advanced Accelerator Applications, 47014 Meldola (FC), Italy Advanced Accelerator Applications, Technopole de l'Aube,10430 Rosières près Troyes, France Seibersdorf Labor GmbH, 2444 Seibersdorf, Austria Instituto Tecnológico PET, SA, 28040 Madrid, Spain Advanced Accelerator Applications, 50100 La Almunia de Doña Godina, Zaragoza, Spain Advanced Accelerator Applications, 10010 Colleretto Giacosa (TO) Italy Nucleis SA, 4000 Liège, Belgium
Maltese: Advanced Accelerator Applications, 47014 Meldola (FC), L-Italja Advanced Accelerator Applications, Technopole de l'Aube,10430
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/941/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/14/941/002
English: VIZAMYL images should only be interpreted by readers trained in the interpretation of PET images with flutemetamol (18F).
Maltese: Skens b'VIZAMYL għandhom jiġu interpretati biss minn qarrejja mħarrġa fl-interpretazzjoni taliskens PET bi flutemetamol (18F).
English: In vivo, quantitative correlation was assessed in end-of-life patients between flutemetamol (18F) uptake in cortical grey matter and the total β-amyloid burden in autopsied samples using 4G8 anti-amyloid antibody that stains β-amyloid found in both neuritic and diffuse plaques.
Maltese: In vivo, korrelazzjoni kwantitattiva kienet evalwata f'pazjenti fi tmiem il-ħajja bejn teħid ta' flutemetamol (18F) fil-materja kortikali griża u l-piż totali ta' β-amyloid f'kampjuni minn awtopsji bl użu ta' antikorp anti-amyloid 4G8 li tagħti kulur lil β-amyloid li jinsab kemm fi plakek newritiċi kif ukoll f'dawk diffużi.
English: In two similar studies of biodistribution and a phase II clinical study, mean quantitative uptake values in PET images differed between pAD and HV subjects in most examined areas of the brain.
Maltese: F'żewġ studji simili ta' bijodistribuzzjoni u studju kliniku tal-fażi II, il-valuri ta' teħid kwantitattiv fl-immaġnijiet PET kienu differenti bejn l-individwi pAD u HV fil-biċċa l-kbira tal-partijiet eżaminati tal-moħħ.
English: Eye swelling
Maltese: Seibersdorf
English: Iterative or filtered back projection reconstruction is recommended with a slice thickness of 2 to 4 mm, and an axial matrix size of 128 x 128 with pixel sizes of approximately 2 mm. Where a postsmoothing filter may be applied with a full width half maximum (FWHM) of not more than 5 mm, the filter FWHM should be chosen to optimize the signal-to-noise ratio while preserving the sharpness of the reconstructed image.
Maltese: Fejn filtru post-twittija jista' jiġi applikat b'nofs massimu ta' wisa' sħiħ (FWHM - full width half maximum) ta' mhux aktar minn 5 mm, il-filtru FWHM għandu jintgħażel biex jottimizza l-proporzjon tas-sinjal għall-ħoss filwaqt li tiġi ppreservata ċ-ċarezza tal-immaġini rikostitwita.
English: Radioactive medicine
Maltese: IL-PRODOTT MEDIĊINALI
English: These adverse events are expected to occur with low probability.
Maltese: Dawn l-avvenimenti avversi huma mistennija li jseħħu bi probabbiltà estremament baxxa.
English: In vitro binding studies have not shown interference of flutemetamol (18F) binding to β-amyloid plaques in the presence of other common medicinal products taken by AD patients.
Maltese: Studji in vitro fuq l-irbit ma wrewx interferenza ta' flutemetamol (18F) li jintrabat ma' plakek βamyloid fil-preżenza ta' prodotti mediċinali komuni oħra meħudin minn pazjenti b'AD.
English: Pharmacodynamic effects At the low concentrations present in VIZAMYL, flutemetamol (18F) has no detectable pharmacodynamic activity.
Maltese: Fil-konċentrazzjonijiet baxxi preżenti f'VIZAMYL, flutemetamol (18F) ma għandu ebda attività farmodinamika traċċabbli.
English: Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Maltese: Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tiegħek tal-mediċina nukleari li se jissorvelja lproċedura tiegħek.
English: Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Maltese: Ġew osservati żbalji fl-interpretazzjoni tal-immaġnijiet fl-istima tad-densità tal-plakka βamyloid newritika tal-moħħ, inklużi negattivi foloz u pożittivi foloz.
English: NAME OF THE MEDICINAL PRODUCT VIZAMYL 400 MBq/mL solution for injection
Maltese: VIZAMYL 400 MBq/mL soluzzjoni għal injezzjoni
English: INSTRUCTIONS ON USE
Maltese: Materjal radjuattiv
English: Liver
Maltese: Ovarji
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING SHIELD LABEL / 10 mL
Maltese: TIKKETTA TAL-PROTEZZJONI / 10 mL
English: Skin tightness Swelling face
Maltese: Skumdità fis-sider Tħoss is-sħana Astenja
English: Facial hypoaesthesia Pruritus
Maltese: Twissijiet speċifiċi
English: spol.
Maltese: A.U.
English: Dizziness Headache Hypoaesthesia Hypotonia Dysgeusia Tremor
Maltese: Tnaqqis tal-glukożju fid-demm Żieda ta' lactate dehydrogenase fid-demm
English: Gallbladder
Maltese: Il-Ġermanja
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VIZAMYL 400 MBq/mL solution for injection flutemetamol (18F)
Maltese: U MNEJN GĦANDU JINGĦATA VIZAMYL 400 MBq/mL soluzzjoni għal injezzjoni flutemetamol (18F)
English: Osteogenic cells Ovaries
Maltese: Ċelloli ostjoġeniċi
English: Heart
Maltese: Timu
English: Pancreas
Maltese: Sfurija
English: β-Amyloid plaques are deposits sometimes present in the brains of people with dementias (such as Alzheimer's disease).
Maltese: Plakek ta' β Amyloid huma depożiti li kultant ikunu preżenti fl-imħuħ ta' persuni biddimenzja (bħall-marda ta' Alzheimer).
English: Interpretation of VIZAMYL images
Maltese: Interpretazzjoni ta' skens b'VIZAMYL).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection contains 400 MBq of flutemetamol (18F) at reference date and time.
Maltese: Kull mL tas-soluzzjoni fih flutemetamol (18F) 400 MBq fid-data u ħin ta' referenza.
English: Organ uptake Maximal flutemetamol (18F) brain uptake of approximately 7% of an injected dose occurs within two minutes of administration.
Maltese: Teħid mill-organi It-teħid massimali mill-moħħ ta' flutemetamol (18F) ta' madwar 7 % ta' doża injettata jseħħ fi żmien żewġ minuti mill-għoti.
English: A region is considered as having a negative (normal) pattern if the tracer signal in cortical regions is low (i.e. distinctly lower signal intensity compared with adjacent white matter and similar in intensity to the grey matter-rich regions of the cerebellum).
Maltese: Reġjun jiġi kkunsidrat li għandu pattern negattiv (normali) jekk is-sinjal tracer f'reġjuni kortikali huwa baxx (jiġifieri intensità tas-sinjal ferm iktar baxxa meta mqabbla ma' materja bajda biswit u simili fl-intensità għar-reġjuni rikki fil-materja griża ta ċ- ċerebellum).
English: Other medicines and VIZAMYL
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Small intestine Spleen
Maltese: Jekk inti tqila
English: Flutemetamol (18F) must not be diluted.
Maltese: Flutemetamol (18F) ma għandux jiġi dilwit.
English: Advanced Accelerator Applications Ibérica S.L.
Maltese: Ibérica S.L.
English: • The material should include VIZAMYL PET demonstration cases with correct PET scan interpretation by an experienced reader; VIZAMYL-PET scans for self-assessment; and a selfqualification procedure to be offered to each trainee.
Maltese: • Il-materjal għandu jinkludi każijiet ta' dimostrazzjoni ta' Vizamyl PET b'interpretazzjoni korretta ta' imaġini PET minn interpretu ta' esperjenza;
English: You must inform the nuclear medicine doctor before you are given VIZAMYL if there is a possibility you might be pregnant, if you have missed your period or if you are breast-feeding.
Maltese: Għandek tgħarraf lit-tabib tal-mediċina nukleari qabel ma tingħata VIZAMYL jekk ikun hemm possibbiltà li inti tqila, jekk qbiżt il-menstrwazzjoni tiegħek jew jekk qed tredda'.
English: No carcinogenicity and reproductive toxicology studies have been performed with flutemetamol (18F).
Maltese: Ma sar l-ebda studju dwar il-karċinoġeniċità u t-tossikoloġija riproduttiva bi flutemetamol (18F).
English: EXPIRY DATE EXP: {hh:mm} {Time Zone} on {dd-mm-yyyy}
Maltese: DATA TA' SKADENZA JIS: {ss:mm} {Żona tal-Ħin} nhar il- {jj-xx-ssss}
English: A pivotal study in 68 end-of-life patients was aimed at establishing the diagnostic performance of flutemetamol (18F) to detect the cortical neuritic plaque density.
Maltese: Studju pivitali f'68 pazjent fit-tmiem tal-ħajja kien immirat biex jistabbilixxi l-kapaċità dijanjostika ta' flutemetamol (18F) biex isib id-densità tal-plakka newritika kortikali.
English: The estimated absorbed radiation doses for adults following intravenous injection of VIZAMYL are shown in Table 2.
Maltese: Id-dożi tar-radjazzjoni assorbiti stmati għall-adulti wara l-injezzjoni ġol-vini ta' VIZAMYL huma murija fit-Tabella 2.
English: After administration of VIZAMYL
Maltese: Il-Belġju
English: Biomedics M.B.
Maltese: 9 mSv.
English: You may experience the following uncommon side effects: headache feeling dizzy feeling anxious feeling sick (nausea) chest discomfort low blood sugar (symptoms: hunger, headache)
Maltese: Tista' tesperjenza l-effetti sekondarji mhux komuni li ġejjin: uġigħ ta' ras tħossok stordut/a tħossok anzjuż/a tħossok se tirremetti (dardir)
English: INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS
Maltese: STRUZZJONIJIET GĦALL-PREPARAZZJONI TA' PRODOTTI RADJUFARMAĊEWTIĊI
English: Further information on Onpattro 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: Other information about Onpattro
Maltese: Informazzjoni oħra dwar Onpattro
English: What are the risks associated with Onpattro?
Maltese: X'inhuma r-riskji assoċjati ma' Onpattro?
English: The most common side effects with Onpattro (which may affect more than 1 in 10 people) are peripheral oedema (swelling, especially of the ankles and feet) and infusion-related reactions including pain, nausea (feeling sick), headache, tiredness, dizziness, cough and breathing problems, reddening of the skin, rapid heartbeat, low or high blood pressure and swelling of the face.
Maltese: L-effetti sekondarji l-aktar komuni b'Onpattro (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma edema periferali (nefħa, speċjalment tal-għekiesi u tas-saqajn) u reazzjonijiet relatati malinfużjoni inklużi uġigħ, nawsja (tħossok ma tiflaħx), uġigħ ta' ras, għeja, sturdament, sogħla u problemi bit-teħid tan-nifs, ħmura tal-ġilda, taħbita mgħaġġla tal-qalb, pressjoni tad-demm għolja jew baxxa u nefħa fil-wiċċ.
English: hATTR amyloidosis is rare, and Onpattro was designated an ‘orphan medicine' (a medicine used in rare diseases) on 15 April 2011.
Maltese: Amilojdosi hATTR hija rari, u Onpattro ġie denominat bħala “mediċina orfni” (mediċina li tintuża f'mard rari) fil-15 ta' April 2011.
English: Onpattro contains the active substance patisiran.
Maltese: Onpattro fih is-sustanza attiva patisiran.
English: The medicine is available as a solution for infusion (drip) into a vein.
Maltese: Il-mediċina tiġi bħala soluzzjoni għall-infużjoni (dripp) ġo vina.
English: As for all medicines, data on the use of Onpattro are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Onpattro hija ssorveljata kontinwament.
English: The active substance in Onpattro, patisiran, is a ‘small interfering RNA' (siRNA), a very short piece of synthetic genetic material that has been designed to attach to and block the genetic material of the cell responsible for producing transthyretin.
Maltese: Is-sustanza attiva f'Onpattro, il-patisiran, hija “RNA żgħira li tinterferixxi” (siRNA), biċċa qasira ħafna ta' materjal ġenetiku sintetiku li ġiet imfassla biex teħel ma' u timblokka l-materjal ġenetiku taċ-ċellola responsabbli għall-produzzjoni ta' transtiretin.
English: The main measure of effectiveness was the change in the patients' nerve damage, as measured using a standard scale called ‘mNIS+7', with scores ranging from 0 to 304 (a higher score indicates more severe nerve damage).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fil-ħsara fin-nervituri tal-pazjenti, kif imkejjel permezz ta' skala standard imsejħa “mNIS+7”, b'punteġġi li jvarjaw minn 0 sa 304 (punteġġ ogħla jindika ħsara aktar serja fin-nervituri).
English: After 18 months of treatment, the mNIS+7 score decreased on average by 6 points with Onpattro (from around 81 to around 75 points), indicating a slight improvement of the patients' condition.
Maltese: Wara 18-il xahar ta' kura, il-punteġġ mNIS+7 naqas bħala medja b'6 punti b'Onpattro (minn madwar 81 punt għal madwar 75), li jindika titjib żgħir fil-kondizzjoni tal-pazjenti.
English: The broken protein forms amyloid deposits in tissues and organs around the body, including around nerves, where it interferes with their normal functions.
Maltese: Il-proteina mkissra tifforma depożiti amilojdi f'tessuti u f'organi madwar il-ġisem, inkluż madwar in-nervituri, fejn tinterferixxi mal-funzjonijiet normali tagħhom.
English: The recommended dose is 300 micrograms per kilogram body weight once every 3 weeks.
Maltese: Id-doża rakkomandata hija ta' 300 mikrogramma għal kull kilogramma ta' piż tal-ġisem, darba kull tliet ġimgħat.
English: Onpattro is a medicine used to treat nerve damage caused by hereditary transthyretin (hATTR) amyloidosis, a disease in which abnormal proteins called amyloids build up in tissues around the body including around the nerves.
Maltese: Onpattro huwa mediċina li tintuża biex tikkura l-ħsara fin-nervituri kkawżata minn amilojdosi transtiretin ereditarja (hATTR), marda li fiha l-proteini anormali msejħa amilojdi jinġemgħu fit-tessuti ta' madwar il-ġisem inkluż madwar in-nervituri.
English: In one main study involving 225 hATTR amyloidosis patients with stage 1 or 2 nerve damage, Onpattro was shown to be more effective than placebo (a dummy treatment) at slowing down the nerve damage caused by the disease.
Maltese: Fi studju ewlieni wieħed li involva 225 pazjent b'amilojdosi hATTR bi ħsara fin-nervituri fl-istadju 1 jew 2, Onpattro ntwera li kien iktar effettiv minn plaċebo (kura finta) biex idewwem il-ħsara fin-nervituri kkawżata mill-marda.
English: Onpattro may be given at home by a healthcare professional if the patient has had at least 3 infusions given in hospital without problems.
Maltese: Onpattro jista' jingħata d-dar minn professjonista fil-qasam tal-kura tas-saħħa jekk il-pazjent ikun ingħata mill-inqas 3 infużjonijiet fi sptar mingħajr problemi.
English: How does Onpattro work?
Maltese: Kif jaħdem Onpattro?
English: To reduce the risk of infusion-related reactions, patients should be given corticosteroid medicines, paracetamol and medicines known as H1 and H2 blockers before receiving Onpattro.
Maltese: Sabiex jitnaqqas ir-riskju ta' reazzjonijiet relatati mal-infużjoni, il-pazjenti għandhom jingħataw mediċini kortikosterojdi, paracetamol u mediċini magħrufa bħala imblokkaturi
English: This compares with an increase on average by 28 points with placebo (from around 75 to around 101 points), indicating that nerve damage got worse in these patients.
Maltese: Bħala medja, dan jikkumpara ma' żieda bi 28 punt bi plaċebo (minn madwar 75 punt għal madwar 101), li jindika li l-ħsara fin-nervituri marret għall-agħar f'dawn il-pazjenti.
English: Why is Onpattro authorised in the EU?
Maltese: Għaliex Onpattro ġie awtorizzat fl-UE?
English: Onpattro was shown to be effective at slowing down nerve damage in hATTR amyloidosis patients with stage 1 or stage 2 nerve damage; available data were not sufficient to assume a beneficial effect in stage 3 patients (those confined to a wheelchair).
Maltese: Onpattro ntwera li huwa effettiv biex idewwem il-ħsara fin-nervituri f'pazjenti b'amilojdosi hATTR bi ħsara fin-nervituri fl-istadju 1 jew fl-istadju 2; id-data disponibbli ma kinitx biżżejjed biex wieħed jassumi effett ta' benefiċċju fil-pazjenti fl-istadju 3 (dawk li qegħdin f'siġġu tar-roti).
English: In patients with hATTR amyloidosis, a protein called transthyretin which circulates in the blood is defective and breaks easily.
Maltese: F'pazjenti b'amilojdosi hATTR, proteina msejħa transtiretin li tiċċirkola fid-demm hija difettuża u tinkiser faċilment.
English: For the full list of side effects and restrictions with Onpattro, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Onpattro, ara l-fuljett ta' tagħrif.
English: This reduces production of defective transthyretin, thereby reducing the formation of amyloids and relieving the symptoms of hATTR amyloidosis.
Maltese: Dan inaqqas il-produzzjoni ta' transtiretin difettuż, u b'hekk inaqqas il-formazzjoni ta' amilojdi u jtaffi s-sintomi tal-amilojdosi hATTR.
English: EU (MA) Number
Maltese: Numru UE (MA) Isem ivvintat
English: EMA/718156/2011 EMEA/H/C/000596
Maltese: EMEA/H/C/000596
English: Yttriga EMA/718156/2011
Maltese: EMA/11565/2011
English: The full EPAR for Yttriga can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Rasilez jinsab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 09-2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'09-2011.
English: This is a summary of the European public assessment report (EPAR) for Yttriga.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Yttriga.
English: Other information about Yttriga
Maltese: Yttriga
English: The European Commission granted a marketing authorisation valid throughout the European Union for Yttriga on 19 January 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Yttriga fid-19 ta' Jannar 2006.
English: What is the risk associated with Yttriga?
Maltese: X'inhu r-riskju assoċjat ma' Yttriga?
English: 90Y, or yttrium-90, is a radioactive form of the chemical element yttrium.
Maltese: Yttriga huwa likwidu radjuattiv li fih is-sustanza attiva klorur tal-ittriju (90Y). 90Y, jew yttrium90, huwa forma radjuattiva tal-element kimiku ittriju.
English: The active substance in Yttriga, yttrium (90Y) chloride, is a radioactive compound that emits a type of radiation known as beta radiation.
Maltese: Is-sustanza attiva f'Yttriga, il-klorur tal-ittriju (90Y) , hija taħlita kimika radjuattiva li temana ċertu tip ta' radjazzjoni msejħa radjazzjoni beta.
English: What is Yttriga?
Maltese: X'inhu Yttriga?
English: The company also presented published information on the effect of using 90Y to radiolabel other medicines, including one study of non-Hodgkin's lymphoma (a cancer of the lymph tissue, part of the immune system).
Maltese: Il-kumpanija ressqet ukoll informazzjoni diġà ppubblikata dwar l-effett tal-użu tal-l-ittriju 90Y sabiex issir ir-radjumarkatura ta' mediċini oħrajn, li inkludiet studju wieħed dwar il-linfoma non
English: Yttriga yttrium (90Y) chloride
Maltese: Tagħrif ieħor dwar Yttriga:
English: The information supplied by the company shows the utility of Yttriga as a precursor to radiolabel medicines with 90Y.
Maltese: L-informazzjoni fornuta mill-kumpanija turi li l-utilità ta' Yttriga bħala prekursur għar-radjummarkar ta' mediċini bl-ittriju 90Y.
English: The company presented information from scientific articles already published on 90Y.
Maltese: Il-kumpanija ppreżentat informazzjoni minn artikoli speċifiċi fuq l-ittriju 90Y li diġà kienu ppubblikati.
English: The radiolabelled medicine is then given to the patient according to the instructions in that medicine's summary of product characteristics (SmPC).
Maltese: Imbagħad l-mediċina radjummarkata tingħata lill-pazjent skont l-istruzzjonijiet li jkun hemm fis-sommarju tal-karatteritiċi tal-prodott (SmPC).
English: The effect of Yttriga depends on the nature of the medicine that is radiolabelled with it. An example of its use is the treatment of some type of tumours, where the radiolabelled medicine carries the radioactivity to the site of a tumour to destroy the tumour cells.
Maltese: Mediċina li tkun immarkata b'Yttriga ma għandhiex tintuża f'nisa li jkunu nqabdu tqal jew li jistgħu jinqabdu tqal.
English: How has Yttriga been studied?
Maltese: Kif ġie studjat Yttriga?
English: Yttriga itself is radioactive and so its use in radiolabelling may carry a risk of cancer and hereditary defects.
Maltese: Yttriga fih innifsu huwa radjuattiv, u għaldaqstahnt l-użu tiegħu jista' joħloq riskju ta' kanċer u ta' difetti ereditarji.
English: Yttriga is a precursor and will not be given on its own.
Maltese: Yttriga huwa prekursur u għaldaqstant ma jingħatax waħdu.
English: Why has Yttriga been approved?
Maltese: Għaliex ġie approvat Yttriga?
English: The CHMP decided that Yttriga's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Yttriga huma akbar mir-riskji tiegħu u għaldaqstant irrikkomanda li jingħata awtorizzazzjoni biex jitpoġġa fis-suq.
English: EU/1/04/288/001 EU/1/04/288/002 EU/1/04/288/003 EU/1/04/288/004 EU/1/04/288/005 EU/1/04/288/006
Maltese: EU/1/04/288/001 EU/1/04/288/002 EU/1/04/288/003 EU/1/04/288/004
English: Relative Risk Reduction vs. placebo (95%CI), p value
Maltese: PROTELOS Tnaqqis fir-Riskju Relattiv vs. plaċebo (95%CI), valur p
English: Anpharm Przedsiebiorstwo Farmaceutyczne S.A. 03-236 Warszawa ul.
Maltese: 03-236 Warszawa ul.
English: PROTELOS contains aspartame (E951):
Maltese: PROTELOS fih aspartame (E951):
English: Manufacturer(s) Les Laboratoires Servier Industrie 905, route de Saran 45520 Gidy
Maltese: Les Laboratoires Servier Industrie 905, route de Saran 45520
English: What PROTELOS contains - The active substance is strontium ranelate.
Maltese: X'fih PROTELOS - Is-sustanza attiva hi strontium ranelate.
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletrali u tattessuti konnettivi