FrancophonIA/ELRC3.0 huggingface dataset:
English: Apalutamide, mainly in the form of metabolites, is eliminated primarily via urine.
Maltese: Apalutamide, l-aktar f'forma ta' metaboliti, jitneħħa primarjament mill-awrina.
English: The median survival for the apalutamide arm was not reached compared to 39.03 months with a 95% CI of (39.03, NE) for the placebo arm. Statistical significance was not reached in overall survival at the pre-specified interim analysis.
Maltese: Il-medjan tas-sopravivenza għall-fergħa ta' apalutamide ma ntlaħaqx meta mqabbel ma' 39.03 xhur b'CI 95% ta' (39.03, NE) għall-fergħa tal-plaċebo.
English: In a fertility study in male rats, a decrease in sperm concentration and motility, copulation and fertility rates (upon pairing with untreated females) along with reduced weights of the secondary sex glands and epididymis were observed following 4 weeks of dosing at doses corresponding to exposures approximately equal to the human exposure based on AUC.
Maltese: Fi studju dwar fertilità fil-firien irġiel, ġie osservat tnaqqis fil-konċentrazzjoni u l-motilità tal-isperma, il-kopulazzjoni u r-rati ta' fertilità (meta akkoppjati ma' nisa mhux trattati) flimkien ma' tnaqqis fl-piż tal-glandoli sekondarji tas-sess u tal-epididymis wara 4 ġimgħat ta' għoti ta' dożi li jaqblu ma' esponimenti bejn wieħed u ieħor daqs l-esponimenti fil-bniedem abbażi tal-AUC.
English: Androgen deprivation therapy may prolong the QT interval In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5), physicians should assess the benefit-risk ratio including the potential for Torsade de pointes prior to initiating Erleada.
Maltese: Terapija ta' deprivazzjoni tal-androġen tista' ttawwal l-intervall QT F'pazjenti bi storja jew fatturi ta' riskju għal intervall tal-QT mtawwal u f'pazjenti li jkunu qed jirċievu prodotti mediċinali konkomitanti li jistgħu jtawlu l-intervall tal-QT (ara sezzjoni 4.5), it-tobba għandhom jevalwaw il-proporzjon ta' benefiċċju u riskju inkluża l-possibbiltà ta' Torsade de pointes qabel jibdew Erleada.
English: Post-progression survival (PFS-2, defined as the time to disease progression after first subsequent therapy or death) was longer for subjects treated with Erleada compared to those treated with placebo (HR = 0.489; 95%CI: 0.361, 0.662; p < 0.0001).
Maltese: Erleada naqqas ir-riskju relattiv ta' metastasi mbegħda jew mewt b'70% meta mqabbla mal-plaċebo (HR = 0.30; 95% CI: 0.24, 0.36; p < 0.0001).
English: PHARMACEUTICAL FORM AND CONTENTS 24 film-coated tablets per wallet pack
Maltese: 24 pillola miksija b'rita f'kull pakkett portafoll
English: Investigations very common: weight decreased
Maltese: Investigazzjonijiet komuni ħafna: tnaqqis fil-piż
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 60 mg (12 count) (Blister sealed in inner wallet)
Maltese: FOLJA 60 mg (għadd ta' 12) (Folja ssiġillata fil-protafoll ta' ġewwa)
English: How to store Erleada
Maltese: Kif tieħu Erleada
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS INNER WALLET 60 mg (30 days)
Maltese: PORTAFOLL TA' BARRA 60 mg (30 jum)
English: • lower high fat levels in the blood (e.g. gemfibrozil)
Maltese: • jbaxxu livelli għoljin ta' xaħam fid-demm (eż. gemfibrozil)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING OUTER WALLET 60 mg (30 days)
Maltese: PORTAFOLL TA' ĠEWWA 60 mg (30 jum)
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS INNER WALLET 60 mg (28 days)
Maltese: PORTAFOLL TA' BARRA 60 mg (28 jum)
English: PHARMACEUTICAL FORM AND CONTENTS 28 film-coated tablets per wallet pack
Maltese: 28 pillola miksija b'rita f'kull pakkett portafoll
English: What Erleada looks like and contents of the pack Erleada film-coated tablets are slightly yellowish to greyish green, oblong-shaped, film-coated tablets (16.7 mm long x 8.7 mm wide), with “AR 60” written on one side.
Maltese: Il-pilloli Erleada miksija b'rita huma pilloli miksija b'rita, minn kemxejn sofor sa ħodor jagħtu fil-griż, f'għamla oblonga (tul ta' 16.7 mm x wisgħa ta' 8.7 mm), b'“AR 60” miktuba fuq naħa waħda.
English: In repeat-dose toxicity studies in male rats and dogs, atrophy, aspermia/hypospermia, degeneration and/or hyperplasia or hypertrophy in the reproductive system were observed at doses corresponding to exposures approximately equal to the human exposure based on AUC.
Maltese: Fi studji dwar tossiċità minn dożi ripetuti fil-firien u fil-klieb irġiel, ġew osservati, atrofija, nuqqas sħiħ ta' sperma/ipospermja, diġenerazzjoni u/jew iperplasja jew ipertrofija fis-sistema riproduttiva b'dożi li jaqblu ma' esponimenti bejn wieħed u ieħor daqs l-esponimenti fil-bniedem fl-AUC.
English: Erleada may reduce male fertility.
Maltese: Erleada jista' jnaqqas il-fertilità tar-raġel.
English: If a ≥ Grade 3 toxicity or an intolerable adverse reaction is experienced by the patient, dosing should be held rather than permanently discontinuing treatment until symptoms improve to ≤ Grade 1 or original grade, then should be resumed at the same dose or a reduced dose (180 mg or 120 mg), if warranted.
Maltese: Jekk pazjent ikollu tossiċità ≥ Grad 3 jew reazzjoni avversa mhux tollerabbli, għandu jitwaqqaf l-għoti ta' dożi minflok twaqqaf it-trattament għalkollox sakemm is-sintomi jitjiebu għal ≤ Grad 1 jew għallgrad oriġinali, imbagħad għandu jitkompla bl-istess doża jew b'doża mnaqqsa (180 mg jew 120 mg), jekk ikun iġġustifikat.
English: • Each 28-day carton contains 112 film coated tablets in 4 cardboard wallet packs of
Maltese: • Kull kartuna ta' 28 jum fiha 112-il pillola miksija b'rita f'4 pakketti portafolli tal-kartun ta'
English: Fill in your weekdays Start date:
Maltese: Data meta bdejt:
English: However, seizures have been reported in patients taking Erleada.
Maltese: Lit-tabib għidlu li inti qed tieħu Erleada jekk it-tabib ikun irid jibdielek mediċina ġdida.
English: • blood test showing high level of cholesterol in the blood
Maltese: • test tad-demm li juri livell għoli ta' kolesterol fid-demm
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING OUTER WALLET 60 mg (28 days)
Maltese: PORTAFOLL TA' ĠEWWA 60 mg (28 jum)
English: P-gp, BCRP or OATP1B1 are co-administered with Erleada, evaluation for loss of efficacy of the substrate should be performed and dose adjustment of the substrate may be required to maintain optimal plasma concentrations.
Maltese: Meta sustrati ta' P-gp, BCRP jew OATP1B1 jingħataw flimkien ma' Erleada, għandha ssir evalwazzjoni għal telf ta' effikaċja tas-sustrat u jista' jkun meħtieġ aġġustament fid-doża biex jinżammu l-aħjar konċentrazzjonijiet fil-plażma.
English: If treatment is started, patients should be monitored for the adverse reactions listed in section 4.8 and dose reduce as per section 4.2 Posology and method of administration.
Maltese: Jekk jinbeda t-trattament, il-pazjenti għandhom jiġu mmonitorjati għar-reazzjonijiet avversi elenkati fis-sezzjoni 4.8 u naqqas id-doża skont is-sezzjoni 4.2 Pożoloġija u metodu ta' kif għandu jingħata.
English: Apalutamide is an orally administered, selective Androgen Receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR.
Maltese: Apalutamide jingħata mill-ħalq u huwa inibitur selettiv tar-Riċettur tal-Androġen (AR, Androgen Receptor) li jintrabat direttament mad-dominju li jorbot miegħu il-ligand ta' AR.
English: Co-administration with warfarin and coumarin-like anticoagulants should be avoided.
Maltese: L-għoti flimkien ma' warfarin u antikoagulanti jixbhu lil coumarin għandu jiġi evitat.
English: The recommended dose is 240 mg (four 60 mg tablets) as an oral single daily dose.
Maltese: Id-doża rrakkomandata hija 240 mg (erba' pilloli ta' 60 mg) bħala doża waħda kuljum mill-ħalq.
English: Swallow the tablets whole.
Maltese: Ibla' l-pilloli sħaħ.
English: The median days to onset of skin rash was 82 days with a range of 1 to 994 days.
Maltese: Il-medjan tal-jiem għall-bidu tar-raxx fil-ġilda kien ta' 82 jum b'firxa minn jum 1 sa 994 jum.
English: Seizure
Maltese: Pożoloġija
English: Pregnancy and contraception information for men and women
Maltese: Informazzjoni dwar tqala u kontraċezzjoni għan-nisa u l-irġiel
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2018 EMA/181295/2018
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: Bearberry leaf EMA/181295/2018
Maltese: Ursi EMA/424828/2016
English: Bearberry leaf
Maltese: Werqa tal-Ulva
English: In its assessment, the HMPC considered laboratory studies which showed bearberry leaf preparations to have antibacterial action.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra studji tat-testijiet fil-laboratorju li wrew li l-preparazzjonijiet tal-werqa tal-ulva ursi għandhom azzjoni antibatterjali.
English: Other information about bearberry leaf medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom il-werqa tal-ulva ursi
English: What are the risks associated with bearberry leaf medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom il-werqa tal-ulva ursi?
English: Bearberry leaf is the common name for the leaves of the plant Arctostaphylos uva-ursi (L.) Spreng.
Maltese: Il-werqa tal-ulva ursi huwa l-isem komuni għall-weraq tal-pjanta Arctostaphylos uva-ursi (L.) Spreng.
English: Nausea, vomiting and stomach ache are side effects that have been reported with bearberry leaf medicines.
Maltese: Dardir, rimettar u uġigħ fl-istonku huma effetti sekondarji li ġew irrapportati b'mediċini li fihom il-werqa tal-ulva ursi.
English: Further information on the risks associated with these bearberry leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom il-werqa tal-ulva ursi, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fil-websajt tal-Aġenzija:
English: Further information on the HMPC assessment of bearberry leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that, on the basis of its long-standing use, these bearberry leaf preparations can be used for relief of symptoms of mild, recurrent infections in the lower urinary tract (the structure that carries urine), such as a burning sensation when passing urine and/or frequently passing urine.
Maltese: Mediċini tal-ħxejjex li fihom dawn il-preparazzjonijiet tal-werqa tal-ulva ursi normalment ikunu disponibbli bħala te tal-ħxejjex li għandhom jinxtorbu u f'forom solidi li għandhom jittieħdu mill-ħalq.
English: What is bearberry leaf?
Maltese: X'inhi l-werqa tal-ulva ursi?
English: The HMPC conclusions only cover bearberry leaf preparations which are obtained by drying and comminuting (reducing into tiny pieces) or powdering the leaves, or by using a technique to extract compounds by putting the plant material in a solvent (such as ethanol or water) to dissolve compounds and form a liquid extract.
Maltese: Il-konklużjonijiet tal-HMPC ikopru biss il-preparazzjonijiet tal-werqa tal-ulva ursi li huma maħduma billi l-weraq jitnixxfu u jindaħnu (f'biċċiet żgħar) jew billi jindaħnu fi trab, jew bl-użu ta' teknika għallestrazzjoni ta' komponenti billi tpoġġi l-materjali tal-pjanta f'solvent (bħall-etanol u l-ilma) biex jinħallu l-komponenti u jiffurmaw estratt likwidu.
English: No clinical studies are available with preparations containing only bearberry leaf.
Maltese: Ma hemm l-ebda studju kliniku disponibbli bi preparazzjonijiet li fihom biss il-werqa tal-ulva ursi.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini talħxejjex hija plawżibbli u hemm evidenza li ilhom jintużaw b'mod sigur b'dan il-mod għal mill-inqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: The HMPC conclusions on the use of these bearberry leaf medicines for lower urinary tract infections are based on their ‘traditional use'.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu ta' dawn il-mediċini li fihom il-werqa tal-ulva ursi għal infezzjonijiet fil-parti t'isfel tal-apparat urinarju huma bbażati fuq l-‘użi tradizzjonali' tagħhom.
English: What evidence supports the use of bearberry leaf medicines?
Maltese: X'evidenza tappoġġa l-użu tal-mediċini tal-werqa tal-ulva ursi?
English: The full EPAR for Pegasys 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 Pegasys
Maltese: Informazzjoni oħra dwar Pegasys
English: The most common side effects with Pegasys (seen in more than 1 patient in 10) are loss of appetite, headache, insomnia (difficulty sleeping), irritability, gut disorders (diarrhoea, nausea, and belly ache) rash, itching, hair loss, pain in muscles and joints, flu-like illness, reactions at the site of the injection and tiredness.
Maltese: L-effetti sekondarji l-aktar komuni b'Pegasys (li dehru f'aktar minn pazjent 1 minn kull 10) huma telf ta' aptit, uġigħ ta' ras, insomnja (diffikultà fl-irqad), irritabilità, disturbi tal-imsaren (dijarea, nawżea u wġigħ ta' żaqq), raxx, ħakk, telf ta' xagħar, uġigħ fil-muskoli u l-ġogi, mard simili għall-influwenza, reazzjonijiet fil-punt tal-injezzjoni u għeja.
English: Pegasys was more effective than lamivudine (another antiviral medicine) at clearing the hepatitis B virus in 2 studies of 1,372 adult patients.
Maltese: Pegasys kien aktar effikaċi minn lamivudine (mediċina antivirali oħra) fit-tneħħija tal-virus tal-epatite B f'2 studji b'1,372 pazjent adult.
English: • chronic (long-term) hepatitis B in adults and children from 3 years of age
Maltese: • l-epatite B kronika (fit-tul) fl-adulti u fi tfal mill-età ta' 3 snin
English: This is a summary of the European public assessment report (EPAR) for Pegasys.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pegasys.
English: The European Commission granted a marketing authorisation valid throughout the EU for Pegasys on 20 June 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni valida għall-kummerċjalizzazzjoni fl-UE kollha għal Pegasys fl-20 ta' Ġunju 2002.
English: Pegasys contains the active substance peginterferon alfa-2a.
Maltese: Pegasys fih is-sustanza attiva peginterferon alfa-2a.
English: Why is Pegasys approved?
Maltese: Għaliex ġie approvat Pegasys?
English: Peginterferon alfa-2a is similar to interferon alfa-2a, which is widely available in the European Union (EU) as Roferon-A.
Maltese: Peginterferon alfa-2a huwa simili għall-interferon alfa-2a, li huwa disponibbli b'mod komuni fl-Unjoni Ewropea (UE) bħala Roferon-A.
English: Pegasys is an antiviral medicine used to treat:
Maltese: Pegasys huwa mediċina antivirali li tintuża biex tikkura:
English: Another study in 1,149 adult patients showed that the combination of Pegasys with ribavirin was also more effective than Pegasys alone (45% responders at follow-up compared with 24%) and as effective as the combination of interferon alfa-2a and ribavirin (39% responders).
Maltese: Studju ieħor b'1,149 pazjent adult wera li l-kombinament ta' Pegasys ma' ribavirin kien ukoll aktar effikaċi minn Pegasys waħdu (45% tal-pazjenti rreaġixxew b'mod favorevoli fiż-żjara ta' segwitu meta mqabbla ma' 24%) u effikaċi daqs il-kombinament ta' interferon alfa-2a u ribavirin (39% tal-pazjenti rreaġixxew b'mod favorevoli).
English: Finally, a study in 55 children showed similar effectiveness with the combination of Pegasys and ribavirin to that seen in adults treated with Pegasys and ribavirin.
Maltese: Finalment, studju b'55 tifel u tifla wera effikaċja fir-rigward tal-kombinament ta' Pegasys u ribavirin li kienet simili għal dik li dehret fl-adulti kkurati b'Pegasys u ribavirin.
English: Among ‘HBeAgnegative' patients (those infected with a virus that has mutated and can be more difficult to treat), the clearance rate was 43% with Pegasys and 29% with lamivudine.
Maltese: Fil-pazjenti ‘negattivi għall-HBeAg' (dawk infettati b'virus li għadda minn mutazzjoni u li l-kura tiegħu tista' tkun aktar diffiċli), ir-rata ta' tneħħija kienet 43% b'Pegasys u 29% b'lamivudine.
English: In a study of 151 children with hepatitis B aged 3 and above, 26% of those treated with Pegasys no longer had viral activity in their blood after 24 weeks, compared with 3% of those not given any treatment.
Maltese: Fi studju b'151 tifel u tifla b'epatite B mill-età ta' 3 snin 'il fuq, 26% minn dawk ikkurati b'Pegasys ma kellhomx iżjed attività virali fid-demm wara 24 ġimgħa, meta mqabbla ma' 3% minn dawk li ma ngħataw l-ebda kura.
English: • chronic hepatitis C in adults and children from 5 years of age.
Maltese: • l-epatite Ċ kronika fl-adulti u fi tfal mill-età ta' 5 snin.
English: The active substance in Pegasys, peginterferon alfa-2a, belongs to the group ‘interferons'.
Maltese: Is-sustanza attiva f'Pegasys, peginterferon alfa-2a, tifforma parti mill-grupp tal-‘interferoni'.
English: Three studies of 1,441 adult patients showed that more patients taking Pegasys alone had no signs of hepatitis viral activity in their blood after treatment (28 to 39%) than patients taking interferon alfa-2a (8 to 19%).
Maltese: Tliet studji b'1,441 pazjent adult urew li kien hemm aktar pazjenti li kienu qed jieħdu Pegasys waħdu li ma kellhomx sinjali ta' attività virali tal-epatite fid-demm wara l-kura (28 sa 39%) minn pazjenti li kienu jieħdu interferon alfa-2a (8 sa 19%).
English: What are the risks associated with Pegasys?
Maltese: X'inhuma r-riskji assoċjati ma' Pegasys?
English: The adult dose is usually 180 micrograms but the children's dose varies depending on their height and weight.
Maltese: Id-doża għall-adulti normalment hija ta' 180 mikrogramma, iżda d-doża għat-tfal tvarja skont it-tul u lpiż tagħhom.
English: In these studies, the proportions of patients with no signs of viral activity in their blood 6 months after treatment were 32% with Pegasys and 22% with lamivudine among HBeAg-positive patients (those with the common type of the hepatitis B virus).
Maltese: F'dawn l-istudji, il-proporzjonijiet ta' pazjenti mingħajr sinjali ta' attività virali fid-demm 6 xhur wara l-kura kienu 32% b'Pegasys u 22% b'lamivudine fil-pazjenti pożittivi għall-HbeAg (dawk bl-aktar tip komuni tal-epatite B).
English: Additional studies showed that peginterferon alfa-2a in combination with telaprevir and ribavirin or with boceprevir and ribavirin significantly increased the proportion of patients who responded to treatment compared with peginterferon alfa-2a plus ribavirin.
Maltese: Studji addizzjonali wrew li peginterferon alfa-2a flimkien ma' telaprevir u ribavirin jew ma' boceprevir u ribavirin żiedu b'mod sinifikanti l-proporzjon tal-pazjenti li rreaġixxew b'mod favorevoli għall-kura meta mqabbla ma' peginterferon alfa-2a flimkien ma' ribavirin.
English: Pegasys is given by injection under the skin in the abdomen (belly) or thigh - once a week for 48 weeks for hepatitis B and once a week for between 16 and 72 weeks for hepatitis C.
Maltese: Pegasys jingħata b'injezzjoni taħt il-ġilda fl-addome (iż-żaqq) jew fil-koxxa - darba fil-ġimgħa għal 48 ġimgħa għall-epatite B u darba fil-ġimgħa għal bejn 16 u 72 ġimgħa għall-epatite Ċ.
English: Interferons are natural substances produced by the body that help it fight infections caused by viruses.
Maltese: Linterferoni huma sustanzi naturali prodotti mill-ġisem ħalli jgħinuh jiġġieled kontra infezzjonijiet ikkawżati minn virusijiet.
English: Studies show that Pegasys is effective at clearing signs of viral infection in adults and children with chronic hepatitis B or C.
Maltese: L-istudji juru li Pegasys huwa effikaċi biex ineħħi s-sinjali tal-infezzjoni virali fl-adulti u t-tfal b'epatite kronika B jew Ċ.
English: Pegasys is usually used alone for hepatitis B infection but is taken in combination with other medicines for hepatitis C. For more information about when to use this medicine in adults and children, see the summary of product characteristics (SmPC).
Maltese: Pegasys normalment jintuża waħdu għal infezzjoni bl-epatite B, iżda jittieħed flimkien ma' mediċini oħra għall-epatite Ċ.
English: Alfa interferons may also block the multiplication of viruses.
Maltese: L-interferoni alfa jistgħu jimblokkaw ukoll il-multiplikazzjoni tal-virusijiet.
English: In Pegasys, the interferon alfa-2a has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Maltese: F'Pegasys, interferon alfa-2a ġie pegilat (mehmuż ma' sustanza kimika msejħa polietilenglikol).
English: Hepatitis B and C are diseases of the liver due to infection with the hepatitis B and C viruses, respectively.
Maltese: L-epatite B u Ċ huma mard tal-fwied ikkawżat minn infezzjoni bil-virus tal-epatite B u Ċ rispettivament.
English: For the full list of restrictions with Pegasys, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Pegasys, ara l-fuljett ta' tagħrif.
English: What measures are being taken to ensure the safe and effective use of Pegasys?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Pegasys?
English: How is Pegasys used?
Maltese: Kif jintuża Pegasys?
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu©EMEA 2008 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) QUADRAMET EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) QUADRAMET Sommarju ta' l-EPAR għall-pubbliku
English: Other information about QUADRAMET:
Maltese: Informazzjoni oħra dwar QUADRAMET:
English: The medicine is given by slow intravenous injection (into a vein) over one minute.
Maltese: Il-mediċina tingħata bil-mod permezz ta' injezzjoni intravenuża (fl-vina) li ddum tingħata minuta.
English: The marketing authorisation was renewed on 5 February 2003 and on 5 February 2008.
Maltese: L-awtorizzazzjoni għattqegħid fis-suq ġiet imġedda fil-5 ta' Frar 2003 u fil-5 ta' Frar 2008.
English: The following side effects have also been reported: asthenia (weakness), nausea (feeling sick), vomiting, diarrhoea, peripheral oedema (fluid retention), headaches, hypotension (low blood pressure), dizziness, myasthenia (muscle weakness), confusion and sweating.
Maltese: Ġew rappurtati wkoll dawn l-effetti sekondarji: astenija (dgħjufija), nawżea, rimettar, dijarrea, edema periferika (żamma tal-fluwidi), uġigħ ta' ras, ipotensjoni (pressjoni baxxa), strudament, mjastenija (dgħjufija fil-muskoli), konfużjoni u ħruġ ta' għaraq.
English: Its active substance is samarium [153Sm] lexidronam pentasodium.
Maltese: QUADRAMET hu soluzzjoni li fiha s-sustanta attiva samarium [153Sm] lexidronam pentasodium.
English: It is a complex (a type of chemical) made up of a radioactive element, samarium-153 (153Sm), bound to another chemical called ‘ethylene diamine tetra methylene phosphonic acid'
Maltese: Dan hu kumpless (tip ta' sustanza kimika) magħmul minn element radjuattiv, samarium-153 (153Sm), magħqud ma' sustanza kimika oħra magħrufa bħala ethylene diamine tetra methylene phosphonic acid (EDTMP).