FrancophonIA/ELRC3.0 huggingface dataset:
English: Opioid-induced constipation in adult patients with advanced illness Methylnaltrexone bromide treatment has not been studied in adult patients with advanced illness in clinical trials for longer than 4 months, and should therefore only be used for a limited period (see section 5.1).
Maltese: It-trattament b'methylnaltrexone bromide ma ġiex studjat f'pazjenti adulti b'mard avvanzat fil-provi kliniċi għal aktar minn 4 xhur u għalhekk għandu jintuża biss għal perijodu limitat (ara sezzjoni 5.1).
English: Methylnaltrexone bromide-treated patients also had significantly higher rates of laxation within 4 hours after at least 2 of the first 4 doses (52 %) than did placebo-treated patients (9 %); p<0.0001.
Maltese: Pazjenti trattati b'methylnaltrexone bromide ukoll kellhom rati ta' ppurgar ogħla b'mod sinifikanti fi żmien 4 sigħat wara ta' lanqas 2 mill-ewwel 4 dożi (52 %) milli kellhom pazjenti trattati bi plaċebo (9 %); p<0.
English: Important information about some of the ingredients of Relistor This medicine contains less than 1 mmol sodium (23 mg) per dose i.e., essentially “sodium free.”
Maltese: Tagħrif importanti dwar xi wħud mis-sustanzi ta' Relistor Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull doża i.e., essenzjalment hija "ħielsa mis-sodium."
English: This medicine is given by an injection under the skin (by subcutaneous injection) in either (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (if not self-injecting).
Maltese: Din il-mediċina tingħata bħala injezzjoni taħt il-ġilda (b'injezzjoni subkutanja) jew (1) fil-parti ta' fuq ta' riġlejk (koxxa), (2) f'żaqqek (l-istonku), u (3) fil-parti ta' fuq ta' dirgħajk (jekk ma tinjettax lilek innifsek).
English: The primary endpoint was the proportion of patients with a rescue-free laxation within 4 hours of the double-blind dose of study medicinal product.
Maltese: L-ewwel punt ta' riferiment aħħari kien il-proporzjon ta' pazjenti b'rescue-free laxation fi żmien 4 sigħat miż-żmien tad-doża double blind tal-prodott mediċinali tal-istudju.
English: Methylnaltrexone bromide-treated patients had a significantly higher rate of laxation within 4 hours of the double-blind dose (62 % for 0.15 mg/kg and 58 % for 0.3 mg/kg) than placebo-treated patients (14 %); p<0.0001 for each dose versus placebo.
Maltese: Pazjenti kkurati b'methylnaltrexone bromide kellhom rata ta' ippurgar ogħla b'mod sinifikanti fi żmien 4 sigħat tad-doża double-blind (62 % għal 0.15 mg/kg u 58 % għal 0.3 mg/kg) mill-pazjenti kkurati bil-plaċebo
English: Results showed no meaningful effect of hepatic impairment on the AUC or Cmax of methylnaltrexone bromide.
Maltese: Ir-riżultati ma wrew ebda effett sinifikanti ta' indeboliment epatiku fuq l-AUC jew Cmax ta' methylnaltrexone bromide.
English: This was achieved in 59% of the patients in the group receiving daily methylnaltrexone 12 mg (p<0.001 vs. placebo), in 61% of those receiving it every other day (p<0.001 vs. placebo), and in 38% of the placebo treated patients.
Maltese: 001 vs. placebo), f'61% ta' dawk li ġie mogħti lilhom ġurnata iva u ġurnata le (p<0.
English: Relistor 8 mg solution for injection in pre-filled syringe Relistor 12 mg solution for injection in pre-filled syringe Methylnaltrexone bromide
Maltese: Informazzjoni għall- utent Relistor 8 mg soluzzjoni għal injezzjoni f'siringa mimlija għal-lest Relistor 12 mg soluzzjoni għal injezzjoni f'siringa mimlija għal-lest
English: SPECIAL STORAGE CONDITIONS Store below 30°C.
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen f'temperatura taħt 30ºC.
English: - The other ingredients are sodium chloride, sodium calcium edetate, glycine hydrochloride,
Maltese: Sodium chloride, sodium calcium edetate, glycine hydrochloride, ilma għall-injezzjonijiet,
English: • To avoid needle-stick injuries, do not recap used needles.
Maltese: Evita li tagħti injezzjonijiet ripetuti eżattament fl-istess post fejn ikunu ngħataw qabel.
English: Dizziness is a common side effect of this medicine.
Maltese: L-isturdament huwa effett sekondarju komuni ta' din il-mediċina.
English: Pack sizes of 1 vial,
Maltese: Daqsijiet tal-pakkett ta' kunjett 1
English: Relistor contains an active substance called methylnaltrexone bromide which acts by blocking the side effects of opioid pain medicines that affect the bowel.
Maltese: Relistor fih sustanza attiva msejjħa methylnaltrexone bromide li taġixxi billi timblokka l-effetti sekondarji ta' mediċini għal kontra l-uġigħ mill-opjojdi li jaffettwaw l-imsaren.
English: STATEMENT OF ACTIVE SUBSTANCE Each pre-filled syringe of 0.4 mL contains 8 mg of methylnaltrexone bromide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull siringa mimlija għal-lest ta' 0.4 mL fiha 8 mg ta' methylnaltrexone bromide.
English: 12 mg once daily, n = 150, methylnaltrexone bromide 12 mg every other day, n = 148, placebo, n = 162) were treated in the double-blind period.
Maltese: methylnaltrexone bromide 12 mg darba iva darba le, n =148, plaċebo n=162) kienu trattati fil-perijodu double-blind.
English: Elderly population No dose adjustment is recommended based on age (see section 5.2).
Maltese: L-ebda aġġustament tad-doża ma huwa rrakkomandat fuq il-bażi tal-età (ara sezzjoni 5.2).
English: The Cmax and area under the plasma concentration-time curve (AUC) increase with dose increase from 0.15 mg/kg to 0.5 mg/kg in a dose proportional manner.
Maltese: tiżdied maż-żieda fid-doża minn 0.15 mg/kg sa 0.5 mg/kg b'mod proporzjonali mad-doża.
English: The effects of methylnaltrexone bromide in pregnant women are not known.
Maltese: L-effetti ta' methylnaltrexone bromide f'nisa waqt it-tqala mhumiex magħrufin.
English: • Vomiting
Maltese: • Gass
English: NAME OF THE MEDICINAL PRODUCT Relistor 12 mg/0.6 mL solution for injection
Maltese: Relistor 12 mg/0.6 mL soluzzjoni għall-injezzjoni
English: Cardiac effects were observed in some non-clinical studies in canines (prolongation of action potentials in Purkinje fibers or prolongation of the QTc interval).
Maltese: Fi studji mhux kliniċi fil-klieb kienu osservati effetti kardjovaskulari (titwil tal-potenzjal t'azzjoni fil-fibri Purkinje jew titwil fl-intervall QTc).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Maltese: Informazzjoni li mhix klinika ma turi ebda periklu speċjali għall-bniedem, fuq il-bażi ta' studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni u potenzjal karċinoġeniku.
English: INSTRUCTIONS FOR PREPARING AND GIVING AN INJECTION OF RELISTOR
Maltese: STRUZZJONIJIET DWAR KIF TIPPREPARA U TAGĦTI INJEZZJONI TA' RELISTOR
English: The effect on race could not be analysed because the study population was predominantly Caucasian (88 %).
Maltese: L-effett fuq ir-razza ma setax jiġi analizzat minħabbali l-popolazzjoni studjata kienet predominantament Kawkaża (88 %).
English: Use of methylnaltrexone bromide in patients with known or suspected mechanical gastrointestinal obstruction, patients at increased risk for recurrent obstruction or in patients with acute surgical abdomen is contraindicated due to the potential for gastrointestinal perforation.
Maltese: L-użu ta' methylnaltrexone bromide f'pazjenti li għandhom sadd mekkaniku intestinali magħruf jew suspettat, pazjenti b'riskju ogħla ta' ostruzzjoni rikorrenti jew f'pazjenti b'addome kirurġiku akut huwa kontra-indikat minħabba l-potenzjal ta' perforazzjoni gastro-intestinali.
English: Relistor can be injected without regard to food.
Maltese: Relistor jista' jiġi injettat mingħajr konsiderazzjoni għall-ikel.
English: Subcutaneous injections of Relistor at 150/100 mg/kg/day to rats resulted in decreased offspring weights; doses up to 25 mg/kg/day (18 times the exposure [AUC] in humans at a subcutaneous dose of 0.3 mg/kg) had no effect on labour, delivery, or offspring survival and growth.
Maltese: Relistor f'dożi ta' 150/100 mg/kg/kuljum għal firien irriżultaw f'piżijiet mnaqqsa tal-ġriewi; dożi ta' 25 mg/kg/jum (18-il darba l-espożizzjoni [AUC] fil-bniedem f'doża ta' 0.3 mg/kg li tigħata taħt ilġilda) ma kellhom ebda effett fuq il-ħlas, it-twelid, jew is-sopravivenza tal-wild u l-iżvilupp.
English: - It is important to be near a toilet with assistance available if necessary, since bowel movement may happen within 30 minutes after injection of the medicine.
Maltese: − Huwa importanti li tkun qrib tojlit bl-assistenza disponibbli jekk ikun hemm bżonn, minħabba li l ippurgar jista' jseħħ fi żmien 30 minuta minn wara li tingħata l-injezzjoni tal-mediċina.
English: Pack containing 7 vials, 7 injection syringes with retractable injection needle, and 14 alcohol swabs (i.e. 7 inner cartons).
Maltese: Pakkett li fih 7 kunjetti, 7 siringi ta' l-injezzjoni b'labra ta' l-injezzjoni li tinġibed lura, u 14-il imselħa ta' l-alkoħol (i.e. 7 kartuni ta' ġewwa)
English: In both studies, patients had advanced terminal illness and limited life expectancy, with the majority having a primary diagnosis of incurable cancer; other primary diagnoses included end-stage COPD/emphysema, cardiovascular disease/heart failure, Alzheimer's disease/dementia, HIV/AIDS, or other advanced illnesses.
Maltese: Fiż-żewg studji, il-pazjenti kellhom mard terminali avvanzat u għomor limitat, bil-maġġoranza jkollhom dijanjożi primarja ta' kanċer li ma jfieqx; dijanjożi primarji oħrajn kienu jinkludu COPD/emfisema, mard kardjovaskulari/insufficjenza tal-qalb, marda ta' Alzheimer/dimenzja,
English: Subcutaneous injections of Relistor at 150 mg/kg/day decreased fertility in rats.
Maltese: Injezzjoni taħt il-ġilda ta' Relistor f'doża ta' 150 mg/kg/jum naqset il-fertilità fil-firien.
English: The effect of severe hepatic impairment on the pharmacokinetics of methylnaltrexone bromide has not been studied.
Maltese: L-effett ta' indeboliment epatiku sever fuq il-farmakokinetika ta' methylnaltrexone bromide ma ġiex studjat.
English: • Abdominal pain (stomach ache)
Maltese: • Dardir (tħossok imdardar)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea dwar il-Mediċini http://www.ema.europa.eu/.
English: Pick up the syringe from your work surface.
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: Relistor is a solution for injection.
Maltese: Relistor hija soluzzjoni għall-injezzjoni.
English: Common: opioid-withdrawal-like symptoms (like chills, tremor, rhinorrhea, piloerection, hot flush, palpitation, hyperhidrosis, vomiting, abdominal pain)
Maltese: piloerezzjoni, fwawar sħan, palpitazzjoni, iperidrożi, remettar, uġigħ addominali)
English: In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of methylnaltrexone bromide should be reduced from 12 mg to 8 mg (0.4 mL of solution) for those weighing 62 to 114 kg.
Maltese: F'pazjenti li għandhom indeboliment renali sever (tneħħija ta' kreatinina ta' inqas minn 30 mL/min), id-doża ta' methylnaltrexone bromide għandha titnaqqas minn 12 mg għal 8 mg (0.4 mL ta'
English: STATEMENT OF ACTIVE SUBSTANCE Each pre-filled syringe of 0.6 mL contains 12 mg of methylnaltrexone bromide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull kunjett ta' 0.6 mL fih 12 mg ta' methylnaltrexone bromide.
English: There were 2 primary endpoints: proportion of patients with a rescue-free laxation within 4 hours of the first dose of study medicinal product and proportion of patients with a rescue-free laxation within 4 hours after at least 2 of the first 4 doses of medicinal product.
Maltese: Kien hemm żewġ punti primarji ta' riferiment aħħarija: il-proporzjon ta' pazjenti b'rescue free laxation fi żmien 4 sigħat mill-ewwel doża tal-prodott mediċinali li qed jiġi studjat u l-proporzjon ta' pazjenti b'rescue-free laxation fi żmien 4 sigħat wara ta' lanqas 2 mill-ewwel 4 dożi tal-prodott mediċinali.
English: Step 3: Injecting Relistor pre-filled syringe
Maltese: Pass 2: Kif tipprepara s-siringa ta' l-injezzjoni
English: Carefully pull back the plunger to correct level on syringe (e.g. 0.4 mL if you have been prescribed 8 mg)
Maltese: B'attenzjoni iġbed lura l planġer għal-livell korrett fuq is-siringa (eż. 0.4 mL jekk inti ġejt ordnat 8 mg)
English: STATEMENT OF ACTIVE SUBSTANCE Each vial of 0.6 mL contains 12 mg of methylnaltrexone bromide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull kunjett ta' 0.6 mL fih 12 mg ta' methylnaltrexone bromide.
English: Methylnaltrexone bromide is a selective antagonist of opioid binding at the mu-receptor.
Maltese: Methylnaltrexone bromide huwa antagonist selettiv ta' opjojdi li jeħel fir-riċettatur-mu.
English: No adverse effects occurred in either juvenile or adult dogs at a dose of 5 mg/kg/day (44 times the exposure {AUC} in adult humans at a subcutaneous dose of 0.15 mg/kg).
Maltese: Ma kien hemm ebda effett avvers la fi klieb għadhom żgħar u lanqas fi klieb adulti b'doża ta' 5 mg/kg/kuljum (44 darba lesponiment {AUC} f'adulti umani f'doża taħt il-ġilda ta' 0.15 mg/kg).
English: Opioid-induced constipation in adult patients with advanced illness The efficacy and safety of methylnaltrexone bromide in the treatment of opioid-induced constipation in patients receiving palliative care was demonstrated in two randomised, double-blind, placebocontrolled studies.
Maltese: Stitikezza mqanqla minn opijojdi f'pazjenti adulti b'uġigħ kroniku mhux ta' kanċer L-effikaċja u s-sigurtà ta' methylnaltrexone bromide fit-trattament ta' stitikezza ikkaġunata minħabba opijojdi f'pazjenti b'uġigħ kroniku mhux ta' kanċer intwera fi studju każwali, double-blind,
English: 4 pre-filled syringes
Maltese: 4 ġbariet tal-alkoħol
English: Hydrochloric acid (to adjust pH)
Maltese: Hydrochloric acid (biex jaġġusta l-pH) Sodium hydroxide (biex jaġġusta l-pH)
English: In these patients, the treatment with usual laxatives should be stopped when commencing treatment with Relistor (see section 5.1).
Maltese: F'pazjenti bi trattament maħsub biex inaqqas l-uġigħ, Relistor jiġi miżjud mat-trattament ta' porog li s-soltu jingħata (ara sezzjoni 5.1)..
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Pack containing 4, 7, 8 or 10 pre-filled syringes with a needle shield.
Maltese: Pakkett li fih 4, 7, 8 jew 10 siringi mimlijin għal-lest b'għant għal-labra.
English: Look at the pre-filled syringe.
Maltese: IL-PLANĠER 'L ISFEL KOLLU.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.6 mL of solution (12 mg methylnaltrexone bromide)
Maltese: INDIVIDWALI 0.6 mL ta' soluzzjoni (12 mg methylnaltrexone bromide)
English: Weight
Maltese: Piż
English: Opioid-induced constipation in adult patients with advanced illness (palliative care patients) The recommended dose of methylnaltrexone bromide is 8 mg (0.4 mL of solution) (for patients weighing 38-61 kg) or 12 mg (0.6 mL of solution) (for patients weighing 62-114 kg).
Maltese: Id-doża rakkomandata għal pazjenti li jirċievu kura t'appoġġ b'mard avvanzat hi ta' 8 mg methylnaltrexone bromide (0.4 mL ta' soluzzjoni) għal pazjenti li jiżnu 38-61 kg jew 12 mg (0.6 mL
English: Your doctor will tell you whether you should stop or continue taking your usual laxatives when you start using this medicine.
Maltese: Din il-mediċini tingħata apparti l-porgi li inti tieħu normalment.
English: An integrated analysis of pharmacokinetic data from healthy subjects indicated that methylnaltrexone bromide mg/kg dose-adjusted exposure increased as body weight increased.
Maltese: Analiżi integrata ta' tagħrif farmakokinetiku minn individwi b'saħħithom indikat li l-espożizzjoni aġġustata għad-doża ta' methylnaltrexone bromide mg/kg żdidet hekk kif il-piz tal-ġisem żdied.
English: Avoid areas with scars or stretch marks.
Maltese: Evita postijiet b'farretti jew marki ta' tiġbid (stretch marks).
English: Solution for injection (injection).
Maltese: L-INJEZZJONI TA'
English: Following intravenous injection of methylnaltrexone bromide, juvenile rats were found to be more sensitive than adult rats to methylnaltrexone-related toxicity.
Maltese: Wara injezzjoni ġol-vini ta' methylnaltrexone bromide, il-firien żgħar instabu li kienu iktar sensittivi minn firien adulti għat-tossiċità relatata ma' methylnaltrexone.
English: 0.4 mL of solution (8 mg methylnaltrexone bromide) Read the package leaflet before use.
Maltese: 0.4 mL ta' soluzzjoni (8 mg methylnaltrexone bromide)
English: Each vial of 0.6 mL contains 12 mg methylnaltrexone bromide.
Maltese: 0.6 mL ta' soluzzjoni (12 mg methylnaltrexone bromide)
English: The recommended dose for patients with long-term pain (except patients receiving supportive care for advanced illness) is 12 mg methylnalrexone bromide (0.6 mL of solution) given as an injection under the skin, as needed, but at least given 4-times a week and up to once a day (7 times a week).
Maltese: Id-doża rakkomandata għal pazjenti b'uġigħ fuq perijodu ta' żmien twil (għajr pazjenti li qed jirċievu kura t'appoġġ għal marda avvanzata) hi ta' 12 mg methylnaltrexone bromide (0.6 mL ta' soluzzjoni) li tingħata bħala injezzjoni taħt il-ġilda, kif meħtieġ, imma tal-anqas li tingħata 4 darbiet fil-ġimgħa u sa darba kuljum (7 darbiet fil-ġimgħa).
English: The use of methylnaltrexone bromide for treating opioid-induced constipation beyond 48 weeks has not been evaluated in clinical trials.
Maltese: L-użu ta' methylnaltrexone bromide għal stitikezza mqanqla minn opijojdi lil hinn minn 48 ġimgħa ma ġietx evalwata fil-provi kliniċi.
English: The three areas of the body recommended for injection of Relistor are: (1) your upper legs (thighs), (2) your abdomen (stomach), and (3) your upper arm (only if injecting another person).
Maltese: (1) in-naħa ta' fuq ta' riġlejk (il-koxox), (2) żaqqek (l-istonku), u (3) in-naħa ta' fuq ta' dirgħajk (jekk tkun se ssir injezzjoni fuq persuna oħra biss).
English: In a study comparing single and multiple-dose pharmacokinetic profiles of intravenous methylnaltrexone bromide at a dose of 24 mg between healthy, young (18 to 45 years of age n = 10) and elderly (65 years of age and over n = 10) subjects, the effect of age on exposure to methylnaltrexone bromide was found to be minor.
Maltese: Fi studju li qabbel profili farmakokinetiċi ta' dożi waħdanin u multipli ta' methylnaltrexone bromide mogħti ġol-vina f'doża ta' 24 mg bejn individwi b'saħħithom, żgħar (18 sa 45 sena n = 10) u anzjani
English: Glycine hydrochloride
Maltese: Kif gћandek tuża Relistor
English: Study 301 compared methylnaltrexone bromide given as a single, double-blind, subcutaneous dose of 0.15 mg/kg, or 0.3 mg/kg versus placebo.
Maltese: L-istudju 301 ipparaguna methylnaltrexone bromide mogħti b'doża waħda double-blind li tingħata taħt il-ġilda ta' 0.15 mg/kg jew 0.3 mg/kg, mal-plaċebo.
English: Step 4: Disposing of supplies
Maltese: Pass 4: Rimi tal-provvisti
English: This allows methylnaltrexone bromide to function as a peripherally acting mu-opioid antagonist in tissues such as the gastrointestinal tract, without impacting opioid-mediated analgesic effects on the central nervous system.
Maltese: Fin-nuqqas ta' studji ta' kompatibbiltà, dan il-prodott mediċinali m'għandux jitħallat ma' prodotti mediċinali oħrajn.
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Pjan tal-ġestjoni tar-riskju (RMP)
English: Patients had a history of chronic non-cancer pain and were taking opioids with stable doses of at least 50 mg of oral morphine equivalents per day.
Maltese: Il-pazjenti kellhom storja ta' uġigħ kroniku mhux ta' kanċer u kienu qed jieħdu opijojdi ma' dożi stabbiliti ta' mill-inqas 50 mg ta' ekwivalenti ta' morfina orali kuljum.
English: 10 March 2014
Maltese: 10 ta' Marzu 2014
English: What is Valebo?
Maltese: X'inhu Valebo?
English: Outcome of a procedure under Article 29(4) of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE
English: TEVA Pharma B.V. submitted Valebo to the German medicines regulatory agency for a decentralised procedure.
Maltese: TEVA Pharma B.V. ippreżentat lil Valebo lill-aġenzija regolatorja tal-mediċini Ġermaniża għal proċedura deċentralizzata.
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom).
Maltese: Din hija proċedura fejn Stat Membru wieħed (l-‘Istat Membru ta' referenza', f'dan ilkaż il-Ġermanja) jevalwa mediċina bil-għan li tingħata awtorizzazzjoni għat-tqegħid fis-suq li tkun valida f'dan il-pajjiż kif ukoll fi Stati Membri oħra (l-‘Istati Membri kkonċernati', f'dan il-każ l-Awstrija, il-Belġju, il-Bulgarija, id-Danimarka, Franza, l-Ungerija, l-Irlanda, il-Pajjiżi l-Baxxi, il-Portugall, isSlovakkja, is-Slovenja, Spanja u r-Renju Unit).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that the benefits of Valebo outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: Austria, Belgium, Bulgaria, Denmark, France, Hungary, Ireland, the Netherlands, Portugal, Slovakia, Slovenia, Spain and the United Kingdom.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li lbenefiċċji ta' Valebo jisbqu r-riskji tiegħu, u l-awtorizzazzjoni għat-tqegħid fis-suq tista' tingħata filĠermanja u fl-Istati Membri li ġejjin tal-UE: l-Awstrija, il-Belġju, il-Bulgarija, id-Danimarka, Franza, lUngerija, l-Irlanda, il-Pajjiżi l-Baxxi, il-Portugall, is-Slovakkja, is-Slovenja, Spanja u r-Renju Unit.
English: On 19 December 2013, the European Medicines Agency completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Valebo.
Maltese: Fid-19 ta' Diċembru 2013, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ wara nuqqas ta' qbil fost l-Istati Membri tal-Unjoni Ewropea (UE) dwar l-awtorizzazzjoni tal-mediċina Valebo.
English: Why was Valebo reviewed?
Maltese: Għalxiex ġie rivedut Valebo?
English: Valebo is a combination of tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol.
Maltese: Valebo huwa kombinazzjoni ta' pilloli li fihom 70 mg ta' aċidu alendroniku u kapsuli li fihom 1 mikrogramma ta' alfakalċidol.
English: Alfacalcidol is a type of vitamin D (a ‘vitamin D analogue'), which is required for calcium absorption and normal bone formation.
Maltese: Alfakalċidol huwa tip ta' vitamina D (‘analogu ta-vitamina D'), li huwa meħtieġ għall-assorbiment talkalċju u l-formazzjoni normali tal-għadam.
English: However, although alfacalcidol has been shown in some clinical studies to reduce the risk of falls in older people, the Committee considered that this information should be included under section 5.1 of the summary of product characteristics (and not in section 4.1).
Maltese: Madankollu, għalkemm f'xi studji kliniċi alfakalċidol intwera li jnaqqas ir-riskju ta' waqgħat f'persuni akbar fl-età, il-Kumitat qies li din l-informazzjoni għandha tiġi inkluża taħt is-sezzjoni 5.1 tas-sommarju tal-karatteristiċi tal-prodott (u mhux fis-sezzjoni 4.1).
English: Questions and answers on Valebo and associated names (tablets containing 70 mg alendronic acid and capsules containing 1 microgram alfacalcidol)
Maltese: Mistoqsijiet u tweġibiet dwar Valebo u ismijiet assoċjati (pilloli li fihom 70 mg ta' aċidu alendroniku u kapsuli li fihom 1 mikrogramma ta' alfakalċidol)