FrancophonIA/ELRC3.0 huggingface dataset:
English: The HMPC conclusions on the use of this sandy everlasting medicine for digestive disorders with a feeling of fullness and bloating are based on its ‘traditional use'.
Maltese: Struzzjonijiet dettaljati dwar kif għandek tieħu mediċini li fihom sandy everlasting u min jista' jużahom jistgħu jinstabu fil-fuljett ta' tagħrif li jiġi mal-mediċina.
English: The review of omega-3 fatty acid medicines was started on 22 March 2018 at the request of the Swedish medicines agency under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami ta' mediċini aċidi grassi omega-3 inbdiet fit-22 ta' Marzu 2018 fuq talba tal-aġenzija Żvediża tal-mediċini skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Omega-3 fatty acid medicines have been authorised for use after a heart attack, in combination with other medicines, in several EU countries since 2000, at a dose of 1 g per day.
Maltese: Il-mediċini aċidi grassi omega-3 ġew awtorizzati għall-użu wara attakk tal-qalb, f'kombinazzjoni ma' mediċini oħra, f'diversi pajjiżi tal-UE sa mill-2000, f'doża ta' 1 g kuljum.
English: • The review concluded that, while a small relative risk reduction was seen in the original open label GISSI Prevenzione study, the beneficial effects were not confirmed in more recent randomised controlled trials.
Maltese: • Ir-rieżami kkonkluda li, filwaqt li deher tnaqqis relattiv żgħir fir-riskju fil-prova miftuħa oriġinali GISSI Prevenzione, l-effetti ta' benefiċċju ma kinux ikkonfermati fi provi kkontrollati randomizzati aktar riċenti.
English: On 29 March 2019 EMA confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 1 g per day are not effective in preventing further problems with the heart and blood vessels in patients who have had a heart attack.
Maltese: Fid-29 ta' Marzu 2019, l-EMA kkonfermat li l-mediċini aċidi grassi omega-3 li fihom kombinazzjoni ta' ester etiliku tal-aċidu ejkosapentenojku (EPA) u l-aċidu dokosaeżaenojku (DHA) f'doża ta' 1 g kuljum mhumiex effettivi fil-prevenzjoni ta' aktar problemi bil-qalb u bil-vażijiet f'pazjenti li kellhom attakk talqalb.
English: The review concerned omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).
Maltese: Ir-rieżami kien jikkonċerna mediċini aċidi grassi omega-3 li fihom kombinazzjoni ta' ester etiliku ta' aċidu ejkosapentenojku (EPA) u aċidu dokosaeżaenojku (DHA).
English: • Omega-3 fatty acid medicines are still authorised for reducing levels of certain types of blood fat called triglycerides.
Maltese: • Il-mediċini aċidi grassi omega-3 għadhom awtorizzati għat-tnaqqis tal-livelli ta' ċerti tipi ta' xaħam fid-demm imsejħa trigliċeridi.
English: • Omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) will no longer be authorised for secondary prevention after myocardial infarction.
Maltese: • Il-mediċini aċidi grassi omega-3 li fihom kombinazzjoni ta' ester etiliku ta' aċidu ejkosapentenojku (EPA) u aċidu dokosaeżaenojku (DHA) mhux se jibqgħu awtorizzati għal prevenzjoni sekondarja wara infart mijokardjali.
English: EPA and DHA are commonly found in fish oils.
Maltese: L-EPA u d-DHA normalment jinsabu fiżżjut tal-ħut.
English: Omega-3 fatty acid medicines are taken by mouth and have been authorised in several EU countries through national procedures.
Maltese: Il-mediċini aċidi grassi omega-3 jittieħdu mill-ħalq u ġew awtorizzati f'diversi pajjiżi tal-UE permezz ta' proċeduri nazzjonali.
English: • The review looked at results of the open-label ‘GISSI Prevenzione' study performed in 1999 which supported the initial authorisation of these medicines, as well as more recent randomised controlled clinical trials, retrospective cohort studies and meta-analyses.
Maltese: • Dan ir-rieżami ħares lejn ir-riżultati tal-prova miftuħa ‘GISSI Prevenzione' li twettqet fl-1999 li appoġġat l-awtorizzazzjoni inizjali ta' dawn il-mediċini, kif ukoll provi aktar kliniċi kkontrollati randomizzati aktar riċenti, studji retrospettivi ta' koorti u metaanaliżijiet.
English: • A review of all available data on omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) shows that these medicines are not effective at preventing further problems with the heart and blood vessels in patients who have had a heart attack.
Maltese: • Rieżami tad-data disponibbli kollha dwar il-mediċini aċidi grassi omega-3 li fihom kombinazzjoni ta' ester etiliku ta' ejkosapentenojku (EPA) u aċidu dokosaeżaenojku (DHA) juri li dawn il-mediċini mhumiex effettivi biex jipprevjenu aktar problemi bil-qalb u bil-vażijiet f'pazjenti li kellhom attakk tal-qalb.
English: This is the outcome of a re-examination requested by some of the companies that market the medicines concerned, following EMA's original recommendation in December 2018.
Maltese: Dan hu l-eżitu ta' rieżami mitlub minn xi wħud mill-kumpaniji li jqiegħdu fis-suq il-mediċini kkonċernati, b'segwitu tar-rakkomandazzjoni oriġinali tal-EMA f'Diċembru 2018.
English: 6 June 2019 EMA/328211/2019
Maltese: 6 ta' Ġunju 2019
English: • If you have any question or concern about omega-3 fatty acid medicines contact your treating doctor.
Maltese: • Jekk għandek xi mistoqsija jew tħassib dwar mediċini aċidi grassi omega-3 ikkuntattjat lit-tabib li qed jikkurak.
English: (injectable formulations)
Maltese: (formulazzjonijiet ta' injezzjoni)
English: Common side effects: Cancer (following long term treatment)
Maltese: Effetti sekondarji komuni: Kanċer (wara trattament fit-tul)
English: Paget's disease
Maltese: Il-marda ta' Paget
English: The effect of calcitonin may be monitored by measurement of suitable markers of bone remodelling, such as serum alkaline phosphatase or urinary hydroxyproline or deoxypyridinoline.
Maltese: Wieħed jista' jqis l-effett tal-calcitonin billi jitkejlu markaturi xierqa tar-rimudellar tal-għadam, bħalma huma serum alkaline phospatase jew il-hydroxyproline jew deoxypyridinoline urinarja.
English: Malignancy (with long term use), frequency: common
Maltese: Il-frekwenza ta' tumuri malinni (meta jkun hemm użu fit-tul): komuni
English: Due to evidence of an increased risk of malignancies and long term calcitonin use (see section 4.4), the treatment duration in all indications should be limited to the shortest period of time possible and using the minimum effective dose.
Maltese: Minħabba l-evidenza ta' żieda fir-riskju ta' tumuri malinni u użu fit-tul ta' calcitonin (ara sezzjoni 4.4), il-kura fit-tul fl-indikazzjonijiet kollha għandha tkun limitata għall-iqsar perjodu ta' żmien possibbli u għall-użu tad-doża minima effettiva.
English: For the treatment of high calcium levels: 100 IU every 6 to 8 hours, given into a muscle or into the tissue just under the skin.
Maltese: - Għat-trattament ta' livelli għolja ta' kalċju: 100 IU kull 6 sa 8 sigħat, mogħtija fil-muskolu jew fit-tessut eżatt ta' taħt il-ġilda.
English: daily at the start of remobilisation.
Maltese: IU kuljum fil-bidu tar-rimobilizzazzjoni.
English: For Paget's disease: 100 IU daily injected into a muscle or into the tissue just under the skin, normally for up to 3 months.
Maltese: - Il-marda ta' Paget: 100 IU kuljum injettati fil-muskolu jew fit-tessut eżatt ta' taħt il-ġilda, normalment sa 3 xhur.
English: These trials demonstrated an increase in the absolute risk of cancer occurrence for patients treated with calcitonin compared to placebo which varied between 0.7% and 2.
Maltese: Dawn il-provi wrew żieda fir-riskju assolut li jitfaċċa kanċer fost pazjenti ttrattati b'calcitonin meta mqabbel mal-plaċebo li kienet tvarja bejn 0.7% u 2.4% meta ngħatat terapija fit-tul.
English: In some cases, it may be given by injection into a vein.
Maltese: IU darbtejn kuljum mogħtija minn taħt ilġilda jew intramuskolarment.
English: daily or 50 I.U.
Maltese: Id-doża tista' tonqos għal 50
English: Analyses of randomised controlled trials conducted in patients with osteoarthritis and osteoporosis have shown that calcitonin is associated with a statistically significant increase in the risk of cancer compared to patients treated with placebo.
Maltese: Analiżi tal-provi kkontrollati fortuwit mwettqa fost pazjenti b'osteoartrite u osteoporożi wrew li calcitonin għandu rabta ma' żieda statistikament sinifikanti fir-riskju ta' kanċers imqabbel ma' pazjenti ttrattati bi plaċebo.
English: The dose may be reduced to 50 IU.
Maltese: Id-doża rrakkomandata hi ta' 100 IU kuljum jew ta' 50
English: Periodic re-treatment may be considered in these patients, and should take into account the potential benefits and evidence of an increased risk of malignancies and long term calcitonin use (see section
Maltese: Kura mill-ġdid perjodika tista' tiġi kkunsidrata f'dawn il-pazjenti, u għandha tqis il-benefiċċji potenzjali u l-evidenza ta' riskju miżjud ta' tumuri malinni u użu fit-tul ta' calcitonin (ara sezzjoni
English: per day administered subcutaneously or intramuscularly, however a minimum dosage regimen of 50 I.U.
Maltese: Id-doża rrakkomandata hi ta' 100 IU kuljum mogħtija minn taħt il-ġilda jew intramuskolarment, madanakollu doża minima ta' 50
English: Patients in these trials were treated with oral or intra-nasal formulations however it is likely that an increased risk also applies when calcitonin is administered subcutaneously, intramuscularly or intravenously especially for long-term use, as systemic exposure to calcitonin in such patients is expected to be higher than for other formulations.
Maltese: Madanakollu ma jidhirx li ż-żieda fir-riskju tgħodd ukoll meta calcitonin jingħata minn taħt il-ġilda, intramuskolarment jew mill-vina b'mod speċjali meta jkun hemm użu fit-tul, minħabba li hu mistenni li l-espożizzjoni sistemika għal calcitonin f'pazjenti bħal dawn tkun ogħla minn dik f'formulazzjonijiet oħrajn.
English: three times a week has achieved clinical and biochemical improvement.
Maltese: IU tliet darbiet fil-ġimgħa wasslet għal titjib kliniku u bijokimiku.
English: 4.8 Undesirable effects [the wording below should be inserted]
Maltese: .8 Effetti mhux mixtieqa [għandu jiddaħħal il-kliem li ġej]
English: Possible side effects [the wording below should be inserted]
Maltese: Effetti sekondarji possibbli [għandu jiddaħħal il-kliem li ġej]
English: In clinical trials, patients treated with calcitonin for osteoporosis and osteoarthritis have shown an increase in the risk of cancer following long term treatment.
Maltese: Waqt provi kliniċi, pazjenti ttrattati b'calcitonin minħabba osteoporożi u osteoartrite kellhom żieda fir-riskju ta' kanċer wara lgħoti ta' trattament fit-tul.
English: The recommended dosage is 100 I.U.
Maltese: - Għall-prevenzjoni ta' telfien ta' għadam: 100 IU kuljum jew 50
English: Annex III Amendments to the relevant sections of the summary of product characteristics and package leaflet
Maltese: Anness III Emendi għat-taqsimiet relevanti tas-sommarju tal-karatteristiċi talprodott u tal-fuljett ta' tagħrif
English: The usual doses are:
Maltese: Id-dożi tas-soltu huma:
English: - Treatment of high calcium levels in the blood (hypercalcaemia) due to cancer.
Maltese: - Trattament ta' livelli għolja ta' kalċju fid-demm (iperkalċemija) minħabba kanċer.
English: Take special care with <invented name>
Maltese: Oqgħod attent ħafna b'<isem ivvintat>
English: The full EPAR for Pregabalin Mylan 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: The maximum dose is 600 mg per day.
Maltese: ᾽ tiżdied għal 300 mg kuljum.
English: • generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: • disturb tal-ansjetà ġeneralizzat (ansjetà u nervi fit-tul dwar kwistjonijiet ta' kuljum).
English: • neuropathic pain (pain due to nerve damage), including peripheral neuropathic pain, such as the pain experienced by patients with diabetes or herpes zoster (shingles), and central neuropathic pain, such as the pain experienced by patients who have had a spinal cord injury;
Maltese: • uġigħ newropatiku (uġigħ dovut għal ħsara fin-nervituri) inkluż uġigħ newropatiku periferiku, bħal uġigħ esperjenzat minn pazjenti bid-dijabete jew li għandhom il-herpes zoster (
English: The active substance in Pregabalin Mylan, pregabalin, is similar in structure to the body's own ‘neurotransmitter' gamma‑amino butyric acid (GABA), but has very different biological effects.
Maltese: -pregabalin, hija simili fl-istruttura għall-aċidu butriku talgamma-amino (GABA) ‘newrotrażmettitur ᾽ tal
English: Pregabalin Mylan contains the active substance pregabalin.
Maltese: Pregabalin Mylan fih is-sustanza attiva pregabalin.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Lyrica, and do not need to be repeated for Pregabalin Mylan.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Lyrica, u ma għandhomx għalfejn jiġu ripetuti għal Pregabalin Mylan.
English: Pregabalin Mylan pregabalin
Maltese: Kif jintuża Pregabalin Mylan?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Mylan on 25 June 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Pregabalin Mylan fil-25 ta' Ġunju 2015.
English: Why is Pregabalin Mylan approved?
Maltese: Għaliex ġie approvat Pregabalin Mylan?
English: Pregabalin Mylan is a ‘generic medicine'.
Maltese: Pregabalin Mylan huwa ‘medi ċina ġenerika᾽.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara d-dokument ta
English: Other information about Pregabalin Mylan
Maltese: Informazzjoni oħra dwar Pregabalin Mylan
English: Neurotransmitters are chemicals that allow nerve cells to communicate with each other.
Maltese: In-newrotrażmettituri huma sustanzi kimiċi li jippermettu liċ-ċelloli tan-nervituri jikkomunikaw ma' xulxin.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pregabalin Mylan has been shown to have comparable quality and to be bioequivalent to Lyrica.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li, skont irrekwiżiti tal-UE, intwera li Pregabalin Mylan għandu kwalità komparabbli u huwa bijoekwivalenti għal Lyrica.
English: The Committee recommended that Pregabalin Mylan be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Pregabalin Mylan ikun approvat għall-użu fl-UE.
English: Pregabalin Mylan is available as capsules (25, 50, 75, 100, 150, 200, 225 and 300 mg) and can only be obtained with a prescription.
Maltese: -doża inizjali rakkomandata hija ta᾽ 150 mg kuljum, maqsuma f
English: This reduces the activity of some of the nerve cells in the brain and spinal cord, reducing the release of other neurotransmitters that are involved in epilepsy and anxiety.
Maltese: ᾽ newrotrażmett involuti fl-epilessija u l-ansjetà.
English: Therefore, the CHMP's view was that, as for Lyrica, the benefit outweighs the identified risk.
Maltese: -benefiċċji u r-riskji ta
English: Pregabalin Mylan is a medicine used to treat adults with the following conditions:
Maltese: Pregabalin Mylan huwa mediċina li tintuża għall-kura ta' adulti bil-kundizzjonijiet li ġejjin:
English: How has Pregabalin Mylan been studied?
Maltese: Kif ġie studjat Pregabalin Mylan?
English: Route of administration
Maltese: Mod ta` amministrazzj oni
English: --1 Live myxoma vectored rabbit haemorrhagic disease (RHD) virus: Strain 009: ≥103.0 and ≤105.8 FFU* Strain MK1899: ≥103.0 and ≤105.8 FFU* *Focus Forming Units
Maltese: --1 Strejn tal-virus ħaj myxoma vectored tal-marda emoraġika (RHD) tal-fniek:
English: Lyophilisate: 50 doses, solvent: 10 ml
Maltese: Lijofilizat: 50 dożi, solvent:
English: In cardboard box:
Maltese: F`kaxxi talkartun:
English: Immediate packaging
Maltese: Ippakjar immedjat
English: EU (MA) number
Maltese: EU (MA) numru Isem ivvintat
English: Content
Maltese: FFU*
English: Lyophilisate: 10 vials, In cardboard box:
Maltese: 10 fjali, F`kaxxi talkartun:
English: Solvent: 10 vials
Maltese: Solvent:
English: EMA/253404/2015 EMEA/H/C/000595
Maltese: EMEA/H/C/000595
English: The full EPAR for Aclasta 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: Aclasta zoledronic acid
Maltese: Aclasta aċidu zoledroniku
English: Other information about Aclasta:
Maltese: Informazzjoni oħra dwar Aclasta:
English: This summary was last updated in 04-2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'04-2015.
English: The European Commission granted a marketing authorisation valid throughout the EU for Aclasta on 15 April 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Aclasta fil-15 ta' April 2005.
English: Aclasta is given as an infusion lasting at least 15 minutes.
Maltese: Aclasta jingħata bħala infużjoni li ddum mill-inqas 15-il minuta.
English: The active substance in Aclasta, zoledronic acid, is a bisphosphonate.
Maltese: Is-sustanza attiva f'Aclasta, l-aċidu zoledroniku, hija bisfosfonat.
English: 13% of the patients receiving placebo (139 out of 1,062).
Maltese: Aclasta kellhom frattura (92 minn 1,065), meta mqabbla ma' 13% tal-pazjenti li rċevew il-plaċebo (139 minn 1,062).
English: This document is a summary of the European Public Assessment Report (EPAR) for Aclasta.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Aclasta.
English: What is Aclasta?
Maltese: X'inhu Aclasta?
English: After six months, around 96% of patients had responded to treatment in the two studies, compared with around 74% of the patients who received risedronate.
Maltese: Wara sitt xhur, madwar 96% talpazjenti rrispondew għall-kura fiż-żewġ studji, meta mqabbla ma' madwar 74% tal-pazjenti li ngħataw risedronat.
English: What is the risk associated with Aclasta?
Maltese: X'inhu r-riskju assoċjat ma' Aclasta?
English: Aclasta is a solution for infusion (drip) into a vein that contains the active substance zoledronic acid.
Maltese: Aclasta huwa soluzzjoni għal infużjoni (dripp) fil-vina li fih is-sustanza attiva aċidu zoledroniku.
English: Zoledronic acid has also been authorised in the European Union (EU) as Zometa since March 2001 for the prevention of bone complications in patients with cancer that is affecting the bone, and for the treatment of hypercalcaemia (high blood calcium levels) caused by tumours.
Maltese: L-aċidu żoledroniku ġie awtorizzat ukoll fl-Unjoni Ewropea (UE) bħala Zometa sa minn Marzu 2001 għall-prevenzjoni ta' kumplikazzjonijiet tal-għadam f'pazjenti bil-kanċer li qed jaffettwa l-għadam, u għall-kura taliperkalċemija (livelli għolja ta' kalċju fid-demm) ikkawzata minn tumuri.
English: For Paget's disease, Aclasta has been compared with risedronate in a total of 357 adults in two studies lasting six months.
Maltese: Għall-marda ta' Paget, Aclasta tqabbel ma' risefronat f'total ta' 357 adult f'żewġ studji li damu sitt xhur.
English: Using paracetamol or ibuprofen (anti-inflammatory medicines) shortly after Aclasta can reduce symptoms such as fever, muscle pain, influenza (flu)-like symptoms, joint pain and headache in the three days following the infusion.
Maltese: L-użu ta' paracetamol jew ibuprofen (mediċini antiinfjamamtorji) eżatt wara Aclasta jista' jnaqqas is-sintomi bħad-deni, l-uġigħ fil-muskoli, sintomi simili għal dawk tal-influwenza, uġigħ fil-ġogi u wġigħ ta' ras fit-tlett ijiem ta' wara l-infużjoni.
English: In osteoporosis, Aclasta was more effective than the comparator medicines.
Maltese: Fl-osteoporożi, Aclasta kien iktar effettiv mill-mediċini ta' tqabbil.
English: Why has Aclasta been approved?
Maltese: Għaliex ġie approvat Aclasta?
English: For osteoporosis, Aclasta has been studied in three main studies.
Maltese: Għall-osteoporożi, Aclasta ġie studjat fi tliet studji ewlenin.
English: The main measure of effectiveness was the number of patients who responded to treatment, defined as blood levels of serum alkaline phosphatase (an enzyme involved in the breakdown of bone) returning to normal or falling at least three-quarters of the way back to normal.
Maltese: Il-kejl ewlieni tal-effikaċja kien in-numru ta' pazjenti li rrispondew għall-kura, imfisser bħala livelli tad-demm ta' serum fosfatażi alkalina (enzima involuta fit-tifrik tal-għadam) li jiġi lura għannormal jew jaqa' għal mill-inqas tliet kwarti fil-proċess għan-normal.
English: Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported rarely (seen in between 1 and 10 patients in 10,000).
Maltese: Osteonekrożi tax-xedaq (ħsara lill-għadam taxxedaq, li tista' twassal għall-uġigħ, nefħiet fil-ħalq/ħalq misluħ jew telf tas-snien) kienet irrappurtata b'mod rari (dehret f'bejn pazjent 1 u 10 f'10,000).
English: How has Aclasta been studied?
Maltese: Kif ġie studjat Aclasta?
English: The first compared Aclasta with placebo (a dummy treatment) in almost 8,000 elderly women with osteoporosis, looking at the number of fractures in the spine and the hip over three years.
Maltese: L-ewwel studju qabbel Aclasta mal-plaċebo (kura finta) fi kważi 8,000 mara anzjana li kienu jbatu bl-osteoporożi, u ffoka fuq in-numru ta' fratturi fis-sinsla tad-dahar u l-ġenbejn fuq tliet snin.
English: In Paget's disease, Aclasta was more effective than risedronate.
Maltese: Fil-marda ta' Paget, Aclasta kien iktar effettiv minn risedronat.
English: In the study of elderly women, the risk of fractures in the spine was reduced by 70% in patients taking Aclasta (without any other medicines for osteoporosis) over three years when compared with those taking placebo.
Maltese: Fl-istudju tan-nisa anzjani, ir-riskju ta' fratturi fis-sinsla tad-dahar tnaqqas b'70% f'pazjenti li kienu qed jieħdu Aclasta (mingħajr mediċini oħra għall-osteoporożi) fuq perjodu ta' tliet snin meta mqabbla mal-pazjenti li kienu qed jieħdu lplaċebo.
English: What benefit has Aclasta shown during the studies?
Maltese: Liema benefiċċju wera Aclasta matul l-istudji?
English: A risk management plan has been developed to ensure that Aclasta is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Aclasta jintuża bl-aktar mod sigur possibbli.
English: The third compared one infusion of Aclasta with daily treatment with risedronate (another bisphosphonate) in 833 men and women with osteoporosis caused by glucocorticoids, and looked at the change in the density of the bones in the spine over a year.
Maltese: Aclasta ma għandux jintuża f'persuni ipersensittivi (allerġiċi) għall-aċidu zoledroniku, għal bisfosfonati oħra jew għal xi ingredjent ieħor tiegħu.
English: There was a 41% risk reduction in hip fractures, when comparing all women taking Aclasta (with or without other osteoporosis medicines) with those taking placebo.
Maltese: Kien hemm tnaqqis fir-riskju ta' 41% fil-fratturi tal-ġenbejn, meta tqabblu n-nisa kollha li kienu qed jieħdu Aclasta (flimkien ma' mediċini oħra għall-osteoporożi jew mingħajrhom) ma' dawk li kienu qed jieħdu l-plaċebo.
English: The company that makes Aclasta will provide educational packs in each Member State for doctors who prescribe Aclasta for osteoporosis, reminding them how the medicine should be used.
Maltese: Il-kumpanija li timmanifattura Aclasta se tipprovdi pakkett edukattiv f'kull Stat Membru għal tobba li jippreskrivu Aclasta għall-osteoporożi, fejn ifakkarhom kif għandha tintuża l-mediċina.