FrancophonIA/ELRC3.0 huggingface dataset:
English: The evidence of the efficacy of valproate in the treatment of bipolar disorder comes from sixteen randomised, comparative double-blind or open-label clinical trials.
Maltese: L-evidenza tal-effikaċja ta' valproate fit-trattament tad-disturb bipolari ġejja minn sittax-il prova klinika fortuwita, komparattiva bit-tikketta mgħottija jew mikxufa.
English: The MAHs should look into their respective safety databases and add the appropriate frequency of occurrence to the above additional adverse events.
Maltese: Il-MAHs għandhom jeżaminaw id-databases tassikurezza rispettivi tagħhom u jżidu l-frekwenza tal-okkorrenza xierqa mal-avvenimenti avversi addizzjonali msemmijin hawn fuq.
English: The MAHs for valproate authorised products who apply for the new indication should contact the national competent authorities (NCAs) of the respective member states in order to submit a Risk Management Plan.
Maltese: Il-MAHs għal prodotti awtorizzati li fihom valproate li japplikaw għall-indikazzjoni l-ġdida għandhom jikkuntattjaw lill-awtoritajiet kompetenti nazzjonali (AKNs) tal-Istati Membri rispettivi sabiex jissottomettu Pjan ta' Ġestjoni tar-Riskju.
English: The recommended initial daily dose is 750 mg.
Maltese: Id-doża rakkomandata tal-bidu hi ta' 750 mg kuljum.
English: In addition, in clinical trials a starting dose of 20 mg sodium valproate/kg body weight has also shown an acceptable safety profile.
Maltese: Flimkien ma' dan, fi provi kliniċi, doża tal-bidu ta' 20 mg ta' sodium valproate għal kull kg ta' piż tal-ġisem, uriet ukoll profil aċċettabbli ta' sigurtà.
English: The MAHs should update the Product Information to include the relevant sections as proposed by the CHMP regarding the proposed amended indication for the treatment of mania in bipolar disorder when lithium is contraindicated or not tolerated.
Maltese: Il-MAHs għandhom jaġġornaw l-Informazzjoni dwar il-Prodott sabiex tinkludi s-sezzjonijiet relevanti kif proposti mis-CHMP fir-rigward tal-indikazzjoni emendata proposta għat-trattament ta' manija f'disturb bipolari meta l-litju jkun kontraindikat jew mhux ittollerat.
English: The continuation of treatment after manic episode could be considered in patients who have responded to <valproate> for acute mania.
Maltese: Il-kontinwazzjoni tal-kura wara episodju ta' manija tista' tiġi kkunsidrata f'pazjenti li rrispondew għall-prodott mediċinali f'manija akuta.
English: The treatment of bipolar disorder includes management of the current mood episode and prevention of recurrence of next mood episodes.
Maltese: It-trattament tad-disturb bipolari jinkludi l-ġestjoni tal-episodju tal-burdata attwali u l-prevenzjoni tarrikorrenza tal-episodji tal-burdata li jmiss.
English: Breast feeding
Maltese: TAL-PRODOTT IPPREŻENTATI
English: To support the bipolar indication the MAHs submitted several published studies.
Maltese: Bħala appoġġ għall-indikazzjoni bipolari, il-MAHs issottomettew bosta studji ppubblikati.
English: Valproate is a well-known anti-epileptic substance.
Maltese: Valproate huwa antiepilettiku magħruf ħafna.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for <active substance>.
Maltese: Il-mekkaniżmu ta' dan ir-riskju mhuwiex magħruf u d-dejta disponibbli ma teskludix il-possibbiltà ta' żieda fir-riskju għal <sustanza attiva>.
English: Whereas the Bowden study which was lithium- and placebo- controlled failed to show a statistically significant difference with respect to the primary outcome criterion (time to recurrence of any mood episode), patients treated with valproate had better outcomes on several secondary outcome measures than those treated with lithium or placebo.
Maltese: L-evidenza tal-effikaċja ta' valproate fil-prevenzjoni tal-episodji tal-burdata għalhekk mhijiex kompletament konvinċenti fuq ilbażi tal-istudji kliniċi mwettqa biss.
English: Ulm, Germany
Maltese: Mnjen jingħata
English: Mean daily dose The recommended daily doses usually range between 1000 mg and 2000 mg.
Maltese: Id-dożi rakkomandati ta' kuljum normalment ivarjaw bejn bejn 1000 mg u 2000 mg.
English: Risk Management Plan
Maltese: SOMMARJU GLOBALI
English: Your doctor will determine the exact dose required on an individual basis.
Maltese: Id-dożaġġ ta' kuljum għandu jiġi stabbilit u kkontrollat individwalment mit-tabib kuranti.
English: Rua Quinta do PinheiroEdifício Tejo 6° Piso Carnaxide P-2790-143 Portugal
Maltese: Dawn l-istudji kienu jinkludu kważi 2,500 pazjent, li minnhom aktar minn 1,400 irċevew valproate.
English: 4.6 Pregnancy and lactation
Maltese: 4.6 TQALA
English: As a consequence,the CHMP has recommended the granting of the variation for which the Summary of Product Characteristics and Package Leaflet is set out in Annex III for Valproate-ratiopharm chrono 300/500 mg Retardtabletten and associated names (see Annex I).
Maltese: B'konsegwenza t'hekk, is-CHMP irrakkomanda l-għoti tal-varjazzjoni li s-Sommarju tal-Karatteristiċi tal-Prodott u l-Fuljett ta' Tagħrif għaliha huma stabbiliti fl-Anness III għal Valproate-ratiopharm chrono 300/500 mg Retardtabletten u l-ismijiet assoċjati (ara l-Anness I).
English: * International units per ml of rabbit serum determined by haemolysis inhibition assay
Maltese: * Unitajiet internazzjonali għall-kull ml ta'serum tal-fenek kif determinat minn assay tal- inħibizzjoni tal-ħimolżi
English: Content Package size Withdrawal period
Maltese: Kontenut Daqs talpakett
English: 500ml 6 bottles
Maltese: 6 fliexken Xejn Granet
English: 500ml 1 bottle
Maltese: 1 flixkun Xejn Granet
English: Medicinal product no longer authorised
Maltese: Prodott mediċinali li m'għadux awtorizzat ta'amministrazzjoni
English: Aclasta (N=3,875) event rate
Maltese: Aclasta (N=3,875) rata tal-każ
English: Unopened bottle: 3 years
Maltese: Flixkun mhux miftuħ: 3 snin
English: Multipack
Maltese: Pakkett multiplu
English: Aclasta contains sodium
Maltese: Aclasta fih sodium
English: The most commonly reported adverse reactions after infusion of zoledronic acid were arthralgia (28%), pyrexia (22%), vomiting (22%), headache (22%), nausea (17%), myalgia (17%), pain (17%), diarrhoea (11%) and hypocalcaemia (11%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati wara l-infużjoni ta' zoledronic acid kienu artralġja (28%), deni (22%), rimettar (22%), uġigħ ta' ras (22%), dardir (17%), mjalġja (17%), uġigħ (17%), dijarea (11%) u ipokalċemija (11%).
English: Frequency categories are defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Maltese: Kategoriji tal-frekwenza huma ddefiniti bl-użu tal-konvenzjoni li jmiss: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli.
English: Cockcroft-Gault formula before each Aclasta dose.
Maltese: Cockcroft-Gault qabel kull doża ta' Aclasta.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class and frequency category.
Maltese: Ir-reazzjonijiet avversi f'Tabella 1 huma mniżżla skont is-sistema MedDRA ta' klassifikazzjoni talorgani u tal-kategorija ta' frekwenza.
English: Aclasta (N=1,065) event rate
Maltese: Aclasta (N=1,065) rata tal-każ
English: This corresponds to a 28% reduction in the risk of all cause mortality (p=0.01).
Maltese: Dan jikkorrispondi għal tnaqqis ta' 28% firriskju ta' mortalità mill-kawżi kollha (p=0.01).
English: The incidence of delayed hip fracture healing was comparable between Aclasta (34 [3.2%]) and placebo (29 [2.7%]).
Maltese: L-inċidenza ta' dewmien fil-fejqan ta' fratturi fil-ġenbejn kienet komparabbli bejn Aclasta (34 [3.2%]) u l-plaċebo (29 [2.7%]).
English: After 6 months, Aclasta showed 96% (169/176) and 89% (156/176) response and serum alkaline phosphatase (SAP) normalisation rates compared to 74% (127/171) and 58% (99/171) for risedronate (all p<0.001).
Maltese: Aclasta wriet rati ta' rispons u ta' treġġigħ lura għan-normal tas-serum alkaline phosphatase (SAP) ta' 96% (169/176) u 89% (156/176) mqabbla ma' 74% (127/171) u 58% (99/171) għal risedronate (kollha kellhom p<0.
English: Five of the 6 patients had SAP within the normal range at month 6 (Last Observation Carried Forward, LOCF).
Maltese: Ħamsa mis-6 pazjenti kellhom SAP filmedda normali fis-6 xahar (L-Aħħar Osservazzjoni Rrappurtata, LOCF).
English: Aclasta 5 mg solution for infusion zoledronic acid
Maltese: Aclasta 5 mg soluzzjoni għall-infużjoni zoledronic acid
English: Placebo (N=1,062) event rate
Maltese: Plaċebo (N=1,062) rata tal-każ
English: Date of first authorisation: 15 April 2005 Date of latest renewal: 19 January 2015
Maltese: Data tal-aħħar tiġdid: 19 ta' Jannar 2015
English: Placebo (N=3,861) event rate
Maltese: Plaċebo (N=3,861) rata tal-każ
English: Aclasta demonstrated a consistent effect over 3 years, resulting in a 41% reduction in the risk of hip fractures (95% CI, 17% to 58%).
Maltese: Aclasta wera effett b'mod konsistenti fuq 3 snin, li wassal għal tnaqqis ta' 41% fir-riskju ta' fratturi fil-ġenbejn (95% CI, 17% sa 58%).
English: (CI)
Maltese: A.
English: Mannitol, sodium citrate and water for injections.
Maltese: Mannitol, sodium citrate u ilma għall-injezzjonijiet.
English: 1 bottle of 100 ml
Maltese: Flixkun 1 ta'100 ml
English: • Key signs and symptoms of serious adverse reactions
Maltese: • Is-sinjali u s-sintomi essenzjali ta' reazzjonijiet avversi serji
English: The Aclasta group revealed approximately 2.5 mm less height loss compared to placebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
Maltese: Il-grupp fuq Aclasta wera madwar 2.5 mm anqas telf fit-tul meta mqabbel mal-plaċebo (95% CI: 1.6 mm, 3.5 mm) [p<0.0001].
English: Other products containing zoledronic acid as an active substance are available for oncology indications.
Maltese: Prodotti oħra li fihom zoledronic acid bħala sustanza attiva huma disponibbli għal indikazzjonijiet onkoloġiċi.
English: Incidence of individual adverse reactions following the first infusion was: pyrexia (17.1%), myalgia (7.8%), influenza-like illness (6.7%), arthralgia (4.8%) and headache (5.1%).
Maltese: L-inċidenza ta' reazzjonijiet avversi individwali wara l-ewwel infużjoni kienu: deni (17.1%), majalġja (7.8%), mard li jixbaħ lill-influwenza (6.7%), artralġja (4.8%) u uġigħ ta' ras (5.1%).
English: CARTON FOR INTERMEDIATE PACK (WITHOUT BLUE BOX)
Maltese: KARTUNA GĦALL-PAKKETT INTERMEDJU (MINGĦAJR KAXXA BLU)
English: What Aclasta contains - The active substance is zoledronic acid.
Maltese: X'fih Aclasta - Is-sustanza attiva hi zoledronic acid.
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving Aclasta and placebo, respectively.
Maltese: Fil-istudju HORIZON - Prova Pivitali dwar il-Ksur [PFT - Pivotal Fracture Trial] (ara sezzjoni 5.1), l-inċidenza globali ta' fibrillazzjoni atrijali kienet 2.5% (96 minn 3,862) u 1.9% (75 minn 3,852) f'pazjenti li kienu qed jirċievu Aclasta u plaċebo, rispettivament.
English: Atrial fibrillation
Maltese: Fibrillazzjoni tal-atriju
English: Zoledronic acid is not highly bound to plasma proteins (approximately 43-55% bound) and interactions resulting from displacement of highly protein-bound medicinal products are therefore unlikely.
Maltese: Zoledronic acid ma jingħaqadx bil-qawwa mal-proteini tal-plażma (madwar 43-55% jingħaqad) u għaldaqstant nuqqas ta' qbil li jirriżulta minn qlugħ ta' prodotti mediċinali li jkunu marbutin mal-proteini mhuwiex probabbli.
English: Non-vertebral fracture (1) *p-value <0.05, **p-value <0.01 (1) Excluding finger, toe and facial fractures (2) Including clinical thoracic and clinical lumbar vertebral fractures
Maltese: Frattura mhux tal-irkiekel (1) *valur-p <0.05, **valur-p <0.01 (1) Esklużi fratturi fis-swaba' tal-idejn, saqajn u fratturi fil-wiċċ (2) Inklużi fratturi kliniċi fl-irkiekel fit-toraċi u dawk kliniċi fil-lumbari
English: Small observed increases in AUC(0-24hr), by about 30% to 40% in mild to moderate renal impairment, compared to a patient with normal renal function, and lack of accumulation of drug with multiple doses irrespective of renal function, suggest that dose adjustments of zoledronic acid in mild (Clcr = 50-80 ml/min) and moderate renal impairment down to a creatinine clearance of 35 ml/min are not necessary.
Maltese: Żidiet żgħar fl-AUC(0-24hr), b'madwar 30% sa 40% fl-indeboliment tal-kliewi ħafif għal moderat, imqabbel ma' pazjent b'funzjoni renali normali, u nuqqas ta' akkumulu tal-mediċina b'dożi multipli irrispettivament mill-funzjoni renali, jissuġġerixxu li tibdil fid-dożi ta' zoledronic acid f'pazjenti li għandhom indeboliment renali ħafif (Clcr = 50-80 ml/min) u moderat sakemm it-tneħħija tal-kreatinina tinżel għal 35 ml/min mhux neċessarju.
English: Therefore, interactions resulting from displacement of highly protein-bound medicinal products are unlikely.
Maltese: Għaldaqstant, nuqqas ta' qbil minħabba qlugħ ta' prodotti mediċinali li jintrabtu ħafna mal-proteini mhuwiex probabbli.
English: - Severe renal impairment with creatinine clearance < 35 ml/min (see section 4.4).
Maltese: Indeboliment renali sever bi tneħħija tal-kreatinina < 35 ml/min (ara sezzjoni 4.4).
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ 0.24 and t½ 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½ 146 hours.
Maltese: Zoledronic acid mogħti ġol-vina jiġi eliminat minn proċess ta' tliet fażijiet: l-għajbien mgħaġġel miċċirkolazzjoni sistemika f'żewġ fażijiet, b'half-lives ta' t½ 0.24 u t½ 1.87 sigħat, segwit b'fażi twila ta' eliminazzjoni b'half-life terminali ta' eliminazzjoni ta' t½ 146 siegħa.
English: - Patients with hypocalcaemia (see section 4.4).
Maltese: Pazjenti f'ipokalċimija (ara sezzjoni 4.4).
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction)
Maltese: Rari ħafna Osteonekrożi tal-kanal estern tas-smigħ (reazzjoni avversa għall-klassi bifosfonati)
English: Aclasta significantly increased BMD at the lumbar spine, hip, and distal radius relative to treatment with placebo at all timepoints (6, 12, 24 and 36 months).
Maltese: Aclasta żiedet b'mod sinifikanti l-BMD fis-sinsla lumbari, fil-ġenbejn u fid-distal radius meta mqabbel mal-kura bil-plaċebo fit-timepoints kollha (6, 12, 24 u 36 xhur).
English: Vitamin D levels were not routinely measured but a loading dose of vitamin D (50,000 to 125,000 IU orally or by intramuscular route) was given to the majority of patients 2 weeks prior to infusion.
Maltese: Il-livelli tal-vitamina D ma ġewx imkejla b'mod regolari iżda ngħatat loading dose ta' vitamina D (50,000 sa 125,000
English: Flu, upper respiratory tract infections, decreased red cell count, loss of appetite, sleeplessness, sleepiness which may include reduced alertness and awareness, tingling sensation or numbness, extreme tiredness, trembling, temporary loss of consciousness, eye infection or irritation or inflammation with pain and redness, spinning sensation, increased blood pressure, flushing, cough, shortness of breath, upset stomach, abdominal pain, constipation, dry mouth, heartburn, skin rash, excessive sweating, itching, skin reddening, neck pain, stiffness in muscles, bones and/or joints, joint swelling, muscle spasms, shoulder pain, pain in your chest muscles and rib cage, joint inflammation, muscular weakness, abnormal kidney test results, abnormal frequent urination, swelling of hands, ankles or feet, thirst, toothache, taste disturbances.
Maltese: Influwenza, infezzjonijiet fin-naħa ta' fuq tal-apparat tan-nifs, tnaqqis fl-għadd taċ-ċelluli ħomor, telf ta' aptit, nuqqas ta' rqad, xejra ta' ngħas li tista' tinkludi li tkun anqas ilvent u konxju ta' x'qed jiġri, sensazzjoni ta' tnemnim jew titrix, għeja estrema, tregħid, tintilef minn sensik temporanjament, infezzjoni jew irritazzjoni jew infjammazzjoni fl-għajn bl-uġigħ u l-ħmura, tħoss kollox idur bik, żieda fil-pressjoni fid-demm, fwawar, sogħla, qtugħ ta' nifs, stonku mqalleb, uġigħ fl-addome, stitikezza, ħalq xott, ħruq ta' stonku, raxx fil-ġilda, għaraq żejjed, ħakk, ħmura fil-ġilda, uġigħ fl-għonq, ebusija fil-muskoli, fl-għadam u/jew fil-ġogi, nefħa fil-ġogi, spażmi fil-muskoli, uġigħ fl-ispalla, uġigħ filmuskoli ta' sidrek jew fil-qafas ta' sidrek, infjammazzjoni fil-ġogi, dgħjufija fil-muskoli, riżultati tattestijiet tal-kliewi mhux normali, tgħaddi l-awrina b'mod frekwenti mhux normali, nefħa tal-idejn, lgħekiesi jew is-saqajn, għatx, uġigħ tas-snien, tibdil fis-sens tat-togħma.
English: Table 2 Summary of vertebral fracture efficacy at 12, 24 and 36 months
Maltese: Tabella 2 Sommarju tal-effikaċja fuq il-fratturi tal-irkiekel mat-12, 24 u 36 xahar
English: Aclasta 5 mg solution for infusion
Maltese: Aclasta 5 mg soluzzjoni għall-infużjoni
English: Zoledronic acid infusion resulted in an increase in the lumbar spine BMD Z-score least square (LS) mean difference of 0.41 at month 12 relative to baseline compared to placebo (95% CI: 0.02, 0.81;
Maltese: L-infużjoni ta' zoledronic acid wasslet għal żieda fid-differenza medja tal-least square (LS) talpunteġġ Z tal-BMD tal-ispina lumbari ta' 0.41 fit-12-il xahar relattiv għal-linja bażi mqabbel malplaċebo (95% CI: 0.02, 0.81; 18 u 16-il pazjent, rispettivament).
English: EXP After opening: 24 hours at 2°C - 8°C.
Maltese: JIS Wara li jinfetaħ: 24 siegħa f'2°C - 8°C.
English: Aclasta contains the active substance zoledronic acid.
Maltese: Aclasta fiha s-sustanza attiva zoeldronic acid.
English: The efficacy and safety of Aclasta in the treatment and prevention of osteoporosis associated with long-term systemic glucocorticoid therapy were assessed in a randomised, multicentre, double-blind, stratified, active-controlled study of 833 men and women aged 18-85 years (mean age for men 56.4 years; for women 53.5 years) treated with > 7.5 mg/day oral prednisone (or equivalent).
Maltese: L-effikaċja u s-sigurtà ta' Aclasta fil-kura u l-prevenzjoni tal-osteoporożi assoċjata mal-kura sistemika bi glukokortikojdi għal perjodu twil ta' żmien kienu stmati fi studju randomised, multiċentriku, double-blind, stratifikat, u kkontrollat b'mod attiv ta' 833 raġel u mara li għandhom bejn it-18 u l-85 sena (età medja għall-irġiel 56.4 snin; għan-nisa 53.5 snin) ikkurati b' > 7.5 mg/kuljum ta' prednisone mill-ħalq (jew ekwivalenti).
English: 100 ml solution in a transparent plastic (cycloolefinic polymer) bottle closed with a fluoro-polymer coated bromobutyl rubber stopper and an aluminium/polypropylene cap with a flip component.
Maltese: Flixkun b'soluzzjoni ta' 100 ml tal-plastik trasparenti (polimeru cycloolefinic) magħluq b'tapp talgomma bromobutyl miksi b'flworopolimeru u għatu ta' aluminju/polypropylene b'komponent li tiftħu b'saba.
English: Treatment with Aclasta resulted in a 6.7% increase in BMD at the lumbar spine, 6.0% at the total hip, 5.1% at the femoral neck, and 3.2% at the distal radius over 3 years as compared to placebo.
Maltese: Il-kura b'Aclasta wasslet għal żieda ta' 6.7% fil-BMD fis-sinsla lumbari, 6.0% tal-ġenb totali, 5.1% fl-għonq femorali, u 3.2% fid-distal radius fuq 3 snin meta mqabbla mal-plaċebo.
English: After opening: 24 hours at 2°C - 8°C
Maltese: Wara li jinfetaħ: 24 siegħa f'2°C - 8°C
English: This is especially important in patients who take diuretics (“water pills”) and in elderly patients (age 65 years or over).
Maltese: Dan hu l-aktar importanti għall-pazjenti li jieħdu d-dijuretiċi (“pilloli tal-ilma”) u għall-pazjenti anzjani (età ta' 65 sena jew aktar).
English: For information on the infusion of Aclasta, see section 6.6.
Maltese: Għal aktar tagħrif dwar l-infużjoni ta' Aclasta, ara sezzjoni 6.6.
English: More patients reported serious adverse events in the zoledronic acid group than in the placebo group (5 [27.8%] patients versus 1 [6.3%] patient).
Maltese: Kien hemm aktar pazjenti li rrappurtaw episodji avversi serji fil-grupp mogħti z-zoledronic acid milli fil-grupp mogħti l-plaċebo (5 [27.8%] pazjenti kontra pazjent 1 [6.3%]).
English: Uncommon Decreased appetite Rare
Maltese: Mhux komuni Tnaqqis fl-aptit Rari
English: In the HORIZON-RFT study 508 men were randomised into the study and 185 patients had BMD assessed at 24 months.
Maltese: Fl-istudju HORIZON-RFT, 508 irġiel ġew randomised fl-istudju u 185 pazjent kellhom il-BMD tagħhom imkejjel wara 24 xahar.
English: The risk reduction was 51% in bisphosphonate-naïve patients and 42% in patients allowed to take concomitant osteoporosis therapy.
Maltese: It-tnaqqis firriskju kien ta' 51% fil-pazjenti li ma ħadux bisphosphone u 42% fil-pazjenti li tħallew jieħdu terapija konkomitanti għall-osteoporożi.
English: - Pregnancy and breast-feeding (see section 4.6).
Maltese: Tqala u t-treddigħ (ara sezzjoni 4.6).
English: The incidence of fractures was 8 for Aclasta-treated patients versus 7 for risedronate-treated patients (p=0.8055).
Maltese: L-inċidenza ta' ksur kienet 8 għal pazjenti kkurati b'Aclasta versus 7 għal pazjenti kkurati b'risedronate-(p=0.8055).
English: Clinical efficacy in the treatment of post-menopausal osteoporosis (PFT)
Maltese: L-effikaċja klinika tal-kura tal-osteoporożi ta' wara l-menopawża (PFT)
English: Aclasta significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01).
Maltese: Aclasta naqqas b'mod sinifikanti l-medja tal-jiem ta' attività limitata u l-jiem ta' serħan ġos-sodda minħabba uġigħ tad-dahar b'17.9 jiem u 11.3 jiem rispettivament meta mqabbla mal-plaċebo u naqqas b'mod sinifikanti l-medja ta' ġranet ta' attività limitata u l-ġranet ta' serħan ġos-sodda minħabba fratturi b'2.9 jiem u 0.5 jiem rispettivament meta mqabbla mal-plaċebo (kollha p<0.01).
English: The efficacy and safety of Aclasta 5 mg once a year for 3 consecutive years were demonstrated in post-menopausal women (7,736 women aged 65-89 years) with either: a femoral neck bone mineral density (BMD) with a T-score ≤ -1.5 and at least two mild or one moderate existing vertebral fracture(s); or a femoral neck BMD T-score ≤ -2.5 with or without evidence of existing vertebral fracture(s).
Maltese: L-effikaċja u s-sigurtà ta' Aclasta 5 mg darba fis-sena għal tliet snin konsekuttivi ntwerew f'nisa ta' wara l-menopawża (7,736 mara ta' etajiet bejn 65-89 sena) b'densità minerali tal-għadam tal-għonq femorali (BMD) bil-punteġġ-T ≤ -1.5 u almenu żewġ fratturi fl-irkiekel ħfief jew jekk ikun hemm frattura(i) tal-irkiekel waħda moderata; jew inkella BMD tal-għonq femorali bil-punteġġ-T ≤ -2.5 b'evidenza ta' frattura(i) fl-irkiekel jew mingħajrha. 85% tal-pazjenti qatt ma kienu ħadu kura b'bisphosphonate.
English: Limited data on re-treatment of Paget's disease are available (see section 5.1).
Maltese: Teżisti informazzjoni limitata dwar trattament mill-ġdid tal-marda ta' Paget (ara sezzjoni 5.1).
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75  33% of the creatinine clearance, which showed a mean of 84  29 ml/min (range 22 to 143 ml/min) in the 64 patients studied.
Maltese: It-tneħħija renali ta' zoledronic acid kienet relatata mat-tneħħija tal-kreatinina, fejn it-tneħħija millkliewi kienet tirrappreżenta 75  33% tat-tneħħija tal-kreatinina, li wriet medja ta' 84  29 ml/min (medda minn 22 sa 143 ml/min) fl-64 pazjent li kien studjat.
English: In the osteoporosis trials (PFT, HORIZON - Recurrent Fracture Trial [RFT]) the pooled atrial fibrillation incidences were comparable between Aclasta (2.6%) and placebo (2.1%).
Maltese: Fil-provi dwar l-osteoporożi (PFT, HORIZON - Prova dwar il-ksur Rikorrenti [RFT - Recurrent Fracture Trial]) l-inċidenza tal-każijiet ta' fibrillazzjoni flatrija miġbura flimkien kienu jaqblu bejn Aclasta (2.6%) u l-plaċebo (2.1%).
English: Uncommon Conjunctivitis, eye pain Rare
Maltese: Mhux komuni Konġunktivite, uġigħ fl-għajnejn Rari