FrancophonIA/ELRC3.0 huggingface dataset:
English: Vimpat solution for infusion can be administered without further dilution, or may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml (5 %) or lactated Ringer's solution.
Maltese: Is-soluzzjoni għall-infużjoni Vimpat jista' jittieħed mingħajr ma jiġi dilwit aktar, jew jista' jiġi dilwit b'dawn is-soluzzjonijiet li ġejjin: sodium chloride 9 mg/ml (0.9 %), glucose 50 mg/ml jew soluzzjoni lactated Ringer's.
English: Sodium (salt): This medicine contains 1.42 mg sodium (main component of cooking/table salt) in each ml.
Maltese: • Sodju (melħ): Din il-mediċina fiha 1.42 mg sodium (il-komponent ewlieni tal-melħ tat-tisjir/talmejda) f'kull mL.
English: Sorbitol (a type of sugar): This medicine contains 187 mg sorbitol in each ml.
Maltese: Din il-mediċina fiha 187 mg sorbitol f'kull mL.
English: Glycerol (E422)
Maltese: • Propylene glycol (E1520):
English: Taking Vimpat with other antiepileptic medicines - Children above 4 years of age weighing less than 20 kg - This is for information only.
Maltese: Meta tuża Vimpat ma' mediċini ta' kontra l-epilessija oħra - Tfal ta' età 'l fuq minn 4 snin li jiżnu inqas minn 20 kg - Din hija għal skopijiet ta' informazzjoni biss.
English: Pinkish, oval film-coated tablets with approximate dimensions of 10.4 mm x 4.9 mm, and debossed with ‘SP' on one side and ‘50' on the other side.
Maltese: 4 mm x 4.9 mm, u mnaqqxin b'‘SP' imnaqqxa fuq naħa waħda u ‘50' fuq in-naħa l-oħra.
English: The treatment initiation pack contains 4 cartons, each carton with 14 Vimpat film-coated tablets of 50 mg, 100 mg, 150 mg and 200 mg.
Maltese: Il-pakkett tal-bidu tat-trattament fih 4 kaxxi, kull kaxxa b'14-il pillola Vimpat miksija b'rita ta'50 mg, 100 mg, 150 mg u 200 mg.
English: Vimpat 200 mg film-coated tablets lacosamide
Maltese: Vimpat 200 mg pilloli miksija b'rita lacosamide
English: Name and address of the manufacturer responsible for batch release Aesica Pharmaceuticals GmbH or
Maltese: Aesica Pharmaceuticals GmbH jew UCB Pharma S.A.
English: EU/1/08/470/010 14 film-coated tablets EU/1/08/470/011 56 film-coated tablets EU/1/08/470/023 56 x 1 film-coated tablet EU/1/08/470/030 14 x 1 film-coated tablet EU/1/08/470/031 28 film-coated tablets EU/1/08/470/035 60 film-coated tablets
Maltese: EU/1/08/470/010 14 pilloli miksija b'rita EU/1/08/470/011 56 pilloli miksija b'rita EU/1/08/470/023 56 x 1 pillola miksija b'rita EU/1/08/470/030 56 x 1 pillola miksija b'rita EU/1/08/470/031 28 pilloli miksija b'rita EU/1/08/470/035 60 pillola miksija b'rita
English: (1) children and adolescents less than 50 kg should preferably start the treatment with Vimpat 10 mg/ml syrup (2) Dosage in adolescents 50 kg or more is the same as in adults.
Maltese: 9 ml (90 mg) (1) Tfal u adoloxxenti inqas minn 50 kg għandhom preferibbilment jibdew it-trattament b'Vimpat 10 mg/ml mistura.
English: Vimpat 150 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Maltese: Vimpat 150 mg <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 56 x 1 u 14 x 1 pillola miksija b'rita
English: Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Vimpat 50 mg film-coated tablets
Maltese: Pakkett tal-bidu tat-trattament (f'adoloxxenti u tfal li jiżnu 50 kg jew aktar u adulti biss) Vimpat 50 mg pilloli miksija b'rita
English: In juvenile rats, a reduced body weight was observed at systemic exposure levels similar to the expected clinical exposure.
Maltese: F'firien ġuvenili, ġie osservat piż tal-ġisem imnaqqas f'livelli ta' esponiment sistemiku simili għall-esponiment kliniku mistenni.
English: If you are taking Vimpat and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).
Maltese: Jekk qed tieħu Vimpat u qed tesperjenza sintomi ta' taħbit tal-qalb mhux normali (bħal taħbit tal-qalb bil-mod, mgħaġġel jew irregolari, palpitazzjonijiet, qtugħ ta' nifs, tħossok sturdut/a, ħass ħażin) fittex parir mediku immedjatament (ara sezzjoni 4).
English: Acesulfame potassium (E950)
Maltese: • Aspartame (E951):
English: The usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
Maltese: Id-doża tal-bidu li normalment tingħata hija ta' 1 mg (0.1 ml), għal kull kilogramma (kg) tal-piż talġisem, darbtejn kuljum.
English: Vimpat 50 mg film-coated tablets lacosamide
Maltese: Vimpat 50 mg pilloli miksija b'rita lacosamide
English: Muscle spasms
Maltese: Kif tuża Vimpat
English: Pharmasud Ltd. Tel: + 356 / 21 37 64 36
Maltese: Tel: + 356 / 21 37 64 36
English: Swallow the Vimpat tablet with a glass of water.
Maltese: • Ibla' l-pillola Vimpat b'tazza ilma.
English: EU/1/08/470/004 14 film-coated tablets EU/1/08/470/005 56 film-coated tablets EU/1/08/470/006 168 film-coated tablets EU/1/08/470/021 56 x 1 film-coated tablet EU/1/08/470/026 14 x 1 film-coated tablet EU/1/08/470/027 28 film-coated tablets EU/1/08/470/033 60 film-coated tablets
Maltese: EU/1/08/470/004 14 pilloli miksija b'rita EU/1/08/470/005 56 pilloli miksija b'rita EU/1/08/470/006 168 pilloli miksija b'rita EU/1/08/470/021 56 x 1 pillola miksija b'rita EU/1/08/470/026 14 x 1 pillola miksija b'rita EU/1/08/470/027 28 pilloli miksija b'rita EU/1/08/470/033 60 pillola miksija b'rita
English: Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Maltese: Vimpat huwa indikat bħala monoterapija u terapija miżjuda fit-trattament ta' aċċessjonijiet tat-tip ‘partial-onset' kemm b'ġeneralizzazzjoni sekondarja kif ukoll mingħajr, f'adulti, adoloxxenti u tfal mill-età ta' 4 snin b'epilessija.
English: Vimpat 150 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
Maltese: Vimpat 150 mg pilloli miksijin b'rita polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172) Vimpat 200 mg pilloli miksijin b'rita polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) indigo carmine aluminium lake (E132)
English: Vimpat solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or PVC bags at temperatures up to 25°C.
Maltese: Vimpat soluzzjoni għall-infużjoni instab li kien fiżikament kompatibli u stabbli kimikament meta mħallat ma dawn id-dilwenti li ġejjin għal mill-inqas 24 siegħa u maħżuna fil-ħġieġ jew basket talPVC f'temperaturi sa 25ºC.
English: Diplopia Vision blurred
Maltese: Għalxiex jintuża Vimpat
English: EU/1/08/470/001 14 film-coated tablets EU/1/08/470/002 56 film-coated tablets EU/1/08/470/003 168 film-coated tablets EU/1/08/470/020 56 x 1 film-coated tablet EU/1/08/470/024 14 x 1 film-coated tablet EU/1/08/470/025 28 film-coated tablets EU/1/08/470/032 60 film-coated tablets
Maltese: EU/1/08/470/001 14 pilloli miksija b'rita EU/1/08/470/002 56 pilloli miksija b'rita EU/1/08/470/003 168 pilloli miksija b'rita EU/1/08/470/020 56 x 1 pillola miksija b'rita EU/1/08/470/024 14 x 1 pillola miksija b'rita EU/1/08/470/025 28 pilloli miksija b'rita EU/1/08/470/032 60 pillola miksija b'rita
English: 56 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 56 pilloli miksija b'rita.
English: Each graduation mark (5 ml) of the 30 ml measuring cup corresponds to 50 mg of lacosamide (for example 2 graduation marks correspond to 100 mg).
Maltese: Kull marka ta' kejl (5 ml) tat-tazza ta' kejl tikkorrispondi għal 50 g lacosamide (pereżempju 2 marki ta' kejl jikkorrispondu għal 100 mg).
English: Vimpat 200 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Maltese: Vimpat 200 mg <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 56 x 1 u 14 x 1 pillola miksija b'rita
English: Slovenská republika UCB s.r.o., organizačná zložka
Maltese: Slovenská republika UCB s.r.o., organizačná zložka Tel: + 421 (0)
English: Vimpat 100 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Maltese: Vimpat 100 mg <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 56 x 1 u 14 x 1 pillola miksija b'rita
English: The carton boxes of Vimpat syrup contain a 30 ml measuring cup with graduation marks and a 10 ml oral syringe.
Maltese: Il-kaxxi tal-kartun tal-mistura Vimpat fihom tazza tal-kejl bil-marki ta' kejl u siringa orali ta' 10 ml.
English: Vimpat 50 mg film-coated tablets Vimpat 100 mg film-coated tablets Vimpat 150 mg film-coated tablets Vimpat 200 mg film-coated tablets lacosamide
Maltese: Vimpat 50 mg pilloli miksija b'rita Vimpat 100 mg pilloli miksija b'rita Vimpat 150 mg pilloli miksija b'rita Vimpat 200 mg pilloli pilloli miksija b'rita lacosamide
English: EU/1/08/470/007 14 film-coated tablets EU/1/08/470/008 56 film-coated tablets EU/1/08/470/022 56 x 1 film-coated tablet EU/1/08/470/028 14 x 1 film-coated tablet EU/1/08/470/029 28 film-coated tablets EU/1/08/470/034 60 film-coated tablets
Maltese: EU/1/08/470/007 14 pilloli miksija b'rita EU/1/08/470/008 56 pilloli miksija b'rita EU/1/08/470/022 56 x 1 pillola miksija b'rita EU/1/08/470/028 14 x 1 pillola miksija b'rita EU/1/08/470/029 28 pilloli miksija b'rita EU/1/08/470/034 60 pillola miksija b'rita
English: Vimpat 50 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Maltese: Vimpat 50 mg <Il-ġustifikazzjoni biex ma jkunx inkluż il-Braille hija aċċettata> 56 x 1 u 14 x 1pillola miksija b'rita
English: Each package has 14 tablets, corresponding to 2 tablets per day for 7 days.
Maltese: Kull pakkett kellu 14-il-pillola, li jsarrfu f' 2 pilloli kuljum għal 7 tijiem.
English: Ltd
Maltese: Sess
English: Vimpat 50 mg film-coated tablets Each film-coated tablet contains 50 mg lacosamide.
Maltese: U KWANTITATTIVA Vimpat 50 mg pilloli miksijin b'rita Kull pillola miksija b'rita fiha 50 mg lacosamide.
English: Put the oral syringe into the adaptor opening (figure 4).
Maltese: • Poġġi s-siringa orali fil-ftuħ tal-adapter (figura 4).
English: Taking Vimpat with other antiepileptic medicines - Children and adolescents with a body weight of 20 kg to under 30 kg - This is for information only.
Maltese: Meta tuża Vimpat ma' mediċini ta' kontra l-epilessija oħra - Tfal u adoloxxenti b'piż tal-ġisem min 20 kg sa inqas minn 30 kg - Din hija għal skopijiet ta' informazzjoni biss.
English: Vimpat may be used on its own or with other antiepileptic medicines.
Maltese: Riskji relatati in ġenerali mal-epilessija u mal-mediċina ta' kontra l-epilessija kollha
English: Citric acid, anhydrous
Maltese: Hydrochloric acid (għall-aġġustament tal-pH)
English: UCB Pharma S.A. Tél: + 33 / (0)1 47 29 44 35
Maltese: Tél: + 33 / (0)1 47 29 44 35
English: The treatment initiation pack contains 56 film-coated tablets in 4 packages: the package marked ‘Week 1'contains 14 tablets of 50 mg,
Maltese: • il-pakkett immarkat ‘ Ġimgħa 1'14-il pillola ta' 50 mg,
English: Drug hypersensitivity(1)
Maltese: Aggressjoni Aġitazzjoni(1)
English: Vimpat 150 mg film-coated tablets
Maltese: Vimpat 150 mg pilloli miksija b'rita
English: Taking Vimpat with other antiepileptic medicines - Children and adolescents with a body weight of 30 kg to under 50 kg - This is for information only.
Maltese: Meta tuża Vimpat ma' mediċini ta' kontra l-epilessija oħra - Tfal u adoloxxenti b'piż tal-ġisem min 30 kg sa inqas minn 50 kg - Din hija għal skopijiet ta' informazzjoni biss.
English: Lacosamide should be used with caution in patients treated with medicinal products known to be associated with PR prolongation (including sodium channel blocking antiepileptic medicinal products) and in patients treated with antiarrhythmics.
Maltese: Lacosamide għandu jintuża b'kawtela f'pazjenti li huma trattati b' prodotti mediċinali magħrufa li huma assoċjati ma' titwil fil-PR (inkluż prodotti mediċinali antiepilettiċi li jimblokkaw il-kanal tassodju) u f' pazjenti trattati b'mediċini anti-arritmiċi.
English: the package marked ‘Week 4' contains 14 tablets of 200 mg.
Maltese: • il-pakkett immarkat ‘ Ġimgħa 4'14-il pillola ta' 200 mg.
English: There is experience with twice daily infusions of Vimpat for up to 5 days.
Maltese: Hemm esperjenza b'infużjonijiet ta' darbtejn kuljum ta' Vimpat sa 5 ijiem.
English: Vimpat 100 mg film-coated tablets lacosamide
Maltese: Vimpat 100 mg pilloli miksija b'rita lacosamide
English: A polar fraction proposed to be serine derivatives accounted for approximately 20 % in urine, but was detected only in small amounts (0-2 %) in human plasma of some subjects.
Maltese: Frazzjoni polari li kienet proposta li tikkonsisti f' derivattivi ta' serine għamlet madwar 20% fl-awrina, imma kienet misjuba biss f'ammonti żgħar (0-2%) fil-plażma umana ta' xi pazjenti.
English: An unusual fracture in a healthy woman on long term alendronate.
Maltese: An unusual fracture in a healthy woman on longterm alendronate.
English: 4 Schneider P. Should bisphosphonates be continued indefinitely?
Maltese: Should bisphosphonates be continued indefinitely?
English: J Bone Miner Res 25 (Suppl 1) 2010; Available at http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=05caf316-b73e-47b8-a011-bf0766b062c0.
Maltese: J Bone Miner Res 25 (Suppl 1) 2010; Disponibbli fuq http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=05caf316-b73e-47b8-a011-bf0766b062c0.
English: Epidemiological studies
Maltese: Studji epidemjoloġiċi
English: The effects of high-dose, long-term alendronate treatment on microarchitecture and bone mineral density of compact and trabecular bone in the proximal femur of adult male rabbits.
Maltese: Hofstaetter JG et al The effects of high-dose, long-term alendronate treatment on microarchitecture and bone mineral density of compact and trabecular bone in the proximal femur of adult male rabbits.
English: Osteoporos Int 2010; DOI 10.1007/s00198-010-1512y 9 Park-Wyllie LY et al Bisphosphonate Use and the Risk of Subtrochanteric or Femoral Shaft Fractures in Older Women.
Maltese: DOI 10.1007/s00198-010-1512y 9 Park-Wyllie LY et al Bisphosphonate Use and the Risk of Subtrochanteric or Femoral Shaft Fractures in Older Women.
English: Non-clinical data
Maltese: Dejta mhux klinika
English: Accessed 5 April 2011
Maltese: Aċċessat fil-5 ta' April 2011
English: Definition of atypical fracture of the femur
Maltese: Definizzjoni ta' frattura atipika tal-femur
English: Lenart BA et al Association of low-energy femoral fractures with prolonged bisphosphonate use: a case control study.
Maltese: 1002/jbmr.233 11 Lenart BA et al Association of low-energy femoral fractures with prolonged bisphosphonate use: a case control study.
English: 7 Abrahamsen B et al Cumulative alendronate dose and the long term absolute risk of subtrochanteric and diaphyseal femur fractures: a register-based national cohort analysis.
Maltese: 7 Abrahamsen B et al Cumulative alendronate dose and the long term absolute risk of subtrochanteric and diaphyseal femur fractures:
English: While some epidemiology studies suggest that subtrochanteric and femoral shaft fractures may be normal osteoporotic fractures (Abrahamsen et al, 20096, Abrahamsen, 20107, Vestergaard et al, 20108) other studies suggest that long-term bisphosphonate use may increase the risk of subtrochanteric and femoral shaft fractures (Park-Wyllie et al, 20119, Wang & Bhattacharyya, 201110).
Maltese: Filwaqt li xi studji epidemjoloġiċi jissuġġerixxu li fratturi subtrockanteriċi u tax-xaft femorali jistgħu jkunu fratturi osteoporotiċi normali (Abrahamsen et al, 20096, Abrahamsen, 20107, Vestergaard et al, 20108), studji oħra jissuġġerixxu li l-użu fit-tul ta' bisfosfonat jista' jżid ir-riskju ta' fratturi subtrockanteriċi u tax-xaft femorali (Park-Wyllie et al, 20119, Wang & Bhattacharyya, 201110).
English: Casecontrol studies have reported a significant association between atypical femur fracture pattern and bisphosphonate use (Lenart et al, 200911, Isaacs et al, 201012).
Maltese: Studji ta' kontroll tal-każ irrapportaw rabta sinifikanti bejn il-mudelli ta' fratturi femorali atipiċi u l-użu ta' bisfosfonat (Lenart et al, 200911, Isaacs et al, 201012).
English: J Bone Miner Res 25 (Suppl 1) 2010; Available at http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=223582c5-f5bb-4d66-bd16d073267b2a47.
Maltese: Available at http://www.asbmr.org/Meetings/AnnualMeeting/AbstractDetail.aspx?aid=223582c5-f5bb-4d66-bd16d073267b2a47.
English: J Clin Endocrinol Metab 2010; 95:5258-5265
Maltese: Osteoporos Int 2010;
English: Osteoporosis Int 2009; 20: 887-894 2 Burr DB et al Effects of one to three years treatment with alendronate on mechanical properties of the femoral shaft in a canine model: implications for subtrochanteric femoral fracture risk.
Maltese: 2 Burr DB et al Effects of one to three years treatment with alendronate on mechanical properties of the femoral shaft in a canine model: implications for subtrochanteric femoral fracture risk.
English: Risk factors
Maltese: Fatturi ta' riskju
English: Although pre-clinical studies have provided limited information on the risk of atypical fractures with bisphosphonates, some of them have demonstrated that suppression of bone turnover by bisphosphonates may increase microdamage accumulation and the accumulation of advanced glycation end-products resulting in changes in the biomechanical properties of bone (Brennan et al, 2011, Hofstaetter et al, 2010, Mashiba et al, 2000, O'Neal et al, Tang et al, 20091).
Maltese: Għalkemm studji pre-kliniċi pprovdew informazzjoni limitata dwar ir-riskju ta' fratturi atipiċi bilbisfosfonati, xi wħud minnhom urew li s-soppressjoni tal-fatturat tal-għadam minħabba l-bisfosfonati jista' jżid l-akkumulazzjoni ta' mikro-ħsara u l-akkumulazzjoni ta' prodotti finali b'glycation avvanzata li jwassal għal tibdil fil-karatteristiċi bijokemikali tal-għadam (Brennan et al, 2011, Hofstaetter et al, 2010, Mashiba et al, 2000, O'Neal et al, Tang et al, 20091).
English: Mashiba T et al Suppressed bone turnover by bisphosphonates increases microdamage accumulation and reduces some biomechanical properties in dog rib.
Maltese: Mashiba T et al Suppressed bone turnover by bisphosphonates increases microdamage accumulation and reduces some biomechanical properties in dog rib. J Bone Miner Res 2000; 15: 613-620
English: • The Committee considered the referral made under Article 31 of Directive 2001/83/EC, as amended for biphosphonates containing medicines;
Maltese: • Il-Kumitat ikkunsidra r-riferiment li sar skont l-Artikolu 31 tad-Direttiva 2001/83/KE, kif emendata għall-mediċini li fihom il-bifosfonati;
English: Although the highest number of possible atypical femoral fracture continue to be reported in association with alendronic acid for osteoporosis, post-marketing reports have also been reported for other bisphosphonates for osteoporosis (etidronic acid, ibandronic acid, risedronic acid and zoledronate), and also for Paget's disease (zoledronate) and oncology indications (ibandronic acid, pamidronic acid and zoledronate), suggesting that these fractures may be a class effect of bisphosphonates.
Maltese: Minkejja li logħla numru ta' fratturi femorali atipiċi possibbli jkomplu jiġu rrapportati b'rabta mal-aċidu alendroniku għall-osteoporożi, ir-rapporti ta' wara t-tqegħid fis-suq ġew irrapportati wkoll għal bisfosfonati oħra għall-osteoporożi (aċidu etidroniku, aċidu ibandroniku, aċidu risedronic u zoledronate), u wkoll għallmarda ta' Paget (zoledronate) u indikazzjonijiet onkoloġiċi (aċidu etidroniku, aċidu pamidronic u zoledronate), li jissuġġerixxu li dawn il-fratturi jistgħu jkunu effett ta' klassi tal-bisfosfonati.
English: Based on the small number of spontaneous reports of comminuted atypical femoral fracture in association with bisphosphonates, one published case report (Schneider, 20064), as well as preliminary data presented at the October meeting of the ASBMR (Nitche et al, 20105), the CHMP for the purpose of its assessment agreed on a modified case definition that lists ‘noncomminuted' as a minor feature rather than a major feature of atypical femur femoral fracture.
Maltese: Fuq bażi tan-numru żgħir ta' rapporti spontanji ta' fratturi mfarrka b'biċċiet żgħar atipiċi femorali b'rabta mal-bisfosfonati, rapport ta' każ wieħed ippubblikat (Schneider, 20064), kif ukoll minn dejta preliminari ppreżentata waqt il-laqgħa ta' Ottubru tal-ASBMR (Nitche et al, 20105), għall-finijiet talvalutazzjoni tiegħu, is-CHMP qabel fuq definizzjoni immodifikata tal-każ li telenka ‘mhux imfarrka f'biċċiet żgħar' bħala karatteristika minuri pjuttost milli karatteristika maġġuri ta' frattura atipika femorali.
English: Glucocorticoids and proton pumps inhibitor (PPI) have been identified as possible important risk factors for atypical femur fracture.
Maltese: Il-glukokortikojdi u l-inibituri tal-pompi tal-proton (PPI) ġew identifikati bħala fatturi ta' riskju importanti possibbli għall-fratturi femorali atipiċi.
English: However not all preclinical studies have found adverse effects of alendronic acid on bone (Burr et al2).
Maltese: Madankollu mhux l-istudji pre-kliniċi kollha sabu effetti avversi tal-aċidu alendroniku fuq l-għadam (Burr et al2).
English: • The Committee considered all the available data submitted (pre-clinical, clinical, epidemiological studies, post-marketing reports, published literature) in relation to the risk of atypical femoral fractures with biphosphonates.
Maltese: • Il-Kumitat ikkunsidra d-dejta kollha disponibbli sottomessa (pre-klinika, klinika, studji epidemjoloġiċi, rapporti ta' wara t-tqegħid fis-suq, dokumentazzjoni ppubblikata) fir-rigward tarriskji ta' fratturi femorali atipiċi bil-bifosfonati.
English: Hofstaetter JG et al.
Maltese: IV ta' din l-Opinjoni.
English: Further to the PhVWP discussions and the emerging data from published literature and post-marketing reports that suggest that atypical stress fractures may be a class effect of bisphosphonates, the UK asked the CHMP in September 2010, to provide an opinion under Article 31 of directive 2001/83 EEC, as amended on whether the Marketing Authorisations for medicinal products containing bisphosphonates should be maintained, varied, suspended or withdrawn.
Maltese: Wara d-diskussjonijiet tal-PhVWP u d-dejta emerġenti mid-dokumentazzjoni ppubblikata u mir-rapporti ta' wara t-tqegħid fis-suq li jissuġġerixxu li fratturi atipiċi minħabba stress jistgħu jkunu effett ta' klassi ta' bisfosfonati, f'Settembru 2010, ir-Renju Unit talab lis-CHMP jagħti opinjoni skont l-Artikolu 31 tadDirettiva 2001/83 KEE, kif emendata dwar jekk l-Awtorizzazzjonijiet għat-Tqegħid fis-Suq għallprodotti mediċinali li fihom il-bisfosfonati għandhomx jinżammu, għandhomx jiġu varjati, sospiżi jew irtirati.
English: The CHMP reviewed the available data from non-clinical and histological studies, relevant clinical trials, epidemiological studies, post-marketing reports and published literature.
Maltese: Is-CHMP irreveda d-dejta disponibbli minn studji mhux kliniċi u istoloġiċi, minn provi kliniċi rilevanti, studji epidemjoloġiċi, rapporti ta' wara t-tqegħid fis-suq u mid-dokumentazzjoni ppubblikata.
English: Geriatrics 2006; 61: 31-33 5 Nitche J et al Subtrochanteric femoral stress fractures in patients on chronic bisphosphonate therapy: a case series.
Maltese: Nitche J et al Subtrochanteric femoral stress fractures in patients on chronic bisphosphonate therapy: a case series.
English: Mechanism of atypical fractures
Maltese: Mekkaniżmi ta' fratturi atipiċi
English: • Addition of atypical femoral fracture to section 4.8 (Undesirable effects) of the SmPC accompanied by a statement that this adverse effect is a class attribution of all bisphosphonates.
Maltese: • Żieda ta' frattura femorali atipika ma' sezzjoni 4.8 (Effetti mhux mixtieqa) tal-SmPC li tiġi akkumpanjata bi stqarrija li dan l-effett avvers huwa attribut ta' klassi tal-bisfosfonati kollha.