FrancophonIA/ELRC3.0 huggingface dataset:
English: After 1 year of treatment, 68% of patients receiving Alecensa lived without their disease getting worse compared with 49% of patients receiving Xalkori.
Maltese: Wara sena ta' kura, 68 % tal-pazjenti li kienu qed jirċievu Alecensa għexu mingħajr ma l-marda tagħhom aggravat meta mqabbla ma' 49 % tal-pazjenti li kienu qed jirċievu Xalkori.
English: In the second study, the complete or partial response rate at the time of analysis was 51% (62 out of 122 patients).
Maltese: Fit-tieni studju, ir-rata ta' rispons komplet jew parzjali fiż-żmien meta saret l-analiżi kienet ta' 51 % (62 minn 122 pazjent).
English: In the first study around 52% of patients given Alecensa (35 out of 67) were considered by the treating doctors to have shown a complete or partial response to the medicine at the time of analysis.
Maltese: Fl-ewwel studju, madwar 52 % tal-pazjenti li ngħataw Alecensa (35 minn 67) kienu kkunsidrati mittobba kuranti bħala li wrew rispons komplet jew parzjali għall-mediċina meta saret l-analiżi.
English: Other information about Alecensa
Maltese: Informazzjoni oħra dwar Alecensa
English: Alecensa is a cancer medicine used to treat adults with a lung cancer called non-small-cell lung cancer (NSCLC), when the disease is advanced and has not been treated before or has been treated before with a cancer medicine called Xalkori (crizotinib).
Maltese: Alecensa huwa mediċina kontra l-kanċer użata biex tikkura adulti b'kanċer fil-pulmun imsejjaħ kanċer tal-pulmun mhux ta' ċellola żgħira (NSCLC, non-small-cell lung cancer), meta l-marda tkun avvanzata u ma tkunx ġiet ikkurata jew tkun ġiet ikkurata qabel b'mediċina kontra l-kanċer imsejħa Xalkori (crizotinib).
English: As for all medicines, data on the use of Alecensa are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Alecensa hija ssorveljata kontinwament.
English: What are the risks associated with Alecensa?
Maltese: X'inhuma r-riskji assoċjati ma' Alecensa?
English: Two main studies involved a total of 225 patients in whom the disease progressed despite previous treatment with Xalkori (crizotinib).
Maltese: Żewġ studji ewlenin involvew total ta' 225 pazjent li fihom il-marda ggravat minkejja kura preċedenti b'Xalkori (crizotinib).
English: The active substance in Alecensa, alectinib, is an ALK inhibitor and works by blocking the activity of ALK, thereby reducing the growth and spread of the cancer.
Maltese: Is-sustanza attiva f'Alecensa, lalectinib, hija inibitur ta' ALK u taħdem billi timblokka l-attività ta' ALK, u b'hekk tnaqqas it-tkabbir u ttixrid tal-kanċer.
English: ALK belongs to a family of proteins called receptor tyrosine kinases (RTKs), which are involved in the growth of cells and the development of new blood vessels that supply them.
Maltese: ALK tagħmel parti minn familja ta' proteini magħrufin bħala riċettur tat-tirożina kinases (RTKs, receptor tyrosine kinases), li huma involuti fit-tkabbir taċ-ċelloli u fl-iżvilupp ta' vażi ġodda li jfornuhom.
English: For patients with severe liver impairment the recommended dose is 3 capsules taken twice a day with food (900 mg in total).
Maltese: Għall-pazjenti b'indeboliment gravi tal-fwied id-doża rakkomandata hi ta' 3 kapsuli li jittieħdu darbtejn kuljum mal-ikel (900 mg b'kollox).
English: The recommended usual dose is 4 capsules taken twice a day with food (1,200 mg in total).
Maltese: Id-doża tas-soltu rakkomandata hi ta' 4 kapsuli li jittieħdu darbtejn kuljum mal-ikel (1,200 mg b'kollox).
English: The most common side effects with Alecensa (which may affect more than 2 in 10 people) are constipation, muscle pain and oedema (swelling) including of the ankles and feet, the face, the eyelids and the area around the eyes.
Maltese: L-effetti sekondarji l-aktar komuni b'Alecensa (li jistgħu jaffettwaw aktar minn 2 persuni minn kull 10) huma stitikezza, uġigħ fil-muskoli u edema (nefħa) inkluż fl-għekiesi u fis-saqajn, fil-wiċċ, fil-kpiepel tal-għajnejn u fil-parti madwar l-għajnejn.
English: Alecensa has been shown to be effective in treating ALK-positive NSCLC in three studies.
Maltese: Alecensa ntwera li huwa effettiv fil-kura tal-NSCLC pożittiv għall-ALK fi tliet studji ewlenin.
English: Response to treatment was assessed using body scans and standardised criteria for solid tumours, with complete response being when the patient had no remaining signs of the cancer.
Maltese: Ir-rispons għall-kura ġie vvalutat permezz ta' skans tal-ġisem u kriterji standardizzati użati għal tumuri solidi, b'rispons komplet meta l-pazjent ma kien baqagħlu l-ebda sinjal tal-kanċer.
English: The third study involved 303 patients whose ALK-positive NSCLC had not been treated before.
Maltese: It-tielet studju involva 303 pazjenti li l-NSCLC pożittiv għall-ALK tagħhom ma kienx ġie kkurat qabel.
English: Genetic defects affecting ALK (‘ALK-positive' status) should be confirmed in advance by appropriate methods.
Maltese: Difetti ġenetiċi li jaffettwaw l-ALK (status ‘pożittiv għall-ALK') għandhom jiġu kkonfermati bil-quddiem permezz ta' metodi adegwati.
English: In patients with ALKpositive NSCLC, an abnormal form of ALK is produced that stimulates the cancer cells to divide and grow in an uncontrolled fashion.
Maltese: F'pazjenti b'NSCLC pożittiv għall-ALK, hija prodotta forma anormali ta' ALK li tistimula liċċelloli tal-kanċer biex jinqasmu u jikbru b'mod mhux ikkontrollat.
English: Alecensa is used on its own and only if the NSCLC is ‘ALK-positive', which means that the cancer cells have certain defects affecting the gene that makes a protein called ALK (anaplastic lymphoma kinase).
Maltese: Alecensa jintuża waħdu u jekk l-NSCLC ikun “pożittiv għall-ALK” biss, li jfisser li ċ-ċelloli tal-kanċer ikun fihom ċerti difetti li jaffettwaw lill-ġene li jagħmel proteina magħrufa bħala ALK (kinase tal-limfoma anaplastika, (anaplastic lymphoma kinase)).
English: For the full list of side effects and restrictions with Alecensa, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Alecensa, ara l-fuljett ta' tagħrif.
English: Response was maintained for an average of 14.9 months in the first study, and 15.2 months in the second study.
Maltese: Ir-rispons inżamm tul medja ta' 14.9 xhur fl-ewwel studju, u 15.2 xhur fit-tieni studju.
English: The safety profile of Alecensa was considered acceptable and in line with that of other ALK inhibitors.
Maltese: Il-profil tas-sigurtà ta' Alecensa kien ikkunsidrat bħala aċċettabbli u f'konformità ma' dak ta' inibituri oħra ta' ALK.
English: Alecensa was also better than Xalkori at treating previously untreated patients with ALK-positive NSCLC.
Maltese: Għaliex Alecensa ġie awtorizzat fl-UE?
English: What benefits of Alecensa have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Alecensa li ħarġu mill-istudji?
English: Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, The Netherlands
Maltese: Accord Healthcare B.V., Winthontlaan 200, 3526 KV Utrecht, L-Olanda
English: UNIQUE IDENTIFIER-2D BARCODE
Maltese: IDENTIFIKATUR UNIKU - BARCODE 2D
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5-methylhexanoic acid].
Maltese: Is-sustanza attiva, pregabalin, hija gamma-aminobutyric acid analogue [(S) 3 (aminomethyl) 5 methylhexanoic acid].
English: Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom
Maltese: Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, Ir-Renju Unit
English: Elevated liver enzymes*
Maltese: Enzimi tal-fwied elevati*
English: • Vertigo, problems with balance, fall.
Maltese: • Vertigo, problemi fil-bilanċ, waqgħat.
English: Date of first authorisation: 28th August 2015
Maltese: Awi 28, 2015
English: The other ingredients are: starch pregelatinise, talc (E553b), gelatin, titanium dioxide (E171), sodium laurilsulfate, black ink, (which contains shellac, propylene glycol, iron oxide black (E172), and , potassium hydroxide).
Maltese: Is-sustanzi l-oħra huma: starch pregelatinise, talc (E553b), gelatin, titanium dioxide (E171), sodium laurilsulfate, linka sewda (li fiha shellac, propylene glycol, iron oxide iswed (E172) u potassium hydroxide).
English: Anorexia, hypoglycaemia
Maltese: Anoressija, ipogliċemija
English: Oxycodone - (used as a pain-killer) Lorazepam - (used for treating anxiety) Alcohol
Maltese: Oxycodone - (użat biex itaffi l-uġigħ) Lorazepam - (użat għall-kura ta' ansjetà) Alkoħol
English: Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Maltese: Testijiet pftalmoloġiċi (inklużi testijiet fuq akutezza viżiva, ittestjar formali tal-kamp viżiv u eżaminazzjoni ta' dilatar funduskopiku) sar fi 3600 pazjent fi studji kliniċi kontrollati.
English: Creatinine clearance (CLcr) (ml/min)
Maltese: CLcr (ml/min) = [
English: Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day in a pharmacokinetic and tolerability study.
Maltese: Il-farmakokinetika ta' pregabalin ġiet evalwata f'pazjenti pedjatriċi bl-epilessija (gruppi ta' età: xahar sa 23 xahar, sentejn sa 6 snin, 7 sa 11-il sena u 12 sa 16-il sena) f'livelli ta' doża ta' 2.5, 5, 10 u 15 mg/kg/jum fi studju dwar il-farmakokinetika u t-tollerabilità.
English: Iron oxide red (E172)
Maltese: Iron oxide iswed (E172)
English: Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Maltese: Ilvarjabilità fil-farmakokinetika bejn persuna u oħra għal pregabalin hija baxxa (<20%).
English: • Convulsions.
Maltese: • Aċċessjonijiet.
English: INSTRUCTIONS ON USE 16.
Maltese: N03AX16.
English: Central nervous system influencing medicinal products Pregabalin may potentiate the effects of ethanol and lorazepam.
Maltese: Prodotti mediċinali li jinfluwenzaw is-sistema nervuża ċentrali Pregabalin jista' jżid l-effetti ta' ethanol u lorazepam.
English: Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Maltese: Il-bijodisponibilità orali ta' pregabalin hija stmata għal 90% u hija indipendenti mid-doża.
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency (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: F'tabella 2 ta' hawn isfel ir-reazzjonijiet avversi kollha, li seħħew b'inċidenza akbar mill-plaċebo u f'aktar minn pazjent wieħed, huma elenkati bil-klassi u l-frekwenza (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: CLcr (ml/min) = [ 1.23 x [140 - age (years)] x weight (kg) ] (x 0.85 for female patients) serum creatinine (µmol/L)
Maltese: 1.23 x [140 - età (snin)] x piż (kg)
English: • Kidney failure, reduced urine volume, urinary retention.
Maltese: • Insuffiċjenza tal-kliewi, volum anqas ta'awrina, ritenzjoni urinarja.
English: Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy
Maltese: Atassja, koordinazzjoni mhux normali, tregħid, dysarthria, amnesija, indeboliment tal-memorja, disturb fl-attenzjoni, parasteżija, ipoestesija, sedazzjoni, disturbi fil-bilanċ, letarġija
English: Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury.
Maltese: Ġiet murija effikaċja fi provi dwar newropatija dijabetika, post herpetic neuralgia u leżjoni tal-korda spinali.
English: Other medicines and Pregabalin Accord
Maltese: Mediċini oħra u Pregabalin Accord
English: Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.
Maltese: Pregabalin jeħel ma' subunit awżiljarju (2-proteini) ta' kanali tal-kalċju kkontrollati b'vultaġġ fissistema nervuża ċentrali.
English: Each hard capsule contains either 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg ta' pregabalin.
English: Ascites, pancreatitis, swollen tongue, dysphagia
Maltese: Aċċessjonijiet, parosmia, ipokinesja, disgrafija
English: Each capsule is approximately 21.4 mm in length.
Maltese: Kull kapsula għandha tul ta' madwar 21.4 mm.
English: Peripheral and central neuropathic pain, Epilepsy or Generalised Anxiety Disorder:
Maltese: Uġigħ nevrotiku periferali u ċentrali, epilessija jew Disturb ta' Ansjetà Ġeneralizzata:
English: Each capsule is approximately 17.8 mm in length.
Maltese: Kull kapsula għandha tul ta' madwar 17.8 mm.
English: Gastrointestinal disorders
Maltese: Disturbi gastro-intestinali Komuni
English: Each capsule is approximately 14.4 mm in length.
Maltese: Kull kapsula għandha tul ta' madwar 14.4 mm.
English: Pregabalin Accord 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin For the full list of excipients, see section 6.1.
Maltese: Pregabalin Accord 300 mg kapsuli ibsin Kull kapsula fiha 300 mg ta' pregabalin, Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: Jaundice
Maltese: Ġestjoni
English: Peripheral and central neuropathic pain
Maltese: Uġigħ nevrotiku periferali u ċentrali
English: Results of a 12-week placebo-controlled study of 295 paediatric patients aged 4 to 16 years performed to evaluate the efficacy and safety of pregabalin as adjunctive therapy for the treatment of partial onset seizures and a 1 year open label safety study in 54 paediatric patients from 3 months to 16 years of age with epilepsy indicate that the adverse events of pyrexia and upper respiratory infections were observed more frequently than in adult studies of patients with epilepsy (see sections 4.2, 4.8 and 5.2).
Maltese: Irriżultati ta'studju ta' 12-il ġimgħa kkontrollat bil-plaċebo ta' 295 pazjent pedjatriku li kellhom bejn 4 u 16-il sena li sar biex jevalwa l-effikaċja u s-sigurtà ta' pregabalin bħala terapija aġġuntiva għall-kura ta' aċċessjonijiet ta' bidu parzjali u studju open label dwar is-sigurtà li dam sena, li sar fuq 54 pazjent pedjatriku li kellhom minn 3 xhur sa 16-il sena, bl-epilessija, jindikaw li l-avvenimenti avversi ta' deni u infezzjonijiet respiratorji fil-parti ta' fuq, ġew osservati b'mod aktar frekwenti milli fl-istudji li saru fuq l-adulti ta' pazjenti b'epilessija (ara sezzjonijiet 4.2, 4.8 u 5.2).
English: • Painful menstrual periods.
Maltese: • Diffikultà biex tibla.
English: Pregabalin Accord 25 mg/ 50 mg/ 150 mg hard capsules
Maltese: Pregabalin Accord 25 mg/ 50 mg/ 150 mg kapsuli ibsin
English: Currently available data are described in section 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 4.8, 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain iron oxide red (E172).
Maltese: Il-kapsuli ta' 75 mg, 100 mg, 200 mg, 225 mg u 300 mg fihom ukoll iron oxide aħmar (E172).
English: In accordance with current clinical practice, if pregabalin has to be discontinued it is recommended this should be done gradually over a minimum of 1 week independent of the indication (see sections 4.4 and 4.8).
Maltese: Konformi ma' prattika klinika kurrenti, jekk ikun hemm bżonn li pregabalin jitwaqqaf, huwa rakkomandat li dan isir fuq perijodu minimu ta' ġimgħa indipendentement mill-indikazzjoni (ara sezzjonijiet 4.4 u 4.8).
English: 225 mg capsules
Maltese: 225 mg kapsuli
English: • When Pregabalin Accord is taken with other medicines that may cause constipation (such as some types of pain medicines) it is possible that gastrointestinal problems may occur (e.g. constipation, blocked or paralysed bowel).
Maltese: • Meta Pregabalin Accord tkun qed tittieħed ma' mediċini oħrajn li jikkawżaw l-istitikezza (bħal ċerti tipi ta' mediċini li jingħataw għall-uġigħ) jista' jkun possibli li jkun hemm problemi gastroinestinali (eż. stitikezza, imsaren imblukkati jew paralizzati).
English: • Swelling of the body including extremities.
Maltese: • Nefħa fil-ġisem, inkluż l-estremitajiet.
English: Each capsule is approximately 19.3 mm in length.
Maltese: Kull kapsula għandha tul ta' madwar 19.3 mm.
English: Pregabalin Accord 25/50/75/100/150/200/225/300mg hard capsules are available in PVC/Aluminium blisterin pack sizes of 14, 21, 56, 60, 84, 90, 100 or 112 hard capsules.
Maltese: Pregabalin Accord 25/50/75/100/150/200/225/300 mg kapsuli ibsin huma disponibbli f'pakketti bilfolji (PVC/Aluminju) li fihom 14, 21, 56, 60, 84, 90, 100 jew 112-il kapsula iebsa.
English: The pregabalin safety profile observed in three paediatric studies in patients with partial seizures with or without secondary generalization (12-week efficacy and safety study in patients with partial onset seizures, n=295; pharmacokinetic and tolerability study, n=65; 1 and year open label follow on safety study, n=54) was similar to that observed in the adult studies of patients with epilepsy .
Maltese: Il-profil tas-sigurtà ta' pregabalin osservat fi tliet studji pedjatriċi f'pazjenti b'aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja (studju ta' 12-il ġimgħa dwar l-effikaċja u s-sigurtà f'pazjenti b'aċċessjonijiet ta' bidu parzjali, n=295; studju farmakokinetiku u studju dwar ittollerabilità, n=65; u studju dwar is-sigurtà open label follow on, n=54, li dam sena) kien simili għal dak osservat fl-istudji fuq l-adulti ta' pazjenti b'epilessija.
English: These estimated doses are approximately 7% of the total daily maternal dose on a mg/kg basis.
Maltese: Id-dożi stmati huma ta' madwar 7% tad-doża materna totali ta' kuljum fuq bażi ta' mg/kg.
English: Hard capsule
Maltese: Qoxra tal-kapsula:
English: Pregabalin Accord 25 mg hard capsules Pregabalin Accord 50 mg hard capsules Pregabalin Accord 75 mg hard capsules Pregabalin Accord 100 mg hard capsules Pregabalin Accord 150 mg hard capsules Pregabalin Accord 200 mg hard capsules Pregabalin Accord 225 mg hard capsules Pregabalin Accord 300 mg hard capsules
Maltese: Pregabalin Accord 25 mg kapsuli ibsin Pregabalin Accord 50 mg kapsuli ibsin Pregabalin Accord 75 mg kapsuli ibsin Pregabalin Accord 100 mg kapsuli ibsin Pregabalin Accord 150 mg kapsuli ibsin Pregabalin Accord 200 mg kapsuli ibsin Pregabalin Accord 225 mg kapsuli ibsin Pregabalin Accord 300 mg kapsuli ibsin
English: Generalised anxiety disorder Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Accord huwa indikat għall-kura tad-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) f'persuni adulti.
English: The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebocontrolled trials.
Maltese: Il-programm kliniku ta' pregabalin kien jinvolvi 'l fuq minn 8900 pazjent esposti għal pregabalin, li minnhom aktar minn 5600 kienu fi provi double-blind ikkontrollati bil-plaċebo.
English: Pulmonary oedema, throat tightness
Maltese: Edema pulmonari għeluq tal-gerżuma
English: Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (< 2% of a dose recovered in urine as metabolites), does not inhibit drug metabolism in vitro, and is not bound to plasma proteins, it is unlikely to produce, or be subject to, pharmacokinetic interactions.
Maltese: Billi pregabalin jitneħħa fil-parti l-kbira mhux mibdul fl-awrina, jgħaddi minn metaboliżmu negliġibbli fin-nies (<2% ta' doża tkun irkuprata fl-awrina bħala metaboliti), ma jostakolax ilmetaboliżmu tal-mediċina in vitro, u ma jeħilx mal-proteini tal-plasma, mhux probabbli li jipproduċi, jew ikun suġġett għal, interazzjonijiet farmakokinetiċi.
English: • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability.
Maltese: • Sensazzjoni ta' ferħ kbir, konfużjoni, diżorjentament, tnaqqis fl-interess sesswali, irritabilità.
English: • Difficulty in swallowing.
Maltese: • Idejn u saqajn kesħin.
English: 30 hard capsules 200 hard capsules
Maltese: 30 kapsula ibsin 200 kapsula iebsa
English: 150 mg capsules
Maltese: 150 mg kapsuli
English: Additionally Pregabalin Accord 75mg hard capsules are also available in PVC/Aluminium blisterin pack sizes of 70 hard capsules.
Maltese: Barra minn hekk Pregabalin Accord 75mg kapsuli ibsin huma wkoll disponibbli f'folji tal-PVC/Aluminju f' daqsijiet ta' pakketti ta' 70 kapsula iebsa.
English: 75 mg capsules
Maltese: 75 mg kapsuli
English: Rare (may affect up to 1 in 1,000 people):
Maltese: Rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000)
English: • Muscle damage.
Maltese: Mhux applikabbli.
English: Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental impairment, speech disorder,
Maltese: Sinkope, sturdament, myoclonus, ħass ħażin, attività psikomotorili eċċessiva, dyskinesia, sturdament talposizzjoni, tregħid waqt moviment volontarju, nystagmus, disturb konoxxittiv, indeboliment mentali, disturb fid-diskors, nuqqas ta' riflessi, iperestesija, sensazzjoni ta' ħruq, telf tattogħma, telqa
English: Pregabalin Accord belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Accord jappartjeni għal grupp ta' mediċini li jintużaw għall-kura ta' l-epilessija, l-uġigħ nevrotiku u d-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) fl-adulti.
English: Gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral
Maltese: Mard tar-rifluss gastroesofagali, sekrezzjoni eċċessiva tassaliva, ipoestesija orali
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti għall-preżentazzjoni tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma stabbiliti fil-lista ta' dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Pregabalin Accord 225 mg hard capsules Each hard capsule contains 225 mg of pregabalin.
Maltese: Pregabalin Accord 225 mg kapsuli ibsin Kull kapsula fiha 225 mg ta' pregabalin.
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics ATC code: N03AX16
Maltese: Kura kontra l-epilessija, kura oħra kontra l-epilessija, Kodiċi ATC:
English: 200 mg capsules
Maltese: 200 mg kapsuli
English: Nervous system disorders Very Common
Maltese: Disturbi fis-sistema nervuża Komuni ħafna
English: Pregabalin Accord 25 mg/ 50 mg/ 75 mg/ 100 mg/ 150 mg/ 200 mg/ 225 mg/ 300 mg hard capsules Capsule content:
Maltese: Pregabalin Accord 25 mg/ 50 mg/ 75 mg/ 100 mg/ 150 mg/ 200 mg/ 225 mg/ 300 mg kapsuli ibsin Kontenut tal-kapsula:
English: Hallucination, panic attack, restlessness, agitation, depression, depressed mood, elevated mood, aggression, mood swings, depersonalisation, word finding difficulty, abnormal dreams, libido increased, anorgasmia, apathy
Maltese: Alluċinazzjoni, attakk ta' paniku, irrekwitezza, aġitazzjoni, depressjoni, burdata depressa, burdata ta' entużjażmu, agressjoni, bidliet fil-burdata, spersonalizzazzjoni, diffikulta' biex issib il-kelma, ħolm anormali, żieda fil-libido, inkapaċità li tilħaq orgażmu, apatija
English: Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness
Maltese: Telf tal-vista, keratite, oscillopsia, perċezzjoni mibdula talfond viżwali, mydriasis, strabismus, luminożità viżwali Disturbi fil-widnejn u fis-sistema labirintika Komuni