FrancophonIA/ELRC3.0 huggingface dataset:
English: Results of a 12-week placebo controlled study of 295 paediatric patients aged 4 to 16 years and a 14-day placebo-controlled study of 175 paediatric patients aged 1 month to younger than 4 years of age 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: Ir-riżultati ta' studju ta' 12-il ġimgħa kkontrollat bil-plaċebo ta' 295 pazjent pedjatriku li kellhom bejn 4 u 16-il sena u studju kkontrollat bil-plaċebo ta' 14-il jum ta' 175 pazjent pedjatriku li kellhom bejn xahar u iżgħar minn 4 snin 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: The N- methylated derivative of pregabalin, the major metabolite of pregabalin found in urine, accounted for 0.9% of the dose.
Maltese: Id-derivattiv Nmethylated ta' pregabalin, li huwa l-metabolit prinċipali ta' pregabalin li nsibu fl-awrina, ammonta għal 0.9% tad-doża.
English: contains lactose monohydrate.
Maltese: TA' EĊĊIPJENTI Fih lactose monohydrate.
English: 150 mg
Maltese: k.s. 150 mg
English: Very rare: may affect up to 1 in 10,000 people
Maltese: Rari ħafna: jistgħu jaffettwaw sa persuna 1 minn kull 10,000
English: 25 mg hard capsules are packed into alu/alu (OPA/alu/PVC/alu) blisters as primary packaging.
Maltese: k.s. 25 mg kapsuli iebsin huma ppakkjati ġo folji tal-alu/alu (OPA/alu/PVC/alu) bħala l-ippakkjar ewlieni.
English: Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
Maltese: Bdil funduskopiku kien innutat fi 12.4% ta' dawk trattati bi pregabalin, u 11.7% tal-pazjenti ttrattati bi plaċebo.
English: Ataxia, coordination abnormal, tremor, dysarthria, amnesia, memory impairment, disturbance in attention, paraesthesia, hypoaesthesia, sedation, balance disorder, lethargy
Maltese: Atassja, koordinazzjoni mhux normali, tregħid, disartrija, amnesija, indeboliment tal-memorja, disturb fl-attenzjoni, paresteżija, iperestesija, sedazzjoni, disturbi fil-bilanċ, letarġija
English: Urinary incontinence, dysuria
Maltese: Inkontinenza tal-awrina, disurja
English: The pregabalin safety profile observed in four paediatric studies in patients with partial seizures with or without secondary generalisation (12-week efficacy and safety study in patients 4 to 16 years of age, n = 295; 14-day efficacy and safety study in patients 1 month to younger than 4 years of age, n = 175; pharmacokinetic and tolerability study, n = 65; and 1 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 f'erba' 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 li kellhom bejn 4 u 16-il sena, n=295; studju dwar l-effikaċja u s-sigurtà ta' 14-il jum f'pazjenti li kellhom bejn xahar sa iżgħar minn 4 snin, n = 175; 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: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 98 hard capsules 100 hard capsules
Maltese: 14-il kapsula iebsa 21 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 98 kapsula iebsa 100 kapsula iebsa
English: In these patients, visual acuity was reduced in 6.5% of patients treated with pregabalin, and 4.8% of placebo-treated patients.
Maltese: F'dawn ilpazjenti, l-akutezza tal-vista kienet imnaqqsa fi 6.5% ta' pazjenti ttrattati bi pregabalin, u fi 4.8% ta' pazjenti ttratati fuq plaċebo.
English: The most common adverse events observed in the 14-day study with pregabalin treatment were somnolence, upper respiratory tract infection, and pyrexia (see sections 4.2, 5.1 and 5.2).
Maltese: L-avvenimenti avversi l-aktar komuni li ġew osservati fl-istudju ta' 14-il jum b'kura bi pregabalin kienu sonnolenza, infezzjoni fil-parti ta' fuq tal-apparat respiratorju, u deni (ara sezzjonijiet 4.2, 5.1 u 5.2).
English: In the 12-week placebo controlled study, paediatric patients (4 to 16 years of age) were assigned to pregabalin 2.5 mg/kg/day (maximum, 150 mg/day), pregabalin 10 mg/kg/day (maximum, 600 mg/day), or placebo.
Maltese: Fl-istudju kkontrollat bi plaċebo ta' 12-il ġimgħa, il-pazjenti pedjatriċi (età bejn 4 u 16-il sena) ġew assenjati għal pregabalin 2.5 mg/kg/jum (massimu, 150 mg/jum), pregabalin 10/mg/kg/jum (massimu, 600 mg/jum), jew il-plaċebo.
English: • When pregabalin 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 tkun qed tittieħed ma' mediċini oħrajn li jistgħu jikkawżaw l-istitikezza (bħal ċerti tipi ta' mediċini li jingħataw għall-uġigħ) jista' jkun possibbli li li jkun hemm problemi gastrointestinali (eż. stitikezza, imsaren imblukkati jew paralizzati).
English: Pregabalin Zentiva k.s.
Maltese: X'fih Pregabalin Zentiva k.s.
English: • Kidney failure, reduced urine volume, urinary retention.
Maltese: • Insuffiċjenza tal-kliewi, volum ta' awrina, , ritenzjoni urinarja..
English: 100 mg
Maltese: k.s. 100 mg
English: Syncope, stupor, myoclonus, loss of consciousness, psychomotor hyperactivity, dyskinesia, dizziness postural, intention tremor, nystagmus, cognitive disorder, mental impairment, speech disorder, hyporeflexia, hyperaesthesia, burning sensation, ageusia, malaise
Maltese: Sinkope, sturdament, myoclonus, ħass ħażin, attività psikomotorili eċċessiva, dyskinesia, sturdament tal-pożizzjoni, tregħid waqt moviment volontarju, nystagmus, disturb konoxxittiv, indeboliment mentali, disturb fid-diskors, nuqqas ta' riflessi, ipoestesija, sensazzjoni ta' ħruq, telf tat-togħma, telqa
English: 21 hard capsules 84 hard capsules 98 hard capsules 100 hard capsules
Maltese: 21 kapsula iebsa 84 kapsula iebsa 98 kapsula iebsa 100 kapsula iebsa
English: Lactation had little to no influence on pregabalin pharmacokinetics.
Maltese: It-treddigħ kellu ftit jew xejn influwenzafuq il-farmakokinetika ta' pregabalin.
English: 14 hard capsules 56 hard capsules 98 hard capsules 100 hard capsules
Maltese: 14-il kapsula iebsa 56 kapsula iebsa 98 kapsula iebsa 100 kapsula iebsa
English: The pregabalin clinical programme involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebo controlled trials.
Maltese: Il-programm kliniku ta' pregabalin kien jinvolvi 'l fuq minn 8,900 pazjent esposti għal pregabalin, li minnhom aktar minn 5,600 kienu fi provi double-blind ikkontrollati bil-plaċebo.
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: The 75 mg, 100 mg, 200 mg, 225 mg and 300 mg capsules also contain red iron oxide (E172), yellow iron oxide (E172).
Maltese: Il-kapsuli ta' 75 mg, 100 mg, 200 mg, 225 mg u 300 mg fihom ukoll iron oxide aħmar (E172), iron oxide isfar (E172).
English: Each hard capsule contains 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg or 300 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg jew 300 mg ta' pregabalin.
English: Efficacy has been shown in trials in diabetic neuropathy, post herpetic neuralgia and spinal cord injury.
Maltese: Ġiet murija l-effikaċja fi provi dwar newropatija dijabetika, post herpetic neuralgia u leżjoni tal-korda spinali li jgħaddu minn ġos-sinsla.
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics; ATC code: N03AX16.
Maltese: Kura kontra l-epilessija, kura oħra kontra l-epilessija; Kodiċi ATC:
English: There have also been postmarketing reports of loss of consciousness, confusion and mental impairment.
Maltese: Kien hemm ukoll rapporti wara t-tqegħid fis-suq ta' ħass ħażin, konfużjoni u indeboliment mentali.
English: Peripheral and central neuropathic pain, epilepsy or generalised anxiety disorder Take the number of hard capsules as instructed by your doctor.
Maltese: Uġigħ nevrotiku periferali u ċentrali, epilessija jew disturbi ta' ansjetà ġeneralizzata Ħu n-numru ta' kapsuli iebsin kif ordnalek it-tabib tiegħek.
English: 25 mg
Maltese: k.s. 25 mg
English: Black iron oxide (E172) Polyethylene glycol
Maltese: - Shellac - Iron oxide iswed (E172) - Polyethylene glycol
English: In controlled clinical trials, multiple oral doses of pregabalin co-administered with oxycodone, lorazepam, or ethanol did not result in clinically important effects on respiration.
Maltese: Fi provi kliniċi kkkontrollati, dożi orali multipli ta' pregabalin mogħtija flimkien ma' oxycodone, lorazepam, jew ethanol ma rriżultawx f'effetti klinikament importanti fuq ir-respirazzjoni.
English: In the 14-day placebo-controlled study, paediatric patients (1 month to younger than 4 years of age) were assigned to pregabalin 7 mg/kg/day, pregabalin 14 mg/kg/day, or placebo.
Maltese: Fl-istudju kkontrollat bil-plaċebo ta' 14-il jum, pazjenti pedjatriċi (età ta' xahar sa iżgħar minn 4 snin) ġew assenjati għal pregabalin 7 mg/kg/jum, pregabalin 14 mg/kg/ jum, jew plaċebo.
English: Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness
Maltese: Dispnea, epistassi, sogħla, konġestjoni flimnieħer, rinite, inħir, nixfa fl-imnieħer
English: Excipient with known effect: Each hard capsule also contains 47.57 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha wkoll 47.57 mg lactose monohydrate.
English: INFORMATION IN BRAILLE Pregabalin Zentiva k.s.
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Zentiva
English: 100 mg, 200 mg is available in pack of 21, 84, 98 and 100 hard capsules.
Maltese: Pregabalin Zentivak.s. 100 mg, 200 mg huma disponibbli f'pakketti ta' 21, 84, 98 u 100 kapsula iebsin.
English: Renal failure, oliguria, urinary retention Reproductive system and breast disorders Common
Maltese: Insuffiċjenza tal-kliewi, oliguria, ritenzjoni urinarja
English: 25 mg and 50 mg is available in pack of 14, 21, 56, 84, 98 and 100 hard capsules.
Maltese: k.s. 25 mg u 50 mg huma disponibbli f'pakketti ta' 14, 21, 56, 84, 98 u 100 kapsula iebsin.
English: The pharmacokinetics of 150 mg pregabalin given every 12 hours (300 mg daily dose) was evaluated in 10 lactating women who were at least 12 weeks postpartum.
Maltese: Il-farmakokinetika ta' 150 mg ta' pregabalin mogħti kull 12-il siegħa (300 mg doża ta' kuljum ta') ġiet evalwata f'10 nisa li kienu qed ireddgħu li kien ilhom mill-inqas 12-il ġimgħa li welldu.
English: Vision loss, keratitis, oscillopsia, altered visual depth perception, mydriasis, strabismus, visual brightness
Maltese: Telf tal-vista, keratite, oscillopsia, perċezzjoni mibdula tal-fond viżwali, mydriasis, strabismus, luminożità viżwali
English: Pregabalin is not bound to plasma proteins.
Maltese: Pregabalin ma jeħilx mal-proteini talplasma.
English: In controlled clinical trials (4 - 8 week duration) 52% of the pregabalin treated patients and 38% of the patients on placebo had at least a 50% improvement in HAM-A total score from baseline to endpoint.
Maltese: Fi provi kliniċi kkontrollati (li damu 4-8 ġimgħat) 52% tal-pazjenti kkurati bi pregabalin u 38% talpazjenti fuq il-plaċebo kellhom titjib ta' mill-anqas 50% fil-punteġġ totali tal-HAM-A mil-linja bażika sal-punt finali.
English: In humans, the apparent volume of distribution of pregabalin following oral administration is approximately 0.56 l/kg.
Maltese: Fil-bniedem, il-volum apparenti tad-distribuzzjoni apparenti ta' pregabalin wara li jiġi amministrat huwa madwar 0.56 l/kg.
English: Pregabalin terminal half-life averaged about 3 to 4 hours in paediatric patients up to 6 years of age, and 4 to 6 hours in those 7 years of age and older.
Maltese: Il-half-life terminali ta' pregabalin kellha medja ta' madwar 3 sa 4 sigħat f'pazjenti pedjatriċi i kellhom sa 6 snin, u minn 4 sa 6 sigħat f'dawk li kellhom 7 snin u aktar.
English: Manufacturer Zentiva, k.s.
Maltese: L-Manifattur Zentiva, k.s.
English: (p = 0.0068 versus placebo), 29.1% of subjects treated with pregabalin 2.5 mg/kg/day (p = 0.2600 versus placebo) and 22.6% of those receiving placebo.
Maltese: Il-persentaġġ ta' suġġetti li kellhom tal-inqas tnaqqis ta' 50% flaċċessjonijiet ta' bidu parzjali kkomparat mal-linja bażi kien ta' 40.6% mis-suġġetti kkurati bi pregabalin 10mg/kg/jum (p = 0.0068 kontra il-placebo), 29.1% ta' suġġetti kkurati bi pregabalin 2.5mg/kg/jum (p = 0.2600 kontra il-plaċebo) u 22.6% ta' dawk li kienu qed jircievu l-plaċebo.
English: In the post-marketing experience, there are reports of respiratory failure and coma in patients taking pregabalin and other central nervous system (CNS) depressant medicinal products.
Maltese: F'esperjenza ta' wara t-tqegħid fis-suq, kien hemm rapporti ta' insuffiċjenza respiratorja u koma f'pazjenti li kienu qed jieħdu pregabalin u prodotti mediċinali oħra dipressanti tas-sistema nervuża ċentrali (CNS).
English: Capsule shell
Maltese: Korp tal-kapsula
English: In the controlled clinical trial in central neuropathic pain 22% of the pregabalin treated patients and 7% of the patients on placebo had a 50% improvement in pain score.
Maltese: Fil-prova klinika kkontrollata dwar uġigħ nevrotiku ċentrali 22% tal-pazjenti kkurati bi pregabalin u 7% tal-pazjenti fuq plaċebo kellhom titjib ta' 50% fil-punteġġ tal-uġigħ.
English: Population pharmacokinetic analysis indicated that oral antidiabetics, diuretics, insulin, phenobarbital, tiagabine and topiramate had no clinically significant effect on pregabalin clearance.
Maltese: Analiżi farmakokinetika tal-popolazzjoni indikat li s-sustanzi orali kontra d-dijabete, id-dijuretiċi, l-insulina, phenobarbital, tiagabine u topiramate ma kellhom l- ebda effett klinikament sinifikanti fuq it-tneħħija ta' pregabalin.
English: BATCH NUMBER Batch:
Maltese: NUMRU TAL-LOTT Lott:
English: Jaundice
Maltese: UŻU
English: The 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, 300 mg capsules also contain polyethylene glycol.
Maltese: Il-kapsuli ta' 25 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg u 300 mg fihom ukoll polyethylene glycol.
English: • Painful menstrual periods.
Maltese: • Diffikultà biex tibla'.
English: Excipient with known effect: Each hard capsule also contains 22.5 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha wkoll 22.5 mg lactose monohydrate.
English: Funduscopic changes were observed in 1.7% of pregabalintreated and 2.1% of placebo-treated patients.
Maltese: Bdil fundoskopiku kien innutat f'1.7% ta' dawk ittrattati bi pregabalin u 2.1% tal-pazjenti ttrattati bi plaċebo.
English: is used to treat generalised anxiety disorder (GAD).
Maltese: k.s. jintuża għall-kura ta' disturb ta' ansjetà ġeneralizzata (GAD - generalised anxiety disorder).
English: 150 mg capsules Light grey cap and light grey body; approx. 18,0 mm in length, hard gelatin capsule with imprinting “150”, containing almost white powder.
Maltese: Kapsuli ta' 150 mg Għatu griż ċar u korp griż ċar; b'tul ta' madwar 18.0 mm, kapsula iebsin talġelatina stampata b'“150”, li fiha trab kważi abjad.
English: Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours).
Maltese: Pregabalin jitneħħa b'mod effettiv mill-plasma b'ħemodijaliżi (50% tal-mediċina f'4 sigħat).
English: Each hard capsule contains 225 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 225 mg pregabalin.
English: Single dose +
Maltese: Doża waħda+
English: S.C. Zentiva, S.A.
Maltese: Zentiva, S.A.
English: Red iron oxide (E172) Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Maltese: - Iron oxide aħmar (E172) - Iron oxide isfar (E172) - Titanium dioxide (E171) - Ġelatina
English: The dose, which has been adjusted for you and your condition, will generally be between 150 mg and 600 mg each day.
Maltese: Id-doża, li ġiet aġġustata għalik u għall-kondizzjoni tiegħek, ġeneralment tkun bejn 150 mg u 600 mg kuljum.
English: • Flushing, hot flushes.
Maltese: • Infjammazzjoni tal-frixa.
English: Excipient with known effect: Each hard capsule also contains 7.5 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha wkoll 7.5 mg lactose monohydrate.
English: Yellow iron oxide (E172) Titanium dioxide (E171) Gelatin
Maltese: - Iron oxide iswed (E172) - Titanium dioxide (E171) - Ġelatina
English: 300 mg capsules
Maltese: Pregabalin Zentiva k.s 300 mg kapsuli ibsin
English: Adjunctive treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: 75 mg, 150 mg, 225 mg and 300 mg is available in pack of 14, 56, 98 and 100 hard capsules.
Maltese: Pregabalin Zentivak.s. 75 mg, 150 mg, 225 mg u 300 mg huma disponibbli f'pakketti ta' 14, 56, 98 u 100 kapsula iebsin.
English: 75 mg capsules
Maltese: Kapsuli ta' 75 mg
English: 150 mg hard capsules Pregabalin
Maltese: k.s. 150 mg kapsuli ibsin Pregabalin
English: In controlled clinical trials in peripheral neuropathic pain 35% of the pregabalin treated patients and 18% of the patients on placebo had a 50% improvement in pain score.
Maltese: Fi provi kliniċi kkontrollati f'dwar uġigħ nevrotiku periferali, 35% tal-pazjenti kkurati bi pregabalin u 18% tal-pazjenti fuq il-plaċebo kellhom titjib ta' 50% fil-punteġġ tal-uġigħ.
English: The rate of pregabalin absorption is decreased when given with food resulting in a decrease in Cmax by approximately 25 - 30% and a delay in tmax to approximately 2.5 hours.
Maltese: Ir-rata ta' assorbiment ta' pregabalin tonqos meta jingħata mal- biex tirriżulta fi tnaqqis ta' madwar 20-30% fil-Cmax tonqos b'madwar 25 - 30% u dewmien fit-tmax ta' madwar 2.5 sigħat.
English: Adverse effects on male reproductive organs and sperm parameters were reversible and occurred only at exposures sufficiently in excess of therapeutic exposure or were associated with spontaneous degenerative processes in male reproductive organs in the rat.
Maltese: Effetti avversi fuq l-organi riproduttivi maskili u l-parametri tal-isperma kienu riversibbli u seħħew biss f'esponimenti li huma kkunsidrati li fil-prattika huma ħafna aktar mill-esponimenti terapewtika jew kienu assoċjati ma' proċessi deġenerattivi spontanji fl-organi riproduttivi tal-far.
English: Excipient with known effect: Each hard capsule also contains 20 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha wkoll 20 mg lactose monohydrate.
English: Gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral
Maltese: Mard ta' rifluss gastroesofagali, sekrezzjoni eċċessiva tas-saliva, ipoestesija tal-ħalq
English: EU/1/16/1166/006 EU/1/16/1166/007 EU/1/16/1166/008 EU/1/16/1166/009 EU/1/16/1166/030 EU/1/16/1166/010
Maltese: EU/1/16/1166/006 EU/1/16/1166/007 EU/1/16/1166/008 EU/1/16/1166/009 EU/1/16/1166/030
English: Reduction of pregabalin dose may be required in patients who have age related compromised renal function (see section 4.2 table 1).
Maltese: Jista' jkun meħtieġ tnaqqis fid-doża ta' pregabalin f'pazjenti li jkollhom funzjoni renali kompromessa marbuta ma' l-eta (ara sezzjoni 4.2 Tabella 1).
English: Each hard capsule contains 150 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 150 mg pregabalin.
English: 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg hard capsules are packed into PVC/alu blisters as primary packaging.
Maltese: k.s. 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg u 300 mg kapsuli iebsin huma ppakkjati ġo folji tal-PVC/alu bħala l-ippakkjar ewlieni.
English: 225 mg hard capsules Capsule cap
Maltese: k.s. 225 mg kapsuli ibsin Għatu tal-kapsula
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galattosju, il-Lapp lactase deficiency jew assorbiment ħażin tal-glukosju-galattosju m'għandhomx jieħdu dan il-prodott mediċinali.
English: Stevens-Johnson syndrome, cold sweat Musculoskeletal and connective tissue disorders Common
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi
English: The following events have been mentioned: insomnia, headache, nausea, anxiety, diarrhoea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis and dizziness, suggestive of physical dependence.
Maltese: Kienu msemmija r-reazzjonijiet li ġejjin: nuqqas ta' rqad, uġigħ ta' ras, dardir, ansjetà, dijarea, sindrome tal-influwenza, aċċessjonijiet, nervożità, depressjoni, uġigħ, iperidrosi u sturdament, li jissuġġerixxu dipendenza fiżika.
English: 50 mg capsules
Maltese: Pregabalin Zentiva k.s 50 mg kapsuli ibsin
English: Because renal elimination is the major elimination pathway, dose reduction in patients with renal impairment and dose supplementation following haemodialysis is necessary (see section 4.2 table 1).
Maltese: Minħabba li pregabalin jiġi eliminat fil-biċċa l-kbira tiegħu mill-kliewi, huwa meħtieġ tnaqqis tad-doża f'pazjenti b'indeboliment tal-kliewi u żieda fid-doża wara ħemodijaliżi (ara sezzjoni 4.2 tabella 1).
English: Each hard capsule contains 75 mg of pregabalin.
Maltese: Kull kapsula iebsaiebsin fiha 75 mg pregabalin.
English: Each hard capsule contains 100 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 100 mg pregabalin.
English: No tumours were observed in rats at exposures up to 24 times the mean human exposure at the maximum recommended clinical dose of 600 mg/day.
Maltese: Ma kienu osservati l-ebda tumuri fil-firien b'esponimenti sa 24 darba aktar mill- esponiment medju tal-bniedem bid-doża klinika massima rakkomandata ta' 600 mg/ġurnata.
English: Excipient with known effect: Each hard capsule also contains 30 mg lactose monohydrate.
Maltese: Kull kapsula iebsa fiha wkoll 30 mg lactose monohydrate.
English: 225 mg capsules
Maltese: Pregabalin Zentiva k.s 225 mg kapsuli ibsin
English: 225 mg hard capsules Pregabalin
Maltese: k.s. 225 mg kapsuli ibsin Pregabalin
English: 75 mg hard capsules Capsule cap
Maltese: k.s. 75 mg kapsuli ibsin Għatu tal-kapsula
English: 75 mg hard capsules Pregabalin
Maltese: k.s. 75 mg kapsuli ibsin Pregabalin
English: 150 mg hard capsules
Maltese: Pregabalin Zentiva k.s 150 mg kapsuli ibsin
English: Printing ink
Maltese: Pregabalin Zentiva
English: 150 mg hard capsules Pregabalin Zentiva k.s.
Maltese: k.s. 150 mg kapsuli ibsin Pregabalin Zentiva
English: 100 mg hard capsules Pregabalin
Maltese: k.s. 100 mg kapsuli ibsin Pregabalin
English: An increased incidence of retinal atrophy commonly observed in aged albino rats was seen after long-term exposure to pregabalin at exposures ≥ 5 times the mean human exposure at the maximum recommended clinical dose.
Maltese: Wara esponiment fit-tul għal pregabalin f'esponimenti ≥ 5 darbiet l-esponiment uman medju bid-doża klinika massima rrakkomandata kienet osservata inċidenza akbar ta' atrofija li normalment tidher f'firien albini xjuħ.
English: 100 mg hard capsules Pregabalin Zentiva k.s.
Maltese: k.s. 100 mg kapsuli ibsin Pregabalin Zentiva
English: Each hard capsule contains 50 mg of pregabalin.
Maltese: Kull kapsula iebsa fiha 50 mg pregabalin.