FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean fasting triglyceride percent change was significantly different between volanesorsen and placebo arms at 3, 6, and 12 months; the volanesorsen arm included patients who did not complete dosing but who returned for assessments over the 52-week study.
Maltese: Il-bidla perċentwali medja ta' trigliċeridi fl-istat sajjem kienet differenti b'mod sinjifikanti bejn il-gruppi ta' volanesorsen u plaċebo wara 3, 6 u 12-il xahar: il-grupp ta' volanesorsen kien jinkludi pazjenti li ma lestewx id-doża imma li rritornaw għal evalwazzjoni matul listudju ta' 52 ġimgħa.
English: Immunisation reaction (3, 3%) Hypersensitivity (1, 1%) Serum sickness-like reaction (1,
Maltese: Reazzjoni għall-immunizazzjoni Sensittività eċċessiva (1, 1%) Reazzjoni bħal tal-marda tasserum (1, 1%)
English: Antithrombotic agents and medicinal products that may lower platelet count It is not known whether the risk of bleeding is increased by concomitant use of volanesorsen and antithrombotic agents or medicinal products that may lower platelet count or affect platelet function.
Maltese: Aġenti antitrombotiċi u prodotti mediċinali li jistgħu jnaqqsu l-għadd ta' plejtlits Mhux magħruf jekk ir-riskju ta' emorraġija jogħliex b'użu fl-istess waqt ta' volanesorsen u aġenti antitrombotiċi jew prodotti mediċinali li jistgħu jnaqqsu l-għadd ta' plejtlits jew jaffettwaw il-funzjoni tal-plejtlits.
English: APPROACH-volanesorsen and CS16-volanesorsen groups were taken from the respective index study.
Maltese: Dsatax mit-33 pazjent fil-grupp ta' volanesorsen lestew 12-il xahar ta' studju bit-trattament.
English: Myalgia (8, 9%) Arthralgia (6, 7%) Pain in extremity (5, 6%) Arthritis (2, 2%) Back pain (2, 2%) Musculoskeletal pain (2, 2%) Neck pain (2, 2%) Muscle spasms (1, 1%) Joint stiffness (1, 1%) Myositis (1, 1%) Pain in jaw (1, 1%) Polymyalgia rheumatica (1, 1%)
Maltese: Tħoss is-sħana (2, 2%) Marda bħall-influwenza (2, 2%) Skonfort fis-sit tal-injezzjoni (2, Infjammazzjoni fis-sit talinjezzjoni (2, 2%) Massa fis-sit tal-injezzjoni (2, Uġigħ (2, 2%)
English: Non-interventional PASS: the applicant should conduct and submit the results of a study based on a Registry in order to evaluate the safety of Waylivra on thrombocytopenia and bleeding(including incidence rate, severity and outcomes) in FCS patients according to the dose recommendation and dose algorithm and investigate adherence with platelet monitoring and dose adjustment requirements.
Maltese: l-applikant għandu jwettaq u jissottometti r-riżultati ta' studju bbażat fuq Reġistru sabiex tiġi evalwata s-sigurtà ta' Waylivra fuq tromboċitopenija u fsada (inkluż ir-rata ta' inċidenza, severità u eżiti) f'pazjenti b'FCS skont ir-rakkomandazzjoni tad-doża u l-algoritmu tad-doża u tinvestiga l-aderenza mal-monitoraġġ talplejtlits u r-rekwiżiti għall-aġġustamenti tad-doża.
English: Elevations of liver enzymes have been observed after administration of other subcutaneously and intravenously administered antisense oligonucleotides.
Maltese: Ġew osservati livelli ogħla ta' enzimi tal-fwied wara l-għoti ta' oligonukleotidi antisens oħrajn mogħtija taħt il-ġilda u ġol-vini.
English: Following subcutaneous administration, terminal elimination half-life is approximately 2 to 5 weeks.
Maltese: Wara l-għoti taħt il-ġilda, il-half-life tal-eliminazzjoni terminali hija ta' madwar 2 sa 5 ġimgħat.
English: It is unknown whether triglyceride lowering by volanesorsen and the potentially ensuing decrease in inflammation leads to normalisation of CYP enzyme expression.
Maltese: Mhux magħruf jekk it-tnaqqis ta' trigliċeridi b'volanesorsen u t-tnaqqis potenzjali sussegwenti flinfjammazzjoni jwasslux għal normalizzazzjoni fl-espressjoni tal-enzima CYP.
English: Table 5: Additional Results for Changes in Triglycerides in the APPROACH study (Primary endpoint at Month 3)
Maltese: Riżultati Addizzjonali għal Bidliet fi Trigliċeridi fl-istudju Approach (Il-punt aħħari primarju fix-Xahar 3)
English: Injection site paraesthesia (1, 1%) Injection site scab (1, 1%) Injection site papule (1, 1%) Oedema (1, 1%)
Maltese: Paraestesija fis-sit tal-injezzjoni Skorċa fis-sit tal-injezzjoni (1, Papule fis-sit tal-injezzjoni (1, Edema (1, 1%)
English: Novartis (Hellas) S.A.C.I.
Maltese: Ελλάδα Novartis (Hellas) S.A.C.l
English: Бул.“Никола Вапцаров“ No. 55 сгр.
Maltese: Бул.“Никола Вапцаров“ No. 55 сгр. 4, ет. 4
English: Capsule content Pregelatinised maize starch Maize starch
Maltese: Kontenut tal-kapsula Pregelatinised maize starch Maize starch
English: CY-000 00 Πόλη: Λεμεσός Τηλ: 00357 25372425 hapanicos@cytanet.com.cy
Maltese: Πόλη: Λεμεσός Τηλ: 00357 25372425 hapanicos@cytanet.com.cy
English: Starting dose (mg/day) Maximum dose (mg/day)
Maltese: Doża inizjali (mg/ġurnata) Doża massima (mg/ġurnata)
English: Pregabalin Sandoz 25 mg hard capsules Pregabalin Sandoz 50 mg hard capsules Pregabalin Sandoz 75 mg hard capsules Pregabalin Sandoz 100 mg hard capsules Pregabalin Sandoz 150 mg hard capsules Pregabalin Sandoz 200 mg hard capsules Pregabalin Sandoz 225 mg hard capsules Pregabalin Sandoz 300 mg hard capsules Pregabalin
Maltese: Pregabalin Sandoz 25 mg kapsuli ibsin Pregabalin Sandoz 50 mg kapsuli ibsin Pregabalin Sandoz 75 mg kapsuli ibsin Pregabalin Sandoz 100 mg kapsuli ibsin Pregabalin Sandoz 150 mg kapsuli ibsin Pregabalin Sandoz 200 mg kapsuli ibsin Pregabalin Sandoz 225 mg kapsuli ibsin Pregabalin Sandoz 300 mg kapsuli ibsin Pregabalin
English: Na Pankráci 1724/129
Maltese: Na Pankráci 1724/129 CZ-140 00 Praha 4 - Nusle
English: [For outer carton only] PC:
Maltese: [Għall-kartuna ta' barra biss] PC:
English: Creatinine clearance (CLcr) (ml/min)
Maltese: Tneħħija tal- krejatinina (CLcr) (mL/min)
English: • Hepatitis (inflammation of the liver).
Maltese: • Epatite (infjammazzjoni tal-fwied).
English: 42 x 1 hard capsules.
Maltese: 42 x 1 kapsula iebsa.
English: organizačná zložka Žižkova 22B
Maltese: Slovenská republika Sandoz d.d. organizačná zložka Žižkova 22B
English: Elevated liver enzymes*
Maltese: Enżimi tal-fwied elevati*
English: Pregabalin mean elimination half-life is 6.3 hours.
Maltese: Il-half life medja tal-eliminazzjoni ta' pregabalin hija 6.3 sigħat.
English: PVC/PVDC//Alu blister.
Maltese: Folja tal-PVC/PVDC//Alu.
English: Ophthamologic 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 3,600 pazjent fi studji kliniċi kontrollati.
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: Εθνική Οδός No 1 (12ο km) Μεταμόρφωση GR-144 51 Αθήνα Τηλ: +30 210 2811712
Maltese: National Road No 1 (12th klm) GR-144 51, Metamorphosis, Athens GreeceTel.: +30 210 2811 712
English: Ελλάδα
Maltese: Twaqqif ta' pregabalin
English: 42 hard capsules.
Maltese: 42 kapsula iebsa.
English: - The other ingredients are pregelatinised maize starch, maize starch, talc, gelatin, titanium dioxide (E171), yellow iron oxide (E172) (all strengths except 150 mg), red iron oxide (E172) (all strengths except 50 mg and 150 mg), black iron oxide (E172) (only 25 mg and 300 mg).
Maltese: • Is-sustanzi l-oħra huma: pregelatinised maize starch, maize starch, talkum, ġelatina, titanium dioxide (E171), yellow iron oxide (E172) (il-qawwiet kollha ħlief 150 mg), red iron oxide (E172) (il-qawwiet kollha ħlief 50 mg u 150 mg), black iron oxide (E172) (25 mg u 300 mg biss).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: Sensittività eċċessiva gћas-sustanza attiva jew gћal kwalunkwe wieħed mill-eċċipjenti elenkati fissezzjoni 6.1.
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 N-methylated ta' pregabalin, li huwa l-metabolit prinċipali ta' pregabalin li nsibu fl-awrina, ammonta għal 0.9 % tad-doża.
English: Container packs: 100, 200 or 250 hard capsules
Maltese: Pakketti bil-kontenituri: 100, 200 jew 250 kapsula iebsa.
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 (α2-δ proteini) ta' kanali tal-kalċju kkontrollati b'vultaġġ fissistema nervuża ċentrali.
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules.
Maltese: U KONTENUT Multipack: 210 x 1 (3 pakketti ta' 70 x 1) kapsula iebsa.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 June 2015
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 19 ta' Ġunju 2015
English: Multipack: 84 (2 packs of 42) hard capsules Multipack: 100 (2 packs of 50) hard capsules Multipack: 120 (2 packs of 60) hard capsules Multipack: 84 x 1 (2 packs of 42 x 1) hard capsules Multipack: 100 x 1 (2 packs of 50 x 1) hard capsules Multipack: 210 x 1 (3 packs of 70 x 1) hard capsules
Maltese: Multipack: 84 (2 pakketti ta' 42) kapsula iebsa Multipack: 100 (2 pakketti ta' 50) kapsula iebsa Multipack: 120 (2 pakketti ta' 60) kapsula iebsa Multipack: 84 x 1 (2 pakketti ta' 42 x 1) kapsula iebsa Multipack: 100 x 1 (2 pakketti ta' 50 x 1) kapsula iebsa Multipack: 210 x 1 (3 pakketti ta' 70 x 1) kapsula iebsa
English: Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Maltese: Ilvarjabilità fil-farmakokinetika bejn persuna u oħra għal pregabalin hija baxxa (< 20 %).
English: PHARMACEUTICAL FORM AND CONTENTS 70 x 1 hard capsules.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 70 x 1 kapsula iebsa.
English: Österreich Sandoz GmbH Biochemiestr.
Maltese: Österreich Sandoz GmbH
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' multipack, ma jistax jinbiegħ separatament.
English: PVC/PVDC//Alu unit dose blisters packed in carton HDPE container with PP screw cap packed in carton.
Maltese: Folji bid-doża tal-unità tal-PVC/PVDC//Alu ppakkjati f'kartuna Kontenitur tal-HDPE b'għatu bil-kamini tal-PP ippakkjat f'kartuna.
English: PHARMACEUTICAL FORM AND CONTENTS 100 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 100 kapsula iebsa
English: PHARMACEUTICAL FORM AND CONTENTS 200 hard capsules
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 200 kapsula iebsa
English: Visual field changes were detected in 12.4% of pregabalin-treated, and 11.7% of placebo-treated patients.
Maltese: Bdil fil-kamp viżiv kien innutat fi 12.4 % ta' dawk trattati bi pregabalin, u 11.7 % ta' pazjenti fuq plaċebo.
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Maltese: Tnaqqis fl-għadd ta' ċelloli bojod tad-demm *Żieda fl- alanine aminotransferase (ALT) u żieda fl- aspartate aminotransferase (AST).
English: Angioedema, allergic reaction Metabolism and nutrition disorders Common
Maltese: Anġoedema reazzjoni allerġika Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: • When Pregabalin Sandoz 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 Sandoz 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: Pulmonary oedema, throat tightness,
Maltese: Edema pulmonari, għeluq tal-gerżuma
English: Funduscopic changes were observed in 1.7% of pregabalin-treated and 2.1% of placebo-treated patients.
Maltese: Bdil funduskopiku kien innutat f'1.7 % ta' dawk trattati bi pregabalin u 2.1 % ta' pazjenti fuq plaċebo.
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-posizzjoni, tregħid waqt moviment volontarju, nystagmus, disturb konoxxittiv, indeboliment mentali, disturb fid-diskors, nuqqas ta' riflessi, iperestesija, sensazzjoni ta' ħruq, telf tat-togħma, telqa
English: In the 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: 150 mg capsules:
Maltese: 150 mg kapsuli:
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 studji kliniċi kkontrollati, dożi orali multipli ta' pregabalin mogħtija flimkien ma' oxycodone, lorazepam, jew ethanol ma rriżultawx f'effetti klinikament importanti fuq ir-respirazzjoni.
English: Unit dose blisters containing 56 x 1, 84 x 1 or 100 x 1 hard capsules.
Maltese: Folji bid-doża tal-unità 56 x 1, 84 x 1 jew 100 x 1 kapsula iebsa.
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 il metaboliżmu tal-mediċina in vitro, u ma jeħilx mal-proteini tal-plasma, mhux probabbli li jipproduċi,jew ikun suġġett għal, interazzjonijiet farmakokinetiċi.
English: Unit dose blisters containing 56, 84 (2 x 42), 100 (2 x 50) or 210 (3 x 70) hard capsules.
Maltese: Folji bid-doża tal-unità 56, 84 (2 x 42), 100 (2 x 50) jew 210 (3 x 70) kapsula iebsa.
English: CZ-140 00 Praha 4 - Nusle Tel: +420 225 775 111 office.cz@sandoz.com
Maltese: Tel: +420 225 775 111 office.cz@sandoz.com
English: The pregabalin clinical program 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: Neuropathic pain Pregabalin Sandoz is indicated for the treatment of peripheral and central neuropathic pain in adults.
Maltese: Uġigħ nevrotiku Pregabalin Sandoz huwa indikat għall-kura ta' uġigħ periferali u ċentrali f'persuni adulti.
English: The percentage of subjects with at least a 50% reduction in partial onset seizures as compared to baseline was 40.6% of subjects treated with pregabalin 10 mg/kg/day (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% fl-aċċessjonijiet ta' bidu parzjali kkomparat mal-linja bażi kien ta' 40.6% mis-suġġetti kkurati bi pregabalin 10mg/kg/jum (p=0.0068 kontra il-plaċebo), 29.1% ta' suġġetti kkurati bi pregabalin 2.5mg/kg/jum (p=0.2600 kontra il-plaċebo) u 22.6% ta' dawk li kienu jirċievu l-plaċebo.
English: variations.nordic@sandoz.com
Maltese: Info.ee@sandoz.com
English: [For outer carton only]
Maltese: [Għall-kartuna ta' barra biss]
English: 225 mg capsules: Blisters containing 14, 56, 70, 84,100 or 120 hard capsules.
Maltese: 225 mg kapsuli: Folji li fihom 14, 56, 70, 84, 100 jew 120 kapsula iebsa.
English: 75 mg capsules:
Maltese: 75 mg kapsuli:
English: Blisters containing 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) or 120 (2 x 60) hard capsules.
Maltese: Folji li fihom 14, 21, 28, 56, 70, 84 (2 x 42), 100 (2 x 50) jew 120 (2 x 60) kapsula iebsa.
English: 200 mg capsules:
Maltese: 200 mg kapsuli:
English: In the 12-week placebo-controlled study, paediatric patients 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 ġew assenjati għal pregabalin 2.5mg/kg/jum (massimu, 150 mg/jum), pregabalin 10mg/kg/jum (massimu, 600mg/jum), jew ilplaċebo.
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; 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 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 it-tollerabilità, 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: 300 mg capsules:
Maltese: 300 mg kapsuli:
English: In the postmarketing 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: HDPE bottles containing 100, 200 or 250 hard capsules.
Maltese: Fliexken tal-HDPE li fihom 100, 200 jew 250 kapsula iebsa.
English: How to take Pregabalin Sandoz
Maltese: Tiħux Pregabalin Sandoz:
English: MARKETING AUTHORISATION HOLDER Sandoz GmbH
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Sandoz GmbH
English: Pregabalin Sandoz may be taken with oral contraceptives.
Maltese: Pregabalin Sandoz jista' jittieħed ma' kontraċettivi orali.
English: 25 mg capsules:
Maltese: 25 mg kapsuli:
English: Pregabalin Sandoz belongs to a group of medicines used to treat epilepsy, neuropathic pain and Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Sandoz jappartjeni għal grupp ta' mediċini li jintużaw għall-kura tal-epilessija, l-uġigħ nevrotiku u d-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) fl-adulti.
English: 100 mg capsules:
Maltese: 100 mg kapsuli:
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 il-plaċebo kellhom titjib ta' 50 % fil-punteġġ tal-uġigħ.
English: Following a dose of radiolabelled pregabalin, approximately 98% of the radioactivity recovered in the urine was unchanged pregabalin.
Maltese: Wara doża ta' pregabalin radjutikkettat, madwar 98 % tar-radjuattività rkuprata fl-awrina kien pregabalin mhux mibdul.
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Sandoz normally except if you have problems with your kidneys.
Maltese: Jekk int pazjent anzjan ('il fuq minn 65 sena), inti għandek tieħu Pregabalin Sandoz b'mod normali ħlief jekk ikollok problemi bil-kliewi.
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 mal-eta (ara sezzjoni 4.2 Tabella 1).
English: Generalised anxiety disorder Pregabalin Sandoz is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Sandoz huwa indikat għall-kura tad-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) f'persuni adulti.
English: • Some patients taking pregabalin have reported symptoms suggesting an allergic reaction.
Maltese: • Xi pazjenti li jużaw pregabalin irrappurtaw sintomi li jindikaw reazzoni allerġika.
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 viżiva kienet imnaqqsa fi 6.5 % ta' pazjenti ttrattati bi pregabalin, u fi 4.8 % ta' pazjenti ttratati bil-plaċebo.
English: Pharmacotherapeutic group: Anti epileptics, other anti-epileptics ATC code: N03AX16 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: 300 mg capsules Red opaque cap and pale yellow-brown opaque body, capsule size 0 (21.7 mm x 7.6 mm) filled with white to nearly white coloured powder.
Maltese: 300 mg kapsuli Għatu opak aħmar u korp opak ta' lewn isfar fil-kannella ċar, daqs talkapsula 0 (21.7 mm x 7.6 mm) mimlija bi trab ta' lewn abjad sa kważi abjad.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/001-010
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/001-010
English: 3 years.
Maltese: 6 xhur.
English: 50 mg capsules:
Maltese: 50 mg kapsuli:
English: INFORMATION IN BRAILLE Pregabalin Sandoz 225 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Sandoz 225 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/042-052
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/042-052
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 Disturbi fil-widnejn u fis-sistema labirintika Komuni
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/057-062
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/15/1011/057-062
English: The most common adverse events observed in the 12-week study with pregabalin treatment were somnolence, pyrexia, upper respiratory tract infection, increased appetite, weight increased, and nasopharyngitis (see sections 4.2, 5.1 and 5.2).
Maltese: L-avvenimenti avversi l-aktar komuni li ġew osservati flistudju ta' 12-il ġimgħa b'kura bi pregabalin kienu ngħas, deni, infezzjoni fl-apparat respiratorju ta' fuq, żieda fl-aptit, żieda fil-piż, u nażofarinġite (ara sezzjonijiet 4.2, 5.1 u 5.2).
English: HDPE container with PP screw cap.
Maltese: Kontenitur tal-HDPE b'tapp tal-kamin tal-PP.
English: 225 mg capsules Pale orange opaque cap and white opaque body, capsule size 1 (19.4 mm x 6.9 mm) filled with white to nearly white coloured powder.
Maltese: 225 mg kapsuli Għatu opak ta' lewn oranġjo ċar u korp opak abjad, daqs tal-kapsula 1 (19.4 mm x 6.9 mm) mimlija bi trab ta' lewn abjad sa kważi abjad.