FrancophonIA/ELRC3.0 huggingface dataset:
English: A fertility study in female rats has shown adverse reproductive effects.
Maltese: Studju ta' fertilità fil-firien femminili wera effetti avversi fuq is-sistema riproduttiva.
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 lebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jistgħu jaffettwaw sa persuna 1 minn kull 1,000:
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 wieћed mill-eċċipjenti elenkati fissezzjoni 6.1.
English: Pregabalin Mylan Pharma 25 mg hard capsules Pregabalin Mylan Pharma 50 mg hard capsules Pregabalin Mylan Pharma 75 mg hard capsules Pregabalin Mylan Pharma 100 mg hard capsules Pregabalin Mylan Pharma 150 mg hard capsules Pregabalin Mylan Pharma 200 mg hard capsules Pregabalin Mylan Pharma 225 mg hard capsules Pregabalin Mylan Pharma 300 mg hard capsules
Maltese: Pregabalin Mylan Pharma 25 mg kapsuli iebsin Pregabalin Mylan Pharma 50 mg kapsuli iebsin Pregabalin Mylan Pharma 75 mg kapsuli iebsin Pregabalin Mylan Pharma 100 mg kapsuli iebsin Pregabalin Mylan Pharma 150 mg kapsuli iebsin Pregabalin Mylan Pharma 200 mg kapsuli iebsin Pregabalin Mylan Pharma 225 mg kapsuli iebsin Pregabalin Mylan Pharma 300 mg kapsuli iebsin
English: Pregabalin is not bound to plasma proteins.
Maltese: Pregabalin ma jeħilx mal-proteini tal-plasma.
English: Starting dose (mg/day)
Maltese: Doża inizjali (mg/ġurnata)
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: 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: Tachycardia, atrioventricular block first degree, sinus bradycardia, congestive heart failure
Maltese: Takikardija, imblokk atrijoventrikolari tal-ewwel grad, sinus bradycardia, insuffiċjenza tal-qalb konġestiva
English: The marketing authorisation holder (MAH) shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
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, iperestesija, sedazzjoni, disturbi fil-bilanċ, letarġija
English: Ascites, pancreatitis, Swollen tongue, dysphagia
Maltese: Aċċessjonijiet, parosmia, ipokinesja, disgrafija
English: Total pregabalin daily dose *
Maltese: Doża totali ta' pregabalin kuljum
English: • When Pregabalin Mylan Pharma 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 Mylan Pharma tkun qed tittieħed ma' mediċini oħrajn li jikkawżaw listitikezza (bħal ċerti tipi ta' mediċini li jingħataw għall-uġigħ) jista' jkun possibli li jkun hemm problemi gastroinestinali (eż. stitikezza, imsaren imblukkati jew paralizzati).
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: Very rare: may affect up to 1 in 10,000 people
Maltese: Rari Ħafna: jistgħu jaffettwaw sa persuna 1 minn kull 10,000
English: Nasopharyngitis
Maltese: Rhabdomyolysis
English: In conventional safety pharmacology studies in animals, pregabalin was well-tolerated at clinically relevant doses.
Maltese: Fi studji konvenzjonali ta' sigurtà farmakoloġika, pregabalin kien ittollerat b'mod tajjeb f'dożi klinikament rilevanti.
English: BID or TID BID or TID
Maltese: BID jew TID BID jew TID Darba Kuljum jew BID
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for pregabalin.
Maltese: Il-mekkaniżmu ta' dan ir-riskju għadu mhux magħruf u l-informazzjoni disponibbli ma teskludix il-possibilita ta' żieda fir-riskju għal pregabalin.
English: Mylan S.A.S
Maltese: FIS-SUQ Mylan S.A.S
English: • Kidney failure, reduced urine volume, urinary retention
Maltese: • Insuffiċjenza tal-kliewi, volum anqas ta'awrina, ritenzjoni urinarja.
English: Pulmonary oedema, throat tightness
Maltese: Edema pulmonari, għeluq tal-gerżuma
English: Elevated liver enzymes Jaundice
Maltese: Enzimi tal-fwied elevati* Suffejra
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-δproteini) ta' kanali tal-kalċju kkontrollati b'vultaġġ fissistema nervuża ċentrali.
English: Mylan Hungary Kft, Mylan utca 1, Komárom, 2900, Hungary McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Maltese: McDermott Laboratories Limited t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, L-Irlanda
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: 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 2.5 mg/kg/jum (massimu, 150 mg/jum), pregabalin 10/mg/kg/jum (massimu, 600 mg/jum), jew ilplaċebo.
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
Maltese: Ir-riżultati ta' 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: • Liver failure.
Maltese: • Waqfien fil-mestruwazzjoni.
English: • Swelling of the body including extremities
Maltese: • Nefħa fil-ġisem, inkluż l-estremitajiet
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 tiġi aġġustata għalik u għall-kondizzjoni tiegħek, ġeneralment tkun bejn 150 mg u 600 mg kuljum.
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 fl-istudju 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: 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: 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, ipoestesija, sensazzjoni ta' ħruq, telf tat-togħma, telqa
English: Pregabalin appears to be additive in the impairment of cognitive and gross motor function caused by oxycodone.
Maltese: Pregabalin jidher li hu addittiv flindeboliment tal-funzjoni konoxxittiva u motorja globali kkawżat minn oxycodone.
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) ġiet evalwata f'10 nisa li kienu qed ireddgħu li kien ilhom mill-inqas 12-il ġimgħa li welldu.
English: Appetite increased Anorexia, hypoglycaemia
Maltese: Anoressija, ipogliċemija
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: 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 li kellhom sa 6 snin, u minn 4 sa 6 sigħat f'dawk li kellhom 7 snin u aktar.
English: Following repeated administration, steady state is achieved within 24 to 48 hours.
Maltese: Wara li jingħata diversi drabi, stat stabbli jinkiseb fi żmien 24 sa 48 siegħa.
English: Pregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Mylan Pharma huwa indikat għall-kura tad-Disturb ta' Ansjetà Ġeneralizzata (GADGeneralised Anxiety Disorder) f'persuni adulti.
English: Pharmaceutical Trading Co. Ltd. Τηλ: + 357 99403969
Maltese: Τηλ: + 357 99403969
English: Discontinuation of pregabalin
Maltese: Pregabalin
English: Following an additional week the dose may be increased to 450 mg per day.
Maltese: Wara ġimgħa addizzjonali d-doża tista' tiżdied għal 450 mg kuljum.
English: Gastrooesophageal reflux disease, salivary hypersecretion, hypoaesthesia oral
Maltese: Mard tar-rifluss gastroesofagali, sekrezzjoni eċċessiva tas-saliva, ipoestesija orali
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: • Inflammation of the pancreas
Maltese: • Żieda fil-piż
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 ittollerabilità, n=65; 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: Epilepsy or Generalised Anxiety Disorder:
Maltese: Epilessija jew Disturb ta' Ansjetà Ġeneralizzata:
English: Nervous system disorders Very common Common
Maltese: Disturbi fis-sistema nervuża Komuni ħafna
English: The pregabalin clinical programme involved over 8900 patients exposed to pregabalin, of whom over 5600 were in double-blind placebo controlled 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: Pregabalin Adverse Drug Reactions System Organ Class
Maltese: Sistema tal-klassifika talorgani
English: Dyspnoea, epistaxis, cough, nasal congestion, rhinitis, snoring, nasal dryness
Maltese: Dispnea, epistassi, sogħla, konġestjoni nażali, rinite, nħir, nixfa nażali
English: Mechanism of action
Maltese: Darba Kuljum
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: In juvenile rats the types of toxicity do not differ qualitatively from those observed in adult rats.
Maltese: It-tipi ta' tossiċità fil-firien żgħar mhumiex differenti minn dawk osservati fil-firien adulti.
English: Supplementary dosage following haemodialysis (mg)
Maltese: Doża supplimentari wara ħemodijaliżi (mg)
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: PHARMACEUTICAL FORM AND CONTENTS Hard capsule.
Maltese: U KONTENUT Kapsula, iebsa.
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: Vision blurred, diplopia
Maltese: Vista mċajpra, vista doppja
English: • Some patients taking Pregabalin Mylan Pharma have reported symptoms suggesting an allergic reaction.
Maltese: • Xi pazjenti li jużaw Pregabalin Mylan Pharma irrappurtaw sintomi li jindikaw reazzoni allerġika.
English: There have also been post-marketing reports of loss of consciousness, confusion and mental impairment.
Maltese: Kien hemm ukoll rapporti ta' wara t-tqegħid fis-suq ta' ħass ħażin, konfużjoni u indeboliment mentali.
English: The estimated infant dose from breast milk (assuming mean milk consumption of 150 ml/kg/day) of women receiving 300 mg/day or the maximum dose of 600 mg/day would be 0.31 or 0.62 mg/kg/day, respectively.
Maltese: Id-doża stmata tat-trabi mill-ħalib tas-sider (jekk wieħed jassumi medja ta' konsum ta' ħalib ta' 150 ml/kg/jum) ta' nisa li kienu qed jirċievu 300 mg/jum jew id-doża massima ta' 600 mg/jum tkun ta' 0.31 jew 0.62 mg/kg/jum, rispettivament.
English: Erectile dysfunction
Maltese: Disfunzjoni tal-erezzjoni
English: V.J.
Maltese: Ltd.
English: Pregabalin Cmax and AUC parameters increased in a linear manner with increasing dose within each age group.
Maltese: Il-parametri tas-Cmax u l-AUC ta' pregabalin żdiedu b'mod lineari ma' żieda fid-doża f'kull grupp ta' età.
English: • Jaundice (yellowing of the skin and eyes).
Maltese: • Suffejra (sfurija tal-ġilda jew ta' l-għajnejn).
English: Pregabalin Mylan Pharma 150 mg hard capsules PVC/PVDC-Al blister pack containing 14, 56 and 100 hard capsules.
Maltese: Pregabalin Mylan Pharma 150 mg kapsuli iebsin Pakkett bil-folji tal-PVC/PVDC-Al li jkun fih 14, 56 u 100 kapsula iebsa.
English: Pregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Maltese: Pregabalin Mylan Pharma huwa indikat bħala terapija aġġuntiva f'persuni adulti li jbatu minn aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Maltese: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, L-Olanda
English: Immune system disorders Uncommon
Maltese: Mhux komuniNewtropenja Disturbi fis-sistema immuni
English: How to store Pregabalin Mylan Pharma 6.
Maltese: Kif taħżen Pregabalin Mylan Pharma 6.
English: EU/1/15/998/016 EU/1/15/998/017 EU/1/15/998/018 EU/1/15/998/022 EU/1/15/998/019 EU/1/15/998/020 EU/1/15/998/021
Maltese: EU/1/15/998/016 EU/1/15/998/017 EU/1/15/998/018 EU/1/15/998/019 EU/1/15/998/020
English: Pharmacotherapeutic group: Anti-epileptics, other anti-epileptics, ATC code: N03AX16.
Maltese: Kura kontra l-epilessija, kura oħra kontra l-epilessija Kodiċi ATC:
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: 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 ilkelma, ħolm anormali, żieda fil-libido, inkapaċità li tilħaq orgażmu, apatija
English: Pregabalin Mylan Pharma may be taken with oral contraceptives.
Maltese: Pregabalin Mylan Pharma jista' jittieħed ma' kontraċettivi orali.
English: Single dose+
Maltese: Doża waħda+
English: • Feeling of elation, confusion, disorientation, decrease in sexual interest, irritability
Maltese: • Sensazzjoni ta' ferħ kbir, konfużjoni, diżorjentament, tnaqqis fl-interess sesswali, irritabilità
English: EU/1/15/998/040 EU/1/15/998/041 EU/1/15/998/042 EU/1/15/998/043 EU/1/15/998/044
Maltese: EU/1/15/998/041 EU/1/15/998/042 EU/1/15/998/043 EU/1/15/998/044
English: Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests.
Maltese: Pregabalin mhux ġenotossiku skond ir-riżultati ta' sensiela ta' testijiet in vitro u in vivo.
English: Pregabalin clearance tends to decrease with increasing age.
Maltese: Hemm tendenza li t-tneħħija ta' pregabalin tonqos aktar ma wieħed jikber fl-età.
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: Adjunctive Treatment
Maltese: TAL-PRODOTT MEDIĊINALI
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 225 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan Pharma 225 mg
English: Neutropaenia
Maltese: Nasofarinġite
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 l-episodji li ġejjin: nuqqas ta' rqad, uġigħ ta' ras, dardir, ansjetà, dijarea, sindrome ta' l-influwenza, nervożità, depressjoni, uġigħ, aċċessjoni, iperidrosi u sturdament, li jindika dipendenza fiżika.
English: EU/1/15/998/035 EU/1/15/998/036 EU/1/15/998/037 EU/1/15/998/038 EU/1/15/998/039
Maltese: EU/1/15/998/036 EU/1/15/998/037 EU/1/15/998/038 EU/1/15/998/039
English: Pregabalin is excreted into human milk (see section 5.2).
Maltese: Pregabalin jiġi eliminat fil-ħalib tas-sider tal-bniedem (ara sezzjoni 5.2).
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: • Blurred vision, double vision
Maltese: • Vista mċajpra, vista doppja
English: Pregabalin is removed effectively from plasma by haemodialysis (50% of drug in 4 hours).
Maltese: Pregabilin jitneħħa b'mod effettiv mill-plasma b'ħemodijaliżi (50% tal-mediċina f'4 sigħat).
English: B. PACKAGE LEAFLET
Maltese: • Diffikultajiet bl-erezzjoni
English: Pregabalin Mylan Pharma 75 mg hard capsules EU/1/15/998/016
Maltese: Pregabalin Mylan Pharma 75 mg kapsuli iebsin EU/1/15/997/016
English: 21 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Maltese: 21 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 84 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 84 x 1, 100 x 1 capsules.
Maltese: Disponibbli f'pakketti bil-folji li jkun fihom 14, 21, 56, 84, 100 kapsula u f'pakketti ta' folji perforati li jkun fihom 56 x 1, 84 x 1, 100 x 1 kapsula.
English: Pregabalin steady-state pharmacokinetics are similar in healthy volunteers, patients with epilepsy receiving anti-epileptic drugs and patients with chronic pain.
Maltese: Il-farmakokinetiċi stabbli ta' pregabalin huma simili f'voluntiera b'saħħithom, f'pazjenti bl-epilessija li jkunu qegħdin jieħdu mediċina kontra l-epilessija u f'pazjenti b'uġigħ kroniku.
English: Fertility studies in male rats have shown adverse reproductive and developmental effects.
Maltese: Studji ta' fertilità fil-firien maskili wera effetti avversi fuq is-sistema riproduttiva u ta' żvilupp.
English: Pregabalin Mylan Pharma 225 mg hard capsule
Maltese: Pregabalin Mylan Pharma 225 mg kapsula iebsa
English: LIST OF EXCIPIENTS
Maltese: Pazjenti dijabetiċi