FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: Pregabalin Mylan Pharma 100 mg hard capsules EU/1/15/998/023
Maltese: Pregabalin Mylan Pharma 100 mg kapsuli iebsin EU/1/15/997/023
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: The degree of dizziness, sleepiness and decreased concentration may be increased if Pregabalin Mylan Pharma is taken together with medicinal products containing:
Maltese: Il-livell ta' sturdament, irqad u konċentrazzjoni mnaqqsa jista' jiżdied jekk Pregabalin Mylan Pharma jittieħed ma' prodotti mediċinali oħra li fihom:
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan Pharma 150 mg
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan Pharma 75 mg
English: If you are an older patient (over 65 years of age), you should take Pregabalin Mylan Pharma normally except if you have problems with your kidneys.
Maltese: Jekk int pazjent aktar anzjan ('il fuq minn 65 sena), inti għandek tieħu Pregabalin Mylan Pharma b'mod normali ħlief jekk ikollok problemi bil-kliewi.
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 ġew 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: 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 proċessi deġenerattivi spontanji fl-organi riproduttivi tal-far.
English: These estimated doses are approximately 7% of the total daily maternal dose on a mg/kg basis.
Maltese: Dawn id-dożi stmati huma ta' madwar 7% tad-doża materna totali ta' kuljum fuq bażi ta' mg/kg.
English: • Pregabalin Mylan Pharma has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in elderly patients.
Maltese: • Pregabalin Mylan Pharma ġie assoċjat ma' sturdament u ngħas, li jistgħu jżidu l-okkorrenza ta' korriment aċċidentali (waqgħat) f'pazjenti anzjani.
English: In repeated dose toxicity studies in rats and monkeys CNS effects were observed, including hypoactivity, hyperactivity and ataxia.
Maltese: Fi studji dwar it-tossiċità b'dożi ripetuti kienu osservati effetti fuq is-CNS filfirien u x-xadini, fosthom nuqqas ta' attività, attività eċċessiva u atassja.
English: Lactation had little to no influence on pregabalin pharmacokinetics.
Maltese: It-treddigħ kellu ftit jew xejn influwenza fuq il-farmakokinetika ta' pregabalin.
English: There are post-marketing reports of events related to reduced lower gastrointestinal tract function (e.g. intestinal obstruction, paralytic ileus, constipation) when pregabalin was co-administered with medications that have the potential to produce constipation, such as opioid analgesics.
Maltese: Tnaqqis fil-funzjoni gastrointestinali fil-parti t'isfel Kien hemm rapporti ta' episodji assoċjati mal-funzjoni gastrointestinali fil-parti t'isfel (eż. imblukkar tal-intestini, ileus paralitiku, stitikezza) fl-esperjenza ta' wara t-tqegħid fis-suq, meta pregabalin ġie mogħti flimkien ma' mediċini li għandhom potenzjal li jikkawżaw stitikezza, bhal analġesiċi opjojdi.
English: Pregabalin Mylan Pharma 200 mg hard capsule
Maltese: Pregabalin Mylan Pharma 200 mg kapsula iebsa
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 ta' pregabalin wara li jiġi amministrat mill-ħalq huwa madwar 0.56 l/kg.
English: EU/1/15/998/045 EU/1/15/998/046 EU/1/15/998/047 EU/1/15/998/050 EU/1/15/998/048 EU/1/15/998/049
Maltese: EU/1/15/998/046 EU/1/15/998/047 EU/1/15/998/048 EU/1/15/998/049
English: Pregabalin Mylan Pharma 75 mg hard capsule
Maltese: Pregabalin Mylan Pharma 75 mg kapsula iebsa
English: Pregabalin Mylan Pharma 200 mg hard capsules EU/1/15/998/035
Maltese: Pregabalin Mylan Pharma 200 mg kapsuli iebsin EU/1/15/997/035
English: Pregabalin undergoes negligible metabolism in humans.
Maltese: Il-metaboliżmu ta' pregabalin fil-bniedem huwa negliġibbli.
English: Investigations Common Uncommon
Maltese: Mhux komuni Rari
English: Pregabalin has been studied in 3 controlled clinical trials of 12 week duration with either BID or TID dosing.
Maltese: Pregabalin ġie studjat fi 3 provi kliniċi kkontrollati li damu 12-il ġimgħa fejn ingħataw dożi BID jew TID.
English: How to store Pregabalin Mylan Pharma
Maltese: Mediċini oħra u Pregabalin Mylan Pharma
English: BGP Products UAB Tel: +370 5 205 1288
Maltese: Tel: +370 5 205 1288
English: Breast-feeding mothers
Maltese: Indeboliment tal-fwied
English: Rash papular, urticaria, hyperhidrosis, pruritus
Maltese: Axxite, pankreatite, ilsien minfuħ, disfaġja
English: Pregabalin Mylan Pharma 25 mg hard capsules EU/1/15/998/001
Maltese: Pregabalin Mylan Pharma 25 mg kapsuli iebsin EU/1/15/998/001
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 200 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan Pharma 200 mg
English: • Oxycodone - (used as a pain-killer)
Maltese: Oxycodone - (użat biex itaffi l-uġigħ) Lorazepam - (użat għall-kura ta' ansjetà) Alkoħol
English: Joint swelling, myalgia, muscle twitching, neck pain, muscle stiffness Rhabdomyolysis
Maltese: Disfunzjoni ta' natura sesswali, dewmien fl-ejakulazzjoni, diżmenorreja, uġigħ fis-sider
English: Pregabalin Mylan Pharma 100 mg hard capsule
Maltese: Pregabalin Mylan Pharma 100 mg kapsula iebsa
English: Pregabalin Mylan Pharma 150 mg hard capsule
Maltese: Pregabalin Mylan Pharma 150 mg kapsula iebsa
English: EU/1/15/998/001 EU/1/15/998/002 EU/1/15/998/003 EU/1/15/998/004 EU/1/15/998/005 EU/1/15/998/006 EU/1/15/998/007 EU/1/15/998/008
Maltese: EU/1/15/998/005 EU/1/15/998/006 EU/1/15/998/007 EU/1/15/998/008
English: Pregabalin Mylan Pharma 225 mg hard capsules EU/1/15/998/040
Maltese: Pregabalin Mylan Pharma 225 mg kapsuli iebsin EU/1/15/997/040
English: EU/1/15/998/023 EU/1/15/998/024 EU/1/15/998/025 EU/1/15/998/026 EU/1/15/998/027
Maltese: EU/1/15/998/025 EU/1/15/998/026 EU/1/15/998/027
English: Pregabalin Mylan Pharma 300 mg hard capsule
Maltese: Pregabalin Mylan Pharma 300 mg kapsula iebsa
English: Pregabalin Mylan Pharma 25 mg hard capsules PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules.
Maltese: Pakkett bil-folji tal-PVC/PVDC-Al li jkun fih 14, 21, 56, 84 u 100 kapsula iebsa.
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 100 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan Pharma 100 mg
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan Pharma 300 mg
English: HDPE bottle pack containing 200 hard capsules.
Maltese: Flixkun tal-HDPE li jkun fih 200 kapsula iebsa.
English: The maximum dose of 600 mg per day may be achieved after an additional week.
Maltese: Id-doża massima ta' 600 mg kuljum tista' tinkiseb wara ġimgħa addizzjonali.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 150 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 150 mg ta' pregabalin.
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Maltese: 14-il kapsula iebsa 21 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 56 x 1 kapsula iebsa 84 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: The safety and efficacy of Pregabalin Mylan Pharma in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Pregabalin Mylan Pharma fit-tfal ta' taħt it-12 -il sena u l-adoloxxenti (12-17 -il sena) ma ġewx determinati s'issa.
English: In the clinical studies where ophthalmologic testing was conducted, the incidence of visual acuity reduction and visual field changes was greater in pregabalin-treated patients than in placebo-treated patients; the incidence of fundoscopic changes was greater in placebo-treated patients (see section 5.1).
Maltese: Fl-istudji kliniċi fejn saru testijiet oftalmoloġiċi, l-inċidenza ta' tnaqqis ta' l-akuita' viżiva u bdil fil-kamp viżwali kienu aktar f'pazjenti fuq kura bi preglabalin milli f'pazjenti fuq plaċebo; linċidenza ta' bdil fundoskopiku kien ogħla minn f'pazjenti ttrattati bi plaċebo (Ara sezzjoni 5.1).
English: Pregabalin Mylan Pharma 150 mg hard capsules EU/1/15/998/028
Maltese: Pregabalin Mylan Pharma 150 mg kapsuli iebsin EU/1/15/997/028
English: No specific pharmacodynamic interaction studies were conducted in elderly volunteers.
Maltese: Ma sarux studji speċifiċi dwar l-interazzjoni farmakodinamika f'voluntiera anzjani.
English: Pregabalin Mylan Pharma 25 mg hard capsule
Maltese: Pregabalin Mylan Pharma 25 mg kapsula iebsa
English: Euphoric mood, confusion, irritability, disorientation, insomnia, libido decreased
Maltese: Burdata ewforika, konfużjoni, irritabilità, diżorjentament, nuqqas ta' rqad, tnaqqis fil-libido,
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan Pharma 25 mg
English: Pregabalin Mylan Pharma 50 mg hard capsule
Maltese: Pregabalin Mylan Pharma 50 mg kapsula iebsa
English: Suicidal ideation and behaviour
Maltese: Ideat u atteġġamenti ta' suwiċidju
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 200 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 200 mg ta' pregabalin.
English: EXP
Maltese: Vertigo
English: Withdrawal symptoms
Maltese: Sintomi ta' l-irtirar tal-mediċina
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 50 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Pregabalin Mylan Pharma 50 mg
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 300 mg ta' pregabalin.
English: PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1, 84 x 1 and 100 x 1 hard capsules.
Maltese: Pakkett bil-folji perforati tal-PVC/PVDC-Al b'doża tal-unità li jkun fih jkun fih 56 x 1, 84 x 1 u 100 x 1 kapsula iebsa.
English: What Pregabalin Mylan Pharma is and what it is used for Pregabalin Mylan Pharma contains the active substance pregabalin which belongs to a group of medicines used to treat epilepsy and Generalised Anxiety Disorder (GAD) in adults.
Maltese: Pregabalin Mylan Pharma fih is-sustanza attiva pregabalin li tappartjeni għal grupp ta' mediċini li jintużaw għall-kura ta' l-epilessija u d-Disturb ta' Ansjetà Ġeneralizzata (GAD - Generalised Anxiety Disorder) fl-adulti.
English: Hypersensitivity Angioedema, allergic reaction
Maltese: Sensittività eċċessiva Anġoedema, reazzjoni allerġika Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: Adverse reactions were usually mild to moderate in intensity.
Maltese: Ġeneralment ir-reazzjonijiet avversi kienu ta' severità ħafifa għal moderata.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 225 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 225 mg ta' pregabalin.
English: Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 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 84 x 1, 100 x 1 kapsula.
English: 14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Maltese: 14 kapsula iebsa 56 kapsula iebsa 100 kapsula iebsa 200 kapsula iebsa 14 x 1 kapsula iebsa 56 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Maltese: 14 kapsula iebsa 21 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 100 kapsula iebsa 84 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: Since pregabalin does not undergo significant metabolism and is excreted predominantly as unchanged drug in the urine, impaired liver function would not be expected to significantly alter pregabalin plasma concentrations.
Maltese: Billi pregabalin ma jiġix metabolizzat b'mod sinifikanti u jitneħħa fil-biċċa l-kbira bħala mediċina mhux mibdula fl-awrina, indeboliment fil-funzjoni tal-fwied mhux mistenni li jbiddel b'mod sinifikanti l-konċentrazzjonijiet ta' pregabalin fil-plasma.
English: This decrease in pregabalin oral clearance is consistent with decreases in creatinine clearance associated with increasing age.
Maltese: Dan it-tnaqqis fittneħħija orali ta' pregabalin huwa konsistenti mat-tnaqqis fit-tneħħija ta' krejatinina assoċjat mattkabbir fl-età.
English: EU/1/15/998/009 EU/1/15/998/010 EU/1/15/998/011 EU/1/15/998/012 EU/1/15/998/013 EU/1/15/998/014 EU/1/15/998/015
Maltese: EU/1/15/998/011 EU/1/15/998/012 EU/1/15/998/013 EU/1/15/998/014
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 100 mg ta' pregabalin.
English: Pregabalin Mylan Pharma 300 mg hard capsules EU/1/15/998/045
Maltese: Pregabalin Mylan Pharma 300mg kapsuli iebsin EU/1/15/997/045
English: Population pharmacokinetic analysis showed that creatinine clearance was a significant covariate of pregabalin oral clearance, body weight was a significant covariate of pregabalin apparent oral volume of distribution, and these relationships were similar in paediatric and adult patients.
Maltese: Analiżi tal-farmakokinetika tal-popolazzjoni wriet li t-tneħħija tal-kreatinina kienet kovarjant sinifikanti ta' tneħħija orali ta' pregabalin; il-piż tal-ġisem kien kovarjant sinifikanti tal-volum apparenti tad-distribuzzjoni ta' pregabalin, u dawn ir-relazzjonijiet kienu simili f'pazjenti pedjatriċi u adulti.
English: Ear and labyrinth disorders Common
Maltese: Disturbi vaskulari Mhux komuni
English: Pregabalin Mylan Pharma 100 mg hard capsules PVC/PVDC-Al blister pack containing 21, 84 and 100 hard capsules.
Maltese: Pakkett bil-folji tal-PVC/PVDC-Al li jkun fih 21, 84 u 100 kapsula iebsa.
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 ma' l-ikel biex tirriżulta fi tnaqqis ta' madwar 20-30% fil-Cmax u dewmien fit-tmax ta' madwar 2.5 sigħat.
English: Pregabalin Mylan Pharma 50 mg hard capsules EU/1/15/998/009
Maltese: Pregabalin Mylan Pharma 50 mg kapsuli iebsin EU/1/15/997/009
English: Hepatic failure, hepatitis
Maltese: Insuffiċjenza tal-fwied, epatite
English: PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard capsules
Maltese: Pakkett bil-folji perforati tal-PVC/PVDC-Al b'doża tal-unità li jkun fih jkun fih 14 x 1, 56 x 1 u 100 x 1 kapsula iebsa.
English: Pregabalin Mylan Pharma and certain other medicines may influence each other (interaction).
Maltese: Pregabalin Mylan Pharma u xi mediċini oħra jistgħu jaffettwaw lil xulxin (interazzjoni).
English: Available in blister packs containing 21, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules.
Maltese: Disponibbli f'pakketti bil-folji li jkun fihom 21, 84, 100 kapsula u f'pakketti ta' folji perforati li jkun fihom 84 x 1, 100 x 1 kapsula.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Maltese: F'okkażjonijiet rari, ġew irrapurtati każijiet ta' koma.
English: Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules.
Maltese: Disponibbli f'pakketti bil-folji li jkun fihom 14, 56, 100 kapsula, f'pakketti ta' folji perforati li jkun fihom 14 x 1, 56 x 1, 100 x 1 kapsula u fi fliexken li jkun fihom 200 kapsula.
English: The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing ≥30 kg.
Maltese: L-AUC kien inqas bi 30% f'pazjenti pedjatriċi b'piż ta' inqas minn 30 kg minħabba żieda fittneħħija aġġustata għall-piż tal-ġisem ta' 43% għal dawn il-pazjenti meta mqabbla ma' pazjenti li kienu jiżnu ≥30 kg.
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
Maltese: • Nuqqas ta' attenzjoni, guffaġni, indeboliment tal-memorja, telf tal-memorja, tregħid, diffikulta'
English: • Hypersensitivity, swollen face, itchiness, hives, runny nose, nose bleed, cough, snoring
Maltese: • Sensittività eċċessiva, nefħa fil-wiċċ, ħakk, urtikarja, imnieħer inixxi, fsada mill-imnieħer, sogħla, inħir.
English: • Weakness, thirst, chest tightness
Maltese: • Sturdament, ħedla, uġigħ ta' ras
English: Available in blister packs containing 14, 56, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules.
Maltese: Disponibbli f'pakketti bil-folji li jkun fihom 14, 56, 100 kapsula u f'pakketti ta' folji perforati li jkun fihom 56 x 1, 100 x 1 kapsula.
English: Urinary incontinence, dysuria Renal failure, oliguria, urinary retention
Maltese: Inkontinenza tal-awrina, disurja
English: Pregabalin Mylan Pharma 75 mg hard capsules The 75 mg capsules are No. 4, light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Maltese: Wara esponiment fit-tul għal pregabalin f'esponimenti ta' ≥ 5 darbiet l-esponiment uman medju bid-doża klinika massima rakkomandata kienet osservata inċidenza akbar ta' atrofija tar-retina li normalment tidher f'firien albini xjuħ.
English: Epilepsy: Pregabalin Mylan Pharma is used to treat a certain form of epilepsy (partial seizures with or without secondary generalisation) in adults.
Maltese: Pregabalin Mylan Pharma tintuża sabiex tiġi kkurata ċerta forma ta' epilessija (aċċessjonijiet parzjali bi jew mingħajr ġeneralizzazzjoni sekondarja) fl-adulti.
English: When taken with certain other medicines, Pregabalin Mylan Pharma may potentiate the side effects seen with these medicines, including respiratory failure and coma.
Maltese: Meta Pregabalin Mylan Pharma tiġi meħuda ma' ċertu mediċini oħra, tista tqawwi l-effetti sekondarji li ntwerew b' dawn il-mediċini u li jinkludu insuffiċjenza respiratorja u koma.
English: Dizziness, somnolence, loss of consciousness, confusion and mental impairment Pregabalin treatment has been associated with dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population.
Maltese: Sturdament, ngħas, ħass ħażin, konfużjoni u indeboliment mentali Il-kura bi pregabalin ġiet assoċjata ma' sturdament u ngħas, li jistgħu jżidu l-okkorrenza ta' korriment aċċidentali (waqgħat) fil-popolazzjoni anzjana.
English: Pregabalin Mylan Pharma 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Maltese: Pregabalin Mylan Pharma 100 mg kapsuli iebsin Pregabalin
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 75 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 75 mg ta' pregabalin.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 50 mg ta' pregabalin.
English: • Painful menstrual periods
Maltese: • Diffikultà biex tibla.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 25 mg pregabalin.
Maltese: Kull kapsula iebsa fiha 25 mg ta' pregabalin.
English: • Change in perception of self, restlessness, depression, agitation, mood swings, difficulty finding words, hallucinations, abnormal dreams, panic attacks, apathy, aggression, elevated mood, mental impairment, difficulty with thinking, increase in sexual interest, problems with sexual functioning including inability to achieve a sexual climax, delayed ejaculation
Maltese: • Bidla fil-mod kif tħares lejk innifsek, irrekwitezza, depressjoni, aġitazzjoni, bidliet fil-burdata, diffikulta' biex issib il-kelma, alluċinazzjonijiet, ħolm anormali, attakk ta' paniku, apatja, agressjoni, burdata ta' entużjażmu, indeboliment mentali, diffikulta' biex taħseb, żieda flinteress sesswali, problemi fil-funzjoni ta' natura sesswali li jinkludu inkapaċità li tilħaq orgażmu, dewmien fl-ejakulazzjoni.
English: Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue
Maltese: Edema periferali, edema, mixja anormali, waqgħat, sensazzjoni ta' wieħed fis-sakra, għeja
English: 14 hard capsules 56 hard capsules 100 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Maltese: 14-il kapsula iebsa 56 kapsula iebsa 100 kapsula iebsa 56 x 1 kapsula iebsa 100 x 1 kapsula iebsa
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Pregabalin has been studied in 1 controlled clinical trial of 56 week duration with BID dosing.
Maltese: Monoterapija (pazjenti li għadhom kemm ġew iddijanjostikati) Pregabalin ġie studjat fi prova klinika waħda kkontrollata li damet 56 ġimgħa b'dożaġġ BID).
English: Pregabalin Mylan Pharma 75 mg hard capsules Each hard capsule contains 75 mg of pregabalin.
Maltese: Pregabalin Mylan Pharma 75 mg kapsuli iebsin Pregabalin
English: As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:
Maltese: Billi t-tneħħija ta' pregabalin hija direttament proporzjonali mat-tneħħija talkreatinina (ara sezzjoni 5.2), it-tnaqqis fid-doża f'pazjenti b'funzjoni renali kompromessa jrid ikun individwalizzat skond it-tneħħija tal-kreatinina (CLcr), kif indikat f'Tabella 1 stabbilit billi tintuża lformula li ġejja:
English: • Flushing, hot flushes
Maltese: • Żieda fl-aptit
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 225 mg hard capsules pregabalin
Maltese: Pregabalin Mylan Pharma 225 mg kapsuli iebsin Pregabalin
English: Pregabalin and lamotrigine were similarly safe and well tolerated.
Maltese: Pregabalin u lamotrigine kellhom sigurtà simili u kienu ttollerati tajjeb.
English: • A small number of people being treated with anti-epileptics such as Pregabalin Mylan Pharma have had thoughts of harming or killing themselves.
Maltese: • Numru zgħir ta' pazjenti li jkunu qed jirċievu kura bi prodotti mediċinali kontra l-epilessija bħal-Pregabalin Mylan Pharma, kellhom ħsibijiet li jweġġgħu lilhom infushom jew li jagħmlu suwiċidju.
English: • Changes in blood and liver test results (blood creatinine phosphokinase increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased,
Maltese: • Bidliet fir-riżultati tat-testijiet tad-demm u tal-fwied (żieda fil-kreatina phosphokinase fiddemm, żieda fl-alanine aminotransferase, żieda fl-aspartate aminotransferase, tnaqqis fl-għadd ta' pjastrini, newtropenja, żieda fil-kreatinina fid-demm, tnaqqis fil-potassju fid-demm).