FrancophonIA/ELRC3.0 huggingface dataset:
English: A wide consultation was done on the request of PRAC to gather all the latest information in terms of scientific and clinical knowledge with the consultation of two scientific groups (neurology and psychiatry), and to collect information from healthcare professionals, female patients themselves as well their families, from patient organisations (public hearing, stake holders meeting) who are advocating to better characterise and increase the awareness on the risk of harm to the foetus when using valproate during pregnancy.
Maltese: Fuq talba tal-PRAC saret konsultazzjoni wiesgħa biex tinġabar l-aħħar informazzjoni kollha f'termini talgħarfien xjentifiku u kliniku bil-konsultazzjoni ta' żewġ gruppi xjentifiċi (newroloġija u psikjatrija), u biex tinġabar informazzjoni mill-professjonisti fil-qasam tal-kura tas-saħħa, mill-pazjenti nisa nfushom kif ukoll il-familji tagħhom, mill-organizzazzjonijiet tal-pazjenti (smigħ pubbliku, laqgħa tal-partijiet ikkonċernati) li qed iħeġġu karatterizzazzjoni aħjar u żieda fis-sensibilizzazzjoni dwar ir-riskju ta' ħsara lill-fetu meta jintuża valproate waqt it-tqala.
English: In one experiment it was shown that a change in gene expression (one gene) in male mice after exposure to a histone deacetylases (HDAC) inhibitor (not valproate) was observed also in the offspring of these mice (Jia et al, 2015)1, so possible in principle.
Maltese: F'esperiment wieħed intwera li bidla fl-espressjoni ġenika (ġene wieħed) fi ġrieden irġiel wara li ġew esposti għal inibitur talhistone deacetylases (HDAC) (mhux valproate) ġiet osservata wkoll fil-wild ta' dawn il-ġrieden (Jia et al, 2015)1, għalhekk dan huwa possibbli fil-prinċipju.
English: The potential impact of paternal use of valproate, the potential effect on the third generation offspring and the potential effects on mitochondria (mitochondrial toxicity) were discussed.
Maltese: Ġew diskussi l-impatt potenzjali tal-użu paternali ta' valproate, l-effett potenzjali fuq il-wild tat-tielet ġenerazzjoni u l-effetti potenzjali fuq mitokondrija (tossiċità mitokondrijali).
English: Jia H, Morris CD, Williams RM, Loring JF, Thomas EA. HDAC inhibition imparts beneficial transgenerational effects in Huntington's disease mice via altered DNA and histone methylation.
Maltese: 1 Jia H, Morris CD, Williams RM, Loring JF, Thomas EA.
English: An early communication of complete information about the risks of valproate is considered essential.
Maltese: Komunikazzjoni bikrija ta' informazzjoni kompluta dwar ir-riskji ta' valproate hija kkunsidrata essenzjali.
English: It was shown in a transgenerational experiment in mice that administration of valproate during pregnancy (day 10) produced autism-like symptoms and increased expression of several proteins in the brains up to the third generation offspring.
Maltese: F'esperiment transġenerazzjonali fil-ġrieden intwera li l-għoti ta' valproate waqt it-tqala (jum 10) ipproduċa sintomi simili għall-awtiżmu u żied lespressjoni ta' diversi proteini fl-imħuħ sal-wild tat-tielet ġenerazzjoni.
English: This may be particularly important as the prescribers of IV formulations of valproate are expected to be different from the usual prescribers targeted during the implementation of additional risk minimisation measures.
Maltese: Dan jista' jkun partikolarment importanti peress li l-preskriventi talformulazzjonijiet IV ta' valproate huma mistennija li jkunu differenti mill-preskriventi tas-soltu mmirati waqt l-implimentazzjoni ta' miżuri tal-minimizzazzjoni tar-riskju addizzjonali.
English: • The PRAC concluded that the minimisation measures for medicinal products containing valproate or related substances should be strengthened through contraindication in all indications (epilepsy, bipolar disorders and prophylaxis of migraine) in women/girls of childbearing potential unless the conditions of the pregnancy prevention programme are complied with.
Maltese: • Il-PRAC ikkonkluda li l-attivitajiet ta' miżuri ta' minimizzazzjoni għal prodotti mediċinali li fihom valproate jew sustanzi relatati għandhom jissaħħu permezz ta' kontraindikazzjoni flindikazzjonijiet kollha (epilessija, disturbi bipolari u profilassi tal-emigranja) fin-nisa/fit-tfajliet li jistgħu joħorġu tqal sakemm ma jiġux ssodisfati l-kundizzjonijiet tal-programm għallprevenzjoni tat-tqala.
English: Therefore, the adapted PASS study on the drug utilisation, the two surveys targeting HCPs or patients, the PASS from registries in order to characterise the foetal anticonvulsant syndrome in children with anti-epileptic drugs in utero exposure, the retrospective observational study on the association between paternal exposure to valproate and the risk of congenital anomalies and neurodevelopmental disorders including autism in offspring and, the observational study to evaluate and identify the best practice for discontinuation and switching of valproate treatment, are not applicable to the injectable formulations.
Maltese: Għalhekk, l-istudju PASS dwar l-użu magħmul mill-mediċina adattat, iż-żewġ stħarriġiet immirati lejn l-HCPs jew il-pazjenti, il-PASS mir-reġistri sabiex jiġi kkaratterizzat issindrome antikonvulsiv fetali fit-tfal b'esponiment in utero għal mediċini antiepilettiċi, l-istudju ta' osservazzjoni retrospettiv dwar l-assoċjazzjoni bejn l-esponiment paternali għal valproate u r-riskju ta' anomaliji konġenitali u d-disturbi li jirrigwardaw l-iżvilupp newroloġiku inkluż l-awtiżmu fil-wild u, listudju ta' osservazzjoni sabiex tiġi evalwata u identifikata l-aħjar prattika għat-twaqqif u l-bidla talkura b'valproate, mhumiex applikabbli għall-formulazzjonijiet injettabbli.
English: • The PRAC confirmed the known risk of intra-uterine exposure to valproate and related substances, associated with an increased risk of developmental disorders and congenital anomalies in the offspring.
Maltese: • Il-PRAC ikkonferma r-riskju magħruf ta' esponiment fl-utru għal valproate u sustanzi relatati, assoċjat ma' riskju akbar ta' disturbi tal-iżvilupp u anomaliji konġenitali fil-wild.
English: Regarding exposure via seminal fluid, estimation was made of the area under curve (AUC) for valproate in a woman following vaginal exposure to valproate via seminal fluid of a man treated with valproate.
Maltese: Fir-rigward tal-esponiment permezz ta' fluwidu seminali, saret stima tal-erja taħt il-kurva (AUC) għal valproate f'mara wara li jkollha esponiment vaġinali għal valproate permezz ta' fluwidu seminali ta' raġel ikkurat b'valproate.
English: The MAHs are encouraged to collaborate and liaise with the national competent authorities to facilitate the dissemination of the agreed educational material.
Maltese: L-MAHs huma mħeġġa jikkollaboraw u jikkomunikaw mal-awtoritajiet nazzjonali kompetenti sabiex jiġi ffaċilitat it-tixrid tal-materjal edukattiv miftiehem.
English: The transgenerational inheritance of autism-like phenotypes in mice exposed to valproic acid during pregnancy.
Maltese: Il-wirt transġenerazzjonali ta' fenotipi simili għall-awtiżmu fil-ġrieden li jiġu esposti għal valproic acid waqt it-tqala.
English: Usage data from the ongoing joint drug utilisation study (DUS) as well as other data (surveys, national surveys, anecdotal evidence etc.) that have been evaluated in the current referral indicate that valproate is still used by a considerable proportion of WCBP in different MSs for both epilepsy and bipolar disorder indications.
Maltese: Id-data dwar l-użu mill-istudju dwar l-użu magħmul mill-mediċina (DUS) konġunt li għaddej, kif ukoll data oħra (stħarriġ, stħarriġ nazzjonali, evidenza aneddotali eċċ.) li ġiet evalwata fir-riferiment attwali jindikaw li valproate għadu jintuża minn proporzjon konsiderevoli ta' WCBP fi Stati Membri differenti kemm għal indikazzjonijiet ta' epilessija kif ukoll ta' disturb bipolari.
English: • For their use in pregnancy for the treatment of epilepsy, the PRAC concluded that these medicinal products are contraindicated unless there is no suitable alternative treatment option.
Maltese: • Għall-użu tagħhom fit-tqala għall-kura tal-epilessija, il-PRAC ikkonkluda li dawn il-prodotti mediċinali huma kontraindikati sakemm ma jkun hemm l-ebda għażla ta' kura alternattiva adatta.
English: The patient guide should provide comprehensive information on risks to the unborn child due to in utero exposure to valproate and related substances, the details of the pregnancy prevention programme to avoid valproate exposure during pregnancy and the required actions in terms of pregnancy or intention to become pregnant.
Maltese: Il-gwida tal-pazjenti għandha tipprovdi informazzjoni komprensiva dwar ir-riskji għat-tarbija li għadha fil-ġuf minħabba esponiment in utero għal valproate u sustanzi relatati, id-dettalji tal-programm għall-prevenzjoni tat-tqala sabiex jiġi evitat l-esponiment għal valproate waqt it-tqala u l-azzjonijiet meħtieġa f'termini ta' tqala jew meta persuna jkollha lintenzjoni li toħroġ tqila.
English: The annual risk acknowledgement form for injectable formulations of valproate and related substances containing products is intended to act as a periodic reminder and acknowledgement of the risks of valproate for women of childbearing potential (WCBP).
Maltese: Il-formola ta' rikonoxximent tar-riskju annwali għal formulazzjonijiet injettabbli ta' prodotti li fihom valproate u sustanzi relatati hija intiża li taġixxi bħala tfakkira perjodika u rikonoxximent tar-riskji ta' valproate għan-nisa li jistgħu joħorġu tqal (WCBP).
English: On 08 March 2017 France triggered a procedure under Article 31 of Directive 2001/83/EC, and requested the PRAC to assess the impact on the concerns regarding the effectiveness of the risk minimisation measures on the benefit-risk balance of medicinal products containing substances related to valproate and issue a recommendation on whether the marketing authorisation(s) of these products should be maintained, varied, suspended or revoked.
Maltese: Fit-8 ta' Marzu 2017, Franza tat bidu għal proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE, u talbet lill-PRAC sabiex jivvaluta l-impatt fuq it-tħassib dwar l-effikaċja tal-amiżuri tal-minimizzazzjoni tar-riskju dwar il-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li fihom sustanzi relatati ma' valproate u sabiex joħroġ rakkomandazzjoni dwar jekk l-awtorizzazzjoni(jiet) għat-tqegħid fis-suq ta' dawn il-prodotti għandhiex(għandhomx) tinżamm(jinżammu), tiġi(jiġu) varjata(i), sospiża(i) jew revokata(i).
English: The CMDh acknowledges correspondence received from a MAH (Laboratoires Aguettant, France) of medicinal products containing valproate injectable (intravenous; IV) formulations, and requesting further clarity for the implementation of the pharmacovigilance activities and risk minimization measures adopted by the PRAC for these IV formulation indicated for the temporary management of epilepsy when administration via oral route is not possible.
Maltese: IV) ta' valproate, u jitlob aktar ċarezza għallimplimentazzjoni tal-attivitajiet tal-farmakoviġilanza u l-miżuri tal-minimizzazzjoni tar-riskju adottati mill-PRAC għal dawn il-formulazzjonijiet IV indikati għall-ġestjoni temporanja tal-epilessija meta ma jkunux jistgħu jingħataw b'mod orali.
English: Further investigation is recommended by PRAC.
Maltese: IlPRAC jirrakkomanda li ssir aktar investigazzjoni.
English: Furthermore, in a literature overview regarding effects on mitochondria, known side effects were described such as liver toxicity, Reye-like syndrome, pancreatitis and immune deficiency (leukopenia).
Maltese: Barra minn hekk, f'ħarsa ġenerali lejn il-letteratura dwar l-effetti fuq il-mitokondrija, ġew deskritti effetti sekondarji magħrufa bħat-tossiċità tal-fwied, sindrome tat-tip Reye, pankreatite u defiċjenza flimmunità (lewkopenja).
English: • The PRAC considered that the pregnancy prevention programme should reflect that in the indication epilepsy, if a woman is planning to become pregnant, a specialist experienced in the management of epilepsy, must reassess valproate therapy and consider alternative treatment options.
Maltese: • Il-PRAC ikkunsidra li l-programm għall-prevenzjoni tat-tqala għandu jirrifletti li fl-indikazzjoni tal-epilessija, jekk mara tkun qed tippjana biex toħroġ tqila, speċjalist esperjenzat fil-ġestjoni tal-epilessija għandu jivvaluta mill-ġdid it-terapija b'valproate u jqis għażliet ta' kura alternattiva.
English: • The PRAC concluded that the risk minimisation measures in place have not been sufficiently effective to prevent unintended in utero exposure to valproate and related substances in all indications.
Maltese: • Il-PRAC ikkonkluda li l-attivitajiet tal-minimizzazzjoni tar-riskju fis-seħħ ma kinux effettivi biżżejjed biex jipprevjenu esponiment in utero għal valproate u sustanzi relatati flindikazzjonijiet kollha.
English: With regards to the other pharmacovigilance activities and the studies are required to further investigate potential risks with products containing valproate and related substances and to measure the effectiveness of the RMMs, the CMDh clarified that these studies would not be relevant for the injectable products as the information that could be collected for these products would be limited and unlikely to be meaningful in view of the short duration of use, often in urgent situations and only when the oral formulations cannot be administered.
Maltese: Fir-rigward tal-attivitajiet tal-farmakoviġilanza l-oħrajn u l-istudji li huma meħtieġa jkomplu jinvestigaw ir-riskji potenzjali bi prodotti li fihom valproate jew sustanzi relatati u jkejlu l-effikaċja talRMMs, is-CMDh iċċara li dawn l-istudji mhux se jkunu rilevanti għall-prodotti injettabbli peress li linformazzjoni li tista' tinġabar għal dawn il-prodotti se tkun limitata u x'aktarx mhux se tkun siewja fiddawl tad-durata qasira tal-użu, spiss f'sitwazzjonijiet urġenti u biss meta ma jkunux jistgħu jingħataw il-formulazzjonijiet orali.
English: The PRAC is of the opinion that the currently available data do not warrant further investigation regarding the potential association between mitochondrial dysfunction and autism.
Maltese: Il-PRAC huwa tal-fehma li d-data disponibbli attwalment ma tiġġustifikax aktar investigazzjoni dwar l-assoċjazzjoni potenzjali bejn id-disfunzjoni mitokondrijali u l-awtiżmu.
English: This was not shown for teratogenic effects as malformations in the first generation offspring was not observed in the second and third generation offspring (Choi et al, 2016)2.
Maltese: tieni u tat-tielet ġenerazzjoni (Choi et al, 2016)2 Għalkemm jeżistu diversi limitazzjonijiet, l-istudju jissuġġerixxi li kien hemm xi effett transġenerazzjonali.
English: • The PRAC considered the totality of the data submitted for valproate and related substances with regard to the teratogenic and neurodevelopmental risks, the use in clinical practice and the effectiveness of the risk minimisation measures in place.
Maltese: • Il-PRAC ikkunsidra t-totalità tad-data ppreżentata għal valproate u sustanzi relatati fir-rigward tar-riskji teratoġeniċi u dawk li jirrigwardaw l-iżvilupp newroloġiku, l-użu fil-prattika klinika u leffikaċja tal-attivitajiet tal-minimizzazzjoni tar-riskju fis-seħħ.
English: To obtain additional robust information on the switch and discontinuation of valproate, the PRAC requested the conduct of an observational study to identify and evaluate the best practices for switching of valproate in clinical practice.
Maltese: Sabiex tinkiseb informazzjoni addizzjonali robusta dwar il-bidla u t-twaqqif ta' valproate, il-PRAC talab li jitwettaq studju ta' osservazzjoni li jidentifika u jevalwa l-aħjar prattiki għallbidla ta' valproate fi prattika klinika.
English: Additionally, as the IV valproate formulations will likely be administered by different HCPs than the usual treating physicians, having a HCP guide in place for these products is crucial and therefore such HCP guide will also be provided to prescribers of IV formulation of valproate containing products.
Maltese: Barra minn hekk, peress li x'aktarx ilformulazzjonijiet IV ta' valproate se jingħataw minn HCPs differenti minflok mit-tobba li jkunu qed jikkuraw tas-soltu, il-fatt li jkun hemm gwida HCP fis-seħħ għal dawn il-prodotti huwa kruċjali u għalhekk tali gwida HCP se tiġi pprovduta wkoll lill-preskriventi ta' formulazzjoni IV ta' prodotti li fihom valproate.
English: 1 vial + 1 pre-filled syringe + 1 'MiniSpike' rec. device
Maltese: 1 kunjett + 1 siringa mimlija għal-lest + 1 'MiniSpike' tagħmir rec.
English: Intravenous use, Intravesical use powder: vial (glass); solvent: pre-filled syringe (glass)
Maltese: Użu għal ġol-vini , Użu intravessikali trab: kunjett (ħġieġ); solvent: siringa mimlija għal-lest (ħġieġ)
English: MA (EU) number (Invented) name
Maltese: Numru ta' l-UE
English: Immediate Packaging
Maltese: Kontenut Daqs tal-pakkett
English: B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266 Romania
Maltese: B-dul Theodor Pallady nr.50, sector 3, Bucharest, cod 032266 Rumānija
English: Linearity/non-linearity
Maltese: Linearità /nuqqas ta' linearità
English: 1.23 × [140 - age (years)] × weight (kg) serum creatinine (µmol/l)
Maltese: 1.23 × [140 - età (snin)] × piż(kg) kreatinina fis-serum (µmol/l)
English: The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5methylhexanoic acid].
Maltese: Is-sustanza attiva, pregabalin, hija gamma-aminobutyric acid analogue [(S)-3-(aminomethyl)-5methylhexanoic acid].
English: Capsules content Lactose monohydrate Pregelatinized maize starch Talc
Maltese: Kontenut tal-kapsuli Lactose monohydrate Pregelatinized maize starch Talc
English: (× 0.85 for female patients)
Maltese: (× 0.85 għall-pazjenti nisa)
English: QT prolongation, sinus tachycardia, sinus arrhythmia
Maltese: Titwil tal-perjodu QT, sinus tachycardia, sinus arrhythmia
English: The active substance is pregabalin.
Maltese: Is-sustanza attiva hija pregabalin.
English: Anorexia, hypoglycaemia
Maltese: Anoreksja, ipogliċemija
English: • alcohol.
Maltese: • l-alkoħol.
English: Pregabalin oral bioavailability is estimated to be ≥ 90% and is independent of dose.
Maltese: Il-bijodisponibilità orali ta' pregabalin stmata għal ≥ 90% u hija indipendenti mid-doża.
English: Ophthalmologic testing (including visual acuity testing, formal visual field testing and dilated funduscopic examination) was conducted in over 3600 patients within controlled clinical trials.
Maltese: Testijiet pftalmoloġiċi (inklużi testijiet fuq l-akutezza viżiva, ittestjar formali tal-kamp viżiv u eżaminazzjoni ta' dilatar funduskopiku) sar fi 3600 pazjent fi provi kliniċi kontrollati.
English: • Interrupted menstrual periods.
Maltese: • Menstrwazzjoni li tiġi interrotta.
English: Total pregabalin daily dose *
Maltese: Doża totali ta' pregabalin kuljum *
English: The other ingredients are lactose monohydrate, pregelatinized maize starch, talc, titanium dioxide (E171), gelatin, shellac, black iron oxide (E172).
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, pregelatinized maize starch, talc, titanium dioxide (E171), ġelatina, shellac, iron oxide iswed (E172).
English: • lorazepam (used for treating anxiety).
Maltese: • lorazepam (użat għall-kura ta' ansjetà).
English: Angioedema, allergic reaction
Maltese: Anġjoedema, reazzjoni allerġika
English: Pregabalin pharmacokinetics were evaluated in paediatric patients with epilepsy (age groups: 1 to 23 months, 2 to 6 years, 7 to 11 years and 12 to 16 years) at dose levels of 2.5, 5, 10 and 15 mg/kg/day in a pharmacokinetic and tolerability study.
Maltese: Il-farmakokinetika ta' pregabalin ġiet evalwtata f'pazjenti pedjatriċi bl-epilessija (gruppi ta' età: xahar sa 23 xahar, sentejn sa 6 snin, 7 sa 11-il sena u 12 sa 16-il sena) f'livelli ta' doża ta' 2.5, 5, 10 u 15 mg/kg/jum fi studju dwar il-farmakokinetika u tollerabilità.
English: Inter-subject pharmacokinetic variability for pregabalin is low (< 20%).
Maltese: Ilvarjabilità fil-farmakokinetika bejn persuna u oħra fil-farmakokinetika għal pregabalin hija baxxa (< 20%).
English: In table 2 below all adverse reactions, which occurred at an incidence greater than placebo and in more than one patient, are listed by class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Fit-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: Pregabalin mean elimination half-life is 6.3 hours.
Maltese: Il- half-life medja tal-eliminazzjoni ta' pregabalin hija 6.3 sigħat.
English: Oral contraceptives, norethisterone and/or ethinyl oestradiol Co-administration of pregabalin with the oral contraceptives norethisterone and/or ethinyl oestradiol does not influence the steady-state pharmacokinetics of either substance.
Maltese: Kontraċettivi orali, norethisterone u/jew ethinyl oestradiol L-amministrazzjoni ta' pregabalin mal-kontraċettivi orali norethisterone u/jew ethinyl oestradiol ma tinfluwenzax il-farmakokinetika stabbli ta' xi waħda mis-sustanzi.
English: Pregabalin 14 mg/kg/day significantly reduced the log-transformed partial onset seizure frequency versus placebo (p=0.0223); pregabalin 7 mg/kg/day did not show improvement relative to placebo.
Maltese: Pregabalin 14 mg/kg/jum naqqas konsiderevolment il-frekwenza ta' aċċessjoni ta' bidu parzjali logtransformed kontra plaċebo (p=0.0223); pregabalin 7 mg/kg/jum ma weriex titjib meta mqabbel malplaċebo.
English: • oxycodone (used as a pain-killer).
Maltese: • oxycodone (użat biex itaffi l-uġigħ).
English: Vision-related effects
Maltese: Effetti relatati mal-vista
English: The adverse events observed in a pharmacokinetic and tolerability study that enrolled patients from 3 months to 16 years of age (n = 65) with partial onset seizures were similar to those observed in adults.
Maltese: L-avvenimenti avversi osservati fi studju farmakokinetiku u studju dwar it-tollerabilità, li rregistraw pazjenti li kellhom minn 3 xhur sa 16il sena (n=65) b'aċċessjonijiet ta' bidu parzjali kienu simili għal dawk osservati fl-adulti.
English: Median 24-hour seizure frequencies at baseline and at the final visit were 4.7 and 3.8 for pregabalin 7 mg/kg/day, 5.4 and 1.4 for pregabalin 14 mg/kg/day, and 2.9 and 2.3 for placebo, respectively.
Maltese: Il-frekwenzi medjani ta' aċċessjoni fi 24 siegħa fil-linja bażi u fl-aħħar vista kienu 4.7 u 3.8 għal pregabalin 7 mg/kg/jum, 5.4 u 1.4 għal pregabalin 14 mg/kg/ jum,u 2.9 u 2.3 għall-plaċebo, rispettivament.
English: Rare: may affect up to 1 in 1,000 people
Maltese: Rari: jistgħu jaffettwaw sa persuna 1 minn kull 1,000
English: * Alanine aminotransferase increased (ALT) and aspartate aminotransferase increased (AST).
Maltese: Tnaqqis fl-għadd ta' ċelluli bojod tad-demm * Żieda fl-alanine aminotransferase (ALT) u żieda fl-aspartate aminotransferase (AST)
English: Table 2: Pregabalin Adverse Drug Reactions
Maltese: Tabella 2: Reazzjonijiet Avversi tal-Mediċina ta' Pregabalin
English: 225 mg
Maltese: k.s. 225 mg
English: may be taken with oral contraceptives.
Maltese: k.s. jista' jittieħed ma' kontraċettivi orali.
English: Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.
Maltese: Pregabalin jeħel ma' subunit awżiljarju (2-proteini) ta' kanali tal-kalċju kkontrollati b'vultaġġfissistema nervuża ċentrali.
English: The 50 mg capsules also contain propylene glycol, strong ammonia solution, potassium hydroxide.
Maltese: Il-kapsuli ta' 50°mg fihom ukoll propylene glycol, soluzzjoni qawwija ta' ammonia u potassium hydroxide.
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 27 February 2017.
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 27 ta' Frar 2017
English: • Convulsions.
Maltese: • Aċċesssjonijiet.
English: Red iron oxide (E172)
Maltese: - Iron oxide iswed (E172)
English: LIST OF EXCIPIENTS Contains lactose monohydrate.
Maltese: LISTA TA' EĊĊIPJENTI Fih lactose monohydrate.