FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients not also taking ciclosporin, concomitant administration of mycophenolate mofetil and rifampicin resulted in a decrease in MPA exposure (AUC0-12 h) of 18 % to 70 %.
Maltese: F'pazjenti li mhux qed jieħdu wkoll ciclosporin, l-għotja ta' mycophenolate mofetil flimkien ma' rifampicin wasslet għal tnaqqis ta' 18 % sa 70 % fl-esponiment għal MPA (AUC0-12 h).
English: Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Maltese: Effetti gastro-intestinali kienu osservati fil-kelb f'livelli ta' esponiment sistemiku ekwivalenti għal jew inqas mill-esponiment kliniku fid-doża rakkomandata.
English: However, the mean single dose MPAG AUC was 3-6-fold higher in subjects with severe renal impairment than in subjects with mild renal impairment or normal healthy subjects, consistent with the known renal elimination of MPAG.
Maltese: Iżda il-medja tal-AUC ta' doża waħda ta' MPAG kienet 3-6 darbiet ogħla f'individwi b'indeboliment renali sever milli f'persuni b'indeboliment renali ħafif jew f'persuni normali f'saħħithom, kosistenti ma' l-eliminazzjoni renali magħrufa ta' MPAG.
English: • Take 3 tablets in the morning and then 3 tablets in the evening.
Maltese: • Ħu 3 pilloli filgħodu u wara 3 pilloli filgħaxija.
English: MPA AUC values across age groups were similar in the early and late posttransplant period.
Maltese: Il-valuri tal-AUC ta' MPA fil-gruppi ta' età differenti kienu simili fil-perijodu bikri u tard wara t-trapjant.
English: In healthy volunteers, no significant interaction was observed when mycophenolate mofetil was concomitantly administered with norfloxacin or metronidazole separately.
Maltese: F'voluntiera f'saħħithom, ma kienet osservata l-ebda interazzjoni sinifikanti meta mycophenolate mofetil ingħata flimkien ma' norfloxacin jew metronidazole separatament.
English: • The daily dose is 6 tablets (3 g of the medicine) taken as 2 separate doses.
Maltese: • Id-doża ta' kuljum hija 6 pilloli (3 g ta' mediċina) li jittieħdu bħala żewġ dożi separati.
English: Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose with 93 % of the administered dose recovered in the urine and 6 % recovered in the faeces.
Maltese: Għoti mill-ħalq ta' mycophenolate mofetil radjutikketjat iwassal għal irkupru komplut tad-doża mogħtija b'93 % tad-doża amministrata rkuprata fl-awrina u 6 % tad-doża rkuprata fl-ippurgar.
English: However, hepatic disease with predominantly biliary damage, such as primary biliary cirrhosis, may show a different effect.
Maltese: Iżda, mard epatiku bi ħsara predominanti tal-biljari, bħal ċirrożi biljari primarja, jistgħu juru effett differenti.
English: Myclausen is indicated in adults, and children and adolescents aged 2 to 18 years in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Maltese: Myclausen huwa indikat f'adulti, u tfal u adolexxenti bejn l-etajiet ta' sentejn u 18-il sena biex jintuża flimkien ma' ciclosporin u kortikosterojdi għall-profilassi ta' tiċħid akut tat-trapjant f'pazjenti li rċevew trapjant alloġeniku tal-kliewi, tal-qalb, jew tal-fwied.
English: Therefore Myclausen is contraindicated in pregnancy unless there are no suitable alternative treatments to prevent transplant rejection.
Maltese: Għalhekk Myclausen huwa kontraindikat waqt it-tqala ħlief jekk ma jkunux disponibbli trattamenti alternattivi xierqa biex jiġi evitat rifjut tat-trapjant.
English: Myclausen contains sodium
Maltese: Jekk tieħu aktar Myclausen milli suppost
English: • You were born with one of the following rare conditions that make pregnancy impossible: the XY genotype, Turner's syndrome or uterine agenesis
Maltese: • Twelidt b'waħda mill-kondizzjonijiet rari li ġejjin li jagħmlu t-tqala impossibbli: il-ġenotip XY, is-sindrome ta' Turner jew aġenesi tal-utru
English: • shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung).
Maltese: • qtugħ ta' nifs, sogħla, li jistgħu jkunu kkawżati minn bronkjektasi (kundizzjoni fejn il-passaġġi tal-pulmun jintefħu iktar minn normal) jew fibrożi pulmonari (brix tal-pulmun).
English: This dose achieved MPA AUC values similar to those seen in adult renal transplant patients receiving mycophenolate mofetil at a dose of 1 g bid in the early and late posttransplant period.
Maltese: Din id-doża laħqet valuri fl-AUC ta' MPA simili għal dawk osservati f'pazjenti adulti bi trapjant renali li jirċievu doża ta' mycophenolate mofetil ta' 1 g bid fil-perijodu bikri jew tard wara t-trapjant.
English: Renal and urinary disorders
Maltese: Trapjant Renali
English: However, at high MPAG plasma concentrations (> 100 µg/mL), small amounts of MPAG are removed.
Maltese: Iżda, f'konċentrazzjonijiet ta' MPAG għoljin fil-plażma (> 100 µg/mL), jitneħħew ammonti żgħar ta' MPAG.
English: Because mycophenolate mofetil has demonstrated teratogenic effects in rats and rabbits, Myclausen capsules should not be opened or crushed to avoid inhalation or direct contact with skin or mucous membranes of the powder contained in Myclausen capsules.
Maltese: Peress li mycophenolate mofetil wera effetti teratoġeniċi fil-firien u l-fniek, kapsuli Myclausen m'għandhomx jinfetħu jew jitfarrku biex jiġi evitat teħid man-nifs jew kuntatt dirett mal-ġilda jew ma' membrani mukużi tat-trab li jinsab fil-kapsuli Myclausen.
English: The full name of your medicine is Myclausen 250 mg hard capsules.
Maltese: L-isem sħiħ tal-mediċina tiegħek huwa Myclausen 250 mg kapsuli ibsin.
English: • olfactory nerve agenesis.
Maltese: • aġenesi tan-nerv tax-xamm.
English: Common Oedema, pyrexia, chills, pain, malaise, asthenia
Maltese: Komuni ħafna Rimettar, uġigħ fl-addome, dijarea, tqalligħ
English: What Myclausen is and what it is used for What you need to know before you take Myclausen How to take Myclausen
Maltese: Reazzjonijiet avversi, Possibilment jew Probabilment Relatati ma' Myclausen, irrappurtati F'pazjenti Kkurati
English: The full EPAR for Lokelma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In a main study of 754 patients with hyperkalaemia, 86% of patients taking Lokelma 10 g had normal potassium levels after 2 days compared with 48% of those taking placebo (a dummy treatment).
Maltese: Fi studju ewlieni ta' 754 pazjent bl-iperkalemija, 86% tal-pazjenti li ħadu Lokelma 10 g kellhom livelli normali tal-potassju wara jumejn, imqabbel ma' 48% ta' dawk li jieħdu plaċebo (kura finta).
English: This is a summary of the European public assessment report (EPAR) for Lokelma.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lokelma.
English: is then eliminated in the stools.
Maltese: kompost li mbagħad jiġi eliminat mal-ippurgar.
English: It contains the active substance sodium zirconium cyclosilicate.
Maltese: Fih is-sustanza attiva sodium zirconium cyclosilicate.
English: Other information about Lokelma
Maltese: Informazzjoni oħra dwar Lokelma
English: Why is Lokelma approved?
Maltese: Għal xiex ġie approvat Lokelma?
English: Lokelma is available as powder sachets (5 g and 10 g).
Maltese: Lokelma jiġi bħala qratas tat-trab (5 mg u 10 mg).
English: What are the risks associated with Lokelma?
Maltese: X'inhuma r-riskji assoċjati ma' Lokelma?
English: The active substance in Lokelma, sodium zirconium cyclosilicate, is a potassium binder.
Maltese: Is-sustanza attiva f'Lokelma, sodium zirconium cyclosilicate, hija legant tal-potassju.
English: The most common side effects with Lokelma (which may affect up to 1 in 10 people) are oedema (fluid build-up with swelling in the ankles and feet) and hypokalaemia (low levels of potassium in the blood).
Maltese: L-effetti sekondarji l-aktar komuni b'Lokelma (li jistgħu jaffettwaw sa persuna 1 minn 10) huma edema (fluwidu li jinbena b'nefħa fl-għekiesi u fis-saqajn), u l-ipokalemija (livelli baxxi ta' potassju fid-demm).
English: Another main study involved 258 patients who had normal potassium levels after Lokelma treatment.
Maltese: Studju ewlieni ieħor involva 258 pazjent li kellhom livelli normali tal-potassju wara l-kura b'Lokelma.
English: The overall safety profile is considered acceptable.
Maltese: Il-profil tas-sigurtà ġenerali jitqies bħala aċċettabbli.
English: Lokelma is a medicine used to treat hyperkalaemia (high levels of potassium in the blood) in adults.
Maltese: Lokelma huwa mediċina li tintuża biex tikkura l-iperkalemija (livelli għoljin ta' potassju fid-demm) fladulti.
English: How does Lokelma work?
Maltese: Kif jintuża Lokelma?
English: Once the blood levels of potassium return within the normal range (usually within 1-2 days), patients should take the lowest effective dose of Lokelma to prevent the return of hyperkalaemia, starting with 5 g once a day and not exceeding 10 g once a day.
Maltese: Ladarba l-livelli tad-demm tal-potassju jirritornaw fi ħdan il-firxa normali (normalment fi żmien jumjumejn), il-pazjenti jenħtieġ li jieħdu l-inqas doża effettiva ta' Lokelma sabiex jipprevjenu r-ritorn taliperkalemija, fejn jibdew b'5 mg darba kuljum u ma jaqbżux l-10 g kuljum.
English: The recommended starting dose of Lokelma is 10 g three times a day.
Maltese: Id-doża tal-bidu rakkomandata ta' Lokelma hija 10 g tliet darbiet kuljum.
English: The Agency considered that Lokelma is effective at controlling blood potassium levels, especially during initial (acute) treatment.
Maltese: L-Aġenzija kkunsidrat li Lokelma huwa effettiv biex jikkontrolla l-livelli tal-potassju fid-demm, speċjalment matul il-kura (akuta) inizjali.
English: Lokelma is effective at lowering blood potassium levels and keeping levels of potassium within the normal range.
Maltese: Lokelma huwa effettiv biex inaqqas il-livelli tal-potassju fid-demm u jżomm il-livelli tal-potassju fi ħdan il-firxa normali.
English: For the full list of all side effects and restrictions with Lokelma, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Lokelma, ara l-fuljett ta' tagħrif.
English: In addition, when patients who had normal potassium levels after Lokelma treatment were given further treatment with either Lokelma or placebo, potassium levels stayed normal for longer with Lokelma than with placebo.
Maltese: Barra minn hekk, meta l-pazjenti li kellhom livelli normali tal-potassju wara l-kura b'Lokelma ngħataw kura ulterjuri jew b'Lokelma jew bil-plaċebo, il-livelli tal-potassju baqgħu normali għal żmien itwal b'Lokelma billi bil-plaċebo.
English: The full EPAR for Ritonavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ritonavir Mylan can be used as a ‘pharmacokinetic enhancer' (booster) to increase the blood levels of other antiviral medicines that belong to the same group as Ritonavir Mylan (protease inhibitors) including amprenavir, atazanavir, darunavir, fosamprenavir, lopinavir, saquinavir, and tipranavir.
Maltese: Ritonavir Mylan jista' jintuża bħala "intensifikatur farmakokinetiku" (booster) biex iżid il-livelli taddemm ta' mediċini antivirali oħra li jappartjenu għall-istess grupp bħal dak ta' Ritonavir Mylan (inibituri tal-protease) inkluż amprenavir, atazanavir, darunavir, fosamprenavir, lopinavir, saquinavir, u tipranavir.
English: The usual dose of Ritonavir Mylan for adults is 100 or 200 mg, once or twice a day.
Maltese: Id-doża tas-soltu ta' Ritonavir Mylan għall-adulti hi ta' 100 jew 200 mg, darba jew darbtejn kuljum.
English: Ritonavir Mylan contains the active substance ritonavir and is a ‘generic medicine'.
Maltese: Ritonavir Mylan fih is-sustanza attiva ritonavir u huwa ‘mediċina ġenerika'.
English: At higher antiviral doses, ritonavir is a ‘protease inhibitor'.
Maltese: B'dożi antivirali ogħla, ritonavir huwa "inibitur tal-protease".
English: The recommended dose for adults (aged 18 years or over) is 600 mg twice a day.
Maltese: Id-doża rakkomandata għall-adulti (ta' 18-il sena jew aktar) hija ta' 600 mg darbtejn kuljum.
English: Ritonavir Mylan is used in combination with other medicines to treat patients over two years of age who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Ritonavir Mylan jintuża flimkien ma' mediċini biex jikkura pazjenti ta' ‘l fuq minn sentejn infettati billvirus tal-immunodefiċjenza umana tat-tip 1 (HIV-1, human immunodeficiency virus type 1), virus li jikkawża sindrome tal-immunodefiċjenza akkwiżita (AIDS, acquired immune deficiency syndrome).
English: Other information about Ritonavir Mylan
Maltese: Informazzjoni oħra dwar Ritonavir Mylan
English: This is a summary of the European public assessment report (EPAR) for Ritonavir Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ritonavir Mylan.
English: This means that it blocks a viral enzyme called protease, which is involved in the multiplication of HIV.
Maltese: Dan ifisser li jimblokka enzima virali li jisimha protease, li hija involuta fil-multiplikazzjoni tal-HIV.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Norvir, and do not need to be repeated for Ritonavir Mylan.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat bil-mediċina ta' referenza, Norvir, u m'għandhomx għalfejn jiġu ripetuti għal Ritonavir Mylan.
English: It is available as tablets (100 mg) and should be taken with food.
Maltese: Dan jiġi bħala pilloli (100 mg) u għandu jittieħed mal-ikel.
English: As a ‘booster', the active substance ritonavir slows the breakdown of other protease inhibitor antivirals.
Maltese: Bħala “booster”, is-sustanza attiva ritonavir iddewwem it-tkissir ta' antivirali oħra tal-inibitur talprotease.
English: Why is Ritonavir Mylan approved?
Maltese: Għaliex ġie approvat Ritonavir Mylan?
English: What are the benefits and risks of Ritonavir Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Ritonavir Mylan?
English: Because Ritonavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Ritonavir Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: For more information on generic medicines, see the question-and-answer document here.
Maltese: Għal aktar informazzjoni dwar il-mediċini ġeneriċi, ara ddokument mistoqsijiet-u-tweġibiet hawnhekk.
English: The Agency recommended that Ritonavir Mylan be approved for use in the EU.
Maltese: L-Aġenzija rrakkomandat li Ritonavir Mylan ikun approvat għall-użu fl-UE.
English: Ritonavir Mylan, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Ritonavir Mylan, meta jittieħed flimkien ma' mediċini antivirali oħra, inaqqas l-ammont tal-HIV fid-demm u jżommu f'livell baxx.
English: When the enzyme is blocked, the virus can no longer multiply normally, slowing down its spread.
Maltese: Meta l-enzima tiġi imblokkata, il-virus ma jkunx jista' jibqa' jimmultiplika normali, u b'hekk jinfirex aktar bil-mod.
English: Ritonavir Mylan can also be used in larger doses for a direct antiviral effect on HIV.
Maltese: Ritonavir Mylan jista' jintuża wkoll f'dożi akbar għal effett antivirali dirett fuq l-HIV.
English: How has Ritonavir Mylan been studied?
Maltese: Kif ġie studjat Ritonavir Mylan?
English: For more information, see the package leaflet provided with the other medicine.
Maltese: Għal aktar informazzjoni, ara l-fuljett ta' tagħrif ipprovvdut mal-mediċina l-oħra.
English: This means that Ritonavir Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Norvir.
Maltese: Dan ifisser li Ritonavir Mylan fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (EU) li jisimha Norvir.
English: Ritonavir Mylan does not cure HIV infection or AIDS, but it may hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Ritonavir Mylan ma jikkurax l-infezzjoni tal-HIV jew l-AIDS, iżda jista' jittardja l-ħsara lis-sistema immuni u jevita l-iżvilupp ta' infezzjonijiet u mard assoċjat mal-AIDS.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Ritonavir Mylan has been shown to have comparable quality and to be bioequivalent to Norvir.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Ritonavir Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Norvir.
English: Extremadura 3, 09400 Aranda De Duero, Burgos, Spain.
Maltese: Extremadura 3, 09400 Aranda De Duero, Burgos, Spanja.
English: • memory problems
Maltese: • problemi bil-memorja
English: • psychotic disorders (severe mental health problems)
Maltese: • disturbi psikotiċi (problemi serji ta' saħħa mentali)
English: Glaxo Wellcome S.A. Avda Extremadura 3 Aranda de Duero E-09400 Burgos Spain
Maltese: Glaxo Wellcome S.A. Avda Extremadura 3 Aranda de Duero E-09400 Burgos Spanja
English: The active substance is retigabine.
Maltese: Is-sustanza attiva hi retigabine.
English: Reproductive toxicology
Maltese: Tossikoloġija riproduttiva
English: Retigabine mg/day mg/day mg/day
Maltese: Retigabine mg/jum mg/jum mg/jum
English: Each tablet contains 50 mg, 100 mg, 200 mg, 300 mg or 400 mg retigabine.
Maltese: Kull pillola fiha 50 mg, 100 mg, 200 mg, 300 mg jew 400 mg ta' retigabine.
English: Study 302 (n=538; n=471)
Maltese: Studju 302 (n=538; n=471)
English: • feeling agitated, aggressive or irritable
Maltese: • tħossok aġitat, aggressiv jew irritabbli
English: ≥1/10,000 to <1/1,000
Maltese: ≥1/10,000 sa <1/1,000
English: Study 205 (n=396; n=303)
Maltese: Studju 205 (n=396; n=303)
English: Interaction with digoxin
Maltese: Interazzjoni ma' digoxin
English: Date of latest renewal: 14 January 2016
Maltese: Data tal-aħħar tiġdid: 14 ta' Jannar 2016
English: Peripheral oedema
Maltese: mard Edima periferali
English: NAME OF THE MARKETING AUTHORISATION HOLDER Glaxo Group Limited
Maltese: Glaxo Group Limited
English: The other ingredients are: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide (E171) , talc (E553b), Lecithin (SOY) and Xanthan gum.
Maltese: Is-sustanzi l-oħra huma: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, titanium dioxide (E171), talc (E553b), Lecithin (SOY) u Xanthan gum.
English: Confusional state Psychotic disorders Hallucinations Disorientation Anxiety
Maltese: Stat ta' konfużjoni Disturbi psikotiċi Alluċinazzjonijiet
English: Doses greater than 900 mg/day are not recommended (see sections 4.4 and 5.2).
Maltese: Dożi ogħla minn 900 mg/jum mhumiex rakkomandati (ara sezzjonijiet 4.4 u 5.2).
English: * Statistically significant, p≤0.05 ~ Dose not studied
Maltese: * Sinifikanti b'mod statistiku, p≤0.05
English: A total of approximately 84% of the dose is recovered in the urine, including the N-acetyl metabolite (18%), N-glucuronides of the parent active substance and of the N-acetyl metabolite (24%), or parent active substance (36%).
Maltese: Total ta' madwar 84% tad-doża jiġi rkuprat mill-awrina, inkluż il-metabolit N-acetyl (18%), ilglukuronidi-N tas-sustanza attiva oriġinali u tal-metabolit N-acetyl (24%), jew is-sustanza oriġinali attiva (36%). 14% biss ta' retigabine jitneħħa mal-ippurgar.
English: A mean increase in Individual Corrected QT Interval (QTcI) of up to 6.7 ms (upper bound of 95% one-sided CI 12.6 ms) was observed within 3 hours of dosing.
Maltese: Individwalment (QTcI) sa 6.7 ms (upper bound ta' 95% one-sided CI 12.6 ms) kienet osservata fi żmien 3 sigħat minn meta ngħatat id-doża.
English: Trobalt contains the active substance retigabine.
Maltese: Trobalt fih is-sustanza attiva retigabine.
English: Marketing Authorisation Holder Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom.
Maltese: Glaxo Group Limited, 980 Great West Road, Brentford, Middlesex TW8 9GS, Ir-Renju Unit.
English: • tremors; sudden jerking of muscles (myoclonus)
Maltese: • tregħid; ġbid involontarju tal-muskoli (mijoklonus)
English: Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Iron oxide yellow (E172).
Maltese: Polyvinyl alcohol Titanium dioxide (E171) Talc (E553b) Iron oxide isfar (E172).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 28 March 2011
Maltese: Data tal-ewwel awtorizzazzjoni: 28 ta' Marzu 2011
English: Acquired Vitelliform
Maltese: Vitelliformi Akkwiżita
English: Mutations in the KCNQ channels underlie several human inheritable disorders, including epilepsy (KCNQ2 and 3).
Maltese: Mutazzjonijiet fil-kanali KCNQ huma l-bażi ta' diversi disturbi li jintirtu fil-bnedmin, inkluż l-epilessija (KCNQ2 u 3).
English: Symptoms include:
Maltese: Sintomi jinkludu:
English: Elderly (65 years of age and above)
Maltese: Anzjani (età ta' 65 sena u aktar)
English: If possible, show them the medicine pack.
Maltese: Jekk ikun possibbli urihom il-pakkett tal-mediċina.
English: Retigabine is approximately 80% bound to plasma protein over the concentration range of 0.1 to 2 µg/ml.
Maltese: Madwar 80% ta' retigabine jintrabat mal-proteini tal-plażma fuq medda tal-konċentrazzjonijiet bejn 0.1 u 2 µg/ml.
English: Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.
Maltese: Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien
English: Confusional state, psychotic disorders and hallucinations were reported in controlled clinical studies with retigabine (see section 4.8).
Maltese: Disturbi psikjatriċi Stat ta' konfużjoni, disturbi psikjatriċi, u alluċinazzjonijiet kienu rrappurtati fi studji kliniċi kkontrollati b'retigabine (ara sezzjoni 4.8).
English: ≥1/1,000 to <1/100
Maltese: ≥1/100 sa <1/10
English: In addition, retigabine and NAMR did not induce CYP1A2 or CYP3A4/5 in human primary hepatocytes.
Maltese: retigabine u NAMR ma induċewx CYP1A2 jew CYP3A4/5 fl-epatoċiti primarji umani.
English: Trobalt 50 mg film-coated tablets Trobalt 100 mg film-coated tablets Trobalt 200 mg film-coated tablets Trobalt 300 mg film-coated tablets Trobalt 400 mg film-coated tablets
Maltese: Trobalt 50 mg pilloli miksijin b'rita Trobalt 100 mg pilloli miksijin b'rita Trobalt 200 mg pilloli miksijin b'rita Trobalt 300 mg pilloli miksijin b'rita Trobalt 400 mg pilloli miksijin b'rita
English: Retigabine was statistically significantly superior to placebo at 600 mg/day (one study), 900 mg/day (two studies) and 1,200 mg/day (two studies).
Maltese: Retigabine kien superjuri b'mod statistikamen sinifikanti għal plaċebo bid-doża ta' 600 mg/jum (studju wieħed), 900 mg/jum (żewġ studji) u 1,200 mg/jum (żewġ studji).
English: See 'Look out for serious symptoms' in section 4.
Maltese: Ara 'Oqgħod attent għal sintomi serji' f'sezzjoni 4.
English: Trobalt is not recommended for children and adolescents aged under 18.
Maltese: Tfal u adolexxenti Trobalt mhuwiex rakkomandat għal tfal u adolexxenti iżgħar minn 18-il sena.
English: Belgique/Belgien
Maltese: Suomi/Finland
English: Data from an in vitro study showed that the N-acetyl metabolite of retigabine (NAMR) inhibited P-glycoprotein-mediated transport of digoxin in a concentration-dependent manner.
Maltese: Dejta minn studju in vitro wriet li l-metabolit N-acetyl ta' retigabine (NAMR) impedixxa t-trasport medjat mill-glikoproteina P ta' digoxin b'manjiera dipendenti mill-konċentrazzjoni.
English: Interaction with anaesthetics
Maltese: Interazzjoni mal-anestetiċi