FrancophonIA/ELRC3.0 huggingface dataset:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/283/008
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/283/008
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with
Maltese: Tagħrif minn studji kliniċi wera li hemm żieda fir-riskju ta' mġiba suwiċidali f'adulti li għandhom inqas minn 25 sena, bi problemi psikjatriċi u li kienu kkurati
English: 30% reported pain reduction was recorded in approximately 65% of duloxetine treated patients versus 40% for placebo.
Maltese: Kważi 65% tal pazjenti kkurati b'duloxetine kontra l-40% ta' dawk fuq plaċebo rreġistraw tnaqqis ta' mill-inqas 30% fl-uġigħ li kien ġie rrappurtat.
English: Liver disease resulting in hepatic impairment (see section 5.2).
Maltese: Madankollu bħal kull mediċina oħra, il-kura ta' l-anzjani għandha tiġi segwita b'attenzjoni (ara sezzjoni 5.2).
English: ARICLAIM with food, drink and alcohol
Maltese: ARICLAIM mal-ikel, max-xorb u mal-alkoħol
English: In an embryotoxicity study in the rabbit, a higher incidence of cardiovascular and skeletal malformations was observed at systemic exposure levels below the maximum clinical exposure (AUC).
Maltese: Fi studji embrojotossiċi fil-fenek, inċidenża ogħla ta' malformażżjoniijiet kardjovaskolari u skeletali kienu osservati f'livelli ta' espożiżżjoni sistemika anqas mill-esponiment massimu kliniku (AUC).
English: Opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
Maltese: Il-parti prinċipali aħdar opak, stampat b' '60 mg' u l-parti ta' fuq blu opak, stampat b' ‘9542'.
English: Reproductive system and breast disorders Erectile dysfunction
Maltese: Disturbi fis-sistema riproduttiva u fis-sider
English: What ARICLAIM looks like and contents of the pack ARICLAIM is a hard gastro-resistant capsule.
Maltese: ARICLAIM issibu bħala kapsula gastro-reżistenti, iebsa.
English: - are taking medicines to treat depression (see ‘Other medicines and ARICLAIM') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly) - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine (see ‘Other medicines and ARICLAIM')
Maltese: għandek problemi f'għajnejk bħal xi tip ta' glawkoma (pressjoni għolja fl-għajn). għandek passat ta' emorraġija (tendenza li tiżviluppa tbenġil). qiegħed/qiegħda f'riskju li jitbaxxielek il-livell ta' sodium(per eżempju jekk qiegħed/qiegħda tieħu d-dijuretiċi, speċjalment jekk inti anzjan/anzjana) qiegħed/qiegħda tirċievi fl-istess waqt kura b'mediċina oħra li tista' tikkawżalek ħsara fil qiegħed/qiegħda tieħu mediċini oħra li fihom duloxetine(ara ‘Mediċini oħra u ARICLAIM')
English: Throat tightness
Maltese: Tendenza ogħla li titbenġel
English: Effect of duloxetine on other medicinal products
Maltese: Effetti ta' prodotti mediċinali oħra fuq duloxetine
English: Opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Maltese: Il-parti prinċipali abjad opak, stampat b' ‘30 mg' u l-parti ta' fuq blu opak, stampat b' ‘9543'.
English: Posology
Maltese: Diskinesja
English: Suicide-related behaviours (suicide attempts and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger), were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Maltese: Imġiba assoċjata mas suwiċidju (attentati ta' suwiċidju u ħsibijiet suwiċidali), u ostilità (l-aktar aggressjoni, imġiba konfrontali, u rabja), kienu osservati aktar spiss f'provi kliniċi fuq tfal u adolexxenti kkurati b'anti depressivi meta mqabbla ma' dawk ikkurati bil-plaċebo.
English: Adverse reactions may be more common during concomitant use of ARICLAIM and herbal preparations containing St John's wort (Hypericum perforatum).
Maltese: John's wort (Hypericum perforatum).
English: However, the majority of common adverse reactions were mild to moderate, they usually started early in therapy, and most tended to subside even as therapy was continued.
Maltese: Madankollu, il-maġġoranza tar-reazzjonijiet avversi komuni kienu ħfief jew moderati, ġeneralment bdew kmieni fit-terapija, u ħafna minnhom kellhom tendenza li jonqsu anki waqt it-tkomplija tat-terapija.
English: Female rats receiving duloxetine (45 mg/kg/day) before and during mating and early pregnancy had a decrease in maternal food consumption and body weight, oestrous cycle disruption, decreased live birth indices and progeny survival, and progeny growth retardation at systemic exposure levels estimated to be at the most at maximum clinical exposure (AUC).
Maltese: (45 mg/kg/ġurnata), qabel u waqt li kienu qed jgħamlu s-sess u fil-bidu tat-tqala, kellhom tnaqqis fil konsum ta' l-ikel matern u fil-piż, diżordni fiċ-ċiklu oestrous, nuqqas fl-indiċi ta' twelid ta' frieħ hajjin u fis-sopravivenza tal-ferħ ta' l-annimal, u dewmien biex jikbru l-frieħ f'livelli ta' espożizzjoni sistemika, stmata li hija mhux anqas mill-esponiment massimu kliniku (AUC).
English: Ejaculation
Maltese: Apatija
English: ARICLAIM hard gastro-resistant capsules contain sucrose.
Maltese: ARICLAIM kapsuli ibsin gastro-reżistenti fihom is-sucrose.
English: In both studies, duloxetine 60 mg once daily and 60 mg twice daily significantly reduced pain compared with placebo.
Maltese: Fiż-żewġ studji, duloxetine 60 mg darba kuljum u 60 mg darbtejn kuljum naqqsu b'mod sinifikanti luġigħ meta mqabbla ma' plaċebo.
English: This may be due to the noradrenergic effect of duloxetine.
Maltese: /noradrenaline (SNRIs), fosthom duloxetine.
English: If a decision to initiate antidepressant pharmacological therapy is taken, the gradual discontinuation of ARICLAIM is recommended (see section 4.2).
Maltese: Huwa rakkomandat it-twaqqif gradwali ta' ARICLAIM jekk tiġi meħuda d-deċisjoni li tinbeda kura farmakoloġika antidepressiva (ara sezzjoni 4.2).
English: Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day administered in evenly divided doses, have been evaluated from a safety perspective in clinical trials.
Maltese: Dożi ta' aktar minn 60 mg darba kuljum, sa doża massima ta' 120 mg kuljum mogħtija f'dożi maqsumin f'partijiet ugwali, ġew valutati mill-aspett tas-sigurtà f'provi kliniċi.
English: Pollakiuria
Maltese: Iponatrimja
English: Hyponatraemia has been reported when administering ARICLAIM, including cases with serum sodium lower than 110 mmol/l.
Maltese: Meta ġie mogħti ARICLAIM, ġiet irrapportata l-iponatrimja, li inkludew każijiet ta' livell ta' sodium fi serum ta' inqas minn 110 mmol/l.
English: Hyponatraemia
Maltese: Emorraġija
English: Capsule content:
Maltese: Il-Qoxra tal-kapsula:
English: Package leaflet: information for the user ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
Maltese: ARICLAIM 30 mg kapsuli gastro-reżistenti ibsin ARICLAIM 60 mg kapsuli gastro-reżistenti ibsin
English: Tachycardia Supra-ventricular arrhythmia, mainly atrial fibrillation
Maltese: • Infjammazzjoni tal-arterji u tal-vini fil-ġilda (vaskulite kutanea) Rappurtar tal-effetti sekondarji
English: • abnormal urine odour
Maltese: Ħolm mhux normali
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules
Maltese: ARICLAIM 30 mg kapsuli gastro-reżistenti ibsin
English: Hypertension3,7 Orthostatic hypotension2 Peripheral coldness
Maltese: .7 Effetti fuq il-ħila biex issuq u tħaddem magni
English: The concomitant use of ARICLAIM with selective, reversible MAOIs, like moclobemide, is not recommended (see section 4.4).
Maltese: Mhux irrakkomandat l-użu fl-istess ħin ta' ARICLAIM ma' MAOIs riversibbli u selettivi bħal moclobemide (ara sezzjoni 4.4).
English: Musculoskeletal and connective tissue disorders
Maltese: Riġidità tal-muskoli
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules
Maltese: ARICLAIM 60 mg kapsuli gastro-reżistenti ibsin
English: Avda.
Maltese: AUCo-t .
English: Caution is advised if ARICLAIM is co-administered with medicinal products that are predominantly metabolised by CYP2D6 (risperidone, tricyclic antidepressants [TCAs] such as nortriptyline, amitriptyline, and imipramine) particularly if they have a narrow therapeutic index (such as flecainide, propafenone and metoprolol).
Maltese: Hu rrakkomandat li ARICLAIM jingħata b'attenzjoni jekk jittieħed flimkien ma' prodotti mediċinali li huma fil-biċċa l-kbira metabolizzati min CYP2D6 (risperidone, anti depressivi triċikliċi [TCAs] bħal nortriptyline, amitriptyline, u imipramine) speċjalment jekk għandhom indiċi terapewtiku dejjaq (bħal flecainide, propafenone u metoprolol).
English: There have been reports of bleeding abnormalities, such as ecchymoses, purpura and gastrointestinal haemorrhage with selective serotonin reuptake inhibitors (SSRIs) and serotonin/noradrenaline reuptake inhibitors (SNRIs), including duloxetine.
Maltese: Ġew irrappurtati fsada mhux normali, bħal ekimosi, purpura u emorraġija gastro-intestinali b'inibituri selettivi ta'ġbir mill-ġdid ta' serotonin (SSRIs) u inibituri ta' ġbir mill-ġdid ta' serotonin
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 30 mg hard gastro-resistant capsules.
Maltese: ARICLAIM 30 mg kapsuli gastro-reżistenti ibsin.
English: In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of ARICLAIM 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory (BPI) 24-hour average pain item.
Maltese: Id-doża ta' ARICLAIM li ssoltu tingħata hija ta' 60 mg darba kuljum, iżda t-tabib jiktiblek ricetta skond id-doza li tgħodd għalik.
English: Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.
Maltese: Dawn jinkludu mediċini miktuba mit-tabib tiegħek li jinkludu benzodiazepines, antidolorifiċi qawwijin, anti-psikotiċi, phenobarbital u anti-istaminiċi.
English: • throat tightness, nose bleeds
Maltese: Madankollu, it-tabib tiegħek jista' jordna ARICLAIM lil pazjenti taħt it-18
English: • blurred eyesight
Maltese: Ħedla Rogħda Parastiżja
English: Syncope2
Maltese: Treddigħ
English: Tachycardia Supra-ventricular arrhythmia,
Maltese: Kontenut tal-kapsula: Hypromellose
English: The European Medicines Agency has waived the obligation to submit the results of studies with ARICLAIM in all subsets of the paediatric population in the treatment of diabetic neuropathic pain.
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Uncommon side effects (may affect up to 1 in 100 people)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 minn kull 100)
English: • menopausal symptoms, abnormal production of breast milk in men or women
Maltese: • Meta l-Aġenzija Ewropea għall-Mediċini titlob din l-informazzjoni;
English: NAME OF THE MEDICINAL PRODUCT ARICLAIM 60 mg hard gastro-resistant capsules.
Maltese: ARICLAIM 60 mg kapsuli gastro-reżistenti ibsin.
English: Hyperprolactinae mia
Maltese: IL-PROVVISTA U L
English: * inducing a virus neutralising antibody response in chickens of ≥ 5.0 log2
Maltese: * jinduċi rispons ta' antikorpi li jinewtralizzaw il-virus fit-tiġieġ ta' ≥5.
English: Spontaneous reports
Maltese: Rapporti spontanji
English: CMDh agreement
Maltese: Ftehim tas-CMDh
English: Data from clinical trials
Maltese: Dejta minn provi kliniċi
English: • Digestive events (nausea, burning sensation and sensation of epigastric heaviness, dyspepsia),
Maltese: • Avvenimenti diġestivi (nawżja, sensazzjoni ta' ħruq u sensazzjoni ta' toqol epigastriku, dispepsja),
English: Respir Dis 1986; 69(Suppl 146):685-693 (PE10387)
Maltese: Eur J Respir Dis 1986; 69(Suppl 146):685-693 (PE10387)
English: Globally, an important proportion of cases had an outcome reported as not recovered or recovered with sequelae (489 cases out of the 2304 reported, i.e. 21.2%).
Maltese: Globalment, proporzjon importanti ta' każi kellhom eżitu rrapportat bħala li ma rkuprawx jew irkupraw b'konsegwenzi negattivi (489 każ mill-2304 irrapportata, jiġifieri 21.2%).
English: 2 Arnaud F., Bertrand A., Charpin J., Chretien J., Decroix G., Guerrin F., Kalb J.C., Lissac J., Michel F.B., Morere P.,
Maltese: 2 Arnaud F., Bertrand A., Charpin J., Chretien J., Decroix G., Guerrin F., Kalb J.C., Lissac J., Michel F.B., Morere P., Paramelle B.,
English: Paramelle B., Pariente R., Perrin-Fayolle M., Rochemaure J., Voisin C..
Maltese: B., Pariente R., Perrin-Fayolle M., Rochemaure J., Sadoul P., Voisin C.
English: 6 Marsac J. The assessment of Almitrine bismesylate in the long-term treatment of chronic obstructive bronchitis.
Maltese: The assessment of Almitrine bismesylate in the long-term treatment of chronic obstructive bronchitis.
English: Pneumology 1998 Mar;52(3):121-7 (PE24412) Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir J.F., Paramelle B., Philip-Joet F., Poirier R., Pouget J., Senant J., Tonnel A.. Sequential administration of a reduced dose of Almitrine in patients with chronic obstrutive lung disease.
Maltese: Pneumology 1998 Mar;52(3):121-7 (PE24412) 11 Weitzenblum E., Arnaud F., Bignon J., Boutin C., Brune J., Castaing Y., Courty G., Derenne J.P., Duroux P., Freour P., Muir
English: Efficacy
Maltese: III.
English: 5 Gonzales-Ruiz J.M., Villamor-Leon J., Garcia-Satue J.L., Sanchez-Agudo L., Calatrava J.M., Carreras J..
Maltese: Gonzales-Ruiz J.M., Villamor-Leon J., Garcia-Satue J.L., Sanchez-Agudo L., Calatrava J.M., Carreras J.. Treatment of chronic respiratory failure by Almitrine bismesylate.
English: The first Marketing Authorisation in the EU was granted in France on 10 December 1982.
Maltese: L-ewwel Awtorizzazzjoni għat-Tqegħid fis-suq fl-UE ngħatat fi Franza fl-10 ta' Diċembru 1982.
English: A total of 11 published clinical studies which became available after the initial Marketing Authorisation were reviewed.
Maltese: Ġew riveduti total ta' 11-il studju kliniku ppubblikati li kienu saru disponibbli wara l-Awtorizzazzjoni inizjali għat-Tqegħid fis-Suq.
English: The CMDh, having considered the PRAC recommendation dated 16 May 2013 with regards to the Almitrine containing medicinal products for oral use, agrees with the recommendation therein as stated below:
Maltese: Is-CMDh, wara li qies ir-rakkomandazzjoni tal-PRAC tas-16 ta' Mejju 2013 fir-rigward tal-prodotti mediċinali għall-użu orali li fihom l-almitrina, jaqbel mar-rakkomandazzjoni fiha kif iddikjarat hawn taħt:
English: • Respiratory events, mainly due to awareness of respiratory movements
Maltese: • Episodji respiratorji, prinċipalment minħabba l-għarfien ta' movimenti respiratorji
English: • The PRAC considered, based on the assessment of the impact of risk minimisation measures already implemented (reduction of the dose and implementation of a sequential treatment scheme) and on the published literature, that the additional risk minimisation measures proposed by the Marketing Authorisation Holder and discussed during the assessment would not be able to adequately reduce the risks of serious adverse reactions to a clinically acceptable level.
Maltese: • Il-PRAC qies, abbażi tal-valutazzjoni tal-impatt ta' miżuri għall-minimizzazzjoni tar-riskji diġà implimentati (tnaqqis fid-doża u l-implimentazzjoni ta' skema ta' kura sekwenzjali) u taddokumentazzjoni ppubblikata, li l-miżuri addizzjonali għall-minimizzazzjoni tar-riskji proposti midDetentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u diskussi matul il-valutazzjoni mhumiex se jkunu kapaċi jnaqqsu b'mod adegwat ir-riskji ta' reazzjonijiet avversi severi għal livell klinikament aċċettabbli.
English: Long-term use of almitrine bismesylate is currently recommended at a dose level of 50 to 100 mg per day with limitation of the dose at 50 mg per day in patients with body weight less than 50 kg. After 3-month treatment, maintenance therapy of the sequential type is recommended: a 1-month interval for every 2 months treatment.
Maltese: The therapeutic value and acceptability of Vectarion 50 mg coated tablets (Almitrine bismesylate) at the dose of 100 mg per day. Rev Mal Resp 1985 ; 2:S61-67 (PE10644)
English: In 50% of the cases, a neuropathy was also reported.
Maltese: F'50% tal-każi kienet ukoll irrapportata newropatija.
English: The decrease in reporting of peripheral neuropathy mentioned by the MAH, is probably mainly related to the decrease in sales over the last 10 years.
Maltese: It-tnaqqis fir-rapportar ta' newropatija periferali msemmija mill-MAH, aktarx hija prinċipalment relatata ma' tnaqqas fil-bejgħ tal-prodott matul l-aħħar 10 snin.
English: Further risk minimisation measures such as additional amendments to the product information (restriction of the indication and contra-indications), communication material (dear Health Care Professional Communication) and restricted prescription were also considered during the discussions.
Maltese: Miżuri ulterjuri għall-minimizzazzjoni tar-riskji bħal emendi addizzjonali fl-informazzjoni dwar il-prodott (restrizzjoni tal-indikazzjoni u kontraindikazzjonijiet), materjal ta' komunikazzjoni u preskrizzjoni ristretta tqiesu wkoll matul id-diskussjonijiet.
English: Effects of Almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate Hypoxaemia: A Multicentre, Randomised, Double-Blind, Placebo- Controlled Study.Resp.
Maltese: Gorecka D., Sliwinski P, Palasiewicz G, Pachocki R., Zielinski J.. Effects of Almitrine bismesylate on arterial blood gases in patients with chronic obstructive pulmonary disease and moderate Hypoxaemia: A Multicentre, Randomised, Double-Blind, Placebo- Controlled Study.
English: • The PRAC took into account the MAH's position that all the available data have been provided and that there was no possibility to provide additional data for the demonstration of the clinical benefit of oral almitrine in chronic obstructive pulmonary disease (COPD).
Maltese: • Il-PRAC qies il-pożizzjoni tal-MAH li d-dejta kollha disponibbli kienet ġiet ipprovduta u li ma kien hemmx il-possibbiltà li tiġi pprovduta dejta addizzjonali għat-turija tal-benefiċċju kliniku tal-lalmitrina orali f'mard pulmonari ostruttiv kroniku (COPD).
English: Moreover, no data is available to support any benefit of almitrine in the restrictive indication proposed by the MAH (patient with PaO2: 55 mmHg< PaO2< 65 mmHg).
Maltese: Barra minn hekk, ma hemm l-ebda dejta disponibbli li tappoġġa xi benefiċċju tal-almitrina fl-indikazzjoni ristretta proposta mill-MAH (pazjent b'PaO2: 55 mmHg< PaO2< 65 mmHg).
English: Bardsley P.A., Howard P., Tang O., Empey D., Harisson B., Peake M.D., O'Reilly J., Riordan J.F., Wilkinson J., Arnaud F., Jarratt J.A.
Maltese: Bull Eur Physiopathol Respir 1987 ; 23(suppl 11) : 169-182 (PE10837) 8 Bardsley P.A., Howard P., Tang O., Empey D., Harisson B., Peake M.D., O'Reilly J., Riordan J.F., Wilkinson J., Arnaud F., Jarratt
English: Long-term Almitrine bismesylate treatment in patients with chronic bronchitis and emphysema: a multicentre double-blind placebo controlled study.
Maltese: Almitrine bismesylate: a long-term placebo- controlled double-blind study in COAD.
English: The first trials, conducted with non-sequential treatment, account for 1670 patients (1006 following a double blind, placebo controlled design).
Maltese: Fl-ewwel provi, li saru b'kura mhux sekwenzjali, ħadu sehem 1670 pazjent (1006 segwew disinn bi blindaġġ doppju, ikkontrollat bi plaċebo).
English: Eur J Respir Dis 1983; 64(Suppl 126):323-330 (PE10377) 3 Bakran I., Vrhovac B., Stangl B., Tabori D., Ivicevic A., Todic V., Kandare F. Double- blind placebo controlled clinical trial of Almitrine bismesylate in patients with chronic respiratory insufficiency.
Maltese: Bakran I., Vrhovac B., Stangl B., Tabori D., Ivicevic A., Todic V., Kandare F. Double- blind placebo controlled clinical trial of Almitrine bismesylate in patients with chronic respiratory insufficiency.
English: Spontaneous reports of peripheral neuropathies persist even after the introduction of sequential administration scheme.
Maltese: Rapporti spontanji ta' newropatiji periferali jippersistu anke wara l-introduzzjoni ta' skema ta' għoti
English: With regards to peripheral neuropathy, a total of 2304 cases of peripheral neuropathy have been spontaneously reported in patients exposed to almitrine since the launch of the product (from 1983 to December 2012).
Maltese: Fir-rigward ta' newropatija periferali, sa mit-tnedija tal-prodott (mill-1983 sa Diċembru 2012) total ta' 2304 każi ta' newropatija periferali kienu rrapportati b'mod spontanju f'pazjenti esposti għall-almitrina.
English: Voisin C., Howard P., Ansquer J.C. Almitrine bismesylate: a long-term placebo- controlled double-blind study in COAD.
Maltese: Pariente R., Perrin-Fayolle M., Rochemaure J., Voisin C.. Long-term Almitrine bismesylate treatment in patients with chronic bronchitis and emphysema: a multicentre double-blind placebo controlled study.
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for almitrine containing products for oral administration (see Annex I).
Maltese: • Il-PRAC qies il-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE bħala riżultat tad-dejta ta' farmakoviġilanza, għal prodotti li fihom l-l-almitrina għall-għoti orali (ara Anness I).
English: The doses of 100-200 mg of almitrine continuously were associated with a higher incidence of adverse effects and withdrawals compared to placebo.
Maltese: Id-dożi ta' 100-200 mg tal-almitrina mogħtija b'mod kontinwu kienu assoċjati ma' inċidenza ogħla ta' avvenimenti avversi u rtirar apparagun mal-plaċebo.
English: Almitrine containing medicinal products for oral use are currently authorised in 3 European Member States (France, Poland and Portugal) and only marketed in France and Poland (see Annex I for the list of almitrine containing medicinal products for oral use authorised in the EU).
Maltese: Prodotti mediċinali għall-użu orali li fihom l-almitrina bħalissa huma awtorizzati fi 3 Stati Membri Ewropej (Franza, il-Polonja u l-Portugall) u mqiegħda fis-suq biss fi Franza u l-Polonja (ara l-Anness I għal-lista ta' prodotti mediċinali għall-użu orali li fihom l-almitrina awtorizzati fl-UE).
English: The PRAC noted that weight loss reported led to almitrine discontinuation in 90,9% of the cases.
Maltese: Il-PRAC innota li t-telf ta' piż irrapportat wassal għall-waqfien mit-teħid tal-almitrina f'90,9% tal-każi.
English: In published clinical studies with continuous administration1234567, peripheral neuropathies and weight loss were encountered when the study duration was longer than 3 months, indicating that the duration of continuous exposure have played a role in their development.
Maltese: Fi studji kliniċi ppubblikati b'għoti kontinwu1234567, instabu newropatiji periferali u telf ta' piż meta l-istudju kien itwal minn 3 xhur, li jindika li t-tul ta' esponiment kontinwu kellu sehem fl-iżvilupp tagħhom.
English: The PRAC noted that most cases of peripheral neuropathies reported from September 2003 to December 2012 were not recovered or recovered with sequelae.
Maltese: Il-PRAC innota li ħafna mill-każi ta' newropatiji periferali rrapportati minn Settembru 2003 sa Diċembru 2012 ma kinux irkupraw jew irkupraw b'konsegwenzi negattivi.
English: The PRAC took in account the MAH's position.
Maltese: It-tul tal-kura dam sa sentejn.