FrancophonIA/ELRC3.0 huggingface dataset:
English: Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg or 300 mg of canagliflozin.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 100 mg jew 300 mg ta' canagliflozin.
English: Janssen-Cilag S.p.A.
Maltese: Manifattur Janssen-Cilag SpA Via C.
English: If an inducer of these UGT enzymes must be co-administered with canagliflozin, increasing the dose to 300 mg once daily may be considered if patients are currently tolerating canagliflozin 100 mg once daily, have an eGFR ≥ 60 mL/min/1.73 m2 or CrCl ≥ 60 mL/min, and require additional glycaemic control.
Maltese: Jekk induttur ta' dawn l-enzimi UGT jkollu jingħata flimkien ma' canagliflozin, għandha titqies żieda fid-doża għal 300 mg darba kuljum jekk f'dak iż-żmien il-pazjenti jkunu qed jittolleraw canagliflozin 100 mg darba kuljum, ikollhom eGFR ≥ 60 mL/min/1.73 m2 jew CrCl ≥ 60 mL/min, u jkunu jeħtieġu kontroll gliċemiku addizzjonali.
English: Invokana is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:
Maltese: Invokana huwa indikat għat-trattament ta' adulti b'dijabete tat-tip 2 li mhijiex ikkontrollata b'mod suffiċjenti biex jiżdied mad-dieta u mal-eżerċizzju:
English: Change from baseline (adjusted mean) Difference from placebo (adjusted mean) (95% CI)
Maltese: Bidla mil-linja bażi (medja aġġustata) Differenza mill-plaċebo (medja aġġustata) (95% CI)
English: Canagliflozin should be discontinued when eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min (see sections 4.4, 4.8, 5.1, and 5.2).
Maltese: Canagliflozin għandu jitwqqaf meta l-eGFR jkun b'mod persistenti taħt 45 mL/min/1.73 m2 jew il-CrCl taħt 45 mL/min b'mod persistenti (ara sezzjonijiet 4.4,
English: Invokana can be used by itself or along with other medicines you may be using to treat your type 2 diabetes (such as metformin, insulin, a DPP-4 inhibitor [such as sitagliptin, saxagliptin, or linagliptin], a sulphonylurea [such as glimepiride or glipizide], or pioglitazone) that lower blood sugar levels.
Maltese: Invokana jista' jintuża waħdu jew flimkien ma' mediċini oħra li inti tista' tkun qed tuża biex tikkura ddijabete tat-tip 2 tiegħek (bħal metformin, insulina, inibitur ta' DPP-4 [bħal sitagliptin, saxagliptin, jew linagliptin], xi sulphonylurea [bħal glimepiride jew glipizide], jew pioglitazone) li jbaxxu l-livelli taz-zokkor fid-demm.
English: In patients tolerating canagliflozin 100 mg once daily who have an estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m2 or CrCl ≥ 60 mL/min and need tighter glycaemic control, the dose can be increased to 300 mg once daily orally (see below and section 4.4).
Maltese: F'pazjenti li jkunu qed jittolleraw canagliflozin 100 mg darba kuljum li għandhom rata stmata ta' filtrazzjoni mill-glomeruli (eGFR) ≥ 60 mL/min/1.73 m2 jew CrCl ≥ 60 mL/min u għandhom bżonn kontroll gliċemiku iktar strett, id-doża tista' tiżdied għal 300 mg darba kuljum mill-ħalq (ara taħt u sezzjoni 4.4).
English: Hypoglycaemia in add-on therapy with insulin or insulin secretagogues
Maltese: Glukows fil-plażma waqt is-sawm
English: Patients (%) achieving HbA1c < 7% Body weight
Maltese: Pazjenti (%) li kisbu HbA1c < 7% Piż tal-ġisem
English: The risk of lower limb amputation was not dose-dependent.
Maltese: Ir-riskju ta' amputazzjoni fir-riġel ma kienx jiddependi mid-doża.
English: Change from baseline (adjusted mean) Difference from sitagliptin (adjusted mean) (95% CI)
Maltese: Bidla mil-linja bażi (medja aġġustata) Differenza minn sitagliptin (medja aġġustata) (95% CI)
English: Canagliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in these patients (see section 5.2).
Maltese: Canagliflozin ma ġiex studjat f'pazjenti b'indebolimet qawwi tal-fwied u mhuwiex rrakkomanadat biex jintuża f'dawn il-pazjenti (ara sezzjoni 5.2).
English: Available pharmacodynamic/toxicological data in animals have shown excretion of canagliflozin/metabolites in milk, as well as pharmacologically mediated effects in breast-feeding offspring and juvenile rats exposed to canagliflozin (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' canagliflozin/metaboliti fil-ħalib, kif ukoll effetti medjati b'mod farmakoloġiku fi frieħ li qed jitreddgħu u f'firien żgħażagħ esposti għal canagliflozin (ara sezzjoni 5.3). Ir-riskju għat-trabi tattwelid/trabi ma jistax jiġi eskluż. Canagliflozin m'għandux jintuża waqt it-treddigħ.
English: Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Maltese: Dehru żidiet moderati (ġeneralment < 400 mL sa 500 mL) filvolum ta' kuljum tal-awrina li naqsu fuq perjodu ta' diversi jiem ta' għoti tad-dożi.
English: Total number of subjects with events, n
Maltese: % ta' Individwi b'Avvenimenti
English: The mean steady-state volume of distribution of canagliflozin following a single intravenous infusion in healthy subjects was 83.5 litres, suggesting extensive tissue distribution.
Maltese: Il-medja tal-volum ta' distribuzzjoni ta' canagliflozin fl-istat fiss wara infużjoni waħda fil-vina f'individwi f'saħħithom kienet 83.5 litru, li tissuġġerixxi distribuzzjoni estensiva fit-tessuti.
English: The incidence rates of all adjudicated bone fracture were 1.2 and 1.1 per 100 patient-years of follow-up to canagliflozin and control, respectively.
Maltese: Ir-rati ta' inċidenza ta' kull ksur iġġudikat fl-għadam kienu 1.2 u 1.1 għal kull 100 sena ta' segwitu ta' pazjent fuq canagliflozin u kontroll, rispettivament.
English: • if you experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat, talk to a doctor or go to the nearest hospital immediately.
Maltese: • Kellem lit-tabib tiegħek immedjatament jekk tiżviluppa taħlita ta' sintomi ta' wġigħ, sensittività, ħmura, jew nefħa tal-ġenitali jew taż-żona bejn il-ġenitali u l-anus flimkien ma' deni jew sensazzjoni li ma tiflaħx.
English: 24 June 2013 EMA/423411/2013
Maltese: 24 ta' Ġunju 2013 EMA/423411/2013
English: The review of cilostazol was initiated at the request of Spain, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' cilostazol inbdiet fuq talba ta' Spanja, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Long-term safety of cilostazol in patients with peripheral artery disease: the CASTLE study (Cilostazol: A Study in Long-term Effects).
Maltese: Hiatt WR, Money SR, Brass EP. Long-term safety of cilostazol in patients with peripheral artery disease: the CASTLE study (Cilostazol: A Study in Long-term Effects).
English: This corresponded to an absolute increase in walking distance of 87.4 metres and 43.7 metres respectively (from a baseline of about 133 metres).
Maltese: Dan jikkorrispondi għal żieda assoluta fid-distanza bil-mixi ta' 87.4 metri u 43.7 metri rispettivament (minn linja bażi ta' madwar 133 metru).
English: Cases of haemorrhage represented about 8% of the spontaneous reports.
Maltese: Każijiet ta' emorraġija irrappreżentaw madwar 8% tar-rapporti spontanji.
English: Medicines containing cilostazol have been approved in the EU through national procedures since 2000 and are available in France, Germany, Italy, Spain, Sweden and the United Kingdom under the invented names Pletal and Ekistol.
Maltese: Mediċini li fihom cilostazol ġew approvati fl-UE permezz ta' proċeduri nazzjonali sa mill-2000 u huma disponibbli fi Franza, il-Ġermanja, l-Italja, Spanja, l-Isvezja u r-Renju Unit taħt l-ismijiet ivvintati Pletal u Ekistol.
English: When a composite endpoint of cardiac morbidity (coronary and cerebrovascular events) and mortality was considered, there were 135 events with cilostazol and 153 with placebo.
Maltese: Meta lendpoint kompost ta' morbidità tal-qalb (avvenimenti koronarji u ċerebrovaskulari) u mortalità kienu kkunsidrati, kien hemm 135 avveniment bi cilostazol u 153 bil-plaċebo.
English: The most common cardiovascular events reported were palpitations and tachycardia (each about 5% of total spontaneous reports).
Maltese: L-avvenimenti kardjovaskulari l-aktar komuni rrapportati kienu palpitazzjonijiet u takikardja (kull wieħed madwar 5% tat-total tar-rapporti spontanji).
English: There were 49 deaths in the cilostazol group, of which 12 were due to cardiac disorders, and 52 in the placebo group (13 cardiac).
Maltese: Kien hemm 49 mewt fil-grupp ta' cilostazol, li minnhom 12 kienu dovuti għal disturbi kardijaċi, u 52 fil-grupp tal-plaċebo (13 kardijaċi).
English: • Long-term cardiovascular safety of cilostazol was examined post-marketing in the CASTLE study1, a randomised double-blind placebo controlled study involving 1,439 patients given cilostazol 100 mg twice daily (reduced to 50 mg twice daily if necessary) or placebo.
Maltese: • Is-sigurtà kardjovaskulari fit-tul ta' cilostazol ġiet eżaminata wara t-tqegħid fis-suq fl-istudju CASTLE1, studju każwali bi blindaġġ doppju kkontrollat bi plaċebo li fih ħadu sehem 1,439 pazjent li ngħataw cilostazol 100 mg darbtejn kuljum (imnaqqas għal 50 mg darbtejn kuljum jekk meħtieġ) jew plaċebo.
English: • Cilostazol has been shown to produce modest increases in walking distance compared with placebo; meta-analysis of pooled individual patient data from nine efficacy trials involving 3,122 patients indicated a mean percentage increase from baseline of 59.4% for cilostazol, compared with 24.3% for placebo.
Maltese: • Cilostazol intwera li jipproduċi żidiet żgħar fid-distanza bil-mixi meta mqabbel ma' plaċebo; metaanaliżi ta' dejta miġbura minn pazjenti individwali minn disa' provi ta' effikaċja li fihom ħadu sehem 3,122 pazjent indikat żieda perċentwali medja mil-linja bażi ta' 59.4% għal cilostazol, meta mqabbel ma' 24.3% għall-plaċebo.
English: The trial, which examined all-cause mortality as a primary endpoint, was terminated early (after about 3 years) because of a high drop-out rate in both groups (397 out of 721 cilostazol patients and 391 out of 718 patients taking placebo) and because of a much lower mortality rate than expected.
Maltese: Il-prova, li eżaminat kull kawża ta' mortalità bħala l-endpoint primarju, twaqqfet kmieni (wara madwar 3 snin) minħabba r-rata għolja ta' persuni li telqu mill-prova fiż-żewġ gruppi (397 minn 721 pazjent li ħadu cilostazol u 391 minn 718-il pazjent li ħadu plaċebo) u minħabba rata ta' mortalità ferm anqas baxxa milli mistenni.
English: The CHMP examined available clinical trial data on the benefits and risks of the medicines provided by the companies that market these medicines, as well as data from scientific literature, reports of suspected side effects, post-marketing studies and experimental studies before making its recommendations.
Maltese: Is-CHMP eżamina dejta minn prova klinika disponibbli dwar il-benefiċċji u r-riskji tal-mediċini pprovduti mill-kumpaniji li jqiegħdu dawn il-mediċini fis-suq, kif ukoll dejta minn letteratura xjentifika, rapporti ta' suspetti ta' effetti sekondarji, studji ta' wara t-tqegħid fis-suq u studji sperimentali qabel ma għamel ir-rakkomandazzjonijiet tiegħu.
English: • Safety data from nearly 14,000 suspected adverse drug reaction reports (in the context of over 6 million patient years' exposure worldwide) and 4,000 events in non-interventional studies confirmed the known adverse effect profile of cilostazol from clinical trials.
Maltese: • Dejta ta' sigurtà minn kważi 14,000 rapport ta' suspetti ta' reazzjonijiet avversi għall-mediċina (filkuntest ta' esponiment ta' aktar minn 6 miljun sena ta' pazjenti madwar id-dinja) u 4,000 avveniment fi studji mhux ta' intervent ikkonfermat il-profil magħruf tal-effett avvers ta' cilostazol minn provi kliniċi.
English: Hiatt WR, Money SR, Brass EP.
Maltese: Aktar tagħrif dwar il-valutazzjoni:
English: On 22 March 2013 the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) recommended that the use of cilostazol-containing medicines in the treatment of intermittent claudication - a condition where poor blood supply to the leg muscles causes pain and affects the ability to walk - should be restricted with a range of new measures aimed at targeting a patient population in which there are clinical benefits, and at the same time minimising important risks.
Maltese: Fit-22 ta' Marzu 2013 il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija Ewropea għall-Mediċini rrakkomanda li l-użu ta' mediċini li fihom cilostazol fil-kura ta' klawdikazzjoni intermittenti - kundizzjoni fejn provvista baxxa ta' demm lill-muskoli tas-saqajn tikkawża uġigħ u taffettwa l-kapaċità tal-mixi- għandu jiġi ristrett b'firxa ta' miżuri ġodda bil-għan li tiġi mmirata popolazzjoni ta' pazjenti li fuqhom ikun hemm benefiċċji kliniċi, u fl-istess ħin jiġu minimizzati riskji importanti.
English: Cilostazol-containing medicines are available in the EU under the names Pletal and Ekistol.
Maltese: Mediċini li fihom cilostazol huma disponibbli fl-UE taħt l-ismijiet Pletal u Ekistol.
English: For the full changes to information for doctors and patients, see under the ‘All documents' tab.
Maltese: Għat-tibdil sħiħ lill-informazzjoni għat-tobba u l-pazjenti, ara taħt it-tab ‘Dokumenti kollha'.
English: In addition, cilostazol-containing medicines should not be used in patients who have suffered severe tachyarrhythmia (fast, abnormal heart rhythm), or recent unstable angina, heart attack or bypass surgery, or who take two or more antiplatelet or anticoagulant medicines such as aspirin and clopidogrel.
Maltese: Barra minn hekk, mediċini li fihom cilostazol m'għandhomx jintużaw fuq pazjenti li jkunu sofrew takiarritmija severa (ritmu mgħaġġel, anormali tal-qalb), jew anġina instabbli, attakk tal-qalb jew kirurġija talbajpass reċenti, jew li jieħdu żewġ mediċini jew aktar kontra l-plejtlits jew mediċini antikoagulanti bħal aspirina u clopidogrel.
English: Cilostazol works by blocking an enzyme called phosphodiesterase type 3, which is found in the walls of arteries and is involved in various processes affecting circulation, including aggregation (clumping together) of blood platelets and narrowing of the arteries.
Maltese: Cilostazol jaħdem billi jimblokka enzima magħrufa bħala phosphodiesterase tat-tip 3, li tinsab fil-ħitan tal-arterji u hija nvoluta fil-proċessi varji li jaffetwaw iċ-ċirkolazzjoni, inkluż aggregazzjoni (tagħqid flimkien) tal-plejtlits tad-demm u tidjiq tal-arterji.
English: Treatment should be stopped in patients who have not shown clinically relevant benefit.
Maltese: Il-kura għandha titwaqqaf f'pazjenti li ma jkunux urew benefiċċju klinikament rilevanti.
English: The CHMP recommendation was sent to the European Commission which endorsed it and adopted a legally-binding decision throughout the European Union (EU) on 24 June 2013.
Maltese: Ir-rakkomandazzjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea li approvatha u adottat deċiżjoni legalment vinkolanti fl-Unjoni Ewropea (UE) kollha fl-24 ta' Ġunju 2013.
English: CHMP concluded that the magnitude of benefit was clinically important in a subgroup of patients, and that response can be adequately assessed after three months of treatment.
Maltese: Is-CHMP ikkonkluda li d-daqs tal-benefiċċju kien klinikament importanti f'sottogrupp ta' pazjenti, u li rrispons jista' jiġi stmat adegwatament wara tliet xhur ta' kura.
English: • The Agency has recommended some restrictions on the use of cilostazol.
Maltese: • L-Aġenzija rrakkomandat xi restrizzjonijiet dwar l-użu ta' cilostazol.
English: Cilostazol is a medicine that is used to improve walking distance in patients who have intermittent claudication due to peripheral arterial obstructive disease (obstruction and narrowing of the arteries of the limbs, leading to reduced blood flow).
Maltese: Cilostazol hija mediċina li tintuża biex ittejjeb id-distanza bil-mixi f'pazjenti bi klawdikazzjoni intermittenti minħabba mard arterjali periferali ostruttiv (imblukkar u tidjiq tal-arterji tal-riġlejn, li jwassal għal tnaqqis fil-fluss tad-demm).
English: Although suspected adverse drug reaction reports have raised some safety concerns, these have not been substantiated in the clinical trial data (including the CASTLE study), and it remains possible to exclude high-risk patients in clinical practice.
Maltese: Għalkemm ir-rapporti ta' suspetti ta' reazzjonijiet avversi tal-mediċina qajmu xi tħassib dwar is-sigurtà, dawn ma ġewx issostanzjati fid-dejta mill-provi kliniċi (inkluż l-istudju CASTLE), u jibqa' possibbli li fil-prattika klinika jiġu esklużi pazjenti f'riskju għoli.
English: • Cilostazol should only be used for intermittent claudication when lifestyle changes (including smoking cessation and exercise programmes) and other appropriate interventions alone have not produced adequate benefit.
Maltese: • Cilostazol għandu jintuża biss għal klawdikazzjoni intermittenti meta jsir tibdil fl-istil tal-ħajja (inkluż waqfien mit-tipjip u programmi ta' eżerċizzju) u interventi adegwati oħra weħidhom ma jkunux ipproduċew benefiċċju adegwat.
English: • Analysis of available data suggests an increased risk of haemorrhage when cilostazol is given to patients also taking both aspirin and clopidogrel.
Maltese: • Analiżi tad-dejta disponibbli tissuġġerixxi żieda fir-riskju ta' emorraġija meta cilostazol jingħata lil pazjenti li wkoll ikunu qed jieħdu kemm aspirina kif ukoll clopidogrel.
English: • Prescribers should be aware of the risk of interactions with cilostazol; its dose should be reduced in patients also taking strong inhibitors of CYP3A4 or CYP2C19.
Maltese: • Min jippreskrivi għandu jkun konxju tar-riskju ta' interazzjonijiet ma' cilostazol; id-doża tiegħu għandha titnaqqas f'pazjenti li jkunu qed jieħdu wkoll inibituri qawwija ta' CYP3A4 jew ta' CYP2C19.
English: The CHMP opinion was forwarded to the European Commission, which issued a final decision endorsing the opinion on 24 June 2013.
Maltese: L-opinjoni tas-CHMP ġiet mgħoddija lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali li tapprova lopinjoni fl-24 ta' Ġunju 2013.
English: More information on the studies and the CHMP's conclusions is available below.
Maltese: Aktar informazzjoni dwar l-istudji u l-konklużjonijiet tas-CHMP hija disponibbli hawn taħt.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/16/1137/001 Granpidam 20 mg Film-coated tablet
Maltese: Isem (ivvintat) Qawwa Għamla farmaċewtika Mnejn għandu jingħata Il-pakkett li jmiss malprodott
English: Eλλάδα ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ ΕΠΕ
Maltese: Eλλάδα ΣΕΡΒΙΕ ΕΛΛΑΣ ΦΑΡΜΑΚΕΥΤΙΚΗ
English: Ethnic groups
Maltese: Gruppi etniċi
English: Absorption and bioavailability
Maltese: Assorbiment u biodisponibilità
English: Hypromellose Yellow iron oxide (E172) Glycerol
Maltese: Hypromellose Iron oxide isfar (E172) Glycerol
English: Mania/hypomania*
Maltese: Manija/ipomanija*
English: Bipolar disorder/ mania / hypomania
Maltese: Disturb bipolari/manija/ipomanija
English: Date of latest renewal : 12 December 2018
Maltese: Data tal-aħħar tiġdid: 12 ta' Diċembru 2018
English: Lactose intolerance
Maltese: Intolleranza tal-lactose
English: • lactose monohydrate, maize starch, povidone (K30), sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica,hypromellose, glycerol, macrogol (6000), yellow iron oxide (E172) and titanium dioxide (E171).
Maltese: • lactose monohydrate, maize starch, povidone (K30), sodium starch glycolate type A, stearic acid, magnesium stearate, colloidal anhydrous silica, hypromellose, glycerol, macrogol (6000), iron oxide isfar (E172), titanium dioxide (E171).
English: Electroconvulsive therapy (ECT)
Maltese: Kura elettrokonvulsiva (ECT)
English: INFORMATION IN BRAILLE Valdoxan 25 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Valdoxan 25 mg
English: EU/1/08/499/002 EU/1/08/499/003 EU/1/08/499/005 EU/1/08/499/006 EU/1/08/499/007 EU/1/08/499/008
Maltese: EU/1/08/499/002 EU/1/08/499/003 EU/1/08/499/005
English: [EU/1/08/499/002] 14 film-coated tablets [EU/1/08/499/003] 28 film-coated tablets [EU/1/08/499/005] 56 film-coated tablets [EU/1/08/499/006] 84 film-coated tablets [EU/1/08/499/007] 98 film-coated tablets [EU/1/08/499/008] 100 film-coated tablets
Maltese: [EU/1/08/499/002] 14-il pillola miksija b'rita [EU/1/08/499/003] 28 pillola miksija b'rita [EU/1/08/499/005] 56 pillola miksija b'rita [EU/1/08/499/006] 84 pillola miksija b'rita [EU/1/08/499/007] 98 pillola miksija b'rita [EU/1/08/499/008] 100 pillola miksija b'rita
English: Kinetics are not modified after repeated administration.
Maltese: Il-kinetika mhijiex immodifikata wara amministrazzjoni ripetuta.
English: Agomelatine is metabolised mainly by cytochrome P450 1A2 (CYP1A2) (90%) and by CYP2C9/19 (10%).
Maltese: Agomelatine jiġi metabolizzat l-iżjed biċ-ċitokromu P450 1A2 (CYP1A2) (90%) u b'CYP2C9/19 (10%).
English: Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist.
Maltese: Agomelatine huwa agonist melatonerġiku (riċetturi MT1 u MT2) u antagonist 5-HT2C.
English: Increased gamma-glutamyltransferase* (GGT)(>3 times the upper limit of the normal range
Maltese: Żieda fil-gamma-glutamyltransferase* (GGT) (>3 darbiet mill-ogħla limitu tal-firxa normali)
English: Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, France Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co. Wicklow, Ireland Przedsiebiorstwo Farmaceutyczne ANPHARM S.A., ul.
Maltese: Les Laboratoires Servier Industrie, 905, route de Saran - 45520 Gidy, Franza Servier (Ireland) Industries Ltd, Gorey Road - Arklow - Co.
English: Arklow - Co. Wicklow - Ireland
Maltese: Wicklow L-Irlanda
English: • printing ink : shellac, propylene glycol and indigo carmine aluminium lake (E132)
Maltese: • linka stampata: shellac, propylene glycol, indigo carmine aluminium lake (E132)
English: 92284 Suresnes cedex - France
Maltese: Suresnes cedex Franza
English: Packs contain 14, 28, 56, 84 or 98 tablets.
Maltese: Il-pakketti fihom 14, 28, 56, 84
English: Valdoxan is indicated for the treatment of major depressive episodes in adults.
Maltese: Valdoxan huwa indikat għall-kura ta' episodji dipressivi maġġuri f'adulti.
English: - if you are a young adult.
Maltese: - jekk int adult żagħżugħ.
English: • Information about the risk of hepatic reactions and clinical signs of liver problems
Maltese: • Informazzjoni dwar ir-riskju ta' reazzjonijiet epatiċi u sinjali kliniċi ta' problemi tal-fwied
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita 84 pillola miksija b'rita 98 pillola miksija b'rita 100 pillola miksija b'rita
English: There is no data on the influence of race on agomelatine pharmacokinetics.
Maltese: M'hemmx informazzjoni fuq l-influwenza ta' razza fuq il-farmakokinetika t'agomelatine.
English: Absolute bioavailability is low (< 5% at the therapeutic oral dose) and the interindividual variability is substantial.
Maltese: Bijodisponibilità assoluta hija baxxa (< 5% tad-doża orali terapewtika) u l-varjabilità interindividwali hija sostanzjali.
English: Tabulated list of adverse reactions
Maltese: Il-lista tabulata ta' reazzjonijiet avversi
English: Valdoxan contains sodium
Maltese: Valdoxan fih sodium
English: Valdoxan is used in adults.
Maltese: Valdoxan jintuża fl-adulti.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, id-defiċjenzja ta'
English: How to switch from an antidepressant medicine (SSRI/SNRI) to Valdoxan?
Maltese: Kif taqleb minn mediċina antidipressanti (SSRI/SNRI) għal Valdoxan?
English: What Valdoxan contains - The active substance is agomelatine.
Maltese: X'fih Valdoxan - Is-sustanza attiva hi agomelatine.
English: Printing ink containing shellac, propylene glycol and indigo carmine aluminium lake (E132).
Maltese: Linka tal-istampar li fiha shellac, propylene glycol u indigo carmine aluminium lake (E132).